[Federal Register Volume 86, Number 221 (Friday, November 19, 2021)]
[Rules and Regulations]
[Pages 64996-66031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23972]



[[Page 64995]]

Vol. 86

Friday,

No. 221

November 19, 2021

Part II





 Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 403, 405, 410, et al.





Medicare Program; CY 2022 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Provider Enrollment Regulation Updates; 
and Provider and Supplier Prepayment and Post-Payment Medical Review 
Requirements; Final Rule

  Federal Register / Vol. 86 , No. 221 / Friday, November 19, 2021 / 
Rules and Regulations  

[[Page 64996]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 403, 405, 410, 411, 414, 415, 423, 424, and 425

[CMS-1751-F]
RIN 0938-AU42


Medicare Program; CY 2022 Payment Policies Under the Physician 
Fee Schedule and Other Changes to Part B Payment Policies; Medicare 
Shared Savings Program Requirements; Provider Enrollment Regulation 
Updates; and Provider and Supplier Prepayment and Post-Payment Medical 
Review Requirements

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

ACTION: Final rule.

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SUMMARY: This major final rule addresses: Changes to the physician fee 
schedule (PFS); other changes to Medicare Part B payment policies to 
ensure that payment systems are updated to reflect changes in medical 
practice, relative value of services, and changes in the statute; 
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 
provider enrollment policies; requirements for prepayment and post-
payment medical review activities; requirement for electronic 
prescribing for controlled substances for a covered Part D drug under a 
prescription drug plan, or a Medicare Advantage Prescription Drug (MA-
PD) plan; updates to the Medicare Ground Ambulance Data Collection 
System; changes to the Medicare Diabetes Prevention Program (MDPP) 
expanded model; and amendments to the physician self-referral law 
regulations.

DATES: These regulations are effective on January 1, 2022.

FOR FURTHER INFORMATION CONTACT: 
[email protected], for any issues not 
identified below.
    Michael Soracoe, (410) 786-6312, or 
[email protected], for issues related to 
practice expense, work RVUs, conversion factor, and PFS specialty-
specific impacts.
    Larry Chan, (410) 786-6864, for issues related to potentially 
misvalued services under the PFS.
    Patrick Sartini, (410) 786-9252, and Larry Chan, (410) 786-6864, 
for issues related to telehealth services and other services involving 
communications technology.
    Julie Adams, (410) 786-8932, for issues related to payment for 
anesthesia services.
    Sarah Leipnik, (410) 786-3933, or 
[email protected], for issues related to split 
(or shared) services.
    Michelle Cruse, (410) 786-7540, and Michael Konieczny, (410) 786-
0825, for issues related to payment for vaccine administration 
services.
    Regina Walker-Wren, (410) 786-9160, for issues related to billing 
for services of physician assistants and PFS payment for teaching 
physician services.
    Pamela West, (410) 786-2302, for issues related to PFS payment for 
therapy services, medical nutrition therapy services, and services of 
registered dietitians and nutrition professionals.
    Liane Grayson, (410) 786-6583, for issues related to coinsurance 
for certain colorectal cancer screening services and PFS payment for 
critical care services.
    Lisa Parker, (410) 786-4949, and Michele Franklin, (410) 786-9226, 
for issues related to RHCs and FQHCs.
    Laura Kennedy, (410) 786-3377, for issues related to drugs payable 
under Part B.
    Heather Hostetler, (410) 786-4515, and Elizabeth Truong, 410-786-
6005, for issues related to removal of selected national coverage 
determinations.
    Sarah Fulton, (410) 786-2749, for issues related to Appropriate Use 
Criteria for Advanced Diagnostic Imaging (AUC); and Pulmonary 
Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac 
Rehabilitation.
    Rachel Katonak, (410) 786-8564, for issues related to Medical 
Nutrition Therapy.
    Sabrina Ahmed, (410) 786-7499, for issues related to the Medicare 
Shared Savings Program (Shared Savings Program) quality reporting 
requirements and quality performance standard.
    Janae James, (410) 786-0801, Elizabeth November, (410) 786-4518, or 
[email protected], for issues related to Shared Savings 
Program beneficiary assignment, repayment mechanism requirements, and 
benchmarking methodology.
    Naseem Tarmohamed, (410) 786-0814, or 
[email protected], for inquiries related to Shared 
Savings Program application, compliance and beneficiary notification 
requirements.
    Amy Gruber, [email protected], for issues related 
to the Medicare Ground Ambulance Data Collection System.
    Juliana Tiongson, (410) 786-0342, for issues related to the 
Medicare Diabetes Prevention Program (MDPP).
    Laura Ashbaugh, (410) 786-1113, for issues related to Clinical 
Laboratory Fee Schedule: Laboratory Specimen Collection and Travel 
Allowance and Use of Electronic Travel Logs.
    Frank Whelan, (410) 786-1302, for issues related to Medicare 
provider enrollment regulation updates.
    Katie Mucklow, (410) 786-0537, for issues related to provider and 
supplier prepayment and post-payment medical review requirements.
    Lindsey Baldwin, (410) 786-1694, and Michele Franklin, (410) 786-
9226, for issues related to Medicare coverage of opioid use disorder 
treatment services furnished by opioid treatment programs.
    Lisa O. Wilson, (410) 786-8852, or Meredith Larson, (410) 786-7923, 
for inquiries related to the physician self-referral law.
    Joella Roland, (410) 786-7638, 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.
    Kathleen Ott, (410) 786-4246, for issues related to open payments.
    Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
    Brittany LaCouture, (410) 786-0481, for inquiries related to 
Alternative Payment Models (APMs).

SUPPLEMENTARY INFORMATION:
    Addenda Available Only Through the Internet on the CMS Website: The 
PFS Addenda along with other supporting documents and tables referenced 
in this final rule are available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/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 
2022 PFS final rule, refer to item CMS-1751-F. Readers with questions 
related to accessing any of the Addenda or other supporting documents 
referenced in this final rule and posted on the CMS website identified 
above should contact [email protected].
    CPT (Current Procedural Terminology) Copyright Notice:

[[Page 64997]]

Throughout this final rule, we use CPT codes and descriptions to refer 
to a variety of services. We note that CPT codes and descriptions are 
copyright 2020 American Medical Association. All Rights Reserved. CPT 
is a registered trademark of the American Medical Association (AMA). 
Applicable Federal Acquisition Regulations (FAR) and Defense Federal 
Acquisition Regulations (DFAR) apply.

I. Executive Summary

    This major final rule revises payment polices under the Medicare 
PFS and makes other policy changes, including to the implementation of 
certain provisions of the Consolidated Appropriations Act, 2021 (CAA, 
2021) (Pub. L. 116-260, December 27, 2020), Bipartisan Budget Act of 
2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018) and the 
Substance Use-Disorder Prevention that Promotes Opioid Recovery and 
Treatment for Patients and Communities Act (SUPPORT Act) (Pub. L. 115-
271, October 24, 2018), related to Medicare Part B payment. In 
addition, this major final rule includes revisions to other Medicare 
payment policies described in sections III. and IV.

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 we establish each year by regulation the payment 
amounts for physicians' services paid under the PFS, including 
geographic adjustments to reflect the variations in the costs of 
furnishing services in different geographic areas.
    In this major final rule, we are establishing RVUs for CY 2022 for 
the PFS to ensure that our payment systems are updated to reflect 
changes in medical practice and the relative value of services, as well 
as changes in the statute. This final rule also includes discussions 
and provisions regarding several other Medicare Part B payment 
policies.
    Specifically, this final rule addresses:

 Practice Expense RVUs (section II.B.)
 Potentially Misvalued Services Under the PFS (section II.C.)
 Telehealth and Other Services Involving Communications 
Technology (section II.D.)
 Valuation of Specific Codes (section II.E.)
 Evaluation and Management Visits (section II.F.)
 Billing for Physician Assistant Services (section II.G.)
 Therapy Services (section II.H.)
 Changes to Beneficiary Coinsurance for Additional Procedures 
Furnished During the Same Clinical Encounter as Certain Colorectal 
Cancer Screening Tests (section II.I.)
 Vaccine Administration Services (section II.J.)
 Payment for Medical Nutrition Therapy Services and Related 
Services (section II.K.)
 Rural Health Clinics (RHCs) and Federally Qualified Health 
Centers (FQHCs) (sections III.A., III.B., and III.C.)
 Requiring Certain Manufacturers to Report Drug Pricing 
Information for Part B and Determination of ASP for Certain Self-
administered Drug Products (sections III.D.1. and 2.)
 Medicare Part B Drug Payment for Drugs Approved under Section 
505(b)(2) of the Federal Food, Drug, & Cosmetic Act (section III.E.)
 Appropriate Use Criteria for Advanced Diagnostic Imaging 
(section III.F.)
 Removal of Selected National Coverage Determinations (section 
III.G.)
 Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive 
Cardiac Rehabilitation (section III.H.)
 Medical Nutrition Therapy (section III.I.)
 Medicare Shared Savings Program (section III.J.)
 Medicare Ground Ambulance Data Collection System (section 
III.K.)
 Medicare Diabetes Prevention Program (MDPP) (section III.L.)
 Clinical Laboratory Fee Schedule: Laboratory Specimen 
Collection and Travel Allowance for Clinical Diagnostic Laboratory 
Tests and Use of Electronic Travel Logs (section III.M.)
 Medicare Provider and Supplier Enrollment Changes (section 
III.N.1.)
 Provider/Supplier Medical Review Requirements: Addition of 
Provider/Supplier Requirements related to Prepayment and Post-payment 
Reviews (section III.N.2.)
 Modifications Related to Medicare Coverage for Opioid Use 
Disorder (OUD) Treatment Services Furnished by Opioid Treatment 
Programs (OTPs) (section III.O.)
 Updates to the Physician Self-Referral Regulations (section 
III.P.)
 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.Q.)
 Open Payments (section III.R.)
 Updates to the Quality Payment Program (section IV.)
 Collection of Information Requirements (section V.)
 Regulatory Impact Analysis (section VI.)
3. Summary of Costs and Benefits
    We have determined that this final rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VI., Regulatory Impact Analysis, of this final rule.

II. Summary of the Proposed Provisions, Analysis of and Response to 
Public Comments, and the Provisions of the Final Rule for the PFS

A. Background

    Since January 1, 1992, Medicare has paid for physicians' services 
under section 1848 of the Social Security Act (the Act), ``Payment for 
Physicians' Services.'' 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 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 payment for physicians' 
services.
    We note that throughout this final rule, unless otherwise noted, 
the term ``practitioner'' is used to describe both physicians and 
nonphysician practitioners (NPPs) who are permitted to bill Medicare 
under the PFS for the services they furnish to Medicare beneficiaries.
1. Development of the RVUs
a. Work RVUs
    The work RVUs established for the initial fee schedule, which was 
implemented on January 1, 1992, were developed with extensive input 
from the physician community. A research team at the Harvard School of 
Public Health developed the original work RVUs for most codes under a 
cooperative agreement with the Department of Health and Human Services 
(HHS). In constructing the code-specific vignettes used in

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determining the original physician work RVUs, Harvard worked with 
panels of experts, both inside and outside the Federal Government, and 
obtained input from numerous physician specialty groups.
    As specified in section 1848(c)(1)(A) of the Act, the work 
component of physicians' services means the portion of the resources 
used in furnishing the service that reflects physician time and 
intensity. We establish work RVUs for new, revised and potentially 
misvalued codes based on our review of information that generally 
includes, but is not limited to, recommendations received from the 
American Medical Association/Specialty Society Relative Value Scale 
Update Committee (RUC), the Health Care Professionals Advisory 
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), 
and other public commenters; medical literature and comparative 
databases; as well as a comparison of the work for other codes within 
the Medicare PFS, and consultation with other physicians and health 
care professionals within CMS and the Federal Government. 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 their 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, crosswalk to key reference or similar 
codes, and magnitude estimation. More information on these issues is 
available in that rule.
b. Practice Expense RVUs
    Initially, only the work RVUs were resource-based, and the PE and 
MP RVUs were based on average allowable charges. Section 121 of the 
Social Security Act Amendments of 1994 (Pub. L. 103-432, October 31, 
1994), amended by section 1848(c)(2)(C)(ii) of the Act and required us 
to develop resource-based PE RVUs for each physicians' service 
beginning in 1998. We were required to consider general categories of 
expenses (such as office rent and wages of personnel, but excluding MP 
expenses) comprising PEs. The PE RVUs continue to represent the portion 
of these resources involved in furnishing PFS services.
    Originally, the resource-based method was to be used beginning in 
1998, but section 4505(a) of the Balanced Budget Act of 1997 (BBA `97) 
(Pub. L. 105-33, August 5, 1997) delayed implementation of the 
resource-based PE RVU system until January 1, 1999. In addition, 
section 4505(b) of the BBA `97 provided for a 4-year transition period 
from the charge-based PE RVUs to the resource-based PE RVUs.
    We established the resource-based PE RVUs for each physicians' 
service in the November 2, 1998 final rule (63 FR 58814), effective for 
services furnished in CY 1999. Based on the requirement to transition 
to a resource-based system for PE over a 4-year period, payment rates 
were not fully based upon resource-based PE RVUs until CY 2002. This 
resource-based system was based on two significant sources of actual PE 
data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's 
Socioeconomic Monitoring System (SMS) data. These data sources are 
described in greater detail in the CY 2012 PFS final rule with comment 
period (76 FR 73033).
    Separate PE RVUs are established for services furnished in facility 
settings, such as a hospital outpatient department (HOPD) or an 
ambulatory surgical center (ASC), and in nonfacility settings, such as 
a physician's office. The nonfacility RVUs reflect all of the direct 
and indirect PEs involved in furnishing a service described by a 
particular HCPCS code. The difference, if any, in these PE RVUs 
generally results in a higher payment in the nonfacility setting 
because in the facility settings some resource costs are borne by the 
facility. Medicare's payment to the facility (such as the outpatient 
prospective payment system (OPPS) payment to the HOPD) would reflect 
costs typically incurred by the facility. Thus, payment associated with 
those specific facility resource costs is not made under the PFS.
    Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) 
(Pub. L. 106-113, November 29, 1999) directed the Secretary of Health 
and Human Services (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. On May 3, 2000, we published the interim final rule 
(65 FR 25664) that set forth the criteria for the submission of these 
supplemental PE survey data. The criteria were modified in response to 
comments received, and published in the Federal Register (65 FR 65376) 
as part of a November 1, 2000 final rule. The PFS final rules published 
in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended 
the period during which we would accept these supplemental data through 
March 1, 2005.
    In the CY 2007 PFS final rule with comment period (71 FR 69624), we 
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for 
CY 2010. In the CY 2010 PFS final rule with comment period, we updated 
the practice expense per hour (PE/HR) data that are used in the 
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, 
we began a 4-year transition to the new PE RVUs using the updated PE/HR 
data, which was completed for CY 2013.
c. Malpractice RVUs
    Section 4505(f) of the BBA `97 amended section 1848(c) of the Act 
to require that we implement resource-based MP RVUs for services 
furnished on or after CY 2000. The resource-based MP RVUs were 
implemented in the PFS final rule with comment period published 
November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and 
physician-owned insurers' MP insurance premium data from all the 
States, the District of Columbia, and Puerto Rico.
d. Refinements to the RVUs
    Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no 
less often than every 5 years. Prior to CY 2013, we conducted periodic 
reviews of work RVUs and PE RVUs independently from one another. We 
completed 5-year reviews of work RVUs that were effective for calendar 
years 1997, 2002, 2007, and 2012.
    Although refinements to the direct PE inputs initially relied 
heavily on input from the RUC Practice Expense Advisory Committee 
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to 
the use of the updated PE/HR data in CY 2010 have resulted in 
significant refinements to the PE RVUs in recent years.
    In the CY 2012 PFS final rule with comment period (76 FR 73057), we 
finalized a proposal to consolidate reviews of work and PE RVUs under 
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued 
codes under section 1848(c)(2)(K) of the Act into one annual process.
    In addition to the 5-year reviews, beginning for CY 2009, CMS and 
the RUC identified and reviewed a number of potentially misvalued codes 
on an annual basis based on various identification screens. This annual 
review of work and PE RVUs for

[[Page 64999]]

potentially misvalued codes was supplemented by the amendments to 
section 1848 of the Act, as enacted by section 3134 of the Affordable 
Care Act, that require the agency to periodically identify, review and 
adjust values for potentially misvalued codes.
e. Application of BN to Adjustments of RVUs
    As described in section VI. of this final rule, the Regulatory 
Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of 
the Act, if revisions to the RVUs cause expenditures for the year to 
change by more than $20 million, we make adjustments to ensure that 
expenditures do not increase or decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
    To calculate the payment for each service, the components of the 
fee schedule (work, PE, and MP RVUs) are adjusted by geographic 
practice cost indices (GPCIs) to reflect the variations in the costs of 
furnishing the services. The GPCIs reflect the relative costs of work, 
PE, and MP in an area compared to the national average costs for each 
component. Please refer to the CY 2020 PFS final rule for a discussion 
of the last GPCI update (84 FR 62615 through 62623).
    RVUs are converted to dollar amounts through the application of a 
CF, which is calculated based on a statutory formula by CMS' Office of 
the Actuary (OACT). The formula for calculating the Medicare PFS 
payment amount for a given service and fee schedule area can be 
expressed as:

Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI 
MP)] x CF
3. Separate Fee Schedule Methodology for Anesthesia Services
    Section 1848(b)(2)(B) of the Act specifies that the fee schedule 
amounts for anesthesia services are to be based on a uniform relative 
value guide, with appropriate adjustment of an anesthesia CF, in a 
manner to ensure that fee schedule amounts for anesthesia services are 
consistent with those for other services of comparable value. 
Therefore, there is a separate fee schedule methodology for anesthesia 
services. Specifically, we establish a separate CF for anesthesia 
services and we utilize the uniform relative value guide, or base 
units, as well as time units, to calculate the fee schedule amounts for 
anesthesia services. Since anesthesia services are not valued using 
RVUs, a separate methodology for locality adjustments is also 
necessary. This involves an adjustment to the national anesthesia CF 
for each payment locality.

B. Determination of PE RVUs

1. Overview
    Practice expense (PE) is the portion of the resources used in 
furnishing a service that reflects the general categories of physician 
and practitioner expenses, such as office rent and personnel wages, but 
excluding 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 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 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 CY 2007 PFS proposed 
notice (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 
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the 
Physician Practice Expense 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.

[[Page 65000]]

    Consistent with our past practice, the previous indirect PE/HR 
values from the supplemental surveys for these specialties were updated 
to CY 2006 using the Medicare Economic Index (MEI) to put them on a 
comparable basis with the PPIS data.
    We also do not use the PPIS data for reproductive endocrinology and 
spine surgery since these specialties currently are not separately 
recognized by Medicare, nor do we have a method to blend the PPIS data 
with Medicare-recognized specialty data.
    Previously, we established PE/HR values for various specialties 
without SMS or supplemental survey data by crosswalking them to other 
similar specialties to estimate a proxy PE/HR. For specialties that 
were part of the PPIS for which we previously used a crosswalked PE/HR, 
we instead used the PPIS-based PE/HR. We use crosswalks for specialties 
that did not participate in the PPIS. These crosswalks have been 
generally established through notice and comment rulemaking and are 
available in the file titled ``CY 2022 PFS final rule PE/HR'' on the 
CMS website under downloads for the CY 2022 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html.
    For CY 2022, we have incorporated the available utilization data 
for two new specialties, each of which became a recognized Medicare 
specialty during 2020. These specialties are Micrographic Dermatologic 
Surgery (MDS) and Adult Congenital Heart Disease (ACHD). We proposed to 
use proxy PE/HR values for these new specialties, as there are no PPIS 
data for these specialties, by crosswalking the PE/HR as follows from 
specialties that furnish similar services in the Medicare claims data:

 Micrographic Dermatologic Surgery (MDS) from Dermatology; and
 Adult Congenital Heart Disease (ACHD) from Cardiology

    These updates are reflected in the ``CY 2022 PFS final rule PE/HR'' 
file available on the CMS website under the supporting data files for 
the CY 2022 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html.
    We received public comments on our proposal to use proxy PE/HR 
values for MDS and ACHD. The following is a summary of the comments we 
received and our responses.
    Comment: One commenter stated that they appreciated and supported 
the proposal incorporating the available utilization data for MDS to 
establish an indirect PE/HR for their newly designated specialty. The 
commenter stated that they also agreed with the proposal to use a proxy 
PE/HR value by crosswalking to the PE/HR for Dermatology and urged CMS 
to finalize this policy.
    Response: We appreciate the support from the commenter for our 
proposed PE/HR crosswalk.
    Comment: Several commenters questioned the assigned specialty 
crosswalk to use for indirect PE when it comes to home PT/INR 
monitoring services. Commenters stated that they appreciated that CMS 
acknowledged their concerns last year and agreed to update the indirect 
factors for home PT/INR monitoring by crosswalking to the General 
Practice specialty which helped address the on-going substantial 
reductions in payment for home PT/INR monitoring. However, the 
commenters stated that the predominant code for PT/INR monitoring 
(HCPCS code G0249) will again be significantly and negatively impacted 
by the proposed changes in the clinical labor rates which will 
completely negate any benefit from the crosswalk to General Practice. 
The commenters requested CMS change the crosswalk for home PT/INR 
monitoring services to All Physicians which would partially offset the 
proposed reduction that HCPCS code G0249 is facing due to changes in 
the clinical labor rates.
    Response: We finalized a crosswalk to the General Practice 
specialty for home PT/INR monitoring services (HCPCS codes G0248, 
G0249, and G0250) in the CY 2021 PFS final rule (85 FR 84477-84478). 
The data submitted by the commenters indicated that the direct-to-
indirect cost percentages to furnish home PT/INR monitoring are in the 
range of 31:69, similar to the ratio associated with the General 
Practice specialty. We disagree that these home PT/INR monitoring 
services should now be reassigned to a different specialty that is less 
reflective of the cost structure for these services to offset 
reductions in payment for the services that result from an unrelated 
policy proposal (the clinical labor pricing update). Additionally, we 
did not propose to change the assigned specialty for PT/INR services. 
As such, this comment is outside the scope of the proposed rule. 
Therefore, we are not finalizing any changes to the assigned specialty 
for PT/INR services. We note however that, recognizing the changing 
practice of medicine and increasing use of innovative technologies and 
supplies to furnish certain services, we are reviewing our underlying 
data as part of a comprehensive review of our PE inputs and overall 
methodology. We continue to engage with stakeholders on this crucial 
topic of updating the PE data, for example, at our recent PE town hall 
this year.
    After consideration of the comments, we are finalizing our proposed 
PE/HR crosswalks for the new MDS and ACHD specialties.
c. Allocation of PE to Services
    To establish PE RVUs for specific services, it is necessary to 
establish the direct and indirect PE associated with each service.
(1) Direct Costs
    The relative relationship between the direct cost portions of the 
PE RVUs for any two services is determined by the relative relationship 
between the sum of the direct cost resources (that is, the clinical 
staff, medical supplies, and medical equipment) typically involved with 
furnishing each of the services. The costs of these resources are 
calculated from the refined direct PE inputs in our PE database. For 
example, if one service has a direct cost sum of $400 from our PE 
database and another service has a direct cost sum of $200, the direct 
portion of the PE RVUs of the first service would be twice as much as 
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
    We allocate the indirect costs at the code level based on the 
direct costs specifically associated with a code and the greater of 
either the clinical labor costs or the work RVUs. We also incorporate 
the survey data described earlier in the PE/HR discussion. The general 
approach to developing the indirect portion of the PE RVUs is as 
follows:
     For a given service, we use the direct portion of the PE 
RVUs calculated as previously described and the average percentage that 
direct costs represent of total costs (based on survey data) across the 
specialties that furnish the service to determine an initial indirect 
allocator. That is, the initial indirect allocator is calculated so 
that the direct costs equal the average percentage of direct costs of 
those specialties furnishing the service. For example, if the direct 
portion of the PE RVUs for a given service is 2.00 and direct costs, on 
average, represent 25 percent of total costs for the specialties that 
furnish the service, the initial indirect allocator would be calculated 
so that it equals 75 percent of the total PE RVUs. Thus, in this 
example, the initial indirect allocator would equal 6.00, resulting in 
a total PE RVU of 8.00

[[Page 65001]]

(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 refer 
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 2022 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html. This file 
contains a table that illustrates the calculation of PE RVUs as 
described in this final rule for individual codes.
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty-specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service.
    Step 2: Calculate the aggregate pool of direct PE costs for the 
current year. We set the aggregate pool of PE costs equal to the 
product of the ratio of the current aggregate PE RVUs to current 
aggregate work RVUs and the projected aggregate work RVUs.
    Step 3: Calculate the aggregate pool of direct PE costs for use in 
ratesetting. This is the product of the aggregate direct costs for all 
services from Step 1 and the utilization data for that service.
    Step 4: Using the results of Step 2 and Step 3, use the CF to 
calculate a direct PE scaling adjustment to ensure that the aggregate 
pool of direct PE costs calculated in Step 3 does not vary from the 
aggregate pool of direct PE costs for the current year. Apply the 
scaling adjustment to the direct costs for each service (as calculated 
in Step 1).
    Step 5: Convert the results of Step 4 to an RVU scale for each 
service. To do this, divide the results of Step 4 by the CF. Note that 
the actual value of the CF used in this calculation does not influence 
the final direct cost PE RVUs as long as the same CF is used in Step 4 
and Step 5. Different CFs would result in different direct PE scaling 
adjustments, but this has no effect on the final direct cost PE RVUs 
since changes in the CFs and changes in the associated direct scaling 
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
    Create indirect allocators.
    Step 6: Based on the survey data, calculate direct and indirect PE 
percentages for each physician specialty.
    Step 7: Calculate direct and indirect PE percentages at the service 
level by taking a weighted average of the results of Step 6 for the 
specialties that furnish the service. Note that for services with TCs 
and PCs, the direct and indirect percentages for a given service do not 
vary by the PC, TC, and global service.
    We generally use an average of the 3 most recent years of available 
Medicare claims data to determine the specialty mix assigned to each 
code. Codes with low Medicare service volume require special attention 
since billing or enrollment irregularities for a given year can result 
in significant changes in specialty mix assignment. We finalized a 
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use 
the most recent year of claims data to determine which codes are low 
volume for the coming year (those that have fewer than 100 allowed 
services in the Medicare claims data). For codes that fall into this 
category, instead of assigning specialty mix based on the specialties 
of the practitioners reporting the services in the claims data, we use 
the expected specialty that we identify on a list developed based on 
medical review and input from expert stakeholders. We display this list 
of expected specialty assignments as part of the annual set of data 
files we make available as part of notice and comment rulemaking and 
consider recommendations from the RUC and other stakeholders 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.

[[Page 65002]]

    We did not make any proposals associated with the list of expected 
specialty assignments for low volume services, however we received 
public comments on this topic from stakeholders. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters stated that they had performed an 
analysis to identify all codes that meet the criteria to receive a 
specialty override under this CMS policy and drafted updated 
recommendations for CY 2022. Commenters stated that the purpose of 
assigning a specialty to these codes was to avoid the major adverse 
impact on MP RVUs that result from errors in specialty utilization data 
magnified in representation (percentage) by small sample size. These 
commenters submitted a lengthy list of low volume HCPCS codes with 
recommended expected specialty assignments. One commenter requested 
changing the override specialty for a series of codes from thoracic 
surgery to cardiac surgery based on whether the procedures in question 
are performed on the heart and surrounding structures versus performed 
on the lungs, esophagus, chest wall and mediastinum.
    Response: We appreciate the submission of expected specialty 
assignments for additional low volume HCPCS codes. After reviewing the 
information provided by the commenters to determine that the submitted 
specialty assignments were appropriate for the service in question, we 
are finalizing the additions in Table 1 to the list of expected 
specialty assignments for low volume services.
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[[Page 65005]]


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[[Page 65006]]


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    Commenters recommended an expected specialty assignment of 
interventional cardiology for CPT codes 33018, 33741, 33745, 33746, 
92975, and 93565 and an expected specialty assignment of cardiac 
electrophysiology for CPT code 33275. However, we do not have PE/HR 
data for the interventional cardiology and cardiac electrophysiology 
specialties as they were not part of the PPIS when it was conducted in 
2007. These specialties both use the cardiology specialty for their PE/
HR data, and therefore, we have also crosswalked the CPT codes in 
question to the cardiology specialty on the list of expected specialty 
assignments for low volume services.
    Based on the information provided by the commenters, we are 
finalizing the changes in expected specialty assignment for the five 
CPT codes in Table 2 which were already included on the list.
[GRAPHIC] [TIFF OMITTED] TR19NO21.004

    We are not finalizing the recommended changes in expected specialty 
assignment for the CPT codes in Table 3 associated with the thoracic 
surgery specialty.

[[Page 65007]]

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[[Page 65008]]


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BILLING CODE 4120-01-C
    Commenters requested that the expected specialty assignment for the 
CPT codes in this group be changed from the thoracic surgery specialty 
to the cardiac surgery specialty. We did not finalize this same request 
in previous rulemaking cycles in both CY 2020 (84 FR 62576) and CY 2021 
(85 FR 84479) for the same group of CPT codes. We finalized a proposal 
in CY 2020 to update the expected specialty list to accurately reflect 
a previously finalized crosswalk to thoracic surgery for the services 
in question. As we stated at the time, we did not finalize a proposal 
to assign the codes in question to the cardiac surgery specialty. 
Instead, we finalized a proposal to update the incorrect documentation 
in our expected specialty list to accurately reflect a previously 
finalized crosswalk to thoracic surgery for these services. The 
previously finalized assignment of the cardiac surgery specialty to 
these services has been in place since the CY 2012 rule cycle, and we 
believe that the expected specialty list should be updated to reflect 
the correct specialty assignment. We have previously considered and 
declined to make the changes suggested by commenters, and we are not 
finalizing such changes in this CY 2022 PFS final rule. We direct 
readers to the discussion of this topic in the CY 2020 PFS final rule 
(84 FR 62574 through 62578) and we reiterate that we do not anticipate 
this finalized proposal from CY 2020 having a discernible effect on the 
valuation of the affected codes due to the similarity between the 
cardiac surgery and thoracic surgery specialties.
    We also note for commenters that each HCPCS code that appears on 
the list of expected specialty assignments for low volume services 
remains on the list from year to year, even if the volume

[[Page 65009]]

for the code in question rises to over 100 services for an individual 
calendar year. The HCPCS codes and expected specialty assignment remain 
on the list, and will be applied should the volume fall below 100 
services in any calendar year; there is no need to ``reactivate'' 
individual codes as some commenters indicated in their submissions.
    Comment: Several commenters stated that in previous years, CMS has 
applied the expected specialty override to services with fewer than 100 
allowed services in a 3-year average of Medicare claims data without 
adjusting the utilization to interpret any CPT modifiers. Although 
commenters agreed with the use of a 3-year average to identify low 
volume services for expected specialty assignment, commenters stated 
that not adjusting for certain modifiers will result in undercounting 
or overcounting of certain services. For example, commenters stated 
that if a single procedure is performed by both a primary surgeon and 
an assistant at surgery, this service should only be counted once even 
though each of the practitioners would report the service on a separate 
claim. Commenters recommended that CMS should set the frequency to zero 
for post-operative only (modifier '55') and assistant at surgery 
(modifier '80') records, multiply the frequency by 2 for bilateral 
surgery records (modifier '50'), and divide the frequency by 2 for co-
surgery records (modifier '62').
    Response: We do not agree that it would be more appropriate to make 
the adjustments to utilization as described by the commenters to 
determine low volume status. As we stated in the CY 2020 PFS final rule 
(84 FR 62576), we finalized a policy in the CY 2018 PFS final rule (82 
FR 52982 through 59283) to use claims data to determine which codes are 
low volume for the coming year, defining ``low volume'' as those that 
had fewer than 100 allowed services in the Medicare claims data. We did 
not finalize a policy to discount this utilization based on modifiers 
that identify certain circumstances, and we do not believe that it 
would be more appropriate to do so, as a service is still furnished and 
billed in each case, even if payment is discounted. Additionally, we 
did not make any proposals concerning the methodology used to identify 
low volume services in the proposed rule, and therefore, we are not 
finalizing any changes to this methodology.
    After consideration of the public comments, we are finalizing the 
updates to the list of expected specialty assignments for low volume 
services as detailed above.
    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 final rule.)
    Step 19: Apply the phase-in of significant RVU reductions and its

[[Page 65010]]

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 4.
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BILLING CODE 4120-01-C
     Crosswalk certain low volume physician specialties: 
Crosswalk the utilization of certain specialties with relatively low 
PFS utilization to the associated specialties.
     Physical therapy utilization: Crosswalk the utilization 
associated with all physical therapy services to the specialty of 
physical therapy.
     Identify professional and technical services not 
identified under the usual TC and 26 modifiers: Flag the services that 
are PC and TC services but do not use TC and 26 modifiers (for example, 
electrocardiograms). This flag associates the PC and TC with the 
associated global code for use in creating the indirect PE RVUs. For 
example, the professional service, CPT code 93010 (Electrocardiogram, 
routine ECG with at least 12 leads; interpretation and report only), is 
associated with the global service, CPT code 93000 (Electrocardiogram, 
routine ECG with at least 12 leads; with interpretation and report).
     Payment modifiers: Payment modifiers are accounted for in 
the creation of the file consistent with current payment policy as 
implemented in claims processing. For example, services billed with the 
assistant at surgery modifier are paid 16 percent of the PFS amount for 
that service; therefore, the utilization file is modified to only 
account for 16 percent of any service that contains the assistant at 
surgery modifier. Similarly, for those services to which volume 
adjustments are made to account for the payment modifiers, time 
adjustments are applied as well. For time adjustments to surgical 
services, the intraoperative portion in the work time file is used; 
where it is not present, the intraoperative percentage from the payment 
files used by contractors to process Medicare claims is used instead. 
Where neither is available, we use the payment adjustment ratio to 
adjust the time accordingly. Table 5 details the manner in which the 
modifiers are applied.
[GRAPHIC] [TIFF OMITTED] TR19NO21.008

    We also make adjustments to 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 requires 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 will apply 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

[[Page 65012]]

time adjustment of 33 percent is made only for medical direction of two 
to four cases since that is the only situation where a single 
practitioner is involved with multiple beneficiaries concurrently, so 
that counting each service without regard to the overlap with other 
services would overstate the amount of time spent by the practitioner 
furnishing these services.
     Work RVUs: The setup file contains the work RVUs from this 
final rule.
(6) Equipment Cost per Minute
    The equipment cost per minute is calculated as:

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

Where:

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

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by section 1848(b)(4)(C) of the Act.
    Useful Life: In the CY 2005 PFS final rule we stated that we 
updated the useful life for equipment items primarily based on the 
AHA's ``Estimated Useful Lives of Depreciable Hospital Assets'' 
guidelines (69 FR 66246). The most recent edition of these guidelines 
was published in 2018. This reference material provides an estimated 
useful life for hundreds of different 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 6.
[GRAPHIC] [TIFF OMITTED] TR19NO21.009

    We did not propose any changes to the equipment interest rates for 
CY 2022.
3. Changes to Direct PE Inputs for Specific Services
    This section focuses on specific PE inputs. The direct PE inputs 
are included in the CY 2022 direct PE input public use files, which are 
available on the CMS website under downloads for the CY 2022 PFS final 
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/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

[[Page 65013]]

clinical labor minutes for the preservice, service, and post service 
periods for each code. In addition to increasing the transparency of 
the information used to set PE RVUs, this level of detail would allow 
us to compare clinical labor times for activities associated with 
services across the PFS, which we believe is important to maintaining 
the relativity of the direct PE inputs. This information would 
facilitate the identification of the usual numbers of minutes for 
clinical labor tasks and the identification of exceptions to the usual 
values. It would also allow for greater transparency and consistency in 
the assignment of equipment minutes based on clinical labor times. 
Finally, we believe that the detailed information can be useful in 
maintaining standard times for particular clinical labor tasks that can 
be applied consistently to many codes as they are valued over several 
years, similar in principle to the use of physician preservice time 
packages. We believe that setting and maintaining such standards would 
provide greater consistency among codes that share the same clinical 
labor tasks and could improve relativity of values among codes. For 
example, as medical practice and technologies change over time, changes 
in the standards could be updated simultaneously for all codes with the 
applicable clinical labor tasks, instead of waiting for individual 
codes to be reviewed.
    In the CY 2016 PFS final rule with comment period (80 FR 70901), we 
solicited comments on the appropriate standard minutes for the clinical 
labor tasks associated with services that use digital technology. After 
consideration of comments received, we finalized standard times for 
clinical labor tasks associated with digital imaging at 2 minutes for 
``Availability of prior images confirmed'', 2 minutes for ``Patient 
clinical information and questionnaire reviewed by technologist, order 
from physician confirmed and exam protocoled by radiologist'', 2 
minutes for ``Review examination with interpreting MD'', and 1 minute 
for ``Exam documents scanned into PACS'' and ``Exam completed in RIS 
system to generate billing process and to populate images into 
Radiologist work queue.'' In the CY 2017 PFS final rule (81 FR 80184 
through 80186), we finalized a policy to establish a range of 
appropriate standard minutes for the clinical labor activity, 
``Technologist QCs images in PACS, checking for all images, reformats, 
and dose page.'' These standard minutes will be applied to new and 
revised codes that make use of this clinical labor activity when they 
are reviewed by us for valuation. We finalized a policy to establish 2 
minutes as the standard for the simple case, 3 minutes as the standard 
for the intermediate case, 4 minutes as the standard for the complex 
case, and 5 minutes as the standard for the highly complex case. These 
values were based upon a review of the existing minutes assigned for 
this clinical labor activity; we determined that 2 minutes is the 
duration for most services and a small number of codes with more 
complex forms of digital imaging have higher values. We also finalized 
standard times for a series of clinical labor tasks associated with 
pathology services in the CY 2016 PFS final rule with comment period 
(80 FR 70902). We do not believe these activities would be dependent on 
number of blocks or batch size, and we believe that the finalized 
standard values accurately reflect the typical time it takes to perform 
these clinical labor tasks.
    In reviewing the RUC-recommended direct PE inputs for CY 2019, we 
noticed that the 3 minutes of clinical labor time traditionally 
assigned to the ``Prepare room, equipment and supplies'' (CA013) 
clinical labor activity were split into 2 minutes for the ``Prepare 
room, equipment and supplies'' activity and 1 minute for the ``Confirm 
order, protocol exam'' (CA014) activity. We proposed to maintain the 3 
minutes of clinical labor time for the ``Prepare room, equipment and 
supplies'' activity and remove the clinical labor time for the 
``Confirm order, protocol exam'' activity wherever we observed this 
pattern in the RUC-recommended direct PE inputs. Commenters explained 
in response that when the new version of the PE worksheet introduced 
the activity codes for clinical labor, there was a need to translate 
old clinical labor tasks into the new activity codes, and that a prior 
clinical labor task was split into two of the new clinical labor 
activity codes: CA007 (Review patient clinical extant information and 
questionnaire) in the preservice period, and CA014 (Confirm order, 
protocol exam) in the service period. Commenters stated that the same 
clinical labor from the old PE worksheet was now divided into the CA007 
and CA014 activity codes, with a standard of 1 minute for each 
activity. We agreed with commenters that we would finalize the RUC-
recommended 2 minutes of clinical labor time for the CA007 activity 
code and 1 minute for the CA014 activity code in situations where this 
was the case. However, when reviewing the clinical labor for the 
reviewed codes affected by this issue, we found that several of the 
codes did not include this old clinical labor task, and we also noted 
that several of the reviewed codes that contained the 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

[[Page 65014]]

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 2022, we are continuing to display two 
versions of the Labor Task Detail public use file: One version with the 
old listing of clinical labor tasks, and one with the same tasks 
crosswalked to the new listing of clinical labor activity codes. These 
lists are available on the CMS website under downloads for the CY 2022 
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html.
b. Technical Corrections to Direct PE Input Database and Supporting 
Files
    For CY 2022, we proposed to address the following:
     Following the publication of the CY 2021 PFS proposed 
rule, several commenters questioned the proposed RVUs associated with 
several occupational therapy evaluation procedures (CPT codes 97165 
through 97167). Commenters stated that the PE valuation for these codes 
appeared to be illogical as it was counterintuitive for the PE RVU to 
go down as the level of complexity increased. Commenters stated that 
the distribution of code usage has not changed in any manner to justify 
a reduction in the code values and that all three evaluation codes 
should reimburse at the same rate. In response to the commenters, we 
noted that although the three codes in question shared the same work 
RVU and the same direct PE inputs, they did not share the same 
specialty distribution in the claims data, and therefore, would not 
necessarily receive the same allocation of indirect PE. In the CY 2021 
PFS final rule (85 FR 84490), we finalized the implementation of a 
technical change intended to ensure that these three services received 
the same allocation of indirect PE. We agreed with commenters that it 
was important to avoid a potential rank order anomaly in which the 
simple case for a service was valued higher than the complex case.
    After the publication of the CY 2021 PFS final rule, stakeholders 
stated their appreciation for the technical change made in the final 
rule to ensure that the indirect PE allocation was the same for all 
three levels of occupational therapy evaluation codes. However, 
stakeholders expressed concern that the PE RVUs we finalized for CPT 
codes 97165-97167 decreased as compared to the PE RVUs we proposed for 
CY 2021. Stakeholders stated that nothing had occurred in the past year 
that would account for a reduction to the proposed PE for these codes, 
especially in a year where the proposed PE increased for the 
corresponding physical therapy evaluation procedures (CPT codes 97161-
97163), and stakeholders questioned whether there had been an error in 
applying the indirect PE methodology.
    We reviewed the indirect PE allocation for CPT codes 97165-97167 in 
response to the stakeholder inquiry and we do not agree that there was 
an error in applying the indirect PE methodology. We finalized a 
technical change in the CY 2021 PFS final rule intended to ensure that 
these three services received the same allocation of indirect PE, which 
achieved its desired goal of assigning equivalent indirect PE to these 
three services. However, by forcing CPT codes 97165-97167 to have the 
same indirect PE allocation, the indirect PE values for these codes no 
longer relied on the claims data, which ended up affecting the indirect 
practice cost index for the wider occupational therapy specialty. 
Because CPT codes 97165-97167 are high volume services, this resulted 
in a lower indirect practice cost index for the occupational therapy 
specialty and a smaller allocation of indirect PE for CY 2021 than 
initially proposed.
    We proposed to address this issue for CY 2022 by assigning all 
claims data associated with CPT codes 97165-97167 to the occupational 
therapy specialty. This should ensure that CPT codes 97165-97167 will 
always receive the same indirect PE allocation, as well as prevent any 
fluctuations to the indirect practice cost index for the wider 
occupational therapy specialty. This is intended to avoid a potential 
rank order anomaly in which the simple case for a service is valued 
higher than the complex case. As the utilization for CPT codes 97165-
97167 is overwhelmingly identified as performed by occupational 
therapists, we do not anticipate that assigning all of the claims data 
for these codes to the occupational therapy specialty will have a 
noticeable effect on their valuation. We solicited public comments 
regarding this proposal, and specifically on what commenters suggest as 
the most appropriate method of assigning indirect PE allocation for 
these services.
    The following is a summary of the comments we received on our 
proposal and our responses.
    Comment: Several commenters stated that they appreciated CMS taking 
steps to review the PE calculations and make the correction to maintain 
the PE values equally for CPT codes 97165, 97166 and 97167. The 
commenters stated that they appreciated and agreed with the correction 
in calculation. The commenters also urged CMS to review this policy 
again if and when the evaluation codes are stratified because the 
current rank order anomaly caused by indirect PE when the codes are 
paid the same will not exist in the future when the code values are 
stratified based on complexity level.
    Response: We appreciate the support for our proposal from the 
commenters.
    After consideration of the public comments, we are finalizing our 
proposal to assign all claims data associated with CPT codes 97165-
97167 to the occupational therapy specialty.
    In the CY 2020 PFS final rule (84 FR 63102 through 63104), we 
created two new HCPCS G codes, G2082 and G2083, effective January 1, 
2020 on an interim final basis for the provision of self-administered 
esketamine. In the CY 2021 PFS final rule, we finalized a proposal to 
refine the values for HCPCS codes G2082 and G2083 using a building 
block methodology that summed the values associated with several codes 
(85 FR 84641 through 84642). Following the publication of the CY 2021 
PFS final rule, stakeholders expressed concerns that the finalized PE 
RVU had decreased for HCPCS codes G2082 and G2083 as compared to the 
proposed valuation and as compared to the previous CY 2020 interim 
final valuation. Stakeholders questioned whether there had been an 
error in the PE allocation since CMS had finalized increases in the 
direct PE inputs for the services.
    We reviewed the indirect PE allocation for HCPCS codes G2082 and 
G2083 in response to the stakeholder inquiry and discovered a technical 
change that was applied in error. Specifically, we inadvertently 
assigned a different physician specialty than we intended (``All 
Physicians'') to HCPCS codes G2082 and G2083 for indirect PE allocation 
in our ratesetting process during valuation of these codes in the CY 
2020 PFS final rule, and continued that assignment into the CY 2021 PFS 
proposed rule. This specialty assignment caused the PE value for these 
services to be higher than anticipated for CY 2020. We intended to 
revise the assigned physician specialty for these codes to ``General 
Practice'' in the CY 2021 PFS final rule; however, we neglected to 
discuss this change in the course of PFS rulemaking for CY 2021. Since 
we initially applied this technical change in the CY 2021 PFS final 
rule without providing an explanation, we

[[Page 65015]]

issued a correction notice (86 FR 14690) to remove this change from the 
CY 2021 PFS final rule, and to instead maintain the All Physicians 
specialty assignment through CY 2021. We apologize for any confusion 
this may have caused.
    For CY 2022, we proposed to maintain the currently assigned 
physician specialty for indirect PE allocation for HCPCS codes G2082 
and G2083. We proposed to assign these two services to the All 
Physicians specialty for indirect PE allocation which will maintain 
payment consistency with the rates published in the CY 2020 PFS final 
rule and the CY 2021 PFS proposed rule. Although we had previously 
intended to assign the General Practice specialty to these codes, 
stakeholders have provided additional information about these services 
suggesting that maintaining the All Physicians specialty assignment for 
these codes will help maintain payment stability and preserve access to 
this care for beneficiaries. We solicited public comments to help us 
discern which specialty would be the most appropriate to use for 
indirect PE allocation for HCPCS codes G2082 and G2083. We note that 
the PE methodology, which relies on the allocation of indirect costs 
based on the magnitude of direct costs, should appropriately reflect 
the typical costs for the specialty the commenters suggest. For 
example, we do not believe it would be appropriate to assign the 
Psychiatry specialty for these services given that HCPCS codes G2082 
and G2083 include the high direct costs associated with esketamine 
supplies. The Psychiatry specialty is an outlier compared to most other 
specialties, allocating indirect costs at a 15:1 ratio based on direct 
costs because psychiatry services typically have very low direct costs. 
Assignment of most other specialties would result in allocation of 
direct costs at roughly a 3:1 ratio. We requested that commenters 
explain in their comments how the indirect PE allocation would affect 
the payment for these services. Specifically, to ensure appropriate 
payment for HCPCS codes G2082 and G2083, we would like to get a better 
understanding of the indirect costs associated with these services, 
relative to other services furnished by the suggested specialty.
    The following is a summary of the comments we received on our 
proposal and our responses.
    Comment: Several commenters supported the proposal to maintain the 
currently assigned physician specialty (All Physicians) for indirect PE 
allocation for HCPCS codes G2082 and G2083. Commenters thanked CMS for 
making technical corrections to restore the payment levels for services 
related to self-administered esketamine to their CY 2020 amounts. One 
commenter encouraged CMS to maintain the current rates to ensure 
payment stability and beneficiary access to this evidence- based 
treatment option. Another commenter urged CMS either to maintain its 
current approach by allowing continued use of the all-physician 
specialty designation or to provide a blend of the Psychiatry (\2/3\) 
and All Physicians (\1/3\) designations.
    Response: We appreciate the support for our proposed policies from 
the commenters.
    Comment: Several commenters stated that esketamine services were 
best identified as procedures assigned to the specialty of Psychiatry. 
Commenters stated that approximately 95 percent of the providers 
administering esketamine are psychiatric professionals and that 
utilization data from CMS demonstrated that nearly 75 percent of 
providers in the non-facility setting fall within the Psychiatry 
specialty for both codes. Commenters stressed the high costs to the 
provider of administering esketamine which result in more risk due to 
up-front supply costs, and several commenters requested assigning HCPCS 
codes G2082 and G2083 to the Psychiatry specialty to offset potential 
decreases in valuation resulting from the proposed clinical labor 
pricing update. One commenter requested a specialty blend of three-
fourths Psychiatry and one-fourth ``All Physicians'' which the 
commenter stated was clinically coherent, consistent with the data 
available, and would result in the total non-facility national average 
reimbursement amount that most closely approximates CY 2021 levels.
    Response: We appreciate the feedback from the commenters regarding 
the costs associated with administering esketamine. However, we 
continue to believe that the All Physicians specialty most accurately 
captures the indirect PE allocation associated with these services. We 
do not assign a blended combination of specialties for any other 
services and the commenters did not provide new data to support a 
change in specialty assignment aside from noting that many providers in 
the non-facility setting fall within the Psychiatry specialty for both 
codes. We continue to believe that it would not be accurate to assign 
the Psychiatry specialty for HCPCS codes G2082 and G2083 due to its 
outlier status amongst specialties, whereby Psychiatry allocates 
indirect costs at a 15:1 ratio based on direct costs as compared to 
most other specialties having approximately a 3:1 ratio. We do not 
believe that this would be an accurate specialty designation for HCPCS 
codes G2082 and G2083 given the high direct costs associated with 
esketamine (which would translate into disproportionately high indirect 
PE allocation at said 15:1 ratio).
    As we noted in the CY 2021 PFS final rule (85 FR 84498 through 
84499) and again in this rule, the RAND Corporation is currently 
studying potential improvements to our PE allocation methodology and 
the data that underlie it. We are interested in exploring ways that the 
PE methodology can be updated, which could include improvements to the 
indirect PE methodology to address unusual codes like G2082 and G2083 
which have a direct to indirect ratio that does not match their most 
commonly billed specialties. Under the current PE methodology, however, 
we agree with the commenters who supported the proposal to maintain the 
currently assigned physician specialty (All Physicians) for indirect PE 
allocation.
    After consideration of the public comments, we are finalizing our 
proposal to maintain the All Physicians specialty for indirect PE 
allocation for HCPCS codes G2082 and G2083.
    A stakeholder contacted us regarding a potential error involving 
the intraservice work time for CPT code 35860 (Exploration for 
postoperative hemorrhage, thrombosis or infection; extremity). The 
stakeholder stated that the RUC recommended an intraservice work time 
of 90 minutes for this code when it was last reviewed in the CY 2012 
PFS final rule and we finalized the work time without refinement at 60 
minutes (76 FR 73131). The stakeholder requested that the intraservice 
work time for CPT code 35860 should be updated to 90 minutes.
    We reviewed the intraservice work time for CPT code 35860 and found 
that the RUC inadvertently recommended a time of 60 minutes for the 
code, which we proposed and finalized without comment in rulemaking for 
the CY 2012 PFS. As a result, we do not believe that this is a 
technical error on our part. However, since the stakeholder has 
clarified that the RUC intended to recommend 90 minutes of intraservice 
work time for CPT code 35860 based on the surveyed median time, we 
proposed to update the intraservice work time to 90 minutes to match 
the survey results.
    We did not receive public comments on our proposal to update the 
intraservice work time for CPT code 35860, and we are finalizing as 
proposed.
    We did not make any proposals specifically associated with the 
utilization crosswalk file or public use

[[Page 65016]]

file as described below, however we received a public comment on these 
topics from one stakeholder. The following is a summary of the comments 
we received and our responses.
    Comment: One stakeholder contacted CMS identifying what appeared to 
be duplicate data in the utilization crosswalk file. The stakeholder 
stated that the first 15,875 rows of the file appeared to almost 
exclusively contain duplicate lines in sets of two, and requested 
clarification on whether the utilization file was in error.
    Response: Due to a technical error, the utilization for anesthesia 
services was unintentionally duplicated in the files associated with 
the proposed rule. We have corrected this error for the final rule and 
we apologize for any confusion which may have resulted from this 
inadvertent mistake in the utilization crosswalk file.
    Comment: One commenter stated that they believed the public use 
files contain an error in the clinical labor portion of the PE RVU 
calculation. The commenter stated that the CY 2022 PE RVU summary file 
provided the pre-, intra-, and post-service costs for CPT codes 65778 
and 65779. The commenter stated that this file showed no cost for pre-
service activities or post-service activities, however the accompanying 
Clinical Labor New Activity Detail public use file showed a series of 
staff activities associated with CPT codes 65778 and 65779. The 
commenter requested that CMS review the pre-service and post-service 
costs and correct or update the clinical labor values for these codes 
accordingly. The commenter also stated that the patient contact time 
reflected in the public use file is understated by approximately 50 
percent for CPT codes 65778 and 65779 and encouraged CMS to evaluate 
whether the public use file values should be updated prior to 
implementation of the PFS for CY 2022.
    Response: We reviewed the public use files described by the 
commenter and we can confirm that there was no error in the calculation 
of the rates for these services. The clinical labor tasks described by 
the commenter for CPT codes 65778 and 65779 all take place during the 
intra-service period, not the pre-service or post-service period, and 
the Clinical Labor New Activity Detail public use file correctly lists 
the clinical labor for these services. If the commenter has reason to 
believe that the clinical labor is undervalued for these services, we 
encourage them to nominate CPT codes 65778 and 65779 as potentially 
misvalued for additional review.
c. 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. For CY 2022, 
we proposed to update the price of six supplies and two equipment items 
in response to the public submission of invoices. Since this is the 
final year of the supply and equipment pricing update, the new pricing 
for each of these supply and equipment items will take effect for CY 
2022 as there are no remaining years of the transition. The six supply 
and equipment items with proposed updated prices are listed in the 
valuation of specific codes section of the preamble under Table 23, CY 
2022 Invoices Received for Existing Direct PE Inputs.
(1) Market-Based Supply and Equipment Pricing Update
    Section 220(a) of the Protecting Access to Medicare Act of 2014 
(PAMA) (Pub. L. 113-93, April 1, 2014) 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.
    As part of our authority under section 1848(c)(2)(M) of the Act, we 
initiated a market research contract with StrategyGen to conduct an in-
depth and robust market research study to update the PFS direct PE 
inputs (DPEI) for supply and equipment pricing for CY 2019. These 
supply and equipment prices were last systematically developed in 2004-
2005. StrategyGen submitted a report with updated pricing 
recommendations for approximately 1300 supplies and 750 equipment items 
currently used as direct PE inputs. This report is available as a 
public use file displayed on the CMS website under downloads for the CY 
2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html.
    The StrategyGen team of researchers, attorneys, physicians, and 
health policy experts conducted a market research study of the supply 
and equipment items currently used in the PFS direct PE input database. 
Resources and methodologies included field surveys, aggregate 
databases, vendor resources, market scans, market analysis, physician 
substantiation, and statistical analysis to estimate and validate 
current prices for medical equipment and medical supplies. StrategyGen 
conducted secondary market research on each of the 2,072 DPEI medical 
equipment and supply items that CMS identified from the current DPEI. 
The primary and secondary resources StrategyGen used to gather price 
data and other information were:
     Telephone surveys with vendors for top priority items 
(Vendor Survey).
     Physician panel validation of market research results, 
prioritized by total spending (Physician Panel).
     The General Services Administration system (GSA).
     An aggregate health system buyers database with discounted 
prices (Buyers).
     Publicly available vendor resources, that is, Amazon 
Business, Cardinal Health (Vendors).
     The Federal Register, current DPEI data, historical 
proposed and final rules prior to CY 2018, and other resources; that 
is, AMA RUC reports (References).
    StrategyGen prioritized the equipment and supply research based on 
current share of PE RVUs attributable by item provided by CMS. 
StrategyGen developed the preliminary Recommended Price (RP) 
methodology based on the following rules in hierarchical order 
considering both data representativeness and reliability.
    (1) If the market share, as well as the sample size, for the top 
three commercial products were available, the weighted average price 
(weighted by percent market share) was the reported RP. Commercial 
price, as a weighted average of market share, represents a more robust 
estimate for each piece of equipment and a more precise reference for 
the RP.
    (2) If no data were available for commercial products, the current 
CMS prices were used as the RP.
    GSA prices were not used to calculate the StrategyGen recommended 
prices, due to our concern that the GSA system curtails the number and 
type of suppliers whose products may be accessed on the GSA Advantage 
website, and that the GSA prices may often be lower than prices that 
are

[[Page 65017]]

available to non-governmental purchasers. After reviewing the 
StrategyGen report, we proposed to adopt the updated direct PE input 
prices for supplies and equipment as recommended by StrategyGen.
    StrategyGen found that despite technological advancements, the 
average commercial price for medical equipment and supplies has 
remained relatively consistent with the current CMS price. 
Specifically, preliminary data indicated that there was no 
statistically significant difference between the estimated commercial 
prices and the current CMS prices for both equipment and supplies. This 
cumulative stable pricing for medical equipment and supplies appears 
similar to the pricing impacts of non-medical technology advancements 
where some historically high-priced equipment (that is, desktop PCs) 
has been increasingly substituted with current technology (that is, 
laptops and tablets) at similar or lower price points. However, while 
there were no statistically significant differences in pricing at the 
aggregate level, medical specialties would experience increases or 
decreases in their Medicare payments if we were to adopt the pricing 
updates recommended by StrategyGen. At the service level, there may be 
large shifts in PE RVUs for individual codes that happened to contain 
supplies and/or equipment with major changes in pricing, although we 
note that codes with a sizable PE RVU decrease would be limited by the 
requirement to phase in significant reductions in RVUs, as required by 
section 1848(c)(7) of the Act. The phase-in requirement limits the 
maximum RVU reduction for codes that are not new or revised to 19 
percent in any individual calendar year.
    We believe that it is important to make use of the most current 
information available for supply and equipment pricing instead of 
continuing to rely on pricing information that is more than a decade 
old. Given the potentially significant changes in payment that would 
occur, both for specific services and more broadly at the specialty 
level, in the CY 2019 PFS proposed rule we proposed 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. This 
approach is consistent with how we have previously incorporated 
significant new data into the calculation of PE RVUs, such as the 4-
year transition period finalized in CY 2007 PFS final rule with comment 
period when changing to the ``bottom-up'' PE methodology (71 FR 69641). 
This transition period will not only ease the shift to the updated 
supply and equipment pricing, but will also allow interested parties an 
opportunity to review and respond to the new pricing information 
associated with their services.
    We proposed to implement this phase-in over 4 years so that supply 
and equipment values transition smoothly from the prices we currently 
include to the final updated prices in CY 2022. We proposed to 
implement this pricing transition such that one quarter of the 
difference between the current price and the fully phased-in price is 
implemented for CY 2019, one third of the difference between the CY 
2019 price and the final price is implemented for CY 2020, and one half 
of the difference between the CY 2020 price and the final price is 
implemented for CY 2021, with the new direct PE prices fully 
implemented for CY 2022. An example of the transition from the current 
to the fully-implemented new pricing is provided in Table 7.
[GRAPHIC] [TIFF OMITTED] TR19NO21.010

    For new supply and equipment codes for which we establish prices 
during the transition years (CYs 2019, 2020 and 2021) based on the 
public submission of invoices, we proposed to fully implement those 
prices with no transition since there are no current prices for these 
supply and equipment items. These new supply and equipment codes would 
immediately be priced at their newly established values. We also 
proposed that, for existing supply and equipment codes, when we 
establish prices based on invoices that are submitted as part of a 
revaluation or comprehensive review of a code or code family, they will 
be fully implemented for the year they are adopted without being phased 
in over the 4-year pricing transition. The formal review process for a 
HCPCS code includes a review of pricing of the supplies and equipment 
included in the code. When we find that the price on the submitted 
invoice is typical for the item in question, we believe it would be 
appropriate to finalize the new pricing immediately along with any 
other revisions we adopt for the code valuation.
    For existing supply and equipment codes that are not part of a 
comprehensive review and valuation of a code family and for which we 
establish prices based on invoices submitted by the public, we proposed 
to implement the established invoice price as the updated price and to 
phase in the new price over the remaining years of the proposed 4-year 
pricing transition. During the proposed transition period, where price 
changes for supplies and equipment are adopted without a formal review 
of the HCPCS codes that include them (as is the case for the many 
updated prices we proposed to phase in over the 4-year transition 
period), we believe it is important to include them in the remaining 
transition toward the updated price. We also proposed to phase in any 
updated pricing we establish during the 4-year transition period for 
very commonly used supplies and equipment that are included in 100 or 
more codes, such as sterile gloves (SB024) or exam tables (EF023), even 
if invoices are provided as part of the formal review of a code family. 
We would implement the new prices for any such supplies and equipment 
over the remaining years of the proposed 4-year transition period. Our 
proposal was intended to minimize any potential disruptive effects 
during the proposed transition period that could be caused by other 
sudden shifts in RVUs due to the high number of services that make

[[Page 65018]]

use of these very common supply and equipment items (meaning that these 
items are included in 100 or more codes).
    We believed that implementing the proposed updated prices with a 4-
year phase-in would improve payment accuracy, while maintaining 
stability and allowing stakeholders the opportunity to address 
potential concerns about changes in payment for particular items. 
Updating the pricing of direct PE inputs for supplies and equipment 
over a longer timeframe will allow more opportunities for public 
comment and submission of additional, applicable data. We welcomed 
feedback from stakeholders on the proposed updated supply and equipment 
pricing, including the submission of additional invoices for 
consideration.
    We received many comments regarding the market-based supply and 
equipment pricing proposal following the publication of the CY 2019 PFS 
proposed rule. For a full discussion of these comments, we direct 
readers to the CY 2019 PFS final rule (83 FR 59475 through 59480). In 
each instance in which one commenter raised questions about the 
accuracy of a supply or equipment code's recommended price, the 
StrategyGen contractor conducted further research on the item and its 
price with special attention to ensuring that the recommended price was 
based on the correct item in question and the clarified unit of 
measure. Based on the commenters' requests, the StrategyGen contractor 
conducted an extensive examination of the pricing of any supply or 
equipment items that any commenter identified as requiring additional 
review. Invoices submitted by multiple commenters were greatly 
appreciated and ensured that medical equipment and supplies were re-
examined and clarified. Multiple researchers reviewed these specified 
supply and equipment codes for accuracy and proper pricing. In most 
cases, the contractor also reached out to a team of nurses and their 
physician panel to further validate the accuracy of the data and 
pricing information. In some cases, the pricing for individual items 
needed further clarification due to a lack of information or due to 
significant variation in packaged items. After consideration of the 
comments and this additional price research, we updated the recommended 
prices for approximately 70 supply and equipment codes identified by 
the commenters. Table 9 in the CY 2019 PFS final rule lists the supply 
and equipment codes with price changes based on feedback from the 
commenters and the resulting additional research into pricing (83 FR 
59479 through 59480).
    After consideration of the public comments, we finalized our 
proposals associated with the market research study to update the PFS 
direct PE inputs for supply and equipment pricing. We continue to 
believe that implementing the updated prices with a 4-year phase-in 
will improve payment accuracy, while maintaining stability and allowing 
stakeholders the opportunity to address potential concerns about 
changes in payment for particular items. We continue to welcome 
feedback from stakeholders on the updated supply and equipment pricing, 
including the submission of additional invoices for consideration.
    For CY 2022, we received invoice submissions from stakeholders for 
approximately half a dozen supply and equipment codes as part of the 
fourth year of the market-based supply and equipment pricing update. We 
used these submitted invoices in many cases to supplement the pricing 
originally proposed for the CY 2019 PFS rule cycle. We reviewed the 
invoices, as well as our own data for the relevant supply/equipment 
codes to make sure the item in the invoice was representative of the 
supply/equipment item in question and aligned with past research. Based 
on this review, we proposed to update the prices of six supply items 
listed in the valuation of specific codes section of the preamble under 
Table 23: CY 2022 Invoices Received for Existing Direct PE Inputs. 
Since this is the final year of the supply and equipment pricing 
update, the new pricing for each of these supply and equipment items 
would take effect immediately for CY 2022.
    The proposed prices for the supply and equipment items listed in 
Table 23 of CY 2022 were generally calculated following our standard 
methodology of averaging together the prices on the submitted invoices. 
In the case of the Liquid coverslip (Ventana 650-010) (SL479) supply, 
we proposed a price of $0.051 based on the median invoice due to the 
presence of an outlier invoice that substantially increased the pricing 
when using an average. We believe that the price of $0.051 will be more 
typical for the SL479 supply based on the pricing information contained 
on the other submitted invoices. We also received several invoices for 
the 3C patch system (SD343) supply; however, since we established a 
price of $625.00 for this supply in last year's CY 2021 PFS final rule 
and the submitted invoices had an average price of $612.50, we did not 
propose to update the price. We believe that the submitted invoices 
confirm that the current pricing of $625.00 is typical for the SD343 
supply.
    We received public comments on the fourth and final year of the 
market-based supply and equipment pricing update. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter urged CMS to update prices for negative 
pressure wound therapy (NPWT) devices given the context of the clinical 
labor pricing update. The commenter stated that while one database 
reported typical costs of $400-$600 for single-use disposable NPWT 
devices, further prices provided by a medical equipment distributor 
show lower costs incurred by providers paying for PICO, Smith+Nephew's 
single-use disposable NPWT device. The commenter submitted five 
invoices for the negative pressure wound therapy, disposable kit 
(SA131) supply and stated that these updated prices for single-use NPWT 
devices could be used in future updates of direct cost inputs, which 
would strengthen the accuracy of Medicare pricing.
    Response: We appreciate the submission of invoices from the 
commenter to update the pricing of the SA131 supply. This kit is 
currently priced at $208 and we are finalizing an update to a price of 
$263.25 based on the median of the five submitted invoices from one 
commenter. We believe that the median value is more reflective of the 
typical price than the average value as there was a clear outlier 
amongst the five invoice prices ($248.33, $252.00, $263.25, $284.50, 
and $340.20).
    Comment: Several commenters stated their concerns regarding 
significant price reductions for several types of radiation therapy 
equipment: The IMRT treatment planning system (ED033), the HDR 
Afterload System Nucletron--Oldelft (ER003), and the SRS system SBRT 
(ER083). Commenters stated that they appreciated CMS' efforts to 
acquire current pricing information but believed that the recommended 
prices for these equipment items are below industry standards. 
Commenters stated that undervaluing equipment inputs has the potential 
to create access to care issues and potentially reduce the utilization 
of services that provide high quality patient outcomes.
    Response: Although we share the concerns of the commenters about 
the importance of ensuring accuracy in pricing and beneficiary access 
to care, the commenters did not submit invoices or provide any other 
pricing information for the three equipment items in question. In the 
absence of other pricing

[[Page 65019]]

data, we continue to believe that the equipment pricing we established 
for these items based on our past market-based research reflects the 
most accurate information for the equipment items in question.
    Comment: An anonymous commenter submitted an invoice that they 
stated could be used to update the pricing of the endovascular laser 
treatment kit (SA074) supply. The commenter stated that the PE may be 
overvalued for CPT code 36478, and the cost of $205.00 per kit detailed 
in this invoice may be more accurately reflective of SA074 kit costs.
    Response: We appreciate the invoice submission from the anonymous 
commenter. The SA074 supply has a current CY 2022 price of $438.60 
based on invoices submitted in last year's CY 2021 rulemaking cycle. 
The new invoice submission is less than half of this price, and when we 
compared the specific kit in question on the invoices, they described 
two different products. The CY 2021 invoices described a 65 cm kit 
while the CY 2022 invoice described a 45 cm version of the same kit. We 
believe that this explains the disparity in pricing between the 
different invoices. Since it is unclear to us which of these two 
products is more typical for use in CPT code 36478, we are maintaining 
the current CY 2022 price of $438.60 pending availability of additional 
information. We encourage stakeholders to submit additional invoices to 
assist in the pricing of the SA074 supply. These invoices can be 
submitted with public comments in next year's CY 2023 rulemaking cycle 
or, if outside the notice and comment rulemaking process, via email at 
[email protected].
    Comment: One commenter requested that CMS establish a national 
physician payment rate for Category III CPT code 0583T, also known as 
tympanostomy under local anesthesia (Tula). The commenter stated that 
this device-intensive procedure has inappropriately low physician MAC-
posted rates resulting from crosswalks to ENT codes that do not involve 
use of single-use implantable medical devices provided in the physician 
office setting. The commenter suggested work RVUs and direct PE inputs 
for Category III code 0583T to be used in national pricing of the 
service, and separately submitted six invoices showing prices paid by 
physicians for the tympanostomy under local anesthesia (Tula) 
implantable device and related supplies. The commenter requested a 
price of $995 for the Tula implantable device.
    Response: We appreciate the submission of invoices and other 
pricing information from the commenter regarding Category III CPT code 
0583T, but we did not propose to establish national pricing for this 
service. Category III CPT codes are typically contractor priced since 
they describe new and emerging technologies. We will review the 
materials provided by the commenter for potential use in future 
rulemaking; however, we are not finalizing national pricing for 
Category III CPT code 0583T or establishing a price for the Tula 
implantable device at this time.
    After consideration of the public comments, we are finalizing the 
supply and equipment prices as detailed individually above. We note 
that the supply and equipment prices finalized for CY 2022 represent 
the fourth and final year of the market-based supply and equipment 
pricing update.
(2) Invoice Submission
    The full list of updated supply and equipment pricing as 
implemented over the 4-year transition period will be made available as 
a public use file displayed on the CMS website under downloads for the 
CY 2022 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html.
    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. Stakeholders are encouraged to submit invoices with their 
public comments or, if outside the notice and comment rulemaking 
process, via email at [email protected].
(3) Autologous Platelet-Rich Plasma (HCPCS Code G0460) Supply Inputs
    We did not make any proposals associated with HCPCS code G0460 
(Autologous platelet rich plasma for chronic wounds/ulcers, including 
phlebotomy, centrifugation, and all other preparatory procedures, 
administration and dressings, per treatment) in the CY 2021 PFS 
proposed rule. Following publication of the rule, stakeholders 
contacted CMS regarding the creation of a new 3C patch system supply, 
which is topically applied for the management of exuding cutaneous 
wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and 
mechanically or surgically-debrided wounds. Stakeholders first sought 
clarification on how CMS calculated the underlying nonfacility PE RVUs 
for HCPCS code G0460. Stakeholders also stated that autologous platelet 
rich plasma administration procedures furnished in clinical trials 
(including the new 3C patch system) are reported using HCPCS code G0460 
and requested that CMS revalue the service to reflect the PEs 
associated with the new patch system supply. The stakeholders stated 
that the use of the new 3C patch system will represent the typical case 
for HCPCS code G0460, and suggested that, therefore, the cost inputs 
for this supply should be used to establish the RVUs for this code, as 
the current PFS payment rate is substantially less than the amount it 
costs to furnish the 3C patch.
    We want to clarify that the direct PE inputs for HCPCS code G0460 
increased for CY 2021 as a result of the ongoing market-based supply 
and equipment pricing update. However, there was also a minor decrease 
in the indirect PE allocation associated with this service for CY 2021, 
with the net result that the proposed PE RVU coincidentally ended up 
remaining the same as in the previous year. We also clarify that HCPCS 
code G0460 is not included in the Anticipated Specialty Assignment for 
Low Volume Services list, and therefore, was unaffected by low 
utilization in the claims data. In addition, as a contractor priced 
service, HCPCS code G0460 is unaffected by inclusion or exclusion from 
this list.
    We share the concerns of the stakeholders that patient access to 
the 3C patch could be materially impacted if CMS maintains the current 
PE RVUs for HCPCS G0460. In the CY 2021 PFS final rule, we established 
contractor pricing for HCPCS code G0460 for CY 2021. We believe that 
the use of contractor pricing again for CY 2022 will allow us 
additional time to consider the most appropriate resource inputs and PE 
RVUs for HCPCS code G0460. We also added the 3C patch system to our 
supply database under supply code SD343 at a price of $625.00 based on 
an average of the submitted invoices. We proposed to maintain 
contractor pricing for CY 2022 for HCPCS code G0460 as we do not 
currently have sufficient information to establish national pricing. It 
remains

[[Page 65020]]

unclear to us what the typical supply inputs would be for HCPCS code 
G0460 and whether they would include the use of the new 3C patch 
system. We believe that it would be more appropriate to maintain 
contractor pricing for the service, which will allow for more 
flexibility in pricing. We solicited any additional information that 
commenters can supply that CMS should consider to establish national 
payment for HCPCS code G0460.
    We did not receive public comments on this proposal and are 
finalizing contractor pricing for HCPCS code G0460 for CY 2022 as 
proposed.
d. 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.
    Since 2019, we have been updating the supply and equipment prices 
used for PE as part of a market-based pricing transition; CY 2022 will 
be 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).
    Stakeholders have raised concerns that the long delay since 
clinical labor pricing was last updated has created a significant 
disparity between CMS' clinical wage data and the market average for 
clinical labor. In recent years, a number of stakeholders have 
suggested that certain wage rates are inadequate because they do not 
reflect current labor rate information. Some stakeholders have also 
stated that updating the supply and equipment pricing without updating 
the clinical labor pricing could create distortions in the allocation 
of direct PE. 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 has been considerable stakeholder interest 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), stakeholders 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. We believe it is 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 this proposal.
    We recognize that the BLS survey of wage data does not cover all 
the staff types contained in our direct PE database. Therefore, we 
crosswalked or extrapolated the wages for several staff types using 
supplementary data sources for verification whenever possible. In 
situations where the price wages of clinical labor types were not 
referenced in the BLS data, we have used the national salary data from 
the Salary Expert, an online project of the Economic Research Institute 
that surveys national and local salary ranges and averages for 
thousands of job titles using mainly government sources. (A detailed 
explanation of the methodology used by Salary Expert to estimate 
specific job salaries can be found at www.salaryexpert.com). We 
previously used Salary Expert information as the primary backup source 
of wage data during the last update of clinical labor pricing in CY 
2002. If we did not have direct BLS wage data available for a clinical 
labor type, we used the wage data from Salary Expert as a reference for 
pricing, then crosswalked these clinical labor types to a proxy BLS 
labor category rate that most closely matched the reference wage data, 
similar to the crosswalks used in our PE/HR allocation. For example, 
there is no direct BLS wage data for the Mammography Technologist 
(L043) clinical labor type; we used the wage data from Salary Expert as 
a reference and identified the BLS wage data for Respiratory Therapists 
as the best proxy category. We calculated rates for the ``blend'' 
clinical labor categories by combining the rates for each labor type in 
the blend and then dividing by the total number of labor types in the 
blend.
    As in the CY 2002 clinical labor pricing update, the proposed cost 
per minute for each clinical staff type was derived by dividing the 
average hourly wage rate by 60 to arrive at the per minute cost. In 
cases where an hourly wage rate was not available for a clinical staff 
type, the proposed cost per minute for the clinical staff type was 
derived by dividing the annual salary (converted to 2021 dollars using 
the Medicare Economic Index) by 2080 (the number of hours in a typical 
work year) to arrive at the hourly wage rate and then again by 60 to 
arrive at the per minute cost. To account for the employers' cost of 
providing fringe benefits, such as sick leave, we used the same 
benefits multiplier of 1.366 as employed in CY 2002. As an example of 
this process, for the Physical Therapy Aide (L023A) clinical labor 
type, the BLS data reflected an average hourly wage rate of $14.03, 
which we multiplied by the 1.366 benefits modifier and then divided by 
60 minutes to arrive at the proposed per-minute rate of $0.32.
    Table 8 lists our updates to the clinical labor prices. The BLS 
occupational code used as a source of wage data is listed for each 
clinical labor type; for the ``blend'' clinical labor types, this may 
include multiple BLS occupational codes and other clinical labor types 
which were calculated separately and then averaged together. Clinical 
labor types without a direct BLS labor category where we are employing 
a proxy BLS wage rate are indicated with an asterisk in Table 8.
BILLING CODE 4120-01-P

[[Page 65021]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.011

BILLING CODE 4120-01-C
    We proposed to use the 75th percentile of the average wage data for 
the Medical Physicist (L152A) clinical labor type because we believe 
this level

[[Page 65022]]

will most closely fit with the historic wage data for this clinical 
labor type. A Medical Physicist is a specific type of physicist, and 
the available BLS wage data describes the more general category of 
physicist which is paid at a lower rate. In this specific case, the 
75th percentile more accurately describes the clinical labor type in 
question based on how it has historically been paid. We also proposed 
to maintain the current clinical labor pricing for the Behavioral 
Health Care Manager (L057B) clinical labor type rather than update it. 
Although the BLS data reflected a decreased clinical labor rate for the 
Behavioral Health Care Manager labor type, we do not believe that the 
typical wages have decreased for this clinical labor type given that 
every other clinical labor type has increased over the past 5 years 
since the Behavioral Health Care Manager clinical labor type was 
created. The Behavioral Health Care Manager labor type was initially 
established in the CY 2017 PFS final rule (81 FR 80350). It seems more 
likely that we misidentified the proper BLS category for this clinical 
labor type than that wages have decreased since 2017. We believe that 
the clinical labor rate for the Behavioral Health Care Manager should 
be held constant for CY 2022 pending additional public feedback.
    We solicited comments on the updated clinical labor pricing. We 
were particularly interested in additional wage data for the clinical 
labor types for which we lacked direct BLS wage data and made use of 
proxy labor categories for pricing. We understand that the clinical 
labor undertaken by, for example, a Histotechnologist (L037B) is not 
the same as the clinical labor provided by the Health Information 
Technologist category of BLS wage data that we employed as a proxy for 
pricing. Although these occupations are not directly analogous to each 
other in terms of the work they do, we nonetheless believe that the 
proposed crosswalks are appropriate in terms of the resulting hourly 
wage data. We indicated that we would appreciate any additional 
information that commenters could supply both in terms of direct wage 
data, as well as identifying the most accurate types of BLS categories 
that could be used as proxies to update pricing for clinical labor 
types that lack direct BLS wage data. We isolated the anticipated 
effects of the clinical labor pricing update on specialty payment 
impacts by comparing the proposed CY 2022 PFS rates with and without 
the clinical labor pricing updates in place as shown in Table 9.
BILLING CODE 4120-01-P

[[Page 65023]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.012


[[Page 65024]]


[GRAPHIC] [TIFF OMITTED] TR19NO21.013

BILLING CODE 4120-01-C
    The potential effects of the clinical labor pricing update on 
specialty payment impacts were largely driven by the share that labor 
costs represent of the direct PE inputs for each specialty. Specialties 
with a substantially lower or higher than average share of direct costs 
attributable to labor would experience significant declines or 
increases, respectively, if this proposal is finalized. For example, 
the Family Practice specialty had a higher share of direct costs 
associated with clinical labor, and payments to services comprising the 
specialty would be expected to increase as a result of this clinical 
labor pricing update. In contrast, Diagnostic Testing Facilities had a 
lower share of direct costs that are associated with clinical labor, 
and payments to services comprising the specialty would be expected to 
decrease. Other specialty-level payment impacts for the proposed 
clinical labor pricing changes were driven by changes in wage rates for 
a clinical labor category that affects a given specialty more than 
average. One such example would be the proposed increase of 11 percent 
for Oncology nurses as opposed to the average increase for nurses of 63 
percent. We emphasized that these are not the projected impacts by 
specialty of all the policies we proposed in the proposed rule for CY 
2022, only the anticipated effect of the isolated clinical labor 
pricing update, should this clinical labor pricing update be finalized 
as proposed.
    When updates to our payment methodology based on new data produce 
significant shifts in payment, we often consider whether it would be 
appropriate to implement the updates through a phased transition across 
several calendar years. For example, we utilized a 4-year transition 
for the market-based supply and equipment pricing update concluding in 
CY 2022. We are considering the use of a similar 4-year transition to 
implement the clinical labor pricing update. A multi-year transition 
could smooth out the increases and decreases in payment caused by the 
pricing update for affected stakeholders, promoting payment stability. 
However, a phased transition would delay the full implementation of 
updated pricing and continue to rely in part on outdated data for 
clinical labor pricing. We discuss a potential 4-year transition for 
the clinical labor pricing update as an alternative considered in the 
Regulatory Impact Analysis (section VI.I of this final rule).
    We received public comments on our proposal to update the clinical 
labor pricing. The following is a summary of the comments we received 
and our responses.
    Comment: Many commenters supported the proposal to update the 
clinical labor pricing. Commenters overwhelmingly agreed that the BLS 
was the most accurate source of wage data and the best source to use 
for updating the clinical labor pricing. Commenters stated that CMS 
needs recurring and accurate sources of data to keep PE RVUs up to date 
and that such data sources should capture the prices of equipment and 
supplies, wage rates for clinical staff, the types and quantities of 
direct PE inputs, and specialties' practice costs. Commenters stated 
that inaccurate prices for PE inputs could lead to distortions in the 
PE RVUs; for example, updating prices for equipment and supplies but 
not clinical labor could lead to undervaluing of services that use a 
high share of clinical labor. Several commenters stated that, after 
almost 20 years, an update to clinical labor pricing was long overdue. 
Several commenters urged CMS to update the prices for clinical labor 
immediately because inaccurate payment rates distort the market for 
clinician services and further prolonging the necessary improvement in 
CMS' PE RVU methodology will result in additional, unnecessary delays 
for an already overdue pricing update. These commenters recognized that 
this update may negatively impact certain specialties and procedures, 
but stated that the lack of pricing updates has likely disadvantaged 
services that rely heavily on clinical labor, such as family medicine, 
for several years.
    Response: We appreciate the support for our proposed policies from 
the commenters.
    Comment: Many commenters supported the proposal to update the 
clinical labor pricing, but stated that the update should be phased in 
using a 4-year transition. Commenters stated that the use of a 4-year 
transition would be consistent with previous PE updates such as the 
market-based supply and equipment pricing update and the implementation 
of the bottom-up PE methodology. Commenters stated that the phased in 
approach would help minimize the reimbursement reductions to specific 
services which rely heavily on supply and equipment costs that 
otherwise could prove detrimental to Medicare beneficiary access to 
services. Commenters stated that these PE decreases coupled with the 
3.75 percent reduction in the conversion factor resulting from the 
expiration of the temporary increase provided under the CY 2021 
Consolidated Appropriations Act are difficult for practices to absorb 
as the country struggles to contain the COVID-19 pandemic, and that 
mitigating the effects of the clinical labor pricing update through the 
use of a 4-year transition would help maintain payment stability.
    Response: We appreciate the support for the proposed clinical labor 
update from the commenters, with the additional request that we 
implement it using a 4-year transition. After consideration of the 
comments, we agree that the use of a multi-year transition will help 
smooth out the changes in payment resulting from the clinical labor 
pricing update, avoiding potentially disruptive changes in payment for 
affected stakeholders, and promoting payment stability from year-to-
year. We believe it would be appropriate to use a 4-year transition, as 
we have for several other broad-based updates or methodological 
changes. While we recognize 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 agree 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. We believe that the use of a 4-year 
transition in implementing the clinical labor pricing update will help 
to maintain payment stability, particularly given the ongoing public 
health emergency (PHE) for COVID-19.
    We are finalizing the implementation of the clinical labor pricing 
update over 4 years to transition from current prices

[[Page 65025]]

to the final updated prices in CY 2025. We considered, as an 
alternative to our proposal, implementing 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. An example of the 
transition from the current to the fully-implemented new pricing that 
we are finalizing is provided in Table 10.
[GRAPHIC] [TIFF OMITTED] TR19NO21.014

    Comment: A few commenters requested the use of a 2-year transition 
as a timetable that they stated would be more equitable to all impacted 
providers. These commenters stated that if a 2-year timetable was not 
feasible, they would support a 4-year transition over a 1-year 
transition.
    Response: While we appreciate the support from the commenters for 
the proposed clinical labor pricing update and the suggestion from some 
that we use a 2-year transition, we believe that a 4-year transition, 
which is consistent with the way we have implemented prior significant 
updates to resource input pricing and the PE methodology, would meet 
the need to update clinical labor pricing while providing the health 
care provider community time to adjust to the resulting shifts in 
payments, especially during the ongoing PHE.
    Comment: Many commenters disagreed with the proposal to update 
clinical labor pricing and urged that the policy should not be 
finalized, with or without a 4-year transition. These commenters 
objected to proposed reductions in payment for many types of services, 
such as but not limited to services in the fields of radiation 
oncology, peripheral arterial disease, PT/INR home monitoring, flow 
cytometry, cardiovascular disease, and many others. Commenters stated 
that the clinical labor pricing update will limit access to care for 
Medicare patients and will force many Medicare beneficiaries into the 
facility-based system at a significantly higher cost to the Medicare 
program and its patients. Commenters stated that this shift in care to 
the facility-based hospital settings will cause great burdens on an 
already overwhelmed hospital system, exacerbate market consolidation, 
and will adversely affect physicians' ability to provide the right care 
to the right patient at the right time. Commenters stated that patients 
may have to travel farther and wait longer for care, as well as pay 
more out-of-pocket since every single case shifted to the facility 
setting means higher cost-sharing for the affected beneficiary. 
Commenters emphasized the benefits of office-based care for a variety 
of services and argued that clinical labor pricing should not be 
updated as we proposed to help maintain access to office-based care. 
Several commenters stated that the proposed decrease in payment for 
certain services will disproportionately affect women's health and 
racial minorities, with a negative impact on some of the most 
vulnerable of Medicare's beneficiaries.
    Response: We share the concerns expressed by the commenters about 
the need to ensure continued access to quality and affordable care for 
all beneficiaries, in both the office and hospital settings. Under 
section 1848 of the Act, we are required to base payment for services 
under the PFS on relative resource costs. To accomplish that, it is 
necessary periodically to update the information on which we base 
relative values. We believe, and commenters overwhelmingly agreed, that 
the BLS wage data is the best source to use for clinical labor pricing, 
and commenters did not identify alternative sources of data that could 
be used to update pricing. Although we recognize that payment for some 
services will be reduced as a result of the pricing update due to the 
BN requirements of the PFS, we do not believe that this is a reason to 
refrain from updating clinical labor pricing to reflect changes in 
resource costs over time as suggested by some commenters. There are 
also other services, such as those primarily furnished by family 
practice and internal medicine specialties, that will be positively 
affected by the pricing update, which we anticipate will increase 
access to care for disadvantaged groups such as women and racial 
minorities. We also note that for many services that involve 
proportionally more clinical labor, payment rates were reduced as a 
result of the prior market-based supply and equipment pricing update, 
and payment rates will increase with the clinical labor pricing update, 
due to the same PFS BN requirements. We believe that the ongoing trend 
of market consolidation and site of service differentials highlight the 
need to update the overall PE data comprehensively, including a full 
accounting of indirect/overhead costs, to account for current trends in 
the delivery of health care, especially with regard to independent 
versus facility-based practices. We believe that CMS efforts to improve 
pricing accuracy would improve the sustainability of the Medicare PFS 
and the broader health system, improve access to care, and reduce 
inequitable disparities. We believe that the use of a 4-year transition 
in implementing the clinical labor pricing update will help to maintain 
payment stability and mitigate potential negative effects on healthcare 
providers by gradually phasing in the changes over a period of time. We 
believe that this transition period is also important given that the 
PHE for COVID-19 is ongoing and industry recovery is likely to take 
time.
    Comment: Many commenters discussed the direct scaling factor used 
in the calculation of PE RVUs. Commenters stated that updating the 
clinical labor rates is estimated to increase direct PE costs by 30 
percent which would equate to approximately $3.5 billion in total 
additional direct costs. Commenters noted that the direct scaling 
factor was proposed to decrease by 24 percent as a result, from 0.5916 
in 2021 to 0.4468 in 2022, with the net

[[Page 65026]]

effect that Medicare will now reimburse 44 cents on the dollar instead 
of 59 cents on the dollar for direct costs. Commenters stated that many 
services require the use of expensive supplies with considerable 
capital costs that need to be stocked and readily available. Commenters 
stated that they did not believe the cost of this labor rate update 
should be borne disproportionately by equipment and supply-heavy 
services, which are the services least able to accommodate sharp and 
sudden payment reductions since equipment costs are fixed. Many 
commenters stated that the proposed policy would place a huge and 
unfair burden on specialties that require expensive supplies and 
equipment; commenters stated that the high costs of maintaining this 
equipment remain the same whether or not the equipment is used. 
Commenters stated that the proposed policy would result in wildly 
fluctuating shifts in reimbursement, violating a core principle of the 
resource-based relative value system which is to stabilize RVUs and 
reduce fluctuations in year-to-year payments. Commenters stated that if 
payments change drastically, there is no way to accommodate those 
shifts through operating expenses without cuts elsewhere, including to 
staff and services offered. Commenters stated that CMS should explore 
options to adjust the scaling factor(s) in order to more appropriately 
reimburse for expenses incurred to treat their beneficiaries.
    Response: We appreciate the estimate provided by commenters of the 
additional spending on direct costs as a result of the proposed 
clinical labor pricing update. However, we disagree with the commenters 
that updating the clinical labor pricing to make use of current wage 
data constitutes an unfair burden or has an inappropriate 
disproportionate impact on certain services. The PFS is a resource-
based relative value payment system that necessarily relies on accuracy 
in the pricing of resource inputs. Continuing to use clinical labor 
cost data that are nearly 2 decades old would create distortions in 
relativity that undervalue many services which involve a higher 
proportion of clinical labor. As noted previously, payment for services 
that involve a higher proportion of clinical labor resources was 
negatively affected by the prior market-based supply and equipment 
pricing update as a result of the same BN requirements and will now be 
positively affected by the clinical labor pricing update. We do not 
agree that updates to pricing for the three categories of direct PE 
(clinical labor, supplies and equipment), create an unfair burden for 
individual services. We do agree with commenters that the impact of the 
proposed clinical labor pricing update is substantial, which is why we 
believe it is appropriate to use a 4-year transition to implement the 
pricing update. We believe the use of this transition will help address 
the concerns of the commenters about stabilizing RVUs and reducing 
large fluctuations in year-to-year payments.
    Comment: Several commenters requested that CMS maintain the CY 2021 
direct scaling factor of 0.5916 if the agency chooses to finalize the 
clinical labor pricing update.
    Response: Under our current PE methodology, we calculate a direct 
PE scaling adjustment to ensure that the aggregate pool of direct PE 
costs does not vary from the aggregate pool of direct PE costs for the 
current year. (This calculation is described in more detail in the ``PE 
RVU Methodology'' section earlier in this rule.) In other words, the 
direct scaling adjustment ensures that the share of direct PE remains 
constant from year to year. If we continued to maintain the direct 
scaling factor from a previous calendar year, without making any 
adjustment to account for the total direct costs increasing as a result 
of the clinical labor pricing update, the amount of PFS spending 
allocated to direct PE would increase at the expense of all other 
spending. This would negatively affect the valuation of many services 
that have few or no direct PE inputs. It would also result in a 
substantial negative adjustment to the conversion factor under the 
statute's BN requirements as the total number of PE RVUs would increase 
and would need to be offset through the conversion factor. We do not 
agree that it would be appropriate to maintain the direct scaling 
factor from a previous calendar year; we did not propose to update our 
PE methodology and we are not finalizing any changes in the 
methodology.
    Comment: Several commenters suggested that CMS spread the cost of 
the clinical labor update across both the direct and indirect PE pools. 
Commenters stated that this suggestion would allocate approximately 27 
percent of the additional costs to the direct cost pool and 73 percent 
to the indirect cost pool. Commenters stated that this change would 
result in minimal changes in allowed charges for specialties such as 
general practice and family medicine, as compared with the changes that 
would result from the proposed approach.
    Response: We disagree with the commenters that it would be 
appropriate to spread the increased spending from the clinical labor 
pricing update across both the direct and indirect PE pools, as opposed 
to solely the direct pool as proposed. This suggested change to the PE 
methodology would have an effect similar to continuing to maintain the 
direct scaling factor from previous calendar years, that is, the amount 
of PFS spending allocated to direct PE would increase at the expense of 
all other spending. In particular, services that have a higher 
proportion of indirect PE would be negatively affected as increases in 
the direct PE pool would be subsidized by the indirect PE pool. We do 
not believe that this would appropriately carry out the statute's 
directive to value services based on relative resource costs. We did 
not propose to update our PE methodology and we are not finalizing any 
changes in the methodology.
    Comment: Several commenters suggested that CMS consider scaling the 
clinical labor and equipment/supply components of the direct PE pool 
separately. Commenters stated that based on the CY 2014 PFS final rule, 
it appeared that the clinical labor component of the pool should be 
weighted at 4.636 percent of PFS expenditures, and should not exceed 
about 66 percent of the direct cost pool.
    Response: We disagree with the commenter that the three components 
of direct PE (clinical labor, supplies, and equipment) should be should 
be scaled separately instead of together. This would have the effect of 
freezing the portion of direct PE allocated to each of the three 
components; if we were to make this change to the PE methodology, 
updating the clinical labor pricing would not allocate any additional 
valuation to clinical labor at all. It would merely shift the 
relationship between the individual clinical labor types as they were 
re-priced. The clinical labor component of direct PE has not been 
updated since 2002, while supply and equipment pricing has been updated 
more recently. The commenters' suggested change to the PE methodology 
would lock in place the relativity between direct PE components at a 
particular time. We believe that this would be inconsistent with the 
statute's directive to value services based on relative resource costs. 
As noted above, we did not propose to modify our PE methodology, and we 
are not finalizing any changes in the methodology.
    Comment: Several commenters stated that they had performed an 
analysis suggesting that the proportion of PFS expenditures allocated 
to direct PE may have shrunk from the proportion

[[Page 65027]]

adopted in 2014. Commenters requested that CMS examine whether, and to 
what extent, the total PE pool has been reduced over time, and, if so, 
requested that it be restored.
    Response: As explained above, the direct scaling adjustment ensures 
that the share of direct PE (and therefore, also indirect PE) remains 
constant from year to year. We can confirm for the commenters that our 
application of BN adjustments, which is required by statute, has 
maintained the total PE pool over time.
    Comment: Several commenters referred to the decrease in the direct 
scaling factor and stated that this would cause huge second order 
effects that are not being considered by CMS. Commenters stated that 
the result would be a PFS that is ever more out of touch with reality 
as conversion factors, direct adjustment factors, and other factors 
make the PFS less and less reflective of what it actually takes to 
provide services in the office.
    Response: We disagree with the commenters that our proposed 
clinical labor update makes the PFS less reflective of the real-world 
cost of providing services. We believe that updating clinical labor 
rates to reflect current pricing has the opposite effect, appropriately 
improving recognition of current clinical labor costs in the PFS 
methodology.
    Comment: Several commenters stated that the PPIS data which 
underlie the share of PE allocated to direct PE and indirect PE are 
outdated, and that it was unreasonable to cap updated direct costs 
based on direct/indirect cost splits from 2006. Commenters stated that 
if the updated clinical labor pricing had been in effect in 2006, then 
direct costs undoubtedly would have constituted a larger proportion of 
the overall PE pool.
    Response: We have no doubt that if the clinical labor pricing in 
2006 had been based on BLS wage data from 2019, direct costs would have 
constituted a larger proportion of the overall PE pool. However, it is 
inappropriate to make use of wage data from 2019 and compare it to the 
direct/indirect cost splits from 2006 without also acknowledging that 
indirect costs such as administrative expenses and office rent have 
also greatly increased over the intervening span of time. While we 
share the concerns of the commenters that the PPIS data used in the PE 
methodology date back more than a decade, we have no evidence at 
present to indicate that direct costs have increased faster than 
indirect costs since 2006, or vice versa. As we noted in the CY 2021 
PFS final rule (85 FR 84498 through 84499) and again in this rule, the 
RAND corporation is currently studying potential improvements to our PE 
allocation methodology and the data that underlie it. We are interested 
in exploring ways that the PPIS data can be updated; however, we do not 
believe that this constitutes a reason to refrain from updating the 
clinical labor pricing.
    Comment: Several commenters referenced the BN requirements for the 
PFS that are included in the statute. Commenters stated that no 
adjustments to the $20 million threshold for BN have been made to 
account for new technology in over 30 years. Commenters stated that CMS 
should publish how the annual $20 million restriction on changes to 
expenditures could have played a role in the clinical labor updates.
    Response: Section 1848(c)(2)(B)(ii)(II) of the Act requires that 
increases or decreases in RVUs may not cause the amount of 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 BN. As this is a statutory 
requirement of the PFS, we are required by law to apply BN adjustments 
to offset the spending impact of any changes exceeding $20 million; 
given the roughly $100 billion in spending associated with the PFS, 
this threshold is exceeded each calendar year by a wide margin. A BN 
adjustment would be avoided only if updating the clinical labor pricing 
failed to reach this $20 million threshold. We found that the estimated 
effect of the proposed clinical labor pricing update was approximately 
$3.5 billion, with our analysis matching the figure supplied by 
commenters, which far exceeds the $20 million threshold. Therefore, we 
were required by statute to make BN adjustments to reflect the expected 
effects of the clinical labor pricing update. We also note that as the 
BN requirement is statutory in nature, we do not have discretion to 
adjust it for new technology or other changes that may have taken 
place.
    Comment: Several commenters urged CMS to use its discretion to 
waive BN in implementing the proposed update to clinical labor pricing. 
Other commenters urged CMS to hold harmless the specialties that are 
bearing the brunt of this proposal and consider alternative ways to 
update clinical labor pricing. Several commenters stated that updated 
clinical labor pricing should not be done within the confines of a 
budget neutral system, unless there were concomitant inflationary 
updates to the entire fee schedule.
    Response: As mentioned above, BN adjustments are a statutory 
requirement of the PFS. We do not have discretion within the terms of 
the statute to waive BN or hold individual specialties harmless in 
implementing the clinical labor pricing update.
    Comment: One commenter stated that while CMS has broad discretion 
to determine and adjust RVUs for physician services, CMS cannot make 
arbitrary changes to RVUs. The commenter stated that CMS must give a 
reasoned explanation for adjustments it makes for certain codes, and 
those explanations must relate to the relative resource use for a 
particular service. The commenter stated that the requirement to 
maintain BN does not authorize the agency to ignore the general rule 
that RVUs, and their individual components, must be based on relative 
resource use. The commenter stated that unless CMS can articulate how 
the relative cost of the other PE inputs--like supplies and medical 
equipment--has gone down, the agency is not authorized to decrease the 
value of those inputs. The commenter stated that CMS is only authorized 
to apply a BN adjustment across all RVUs and the BN provisions do not 
authorize CMS to manipulate the inputs to the two RVU components.
    Response: We disagree with the commenter that we have proposed 
arbitrary changes to the valuation of individual services; we detailed 
the methodology behind our proposed clinical labor pricing update and 
provided an opportunity for commenters to submit feedback through 
notice and comment rulemaking. We believe that updating the clinical 
labor pricing makes the relative resource use basis dictated by the 
statute more accurate, not less accurate, for the valuation of 
services. While the relative resource cost of the other non-clinical 
labor direct PE inputs, such as supplies and equipment, would in fact 
decrease for CY 2022 based on our proposed update to clinical labor 
pricing, they have only decreased in relative terms because the PFS is 
based on the use of RVUs as part of a budget neutral methodology. We 
note again that the use of a 4-year transition in implementing the 
clinical labor pricing update should help to mitigate potential 
negative effects of these shifts in relative resource costs by 
spreading them out over a longer period of time.
    Comment: Several commenters stated that the specialty impacts 
tables isolating the effects of the clinical labor pricing update in 
the CY 2022 PFS proposed rule were misleading. Commenters stated that 
in reality the negative impact for many services was

[[Page 65028]]

much greater than displayed on these tables. Commenters stated that it 
would be more transparent to share impacts for individual services when 
they had a potentially large negative effect on providers of office-
based procedures with high supply and equipment costs.
    Response: Although we share the concerns of commenters regarding 
the importance of providing transparency in the published data, we 
disagree that the specialty impacts tables included in the CY 2022 PFS 
proposed rule were misleading, or that commenters lacked sufficient 
information about the pricing of individual services. We noted in the 
CY 2022 PFS proposed rule (86 FR 39532) that the impact tables are for 
illustrative purposes for aggregate impacts on specialties, and are not 
meant to be code specific; 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. 
This has been a feature of the specialty impact tables published in the 
PFS for many years, and we believe it is generally well understood by 
stakeholders. We also note that the proposed RVUs for every HCPCS code 
were published in Addendum B as part of the CY 2022 PFS proposed rule 
to allow stakeholders the opportunity to provide comment on the 
proposed valuations for each code. Due to the thousands of HCPCS codes 
affected by the clinical labor pricing update, we did not publish a 
service-level analysis of the pricing update in the preamble, but did 
include this information in Addendum B for consideration by 
stakeholders. We will consider suggestions to improve the information 
available to stakeholders for future rulemaking.
    Comment: Many commenters noted that 14 of the 32 clinical labor 
staff types had proposed valuations using a BLS crosswalk because an 
exact match was not available. Commenters stated that to maintain 
transparency CMS should publish the ``other sources'' wage data details 
for these clinical labor types. Commenters stated that CMS should 
update specific clinical labor wage rates based on stakeholder comments 
and data.
    Response: We agree with the commenters that stakeholder comments 
and data will be valuable in updating the clinical labor pricing, and 
we share the concerns of the commenters regarding transparency in the 
data used for pricing. As we stated in the proposed rule, we used the 
national salary data from the Salary Expert as a reference for pricing, 
then crosswalked these clinical labor types to a proxy BLS labor 
category rate that most closely matched the reference wage data. 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 for Mammography Technologists as a reference and 
identified the BLS wage data for Respiratory Therapists as the best 
proxy category. In the interest of transparency, Table 11 lists the 
Salary Expert wage data used for the clinical labor types which did not 
have direct BLS matches.
[GRAPHIC] [TIFF OMITTED] TR19NO21.015

    Comment: Many commenters stated that CMS proposed to utilize the 
mean wage data to establish updated clinical labor rates, while the 
majority of the data inputs for the PFS are based on the median value. 
Commenters used as an example how RUC recommendations for work RVUs, 
work times, and direct PE inputs were based on the median or typical 
case. Commenters requested that CMS use the median wage data, instead 
of mean wage data, to more accurately capture typical wage rates and to 
be consistent with the median statistic used for clinical staff time.
    Response: We appreciate the feedback from the commenters regarding 
the use of mean versus median wage data in updating the clinical labor 
pricing. Based on the feedback from the commenters, we agree that the 
use of median BLS wage data would be more appropriate than average or 
mean wage data. We agree that the median value is less susceptible to 
outlier values, and therefore, better captures the ``typical'' case. We 
will use the median wage data when finalizing the pricing for the 
clinical labor update.
    Comment: Many commenters disagreed with the proposal to use the 
same fringe benefits multiplier of 1.366 that was utilized during the 
previous clinical labor pricing in CY 2002. Commenters stated that 
using the fringe benefits multiplier rate from 20 years ago was not 
consistent with CMS' premise for updating the clinical labor pricing 
which was to maintain relativity

[[Page 65029]]

with the recent supply and equipment pricing updates. Commenters stated 
that the BLS publishes benefits data routinely and that CMS should use 
a current fringe benefits multiplier; many commenters suggested using a 
multiplier of 1.296 from the most recent available BLS data.
    Response: We agree with the commenters that it would be appropriate 
to use a more current fringe benefits multiplier as opposed to our 
proposal to use the same multiplier from 2002. According to a BLS 
release from June 17, 2021 (USDL-21-1094), the current fringe benefits 
multiplier for employees in private industry is 1.296, as noted and 
requested by the commenters. We believe that this will be more 
appropriate than the proposed fringe benefits multiplier of 1.366 from 
2002.
    Comment: Many commenters requested that CMS should delay the 
implementation of the clinical labor pricing update for one year, or 
finalize a 5-year transition with no update in the first year which was 
functionally the same request. Commenters stated that the current 
clinical labor proposal requires additional analysis and modifications 
prior to implementation and there was further work to be done by both 
CMS and stakeholders to ensure accurate data are used and appropriate 
methodological steps are taken for implementation. Some commenters 
stated that CMS should wait until after the market-based supply and 
equipment pricing update was concluded before beginning the process of 
updating clinical labor pricing. Many commenters mentioned the negative 
impacts of the ongoing COVID-19 PHE and the finalization of updated 
values for E/M visits in last year's CY 2021 PFS final rule as reasons 
to delay the clinical labor pricing update for a year.
    Response: We disagree that the clinical labor pricing update should 
be delayed for another year before beginning the 4-year implementation 
timeline. We do not agree that delaying the pricing update will provide 
meaningful improvements in our data; commenters overwhelmingly agreed 
that BLS data was the best choice and did not suggest alternative 
sources of wage data which would have required additional research. In 
places where we made use of crosswalks to value individual clinical 
labor types, commenters provided helpful feedback (see discussion 
below) and will continue to have the opportunity to provide further 
engagement over the course of the 4-year implementation timeline. It is 
not clear to us what further work the commenters believe must be done 
to ensure appropriate clinical labor pricing given the near-universal 
support for the use of BLS wage data for the update. While we share the 
concerns of commenters regarding the effects of the ongoing COVID-19 
pandemic, we believe that the use of a 4-year transition in 
implementing the clinical labor pricing update will help to maintain 
payment stability and mitigate potential negative effects on healthcare 
providers. Given that the statute requires PFS payment to be based on 
relative resource costs, and that the proposed update to clinical labor 
wages using the latest available BLS data was overwhelmingly supported 
by commenters, we do not believe that we should delay the transition 
from outdated pricing from 2002. All of the same issues concerning 
redistribution of payments through BN will still remain in place 
whether the clinical labor pricing update begins in CY 2022 or CY 2023.
    Comment: One commenter stated that CMS should delay any repricing 
of clinical labor until it can also collect the latest prices paid for 
medical equipment and supplies. The commenter stated that this would 
ensure all updated prices for direct cost inputs used in setting PE 
payment are factored into Medicare physician rates concurrently.
    Response: CY 2022 is the final year of the market-based supply and 
equipment pricing transition; we proposed to begin implementing the 
update to clinical labor pricing in this calendar year so that it could 
take place in conjunction with a portion of the supply and equipment 
pricing update. We agree with the commenter that it is important to 
update the clinical labor pricing to maintain relativity with the 
recent supply and equipment pricing updates.
    Comment: Several commenters stated that CMS is currently 
considering more significant future changes to the PE methodology as 
explained at a June 16, 2021 Town Hall meeting (further details 
available on the CMS website at https://www.cms.gov/medicare/physician-fee-schedule/practice-expense-data-methods). Commenters stated that 
given the potential for significant future updates to the data or PE 
methodology that could also have major impacts, CMS should postpone the 
update to clinical labor pricing until those changes can be analyzed in 
combination with other major changes to the PE methodology.
    Response: As we noted in the CY 2021 PFS final rule (85 FR 84498 
through 84499) and again in this rule, the RAND corporation is 
currently studying potential improvements to CMS' PE allocation 
methodology and the data that underlie it. We are interested in 
exploring ways that the PE methodology can be updated; however, we do 
not believe that this constitutes a reason to refrain from updating the 
clinical labor pricing or delay the implementation of the pricing 
update. We will employ a 4-year transition period for the clinical 
labor pricing update in order to provide payment stability and soften 
the effects of the pricing update in each calendar year.
    Comment: Several commenters stated that the BLS is planning an 
update to the estimation methodology for the Occupational Employment 
and Wage Statistics (OEWS) survey next year that may impact their wage 
data. Commenters stated that although they could not predict the impact 
of these modifications, it is possible the revised BLS methodology will 
result in important changes to the hourly wage estimates that CMS 
proposed to use to update clinical labor pricing. Several commenters 
requested delaying the implementation of the clinical labor pricing 
update for one year to make use of updated BLS wage data.
    Response: We appreciate the feedback from the commenters regarding 
ongoing improvements to the BLS methodology for the OEWS. However, we 
do not agree that this is a sufficient justification for continuing to 
maintain current clinical labor prices for another year. The BLS 
routinely updates its wage data and searches for ways to improve the 
survey methodology. We also note that the commenters who brought this 
issue to our attention stated that they could not predict the impact of 
these BLS methodological changes which we believe argues against 
delaying the pricing update for another year. We believe that the 2019 
wage data from the BLS will certainly be an improvement over the 
current 2002 data, and we will continue to review and evaluate future 
BLS wage data to consider whether it would be appropriate to propose to 
incorporate them into the clinical labor pricing update during the 
course of the 4-year transition period or otherwise through future 
rulemaking.
    Comment: One commenter stated that CMS appeared to have used only 
the BLS OEWS survey; however, when CMS last updated these data in 2002, 
CMS also leveraged the BLS National Compensation Survey (NCS). The 
commenter stated that while the OEWS survey can produce estimates at 
metropolitan statistical areas (MSAs), the NCS can produce estimates at 
the national and census region level. The commenter stated that OEWS 
wage estimates represent only wages and salaries and do not include 
nonwage

[[Page 65030]]

benefits, such as health insurance, retirement contributions, and 
bonuses; whereas NCS data also includes nonwage benefits. The commenter 
stated that CMS used the national median wage across all employer types 
rather than the wage for physician office employers, and the commenter 
believed that CMS should use the physician office setting of care where 
possible rather than a median (or average) across all employer types.
    Response: We appreciate the feedback from the commenters regarding 
additional aspects of the wage data provided by the BLS. We are aware 
that OEWS wage estimates represent only wages and salaries and do not 
include nonwage benefits, which is why we included a fringe benefits 
multiplier in our clinical labor pricing update as discussed above. We 
disagree with the commenter that using the physician office setting of 
care rather than a median across all employer types would be more 
accurate for clinical labor pricing; clinical labor is employed in many 
different sites of service, not solely in the physician office setting. 
We encourage commenters to submit additional information regarding 
clinical labor pricing, especially wage data for individual clinical 
labor types, during future rulemaking, especially over the course of 
the 4-year transition period for the update to clinical labor pricing.
    Comment: Many commenters requested that CMS update pricing data on 
a more frequent basis for all inputs so that adjustments will not be as 
dramatic. Commenters stated that more frequent updates would prevent 
significant redistributive effects to specialties in the future and 
help ensure stability in payments. Commenters stated that CMS should 
make year-to-year payment stability a goal of the PFS, and large 
redistributive impacts on payment should occur infrequently.
    Response: We agree with the commenters that the pricing data that 
underlie the PE methodology should be updated frequently to ensure its 
accuracy. For this reason, we believe that it is important to begin the 
transition process of updating the clinical labor pricing for CY 2022. 
We agree that more frequent updates to all direct PE inputs, clinical 
labor and supplies and equipment, would help to maintain payment 
stability across the PFS.
    Comment: Several commenters recommended that CMS address the 
problems related to high-cost supplies by establishing Healthcare 
Common Procedure Coding System (HCPCS) Level II codes for supplies that 
exceed $500. Commenters stated that the establishment of individual 
coding for high cost supplies would help maintain patient access to 
care in the office setting by offsetting the projected decreases in 
payment from the clinical labor pricing update.
    Response: We did not make any proposals to establish HCPCS Level II 
codes for high cost supplies. We have received in previous rulemaking 
cycles a number of prior requests from stakeholders, including the RUC, 
to implement separately billable alpha-numeric Level II HCPCS codes to 
allow practitioners to be paid for high cost disposable supplies per 
patient encounter instead of in connection with payment for the CPT 
code with which the supplies are furnished. We stated at the time, and 
we continue to believe, that this option presents a series of potential 
problems that we have addressed previously in the context of the 
broader challenges regarding our ability to price high cost disposable 
supply items. (For a discussion of this issue, we direct the reader to 
our discussion in the CY 2011 PFS final rule with comment period (75 FR 
73251)).
    Comment: One commenter stated that, as participating practitioners 
in the Medicare program, audiologists should not be included in the 
proposed clinical labor pricing update. The commenter stated that they 
are performing professional services for which they are billing 
Medicare independently, and should not be assigned any additional 
clinical labor time for their efforts. The commenter stated that this 
oversight has created significant rank order anomalies within the 
audiology code family as included in the proposed rule. The commenter 
identified several CPT codes which they stated contained significant 
rank order anomalies and requested again that audiologists be removed 
from the labor update pool.
    Response: We would like to clarify for the commenter that we are 
proposing to update the rates for individual clinical labor types, not 
updating the pricing for individual specialties. The statute requires 
that valuation under the PFS is to be based on relative resource costs; 
as such, we do not believe that an individual clinical labor type could 
be priced at one rate when billed by some specialties and at a 
different rate when billed by other specialties. If the commenter 
believes that certain CPT codes have rank order anomalies in their 
valuation, we encourage them to nominate those codes as potentially 
misvalued for our additional review; see section II.C of this final 
rule (Potentially Misvalued Services under the PFS) for additional 
information.
    After consideration of the comments detailed above, we are 
finalizing our proposal to implement the clinical labor pricing update 
through the use of a 4-year transition, with modifications. Rather than 
using the proposed BLS fringe benefits multiplier and the BLS mean wage 
data, in response to public comments, we will apply the BLS private 
industry fringe benefits multiplier for 2019 and use the BLS median 
wage data.
    We also received a number of comments regarding the pricing of 
individual clinical labor types which are summarized along with our 
responses below. We note that, given our final policy to use the BLS 
median wage data instead of mean as we had proposed, we refer in our 
responses below to the median wage data.
    Comment: Several commenters stated that they supported the proposal 
to use BLS category 19-1040 (Medical Scientist) for the Vascular 
Technologist (L054A) clinical labor type. Commenters stated that both 
vascular technologists and medical dosimetrists play critical roles in 
independently providing clinically accurate, reproducible and high-
quality data for physician decision making. Commenters stated that 
although they did not have additional wage data to offer, they believed 
that the proposed crosswalk for the L054A clinical labor type is 
appropriate in terms of the resulting hourly wage rate and level of 
technical skill, physical and mental effort, judgment and stress 
relative to other professions utilizing ultrasound.
    Response: We appreciate the support from the commenters for our 
proposed pricing of the Vascular Technologist (L054A) clinical labor 
type.
    Comment: One commenter stated that they supported the proposed 
pricing of the Mammography Technologist (L043A), CT Technologist 
(L046A), and Vascular Technologist (L054A) clinical labor types based 
on their individual BLS categories.
    Response: We appreciate the support from the commenter for our 
proposed clinical labor pricing.
    Comment: Several commenters noted that the Angio Technician (L035A) 
clinical labor type does not have a direct BLS labor category and CMS 
proposed using BLS category 29-9000 (Other Healthcare Practitioners and 
Technical Occupations) at $27.20 as the proxy BLS wage rate. Commenters 
stated that they believed the Angio Technician was best represented by 
an advanced level VI certified Radiologic Technologist or an MR 
technologist. Commenters stated that according to the BLS, the median 
annual wage for magnetic resonance

[[Page 65031]]

imaging technologists was $74,690 in May 2020, and the median annual 
wage for radiologic technologists and technicians was $61,900 in May 
2020. Commenters recommended using BLS category 29-2035 Magnetic 
Resonance Imaging (MRI) Technologist as the proxy BLS wage rate for the 
Angio Technician clinical labor type.
    Response: We appreciate the additional information provided by the 
commenters concerning the pricing of the Angio Technician (L035A) 
clinical labor type. However, we disagree that a Magnetic Resonance 
Imaging (MRI) Technologist described under BLS category 29-2035 would 
be the most appropriate choice to use in pricing the L035A clinical 
labor type. The median hourly wage for a Magnetic Resonance Imaging 
(MRI) Technologist under this BLS category is $35.30 while the hourly 
wage data for an Angio Technician that we have from Salary Expert is 
only $26.81. As such, we disagree that MRI Technologist would be an 
appropriate crosswalk for valuation. However, in response to the 
additional certification information provided by the commenters for 
this occupation, we are modifying our proposed crosswalk. We will 
instead crosswalk the Angio Technician to the Lab Tech/
Histotechnologist (L035A) clinical labor type with a median hourly rate 
of $26.63 (or an annual rate of $55,390). We believe that this 
crosswalk better matches the wage data that we have available from 
Salary Expert for Angio Technicians.
    Comment: Several commenters stated that CMS updated the RN/OCN 
(L056A) clinical labor type in CY 2004, which had been previously 
updated in 2002, with survey data provided by the American Society of 
Clinical Oncology (ASCO). Commenters noted that the proposed pricing 
for the L056A clinical labor type increased by only 11 percent, the 
third lowest increase among the 50 clinical labor types proposed in the 
update; and the commenters were concerned that the ASCO wage data were 
not appropriately captured in the proposed update. Commenters stated 
that the RN/OCN clinical labor type, which was proposed at a rate only 
3.5 percent higher than the regular RN (L051A) clinical labor type, is 
clearly undervalued and should receive an upward adjustment prior to 
finalizing the clinical labor pricing update. Commenters urged CMS to 
delay implementation of the labor price update until they could work 
with the agency to establish an accurate methodology and labor price 
inputs for current RN/OCN labor.
    Response: We appreciate the additional information provided by the 
commenter regarding the historical pricing of the RN/OCN (L056A) 
clinical labor type, and we will be happy to consider any wage data 
that they can provide. However, we did not receive any additional data 
from the commenter to be used in pricing the L056A clinical labor type, 
and in the absence of other information on current wage rates, we 
believe that our proposed use of BLS category 29-2033 (Nuclear Medicine 
Technologists) at $37.48 remains the most appropriate accurate pricing 
for L056A. We welcome the submission of additional pricing data for the 
RN/OCN clinical labor type in future rulemaking cycles, particularly 
over the course of the 4-year transition period.
    Comment: One commenter provided recommendations on the pricing of 
several clinical labor types, as indicated in the next 13 comment 
summaries and responses. The commenter disagreed that BLS category 29-
9098 (Health Information Technologists, Medical Registrars, Surgical 
Assistants, and Healthcare Practitioners and Technical Workers, All 
Other) at an hourly rate of $28.17 was the correct crosswalk for the 
Histotechnologist (L037B) clinical labor type. The commenter stated 
that BLS category 29-2010 (Clinical Laboratory Technologists and 
Technicians) more accurately describes the clinical staff type 
associated with Histotechnologists.
    Response: We appreciate the additional information provided by this 
commenter concerning the pricing of the Histotechnologist (L037B) 
clinical labor type and the others that follow. We reviewed the request 
from the commenter and we agree that BLS category 29-2010 is a more 
appropriate crosswalk for the L037B clinical labor type, which has an 
updated median hourly wage of $25.54. This BLS category is a close 
match for the wage data that we have from the Salary Expert reference 
information that we discussed above.
    Comment: The same commenter disagreed that BLS category 21-1023 
(Mental Health and Substance Abuse Social Workers) at an hourly rate of 
$24.84 was the correct crosswalk for the Child Life Specialist (L037E) 
clinical labor type. The commenter stated that a child life specialist 
was described as a professional armed with a strong background in child 
development and family systems who promotes effective coping through 
play, preparation, education, and self-expression activities--not child 
mental health or substance abuse treatment. The commenter stated that 
that BLS category 21-1021 (Child, Family, and School Social Workers) 
more accurately describes the clinical staff type associated with 
Orthoptists.
    Response: We reviewed the request from the commenter and we agree 
that BLS category 21-1021 is a more appropriate crosswalk for the L037E 
clinical labor type, which has an updated median hourly wage of $22.78. 
This BLS category is a close match for the wage data that we have from 
the Salary Expert reference information that we discussed above.
    Comment: The commenter disagreed that BLS category 31-2011 
(Occupational Therapy Assistants) at an hourly rate of $29.75 was the 
correct crosswalk for the Cardiovascular Technician (L038B) clinical 
labor type. The commenter stated that BLS category 29-2031 
(Cardiovascular Technologists and Technicians) was a direct crosswalk 
for the L038B clinical labor type.
    Response: We reviewed the request from the commenter and we agree 
that BLS category 29-2031 is a more appropriate crosswalk for the L038B 
clinical labor type, which has an updated median hourly wage of $27.75. 
This BLS category is a close match for the wage data that we have from 
the Salary Expert reference information that we discussed above.
    Comment: The commenter disagreed that BLS category 29-1126 
(Respiratory Therapists) at an hourly rate of $30.75 was the correct 
crosswalk for the Mammography Technologist (L043A) clinical labor type. 
The commenter stated that BLS category 29-2034 (Radiologic 
Technologists and Technicians) more accurately describes the clinical 
staff type associated with Mammography Technologists.
    Response: We reviewed the request from the commenter and we agree 
that BLS category 29-2034 is a more appropriate crosswalk for the L043A 
clinical labor type, which has an updated median hourly wage of $29.09. 
This BLS category is a close match for the wage data that we have from 
the Salary Expert reference information that we discussed above.
    Comment: The commenter disagreed with crosswalking the Certified 
Surgical Technician (CST) to BLS category 19-4010 (Agricultural and 
Food Science Technicians) at an hourly rate of $21.37 as part of the 
blended COMT/COT/RN/CST (L038A) clinical labor type. The commenter 
stated that BLS category 29-2055 (Surgical Technologist) was a direct 
crosswalk for the L038A clinical labor type.
    Response: We believe that there may have been a misunderstanding on 
the part of the commenter; we proposed to crosswalk Certified Surgical

[[Page 65032]]

Technicians to BLS category 29-2061, not BLS category 19-4010, at a 
median hourly rate of $22.83. There may have been some confusion 
regarding the COT and CST clinical labor types in this blend. 
Nevertheless, we reviewed the request from the commenter and we agree 
that BLS category 29-2055 is a more appropriate crosswalk for the CST 
portion of the L038A clinical labor type. This BLS category has a 
median hourly rate of $23.22 which was very similar to our previous 
pricing of $22.83. After we ran this updated rate for the CST through 
the blended methodology for the L038A clinical labor type, the per-
minute pricing (including the fringe benefits multiplier) remained 
unchanged at $0.52.
    Comment: The commenter disagreed that BLS category 29-2010 
(Clinical Laboratory Technologists and Technicians) at an hourly rate 
of $26.34 was the correct crosswalk for the Certified Retinal 
Angiographer (L039A) clinical labor type. The commenter stated that BLS 
category 29-9000 (Other Healthcare Practitioners and Technical 
Occupations) or BLS category 29-2057 (Ophthalmic Medical Technician) 
more accurately described the clinical staff type associated with 
Certified Retinal Angiographers.
    Response: We reviewed the request from the commenter and we agree 
that BLS category 29-9000 is a more appropriate crosswalk for the L039A 
clinical labor type, which has an updated median hourly wage of $23.93. 
The other suggested crosswalk to BLS category 29-2057 had a median 
hourly wage of $17.76, which did not fit with the data that we had from 
Salary Expert for Certified Retinal Angiographers; we believe the 
crosswalk to BLS category 29-9000 is a more appropriate choice.
    Comment: The commenter disagreed that BLS category 29-1141 
(Registered Nurses) at an hourly rate of $37.24 was the correct 
crosswalk for the Orthoptist (L037C) clinical labor type. The commenter 
stated that that BLS category 29-2057 (Ophthalmic Medical Technician) 
more accurately describes the clinical staff type associated with 
Orthoptists. The commenter also stated that the L037C clinical labor 
type is incorrectly assigned to the CPT code 62304. The commenter 
stated that the correct clinical labor type for CPT code 62304 should 
be L037D (RN/LPN/MTA), not L037C.
    Response: We disagree with the commenter that an Ophthalmic Medical 
Technician described under BLS category 29-2057 would be the most 
appropriate choice to use in pricing the L037C clinical labor type. The 
median hourly wage for an Ophthalmic Medical Technician under this BLS 
category is $17.76 while the hourly wage data for an Orthoptist that we 
have from Salary Expert is substantially higher at $37.41. We continue 
to believe that our crosswalk to BLS category 29-1141 is a more 
appropriate choice for valuation. While we appreciate the feedback from 
the commenter, we reviewed CPT code 62304 and we did not find any 
errors in its clinical labor inputs. We did not propose to change the 
clinical labor type for CPT code 62304 and we are not finalizing any 
changes to the clinical labor types of this CPT code at this time.
    Comment: The commenter disagreed that BLS category 21-1029 (Social 
Workers, All Other) at an hourly rate of $29.69 was the correct 
crosswalk for the Psychometrist (L039C) clinical labor type. The 
commenter stated that BLS category 31-1133 (Psychiatric Aide) more 
accurately describes the clinical staff type associated with 
Psychometrists.
    Response: We disagree with the commenter that a Psychiatric Aide 
described under BLS category 31-1133 would be the most appropriate 
choice to use in pricing the L039C clinical labor type. The median 
hourly wage for a Psychiatric Aide under this BLS category is $14.96 
while the hourly wage data for a Psychometrist that we have from Salary 
Expert is substantially higher at $29.29. We continue to believe that 
our crosswalk to BLS category 21-1029 is a more accurate choice for 
valuation.
    Comment: The commenter disagreed that BLS category 29-9000 (Other 
Healthcare Practitioners and Technical Occupations) at an hourly rate 
of $27.22 was the correct crosswalk for the Angio Technician (L041A) 
clinical labor type. The commenter stated that BLS category 29-2034 
(Radiologic Technologists and Technicians) was the previous BLS 
crosswalk used during the 2002 pricing of clinical labor and remains 
the correct crosswalk for an angiography technician.
    Response: We disagree with the commenter that a Radiologic 
Technologist described under BLS category 29-2034 would be the most 
appropriate choice to use in pricing the L041A clinical labor type. The 
median hourly wage for a Radiologic Technologist under this BLS 
category is $29.09 and, as we discussed above, the hourly wage data for 
an Angio Technician that we have from Salary Expert is only $26.81. We 
are instead crosswalking the Angio Technician to the Lab Tech/
Histotechnologist (L035A) clinical labor type with a median hourly rate 
of $26.63 as described above. We believe that this crosswalk better 
matches the wage data that we have available from Salary Expert for 
Angio Technicians. The previous BLS crosswalk may have been the most 
appropriate choice in 2002 but we have data from Salary Expert 
suggesting that it is no longer the best option.
    Comment: The commenter disagreed that BLS category 29-2035 
(Magnetic Resonance Imaging Technologists) at an hourly rate of $35.70 
was the correct crosswalk for the Cytotechnologist (L045A) clinical 
labor type. The commenter stated that BLS category 29-2010 (Clinical 
Laboratory Technologists and Technicians) was the previous BLS 
crosswalk used during the 2002 pricing of clinical labor and remains 
the correct crosswalk for a cytotechnologist.
    Response: We disagree with the commenter that the Clinical 
Laboratory Technologists described under BLS category 29-2010 would be 
the most accurate choice to use in pricing the L045A clinical labor 
type. The median hourly wage for a Clinical Laboratory Technologist 
under this BLS category is $25.54 while the hourly wage data for a 
Cytotechnologist that we have from Salary Expert is substantially 
higher at $36.19. We continue to believe that our proposed crosswalk to 
BLS category 29-2035 is a more appropriate choice for valuation. The 
previous BLS crosswalk we used in 2002 was based on available 
information at that time, but we have data suggesting that it is no 
longer the best option.
    Comment: The commenter disagreed that BLS category 29-1124 
(Radiation Therapists) at an hourly rate of $44.05 was the correct 
crosswalk for the Electron Microscopy Technologist (L045B) clinical 
labor type. The commenter stated that BLS category 29-2010 (Clinical 
Laboratory Technologists and Technicians) more accurately describes the 
clinical staff type associated with Electron Microscopy Technologists.
    Response: We disagree with the commenter that the Clinical 
Laboratory Technologists described under BLS category 29-2010 would be 
the most appropriate choice to use in pricing the L045B clinical labor 
type. The median hourly wage for a Clinical Laboratory Technologist 
under this BLS category is $25.54 while the hourly wage data for an 
Electron Microscopy Technologist that we have from Salary Expert is 
substantially higher at $44.90. We continue to believe that our 
crosswalk to BLS category 29-1124 is a more appropriate choice for 
valuation.
    Comment: The commenter disagreed that BLS category 19-1040 (Medical 
Scientists) at an hourly rate of $46.95 was the correct crosswalk for 
the

[[Page 65033]]

Medical Dosimetrist (L063A) clinical labor type. The commenter stated 
that BLS category 29-2098 (Medical Dosimetrists, Medical Records 
Specialists, and Health Technologists and Technicians, All Other) more 
accurately describes the clinical staff type associated with Medical 
Dosimetrists.
    Response: We disagree with the commenter that the clinical labor 
described under BLS category 29-2098 would be the most appropriate 
choice to use in pricing the L045B clinical labor type. The median 
hourly wage under this BLS category is $20.50 while the hourly wage 
data for a Medical Dosimetrist that we have from Salary Expert is 
substantially higher at $48.31. We recognize that BLS category 29-2098 
includes Medical Dosimetrists in its heading, however this is an 
aggregated category that also includes many other miscellaneous types 
of technicians. If we were to use this category for pricing Medical 
Dosimetrists, the clinical labor type would be priced significantly 
lower than its 2002 valuation ($27.67) which we do not believe would be 
accurate for this profession, especially in the context of the wage 
data that we have from Salary Expert for the profession. We continue to 
believe that our crosswalk to BLS category 19-1040 is a more 
appropriate choice for valuation.
    Comment: The commenter disagreed that the 75th percentile of BLS 
category 19-2012 (Physicists) at an hourly rate of $78.95 was the 
correct crosswalk for the Medical Physicist (L152A) clinical labor 
type. The commenter stated that the rationale to use the 75th 
percentile was based on maintaining the historical wage level for 
clinical labor type L152A which defeats the purpose of updating 
clinical labor rates. The commenter stated that BLS category 19-2012 
(Physicist) was the highest of several options and would suffice as a 
crosswalk without using the 75th percentile rate.
    Response: We disagree with the commenter that the Physicists 
described under BLS category 19-2012 would be the most accurate choice 
to use in pricing the L152A clinical labor type. The median hourly wage 
for a Physicist under this BLS category is $59.06 while the hourly wage 
data for a Medical Physicist that we have from Salary Expert is 
substantially higher at $66.90. While we also have our reservations 
about the use of 75th percentile wage data from the BLS, we continue to 
believe that it is a more accurate choice for valuation than BLS 
category 19-2012.
    Comment: Several commenters stated that the BLS wage data for a 
Physicist are not equivalent or representative of a Medical Physicist, 
even at the CMS proposed 75th percentile labor rate. Commenters stated 
that the sophistication and complexity of radiation therapy technology 
has increased exponentially in the past few decades and as radiation 
treatments have become more targeted and precise, they have also 
required increasingly complex equipment and processes. Commenters 
stated that as the complexity of radiation therapy treatments has 
grown, the work of ensuring treatment accuracy and patient safety 
throughout a prescribed course of treatment has also become more 
demanding in expertise and attention. These commenters recommended that 
CMS utilize the CY 2020 Professional Survey Report on salary data from 
the American Association of Physicists in Medicine (AAPM) to determine 
the updated clinical labor rate per minute for the Medical Physicist 
clinical labor type. Commenters also noted that CMS utilized the AAPM 
2005 salary data, inflated to 2006, when CMS updated the clinical labor 
wage rates for CY 2002. This report on Medical Physicist salary data 
was submitted as a public comment and commenters recommended that the 
Medical Physicist clinical labor rate be updated to $2.25 per minute 
based on the weighted median salary of certified qualified Medical 
Physicists multiplied by the CMS proposed benefits factor of 1.366.
    Response: We appreciate the submission of this additional wage data 
specifically for Medical Physicists to supplement the BLS wage data. We 
agree with the commenters that the BLS wage data for a Physicist is not 
representative of a Medical Physicist, which was why we proposed to use 
the 75th percentile of the BLS wage data due to a lack of other sources 
of information. We agree with the commenters that the submitted AAPM 
wage data more accurately captures the salary of Medical Physicists and 
better matches the data that we have from Salary Expert. The submitted 
AAPM data had an average salary of $205,838 for certified qualified 
Medical Physicists with a Masters or Ph.D. degree; according to our 
proposed methodology we divide this by 2080 hours annually for a per-
hour rate of $98.96 and a per-minute rate of $1.65. However, since we 
are finalizing a different fringe benefits multiplier in response to 
comments (1.296 instead of the proposed 1.366), we arrive at a final 
adjusted clinical labor rate of $2.14 per minute instead of the $2.25 
detailed by the commenters. As noted by the commenters, the L152A 
clinical labor type is included as part of the blended Medical 
Dosimetrist/Medical Physicist (L107A) clinical labor type, which we 
have also updated in response to the new $2.14 pricing.
    After consideration of the comments, we are finalizing the clinical 
labor prices as shown in Table 12.
BILLING CODE 4120-01-P

[[Page 65034]]

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[[Page 65035]]


[GRAPHIC] [TIFF OMITTED] TR19NO21.017

BILLING CODE 4120-01-C
    We once again isolated the anticipated effects of the clinical 
labor pricing update on specialty payment impacts by comparing the CY 
2022 PFS rates with and without the clinical labor pricing updates in 
place, including with both the fully implemented pricing update and the 
first year of a 4-year transition as shown in Table 13.

[[Page 65036]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.018


[[Page 65037]]


[GRAPHIC] [TIFF OMITTED] TR19NO21.019

BILLING CODE 4120-01-C
    We emphasize again that these are not the projected impacts by 
specialty of all the policies we are finalizing for CY 2022, only the 
anticipated effect of the isolated clinical labor pricing update (the 
allowed changes for each specialty therefore may not match the allowed 
charges listed in the Regulatory Impacts Analysis section of this 
rule). Several commenters asked CMS to clarify that the 4-year 
transition would only be implementing the first year of the projected 
adjustment amount for CY 2022, and not impose some other compounded 
effect that would deepen the payment reduction. These commenters 
pointed to Table 135 in the CY 2022 PFS proposed rule (86 FR 39563-
39564) and sought assurances that the -1 percent in a 4-year transition 
would not grow to be a -4 percent by the end of the 4-year transition, 
rather than the -2 percent listed on the table for the full transition. 
We are happy to clarify for commenters that these cases, such as 
applying to the Audiologist specialty in the above table, are caused by 
rounding and the ``Fully Updated'' column contains the full effects of 
the entire clinical labor pricing update.
    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 welcome additional 
feedback on clinical labor pricing from commenters in next year's 
rulemaking cycle, especially any data that will continue to improve the 
accuracy of our finalized pricing.
e. Establishment of Values for Remote Retinal Imaging (CPT Code 92229), 
Comment Solicitation for Fractional Flow Reserve Derived From Computed 
Tomography (CPT Code 0503T), and Comment Solicitation for Codes 
Involving Innovative Technology
    Rapid advances in innovative technology are having a profound 
effect on every facet of the economy, including in the delivery of 
health care. Emerging and evolving technologies are introducing 
advances in treatment options that have the potential to increase 
access to care for Medicare beneficiaries, improve outcomes, and reduce 
overall costs to the program. While new services have emerged over the 
last several years, it is possible that the COVID-19 PHE could be 
accelerating the supply and demand for these innovations. Emerging and 
evolving technologies could be useful tools for improving disparities 
in care that have been exacerbated by the PHE. Some of these new 
applications have codes for which innovative technology is substituting 
for and/or augmenting physician work. For example, the CPT Editorial 
Panel created CPT code 92229 (Imaging of retina for detection or 
monitoring of disease; point-of-care automated analysis and report, 
unilateral or bilateral), a diagnostic test for diabetic retinopathy 
that uses a software algorithm, and the RUC provided valuation 
recommendations which included a retinal camera and an analysis fee for 
remote imaging. In the CY 2021 PFS final rule (85 FR 84629 through 
84630), we considered CPT code 92229 to be a diagnostic service under 
the PFS, contractor-priced it, and stated that we would have ongoing 
conversations with stakeholders. In the proposed rule, we discussed a 
proposal to establish RVUs for CPT code 92229, solicited feedback to 
establish RVUs 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), and 
solicited feedback to help us better understand the resource costs for 
services involving the use of innovative technologies such as software 
algorithms and artificial intelligence (AI).
    In our discussion of CPT code 92229 in the CY 2021 PFS final rule 
(85 FR 84629 through 84630), we wrote that as the data used in our PE 
methodology have aged, and more services have begun to include 
innovative technology such as software algorithms and AI, these 
innovative applications are not well accounted for in our PE 
methodology. As described earlier in this section, PE resources 
involved in furnishing services are characterized as either direct or 
indirect costs. Direct costs of the PE resources involved in furnish a 
service are estimated for each code and include clinical labor, medical 
supplies, and medical equipment. Indirect costs include administrative 
labor, office expenses, and all other expenses. Indirect PE is 
allocated to each service based on physician work, direct costs, and a 
specialty-specific indirect percentage. The source of the specialty 
specific indirect percentage was the Physician Practice Information 
Survey (PPIS), last administered in 2007 and 2008, when emerging 
technologies that rely primarily on software, licensing, and analysis 
fees, with minimal costs in equipment and hardware may not have been 
typical. Thus, these costs are not well accounted for in the PE 
methodology.
    Consistent with our PE methodology and as we have stated in past 
PFS rulemaking (83 FR 59557), we have considered most computer software 
and associated analysis and licensing fees to be indirect costs tied to 
costs for associated hardware that is considered to be medical 
equipment. In the case of CPT code 92229, the hardware is a retinal 
camera used for remote imaging. Given that indirect costs are based on 
physician work, direct costs, and specialty-specific indirect 
percentages that can include high-cost equipment, our concern is that 
if we were to consider an analysis fee to be a supply cost, as was 
recommended by the RUC, it is possible that we would inadvertently 
allocate too many indirect costs for a supply item that may not require 
additional indirect expenses. Unlike a piece of equipment, such as the 
retinal camera, an analysis fee for software does not require physical 
space in an office or administrative staff hours to maintain it.
    However, increasingly, stakeholders have routinely expressed 
concerns with our policy to consider analysis fees as indirect costs, 
especially for evolving technologies that rely primarily on these fees 
with minimal costs in equipment or hardware. In comments in the CY 2021 
PFS final rule (85 FR 84629 through 84630) responding to our proposal 
to price the analysis fee for remote imaging as an indirect cost, 
stakeholders stated

[[Page 65038]]

that there would be no service if the software was not used. There are 
two aspects that distinguish CPT code 92229 from other services. First, 
most of the RUC's recommended resource costs for CPT code 92229 were 
for the analysis fee, rather than high-cost equipment or other supplies 
that require commensurate indirect costs to accommodate for space or 
administrative labor. Second, the innovative technology incorporated 
into the service is a software algorithm, which interprets data 
collected during the test, either augmenting the work of the physician 
or NPP performing the test, or in some cases replacing at least some 
work that a physician would typically furnish. In general, it is 
possible that physician work time and intensity of furnishing care to 
patients could be affected as more services that involve innovative 
technologies such as software algorithms or AI become available.
    We finalized a policy to establish contractor pricing for CPT code 
92229 (85 FR 84629 through 84630) because analysis fees for software 
algorithms and AI applications are not well accounted for our PE 
methodology, and to recognize that practitioners do incur resource 
costs for purchase and ongoing use of the software. We stated that we 
would continue to seek out new data sources and have ongoing 
conversations with stakeholders while also considering other approaches 
to reflect overall resource costs for these technologies in our PE 
methodology.
    As we described in the CY 2021 PFS final rule (85 FR 84498 through 
84499), the RAND Corporation is currently studying potential 
improvements to CMS' PE allocation methodology and the data that 
underlie it. RAND has found that the PPIS data last collected in 2007-
2008 may no longer reflect the resource allocation, staffing 
arrangements, and cost structures that describe practitioners' resource 
requirements in furnishing services to Medicare beneficiaries, and 
consequently may not accurately capture the indirect PE resources 
required to furnish services to Medicare fee-for-service (FFS) 
beneficiaries. Our experience with the challenge of accurately 
accounting for resource costs for innovative and emerging technologies 
such as ongoing service-specific software costs that are included in 
CPT code 92229 is another reason we continue to be interested in 
potentially refining the PE methodology and updating the data used to 
establish RVUs and payment rates under the PFS. We commonly employ a 
crosswalk to recognize resource costs when we lack the inputs that we 
would need to calculate work, PE, and/or malpractice RVUs for a service 
otherwise. When we use a crosswalk to value a service, we substitute 
the established RVUs for other services with similar resource costs in 
the physician office setting to set RVUs and the national payment rates 
for that particular service.
    For CY 2022, we proposed to establish values for CPT code 92229 
using our crosswalk approach, and thus this service would no longer be 
contractor-priced. We continue to believe that the software algorithm 
present in the analysis fee for CPT code 92229 is not well accounted 
for in our PE methodology; however, we recognize that practitioners are 
incurring resource costs for purchase of the software and its ongoing 
use. We proposed to use a crosswalk that reflects the overall relative 
resource costs for this service while we continue to consider 
potentially refining the PE methodology and updating the data we use to 
establish PE RVUs under the PFS. Specifically, we proposed a crosswalk 
to CPT code 92325 (Modification of contact lens (separate procedure), 
with medical supervision of adaptation), a PE-only code used for the 
eye, as we believe it reflects overall resource costs for CPT code 
92229 in the physician office setting. We recognize that the services 
described by CPT code 92325 are not the same as the services in CPT 
code 92229; however, we believe that the total resource costs would be 
similar across these two codes. We believe that crosswalking the RVUs 
for CPT code 92229 to a code with similar resource costs allows CMS to 
recognize that practitioners are incurring resource costs for the 
purchase and ongoing use of the software employed in CPT code 92229, 
which would not typically be considered direct PE under our current 
methodology. We also solicited comments on our proposal to crosswalk 
CPT code 92229 to CPT code 92325, and whether other codes would provide 
a more appropriate crosswalk in terms of resource costs. In addition, 
as discussed in section II.E of this final rule, we proposed to use our 
crosswalk approach for CPT code 77089 (Trabecular bone score (TBS), 
structural condition of the bone microarchitecture; using dual X-ray 
absorptiometry (DXA) or other imaging data on gray-scale variogram, 
calculation, with interpretation and report on fracture risk) and CPT 
code 77091 (Trabecular bone score (TBS), structural condition of the 
bone microarchitecture; using dual X-ray absorptiometry (DXA) or other 
imaging data on gray-scale variogram, calculation, with interpretation 
and report on fracture risk, technical calculation only).
    We received public comments on our proposal to crosswalk CPT code 
92229 to CPT code 92325. The following is a summary of the comments we 
received and our responses.
    Comment: Many commenters supported the proposal to crosswalk CPT 
code 92229 to CPT code 92325 to better reflect the overall relative 
resource costs for this service. Commenters stated that that these 
services were not clinically similar but the total direct practice cost 
of CPT code 92325 was similar to the RUC-recommended total direct PE 
cost for CPT code 92229 and commenters agreed with the CMS proposal to 
implement relative values for this service. Commenters stated that 
although many of the MACs have worked with providers to establish 
pricing, there remains significant variability in payment across MAC 
jurisdictions and a lack of transparency in the valuation methodology. 
Commenters stated that this variability in the current MAC pricing can 
impact provider and beneficiary access to novel and vision-saving 
technologies. These commenters supported national pricing for CPT code 
92229 through the use of the proposed crosswalk code to help provide 
transparency and facilitate beneficiary access to care. We did not 
receive comments requesting that CMS return to the contractor pricing 
finalized for CY 2021 for CPT code 92229.
    Response: We appreciate the support for our proposed crosswalk from 
the commenters.
    Comment: Several commenters expressed concern that CMS repeatedly 
stated that software and analysis fees are not direct expenses. 
Commenters disagreed and stated that software that is directly 
attributed to a specific physician service is a direct expense, and 
furthermore that there are multiple examples of the implementation of 
such costs. Several comments provided a list of current CPT codes that 
they stated included software as a direct PE input, such as CPT code 
95905 (Motor and/or sensory nerve conduction, using preconfigured 
electrode array(s), amplitude and latency/velocity study, each limb, 
includes F-wave study when performed, with interpretation and report). 
Several commenters raised the issue of software as a medical device 
(SaMD) and stated that it should be considered a direct PE expense 
similar to other medical equipment. Commenters stated that even though 
SaMD does not require physical space in an office or administrative 
staff hours

[[Page 65039]]

to maintain it, SaMD does require ongoing upgrades, improvements, and 
security mitigation, as well as the same regulatory oversight by the 
Food and Drug Administration (FDA) as hardware medical devices. 
Commenters stated that the legal, regulatory, and financial burdens 
incumbent of a SaMD manufacturer are no different than those of 
hardware medical device manufacturers.
    Response: We appreciate the detailed feedback from the commenters 
regarding the issues surrounding software and analysis fees. We agree 
with the commenters that there have been occasions in the past where we 
have finalized the inclusion of software as a direct PE expense if it 
met our criteria as typical and medically necessary for the service in 
question and could be individually allocable to a particular patient 
for a particular service. For example, we included the sheer wave 
elastography software (ED060) as a direct PE input for CPT codes 76981-
76983 in CY 2019. In this case, the sheer wave elastography software 
was an additional resource cost added to the general ultrasound room 
(EL015) equipment without which the service cannot be performed. We 
have been more hesitant to classify software, licensing, and analysis 
fees that are not associated with physical equipment used in the 
performance of a service as they pose more significant challenges for 
our traditional PE methodology. Therefore, we wish to clarify that 
although we have typically considered software costs to be indirect PE 
under our methodology, as these costs were not individually allocable 
to a particular patient for a particular service, there have been 
exceptions to this general principle where software costs have been 
included directly in the service under review.
    As we stated in the proposed rule, we believe that costs associated 
with software, licensing, and analysis fees are not well accounted for 
in the PE methodology. Unlike a piece of equipment, such as the retinal 
camera, an analysis fee for software does not require physical space in 
an office or administrative staff hours to maintain it. These types of 
costs were much less prevalent when the Physician Practice Information 
Survey (PPIS) was last administered in 2007 and 2008 and of course did 
not exist at all in the case of AI-based services. We remain concerned 
that if we were to consider software analysis fees and software as a 
medical device expenses to be direct costs in all cases, we may 
inadvertently allocate too many indirect costs for supplies that may 
not require additional indirect expenses. The data underlying the PPIS 
assumes that direct expenses will require costs associated with 
physical space and physical maintenance that may not appropriate for 
these new types of software. However, we do recognize that 
practitioners are incurring resource costs for purchase of the software 
and its ongoing use, which is why we proposed the crosswalk to CPT code 
92325 to capture these resource costs for CPT code 92229. We believe 
that the use of this crosswalk and other similar crosswalks are the 
best way to value services that make use of software, licensing, and 
analysis fees at the moment while we explore ongoing potential updates 
to the PE methodology.
    Comment: One commenter stated that CMS should consider crosswalks 
to CPT codes 95249 (Ambulatory CGM of interstitial tissue fluid via a 
subcutaneous sensor for a minimum of 72 hours; patient provided 
equipment, sensor placement, hook-up, calibration of monitor, patient 
training, and printout of recording) and 92977 (Thrombolysis, coronary; 
by intravenous infusion). The commenter stated that these codes are 
expected to be utilized in primary care and diabetes care settings and 
reflect similar resource costs.
    Response: We appreciate the additional suggested crosswalk codes 
from the commenter. However, we continue to believe that our proposed 
crosswalk to CPT code 92325 is a more appropriate choice to use for 
valuing CPT code 92229 because it more closely matches the RUC-
recommended total direct PE costs for CPT code 92229. Although CPT 
codes 95249 and 92977 share some clinical similarities with CPT code 
92229, they both include additional resource costs which would result 
in an inappropriately higher valuation if we were to employ them as our 
crosswalk code.
    After consideration of the public comments, we are finalizing our 
proposal to establish values for CPT code 92229 based on a direct 
crosswalk to CPT code 92325.
    We are aware of other services that use similar innovative 
technologies to those used for the diagnostic test for diabetic 
retinopathy and trabecular bone score, and that those technologies also 
are not well-accounted for in our PE methodology. For CY 2018, the AMA 
CPT Editorial Panel established four new Category III CPT codes for 
fractional flow reserve derived from computed tomography (FFRCT): CPT 
code 0501T (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; data 
preparation and transmission, analysis of fluid dynamics and simulated 
maximal coronary hyperemia, generation of estimated FFR model, with 
anatomical data review in comparison with estimated FFR model to 
reconcile discordant data, interpretation and report); CPT code 0502T 
(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; data 
preparation and transmission); 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); and CPT code 0504T (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; anatomical data review in comparison with 
estimated FFR model to reconcile discordant data, interpretation and 
report). FFRCT is a noninvasive diagnostic service that allows 
physicians to measure coronary artery disease in a patient through 
coronary CT scans. It uses a proprietary data analysis process 
performed at a central facility to develop a three-dimensional image of 
a patient's coronary arteries, which allows physicians to identify the 
fractional flow reserve to assess whether or not patients should 
undergo further invasive testing or treatment (typically, a coronary 
angiogram). We understand that FFRCT can show through non-invasive 
imaging whether a beneficiary has coronary artery disease thereby 
potentially avoiding an invasive coronary procedure. Medicare began 
payment for CPT code 0503T in the HOPD 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

[[Page 65040]]

technology and services. We followed this established process for 
Category III codes by assigning and listing them as contractor pricing 
in Appendix B in the CY 2018 PFS final rule (available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1676-F).
    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, 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 have shown the costs in the physician 
office setting to be similar to costs reflected in payment under the 
OPPS (85 FR 84630). For the CY 2021 OPPS/ASC final rule, we found that 
the geometric mean cost reported by HOPDs for the service was $804.35 
(85 FR 85943). We believe the costs reported under the OPPS are 
instructive as they reflect actual costs that hospitals incurred in 
furnishing the service described by CPT code 0503T to Medicare 
beneficiaries, and, as we stated in the CY 2021 PFS final rule, we 
believe that these costs would be similar in the physician office 
setting. Using the geometric mean costs under the OPPS as a proxy, we 
then searched for services paid under the PFS that could potentially 
serve as a crosswalk. Specifically, we looked for services paid under 
the PFS that include only a TC because CPT code 0503T is a TC-only 
service, and that have similar total costs to CPT code 0503T. We 
identified the following potential crosswalks, and solicited public 
comment on which, if any of them, would be appropriate: CPT code 93455 
(Catheter placement in coronary artery(s) for coronary angiography, 
including intraprocedural injection(s) for coronary angiography, 
imaging supervision and interpretation; with catheter placement(s) in 
bypass graft(s) (internal mammary, free arterial, venous grafts) 
including intraprocedural injection(s) for bypass graft angiography) 
and CPT code 93458 (Catheter placement in coronary artery(s) for 
coronary angiography, including intraprocedural injection(s) for 
coronary angiography, imaging supervision and interpretation; with left 
heart catheterization including intraprocedural injection(s) for left 
ventriculography, when performed). We also solicited comment on whether 
other codes would provide a more appropriate crosswalk in terms of 
resource costs.
    We received public comments on our comment solicitation for 
potential crosswalks to use to establish national payment for CPT code 
0503T. The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters supported the proposal to use a crosswalk 
to recognize resource costs and appropriately pay for CPT code 0503T. 
These commenters disagreed, however, with the proposal to use costs 
reported under the OPPS as a proxy to inform our selection of a 
crosswalk to similarly resourced services under the PFS. Some of these 
commenters, including the AMA RUC, expressed concern about our reliance 
on data from the OPPS in establishing relative values for the PFS. 
These commenters cited Section 4505 of the Balanced Budget Act of 1997 
and highlighted what they believed to be requirements for what data CMS 
should consider in establishing payments under the PFS. Specifically, 
they stated that CMS must utilize generally accepted cost accounting 
principles to recognize all staff, equipment, supplies and expenses, 
not just those which can be tied to specific procedures, and to use 
actual data on equipment utilization and other key assumptions, as well 
as to consult with organizations representing physicians regarding 
methodology. They asserted that any proposal to use the relativity of 
hospital charge data to determine the relativity of practice costs 
within a physician office is not consistent with the statutory 
provisions established by the BBA of 1997. The AMA RUC stated that it 
would solicit the national specialty societies to determine if RUC 
recommendations may be developed for this service.
    Response: In response to commenters' concerns about our potential 
use of OPPS cost data, we note that section 1848(c)(2)(N) of the Act 
authorizes our use of alternative approaches to establishing PE 
relative values using cost, charge, or other data from suppliers or 
providers of services in order to ensure accurate valuation of services 
under the PFS. As previously stated, we believe this is an appropriate 
approach as our recent reviews for the overall cost of CPT code 0503T 
have shown the costs in the physician office setting to be similar to 
costs reflected in payment under the OPPS.
    Comment: Some commenters requested that CMS use submitted invoice 
information, which included a price of $1,100 for furnishing the whole 
service described under CPT code 0503T, as a direct expense input to 
establish national payment for CPT code 0503T.
    Response: We thank the commenters for the invoice information they 
provided. We note that, in recent years, these services have been 
contractor priced, both out of consideration for the relative newness 
of the technology involved in the services and to allow time for CMS to 
consider how best to appropriately reflect costs for the service in 
payments established under the PFS. Stakeholders have worked with MACs 
to establish payment for the service but have expressed concern with 
the variability in payments across the different MAC jurisdictions 
during this time and have continued to urge CMS to establish national 
payment rates. In response, CMS in recent years has reviewed cost 
information for this service. Our recent reviews for the overall cost 
of CPT code 0503T have shown that the costs in the physician office 
setting are similar to costs reflected in payment under the OPPS (85 FR 
84630). We continue to believe the costs and resulting payment reported 
under the OPPS are instructive as they reflect actual costs that 
hospitals incurred in furnishing the service described by CPT code 
0503T to Medicare beneficiaries. Further, as we stated in the CY 2021 
PFS final rule, we believe that these costs would be similar in the 
physician office setting, given stakeholders' description of the way 
that this TC-only service is furnished (that is, a technician conducts 
a proprietary data analysis process at a central facility). In 
soliciting comments on the appropriate crosswalk for use to establish a 
PFS payment for this service, we had referenced the CY 2021 OPPS/ASC 
geometric mean cost of $804.35 for 0503T. We note, however that we 
finalized an OPPS payment rate of $950.50 for the service based on an 
assignment to a new technology Ambulatory Payment Classification (APC) 
in order to provide payment stability and equitable payment for 
providers as they continue to become more familiar with the proper cost 
reporting for CPT 0503T and other services that similarly use 
artificial intelligence technologies. Based on our reference to the 
underlying OPPS/ASC geometric mean cost data for the service, we had 
identified CPT code 93455 (Catheter placement in coronary artery(s) for 
coronary angiography, including intraprocedural injection(s) for 
coronary angiography, imaging supervision and interpretation; with

[[Page 65041]]

catheter placement(s) in bypass graft(s) (internal mammary, free 
arterial, venous grafts) including intraprocedural injection(s) for 
bypass graft angiography) and CPT code 93458 (Catheter placement in 
coronary artery(s) for coronary angiography, including intraprocedural 
injection(s) for coronary angiography, imaging supervision and 
interpretation; with left heart catheterization including 
intraprocedural injection(s) for left ventriculography, when performed) 
as potential crosswalks. We had intended in the CY 2022 PFS proposed 
rule to reference and use the OPPS payment rate to identify an 
appropriate crosswalk for CPT code 0503T, but due to a technical error, 
we inadvertently referenced the cost information to identify potential 
resource-based crosswalks under the PFS. As discussed briefly above, 
the geometric mean cost information is used under the OPPS to identify 
an APC assignment based on similarity of cost and clinical 
characteristics to other services. We believe that using the CY 2021 
OPPS payment rate for 0503T ($950.50), as the reference for cost to 
identify an appropriate crosswalk code under the PFS, which is higher 
than the underlying geometric mean cost-based information we had 
proposed ($804.35) to use, strikes the right balance between 
acknowledging the invoice information we received from commenters and 
the OPPS payment information informed by hundreds of claims with cost 
data for the FFRCT service. We reiterate that given stakeholders' 
description of the way that this TC-only service is furnished (that is, 
a technician conducts a proprietary data analysis process at a central 
facility), we believe that the costs for the FFRCT service as reflected 
in the OPPS payment that we used to identify a suitable resource-based 
crosswalk, would be similar in the physician office setting. Using the 
CY 2021 OPPS payment rate (which is based on the geometric mean costs 
data) as a proxy, we identified the TC for CPT code 93457 (Catheter 
placement in coronary artery(s) for coronary angiography, including 
intraprocedural injection(s) for coronary angiography, imaging 
supervision and interpretation; with catheter placement(s) in bypass 
graft(s) (internal mammary, free arterial, venous graft(s) including 
intraprocedural injection(s) for bypass grafts angiography and right 
heart catherization) as a more appropriate crosswalk. After 
consideration of the public comments, we are finalizing national 
pricing for CPT code 0503T, based on a valuation crosswalk to the TC of 
CPT code 93457 (Catheter placement in coronary artery(s) for coronary 
angiography, including intraprocedural injection(s) for coronary 
angiography, imaging supervision and interpretation; with catheter 
placement(s) in bypass graft(s) (internal mammary, free arterial, 
venous graft(s) including intraprocedural injection(s) for bypass 
grafts angiography and right heart catherization). We intend to 
continue working with stakeholders to help us better understand the 
resource costs that should be reflected in payment for services 
involving the use of innovative technologies, address payment for 
innovative services (such as CPT code 0503T), and consider how the cost 
for such services should be accounted for in our PE methodology.
    We also more broadly solicited public comment to help us better 
understand the resource costs for services involving the use of 
innovative technologies, including but not limited to software 
algorithms and AI. We refer readers to the CY 2022 PFS proposed rule 
(86 FR 39125) for more detail on the questions we asked the public to 
consider.
    We received public comments on the resource costs for services 
involving the use of innovative technologies, including but not limited 
to software algorithms and AI. The following is a summary of the 
comments we received and our response.
    Comment: Commenters were unanimously appreciative of the effort to 
understand and proactively engage on AI topics, and the acknowledgment 
that AI and innovative technologies are not well accounted for in the 
current PE methodology. Many commenters noted that the approach to 
understanding costs and impact on providers, systems, and patients is 
highly dependent upon the service and circumstances of the clinical 
encounter, and that it is difficult to broadly assess the impact of 
innovations on individual components of the RVU for a service. Some 
commenters encouraged CMS to issue a separate, stand-alone, request for 
information (RFI) that looks holistically at this issue rather than in 
the context of a specific payment rule or structure, noting this would 
help to ensure a broader range of stakeholder views are represented.
    Many commenters noted that while there may be one-time or start-up 
costs associated with implementing an AI-enabled technology or software 
algorithm, the costs are more likely recurring, and consider these 
technologies a direct PE instead of an indirect PE. One commenter 
suggested that the specific AI work and related AI cost should be paid 
separately under a new code, or added on to the existing code. Another 
commenter encouraged CMS to exercise flexibility in how it considers 
costs to allow for a range of cost structures, such as subscription 
models, per-use costs, device/supply purchases, and AI service 
purchases, when determining its approach. One commenter noted that the 
costs associated with innovative technologies should align with the 
rest of the RBRVS, with staff, supplies and equipment costs resource-
based, and with appropriate updates to the PPI Survey to accurately 
capture these indirect costs. Another commenter encouraged an 
assessment and analysis of how these and other methodologies for 
calculating a per-patient cost can accommodate emerging business models 
for these innovative technologies.
    Many commenters disagreed with any characterization of innovative 
technologies as a replacement for physician work. One commenter stated 
that the new technologies do not categorically increase or decrease 
physician work time and intensity, but rather, they change what 
physicians do. Many commenters referred to the following three broad 
categories when describing the different roles these technologies play 
in physician work: (1) Assistive, which enhances clinical management, 
but does not generate additional physician work; (2) automated, which 
provides additional insight that informs the physician's actions); and 
(3) autonomous, which provides diagnosis or clinical management 
decisions, but does not require physician intervention. Commenters 
further note that applications in each of these categories can either 
increase or decrease physician work and intensity. Some commenters 
noted that technologies such as AI are so nascent or absent in their 
respective specialties that there are insufficient examples to even 
illustrate the impact on physician work.
    Many commenters noted the potential for these technologies to 
facilitate more efficient and timely care. A few commenters noted that 
while these technologies have the potential to increase access to care, 
beneficiaries in rural areas with limited broadband access could face 
barriers. One commenter noted that these technologies often require 
specific hardware, software, broadband and other capabilities that may 
exceed the resources of a physician, and in turn have an impact on 
quality and equity. The commenter encouraged CMS to consider policies 
outside the PFS to mitigate disparities in equitable diffusion and 
uptake of these

[[Page 65042]]

technologies. Some commenters acknowledged that these technologies may 
foster or perpetuate bias, citing the established literature base on 
bias in machine-learning algorithms. One commenter noted that the FDA 
approval process includes an assessment of bias in these technologies. 
One commenter asserts that while software algorithms and AI improve 
health care disparities, demonstrated by the diabetic retinopathy 
example, the potential to worsen or widen health disparities also 
exists.
    Commenters also noted the importance of establishing monitoring and 
other guardrails to mitigate fraud, waste, and abuse, and to ensure 
that bias does not lead to compromised patient care.
    Response: We thank the commenters for all the information 
submitted. We will review the many public comments we received on this 
topic and will also consider how best to continue to engage with all 
stakeholders as we consider this issue further for potential future 
rulemaking.
    As we described in the CY 2021 PFS final rule (85 FR 84498 through 
84499), the RAND Corporation has been studying potential improvements 
to CMS' PE allocation methodology and the data that underlie it. CMS 
and RAND hosted a virtual Town Hall meeting on June 16, 2021 and 
materials are available at https://www.cms.gov/medicare/physician-fee-schedule/practice-expense-data-methods. Prior RAND research reports are 
also available at https://www.rand.org/pubs/research_reports/RR2166.html and https://www.rand.org/t/RR3248. RAND has issued the 
results of its final phase of research, available at www.rand.org/t/RRA1181-1. This report is also available as a public use file displayed 
on the CMS website under downloads for the CY 2022 PFS final rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html.

C. Potentially Misvalued Services Under the PFS

1. Background
    Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a 
periodic review, not less often than every 5 years, of the relative 
value units (RVUs) established under the PFS. Section 1848(c)(2)(K) of 
the Act requires the Secretary to periodically identify potentially 
misvalued services using certain criteria and to review and make 
appropriate adjustments to the relative values for those services. 
Section 1848(c)(2)(L) of the Act also requires the Secretary to develop 
a process to validate the RVUs of certain potentially misvalued codes 
under the PFS, using the same criteria used to identify potentially 
misvalued codes, and to make appropriate adjustments.
    As discussed in section II.E. of this final rule, 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 stakeholders. 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 consider information provided by other 
stakeholders. We conduct 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 rises.
    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.

[[Page 65043]]

     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, other individuals and stakeholder 
groups submit nominations for review of potentially misvalued codes as 
well. Individuals and stakeholder groups may submit codes for review 
under the potentially misvalued codes initiative to CMS in one of two 
ways. Nominations may be submitted to CMS via email or through postal 
mail. Email submissions should be sent to the CMS emailbox 
[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 Medicare Program; Payment Policies Under the Physician Fee 
Schedule, Five-Year Review of Work Relative Value Units, Clinical 
Laboratory Fee Schedule: Signature on Requisition, and Other Revisions 
to Part B for CY 2012; final rule (76 FR 73052 through 73055) 
(hereinafter referred to as the ``CY 2012 PFS final rule with comment 
period''). In the CY 2012 PFS final rule with comment period (76 FR 
73055 through 73958), 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 Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the 
Requirement for Termination of Non-Random Prepayment Complex Medical 
Review and Other Revisions to Part B for CY 2013 (77 FR 68892) 
(hereinafter referred to as the ``CY 2013 PFS final rule with comment 
period''), 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''). In the 
Medicare Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2009; and Revisions to 
the Amendment of the E-Prescribing Exemption for Computer Generated 
Facsimile Transmissions; Proposed Rule (73 FR 38589) (hereinafter 
referred to as the ``CY 2009 PFS proposed rule''), 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 (76 FR 32410), 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.
3. CY 2022 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 67606 
through 67608), we modified this process whereby the public and 
stakeholders 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.

[[Page 65044]]

     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 that year's final rule, we finalize our 
list of potentially misvalued codes.
a. Public Nominations
    In the proposed rule, we solicited comments regarding the codes 
that were nominated by the public and stakeholders as potentially 
misvalued. In this final rule, we review and summarize the comments we 
received regarding such codes, and we explain whether we are finalizing 
such codes as potentially misvalued. We received public nominations for 
potentially misvalued codes by February 10th and we displayed those 
nominations on our public website, where we also included the 
submitter's name and their associated organization for full 
transparency. Some submissions were for specific, PE-related inputs for 
codes, and we refer readers to section II.B. of this final rule 
Determination of PE RVUs for further discussions on PE-related 
submissions. Discussed below is the summary of this year's submissions 
under the potentially misvalued code initiative and the comments 
received from the proposed rule.
    A stakeholder nominated CPT code 22551 (Fusion of spine bones with 
removal of disc at upper spinal column, anterior approach, complex) 
``and common related services'' as potentially misvalued. Citing the CY 
2021 PFS final rule (84 FR 84501) where CMS agreed with the public 
nomination of CPT code 22867 (Insertion of interlaminar/interspinous 
process stabilization/distraction device, without fusion, including 
image guidance when performed, with open decompression, lumbar; single 
level) as potentially misvalued, and discussed the relationship between 
CPT code 22867 and CPT code 63047 (Laminectomy, facetectomy and 
foraminotomy (unilateral or bilateral with decompression of spinal 
cord, cauda equina and/or nerve root[s], [e.g., spinal or lateral 
recess stenosis]), single vertebral segment; lumbar), this stakeholder 
suggests that there are additional CPT code values related to spine 
procedures that are in need of contemporaneous review with CPT code 
22867. The stakeholder believes that CMS has an interest in reviewing 
associated anterior cervical discectomy and fusion (ACDF) procedures as 
well, and suggests that CPT code 22551 ``and common related services'' 
can result in cumulative RVUs that do not sufficiently reflect 
physician work, time, or outcomes.
    In their submission, the stakeholder expressed concern that there 
is a discrepancy between the typical total RVUs for codes billed for 
vertebral fusion procedures performed using three synthetic cage 
devices with plate and vertebral fusion procedures performed using 
three allografts with plate. Both methods of vertebral fusion are 
described by CPT code 22551 (includes a 90-day global period), which 
has a work RVU of 25.00. Both methods of vertebral fusion involve two 
units of CPT code 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) 
(ZZZ global period)) with a total work RVU of 13.00 (6.50 x 2); and 
both methods of vertebral fusion involve 1 unit of CPT code 22846 
(Anterior instrumentation; 4 to 7 vertebral segments (List separately 
in addition to code for primary procedure) (ZZZ global period)) with a 
work RVU of 12.40. The vertebral fusion method employing three 
synthetic cage devices with a plate would involve CPT code 22853 
(Insertion of interbody biomechanical device(s) (e.g., synthetic cage, 
mesh) with integral anterior instrumentation for device anchoring 
(e.g., screws, flanges), when performed, to intervertebral disc space 
in conjunction with interbody arthrodesis, each interspace (List 
separately in addition to code for primary procedure) (ZZZ global 
period)) for the insertion of synthetic cage devices for a total work 
RVU of 12.75 (4.25 x 3), and CPT code 20930 (Allograft, morselized, or 
placement of osteopromotive material, for spine surgery only (List 
separately in addition to code for primary procedure)) with a work RVU 
of 0.00 (because Medicare considers this code to be bundled into codes 
for other services). The stakeholder stated that the total work RVUs 
for the typical vertebral fusion employing three synthetic cage devices 
with plate would be 63.15 work RVUs.
    In contrast, the stakeholder asserted that the vertebral fusion 
method employing three allografts with plate involves the same set of 
services and codes (CPT code 22551 (090 global period) and CPT code 
22846 (ZZZ global period)), but instead of CPT codes 22853 or 20930, 
involve CPT code 20931 (Allograft, structural, for spine surgery only 
(List separately in addition to code for primary procedure) (ZZZ global 
period)) with a work RVU of 1.81. Altogether, the total work RVUs for 
CPT codes involved in this vertebral fusion method is 52.21. The 
stakeholder suggested that this difference in total work RVUs, 63.15 
versus 52.21, is evidence that these services are misvalued, and that 
the total work RVUs do not reflect the differences in the amount of 
work, resources, and intensity between the two vertebral fusion 
methods.
    This stakeholder's description of the potential misvaluation of CPT 
code 22551 ``and common related services'' differs from the CMS 
approach to identifying potentially misvalued services by using certain 
criteria, as described in the beginning of this section. Our 
determination that one or more codes are potentially misvalued 
generally revolves around the specific RVUs assigned to an individual 
code, or several codes within a family of codes. CMS generally does not 
examine the summed differences in total RVUs based on billing patterns 
using different codes in different scenarios, representing different 
physician work, and then comparing the two methods of a procedure, in 
this case, the use or non-use, of the synthetic cage devices in the 
vertebral fusion with removal of the disc in the upper spinal column. 
We do not believe that the stakeholder has provided support for the 
premise that CPT code 22551 alone is misvalued, or

[[Page 65045]]

that any of the codes identified as common related services are 
misvalued. Therefore, we were not inclined to propose this code as 
potentially misvalued. However, we solicited comment, including any 
analysis or studies demonstrating that one or more of these codes meet 
the criteria listed above under ``Identification and Review of 
Potentially Misvalued Services,'' particularly in regard to any changes 
in the resources to providing a service, or are otherwise potentially 
misvalued.
    A stakeholder nominated CPT code 49436 (Delayed creation of exit 
site from embedded subcutaneous segment of intraperitoneal cannula or 
catheter) as potentially misvalued, as it has not been valued for 
payment in the non-facility/office setting. This stakeholder did not 
include in their submission detailed recommendations for the items, 
quantities, and unit costs for the supplies, equipment types, and 
clinical labor (if any), that might be incurred in the non-facility/
office setting, all of which are key factors when determining potential 
valuation or mis-valuation of a service. Medicare claims data for 2018, 
2019, and 2020 show that CPT code 49436 is solely performed in the 
facility ASC setting. We solicited comment, including any analysis or 
studies demonstrating that this code meets the criteria listed above 
under ``Identification and Review of Potentially Misvalued Services,'' 
particularly in regard to any changes in the resources to providing a 
service, or is otherwise potentially misvalued.
    A stakeholder nominated CPT code 55880 (Ablation of malignant 
prostate tissue, transrectal, with high intensity-focused ultrasound 
(HIFU), including ultrasound guidance) as potentially misvalued, as it 
has not been valued in the non-facility/office setting. This 
stakeholder also did not include in their submission detailed 
recommendations for items, quantities, and unit costs for the supplies, 
equipment types, and clinical labor (if any), that might be incurred in 
the non-facility/office setting, all of which are key factors when 
determining valuation or mis-valuation. This stakeholder stated that 
the advances in High Intensity Focused Ultrasound (HIFU) technology 
toward the destruction of cancerous tissues in the prostate gland have 
matured to the point where this procedure is now equally as effective 
and as safe as the cryoablation procedure described by CPT code 55873 
(Cryosurgical ablation of the prostate (includes ultrasonic guidance 
and monitoring)), which is currently valued in the non-facility/office 
setting (186.69 total RVUs, approximately $6,514) and has been for 
approximately 10 years. We note that CPT code 55880 was reviewed and 
valued in the CY 2021 PFS final rule (85 FR 84614 through 84615) in the 
facility setting only. Accordingly, we do not have enough claims data 
for this code to make accurate comparisons to similar codes that may be 
furnished in non-facility settings. In the proposed rule, we explained 
that there was no case presented that constituted a misvaluation of CPT 
code 55880, and therefore, we were not inclined to put this code 
forward as potentially misvalued for CY 2022; however, we solicited 
comment, including any analysis or studies demonstrating that this code 
meets the criteria listed above under ``Identification and Review of 
Potentially Misvalued Services,'' particularly in regard to any changes 
in the resources to providing a service, or is otherwise potentially 
misvalued.
    A stakeholder nominated CPT code 59200 (Insertion cervical dilator 
(e.g., laminaria, prostaglandin)) as potentially misvalued because the 
direct PE inputs do not include the supply item, Dilapan-S. This 
stakeholder had sought to establish a Level II HCPCS code for Dilapan-
S, but CMS did not find sufficient evidence to support that request. 
The stakeholder submitted Dilapan-S to be considered as PE supply input 
to a Level I CPT code(s). This stakeholder seeks to add Dilapan-S to 
the nonfacility/office PE inputs for CPT code 59200. Specifically, the 
stakeholder recommends adding 4 rods of Dilapan-S at $80.00 per unit, 
for a total of $320.00, as a replacement for the current PE supply 
item, laminaria tent (a small rod of dehydrated seaweed that when 
inserted in the cervix, rehydrates, absorbing the water from the 
surrounding tissue in the woman's body), which is currently listed at 
$4.0683 per unit, with a total of 3 units, for a total of $12.20. We 
solicited comment, including any analysis or studies demonstrating that 
this code meets the criteria listed above under ``Identification and 
Review of Potentially Misvalued Services,'' particularly in regard to 
any changes in the resources to providing a service, or is otherwise 
potentially misvalued.
    A stakeholder nominated CPT codes 66982 through 66986 as 
potentially misvalued, as they have not been valued in the non-
facility/office setting. This stakeholder did not submit other details 
or reasoning to support their nomination. We note that some of these 
cataract-related procedures were initially reviewed and valued in CY 
2020 PFS final rule (84 FR 62751), and that presently, additional codes 
in this family are scheduled to be reviewed and valued in this CY 2022 
PFS final rule (we refer readers to section II.E. of this final rule, 
Valuation of Specific Codes). The highest utilization of these cataract 
codes are CPT code 66982 (Extracapsular cataract removal with insertion 
of intraocular lens prosthesis (1-stage procedure), manual or 
mechanical technique (e.g., irrigation and aspiration or 
phacoemulsification), complex, requiring devices or techniques not 
generally used in routine cataract surgery (e.g., iris expansion 
device, suture support for intraocular lens, or primary posterior 
capsulorrhexis) or performed on patients in the amblyogenic 
developmental stage; without endoscopic cyclophotocoagulation)) and CPT 
code 66984 (Extracapsular cataract removal with insertion of 
intraocular lens prosthesis (1 stage procedure), manual or mechanical 
technique (e.g., irrigation and aspiration or phacoemulsification); 
without endoscopic cyclophotocoagulation). In 2018 and 2019, these 
services were almost all performed in the ASC facility setting, but 
based on 2020 claims, the most common setting appears to have shifted 
to the hospital inpatient or hospital outpatient facility setting. In 
the proposed rule, we noted that there was no case presented that 
constituted a misvaluation of CPT codes 66982 to 66986, and therefore, 
we were not inclined to put this code family forward as potentially 
misvalued for CY 2022; however, we solicited comment, including any 
analysis or studies demonstrating that one or more of these codes meet 
the criteria listed above under ``Identification and Review of 
Potentially Misvalued Services,'' particularly in regard to any changes 
in the resources involved in providing a service, or that the code(s) 
are otherwise potentially misvalued. See Table 14.

[[Page 65046]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.020

    In response to the proposed rule, we received public comments on 
the CY 2022 identification and review of potentially misvalued 
services. The following is a summary of the comments we received and 
our responses.
    Comment: We received one comment regarding CPT code 22551 ``and 
other common related services typically billed with CPT 22551'' on the 
same day of service, with the same patient, with the same provider(s). 
The commenter stated they believe that this code is not misvalued.
    Response: We do not typically look at a collection of services to 
see if any one combination of services is misvalued against any other 
combination of services. This is true not just of vertebral fusion 
procedures, but of any combination of codes that are furnished by a 
billing physician. We generally only examine the potential misvaluation 
of a single code, and not a possible mix of multiple codes/services 
that might be furnished and billed together. Since CPT code 22551 was 
not nominated as being potentially misvalued for any of the reasons 
that we have described above in our criteria of being potentially 
misvalued, we are finalizing our proposal that this code will not be 
considered as potentially misvalued for CY 2022.
    Comment: We received one comment for CPT code 55880, informing us 
that this service is expected to see further review for valuation 
recommendations with the AMA RUC in 2022 for possible CY 2024 
recommendations to CMS, and that we should reconsider the valuation of 
CPT code 55880 at that later time.
    Response: We appreciate this information, and note that this CPT 
code is already slated for review by the AMA RUC in the coming year. 
Therefore, we are finalizing our proposal that CPT code 55880 will not 
be considered as potentially misvalued for CY 2022.
    Comment: We received comments regarding CPT code 59200 concerning 
the addition of the supply item Dilapan-S, and one of the comments was 
from the stakeholder that nominated CPT code 59200 as potentially 
misvalued. The commenters restated that Dilapan-S is not on the list of 
direct PE supplies for this code, and that the much less costly 
equivalent item, ``laminaria tent,'' is on the list of direct PE 
supplies for this code. One commenter cited evidence suggesting an 
increased risk of infections in using the laminaria tent as compared to 
Dilapan-S and that Dilapan-S achieves faster cervical ripening for 
quicker deliveries by 4 hours. This information was not echoed by other 
commenters and there were no other reasons given as to why Dilapan-S 
should replace the item laminaria tent and no evidence that Dilapan-S 
was in any other way a better performing supply that is widely used as 
a replacement.
    Response: Based on these public comments, and the absence of 
broader support from any additional commenters on this nomination, we 
are not finalizing CPT code 59200 as potentially misvalued for CY 2022.
    Comment: One commenter posited that the drug administration CPT 
codes 96401 to 96549 are potentially misvalued because claims in that 
code range are being adjusted by Medicare Administrative Contractors 
(MACs) and replaced with the less complex CPT codes [96360 to 96379].
    Response: These ``Complex Biological Agent Administration'' codes 
(that is, CPT codes 96401 to 96549 and CPT codes 96360 to 96379) were 
not nominated as potentially misvalued for our consideration in the CY 
2022 PFS proposed rule, and therefore, we did not address them in the 
proposed rule. As such, they are outside the scope of this CY 2022 PFS 
rulemaking process. Therefore, we decline to directly address this 
comment. However, we note that it is not clear to us how the 
commenter's assertion that MACs are making adjustments to the codes 
they use in their drug administration claims is relevant to the 
question of whether the codes are potentially misvalued. If the 
commenter continues to believe there is a potential code misvaluation, 
we suggest they consider submitting a nomination that addresses the 
criteria we use to assess whether a code is potentially misvalued, as 
explained above, before our February 10th deadline for a future 
rulemaking cycle.
    Comment: We received comments on the nomination of CPT code 49436 
only from the nominator of the code. The nominator provided additional 
documentation that CPT code 49436 can be safely performed in the 
nonfacility/office setting. The nominator noted that the total Medicare 
payment amount for this procedure when done in the nonfacility/office 
setting would be less than when furnished in the HOPD or ASC facility 
setting. The nominator stated that performing this procedure in the 
nonfacility/office rather than in an ASC is a significant ease in 
burden to the practitioner and the patient since there would be no need 
to coordinate and schedule an ASC time slot, travel to and from the 
ASC, or incur the cost involved in utilizing the ASC facility. The 
nominator also states that easing access to this service would promote 
peritoneal dialysis in the home setting (and may avoid in-center 
hemodialysis with a central venous catheter). The nominator also noted 
that dialysis in the home may be favorable to the patient during the 
public health emergency (PHE) for COVID-19, which imposes social 
distancing and self-isolation for a measure of safety from the 
transmission of infection. The nominator states that the PHE for COVID-
19 may also be constraining access to ASC operating facilities due to 
their restricted schedules of operation.
    Response: We agree with the nominator that CPT code 49436 can be 
safely performed in the nonfacility/office setting. We are also aware 
that the PHE for COVID-19 may also be constraining access to ASC 
operating facilities where CPT code 49436 is performed, and if this 
service were to be done in the nonfacility/office setting, there may 
well be an ease in the burden to the provider and the patient, when 
trying to coordinate access with the current PHE ASC restricted 
schedules. We expect that a nonfacility/office valuation for CPT code 
49436, would include the similar supplies, equipment, and clinical 
labor (if any), that is part of

[[Page 65047]]

the ASC/Hospital Outpatient facility's service, plus the payment of the 
physician's work. The sum of these PEs incurred in the nonfacility/
office, will likely be less than current amount paid to the ASC/
Hospital Outpatient facility and may result in a net savings when CPT 
code 49436 is provided in the nonfacility/office setting. After 
considering the additional information provided by the nominator in 
combination with our above criteria that a code's typical site of 
service may need to change since it was last valued, we believe it may 
be appropriate to explore establishing a value for CPT code 49436 in 
the non-facility/office setting, and therefore, we are finalizing this 
code as potentially misvalued for CY 2022.
    We received no comments recommending that CPT codes 66982 through 
66986 should be valued for payment in the non-facility/office setting, 
and the nominator supplied no reasoning in support of their nomination 
of these codes as potentially misvalued codes. Since, as we explained 
in the proposed rule, there is no case presented with this nomination 
that constitutes a potential code misvaluation, we are finalizing our 
proposal that these codes will not be considered as potentially 
misvalued for CY 2022.
    We received two comments requesting that CMS establish a national 
payment rate for Category III CPT code 0583T (Insertion of ventilating 
tube in eardrum using an automated tube delivery system under local 
anesthesia), also known as tympanostomy under local anesthesia (Tula). 
This code is currently carrier-priced and was not discussed in the CY 
2022 PFS proposed rule. As such, these comments are outside the scope 
of the CY 2022 PFS rulemaking process, and we will not formally respond 
to them. However, the commenters are welcome to submit this code by 
February 10 of the coming year for consideration as potentially 
misvalued for the CY 2023 PFS proposed rule. See above for more 
information on how to submit a nomination for a potentially misvalued 
code.

D. Telehealth and Other Services Involving Communications Technology, 
and Interim Final Rule With Comment Period for Coding and Payment of 
Virtual Check-In Services--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 symptom.
     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 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

[[Page 65048]]

telehealth services list using the Category 3 criteria described above. 
In this final 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 2022, requests to add services to the Medicare 
telehealth services list must have been submitted and received by 
February 10, 2021. 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 2022
    Under our current policy, we add services to the Medicare 
telehealth services list on a Category 1 basis when we determine that 
they are similar to services on the existing Medicare telehealth 
services list for the roles of, and interactions among, the 
beneficiary, physician (or other practitioner) at the distant site and, 
if necessary, the telepresenter. As we stated in the CY 2012 PFS final 
rule with comment period (76 FR 73098), we believe that the Category 1 
criteria not only streamline our review process for publicly requested 
services that fall into this category, but also expedite our ability to 
identify codes for the Medicare telehealth services list that resemble 
those services already on the Medicare telehealth services list.
    We received several requests to permanently add various services to 
the Medicare telehealth services list effective for CY 2022. 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 15.
BILLING CODE 4120-01-P

[[Page 65049]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.021


[[Page 65050]]


[GRAPHIC] [TIFF OMITTED] TR19NO21.022

BILLING CODE 4120-01-C
    We remind stakeholders 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 met the Category 1 criterion.
    We received a request to permanently add CPT code 51741 (Complex 
uroflowmetry (e.g., calibrated electronic equipment)) to the Medicare 
telehealth services list. This CPT code describes the acquisition of 
uroflowmetric information and analysis of that information. The code 
includes a technical component and a professional component. The 
technical component describes the acquisition of the uroflowmetric 
information when billed as a standalone service. The professional 
component describes the analysis for the uroflowmetric information when 
it is billed as a standalone service. As we have explained in previous 
rulemaking (see 83 FR 59483), the remote interpretation of diagnostic 
tests is not considered to be a telehealth service under section 
1834(m) of the Act or our regulation at Sec.  410.78. We do not believe 
that the technical component, which includes acquisition of the 
uroflowmetric information, will meet the criterion to

[[Page 65051]]

be added on a Category 1 basis, because it is not similar to other 
services on the Medicare telehealth list. Moreover, we do not believe 
the uroflowmetric information can be accurately and effectively 
collected using two-way, audio/video communications technology to the 
degree that will make the results clinically useful. We believe the 
patient would need to be in the same location as the equipment; thus, 
making it impracticable to achieve via telehealth. Due to these 
concerns, we do not believe that the submitted information demonstrates 
sufficient clinical benefit to support the addition of CPT code 51741 
to the Medicare telehealth services list.
    We received a request to permanently add several biofeedback, 
services, CPT codes 90901, 90912, and 90913, to the Medicare telehealth 
services list. We do not believe these services are similar to Category 
1 services on the Medicare telehealth list in that these services 
describe the application of electrodes directly to the patient's skin 
and using them to monitor the patient's response. Therefore, we do not 
believe they meet the criterion for addition to the Medicare telehealth 
services list on a Category 1 basis. We also believe that proper 
application of electrodes and monitoring of the patient's response 
would require the furnishing practitioner to be in the same physical 
location as the beneficiary. As such, we do not believe these services 
meet the criteria for addition to the Medicare telehealth list on a 
Category 2 basis. When we reviewed these biofeedback services on a 
Category 2 basis, we found that the information supplied with the 
requests was not detailed enough to determine if the objective 
functional outcomes (that is, Activities of Daily Living (ADLs) and 
Instrumental Activities of Daily Living (IADLs) of the telehealth 
patients) were similar to that of patients treated in person. Moreover, 
we believe that the ADLs/IADLs alone are not sufficient to determine if 
these services, when performed via telehealth, demonstrate a clinical 
benefit to a patient. We request that stakeholders supply a more 
comprehensive set of objective data in order to fully illustrate any 
benefits, to better enable us to evaluate all outcomes.
    We received requests to permanently add Neuropsychological/
Psychological Testing services, CPT codes 96130-96133 and 96136-96139, 
to the Medicare telehealth services list. We separately reviewed each 
of the services in these two code families. In prior years' rulemaking, 
we have declined to add these services on a Category 1 basis because, 
in contrast to other services on the telehealth list, these services 
require close observation by the furnishing practitioner to monitor how 
a patient responds and progresses through the testing (see 81 FR 
80197). We continue to believe that this is the case. All of these 
codes describe services that involve a very thorough observation and 
testing process, and require the tester to observe the following: Speed 
of responses; the ability to adjust focus; written, sometimes manual 
tasks; following tasks that display the patients' visuospatial mapping 
abilities, pattern recognition, abstraction, calculation--all while 
appreciating that the patient may be distracted or aided by 
environmental cues. The tester must also maintain some subjective 
amount of flexibility to allow the patient to be in their environment. 
Additionally, the tester has to maintain professional scrutiny through 
dynamic tasks. Given all of the above, remote observation by the 
furnishing practitioner to accomplish the testing in question seems 
impractical and potentially creates the risk of inaccuracies in 
diagnosis and subsequent treatment. We note that the information 
supplied by stakeholders did not address these concerns, and as such, 
we have concerns over patient safety and the ability of these services 
to be accurately and thoroughly performed via telehealth to demonstrate 
a clinical benefit to Medicare beneficiaries. Therefore, we do not 
believe these services meet the Category 2 criteria for permanent 
addition to the Medicare telehealth list of services. Consequently, we 
did not propose to add these services to the Medicare telehealth 
services list. We encourage stakeholders to submit information 
addressing the concerns we have stated in any future requests to have 
these services added to the Medicare telehealth list of services.
    We received requests to add Therapy Procedures, CPT codes 97110, 
97112, 97116, 97150, and 97530; Physical Therapy Evaluations, CPT codes 
97161-97164; Therapy Personal Care services, CPT codes 97535, 97537, 
and 97542; and Therapy Tests and Measurements services, CPT codes 
97750, 97755, and 97763, to the Medicare telehealth services list. In 
the CY 2017 PFS final rule (81 FR 80198), we noted that section 
1834(m)(4)(E) of the Act specifies the types of practitioners who may 
furnish and bill for Medicare telehealth services as those 
practitioners under section 1842(b)(18)(C) of the Act. Physical 
therapists (PTs), occupational therapists (OTs), and speech-language 
pathologists (SLPs) are not among the practitioners identified in 
section 1842(b)(18)(C) of the Act. We also stated in the CY 2017 PFS 
final rule that, because these services are predominantly furnished by 
PTs, OTs, and SLPs, we did not believe it would be appropriate to add 
them to the Medicare telehealth services list at that time. In a 
subsequent request to consider adding these services for 2018, the 
original requester suggested that we might propose these services be 
added to the Medicare telehealth services list so that payment can be 
made for them when furnished via telehealth by physicians or 
practitioners who can serve as distant site practitioners. We stated 
that, since the majority of the codes are furnished over 90 percent of 
the time by therapy professionals who are not included on the statutory 
list of eligible distant site practitioners, 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. We continue to believe this to 
be true; however, we reviewed each therapy service separately, and have 
categorized them together here for convenience as the same set of 
information accompanied the request for each of these services.
    We determined that these services did not meet the Category 1 
criteria for addition to the Medicare telehealth services because they 
are therapeutic in nature and in many instances involve direct physical 
contact between the practitioner and the patient. In assessing the 
evidence that was supplied by stakeholders in support of adding these 
services to the Medicare telehealth services list on a Category 2 
basis, we concluded that it did not provide sufficient detail to 
determine whether all of the necessary elements of the service could be 
furnished remotely, and whether the objective functional outcomes of 
ADL and IADL for the telehealth patients were similar to those of 
patients receiving the services in person. As we stated above when 
discussing the request to add certain biofeedback services to the 
telehealth list, we do not believe ADLs and IADLS alone are sufficient 
to demonstrate clinical benefit to a Medicare beneficiary. We have 
enumerated above some examples of the types of clinical benefits we 
will consider when evaluating services using the Category 2 criterion.
    Therefore, we do not believe the supplied information demonstrates 
that the services meet either the Category 1 or the Category 2 
criteria. We did not propose to add these services to the Medicare 
telehealth services list. We

[[Page 65052]]

continue to encourage commenters to supply sufficient data for us to be 
able to see all measurements/parameters performed, so that we may 
evaluate all outcomes.
    We received requests to add the services in Table 16, and we note 
that these services are generally not separately payable under the 
Medicare PFS. Given that these services are not separately payable when 
furnished in-person, they likewise will not be separately payable when 
furnished as telehealth. Section 1834(m)(2)(A) of the Act provides that 
payment for a service when furnished as a telehealth services is equal 
to the payment when the service is furnished in person. CPT code 90849 
has a restricted payment status, indicating that claims must be 
adjudicated on a case-by-case basis when furnished in-person. 
Accordingly, any separate payment for that service will require special 
consideration and not be routine. Therefore, we do not believe this 
service should be added to the Medicare telehealth list. CPT codes 
98960-98962 are bundled services, and therefore, payment for these 
services is always bundled into payment of other services. For that 
reason, we did not propose to add them to the Medicare list of 
telehealth services.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR19NO21.023

BILLING CODE 4120-01-C
    We received requests to temporarily add Neurostimulators, CPT codes 
95970-95972, and Neurostimulators, Analysis-Programming services, CPT 
codes 95983 and 95984, to the Medicare telehealth services list using 
the Category 3 criteria (see Table 17). In their submission, the 
requestor noted they would conduct a future study and would submit the 
study data to CMS at a later date. These services are on the expanded 
telehealth services list for the PHE, but were not added by CMS on a 
category 3 basis in the CY 2021 PFS final rule. We do not yet have 
sufficient information to adjudicate whether these services are likely 
to meet the category 1 or category 2 criteria given additional time on 
the Medicare telehealth services list, without having evaluated the 
full data, and we encourage commenters to submit all available 
information, when available, for future consideration. As a result, we 
did not propose to add these services to the Medicare telehealth list 
of services on a Category 3 basis at this time.

[[Page 65053]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.024

    We received public comments on the requests to add services to the 
Medicare telehealth services list. The following is a summary of the 
comments we received and our responses.
    Comment: Commenters expressed disappointment that CMS did not 
propose to add Neurostimulators, CPT codes 95970-95972, and 
Neurostimulators, Analysis-Programming services, CPT codes 95983 and 
95984, to the Medicare telehealth services list on a Category 3 basis. 
Commenters stated that, by not adding these services to the Medicare 
telehealth list on a Category 3 basis, CMS is risking disruption of 
care for patients who may have become accustomed to receiving these 
services as telehealth during the PHE.
    Some commenters requested that CMS add all codes that were added to 
the Medicare telehealth services list on an interim basis (in response 
to the PHE for COVID-19) to the Medicare telehealth list on a Category 
3 basis (Table 18), but these commenters did not provide any additional 
clinical information.
    Many commenters opposed CMS' decision not to add CPT codes 
describing therapy services permanently to the list of Medicare 
telehealth services. They stated that adding these CPT codes to the 
list of covered telehealth services would better ensure a seamless 
transition if additional practitioners, such as physical therapists, 
become eligible to furnish and bill for telehealth services under 
Medicare.
    Some commenters stated that CMS should maintain payment for 
Medicare telehealth services at the non-facility, rather than facility 
payment rates.
    Response: We added services 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. The comments provided did not include 
sufficient clinical information to support adding these services to the 
telehealth services list. Absent additional clinical information from 
the commenters, we still believe that these services are not 
appropriate for addition on either a permanent or Category 3 basis; 
however, we are continuing to collect information on the use of these 
services during the PHE for COVID-19, and we invite stakeholders to 
provide additional information and to submit requests for addition to 
the telehealth list through our usual process. With regard to the 
comment requesting Medicare telehealth payment at the non-facility 
versus facility rate, we refer readers to discussion of this issue in 
the CY 2017 PFS final rule (81 FR 80199-

[[Page 65054]]

80201). Payment for telehealth services using the facility PE RVUs is 
consistent with our belief that the direct practice expense costs are 
generally incurred at the originating site where the beneficiary is 
located, and not by the distant site practitioner. With respect to 
commenters' concerns about potential disruption of care, we do not 
agree that this will occur. These services have been included on the 
Medicare telehealth services list only in response to the PHE for 
COVID-19. We believe patients and practitioners have a longstanding 
history of in-person delivery of care. We anticipate that the end of 
the PHE will not be declared abruptly, and note that healthcare has 
already begun to transition back to typical, in-person delivery.
    After consideration of public comments, we are finalizing our 
proposal not to add the aforementioned codes to the telehealth list.
c. Revised Timeframe for Consideration of Services Added to the 
Telehealth List on a Temporary Basis
    In the CY 2021 PFS final rule (85 FR 84506), in response to the PHE 
for COVID-19, we created a third category of criteria for adding 
services to the Medicare telehealth services list on a temporary basis. 
We included in this category the services that were added during the 
PHE for COVID-19 for which we believed there is likely to be clinical 
benefit when furnished via telehealth, but for which there is not yet 
sufficient evidence available to consider the services as permanent 
additions under Category 1 or Category 2 criteria. We recognized that 
the services we added on a temporary basis under Category 3 will 
ultimately need to meet the criteria under Categories 1 or 2 in order 
to be permanently added to the Medicare telehealth services list, and 
that there was a potential for evidence development that could continue 
through the Category 3 temporary addition period. We also stated that 
any service added on a temporary basis under Category 3 will remain on 
the Medicare telehealth services list through the end of the calendar 
year in which the PHE for COVID-19 ends.
    We added 135 services to the Medicare telehealth list in CY 2020 on 
an interim basis in response to the PHE for COVID-19 through the 
interim final rule with comment period (IFC) (March 31st COVID-19 IFC 
(85 FR 19234-19243) and the subregulatory process established in the 
May 8th COVID-19 IFC (85 FR 27550-27649). Since the publication of the 
May 8th COVID-19 IFC, we have added several services to the Medicare 
telehealth list of services using this subregulatory process (please 
see https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes for the list of codes available for 
telehealth under the PFS). As discussed in the CY 2021 PFS final rule 
(FR 85 84507), at the conclusion of the PHE for COVID-19, associated 
waivers and interim policies will expire, payment for Medicare 
telehealth services will once again be limited by the requirements of 
section 1834(m) of the Act, and we will return to the policies 
established through the regular notice-and-comment rulemaking process, 
including the previously established Medicare telehealth services list, 
as modified by subsequent changes in policies and additions to the 
telehealth services list adopted through rulemaking. Many services that 
were temporarily added on an interim basis during the PHE for COVID-19 
will not be continued on the list after the end of the PHE for COVID-
19.
    Numerous stakeholders have continued to note that there is 
uncertainty about when the PHE for COVID-19 may end, and express 
concerns that the services added to the telehealth list on a temporary 
basis could be removed from the list before practitioners have had time 
to compile and submit evidence to support the permanent addition of 
these services on a Category 1 or Category 2 basis. To respond to these 
continuing concerns, we proposed to revise the timeframe for inclusion 
of the services we added to the Medicare telehealth services list on a 
temporary, Category 3 basis. Extending the temporary inclusion of 
these, Category 3 services on the telehealth list will allow additional 
time for stakeholders to collect, analyze, and submit data on those 
services to support their consideration for permanent addition to the 
list on a Category 1 or Category 2 basis.
    We proposed to retain all services added to the Medicare telehealth 
services list on a Category 3 basis until the end of CY 2023. We noted 
that this proposal would allow us time to collect more information 
regarding utilization of these services during the pandemic, and 
provide stakeholders the opportunity to continue to develop support for 
the permanent addition of appropriate services to the telehealth list 
through our regular consideration process, which includes notice-and-
comment rulemaking. By keeping these services on the Medicare 
telehealth services list through CY 2023, we will facilitate the 
submission of requests to add services permanently to the Medicare 
telehealth services list for consideration in the CY 2023 PFS 
rulemaking process and for consideration in the CY 2024 PFS rule.
    We recognize that, during the time between the publication of the 
CY 2021 PFS final rule and this final rule, practitioners may have used 
that time to compile new evidence of clinical benefit to support 
addition to the Medicare telehealth services list on a Category 3 
basis, including information that suggests that a certain service will 
likely meet the Category 1 or Category 2 criteria if provided with more 
time. We solicited comment on whether any of the services that were 
added to the Medicare telehealth list for the duration of the PHE for 
COVID-19 should now be added to the Medicare telehealth list on a 
Category 3 basis, to allow for additional data collection for 
submission for CMS to consider as part of the rulemaking process 
described in prior paragraphs.
    We received public comments on the proposed revised timeframe for 
consideration of services added to the telehealth list on a temporary 
basis and our comment solicitation on any additional services we should 
consider under Category 3 criteria. The following is a summary of the 
comments we received and our responses.
    Comment: Commenters supported our proposal to maintain services 
temporarily added to the Medicare telehealth services list on a 
Category 3 basis through the end of CY 2023. Commenters stated that by 
extending the inclusion of these services on the telehealth services 
list through a set date that is not linked to the end of the PHE, CMS 
is eliminating the unnecessary suspense and confusion that would have 
come from a more abrupt change. Some commenters suggested that CMS 
extend the timeframe beyond the end of 2023, if the PHE is extended 
beyond that point.
    Response: We appreciate commenters support for a more definitive 
timeframe for Category 3 codes to remain available on the Medicare 
telehealth services list. Consideration of any extensions at this time 
is outside the scope of this final rule.
    Comment: Some commenters requested that CMS add certain therapy, 
audiology, and speech-language pathology services to the Medicare 
telehealth list on a Category 3 basis to facilitate the collection of 
information on how these services can be furnished via telehealth and 
so that these services may be furnished via telehealth outside of the 
PHE, billed incident to a physician's professional services. These 
commenters also suggested that this may also aid in CMS' efforts to 
continue to gather information on these services

[[Page 65055]]

when performed via telehealth. These commenters did not provide any 
additional clinical information to support their request.
    Response: The commenters did not provide any additional clinical 
information with their request, especially clinical information that 
would satisfy our criteria for inclusion on the Medicare telehealth 
list, in any category. We are not finalizing addition of these services 
to the Medicare telehealth list.
    Comment: Some commenters requested that CMS add CPT codes 93797 
(Physician or other qualified health care professional services for 
outpatient cardiac rehabilitation; without continuous ECG monitoring 
(per session)) and 93798 (Physician or other qualified health care 
professional services for outpatient cardiac rehabilitation; with 
continuous ECG monitoring (per session)) and HCPCS codes G0422 
(Intensive cardiac rehabilitation; with or without continuous ecg 
monitoring with exercise, per session) and G0423 (Intensive cardiac 
rehabilitation; with or without continuous ecg monitoring; without 
exercise, per session) to the Medicare telehealth list on a Category 3 
basis. These commenters provided a number of studies on the safety and 
efficacy of at-home cardiac rehabilitation services.
    Response: We agree with commenters that it would be appropriate to 
add CPT codes 93797 and 93798 and HCPCS codes G0422 and G0423 to the 
telehealth services list on a Category 3 basis. We also remind 
commenters that any services added on a Category 3 basis would 
ultimately need to meet the criteria for addition to the telehealth 
services list on either a Category 1 or 2 basis in order to be 
permanently added to the Medicare telehealth services list. In the 
future, we would expect to see evidence that the risk:benefit ratio of 
these services when provided via telehealth is clearly in favor of the 
patient and that the welfare of beneficiaries is not compromised nor 
are their outcomes diminished. We would also be interested in 
considering the patient characteristics which allow the treating 
practitioner to select the most appropriate recipients of these 
services via telehealth. As the evidence evolves on this subject 
matter, we welcome further discussion with stakeholders on this topic.
    Comment: Many commenters requested that CPT codes 99441-99443 
(Telephone evaluation and management services by a physician or other 
qualified health care professional who may report evaluation and 
management services provided to an established patient, parent, or 
guardian not originating from a related E/M service provided within the 
previous 7 days nor leading to an E/M service or procedure within the 
next 24 hours or soonest available appointment) be added to the 
Medicare telehealth list on a Category 3 basis. The commenters noted 
that these codes could be used for mental health services and should be 
permanently available as part of the expansion of availability of 
mental health services via telehealth.
    Response: We note that for services for the diagnosis, evaluation 
or treatment of mental health conditions, we are finalizing a policy to 
revise the definition of ``telecommunications system'' for purposes of 
section 1834(m) of the Act to allow the use of audio-only technology 
under certain circumstances, described in detail below, that will allow 
visits and others services furnished via audio-only technology to be 
reported as telehealth services with the appropriate modifier. For 
example, the office/outpatient E/M codes are on the telehealth list 
permanently and when used to describe care for mental health 
conditions, will be reportable when furnished via audio-only technology 
to patients in their homes. Since audio-only telecommunications 
technology can be used to furnish mental health telehealth services to 
patients in their homes, the addition of these codes to the telehealth 
services list is unnecessary for mental health telehealth services. For 
telehealth services other than mental health care, we continue to 
believe that two-way, audio/video communications technology is the 
appropriate, general standard that will apply for telehealth services 
after the PHE, so we do not believe it would be appropriate for these 
codes to remain on the telehealth list after the end of the PHE.
    After consideration of public comments, we are finalizing as 
proposed the revised timeframe for inclusion of the services we added 
to the Medicare telehealth services list on a temporary, Category 3 
basis. We will retain all services added to the Medicare telehealth 
services list on a Category 3 basis until the end of CY 2023. 
Additionally, we are adding CPT codes 93797 and 93798 and HCPCS codes 
G0422 and G0423 to the Category 3 Medicare telehealth services list. 
These services appear on the list of telehealth services on the CMS 
telehealth website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html with a status of ``Available through 
December 31, 2023.''
d. Implementation of Provisions of the Consolidated Appropriations Act, 
2021 (CAA)
    The Consolidated Appropriations Act, 2021 (CAA) (Pub. L. 116-260, 
December 27, 2020) included a number of provisions pertaining to 
Medicare telehealth services. The Medicare telehealth statute at 
section 1834(m)(4)(C) of the Act generally limits the scope of 
telehealth services to those furnished in rural areas and in certain 
enumerated types of ``originating sites'' including physician offices, 
hospitals, and other medical care settings. Section 1834(m)(7) of the 
Act, (as added by section 2001(a) of the SUPPORT for Patients and 
Communities Act (Pub. L. 115-271, October 24, 2018), specifies that the 
geographic restrictions under section 1834(m)(4)(C)(i) of the Act do 
not apply, and includes the patient's home as a permissible originating 
site, for telehealth services furnished to a patient with a diagnosed 
substance use disorder (SUD) for treatment of that disorder or a co-
occurring mental health disorder. Section 123(a) of Division CC of the 
CAA amended section 1834(m)(7)(A) of the Act to broaden the scope of 
services for which the geographic restrictions under section 
1834(m)(4)(C)(i) of the Act do not apply and for which the patient's 
home is a permissible originating site to include telehealth services 
furnished for the purpose of diagnosis, evaluation, or treatment of a 
mental health disorder, effective for services furnished on or after 
the end of the PHE for COVID-19.\1\
---------------------------------------------------------------------------

    \1\ We note that neither the SUPPORT Act nor the CAA amended 
section 1862 of the Act. Section 1862(a)(4) of the Act and our 
corresponding regulation at 42 CFR 411.9 prohibit Medicare payment 
for services that are not furnished within the United States. Both 
the originating site and the distant site are subject to the 
statutory payment exclusion.
---------------------------------------------------------------------------

    Section 123(a) of the CAA also added subparagraph (B) to section 
1834(m)(7) of the Act to prohibit payment for a telehealth service 
furnished in the patient's home under paragraph (7) unless the 
physician or practitioner furnishes an item or service in-person, 
without the use of telehealth, within 6 months prior to the first time 
the physician or practitioner furnishes a telehealth service to the 
beneficiary, and thereafter, at such times as the Secretary determines 
appropriate. However, section 123(a) of the CAA added a clarification 
at section 1834(m)(7)(B)(ii) of the Act that the periodic requirement 
for an in-person item or service does not apply if payment for the 
telehealth service furnished would have been allowed without the new 
amendments. As such, the requirement for a periodic

[[Page 65056]]

in-person item or service applies only for telehealth services 
furnished for purposes of diagnosis, evaluation, or treatment of a 
mental health disorder other than for treatment of a diagnosed SUD or 
co-occurring mental health disorder, and only in locations that do not 
meet the geographic requirements in section 1834(m)(4)(C)(i) of the Act 
or when the originating site is the home of the patient, regardless of 
geography. We solicited comments on whether we should adopt a claims-
based mechanism to distinguish between the mental health telehealth 
services that are within the scope of the CAA amendments and those that 
are not (in other words, the services for which payment was newly 
authorized by the CAA amendments, and those for which payment was 
authorized before the CAA amendments), and if so, what that mechanism 
should be. In the event that we need to distinguish between the mental 
health telehealth services that are within the scope of the CAA 
amendments and those that are not, we also solicited comments on 
whether a clarification should be added to the regulation at Sec.  
410.78 as follows (which will take into account the other amendments we 
proposed to Sec.  410.78):
    The requirement that the physician or practitioner must furnish an 
item or service in person, without the use of telehealth, within a 
specified time frame shall not apply to telehealth services furnished 
for treatment of a diagnosed substance use disorder or co-occurring 
mental health disorder, or to services furnished in an originating site 
described in paragraphs (b)(3)(i) through (viii) or (xiii) that meets 
the geographic requirements specified in paragraph (b)(4) other than 
paragraph (b)(4)(iv)(D).
    As we noted above, section 123(a) of the CAA amends section 
1834(m)(7)(B)(i)(I) of the Act to prohibit payment for telehealth 
services under that paragraph unless the physician or practitioner 
furnished an item or service to the patient in person, without the use 
of telehealth, within 6 months before the first telehealth service. 
Thereafter, section 1834(m)(7)(B)(i)(II) of the Act leaves the 
Secretary discretion to specify the times or intervals at which an in-
person, non-telehealth service is required as a condition of payment 
for these telehealth services. Therefore, in order to implement the new 
statutory requirement to specify when an in-person service is required, 
we proposed that, as a condition of payment for a mental health 
telehealth service described in section 1834(m)(7)(A) of the Act other 
than services described in section 1834(m)(7)(B)(ii) of the Act (that 
is, services for which payment was authorized before the CAA 
amendments), the billing physician or practitioner must have furnished 
an in-person, non-telehealth service to the beneficiary within the 6-
month period before the date of the telehealth service.
    We also solicited comments on whether the required in-person, non-
telehealth service could also be furnished by another physician or 
practitioner of the same specialty and same subspecialty within the 
same group as the physician or practitioner who furnishes the 
telehealth service. We note that the language in the CAA states that 
the physician or practitioner furnishing the in-person, non-telehealth 
service must be the same person as the practitioner furnishing the 
telehealth service. There are several circumstances, however, under 
which we have historically treated the billing practitioner and other 
practitioners of the same specialty or subspecialty in the same group 
as if they were the same individual. For instance, for purposes of 
deciding whether a patient is a new or established patient, or whether 
to bill for initial or subsequent visit, practitioners of the same 
specialty/subspecialty in the same group are treated as the same 
person. For example, when Physician A and Physician B are of the same 
specialty and subspecialty and in the same group, if Physician A 
furnishes an initial critical care service to a patient, and Physician 
B subsequently furnishes additional critical care services to the same 
beneficiary for the same condition on the same day, Physician B will 
bill for a subsequent critical care service rather than an initial 
critical care visit. As we explain in section II.F of this final rule, 
because practitioners in the same specialty and same group often cover 
for one another to provide concurrent services, we believe the total 
time for critical care services furnished to a patient on the same day 
by the practitioners in the same group with the same specialty should 
be reflected as if it were a single set of critical care services 
furnished to the patient. See section II.F.2 of this final rule for 
further discussion of our current policies for billing critical care 
services. Similarly, if Physician A furnished a service to a patient, 
and then Physician B furnished a service to the patient a few months 
later, that patient will be considered an established patient with 
respect to both Physician A and Physician B. For example, Physician B 
could initiate care management services for the patient as an 
established patient. An example of guidance to this effect can be found 
in the Medicare Claims Processing Manual (IOM Pub. 100-04, Chapter 12, 
Sec.  30.6.7), which defines ``new patient'' as a patient who has not 
received any professional services, that is, E/M service or other face-
to-face service (for example, surgical procedure) from the physician or 
physician group (same physician specialty) within the previous 3 years, 
for E/M services.
    We note that this manual provision is also consistent with CPT 
guidance on whether a patient is a new or established patient.\2\
---------------------------------------------------------------------------

    \2\ American Medical Association. (2020). CPT 2021 professional 
edition. Chicago, Ill.: American Medical Association.
---------------------------------------------------------------------------

    We solicited comments regarding the extent to which a patient 
routinely receiving mental health services from one practitioner in a 
group might have occasion to see a different practitioner of the same 
specialty in that group for treatment of the same condition. This might 
occur when practitioners in a group cover for each other when a 
particular practitioner is unavailable or when a practitioner has left 
the group, but the beneficiary continues to receive services furnished 
by the group. In addition, fee-for-time compensation arrangements 
(formerly referred to as locum tenens arrangements), as described in 
section 1842(b)(6)(D) of the Act, allow for payment to be made to a 
physician for physicians' services (and services furnished incident to 
such services) furnished by a second physician to patients of the first 
physician if the first physician is unavailable to provide the 
services, and the services are furnished pursuant to an arrangement 
that is either informal and reciprocal, or involves per diem or other 
fee-for-time compensation for such services.
    Recognizing the importance of ensuring access to mental health 
telehealth services for beneficiaries who are unable to see the same 
practitioner who furnished the prerequisite in-person services due to 
the practitioner's unavailability, we solicited comments on an 
alternative policy to also allow the prerequisite in-person, non-
telehealth service for certain mental health telehealth services to be 
furnished by a practitioner in the same specialty/subspecialty in the 
same group when the physician or practitioner who furnishes the 
telehealth service is unavailable or the two professionals are 
practicing as a team.
    As amended by the CAA, section 1834(m)(7)(B)(i)(II) of the Act 
specifies that for subsequent mental health telehealth service, an in-
person, non-telehealth service is required at such

[[Page 65057]]

times as the Secretary determines appropriate. We proposed to require 
that an in-person, non-telehealth service must be furnished by the 
physician or practitioner at least once within 6 months before each 
telehealth service furnished for the diagnosis, evaluation, or 
treatment of a mental health disorder by the same practitioner, other 
than for treatment of a diagnosed SUD or co-occurring mental health 
disorder, and that the distinction between the telehealth and non-
telehealth services must be documented in the patient's medical record. 
We are clarifying here that, consistent with the conditions specified 
in section 1834(m)(7)(B)(i) of the Act, the in-person non-telehealth 
service requirements apply only to telehealth services furnished to a 
patient in a home originating site. We distinguish between mental 
health services furnished for a diagnosed SUD or co-occurring mental 
health disorder and those furnished to beneficiaries without a SUD 
diagnosis on the basis of ICD-10 diagnosis codes included on claims 
when the services are billed. We chose this interval because we are 
concerned that an interval less than 6 months may impose potentially 
burdensome travel requirements on the beneficiary, but that an interval 
greater than 6 months could result in the beneficiary not receiving 
clinically necessary in-person care/observation. The 6-month interval 
also matches the specified statutory interval for the initial 
telehealth service. We believe that a 6-month interval strikes an 
appropriate balance between these competing considerations, but 
solicited comments on whether a different interval, whether shorter, 
such as 3-4 months or longer, such as 12 months, may be appropriate to 
balance program integrity and patient safety concerns with increased 
access to care. We noted, however, that regardless of the time interval 
we establish, the practitioner is not precluded from scheduling in-
person visits at a more frequent interval, should such visit be 
determined to be clinically appropriate or preferred by the patient.
    As discussed below in this section of this final rule, ``e. Payment 
for Medicare Telehealth Services Furnished Using Audio-Only 
Communications Technology,'' we proposed to revise our regulatory 
definition of ``interactive telecommunications system'' to permit use 
of audio-only communications technology for mental health telehealth 
services under certain conditions when provided to beneficiaries 
located in their home. Therefore, we solicited comments on whether it 
would be appropriate to establish a different interval for these 
telehealth services, for the diagnosis, evaluation, or treatment of 
mental health disorders, other than for treatment of diagnosed SUD or 
co-occurring mental health disorder, when furnished as permitted 
through audio-only communications technology.
    In any event, we proposed that there would need to be an in-person 
visit within 6 months of any telehealth service furnished for the 
diagnosis, evaluation, or treatment of mental health disorders (other 
than for treatment of a diagnosed SUD or co-occurring mental health 
disorder), and the in-person visit would need to be documented in the 
patient's medical record. Payment would not be made for these 
telehealth services unless the required in-person service was furnished 
within 6 months of the telehealth service.
    Given the addition of the home of the individual as a permissible 
originating site for telehealth services for purposes of diagnosis, 
evaluation, or treatment of a mental health disorder, we proposed to 
revise our regulation at Sec.  410.78(b)(3) to add a new paragraph 
(xiv) to identify the home of a beneficiary as an originating site for 
telehealth services for the diagnosis, evaluation, or treatment of a 
mental health disorder, effective for services furnished on or after 
the first day after the end of the PHE as defined Sec.  400.200 of our 
regulations; and to provide that 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 
of the telehealth service. We also proposed to revise our regulation at 
Sec.  410.78(b)(4)(iv)(D) to specify that the geographic restrictions 
in Sec.  410.78(b)(4) do not apply to telehealth services furnished for 
the diagnosis, evaluation, or treatment of a mental health disorder, 
effective for services furnished on or after the first day after the 
end of the PHE as defined in our regulation at Sec.  400.200.
    In addition, section 125(c) of the CAA amended section 
1834(m)(4)(C)(ii) of the Act to add to the list of permissible 
telehealth originating sites a rural emergency hospital, which is a new 
Medicare provider type added by section 125 of the CAA effective 
beginning in CY 2023.
    We also proposed to amend our regulation at Sec.  410.78, 
Telehealth services, to conform with the statutory change to include 
rural emergency hospitals as telehealth originating sites beginning in 
CY 2023. In accordance with section 1834(m)(4)(C)(ii)(XI) of the Act, 
as added by section 125(c) of the CAA, we proposed to revise Sec.  
410.78(b)(3) of our regulations to add a rural emergency hospital, as 
defined in section 1861(kkk)(2) of the Act, as a permissible 
originating site for telehealth services furnished on or after January 
1, 2023.
    We received public comments on the implementation of provisions of 
the CAA, 2021. The following is a summary of the comments we received 
and our responses.
    Comment: Commenters generally supported our proposals to implement 
sections 123 and 125 of the CAA, 2021.
    Many commenters opposed our proposal to require an in-person, non-
telehealth visit every 6 months for beneficiaries receiving mental 
health telehealth services in their home under the amendments made by 
section 123 of the CAA, 2021. They opined that requiring another in-
person visit would be excessive and limit access to services, 
particularly given the ongoing shortage of mental health practitioners, 
and that the telehealth practitioner should be able to use professional 
judgement as to when an in-person interaction is necessary. Some 
commenters also noted that, during the PHE for COVID-19, there have 
been no requirements for in-person visits, and this illustrates that 
the in-person requirement is unnecessary. Other commenters stated that 
if we do require a subsequent in-person, non-telehealth visit, then the 
required in-person visit interval should be extended as long as 
possible, for example at least 12 months. Some commenters also 
suggested, in keeping with the definition of an established patient, 
that if CMS were to implement a requirement for in-person services, 
they should consider an interval of once every 3 years. Other 
commenters suggested CMS implement a list of exceptions to any in-
person visit requirement that could be noted in the medical record, and 
allow the patient to opt out of the requirement.
    Some commenters, such as MedPAC, supported our proposal to require 
in-person, non-telehealth visits for beneficiaries receiving mental 
health services via telehealth, stating that this policy would help 
safeguard beneficiaries and the Medicare program from fraud. MedPAC 
also noted that this requirement may limit access to mental health 
services via telehealth, and encouraged CMS to study the impact of this 
policy and consider adjustments through future rulemaking. MedPAC

[[Page 65058]]

also recommended that CMS apply additional scrutiny to outlier 
clinicians who bill many more telehealth services per beneficiary than 
other clinicians or who bill for a high number of services in a week or 
a month, and prohibit ``incident to'' billing for telehealth services 
provided by any clinician who can bill Medicare directly.
    Response: We appreciate the many comments and suggestions regarding 
our implementation of the amendments made by section 123 of the CAA, 
especially regarding the frequency with which a beneficiary receiving 
mental health services in their home through telehealth would need to 
receive an in-person, non-telehealth service. While we agree with 
MedPAC and others that requiring an in-person, non-telehealth service 
for beneficiaries receiving mental health services via telehealth in 
their home may help to safeguard beneficiaries and the Medicare program 
from possible program integrity issues we must balance those concerns 
with concerns raised by commenters about ensuring access to valuable 
(and underutilized) mental health services. We are also concerned about 
access to services, particularly given the ongoing shortage of mental 
health practitioners, and that there is not a ``one size fits all'' 
model in the management of mental health where some patients may 
require more frequent in-person visits and some may require less, which 
is also why we have an exceptions process. Therefore, in response to 
comments, we are finalizing an interval for the in-person visit 
requirement of 12 months, rather than the proposed 6-month timeframe.
    We note that patients and practitioners should ultimately determine 
the cadence of meeting during the year, who may decide to meet more 
often than annually, which is permissible under our policy, as driven 
by clinical needs on a case-by-case basis. Further, the exceptions 
process will allow for situations where an in-person annual visit is 
not needed. CMS will monitor claims data regarding use of telehealth 
mental health services to identify areas for further investigation and 
to inform future rulemaking, including situations where there is 
evidence beneficiaries are potentially experiencing adverse health 
outcomes or increased difficulty accessing in-person care, or if 
inappropriate use or billing of telehealth mental health services is 
suspected.
    We also agree with commenters that there may be specific 
circumstances when an in-person visit requirement within 12 months of 
each mental health telehealth service furnished in a beneficiary's home 
may be inadvisable or impracticable for an individual beneficiary. If 
the patient and practitioner consider the risks and burdens of an in-
person service and agree that, on balance, these outweigh the benefits 
(such as the opportunity to assess in-person body language or 
conducting a physical exam to monitor for medication side effects), and 
the practitioner documents the basis for that decision in the patient's 
medical record, then the in-person visit requirement is not applicable 
for that 12-month period. Therefore, we are finalizing our proposed 
policy with a modification to require, in general, that after the first 
mental health telehealth service in the patient's home, there must be 
an in-person, non-telehealth service within 12 months of each mental 
health telehealth service--but to allow for limited exceptions to the 
requirement. Specifically, if the patient and practitioner agree that 
the benefits of an in-person, non-telehealth service within 12 months 
of the mental health telehealth service are outweighed by risks and 
burdens associated with an in-person service, and the basis for that 
decision is documented in the patient's medical record, the in-person 
visit requirement will not apply for that particular 12-month period. 
For example, situations in which the risks and burdens associated with 
an in-person service may outweigh the benefit could include, but are 
not limited to instances when an in-person service is likely to cause 
disruption in service delivery or has the potential to worsen the 
patient's condition(s). The risks and burdens associated with an in-
person service could also outweigh the benefit if a patient is in 
partial or full remission and only requires a maintenance level of 
care. Other examples of such instances may include the clinician's 
professional judgement that the patient is clinically stable and/or 
that an in-person visit has the risk of worsening the patient's 
condition, creating undue hardship on self or family, or if it is 
determined that the patient is at risk for disengagement with care that 
has been effective in managing the illness. Practitioners must also 
document that the patient has the ability to obtain any needed point of 
care testing, including vital sign monitoring and laboratory studies. 
Practitioners must note the exception for any applicable 12-month 
interval. We note that there is no exception to the statutory 
requirement that the physician or practitioner must furnish to the 
beneficiary an in-person, non-telehealth service within 6 months prior 
to initiation of mental health services via telehealth.
    Comment: Many commenters agreed with the alternative policy we 
considered to allow the required in-person, non-telehealth service to 
be furnished by another physician or practitioner of the same specialty 
and subspecialty in the same group as the practitioner who furnishes 
the mental health telehealth service to the beneficiary if the 
practitioner who furnishes the telehealth service is unavailable.
    Response: We are adopting the alternative policy discussed in the 
proposed rule to allow a clinician's colleague in the same subspecialty 
in the same group to furnish the in-person, non-telehealth service to 
the beneficiary if the original practitioner is unavailable. This is 
also consistent with longstanding policy, which defines an established 
patient as an individual who receives professional services from the 
physician/NPP or another physician of the same specialty and 
subspecialty who belongs to the same group within the previous three 
years, for purposes of billing for E/M services.
    Comment: A few commenters provided suggestions as to how CMS would 
distinguish between mental health services provided to beneficiaries in 
their homes via telehealth that co-occur with a SUD (and therefore, 
would not be subject to the requirement for an in-person, non-
telehealth visit every 6 months) and those that are not co-occurring 
with a SUD. A few commenters stated that use of a mental health or 
behavioral health diagnosis code(s) on the claim (for which no 
substance use disorder code is reported), place of service is home, and 
for which modifier 95 is used would identify a mental health telehealth 
visit that is newly covered under the CAA.
    Response: We will consider these suggestions and undertake future 
rulemaking as necessary. We note that we are not finalizing any changes 
to our policies regarding payment for telehealth services furnished for 
treatment of a patient with a diagnosed SUD or co-occurring mental 
health disorder, although we are clarifying that these telehealth 
services are considered mental health services for purposes of the 
audio-only policy we are finalizing as discussed in the section that 
follows below.
    Comment: A few commenters requested that CMS implement a broad 
definition of the term ``home'' in terms of mental healthcare delivery 
site, as a strict definition would only serve to exacerbate existing 
socioeconomic barriers and reduce access to care for an already 
underserved and vulnerable patient population. For example, some

[[Page 65059]]

patients may not have access to traditional living space, as they may 
be living in places such as shelters and transitional housing or lack 
access to housing entirely. According to these commenters, requiring 
patients to access telehealth from their own residence creates an 
unnecessary barrier to telehealth services and may reinforce health 
inequities for individuals of lesser financial means. Commenters 
further pointed out that, for privacy reasons, a beneficiary may not be 
comfortable receiving mental health services in their home and may wish 
to receive mental health services in a temporary location, such as a 
car or other private location.
    Response: Our definition of home, both in general and for this 
purpose, can include temporary lodging, such as hotels and homeless 
shelters. We clarify 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, the service 
is still considered to be furnished ``in the home of an individual'' 
for purposes of section 1834(m)(4)(C)(ii)(X) of the Act.
    After consideration of public comments, we are finalizing the 
proposed amendments to our regulation at Sec.  410.78, Telehealth 
services, to implement the amendments made by section 123 of the CAA as 
explained above, with some modifications. We are finalizing amendments 
to Sec.  410.78(b)(3) and (4) to add the home of a beneficiary as an 
originating site for telehealth services for the diagnosis, evaluation, 
or treatment of mental health disorders, to specify that the geographic 
restrictions do not apply to these services, to add the conditions of 
payment requiring an in-person, non-telehealth visit within 6 months of 
the mental health telehealth service in the patient's home, and to add 
the exception for subsequent mental health telehealth services when the 
risks and burdens outweigh the benefits of this requirement. 
Specifically, we are modifying the proposed amendments to clarify that 
payment will not be made for a telehealth service furnished under Sec.  
410.78(b)(3)(xiv) unless the following conditions are met:
    (1) 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;
    (2) The physician or practitioner has furnished an item or service 
in-person, without the use of telehealth, at least once within 6 months 
of each subsequent telehealth service described in this paragraph, with 
exceptions as noted above.
    (3) The requirements of paragraph (2) may be met by another 
physician or practitioner of the same specialty and subspecialty in the 
same group as the physician or practitioner who furnishes the 
telehealth service, if the physician or practitioner who furnishes the 
telehealth service described under this paragraph is not available.
    We are also finalizing our proposal to add a rural emergency 
hospital, as defined in section 1861(kkk)(2) of the Act, as a 
permissible originating site.
    We are also clarifying that, as proposed, our definition of home 
can include temporary lodging such as hotels and homeless shelters as 
well as locations a short distance from the beneficiary's home.
e. Payment for Medicare Telehealth Services Furnished Using Audio-Only 
Communications Technology
    Section 1834(m) of the Act outlines the requirements for Medicare 
payment for telehealth services that are furnished via a 
``telecommunications system,'' and specifies that, only for purposes of 
Medicare telehealth services through a Federal telemedicine 
demonstration program conducted in Alaska or Hawaii, the term 
``telecommunications system'' includes asynchronous, store-and-forward 
technologies. We further defined the term, ``telecommunications 
system,'' in the regulation at Sec.  410.78(a)(3) to mean an 
interactive telecommunications system, which is defined as multimedia 
communications equipment that includes, at a minimum, audio and video 
equipment permitting two-way, real-time interactive communications 
between the patient and distant site physician or practitioner.
    During the PHE for COVID-19, we used waiver authority under section 
1135(b)(8) of the Act to temporarily waive the requirement, for certain 
behavioral health and/or counseling services and for audio-only 
evaluation and management (E/M) visits, that telehealth services must 
be furnished using an interactive telecommunications system that 
includes video communications technology. Therefore, for certain 
services furnished during the PHE for COVID-19, we make payment for 
these telehealth services when they are furnished using audio-only 
communications technology. Emergency waiver authority is no longer 
available after the PHE for COVID-19 ends, and telehealth services will 
again be subject to all statutory and regulatory requirements.
    In the CY 2021 PFS final rule (85 FR 84535), we noted that we 
continued to believe that our longstanding regulatory definition of 
``telecommunications system'' reflected the intent of statute and that 
the term should continue to be defined as including two way, real-time, 
audio/video communications technology.
    Historically, we have not proposed any permanent modifications to 
the definition of ``interactive telecommunications system'' to allow 
for use of audio-only communications technology due to our 
interpretation of the statutory requirements, as well as concerns over 
program integrity and quality of care. Specifically, we were concerned 
that the use of audio-only communications technology for Medicare 
telehealth services could lead to inappropriate overutilization, and 
believed that video visualization of the patient generally was 
necessary to fulfill the full scope of service elements of the codes 
included on the Medicare telehealth list. We believe it is reasonable 
to reassess these concerns, given the now widespread utilization during 
the PHE for COVID-19 of Medicare telehealth services furnished using 
audio-only communications technology. Based upon an initial review of 
claims data collected during the PHE for COVID-19, which describe 
audio-only telephone E/M services, we observed that the audio-only E/M 
visits have been some of the most commonly performed telehealth 
services during the PHE, and that most of the beneficiaries receiving 
these services were receiving them for treatment of a mental health 
condition. Given the generalized shortage of mental health care 
professionals (https://bhw.hrsa.gov/data-research/review-health-workforce-research), and the existence of areas and populations where 
there is limited access to broadband due to geographic or socioeconomic 
challenges, we believe beneficiaries may have come to rely upon the use 
of audio-only communications technology in order to receive mental 
health services, and that a sudden discontinuation of this flexibility 
at the end of the PHE could have a negative impact on access to care.
    As explained above, section 123 of the CAA removes the geographic 
restrictions for Medicare telehealth services for the diagnosis, 
evaluation, or treatment of a mental health disorder, and adds the 
patient's home as a permissible originating site for these telehealth 
services. We also believe that mental health services are different 
from

[[Page 65060]]

most other services on the Medicare telehealth services list in that 
many of the services primarily involve verbal conversation where 
visualization between the patient and furnishing physician or 
practitioner may be less critical to provision of the service. While we 
continue to believe that two-way, audio/video communications technology 
is the appropriate, general standard for telehealth services, and that 
there may be particular instances where visual cues may help a 
practitioner's ability to assess and treat patients with mental health 
disorders, especially where opioids or mental health medications are 
involved (for example, visual cues as to patient hygiene, or indicators 
of self-destructive behavior), we note that stakeholders have suggested 
to us that the availability of telehealth services for mental health 
care via audio-only communications technology will increase access to 
care. This is especially true in areas with poor broadband 
infrastructure and among patient populations that do not wish to use, 
do not have access to, and/or are unable to utilize devices that permit 
a two-way, audio/video interaction. Our preliminary analysis of 
Medicare claims data, as well as information provided to us by 
stakeholders on the popularity of these services, indicates that use of 
interactive communications technology for mental health care will 
likely continue to be high even beyond the circumstances of the COVID-
19 pandemic. According to our analysis of Medicare Part B claims data 
for services furnished via Medicare telehealth during the PHE for 
COVID-19, utilization of telehealth for many professional services 
spiked around April 2020 and has diminished over the ensuing months. In 
contrast, preliminary analysis of Medicare claims data suggests that, 
for many mental health services that were permanently and temporarily 
added to the Medicare Telehealth list, there is a steady utilization 
trend from April 2020 and thereafter. Furthermore, as described above, 
according to preliminary analysis of claims data which examined 
utilization by diagnosis, the codes for audio-only E/M services have 
been highly utilized during the PHE, particularly for beneficiaries 
with mental health conditions.
    Given these considerations, we now believe that it will be 
appropriate to revisit our regulatory definition of ``interactive 
telecommunications system'' beyond the circumstances of the PHE to 
allow for the inclusion of audio-only services under certain 
circumstances. Therefore, we proposed to amend our regulation at Sec.  
410.78(a)(3) to define interactive telecommunications system to include 
audio-only communications technology when used for telehealth services 
for the diagnosis, evaluation, or treatment of mental health disorders 
furnished to established patients when the originating site is the 
patient's home. We believe this proposal is consistent with the 
expansion of at-home access to mental health telehealth services in 
section 1834(m)(7) of the Act, as amended by section 123 of the CAA, 
which required that the beneficiary must have received a Medicare-paid 
(or payable), in-person item or service from the physician or 
practitioner furnishing the mental health services through telehealth 
within 6 months of the first mental health telehealth service. We 
proposed to adopt a similar, ongoing requirement that an in-person item 
or service must be furnished within 6 months of such a mental health 
telehealth service. We reiterate that our policy to permit audio-only 
telehealth services is limited to services where the home is the 
originating site. This is because the other enumerated telehealth 
originating sites are medical settings that are far more likely to have 
access to reliable broadband internet service. When a patient is 
located at one of these originating sites, access to care is far less 
likely to be limited by access to broadband that facilitates a video 
connection. In contrast, access to broadband, devices, and user 
expertise to enable a video connection is less likely to be available 
in the patient's home. As described in prior paragraphs, we also 
believe that mental health services are distinct from other kinds of 
services on the Medicare telehealth list in that many of the services 
do not necessarily require visualization of the patient to fulfill the 
full scope of service elements
    We also proposed to limit payment for audio-only services to 
services furnished by physicians or practitioners who have the capacity 
to furnish two-way, audio/video telehealth services but are providing 
the mental health services via audio-only communication technology, in 
instances where the beneficiary is unable to use, does not wish to use, 
or does not have access to two-way, audio/video technology. We believe 
that this requirement will ensure that mental health services furnished 
via telehealth are only conducted using audio-only communications 
technology in instances where the use of audio-only technology is 
facilitating access to care that would be unlikely to occur otherwise, 
given the patient's technological limitations, abilities, or 
preferences. In the interests of monitoring utilization and program 
integrity concerns for audio-only telehealth services furnished under 
the terms of this exception, we proposed to create a service-level 
modifier that would identify these mental health telehealth services 
furnished to a beneficiary in their home using audio-only 
communications technology. The use of this modifier will also serve to 
certify that the audio-only telehealth service meets the requirements 
for the exception specified in Sec.  410.78(a)(3), including that the 
furnishing physician or practitioner has the capacity to furnish the 
service using interactive two-way, real-time audio/video communications 
technology, but instead used audio-only technology under the conditions 
specified in the regulation.
    We proposed to amend our regulation at Sec.  410.78(a)(3) to 
specify that an interactive telecommunications system can include 
interactive, real-time, two-way audio-only technology for telehealth 
services furnished for the diagnosis, evaluation, or treatment of a 
mental health disorder as described under paragraph (b)(4)(D), under 
the following conditions: The patient is located in their home at the 
time of service as described at Sec.  410.78 (b)(3)(xiv); The distant 
site physician or practitioner has the technical capability at the time 
of the service to use an interactive telecommunications system that 
includes video; and the patient is not capable of, or does not consent 
to, the use video technology for the service.
    We solicited comments on these proposals, as well as what, if any, 
additional documentation should be required in the patient's medical 
record to support the clinical appropriateness of providing audio-only 
telehealth services for mental health in the event of an audit or 
claims denial. Additional required documentation could include 
information about the patient's level of risk and any other guardrails 
that are appropriate to demonstrate clinical appropriateness, and 
minimize program integrity and patient safety concerns.
    We solicited comment on whether, for purposes of the proposed 
audio-only mental health telehealth services exception, we should 
exclude certain higher-level services, such as level 4 or 5 E/M visit 
codes, when furnished alongside add-on codes for psychotherapy, or 
codes that describe psychotherapy with crisis. We solicited comment on 
whether the full scope of service elements for these codes could be 
performed via audio-only communications technology. However, we also 
noted that maintaining the

[[Page 65061]]

availability of these services through audio-only communications 
technology might give patients access to care needed to address their 
higher level or acute mental health needs in instances where they are 
unable to access two-way, audio/video communications technology.
    We received public comments on the payment for Medicare telehealth 
services furnished using audio-only communications technology. The 
following is a summary of the comments we received and our responses.
    Comment: Commenters were very supportive of our proposal to allow 
for mental health services to be furnished using audio-only 
communications technology. A few commenters, while supportive of the 
use of audio-only communications technology during the PHE, urged CMS 
to further study and evaluate the safety and effectiveness of the 
audio-only modality for various levels of care and treatments to 
determine appropriateness of continuing payment after the PHE expires.
    Some commenters requested that CMS allow office/outpatient E/M 
services furnished via telehealth to be conducted via audio-only 
communications technology, at least through the end of year in which 
the PHE ends. Some commenters requested that CMS clarify that SUD 
services are considered mental health services for purposes of the 
expanded definition of ``interactive telecommunications system'' to 
include audio-only services under Sec.  410.78(a)(3), as well as to 
ensure that the periodic in-person non-telehealth visit requirements 
would not apply when audio-only communications technology is used for 
services for the treatment of a SUD or co-occurring mental health 
disorder to established patients with a SUD diagnosis. Other commenters 
suggested that CMS allow all Medicare telehealth services, not just 
mental health services, to be conducted via audio-only communications 
technology. Some commenters requested that CMS permit audio-only 
communications technology to be used to furnish psychological and 
neuropsychological testing evaluation (CPT codes 96130-96133) and 
Health Behavior Assessment and Intervention (HBAI) services (CPT codes 
96156-96171) as these services do not require visualization of the 
patient. Some commenters expressed disappointment that CMS did not 
propose to continue payment beyond the PHE for COVID-19 for CPT codes 
99441-99443, which describe audio-only office/outpatient visits, as the 
commenter believes these services are also important for beneficiaries 
who do not have access to two-way, audio/video communications 
technology.
    Response: As we explain above, we continue to believe that mental 
health services are different from most other services on the Medicare 
telehealth services list in that they primarily involve verbal 
conversation where visualization between the patient and the furnishing 
physician or practitioner may be less critical to provision of the 
service. We continue to believe that office/outpatient E/M visits 
furnished via telehealth that are not for the diagnosis, evaluation, or 
treatment of a mental health disorder are most appropriately furnished 
via an interactive telecommunications system that includes two-way, 
audio/video communications technology. We would like to clarify that 
SUD services are considered mental health services for purposes of the 
expanded definition of ``interactive telecommunications system'' to 
include audio-only services under Sec.  410.78(a)(3). CMS used waiver 
authority under section 1135(b)(8) of the Act to waive the video 
requirement under the regulation at Sec.  410.78(a)(3) during the 
pandemic for certain behavioral health and/or counseling services, and 
this waiver expires with the expiration of the PHE. We proposed to 
amend the definition of interactive telecommunications system to 
include audio-only technology only for certain mental health telehealth 
services; and we continue to believe that, except for those mental 
health services and outside the circumstances of the PHE, it is 
appropriate to continue the current policy of defining ``interactive 
telecommunications system'' as technology that allows two-way, real-
time interactive audio and video communications.
    Regarding telephone E/M services CPT codes 99441, 99442, and 99443, 
please see above for a discussion of these services These telephone E/M 
codes will remain on the telehealth services list temporarily through 
the end of the PHE for COVID-19.
    Comment: A few commenters suggested other conditions for which 
audio-only communications technology could be appropriate, such as 
neurologic services in treatment for headache, seizure, dementia, pain, 
along with adherence and side-effect follow-up. Other commenters stated 
that audio-only technology could also be used for other conditions such 
as patients with chronic pain or for provision of MNT services.
    Response: As stated earlier, we continue to believe that mental 
health services are different from other services because they 
principally involve verbal exchanges between patient and practitioner. 
We note that the home is not a permissible originating site for the 
vast majority of telehealth services; that the geographic limitations 
for telehealth originating sites apply outside the circumstances of the 
PHE; and that, when telehealth services are furnished in an originating 
site other than the patient's home, the facility/office that serves as 
the originating site should have available broadband/video to allow the 
patient the ability to have real-time, audio/video interaction with 
their physician/practitioner. Additionally, given that payment for 
Medicare telehealth services under section 1834(m) of the Act is at the 
same rate as for in-person services, we have some concerns about making 
sure that the telehealth service provided is a sufficiently close 
substitute for what the patient would get in an in-person service. As 
such, we are not expanding the scope of Medicare telehealth services 
for which audio-only communications technology may be used to include 
services other than those furnished in the home to diagnose, evaluate 
or treat a mental health condition.
    Comment: Commenters supported the proposal to create a service-
level modifier to identify mental health telehealth visits ``furnished 
to a beneficiary in their home using audio-only communications 
technology.'' Some commenters stated that the creation of a service-
level modifier to identify telehealth services furnished using audio-
only would help facilitate further study of the use of audio-only 
technology for telehealth services.
    Some commenters did not support additional documentation 
requirements for audio-only visits beyond those already required, while 
others recommended that CMS require practitioners to document the 
reason the beneficiary declined to participate in a live, two-way video 
visit and specify if it was due to lack of access, the inability to use 
the technology, or the patient's unwillingness to consent.
    A few commenters suggested that CMS remove the requirement that the 
practitioner have access to two-way, audio/video communications 
technology in order to furnish audio-only telehealth services, stating 
that practitioners in rural areas may not have access to reliable 
broadband and should not be precluded from providing audio-only 
telehealth services due to this lack of access.
    Response: We appreciate commenters' concerns. However, we continue 
to believe that, because a telehealth service

[[Page 65062]]

is generally analogous to and must include the elements of the in-
person service, it is generally appropriate to continue to require the 
use of two-way, real-time audio/video communications technology to 
furnish the service. Therefore, we are maintaining the requirement that 
distant site physicians and practitioners must have the technical 
capability to use an interactive telecommunications system that 
includes two-way, real-time, interactive audio and video communications 
at the time that an audio-only telehealth service is furnished. With 
regard to documentation requirements, we are finalizing a requirement 
that the reason for using audio-only technology to furnish a telehealth 
service must be documented in the patient's medical record.
    Comment: A few commenters provided examples of services that they 
believe should not be conducted via audio-only communications 
technology. These included: Level 4 and 5 office visits as well as 
services describing psychotherapy for crisis (CPT codes 90839-90840), 
group psychotherapy (CPT code 90853), psychological and 
neuropsychological testing (CPT codes (96130-96133 and 96136-96139), 
psychological and neuropsychological testing), and Applied Behavior 
Analysis Therapy (CPT codes 97151-97157).
    Other commenters stated that there should be no restrictions on 
furnishing higher level mental health telehealth visits to patients in 
the home via audio-only technology.
    In response to our statement regarding utilization of CPT codes 
99441-99443 (telephone E/M services), a few commenters requested the 
agency share with the public the audio-only utilization data that has 
been collected during the public health emergency to provide 
stakeholders with a better understanding of how these services have 
been utilized outside of the treatment of mental health conditions.
    Response: We would like to thank commenters for their support and 
suggestions. We continue to believe that real-time, audio-video 
telehealth interactions are the standard for Medicare telehealth 
services in most instances. We will continue to consider how the 
delivery of certain services via telehealth impacts patient care, and 
we encourage stakeholders to submit requests with supporting 
documentation using our process for the addition or removal of services 
on the Medicare telehealth services list. Regarding CPT codes 99441-
99443, which describe telephone E/M services, please find our 
discussion earlier in this preamble. In response to the request for 
utilization data on audio-only telehealth services furnished during the 
PHE for COVID-19, we refer readers to publicly available utilization 
data (an example available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Research-Statistics-Data-and-Systems).
    After consideration of public comments, we are finalizing as 
proposed creation of a service-level modifier for use to identify 
mental health telehealth services furnished to a beneficiary in their 
home using audio-only communications technology. We are also amending 
our regulation at Sec.  410.78(a)(3) to specify that an interactive 
telecommunications system can include interactive, real-time, two-way 
audio-only technology for telehealth services furnished for the 
diagnosis, evaluation, or treatment of a mental health disorder as 
described under paragraph (b)(4)(iv)(D), under the following 
conditions: The patient is located in their home at the time of service 
as described at Sec.  410.78 (b)(3)(xiv); the distant site physician or 
practitioner has the technical capability at the time of the service to 
use an interactive telecommunications system that includes video; and 
the patient is not capable of, or does not consent to, the use of video 
technology for the service. We are also clarifying that SUD services 
are considered mental health services for purposes of the amended 
definition of ``interactive telecommunications system'' to include 
audio-only services under Sec.  410.78(a)(3). We anticipate that this 
will have a positive impact on access to care for mental health 
conditions and contribute to overall health equity.
2. Other Non-Face-to-Face Services Involving Communications Technology 
Under the PFS
a. Expiration of PHE Flexibilities for Direct Supervision Requirements
    Under section 1861 of the Act and at Sec.  410.32(b)(3) of the 
regulations, Medicare requires certain types of services to be 
furnished under specific levels of supervision of a physician or 
practitioner, including diagnostic tests, services incident to 
physician services, and other services. For professional services 
furnished incident to the services of a 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), requirements for immediate availability and accessibility of a 
physician are considered to be satisfied if the physician meets the 
requirements for direct supervision for physician office services at 
Sec.  410.26 and for hospital outpatient services at Sec.  410.27. 
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, and we have interpreted this ``immediate 
availability'' requirement to mean in-person, physical, not virtual, 
availability.
    Through the March 31st 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 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 that rule, we also solicited comment on 
issues related to the policy allowing virtual provision of direct 
supervision, specifically whether there should be any additional 
guardrails or limitations put in place to ensure patient safety/
clinical appropriateness, beyond typical clinical standards, and 
whether we should consider potential restrictions to prevent fraud or 
inappropriate use. We also stated that we will consider this and other 
information as we contemplate future policy regarding use of 
communications technology to satisfy supervision requirements, as well 
as the best approach for safeguarding patient safety while promoting 
use of technology to enhance access.
    We also noted that the temporary exception to allow immediate 
availability for direct supervision through virtual presence 
facilitates the provision of telehealth services by clinical staff of 
physicians and other practitioners incident to their own professional 
services. This is discussed in the March 31st COVID-19 IFC (85 FR 
19246). This is especially relevant for services such as physical 
therapy, occupational therapy, and speech language pathology services, 
since those practitioners can only bill Medicare directly for 
telehealth services under telehealth waivers that are effective only 
during the PHE for COVID-19. We note that sections 1834(m)(4)(D) and 
(E) of the Act specifies the types of clinicians

[[Page 65063]]

who may furnish and bill for Medicare telehealth services, and 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 solicited information on whether this flexibility should be 
continued beyond the later of the end of the PHE for COVID-19 or CY 
2021. Specifically, we solicited comments on the extent to which the 
flexibility to meet the immediate availability requirement for direct 
supervision through the use of real-time, audio/video technology is 
being used during the PHE, and whether physicians and practitioners 
anticipate relying on this flexibility after the end of the PHE. We 
solicited comments on whether this flexibility should potentially be 
made permanent, meaning that we would revise the definition of ``direct 
supervision'' at Sec.  410.32(b)(3)(ii) to include immediate 
availability through the virtual presence of the supervising physician 
or practitioner using real-time, interactive audio/video communications 
technology without limitation after the PHE for COVID-19, or if we 
should continue the policy in place for a short additional time to 
facilitate a gradual sunset of the policy. We solicited comment on 
whether the current timeframe for continuing this flexibility at Sec.  
410.32(b)(3)(ii), which is currently the later of the end of the year 
in which the PHE for COVID-19 ends or December 31, 2021, remains 
appropriate, or if this timeframe should be extended through some later 
date to facilitate the gathering of additional information in 
recognition that, due to the on-going nature of the PHE for COVID-19, 
practitioners may not yet have had time to assess the implications of a 
permanent change in this policy. We also solicited comment regarding 
the possibility of permanently allowing immediate availability for 
direct supervision through virtual presence using real-time audio/video 
technology for only a subset of services, as we recognize that it may 
be inappropriate to allow direct supervision without physical presence 
for some services, due to potential concerns over patient safety if the 
practitioner is not immediately available in-person. We also solicited 
comments on, if this policy to be made permanent, whether a service-
level modifier should be required to identify when the requirements for 
direct supervision were met using two-way, audio/video communications 
technology.
    We received public comments on the expiration of PHE flexibilities 
for direct supervision requirements. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters supported continuing to allow 
requirements for direct supervision of services to be met through 
virtual presence using telecommunications technology beyond the PHE. 
They stated that COVID-19 may not be completely eradicated for at least 
a year after the end of the PHE, and that health professionals will 
need time to recover from the pandemic's effects. Other commenters 
stated that CMS should permanently modify the definition of direct 
supervision to include the presence of the supervising practitioner via 
real-time, interactive audio/video technology in certain cases. Some 
commenters encouraged CMS to create a service-level modifier for 
purposes of identifying advanced practice provider involvement in care 
and requested that CMS consult with specialty societies as this change 
is developed.
    Some commenters supported use of a service-level modifier to 
identify services furnished under direct supervision where the 
supervising physician was available through two-way, audio/video 
communications technology.
    Some commenters specifically requested that CMS maintain the 
flexibility for the supervising physician to be available using two-
way, audio/video when a nurse practitioner is furnishing a behavioral 
health service, as these are services that do not require a physical 
exam.
    MedPAC, while supportive of our extension of this policy through 
the year in which the PHE ends, stated two concerns about making it 
permanent after the PHE in the absence of evidence about its effects on 
safety, quality, and spending. First, allowing clinicians to supervise 
``incident to'' services virtually could pose a safety risk to 
beneficiaries because the clinician would not be physically available 
to help the individual being supervised, if necessary, which is 
important if the service is a complex procedure. Second, allowing 
virtual supervision could potentially enable a clinician to supervise 
many individuals at multiple locations at the same time. It could be 
difficult for a clinician to address urgent, clinical needs while 
virtually supervising many people at multiple locations simultaneously. 
This scenario could also lead to higher spending by allowing clinicians 
to bill for more ``incident-to'' services during a single day.
    Some commenters stated that, if CMS were to make this policy 
permanent, certain services should be precluded, such as complex drug 
therapies or anesthesia services.
    Response: We thank commenters for their input and will consider 
addressing the issues raised by these comments in future rules or 
guidance, as appropriate.
b. Interim Final Provisions in the CY 2021 PFS Final Rule
    In the CY 2021 PFS final rule (85 FR 84536), we finalized the 
establishment of HCPCS code G2252 (Brief communication technology-based 
service, e.g., virtual check-in service, by a physician or other 
qualified health care professional who can report evaluation and 
management services, provided to an established patient, not 
originating from a related E/M service provided within the previous 7 
days nor leading to an E/M service or procedure within the next 24 
hours or soonest available appointment; 11-20 minutes of medical 
discussion) on an interim basis. We stated that, given the widespread 
concerns expressed by commenters about the continuing need for audio-
only conversations with patients and our determination that we will not 
continue to pay for audio-only E/M visits after the conclusion of the 
PHE (see 85 FR 84533 through 84535 for further discussion of that 
policy), we believed it will be expedient to establish additional 
coding and payment for an extended virtual check-in, which could be 
furnished using any form of synchronous communications technology, 
including audio-only, on an interim basis for CY 2021. We stated that 
we believed establishing payment for this service on an interim basis 
will support access to care for beneficiaries who may be reluctant to 
return to in-person visits unless absolutely necessary, and allow us to 
consider whether this policy should be adopted on a permanent basis. In 
that rule, we finalized a direct crosswalk to CPT code 99442, the value 
of which we believe most accurately reflects the resources associated 
with a longer service delivered via synchronous communications 
technology, which can include audio-only communications. Commenters 
supported the creation and interim final adoption of this service. 
Commenters stated that, as beneficiaries and practitioners may be 
reluctant to return to primarily in-person services post-PHE, payment 
for a longer virtual check-in will be necessary to account for 
circumstances where more time is spent determining whether an in-person 
visit is needed beyond the 5-10 minutes accounted for by HCPCS code 
G2012 (Brief communication technology-based service, e.g. virtual 
check-in, by a physician or other qualified health care

[[Page 65064]]

professional who can report evaluation and management services, 
provided to an established patient, not originating from a related e/m 
service provided within the previous 7 days nor leading to an e/m 
service or procedure within the next 24 hours or soonest available 
appointment; 5-10 minutes of medical discussion). Commenters also 
supported valuing HCPCS code G2252 through a direct crosswalk to CPT 
code 99442. We agree with commenters that additional time may be needed 
to assess the necessity of an in-person service given concerns over 
exposure to illnesses beyond the duration of the PHE for COVID-19 and 
that current coding may not accurately reflect that time. Based on 
support from commenters, we proposed to permanently adopt coding and 
payment for CY 2022, HCPCS code G2252 as described in the CY 2021 PFS 
final rule.
    We received public comments on the interim final provisions in the 
CY 2021 PFS final rule. The following is a summary of the comments we 
received and our responses.
    Comment: Commenters supported CMS' finalizing separate coding and 
payment for a longer virtual check-in.
    Some commenters, including the AMA RUC, supported valuing HCPCS 
code G2252 through a direct crosswalk to the value of CPT code 99442 
but recommended that CMS work with the CPT Editorial Panel to 
editorially revise CPT codes 99441-99443 so that the CPT codes may be 
consistently reported by all payors to describe audio-only services.
    Some commenters stated that CMS should create a parallel code to 
HCPCS code G2252 billable by those practitioners who cannot 
independently bill for E/M services. Commenters pointed out that, in 
the CY 2021 PFS final rule, CMS implemented a similar policy for HCPCS 
codes G2010 and G2012.
    Response: With regard to HCPCS code G2252 being billable by those 
practitioners who cannot independently bill for E/M services, we 
appreciate commenters bringing this issue to our attention, and we will 
consider these comments for future rulemaking.
    After consideration of public comments, we are finalizing our 
proposal to permanently establish separate coding and payment for the 
longer virtual check-in service described by HCPCS code G2252 for CY 
2022 using a crosswalk to the value of CPT code 99442, as proposed. As 
described in the CY 2021 PFS final rule (85 FR 84536), we believe that 
the value of CPT code 99442 most accurately reflects the resources 
associated with a longer service delivered via synchronous 
communications technology, which can include audio-only communications. 
This is consistent with our approach to valuing the virtual check-in 
service (HCPCS code G2012), which used CPT code 99441 as the basis for 
valuation. In the case of HCPCS code G2252 and CPT code 99442, both 
codes describe 11-20 minutes of medical discussion when the 
practitioner may not necessarily be able to visualize the patient, and 
is used when the acuity of the patient's problem is not necessarily 
likely to warrant a visit, but when the needs of the particular patient 
require more assessment time from the practitioner. In the case of 
HCPCS code G2252, the additional time would be used to determine the 
necessity of an in-person visit and result in a work time/intensity 
that is similar to the crosswalk code.
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.
    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 originating site 
facility fee for telehealth services furnished in CY 2022 is $27.59.
    The MEI increase for CY 2022 is 2.1 percent and is based on the 
most recent historical percentage increase of the MEI for the second 
quarter of 2021 (2.3 percent), and the most recent historical 
productivity adjustment for calendar year 2020 (0.2 percent).
    Therefore, for CY 2022, the payment amount for HCPCS code Q3014 
(Telehealth originating site facility fee) is $27.59. The Medicare 
telehealth originating site facility fee and the MEI increase by the 
applicable time period is shown in Table 18.

[[Page 65065]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.025

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 final 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

[[Page 65066]]

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 stakeholders, 
including the RUC, with regard to our approach for accurately valuing 
codes, and as we prioritize our obligation to value new, revised, and 
potentially misvalued codes. We continue to welcome feedback from all 
interested parties regarding valuation of services for consideration 
through our rulemaking process.
2. Methodology for Establishing Work RVUs
    For each code identified in this section, we conduct a review that 
includes the current work RVU (if any), RUC-recommended work RVU, 
intensity, time to furnish the preservice, intraservice, and 
postservice activities, as well as other components of the service that 
contribute to the value. Our reviews of recommended work RVUs and time 
inputs generally include, but have not been limited to, a review of 
information provided by the RUC, the HCPAC, and other public 
commenters, medical literature, and comparative databases, as well as a 
comparison with other codes within the PFS, consultation with other 
physicians and health care professionals within CMS and the Federal 
Government, as well as Medicare claims data. We also assess the 
methodology and data used to develop the recommendations submitted to 
us by the RUC and other public commenters and the rationale for the 
recommendations. In the CY 2011 PFS final rule with comment period (75 
FR 73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalks to key reference or similar codes, and magnitude 
estimation (see the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329) for more information). When referring to a survey, 
unless otherwise noted, we mean the surveys conducted by specialty 
societies as part of the formal RUC process.
    Components that we use in the building block approach may include 
preservice, intraservice, or postservice time and post-procedure 
visits. When referring to a bundled CPT code, the building block 
components could include the CPT codes that make up the bundled code 
and the inputs associated with those codes. We use the building block 
methodology to construct, or deconstruct, the work RVU for a CPT code 
based on component pieces of the code. Magnitude estimation refers to a 
methodology for valuing work that determines the appropriate work RVU 
for a service by gauging the total amount of work for that service 
relative to the work for a similar service across the PFS without 
explicitly valuing the components of that work. In addition to these 
methodologies, we frequently utilize an incremental methodology in 
which we value a code based upon its incremental difference between 
another code and another family of codes. Section 1848(c)(1)(A) of the 
Act specifically defines the work component 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 
stakeholder reactions to our approach. We note that many commenters and 
stakeholders 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 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

[[Page 65067]]

the RUC-recommended work RVU. When the recommended work RVUs do not 
appear to account for significant changes in time, we have employed the 
different approaches to identify potential values that reconcile the 
recommended work RVUs with the recommended time values. Many of these 
methodologies, such as survey data, building block, crosswalks to key 
reference or similar codes, and magnitude estimation have long been 
used in developing work RVUs under the PFS. In addition to these, we 
sometimes use the relationship between the old time values and the new 
time values for particular services to identify alternative work RVUs 
based on changes in time components.
    In so doing, rather than ignoring the RUC-recommended value, we 
have used the recommended values as a starting reference and then 
applied one of these several methodologies to account for the 
reductions in time that we believe were not otherwise reflected in the 
RUC-recommended value. If we believe that such changes in time are 
already accounted for in the RUC's recommendation, then we do not make 
such adjustments. Likewise, we do not arbitrarily apply time ratios to 
current work RVUs to calculate proposed work RVUs. We use the ratios to 
identify potential work RVUs and consider these work RVUs as potential 
options relative to the values developed through other options.
    We do not imply that the decrease in time as reflected in survey 
values should always equate to a one-to-one or linear decrease in newly 
valued work RVUs. Instead, we believe that, since the two components of 
work are time and intensity, absent an obvious or explicitly stated 
rationale for why the relative intensity of a given procedure has 
increased, significant decreases in time should be reflected in 
decreases to work RVUs. If the RUC's recommendation has appeared to 
disregard or dismiss the changes in time, without a persuasive 
explanation of why such a change should not be accounted for in the 
overall work of the service, then we have generally used one of the 
aforementioned methodologies to identify potential work RVUs, including 
the methodologies intended to account for the changes in the resources 
involved in furnishing the procedure.
    Several stakeholders, 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 
stakeholders 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.
    We received several comments regarding our methodologies for work 
valuation in response to the CY 2022 PFS proposed rule and those 
comments are summarized below.
    Comment: Several commenters disagreed with our reference to older 
work time sources, and stated that their use led to the proposal of 
work RVUs based on flawed assumptions. Commenters stated that codes 
with ``CMS/Other'' or ``Harvard'' work time sources, used in the 
original valuation of certain older services, were not surveyed, and 
therefore, were not resource-based. Commenters also stated that it was 
invalid to draw comparisons between the current work times and work 
RVUs of these services to the newly surveyed work time and work RVUs as 
recommended by the RUC.
    Response: We agree that it is important to use the recent data 
available regarding work times, and we note that when many years have 
passed since work time has been measured, significant discrepancies can 
occur. However, we also believe that our operating assumption regarding 
the validity of the existing values as a point of comparison is 
critical to the integrity of the relative value system as currently 
constructed. The work times currently associated with codes play a very 
important role in PFS ratesetting, both as points of comparison in 
establishing work RVUs and in the allocation of indirect PE RVUs by 
specialty. If we were to operate under the assumption that previously 
recommended work times had been routinely overestimated, this would 
undermine the relativity of the work RVUs on the PFS in general, in 
light of the fact that codes are often valued based on comparisons to 
other codes with similar work times. Such an assumption would also 
undermine the validity of the allocation of indirect PE RVUs to 
physician specialties across the PFS.
    Instead, we believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times 
that have been used in PFS ratesetting are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available, and that we 
are statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the CY 2017 PFS final rule 
(81 FR 80273 through 80274).
    Comment: Several commenters disagreed with the use of time ratio 
methodologies for work valuation. Commenters stated that this use of 
time ratios is not a valid methodology for valuation of physician 
services. Commenters stated that treating all components of physician 
time (preservice, intraservice, postservice and post-operative visits) 
as having identical intensity is incorrect, and inconsistently applying 
it to only certain services under review creates inherent payment 
disparities in a payment system, which is based on relative valuation. 
Commenters stated that in many scenarios, CMS selects an arbitrary 
combination of inputs to apply rather than seeking a valid clinically 
relevant relationship that would preserve relativity. Commenters 
suggested that CMS determine the work valuation for each code based not 
only on surveyed work times, but also the intensity and complexity of 
the service and relativity to other similar services, rather than 
basing the work value entirely on time.
    Response: We disagree and continue to believe that the use of time 
ratios is one of several appropriate methods for identifying potential 
work RVUs for particular PFS services, particularly when the 
alternative values recommended by the RUC and other commenters do not 
account for survey information that suggests the amount of

[[Page 65068]]

time involved in furnishing the service has changed significantly. We 
reiterate that, consistent with the statute, we are required to value 
the work RVU based on the relative resources involved in furnishing the 
service, which include time and intensity. When our review of 
recommended values reveals that changes in time are not accounted for 
in a recommended work RVU, we believe we have an obligation to account 
for that change in establishing work RVUs since the statute explicitly 
identifies time as one of the two elements of the work RVUs.
    We recognize that it would not be appropriate to develop work RVUs 
solely based on time given that intensity is also an element of work, 
but in applying the time ratios, we are using derived intensity 
measures based on current work RVUs for individual procedures. We 
clarify again that we do not treat all components of physician time as 
having identical intensity. If we were to disregard intensity 
altogether, the work RVUs for all services would be developed based 
solely on time values and that is not the case, as indicated by the 
many services that share the same time values but have different work 
RVUs. For example, among the codes reviewed in this CY 2022 PFS final 
rule, CPT codes 63053 (Laminectomy, facetectomy, or foraminotomy 
(unilateral or bilateral with decompression of spinal cord, cauda 
equina and/or nerve root[s] [eg, spinal or lateral recess stenosis]), 
during posterior interbody arthrodesis, lumbar; each additional 
segment), 67335 (Placement of adjustable suture(s) during strabismus 
surgery, including postoperative adjustment(s) of suture(s)), 80504 
(Pathology clinical consultation; for a moderately complex clinical 
problem, with review of patient's history and medical records and 
moderate level of medical decision making. When using time for code 
selection, 21-40 minutes of total time is spent on the date of the 
consultation), and 99425 (Principal care management services, for a 
single high-risk disease; additional 30 minutes provided personally by 
a physician or other qualified health care professional, per calendar 
month) all share the same intraservice and total work time of 30 
minutes. However, these codes have very different proposed work RVUs of 
2.31 and 3.23 and 0.91 and 1.00 respectively. These examples 
demonstrate that we do not value services purely based on work time; 
instead, we incorporate time as one of multiple different factors 
employed in our review process. Furthermore, we reiterate that we use 
time ratios to identify potentially appropriate work RVUs, and then use 
other methods (including estimates of work from CMS medical personnel 
and crosswalks to key reference or similar codes) to validate these 
RVUs. For more details on our methodology for developing work RVUs, we 
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272 
through 80277).
    We also clarify for the commenters that our review process is not 
arbitrary in nature. Our reviews of recommended work RVUs and time 
inputs generally include, but have not been limited to, a review of 
information provided by the RUC, the HCPAC, and other public 
commenters, medical literature, and comparative databases, as well as a 
comparison with other codes within the PFS, consultation with other 
physicians and health care professionals within CMS and the Federal 
Government, as well as Medicare claims data. We also assess the 
methodology and data used to develop the recommendations submitted to 
us by the RUC and other public commenters and the rationale for the 
recommendations. In the CY 2011 PFS final rule with comment period (75 
FR 73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalks to key reference or similar codes, and magnitude 
estimation (see the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329) for more information). With regard to the 
invocation of clinically relevant relationships by the commenters, we 
emphasize that we continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes that describe 
clinically similar services are sometimes stronger comparator codes, we 
do not agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk.
    Comment: Several commenters discouraged the use of valuation of 
codes based on work RVU increments. Commenters stated that this 
methodology for valuing codes inaccurately treats all components of the 
physician time as having identical intensity and would lead to 
incorrect work valuations. Commenters stated that CMS should carefully 
consider the clinical information justifying the changes in physician 
work intensity provided by the RUC and other stakeholders.
    Response: We believe the use of an incremental difference between 
the work RVUs of codes is a valid methodology for setting values, 
especially in valuing services within a family of revised codes where 
it is important to maintain appropriate intra-family relativity. 
Historically, we have frequently utilized an incremental methodology in 
which we value a code based upon the incremental work RVU difference 
between the code and another code or another family of codes. We note 
that the RUC has also used the same incremental methodology on occasion 
when it was unable to produce valid survey data for a service. We have 
no evidence to suggest that the use of an incremental difference 
between the work RVUs of codes conflicts with the statute's definition 
of the work component as the resources in time and intensity required 
in furnishing the service. We do consider clinical information 
associated with physician work intensity provided by the RUC and other 
stakeholders as part of our review process, although we remind readers 
again that we do not believe that it is necessary for codes to share 
the same site of service, patient population, or utilization level in 
order to serve as an appropriate crosswalk.
    Comment: Several commenters stated that they were concerned about 
CMS' lack of consideration for compelling evidence that services have 
changed. Commenters stated that CMS appeared to dismiss the fact that 
services may change due to technological advances, changes in the 
patient population, shifts in the specialty of physicians providing 
services or changes in the physician work or intensity required to 
perform services. Commenters stated that CMS' failure to discuss 
compelling evidence does not reflect the long history of reviewing 
potentially misvalued codes, first through the statutorily mandated 5-
year review processes and more recently from continuous annual reviews. 
Commenters stated that CMS has discussed compelling evidence in 
rulemaking since the inception of the RBRVS and has informed public 
commenters to consider compelling evidence to identify potentially 
misvalued codes. Commenters requested that CMS address the compelling 
evidence submitted with the RUC recommendations when the agency does 
not accept the RUC's recommended work RVUs.
    Response: The concept of compelling evidence was developed by the 
RUC as part of its work RVU review process for individual codes. The 
RUC determines whether there is compelling evidence to justify an 
increase in valuation. The

[[Page 65069]]

RUC's compelling evidence criteria include documented changes in 
physician work, an anomalous relationship between the code and multiple 
key reference services, evidence that technology has changed physician 
work, analysis of other data on time and effort measures, and evidence 
that incorrect assumptions were made in the previous valuation of the 
service. While we appreciate the submission of this additional 
information for review, we emphasize that the RUC developed the concept 
of compelling evidence for its own review process; an evaluation of 
``compelling evidence,'' at least as conceptualized by the RUC, is not 
part of our review process, as our focus is the time and intensity of 
services, in accordance with the statute. With that said, we do 
consider changes in technology, patient population, and other 
compelling evidence criteria, as such evidence may affect the time and 
intensity of a service under review. For example, new technology may 
cause a service to become easier or more difficult to perform, with 
corresponding effects on the time and intensity of the service. 
However, we are under no obligation to adopt the same review process or 
compelling evidence criteria as the RUC. We instead focus on evaluating 
and addressing the time and intensity of services when reviewing 
potentially misvalued codes because 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.
    Comment: A commenter stated that there has been a disparate impact 
on the valuation of cardiothoracic services over the past decade. The 
commenter stated that CMS has taken a prejudicial approach to services 
from this specialty over the period 2009-2019 by making refinements to 
the RUC's recommended work RVUs at a higher percentage than all other 
specialties.
    Response: We disagree with the commenter that there has been any 
prejudicial approach to the valuation of services from the 
cardiothoracic specialty or any other specialty. We value services on 
an individual case-by-case basis using time and intensity as directed 
by the statute. When the recommended work RVUs from the RUC do not 
appear to account for significant changes in time, we have employed 
different approaches (such as survey data, building block, crosswalks 
to key reference or similar codes, and magnitude estimation) to 
identify potential values that reconcile the recommended work RVUs with 
the recommended time values. We continue to believe that the nature of 
the PFS relative value system is such that all services are 
appropriately subject to comparisons to one another, and the dominant 
specialty of the service under review is not part of our work valuation 
methodology.
    Comment: Several commenters raised the issue of the refinement 
panel which was last reformed in CY 2016. Commenters stated that the 
refinement panel was not obsolete and was not mutually exclusive with 
the change to include all proposed valuations in each year's proposed 
rule. Commenters stated that for two decades, the refinement panel 
process was considered by stakeholders to be an appeals process and its 
elimination discontinued CMS' reliance on outside stakeholders to 
provide accountability through a transparent appeals process. 
Commenters requested that CMS consider these issues and create an 
objective, transparent and consistently applied formal appeals process 
that would be open to any commenting organization.
    Response: We did not propose any changes to the refinement panel 
and we are not finalizing any changes to the refinement panel for CY 
2022. As we stated in the CY 2016 PFS final rule (80 FR 70917-70918), 
the refinement panel was established to assist us in reviewing the 
public comments on CPT codes with interim final work RVUs and in 
balancing the interests of the specialty societies who commented on the 
work RVUs with the budgetary and redistributive effects that could 
occur if we accepted extensive increases in work RVUs across a broad 
range of services. We did not believe that the refinement panel had 
generally served as the kind of ``appeals'' or reconsideration process 
that some stakeholders envisioned in their comments. We also believe 
that the refinement panel was not achieving its intended purpose. 
Rather than providing us with additional information, balanced across 
specialty interests, to assist us in establishing work RVUs, the 
refinement panel process generally served to rehash the issues raised 
and information already discussed at the RUC meetings and considered by 
CMS. In contrast to the prior process of establishing interim final 
values and using a refinement panel process that generally was not 
observed by members of the public, we continue to believe that the 
current process of proposing the majority of code values in a proposed 
rule, giving the public the opportunity to comment on those proposed 
values, and then finalizing those values in a final rule offers greater 
transparency and accountability.
    We also note that we did not finalize our proposal to eliminate the 
refinement panel completely in CY 2016. We retain the ability to 
convene refinement panels for codes with interim final values under 
circumstances where additional input provided by the panel is likely to 
add value as a supplement to notice and comment rulemaking. We also 
remind stakeholders that we have established an annual process for the 
public nomination of potentially misvalued codes. This process, 
described in the CY 2012 PFS final rule (76 FR 73058), provides an 
annual means for those who believe that values for individual services 
are inaccurate and should be readdressed through notice and comment 
rulemaking to bring those codes to our attention.
    Comment: Several commenters requested that CMS use the interim RUC 
recommendations from the April 2021 meeting for several code families 
which had previously been reviewed at the October 2020 RUC meeting or 
the January 2021 RUC meeting. Commenters stated that the earlier RUC 
recommendations were made on an interim basis and requested an 
expedited review of the recommendations from the April 2021 RUC 
meeting; the RUC resubmitted its recommendations for these code 
families as part of its comment submission.
    Response: We finalized a policy in the CY 2015 PFS final rule to 
make all changes in the work and MP RVUs and the direct PE inputs for 
new, revised, and potentially misvalued services under the PFS by 
proposing and then finalizing such changes through notice and comment 
rulemaking, as opposed to initially finalizing changes on an interim 
final basis (79 FR 67602 through 67609). As we stated when promulgating 
the CY 2015 PFS final rule, this approach has the significant advantage 
that the RVUs for all services under the PFS are established using a 
full notice and comment procedure, including consideration of the RUC 
recommendations, before they take effect, providing the public the 
opportunity to comment on a specific proposal prior to it being 
implemented. We continue to believe that this is a far more transparent 
process which assures that we have the full benefit of stakeholder 
comments before establishing values. Since we did not make proposals on 
the code families in question using the RUC's recommendations from the 
April 2021 meeting, we would be forced to finalize valuation for these 
codes on an interim

[[Page 65070]]

final basis, without the opportunity for public comment. This would 
contradict the policy that we finalized in the CY 2015 PFS final rule, 
and we do not believe that it would serve the interests of 
transparency. Although we will consider any information submitted by 
stakeholders for valuation during the comment period, as we do for all 
codes which are subject to notice and comment rulemaking, we will 
formally review the recommendations from the April 2021 RUC meeting 
next year as part of the CY 2023 PFS rulemaking cycle.
    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 
stakeholder feedback, we will 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. 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 stakeholders and 
commenters, including the RUC, as we prioritize our obligation to value 
new, revised, and potentially misvalued codes; and 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 21 contains a list of codes and 
descriptors for which we proposed work RVUs; this includes all codes 
for which we received RUC recommendations by February 10, 2021. The 
finalized work RVUs, work time and other payment information for all CY 
2022 payable codes are available on the CMS website under downloads for 
the CY 2022 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/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 22 details 
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this final rule, Determination of 
Practice Expense Relative Value Units (PE RVUs), we addressed 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 noted that for each refinement, we indicated 
the impact on direct costs for that service. We noted that, on average, 
in any case where the impact on the direct cost for a particular 
refinement is $0.35 or less, the refinement has no impact on the PE 
RVUs. This calculation considers both the impact on the direct portion 
of the PE RVU, as well as the impact on the indirect allocator for the 
average service. In the proposed rule, we also noted that many of the 
refinements listed in Table 21 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 2022 are displayed in the 
CY 2022 direct PE input files, available on the CMS website under the 
downloads for the CY 2022 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs displayed there have been 
used in developing the CY 2022 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

[[Page 65071]]

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.
    Comment: Several commenters stated that CMS is proposing to refine 
the facility pre-service clinical labor times for major procedures to 
conform to the 000-day or 010-day global period standards for 
``Extensive use of clinical staff'' despite the RUC recommendation of 
standard 090-day preservice clinical labor times. Commenters stated 
that these procedures are performed under general anesthesia in the 
facility setting and require specialized supplies and equipment and 
pre-operative coordination between multiple specialists necessitating 
office clinical staff time typical of 90-day global procedures 
performed in the facility setting. Commenters stated that reassignment 
of global periods for select codes does not negate the fact that a 
major procedure is a major procedure and the pre-service facility 
clinical staff time for a major procedure is independent of the global 
period assignment. Commenters stated that each procedure should be 
evaluated on a case-by-case basis.
    Response: We agree with the commenters that the direct PE inputs 
for each service should be evaluated on a case-by-case basis based on 
our criteria of what would be reasonable and medically necessary in the 
typical case. We reviewed the individual codes in question and 
concluded that the use of 000-day or 010-day global period standards 
for ``Extensive use of clinical staff'' would be most typical in these 
cases. As we noted under the Standardization of Clinical Labor Tasks 
(section II.B) part of this final rule, we continue to believe that 
setting and maintaining clinical labor standards provides greater 
consistency among codes that share the same clinical labor tasks and 
could improve relativity of values among codes. For additional 
discussion, we direct readers to the individual code families affected 
by our proposed preservice clinical labor times (CPT codes 46020 and 
46030 and CPT codes 61736 and 61737).
    We refer readers to section II.B. of this final rule, Determination 
of Practice Expense Relative Value Units (PE RVUs), for more 
information regarding the collaborative work of CMS and the RUC in 
improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
    In some cases, the PE worksheets included with the RUC's 
recommendations include items that are not clinical labor, disposable 
supplies, or medical equipment or that cannot be allocated to 
individual services or patients. We addressed these kinds of 
recommendations in previous rulemaking (78 FR 74242), and we do not use 
items included in these recommendations as direct PE inputs in the 
calculation of PE RVUs.
(5) New Supply and Equipment Items
    The RUC generally recommends the use of supply and equipment items 
that already exist in the direct PE input 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 2022 we received invoices for several new supply and 
equipment items. Tables 23 and 24 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of this final rule, Determination of Practice Expense Relative 
Value Units, we encourage stakeholders 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 
stakeholders 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 stakeholders 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 23 and 24 also include the number of 
invoices received and the number of nonfacility allowed services for 
procedures that use these equipment items. We provide the nonfacility 
allowed services so that stakeholders 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 stakeholders 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 stakeholders 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

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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 
2022 are available on the CMS website under downloads for the CY 2022 
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/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 2022, we identified new and revised codes to determine which 
services meet the definition of ``imaging services'' as defined above 
for purposes of this cap. Beginning for CY 2022, we proposed to include 
the following services on the list of codes to which the OPPS cap 
applies: CPT codes 0633T (Computed tomography, breast, including 3D 
rendering, when performed, unilateral; without contrast material), 
0634T (Computed tomography, breast, including 3D rendering, when 
performed, unilateral; with contrast material(s)), 0635T (Computed 
tomography, breast, including 3D rendering, when performed, unilateral; 
without contrast, followed by contrast material(s)), 0636T (Computed 
tomography, breast, including 3D rendering, when performed, bilateral; 
without contrast material(s)), 0637T (Computed tomography, breast, 
including 3D rendering, when performed, bilateral; with contrast 
material(s)), 0638T (Computed tomography, breast, including 3D 
rendering, when performed, bilateral; without contrast, followed by 
contrast material(s)), 0648T (Quantitative magnetic resonance for 
analysis of tissue composition (eg, fat, iron, water content), 
including multiparametric data acquisition, data preparation and 
transmission, interpretation and report, obtained without diagnostic 
MRI examination of the same anatomy (eg, organ, gland, tissue, target 
structure) during the same session), 0649T (Quantitative magnetic 
resonance for analysis of tissue composition (eg, fat, iron, water 
content), including multiparametric data acquisition, data preparation 
and transmission, interpretation and report, obtained with diagnostic 
MRI examination of the same anatomy (eg, organ, gland, tissue, target 
structure) (List separately in addition to code for primary 
procedure)), 77089 (Trabecular bone score (TBS), structural condition 
of the bone microarchitecture; using dual X-ray absorptiometry (DXA) or 
other imaging data on gray-scale variogram, calculation, with 
interpretation and report on fracture risk), 77090 (Trabecular bone 
score (TBS), structural condition of the bone microarchitecture; using 
dual X-ray absorptiometry (DXA) or other imaging data on gray-scale 
variogram, calculation, with interpretation and report on fracture 
risk, technical preparation and transmission of data for analysis to be 
performed elsewhere), 77091 (Trabecular bone score (TBS), structural 
condition of the bone microarchitecture; using dual X-ray 
absorptiometry (DXA) or other imaging data on gray-scale variogram, 
calculation, with interpretation and report on fracture risk, technical 
calculation only), 77092 (Trabecular bone score (TBS), structural 
condition of the bone microarchitecture; using dual X-ray 
absorptiometry (DXA) or other imaging data on gray-scale variogram, 
calculation, with interpretation and report on fracture risk 
interpretation and report on fracture risk only, by other qualified 
health care professional), 91113 (Gastrointestinal tract imaging, 
intraluminal (eg, capsule endoscopy), colon, with interpretation and 
report), and 93319 (3D echocardiographic

[[Page 65073]]

imaging and postprocessing during transesophageal echocardiography or 
transthoracic echocardiography for congenital cardiac anomalies for the 
assessment of cardiac structure(s) (eg, cardiac chambers and valves, 
left atrial appendage, intraterial septum, interventricular septum) and 
function, when performed). 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 did not receive public comments on this proposal. We are 
finalizing the addition of the services listed above to the list of 
codes to which the OPPS cap applies, as proposed.
4. Valuation of Specific Codes for CY 2022
(1) Anesthesia for Cardiac Electrophysiologic Procedures (CPT Code 
00537)
    In October 2019, the RUC reviewed CPT code 00537 (Anesthesia for 
cardiac electrophysiologic procedures including radiofrequency 
ablation) and recommended that the code be surveyed for the October 
2020 meeting. This service was identified by the RUC via the high 
volume growth screen for services with total Medicare utilization of 
10,000 or more that have increased by at least 100 percent from 2009 
through 2014. Additionally, at the October 2019 RUC meeting, the RUC 
approved an anesthesia reference service list (RSL) and a method to 
assess the relativity among services on the anesthesia fee schedule 
that uses a revised building block methodology and a regression line 
analysis. The RUC has stated that the revised building block 
methodology generates ``proxy RVUs'' that are then compared against the 
RSL regression line to assess relativity among anesthesia services. The 
RUC has indicated that their primary and approved method for anesthesia 
base unit valuation continues to be the anesthesia survey results, and 
that the building block and regression line analysis are used as a 
supplemental validation measure.
    The RUC recommended a valuation of 12 base units for CPT code 
00537. We disagree with the RUC-recommended valuation of 12 base units 
for CPT code 00537. After performing a RUC database search of codes 
with similar total times and post-induction period procedure anesthesia 
(PIPPA) times, 12 base units appears to be on the very high range. We 
proposed a valuation of 10 base units supported by reference codes CPT 
code 00620 (anesthesia for procedures on the thoracic spine and cord, 
not otherwise specified) and CPT code 00600 (Anesthesia for procedures 
on cervical spine and cord; not otherwise specified), which both have a 
valuation of 10 base units. CPT code 00620 has a very similar total 
time of 235 minutes and CPT code 00600 has a higher total time of 257 
minutes and the same base unit value of 10, which indicates that this 
is an appropriate valuation. Additionally, we note that the survey 
total time for CPT code 00537 increased from 150 to 238 minutes, 
resulting in a survey result 25th percentile valuation of 10 base 
units.
    We proposed the RUC-recommended direct PE inputs for CPT code 
00537.
    Comment: Commenters disagreed with the proposed valuation of 10 
base units for CPT code 00537 and stated that CMS should instead 
finalize the RUC-recommended valuation of 12 base units. Commenters 
disagreed with CMS using reference codes CPT code 00620 (anesthesia for 
procedures on the thoracic spine and cord, not otherwise specified) and 
CPT code 00600 (Anesthesia for procedures on cervical spine and cord; 
not otherwise specified) as a basis for the valuation of 10 base units. 
Commenters stated that CMS ignored the reference codes chosen by the 
RUC and instead used reference codes that were not surveyed, which 
makes the time source unknown. They also stated that CMS ignored the 
validation measures that the RUC used to support their recommendations 
and that CMS only considered the total times of the reference codes and 
not all inputs of time, such as post induction time. Additionally, 
commenters stated that they believe CMS did not consider the intensity 
of the service for CPT code 00537, as the supporting reference codes 
have a lower intensity and are not clinically similar.
    Response: We disagree and continue to believe that using multiple 
methodologies for identifying potential base units for anesthesia 
services is appropriate. Codes are, and have been over many years, 
often valued by comparisons to codes with similar times, including the 
total time of a service. Therefore, we consider total time to be an 
appropriate measure for comparison. We also use reference codes to 
validate a base unit valuation. When using reference codes to support a 
proposed valuation, we do not consider them as a direct ``cross-walk'' 
between the CPT code that is being revalued and the chosen reference 
code. Instead, a reference code is used as a supportive check in 
validating times. For CPT code 00600 and CPT code 00620, we believe 
that the similarities in time, as well as the base unit value of 10 
being the survey 25th percentile result, make them appropriate 
reference codes. We continue to believe that the relative value system 
of the PFS is such that all services are appropriately subject to 
comparison to one another. We do not agree that codes must share the 
same patient population, utilization, age of the CPT code, or survey 
tool to serve as an appropriate reference code. We do consider clinical 
information associated with the intensity of a physician's work 
provided by the RUC and other stakeholders as part of our review 
process, although we remind readers again that we do not agree that 
codes must share the same clinical aspects of work to serve as an 
appropriate reference code. For CPT code 00537, we considered the 
intensity of the service as it relates to other CPT codes on the fee 
schedule, the total time of the service, as well as aspects of time 
compared to supporting reference codes to determine the base unit 
valuation for this CPT code. For additional information regarding our 
use of supporting reference codes and our use of time inputs as a tool 
for comparison, we refer readers to our discussion of the subject in 
the Methodology for Establishing Work RVUs section of this final rule 
(section II.E.2. of the final rule).
    Comment: We received one comment in support of our proposed 
valuation for CPT code 00537.
    Response: We acknowledge and appreciate the support of a base unit 
valuation of 10 for CPT code 00537.
    After consideration of these public comments, we are finalizing the 
base unit valuation and direct PE inputs for CPT code 00537 as 
proposed.
(2) Anesthesia Services for Image-Guided Spinal Procedures (CPT Codes 
01937, 01938, 01939, 01940, 01941, and 01942)
    In 2017, the RUC identified CPT code 01936 (Anesthesia for 
percutaneous image guided procedures on the spine and spinal cord; 
therapeutic) as possibly needing refinement due to inaccurate reporting 
via the high-volume growth screen. The Relativity Assessment Workgroup 
reviewed data on what procedures were reported with this anesthesia 
code. In October 2019, the Workgroup reviewed this service and 
recommended that it be referred to the CPT Editorial Panel to create 
more granular codes. In October 2020, the CPT Editorial Panel replaced 
CPT codes 01935 and 01936 with six new codes to report percutaneous 
image-guided spine and spinal cord anesthesia procedures. These CPT 
codes are 01937 (Anesthesia for percutaneous image-guided

[[Page 65074]]

injection, drainage or aspiration procedures on the spine or spinal 
cord; cervical or thoracic), 01938 (Anesthesia for percutaneous image 
guided injection, drainage or aspiration procedures on the spine or 
spinal cord; lumbar or sacral), 01939 (Anesthesia for percutaneous 
image guided destruction procedures by neurolytic agent on the spine or 
spinal cord; cervical or thoracic), 01940 (Anesthesia for percutaneous 
image guided destruction procedures by neurolytic agent on the spine or 
spinal cord; lumbar or sacral), 01941, (Anesthesia for percutaneous 
image guided neuromodulation or intravertebral procedures) (e.g., 
Kyphoplasty, vertebroplasty) on the spine or spinal cord; cervical or 
thoracic) and 01942 (Anesthesia for percutaneous image guided 
neuromodulation or intravertebral procedures (e.g., Kyphoplasty, 
vertebroplasty) on the spine or spinal cord; lumbar or sacral).
    We proposed the RUC-recommended valuation of 4 base units for CPT 
codes 01937, 01938, 01939, and 01940.
    We disagreed with the RUC-recommend valuation of 6 base units for 
CPT codes 01941 and 01942. After performing a RUC database search of 
codes with similar total times and post-induction period procedure 
anesthesia (PIPPA) times, 6 base units for CPT codes 01941 and 01942 
appeared to be a high valuation. We proposed a valuation of 5 base 
units for both codes supported by a reference code, CPT code 00813 
(Anesthesia for combined upper and lower gastrointestinal endoscopic 
procedures, endoscope introduced both proximal to and distal to the 
duodenum). CPT code 00813 has a valuation of 5 base units with a higher 
PIPPA time of 40 minutes, as well as a higher total time of 70 minutes. 
The RUC noted that CPT codes 01941 and 01942 should have a higher base 
unit valuation than the other similar codes within this family due to 
the complex nature of these procedures that have a more intensive 
anesthesia process. The RUC supported their recommendation with a 
crosswalk code, CPT code 00732 (Anesthesia for upper gastrointestinal 
endoscopic procedures, endoscope introduced proximal to duodenum; 
endoscopic retrograde cholangiopancreatography (ECRP)). CPT code 00732 
has a valuation of 6 base units, a total time of 100 minutes, and a 
PIPPA time of 65 minutes. CPT codes 01941 and 019427 have a total time 
of 58 minutes and a PIPPA time of 20 minutes. We agreed that a more 
complex procedure may require a higher base unit valuation within a 
code family; however, given the disparity in total and PIPPA time, we 
disagreed with the use of this crosswalk code to support a valuation of 
6 base units and instead proposed a valuation of 5 base units supported 
by reference CPT code 00813, which has higher times and the same base 
unit valuation.
    We proposed the RUC-recommended direct PE inputs for all six codes 
in the family.
    Comment: Commenters disagreed with the proposed valuation of 5 base 
units for CPT code 01941 and CPT code 01942 and stated that CMS should 
finalize the RUC-recommended base unit of 6 for both CPT codes. 
Commenters disagreed with our use of CPT code 00813 (Anesthesia for 
combined upper and lower gastrointestinal endoscopic procedures, 
endoscope introduced both proximal to and distal to the duodenum) as a 
reference code for the proposed valuation of 5 base units for CPT code 
01941 and CPT code 01942. Commenters stated that from a clinical 
perspective, the RUC's reference code was more appropriate and similar 
in complexity.
    Response: We disagree that a supporting reference code must have 
similar clinical features. We believe that other methods of comparison, 
such as total and intra-service time, can also be used to reach 
appropriate valuations when clinical features are disparate. The 
relativity of the PFS allows for comparisons amongst all codes. We also 
do not consider supporting reference codes as direct ``cross-walks''. 
We use supporting reference codes to further validate valuations that 
are based on comparisons of time and intensity, but not necessarily 
clinical similarities. The higher total and post induction times for 
our chosen reference code, with a base unit value of 5, make it an 
appropriate code for purposes of comparison with CPT code 01941 and CPT 
code 01942 to reach a base unit valuation. Additionally, we note that 
the RUC chose the survey 25th percentile result or lower for every 
other CPT code in this family, but for CPT code 01941 and 01942 they 
chose a survey result value that is above the 25th percentile. We 
believe that using the survey 25th percentile of 5 base units is 
appropriate to maintain consistency within the family for purposes of 
valuation and that a base unit valuation of 5 will also account for the 
increase in intensity of CPT code 01941 and CPT code 01942. For 
additional information regarding our use of supporting reference codes, 
we refer readers to our discussion of the subject in the Methodology 
for Establishing Work RVUs section of this final rule (section II.E.2. 
of this final rule).
    After consideration of these public comments, we are finalizing the 
base unit valuation and direct PE inputs for this code family as 
proposed.
(3) Closed Treatment of Nasal Bone Fracture (CPT Codes 21315 and 21320)
    We agreed with the RUC's recommendation to change CPT codes 21315 
(Closed treatment of nasal bone fracture; without stabilization) and 
21320 (Closed treatment of nasal bone fracture; with stabilization) to 
000-day global period codes from 010-day global period codes to account 
for the degree of swelling within 10 days post-procedure, and because 
the patient can remove their own splint at home for CPT code 21320. For 
CPT codes 21315 and 21320, we disagreed with the RUC-recommended work 
RVUs of 2.00 and 2.33, respectively, as we believe these values do not 
adequately reflect the surveyed reductions in physician time and the 
change to a 000-day global period from a 010-day global period for 
these CPT codes. We proposed a work RVU of 0.96 for CPT code 21315 and 
1.59 for CPT code 21320 based on the reverse building block methodology 
to remove the RVUs associated with the 010-day global period and the 
surveyed reductions in physician time. We believe that the proposed 
work RVU of 0.96 for CPT code 21315 adequately accounts for the 50 
percent decrease in intraservice and postservice time, a 31-minute 
decrease in total time, and a change to a 000-day global period which 
will allow for separately billable E/M visits as medically necessary. 
We believe that the proposed work RVU of 1.59 for CPT code 21320 
adequately accounts for the 5-minute decrease in intraservice time, 3-
minute decrease in total time, and 48 percent decrease in postservice 
time. Absent an explicitly stated rationale for an intensity increase 
for CPT codes 21315 and 21320, we proposed to adjust the work RVU to 
reflect significant decreases in surveyed physician time.
    The global period changes from 010-day to 000-day allow for 
separately billable E/M visits relating to CPT codes 21315 and 21320, 
therefore we removed RVUs that we believed were attributable to the 
currently bundled E/M visits totaling 1.30 RVUs for CPT code 21315 and 
0.35 RVUs for CPT code 21320. CPT code 21315 is currently bundled with 
one post-operative follow up office visit, CPT code 99213 (Office or 
other outpatient visit for the evaluation and management of an 
established patient, which requires a medically appropriate history 
and/or examination and low

[[Page 65075]]

level of medical decision making. When using time for code selection, 
20-29 minutes of total time is spent on the date of the encounter). CPT 
code 21320 is currently bundled with half of a post-operative follow up 
office visit, CPT code 99212 (Office or other outpatient visit for the 
evaluation and management of an established patient, which requires a 
medically appropriate history and/or examination and straightforward 
medical decision making. When using time for code selection, 10-19 
minutes of total time is spent on the date of the encounter). We do not 
believe the RUC adequately accounted for the loss of these E/M visits 
in their recommended work RVUs for CPT codes 21315 and 21320. The RUC's 
recommendations also seem to dismiss the significant changes in 
surveyed physician time, without a persuasive explanation of a 
significant increase in IWPUT that results from the RUC's recommended 
work RVUs for CPT codes 21315 and 21320. We believe the surveyed 
decreases in physician time in conjunction with the loss of the post-
operative visits for CPT codes 21315 and 21320 merit decreases in the 
work RVUs from the current work RVUs.
    We considered using a modified total time ratio methodology given 
the age and potentially flawed methodology used to arrive at the 
current valuation. The modified total time ratio calculation does not 
include the loss of 8 minutes of post-operative time attributable to 
the change from a 010-day global period to a 000-day global period for 
CPT code 21320 and loss of 23 minutes of post-operative time for CPT 
code 21315. This modified time ratio methodology reflects how the 
physician time is changing in the pre-, intra-, and postservice periods 
when a code's global period is changing, given that E/M services can be 
billed as medically necessary and appropriate for a 000-day global 
code. The total time ratio between the current and proposed total times 
for CPT code 21315, excluding the 23 minutes of post-operative time in 
the current total time, equals 1.64. We arrived at 1.64 by modifying 
the original total time ratio equation to equal the proposed new total 
time divided by the current time, less any time attributable to the 
post-operative global period, then multiplied by the current work RVU. 
The current total time for CPT code 21315 without the 23 minutes of 
post-operative time that will be lost by going from a 010-day to a 000-
day global period code is 76 minutes, therefore, the modified total 
time ratio = (68 minutes/(99 minutes - 23 minutes)) * 1.83 = 1.64. When 
using the original total time ratio methodology for CPT code 21315, it 
shows a 31 percent decrease in total time [(68 minutes - 99 minutes)/99 
minutes = -0.31], whereas the modified methodology shows that there is 
only an 11 percent decrease in newly proposed pre-, intra-, and 
postservice time from the current times [(68 minutes - 76 minutes)/76 
minutes = -0.11].
    The same modified total time ratio methodology could be applicable 
to CPT code 21320. The current total time for CPT code 21320 without 
the 8 minutes of post-operative time that will be lost by going from a 
010-day to a 000-day global period code is 70 minutes, therefore, the 
modified total time ratio = (75 minutes/(78 minutes-8 minutes) * 1.88 = 
2.01. The modified methodology shows that the pre-, intra-, and 
postservice time is increasing by 7 percent for CPT code 21320, whereas 
the original methodology, which accounts for the loss of the 8 post-
operative minutes in the total time ratio, shows a 4 percent decrease 
in total time that would indicate the need for a work RVU decrease. We 
recognize that we have not previously used a modified total time 
approach to consider work RVU values when there is a change in the 
global period for a service in conjunction with significant surveyed 
changes to the pre-, intra-, and postservice times; therefore, we 
solicited comment on application of the modified total time ratio 
approach to value services that have a global period change and 
significant surveyed physician time changes. We believe this 
methodology may account for the loss of post-operative visits and the 
surveyed changes in the pre-, intra-, and postservice times in this 
unique situation.
    Comment: Commenters stated that CMS did not address the compelling 
evidence submitted with the RUC recommendations for CPT codes 21315 and 
21320. Commenters stated that CMS dismisses the fact that services may 
change due to technological advances, changes in the patient 
population, shifts in the specialty of physicians providing services or 
changes in the physician work or intensity required to perform 
services, and CMS only proposes blanket reductions instead of 
considering how a service may have changed or increased over time. 
Commenters requested that CMS address the compelling evidence submitted 
with the RUC recommendations when the agency does not accept the RUC's 
recommended work RVUs.
    Response: The concept of compelling evidence was developed by the 
RUC as part of its work RVU review process for individual codes. The 
RUC determines whether there is compelling evidence to justify an 
increase in valuation. The RUC's compelling evidence criteria include 
documented changes in physician work, an anomalous relationship between 
the code and multiple key reference services, evidence that technology 
has changed physician work, analysis of other data on time and effort 
measures, and evidence that incorrect assumptions were made in the 
previous valuation of the service. While we appreciate the submission 
of this additional information for review, we emphasize that the RUC 
developed the concept of compelling evidence for its own review 
process; an evaluation of ``compelling evidence,'' at least as 
conceptualized by the RUC, is not part of our review process, as our 
focus is the time and intensity of services, in accordance with the 
statute. With that said, we do consider changes in technology, patient 
population, and other compelling evidence criteria, as such evidence 
may affect the time and intensity of a service under review. For 
example, new technology may cause a service to become easier or more 
difficult to perform, with corresponding effects on the time and 
intensity of the service. However, we are under no obligation to adopt 
the same review process or compelling evidence criteria as the RUC. We 
instead focus on evaluating and addressing the time and intensity of 
services when reviewing potentially misvalued codes because 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.
    Comment: Commenters disagreed with our reference to older work time 
sources, and stated that their use led to the proposal of work RVUs 
based on flawed assumptions. Commenters also stated that it was invalid 
to draw comparisons between the current work times and work RVUs to the 
newly surveyed work time and work RVUs as recommended by the RUC, 
particularly with regards to the removal of RVUs that we believed were 
attributable to the global period. Commenters unanimously disagreed 
with the subtraction of the increased CY 2021 office/outpatient E/M 
work RVUs of 0.70 and 1.30 for CPT codes 99212 and 99213, respectively, 
to arrive at our proposed work RVUs for CPT codes 21315 and 21320.
    Response: The global period changes from 010-day to 000-day allow 
for separately billable E/M visits relating to CPT codes 21315 and 
21320, therefore we removed RVUs that we believed

[[Page 65076]]

were attributable to the currently bundled E/M visits totaling 1.30 
RVUs (when billed separately) for CPT code 21315 and 0.35 RVUs (when 
billed separately) for CPT code 21320. We used the reverse building 
block methodology to calculate the proposed work RVUs, which accounts 
for the longstanding time and intensity associated with CPT code 99212 
and CPT code 99213 for bundled office visits in the surgical global 
period, rather than the increased CY 2021 office/outpatient E/M work 
RVUs of 0.70 and 1.30 for CPT codes 99212 and 91213, respectively, as 
commenters suggested. In the proposed rule, we stated that CPT code 
21315 is currently bundled with one post-operative follow up office 
visit, CPT code 99213. When separately furnished, practitioners could 
bill for a total of 1.30 work RVUs, as the post-operative follow up 
office visit would no longer be bundled in the global period, therefore 
the practitioner could bill for the increased CY 2021 office/outpatient 
E/M value. CPT code 21320 is currently bundled with half of a post-
operative follow up office visit, CPT code 99212. When separately 
furnished, practitioners could bill for the increased CY 2021 office/
outpatient E/M value a total of 0.35 work RVUs for the half of a post-
operative follow up office visit, CPT code 99212, as the half of a 
post-operative follow up office visit would no longer be bundled in the 
global period. We continue to believe that the RUC did not adequately 
account for the removal of these E/M visits as a result of the global 
period changes in their recommended work RVUs for CPT codes 21315 and 
21320.
    We believe that it is crucial that the code valuation process take 
place with the understanding that the existing work times that have 
been used in PFS ratesetting are accurate. We recognize that adjusting 
work RVUs for changes in time is not always a straightforward process 
and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available, and that we 
are statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the CY 2017 PFS final rule 
(81 FR 80273 through 80274).
    Comments: Commenters opposed our proposed work RVUs for CPT codes 
21315 and 21320 and urged us to finalize the RUC-recommended work RVUs 
for these codes. Commenters stated that CMS' reverse building block, 
total time ratio, and modified total time ratio calculations ignore 
magnitude estimates as indicated by physicians who perform these 
services and compromise the correct relativity of these services. 
Commenters also stated that CMS' calculations ignore and discount the 
intensity of these services.
    Response: We disagree with the commenters and continue to believe 
that reverse building block and time ratio calculations are appropriate 
methods for identifying potential work RVUs for PFS services, 
particularly when the alternative values recommended by the RUC and 
other commenters do not account for information provided by surveys 
which suggests that the amount of time involved in furnishing the 
service has changed significantly. For additional information regarding 
the use of old work time values that were established many years ago 
and have not since been reviewed in our methodology, we refer readers 
to our discussion of the subject in the Methodology for Establishing 
Work RVUs section of this final rule (section II.E.2.), as well as a 
comprehensive discussion in the CY 2017 PFS final rule (81 FR 80273 
through 80274). We note that the modified total time ratio discussed 
above was not used to arrive at the valuation for CPT codes 21315 or 
21320, but was discussed solely to seek comment on a potential approach 
to value services that have a global period change and significant 
surveyed physician time changes.
    We continue to believe that using the reverse building block 
methodology to calculate a proposed work RVU of 0.96 for CPT code 21315 
and 1.59 for CPT code 21320 was appropriate. Based on the 
aforementioned references to section II.E.2. and the CY 2017 PFS final 
rule (81 FR 80273 through 80274) and consideration of the comments, we 
are finalizing the work RVUs for CPT codes 21315 and 21320 as proposed. 
We believe the work RVU of 0.96 for CPT code 21315 adequately accounts 
for the 50 percent decrease in intraservice and postservice time, a 31-
minute decrease in total time, and a change to a 000-day global period 
which will allow for separately billable E/M visits as medically 
necessary for CPT code 21315. We also believe that the work RVU of 1.59 
for CPT code 21320 adequately accounts for a 5-minute decrease in 
intraservice time, 3-minute decrease in total time, 48 percent decrease 
in postservice time, and a change to a 000-day global period which will 
allow for separately billable E/M visits as medically necessary for CPT 
code 21320.
    We are also finalizing the RUC-recommended direct PE inputs without 
refinements and the surveyed physician times for CPT codes 21315 and 
21320 as proposed.
(4) Insertion of Interlaminar/Interspinous Device (CPT Code 22867)
    We proposed the RUC-recommended work RVU of 15.00 for CPT code 
22867 (Insertion of interlaminar/interspinous process stabilization/
distraction device, without fusion, including image guidance when 
performed, with open decompression, lumbar; single level). The RUC did 
not recommend changes to the current PE inputs, and we did not propose 
any changes to the current PE inputs.
    Comment: Several commenters stated that they supported the proposal 
of the RUC-recommended work RVU 15.00 for CPT code 22867.
    Response: We appreciate the support from the commenters for our 
proposed RUC-recommended work RVU of 15.00 for CPT code 22867.
    Comment: Some commenters expressed appreciation for the acceptance 
of the new, higher work RVU of 15.00, but urged consideration of adding 
additional work RVUs to the adjusted value to represent the physician 
work and intensity of CPT code 22867. The commenters stated that CPT 
code 22867 includes the work of an open laminectomy, which is coded as 
CPT code 63047 (Laminectomy, facetectomy and foraminotomy (unilateral 
or bilateral with decompression of spinal cord, cauda equina and/or 
nerve root[s], [eg, spinal or lateral recess stenosis]), single 
vertebral segment; lumbar). One commenter stated that a work RVU of 
19.62 would be more appropriate for CPT code 22867. This work RVU was 
derived by adding the work RVU of CPT code 63047, valued at 15.37, to 
the work RVU of add-on CPT code 22853 (Insertion of interbody 
biomechanical device(s) (eg, synthetic cage, mesh) with integral 
anterior instrumentation for device anchoring (eg, screws, flanges), 
when performed, to intervertebral disc space in conjunction with 
interbody arthrodesis, each interspace (List separately in addition to 
code for primary procedure)), valued at 4.25. Other commenters asserted 
that a work RVU of 20.00 is more appropriate.

[[Page 65077]]

Commenters stated that new research was available as of July 1, 2021 
that suggests CPT code 22867 requires more physician work than CPT code 
63047 alone.
    Response: We appreciate the additional information, but we continue 
to believe that the original survey results and RUC's reaffirmed value 
for CPT code 22867 accurately reflect the time and intensity of CPT 
code 22867. At the January 2021 meeting, the RUC agreed that a third 
survey would not be useful at the time and agreed to reaffirm the 
January 2016 RUC recommendations. Although we will consider any 
information submitted by stakeholders for valuation during the comment 
period, as we do for all codes which are subject to notice and comment 
rulemaking, the newly available research was not discussed in the 
proposed rule, and CMS did not broach the topic of the amount of 
physician work that factors into CPT code 22867 versus CPT code 63047 
alone. Further, CMS did not propose a work RVU of 20.00 for CPT code 
22867, therefore the public has not had notice or the opportunity to 
comment on this potential policy. Lastly, the AMA RUC did not review or 
consider the validity of the assertions in the research in their 
recommendations for CPT code 22867. We continue to believe that this is 
important to be transparent and have the full benefit of stakeholder 
comments before establishing values, so we are not finalizing a work 
RVU of 20.00 for CPT code 22867. We expect that new research would be 
considered in any future recommendations or rulemaking.
    After consideration of the comments, we are finalizing the proposed 
work RVU of 15.00 for CPT code 22867.
(5) Treatment of Foot Infection (CPT Codes 28001, 28002, and 28003)
    Through a screen of codes with 010-day global period service with 
more than one post-operative follow-up office visit, the RUC identified 
this family of major surgical codes that did not have consistent global 
periods. The RUC conducted a survey of these codes as 000-day globals 
for their April 2020 meeting, and the review was postponed until 
October 2020. CPT code 28001 (Incision and drainage, bursa, foot) (work 
RVU of 2.78 with 31 minutes of intraservice time) currently has a 010-
day global period with one post-operative follow-up office visit, CPT 
code 99212 (Office or other outpatient visit for the evaluation and 
management of an established patient, which requires at least 2 of 
these 3 key components: A problem focused history; A problem focused 
examination; Straightforward medical decision making. 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 
presenting problem(s) are self limited or minor. Typically, 10 minutes 
are spent face-to-face with the patient and/or family). Survey results 
from podiatrists and orthopedic surgeons yielded a median work RVU of 
2.00 with 17 minutes of preservice evaluation time, 3 minutes of 
preservice positioning time, 5 minutes of preservice scrub/dress/wait 
time, 20 minutes intraservice time, and 15 minutes immediate 
postservice time for a total of 60 minutes total time. We proposed the 
RUC-recommended work RVU of 2.00 and the surveyed physician times for 
this 000-day global code.
    CPT code 28002 (Incision and drainage below fascia, with or without 
tendon sheath involvement, foot; single bursal space) (work RVU of 5.34 
with 30 minutes of intraservice time) currently has a 010-day global 
period with two post-operative follow-up office visits, CPT code 99213 
(Office or other outpatient visit for the evaluation and management of 
an established patient, which requires at least 2 of these 3 key 
components: An expanded problem focused history; An expanded problem 
focused examination; Medical decision making of low complexity. 
Counseling and 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 presenting problem(s) are of low to 
moderate severity. Typically, 15 minutes are spent face-to-face with 
the patient and/or family); and a half day hospital discharge CPT code 
99238 (Hospital discharge day management; 30 minutes or less). For CPT 
code 28002, the RUC recommended 30 minutes of preservice evaluation 
time, 5 minutes of preservice positioning time, 15 minutes of 
preservice scrub/dress/wait time, 30 minutes of intraservice time, and 
20 minutes of immediate postservice time, for a total of 100 minutes 
total time. The RUC recommended a work RVU of 3.50 and the surveyed 
physician times for this 000-day global code.
    We note that the result from the survey's 50th percentile work RVU 
was 3.73 and that the survey's 25th percentile work RVU was 2.80. As 
this CPT code is converting from a 010-day global to a 000-day global 
we find the reference CPT code 43193 (Esophagoscopy, rigid, transoral; 
with biopsy, single or multiple) as a more suitable value of 2.79 work 
RVUs with a similar 30 minutes of intraservice physician time and 106 
minutes of total time. We proposed a work RVU of 2.79 for CPT code 
28002 and we proposed the RUC surveyed physician times for this 000-day 
global code.
    CPT code 28003 (Incision and drainage below fascia, with or without 
tendon sheath involvement, foot; multiple areas) currently has a 090-
day global period with two post-operative follow-up office visits, CPT 
code 99212 (Office or other outpatient visit for the evaluation and 
management of an established patient, which requires at least 2 of 
these 3 key components: A problem focused history; A problem focused 
examination; Straightforward medical decision making. 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 
presenting problem(s) are self limited or minor. Typically, 10 minutes 
are spent face-to-face with the patient and/or family); three post-
operative follow-up office visits, CPT code 99213 (Office or other 
outpatient visit for the evaluation and management of an established 
patient, which requires at least 2 of these 3 key components: An 
expanded problem focused history; An expanded problem focused 
examination; Medical decision making of low complexity. Counseling and 
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 
presenting problem(s) are of low to moderate severity. Typically, 15 
minutes are spent face-to-face with the patient and/or family.); one 
post-operative CPT code 99231 (Subsequent hospital care, per day, for 
the evaluation and management of a patient, which requires at least 2 
of these 3 key components: A problem focused interval history; A 
problem focused examination; 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 patient is 
stable, recovering or improving. Typically, 15 minutes are spent at the 
bedside and on the patient's hospital floor or unit); one post-
operative CPT code 99232 (Subsequent hospital care, per day, for the 
evaluation and

[[Page 65078]]

management of a patient, which requires at least 2 of these 3 key 
components: An expanded problem focused interval history; An expanded 
problem focused examination; 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 patient is responding inadequately 
to therapy or has developed a minor complication. Typically, 25 minutes 
are spent at the bedside and on the patient's hospital floor or unit), 
and one hospital discharge CPT code 99238 (Hospital discharge day 
management; 30 minutes or less), for a total of eight post op follow-up 
visits, across five types of E/M and hospital care codes. For CPT code 
28003, the RUC recommends 40 minutes of preservice evaluation time, 10 
minutes of preservice positioning time, 15 minutes of preservice scrub/
dress/wait time, 45 minutes of intraservice time, and 20 minutes of 
immediate postservice time, for a total time of 130 minutes. We 
proposed the RUC-recommended work RVU of 5.28 and surveyed physician 
times for this 000-day global code.
    In order to complete the adjustments for making these Treatment of 
Foot Infection codes consistent as 000-day global codes, the RUC 
adjusted the PE inputs for these codes to reflect their proposed global 
periods from 010 and 090-day globals to 000-day global, and to reflect 
the use of more typical supplies, equipment, and clinical labor 
employed now, than what was necessary a decade ago. Some relatively 
small valued supply items were removed, while other items were added, 
and clinical labor times were largely adjusted to remove minutes from 
the post-operative follow-up office visit times in the 010 and 090-day 
global codes. We proposed all of the PE refinements as recommended by 
the RUC for these codes.
    Comment: Commenters supported CMS' proposal to adopt the AMA RUC-
recommended work RVU of 2.00 for CPT code 28001 and work RVU of 5.28 
for CPT code 28003, in this family of codes. However, commenters 
objected to the CMS proposed work RVU of 2.79 for CPT code 28002, as 
the AMA RUC recommended a higher work RVU of 3.50. Commenters stated 
that a work RVU of 2.79 for this code is too low and does not reflect 
the work intensity of CPT code 28002. Commenters objected to CMS' 
consideration of the physician work value 25th percentile survey 
result, which has a work RVU of 2.80. Commenters noted that the AMA 
RUC's 50th percentile survey result--a work RVU of 3.73--was too high, 
indicating that the AMA RUC recommend work RVU should fall somewhere 
between these two percentiles.
    Response: We note that the current work RVU for CPT code 28002 as a 
010-day global code with 30 minutes of intra-service time and 163 
minutes of total time is 5.34. Since the AMA RUC recommended that this 
family of codes (Treatment of Foot Infection (CPT codes 28001, 28002, 
and 28003)) be revised to 000-day globals, any post-op follow-up visits 
included with CPT code 28002 and this family of codes, would be billed 
separately. We would expect that total time for CPT code 28002 would be 
revised to reflect this change. Specifically, CPT code 28002, a 010-day 
global code, is bundled with two E/M visits: CPT code 99213 (0.97 work 
RVUs and 23 minutes total time) and one half-day CPT code 99238 
Hospital Discharge Day service (1.28 work RVUs and 38 minutes total 
time). Removing these postoperative services from the bundle should 
change the total time of CPT code 28002 from 163.0 minutes to 100.0 
minutes.
    Removing the post-op follow-up visits from the total time of CPT 
code 28002 results in a total time decrease of 65 minutes, but the AMA 
RUC recommended adding 2 minutes to the procedure's pre-positioning 
time, which nets to removing 63 minutes from current total of 163 
minutes to a new total time of 100 minutes. This is a reduction of 
about 39 percent from the current total time for CPT code 28002. CPT 
code 99213 has a work RVU of 0.97. CMS multiplies this work RVU by two 
post-op visits, which totals 1.94, and the half-day Hospital discharge 
of CPT code 99239 is 0.64 work RVUs (1.28 divided by 2). CMS adds 1.94 
and 0.64 work RVUs to get 2.58 work RVUs. Subtracting 2.58 work RVUs 
from the original 5.34 work RVUs for CPT code 28002 is 2.76 work RVUs. 
This 2.76 value, plus the survey's 25th percentile level work RVU of 
2.80, and the comparator CPT code 43193 with a work RVU of 2.79, in 
combination suggests that the proposed work value of 2.79 is a proper 
valuation for CPT code 28002. This value maintains a proper relative 
relationship of work RVUs and time within this family of codes.
    Comment: Commenters suggested alternative cross walk codes for CPT 
code 28002 that differed from the comparator code proposed by CMS (CPT 
code 43193). Specifically, they suggested CPT codes with the same 000-
day global periods and the same intra-service minutes but with much 
higher work RVUs. The AMA RUC specifically suggested several codes as 
alternative crosswalks, including CPT code 31287 (Nasal/sinus 
endoscopy, surgical, with sphenoidotomy; with a work RVU of 3.50, 30 
minutes of intra-service time, and 86 minutes of total time), CPT code 
41530 (Submucosal ablation of the tongue base, radiofrequency, 1 or 
more sites, per session; with a work RVU of 3.50, 20 minutes intra-
service time, and 95 minutes total time), CPT code 52334 
(Cystourethroscopy with insertion of ureteral guide wire through kidney 
to establish a percutaneous nephrostomy, retrograde; with a work RVU of 
3.37, 30 minutes intra-service time, and 75 minutes total time), CPT 
code 43194 (Esophagoscopy, rigid, transoral; with removal of foreign 
body(s); with a work RVU of 3.51, 30 minutes of intra-service time, and 
107 minutes total time) and CPT code 58558 (Biopsy and/or removal of 
polyp of the uterus using an endoscope; with a work RVU of 4.17, 30 
minutes of intra-service time, and 106 minutes total time), all of 
which are varying in levels of work and intensity, but all equal in 
intra-service times.
    Response: The AMA RUC recommended a median intra-service time of 20 
minutes for CPT code 28001, which is a reduction from 31 minutes, which 
is indicative of a reduction in this procedure's work intensity. The 
AMA RUC recommended median intra-service time for CPT code 28002 
remains the same at 30 minutes, and indicates that the work intensity 
for this procedure has not changed. The AMA RUC recommended median 
intra-service time of 45 minutes for CPT code 28003 is a reduction from 
53 minutes, which indicates a reduction in this procedure's work 
intensity. The AMA RUC has not recommended an increase in median intra-
service time for any of the codes in this family, which indicates that 
work intensity for these codes is not increasing. Even so, the AMA RUC 
has recommended that physician time be added back to these services in 
pre-times and in immediate post-times. CMS' comparator CPT code 43193 
accounts for these increases in pre-service and immediate post service 
minutes, whereas the example comparison codes that the AMA RUC has 
recommended, do not, and we believe them to be a less suitable match 
than CPT code 43193. CPT code 28002 maintains its intra-service time 
and is not changing its intensity to justify a higher work RVU as 
recommended by the AMA RUC.
    Comment: One commenter stated that CMS' decision to reduce the work 
RVU for CPT code 28002 for CY 2010 unfairly

[[Page 65079]]

devalued CPT code 28002, and that CMS is further perpetuating that 
undervaluation now. This commenter stated that a flawed assumption 
about the site of service for CPT code 28002 was based on early 2009 
data indicating that this service was performed in the inpatient 
setting 49.2 percent of the time. Subsequent utilization information 
indicated that the service was actually performed over 50 percent of 
the time in the inpatient setting. The commenter stated that this 
incorrect assumption led to the inclusion of only a half-day CPT code 
99238 hospital discharge day for CPT code 28002's post-op services and 
a recommended reduction of 10 percent in work RVU. The commenter 
offered recent Medicare utilization claims for CPT code 28002 
suggesting that the service is furnished in the inpatient setting over 
60 percent of the time, which likely indicates that it was probably 
always an inpatient procedure, and that the CY 2010 work RVU reduction 
was unjustified because CMS assumed that this service was performed in 
the inpatient setting less than half of the time.
    Response: The values for CPT code 28002 were finalized in CY 2010 
and have been the basis of payment ever since then. Even if the AMA RUC 
agreed that CPT code 28002 was performed more often in the inpatient 
setting as compared to the outpatient setting in 2010, and recommended 
a full day hospital discharge instead of a half day discharge and 
reduced the payment for CPT code 28002, we still cannot say what their 
recommended final valuation might have been back then. CMS expects that 
any changes in valuation that reflect new information would come to CMS 
in the form of AMA RUC recommendations and if there was a flaw in the 
CY 2010 final valuation, commenters would have flagged this code for 
CMS review sooner, as 11 years have passed since CY 2010. CPT code 
28002's current conversion to 000-day global code from a 010-day global 
code, makes the original half-day CPT code 99238 hospital discharge 
assignment irrelevant, since 000-day global codes do not have post-
service discharge activities, and include no post-service follow-up 
visits.
    After review of comments, we are finalizing the proposed work RVU 
value of 2.79 for CPT code 28002, as well as our proposal of the AMA 
RUC-recommended work RVUs for the other two codes in the family: CPT 
code 28001 and CPT code 28003. We are also finalizing the direct PE 
inputs recommended by the AMA RUC for all three CPT codes, as proposed.
(6) Percutaneous Cerebral Embolic Protection (CPT Codes 33370)
    CPT code 33370 (Transcatheter placement and subsequent removal of 
cerebral embolic protection device(s), including arterial access, 
catheterization, imaging, and radiological supervision and 
interpretation, percutaneous (List separately in addition to code for 
primary procedure)) was created in October 2020, by the CPT Editorial 
Panel as a new add-on code to report transcatheter placement and 
subsequent removal of cerebral embolic protection device(s). The CPT 
Editorial Panel also added instructions to report the new code in the 
Aortic Valve guidelines. The RUC reviewed the survey results for the 
new add-on code and noted that the survey respondents likely overvalued 
the physician work involved in performing this service, with a 25th 
percentile work value of 3.43. The RUC recommends a work RVU of 2.50 
for CPT code 33370.
    We proposed the RUC-recommended work RVU of 2.50 for CPT code 
33370. This is a facility-based add-on code with no direct PE inputs.
    Comment: Commenters stated that they were pleased that CMS accepted 
the RUC-recommended values for CPT code 33370.
    Response: We are finalizing a work RVU of 2.50 for this code as 
proposed.
(7) Exclusion of Left Atrial Appendage (CPT Codes 33267, 33268, and 
33269)
    In May 2020, the CPT Editorial Panel approved the creation of three 
new codes to describe open and thoracoscopic left atrial appendage 
management procedures when performed as stand-alone procedures or in 
conjunction with other procedures. The codes represent new technology 
and surgical techniques that may be used to treat atrial fibrillation 
at the time of another surgical procedure and include CPT code 33267 
(Exclusion of left atrial appendage, open, any method (e.g., excision, 
isolation via stapling, oversewing, ligation, plication, clip), CPT 
code 33268 (Exclusion of left atrial appendage, open, performed at the 
time of other sternotomy or thoracotomy procedure(s), any method (e.g., 
excision, isolation via stapling, oversewing, ligation, plication, 
clip) (List separately in addition to code for primary procedure)), and 
CPT code 33269 (Exclusion of left atrial appendage, thoracoscopic, any 
method (e.g., excision, isolation via stapling, oversewing, ligation, 
plication, clip)). CPT codes 33267 and 33269 are 090-day global codes 
while CPT code 33268 is a ZZZ global code.
    In October 2020, the RUC reviewed and recommended work and PE 
values for the three new codes. Recommended work values include 18.50 
RVUs for CPT code 33267, 2.50 work RVUs for CPT code 33268, and 14.31 
work RVUs for CPT code 33269.
    We proposed the RUC-recommended work RVUs for the three new codes. 
We also proposed the RUC-recommended direct PE inputs for CPT codes 
33267 and 33269. We note that CPT code 33268 has no direct PE inputs.
    Comment: A few commenters supported our decision to propose the 
RUC-recommended valuations on the proposed values for the three new 
Exclusion of the Left Atrial Appendage codes.
    Response: We thank commenters for their feedback. We are finalizing 
the proposed values for the codes: 18.50 RVUs for CPT code 33267, 2.50 
work RVUs for CPT code 33268, and 14.31 work RVUs for CPT code 33269. 
We are also finalizing the direct PE inputs as proposed for all three 
codes.
(8) Endovascular Repair of Aortic Coarctation (CPT Codes 33894, 33895, 
and 33897)
    In October 2020, the CPT Editorial Panel created CPT codes 33894 
(Endovascular stent repair of coarctation of the ascending, transverse, 
or descending thoracic or abdominal aorta, involving stent placement; 
across major side branches) and 33895 (Endovascular stent repair of 
coarctation of the ascending, transverse, or descending thoracic or 
abdominal aorta, involving stent placement; not crossing major side 
branches) to report endovascular stent repair of coarctation of the 
thoracic or abdominal aorta; and CPT code 33897 (Percutaneous 
transluminal angioplasty of native or recurrent coarctation of the 
aorta) to report trans-liminal angioplasty for repair of native or 
recurrent percutaneous coarctation of the aorta. For CY 2022, the RUC 
recommended a work RVU of 21.70 for CPT code 33894, a work RVU 17.97 
for CPT code 33895, and a work RVU 14.00 for CPT code 33897.
    We disagree with the RUC-recommended work RVUs for the CPT code 
family of 33894, 33895, and 33897. We found that the recommended work 
RVUs for these CPT codes were high when compared to other codes with 
similar time values. Therefore, we proposed the RUC survey 25th 
percentile of 18.27 as the work RVU for 33894, we proposed a work RVU 
of

[[Page 65080]]

14.54 for 33895, and we proposed a work RVU of 10.81 for 33897.
    When we reviewed CPT code 33894, we found that the recommended work 
RVU was high compared to other codes with similar time values. The RUC 
survey 25th percentile of 18.27 falls within the range of RVUs with 
similar intra service time. This is supported by the reference CPT 
codes we compared to CPT code 33894 with intra service time similar to 
the 134 minutes of intra service time for CPT code 33894; reference CPT 
code 37231 (Revascularization, endovascular, open or percutaneous, 
tibial, peroneal artery, unilateral, initial vessel; with transluminal 
stent placement(s) and atherectomy, includes angioplasty within the 
same vessel, when performed) has a work RVU of 14.75 with 135 minutes 
of intra service time, and CPT code 93590 (Percutaneous transcatheter 
closure of paravalvular leak; initial occlusion device, mitral valve) 
has a work RVU of 21.70 with 135 minutes of intra service time. We note 
that the RUC-recommended RVU of 21.70 is a crosswalk from CPT code 
93590 and is the highest value code within the range of reference codes 
we reviewed with similar intra service time. Again, we believe the RUC 
survey 25th percentile of 18.27 is a more appropriate value overall 
than 21.70 when compared to the range of codes with similar intra 
service time.
    The RUC-recommended RVU of 17.97 for CPT code 33895 was higher than 
other codes with the same 120 minutes of intra service time and similar 
total time. Although we disagree with the RUC-recommended work RVU for 
33895, we concur that the relative difference in work between CPT codes 
33894 and 33895 is equivalent to the RUC-recommended interval of 3.73 
RVUs. We believe the use of an incremental difference between these CPT 
codes is a valid methodology for setting values, especially in valuing 
services within a family of codes where it is important to maintain an 
appropriate intra-family relativity. Therefore, we proposed a work RVU 
of 14.54 for CPT code 33895, based on the RUC-recommended interval of 
3.73 RVUs below our proposed work RVU of 18.27 for CPT code 33894.
    The RUC-recommended work RVU of 14.00 for CPT code 33897 was higher 
than other codes with the same 90 minutes of intra service time and 
similar total time and we believe it will be more accurate to propose a 
work RVU that maintains the 3.73 incremental difference between the 
codes in this family. Therefore, for CPT code 33897, we proposed a work 
RVU of 10.81 which also continues the 3.73 incremental difference used 
between CPT codes 33894 and 33895, instead of the RUC incremental 
difference of 3.97 between CPT codes 33895 and 33897. Although the work 
RVU of 10.81 we proposed for CPT code 33897 is lower than the RUC 
recommendation, the 3.73 incremental difference between CPT codes 33895 
and 33897 we proposed is more generous than the RUC incremental 
difference of 3.97 between CPT codes 33895 and 33897.
    We proposed no direct PE inputs for the CPT code family of 33894, 
33895, and 33897, as recommended by the RUC. These services are 
provided exclusively in the facility setting.
    Comment: Commenters disagreed with our proposal and stated that we 
did not provide any clinical foundation for the proposed alternate 
value of CPT code 33894 and that we made no acknowledgement that this 
service is for pediatric patients with congenital defects and the extra 
work that goes into working with these special patients. Also, there 
are no 000-day global services with similar times. Some commenters 
stated that our use of CPT code 37231 as a reference code for CPT code 
33894 was not suitable since it has 81 fewer minutes of total time. 
Commenters stated that beyond having similar intra-service time, 
reference CPT code 37231 has few similarities to CPT code 33894 and is 
a service that is less intensive to perform than CPT code 33894. In 
addition, commenters noted that CPT code 37231 is vastly different than 
CPT code 33894. The other reference code we used for CPT code 33894 was 
CPT code 93590, and commenters noted that CPT code 93590 was the code 
that the RUC had recommended to use as a direct work RVU crosswalk. 
Code 93590 has much less total time than CPT code 33894, though it was 
used by the RUC as a crosswalk due to the lack of services with similar 
total times.
    Response: We continue to believe that the RUC-recommended work RVU 
of 21.70 for CPT code 33894 was high when compared to other codes with 
similar time values, and that the RUC survey 25th percentile work RVU 
of 18.27 is appropriate for CPT code 33894. We did use other 000-day 
Global services within a range of 120 to 135 minutes of intra-service 
time, and 203 to 223 minutes of total time, in our comparisons. Such 
comparison codes included reference CPT code 37231 on the low end of 
the range and CPT code 93590 on the high end of the range. The 25th 
percentile work RVU of 18.27 falls within the range of RVUs with 
similar intra-service time and total time. A direct work RVU crosswalk 
from CPT code 93590 would have put CPT code 33894 at the top end of the 
reference code range between CPT codes 37231 and 93590.
    We continue to believe that the nature of the PFS relative value 
system is such that all services are appropriately subject to 
comparison to one another. Although codes that describe clinically 
similar services are sometimes stronger comparator codes, we do not 
agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk.
    Comment: Commenters stated that relative to adult patients with 
normal cardiac anatomy, the pre-service evaluation time for pediatric 
patients with congenital defects includes additional time to discuss a 
patient's procedure with the parent. Commenters went on to say that 
similarly, the post-procedure work includes additional time to explain 
the pathology of the child to the parent. Also, commenters stated that 
congenital heart programs are now required to enter hemodynamic data 
and other procedural details into national registries which can add 
significant post procedure work time. By solely comparing CPT code 
33894 to adult patient population services with much lower total times, 
commenters argue that we are not providing adequate consideration for 
the additional work or that a pediatric population with congenital 
defects is a more intense and complex patient population. In addition, 
commenters said we did not provide any discussion regarding the 
clinical attributes of CPT code 33894 or any of the reference codes and 
strongly recommended that we accept the RUC-recommended work RVU of 
21.70 for CPT code 33894.
    Response: We continue to believe that the RUC-recommended work RVU 
of 21.70 for CPT code 33894 was high when compared to other codes with 
similar time values, and that the RUC survey 25th percentile of 18.27 
is appropriate for CPT code 33894. Regarding consideration of the 
clinical attributes and the complexity of working with the pediatric 
population for CPT code 33894, the review we conducted included the 
RUC-recommended work RVU, intensity, time to furnish the preservice, 
intra-service, and post-service activities, as well as other components 
of the service that contributed 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, other 
public commenters, medical literature,

[[Page 65081]]

as well as a comparison with other codes within the PFS, and 
consultation with other physicians and health care professionals within 
CMS and the Federal Government. We are obligated under the statute to 
consider both time and intensity in establishing work RVUs for PFS 
services. As stated in the response above, we also continue to believe 
that the nature of the PFS relative value system is such that all 
services are appropriately subject to comparisons to one another. 
Although codes that describe clinically similar services are sometimes 
stronger comparator codes, we do not agree that codes must share the 
same site of service, patient population, or utilization level to serve 
as an appropriate crosswalk.
    Comment: Commenters disagreed with our proposed work RVU of 14.54 
for CPT code 33895, which was calculated by subtracting the 3.73 
incremental difference between the RUC-recommend work RVUs for CPT 
codes 33894 and 33895 from our proposed work RVU of 18.27 for CPT code 
33894 (18.27-3.73 = 14.54). Commenters noted that our rejection of the 
RUC-recommended work RVU of 21.70 for 33894 is flawed, and therefore, 
the proposed work RVU of 14.54 for 33895 instead of the RUC-recommended 
work RVU of 17.97 is inaccurate.
    Response: In the responses above, we address the work RVU of 18.27 
that we proposed for CPT code 33894. Although we disagreed with the 
RUC-recommended work RVU for CPT code 33895, we concurred that the 
relative difference in work between CPT codes 33894 and 33895 is 
equivalent to the RUC-recommended interval of 3.73 RVUs. Therefore, the 
work RVU of 14.54 for CPT code 33895 is valid, based on the RUC-
recommended interval of a 3.73 reduction in RVUs below our proposed 
work RVU of 18.27 for CPT code 33895.
    Comment: Commenters disagreed with our proposal to continue to use 
the 3.73 incremental difference between the other codes in this family 
(CPT codes 33894 and 33895) to calculate the proposed work RVU of 10.81 
for CPT code 33897. Commenters said the RUC recommendation of a work 
RVU of 14.00 for CPT code 33897 does not have that increment with the 
other services in this family so CMS' rationale does not make sense, 
and the incremental difference between the other codes in this family 
should not be used as the basis to derive a new value for CPT code 
33897.
    Response: The 3.73 incremental difference is based on the RUC-
recommended incremental difference between CPT codes 33894 and 33895. 
We believe that it is appropriate to have the same incremental 
difference of 3.73 between all three codes in the family. Therefore, we 
applied the same 3.73 increment to the work RVUs for 33895 and 33897 
which resulted in our proposed work RVU of 10.81 for CPT code 33897. 
The RUC recommended incremental difference between CPT codes 33895 and 
33897 was 3.97, which would have resulted in a lower proposed work RVU 
for 33897 if we had applied that same incremental difference to our 
proposed work RVU of 14.54 for CPT code 33895. Using the RUC-
recommended incremental difference between CPT codes 33895 and 33897 
would have brought our proposed work RVU for CPT code 33897 down to 
10.57 instead of 10.81.
    We believe the use of an incremental difference between codes is a 
valid methodology for setting work RVUs, especially in valuing services 
within a family of codes where it is important to maintain appropriate 
intra-family relativity. Historically, we have frequently utilized an 
incremental methodology in which we value a code based upon its 
incremental difference between another code or another family of codes.
    Comment: Commenters stated that in general, CMS' review process for 
this code family and the reference code comparison seemed like CMS 
selecting an arbitrary and capricious value from the vast array of 
possible mathematical calculations, rather than seeking a valid, 
clinically relevant relationship that would preserve relativity between 
work RVUs. Also, commenters stated that CMS did not provide any 
clinical foundation for the proposed alternate value and made no 
acknowledgement that this service is for pediatric patients with 
congenital defects. Further, commenters thought that CMS did not 
provide a discussion regarding the clinical attributes of the surveyed 
procedure or any of the reference codes.
    Response: We clarify for the commenters that our review process is 
not arbitrary in nature. Our reviews of recommended work RVUs and time 
inputs generally include, but have not been limited to, a review of 
information provided by the RUC, the HCPAC, and other public 
commenters, medical literature, and comparative databases, as well as a 
comparison with other codes within the PFS, consultation with other 
physicians and health care professionals within CMS and the Federal 
Government, as well as Medicare claims data. We also assess the 
methodology and data used to develop the recommendations submitted to 
us by the RUC and other public commenters and the rationale for the 
recommendations. In the CY 2011 PFS final rule with comment period (75 
FR 73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalks to key reference or similar codes, and magnitude 
estimation (see the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329) for more information). With regard to clinically 
relevant relationships, we emphasize that we continue to believe that 
the nature of the PFS relative value system is such that all services 
are appropriately subject to comparisons to one another. Although codes 
that describe clinically similar services are sometimes stronger 
comparator codes, we do not agree that codes must share the same site 
of service, patient population, or utilization level to serve as an 
appropriate crosswalk. We also refer readers to the discussion of this 
subject in the Methodology for Establishing Work RVUs section of this 
final rule (section II.E.2.) for more information.
    After consideration of the public comments, we are finalizing the 
proposed work RVU of 18.27 for CPT code 33894, the work RVU of 14.54 
for CPT code 33895, and the work RVU of 10.81 for CPT code 33897. There 
are no direct PE inputs for the CPT code family of 33894, 33895, and 
33897, as these services are provided exclusively in the facility 
setting.
(9) Harvest of Upper Extremity Artery (CPT Codes 33509 and 35600)
    In May 2020, the CPT Editorial Panel created CPT code 33509 
(Harvest of upper extremity artery, 1 segment, for coronary artery 
bypass procedure, endoscopic) to describe endoscopic radial artery 
harvest via an endoscopic approach, and CPT code 35600 (Harvest of 
upper extremity artery, 1 segment, for coronary artery bypass 
procedure, open) was modified to only include an open approach for the 
upper extremity harvesting procedure. The RUC also stated that CPT 
codes 33509 and 35600 are almost always exclusively performed in 
conjunction with coronary artery bypass grafting (CABG) procedures. For 
CY 2022, the RUC-recommended a work RVU of 3.75 for CPT code 33509 and 
a work RVU of 4.00 for CPT code 35600.
    We disagree with the RUC-recommended RVUs for the CPT code family 
of 33509 and 35600. We found that the recommended work RVUs for these 
CPT codes were high when compared to other codes with similar

[[Page 65082]]

time values. Therefore, we proposed 3.34 as the work RVU for 33509 and 
we proposed a work RVU of 3.59 for 35600.
    We disagree with the RUC-recommended work RVU for CPT code 33509 
and we proposed an RVU of 3.34 which is a direct work RVU crosswalk 
from CPT code 35686 (Creation of distal arteriovenous fistula during 
lower extremity bypass surgery (non-hemodialysis) (List separately in 
addition to code for primary procedure)). The RUC-recommended value of 
3.75 is higher than other codes with similar intra service time and 
total time. This is supported by the reference CPT codes we compared to 
CPT code 33509 with the same 35 minutes of intra service time and 35 
minutes of total time as CPT code 33509; reference CPT code 74713 
(Magnetic resonance (e.g., proton) imaging, fetal, including placental 
and maternal pelvic imaging when performed; each additional gestation 
(List separately in addition to code for primary procedure)) has a work 
RVU of 1.85, and CPT code 35686 has a work RVU of 3.34.
    Although we disagree with the RUC-recommended work RVU for CPT code 
35600, we concur that the relative difference in work between CPT codes 
33509 and 35600 is equivalent to the RUC-recommended interval of 0.25 
RVUs. We believe the use of an incremental difference between these CPT 
codes is a valid methodology for setting values, especially in valuing 
services within a family of codes where it is important to maintain an 
appropriate intra-family relativity. Therefore, we proposed a work RVU 
of 3.59 for CPT code 35600, based on the RUC-recommended interval of 
0.25 RVUs above our proposed work RVU of 3.34 for CPT code 33509.
    We proposed no direct PE inputs for the CPT code family of 33509 
and 35600 as recommended by the RUC. These services are provided 
exclusively in the facility setting.
    The RUC acknowledged that CPT codes 33509 and 35600 are almost 
always exclusively performed in conjunction with coronary artery bypass 
grafting (CABG) procedures. Such codes are designated as add-on 
procedures and are assigned a ZZZ-day global period (that is, code 
related to another service and is always included in the global period 
of the other service). The RUC also requested that the global period 
for both CPT codes 33509 and 35600 be an XXX-day global period (that 
is, global concept does not apply) and not a ZZZ-day global period as 
is customary for add-on codes. The RUC stated that an XXX-day global 
period would allow the individual that performs the harvest of upper 
extremity artery procedure (often separate from the surgeon performing 
the base CABG procedure) to report it under their own provider number. 
The RUC noted that it is often a nurse practitioner (NP) or physician's 
assistant (PA) who performs the harvest procedure. However, the RUC 
surveyed CPT codes 33509 and 35600 using reference codes with the ZZZ-
day global period. Therefore, we believe it is appropriate to use that 
same ZZZ-day global period for CPT codes 33509 and 35600, and we 
proposed to assign the ZZZ-day global period to CPT codes 33509 and 
35600 for CY 2022. Through our scrutiny of comparing the code 
descriptions of codes with matching intra service times, we find much 
more clinically coherent similarities with codes with a ZZZ-day global 
period (procedures complementary, and sometimes necessary, to complete 
a larger procedure) than codes with an XXX-day global period.
    However, we were compelled to understand more about the billing 
circumstances presented by the RUC and stakeholders that have presented 
this approach for CPT codes 33509 and 35600 to CMS for consideration. 
We solicited comments and requested information that could inform why 
CPT codes 33509 and 35600 should have an XXX-day global period instead 
of the ZZZ-day global period that is customary for add-on codes.
    Comment: Commenters disagreed with our proposed work RVU of 3.34 
for CPT code 33509 and stated that unlike reference CPT codes 35686 and 
74713, CPT code 33509 is typically performed by a separate practitioner 
than the one that is performing the base procedure. Also, there were 
concerns that we did not take into consideration the intraoperative 
evaluation, the total physician work, and the intensity associated with 
the procedure, which also contributed to the RUC's recommendation for a 
value that is higher than other procedures with similar intra and total 
times.
    Response: We disagree with the commenters regarding our use of CPT 
codes 35686 and 74713 as reference codes to determine our proposed work 
RVU of 3.34 for CPT code 33509. Whether or not the practitioner 
performing CPT code 33509 is the same practitioner who performed the 
base procedure or is a separate practitioner does not change the work 
RVU for this procedure. For CPT code 33509, we proposed an RVU of 3.34 
which is a direct work RVU crosswalk from CPT code 35686. When we 
looked at codes with the same 35 minutes of intra-service time and 35 
minutes of total time as CPT code 33509, reference CPT code 35686 had 
the highest RVU of the codes with the same 35 minutes of intra-service 
time and total time.
    Comment: Commenters stated that the reference code CMS used, CPT 
code 35686, as a direct work RVU crosswalk for CPT code 33509 has not 
been reviewed by the RUC or CMS in 20 years and has virtually no 
volume. Furthermore, the reference code that CMS cited as support for 
their proposal--CPT code 74713--is an imaging code that has no clinical 
similarities to the survey code.
    Response: We disagree with the commenters' statement that CPT code 
35686 should not be used as a reference code because it has not been 
reviewed in 20 years and has low utilization. We also disagree with the 
commenters' statement that CPT code 74713 should not be used as a 
reference code because it is not a service similar to CPT code 33509. 
We agree that it is important to use the recent data available 
regarding time, and we acknowledge that when many years have passed 
since work time is measured, significant discrepancies can occur. 
However, we also believe that our operating assumption regarding the 
validity of the existing values as a point of comparison is critical to 
the integrity of the relative value system as currently constructed. 
The times currently associated with codes are a very important element 
in PFS ratesetting, both as points of comparison in establishing work 
RVUs and in the allocation of indirect PE RVUs by specialty. If we were 
to operate under the assumption that previously recommended work times 
had routinely been underestimated or overestimated, this would 
undermine the relativity of the work RVUs on the PFS in general, given 
the process under which codes are often valued by comparisons to codes 
with similar times and it undermines the validity of the allocation of 
indirect PE RVUs to physician specialties across the PFS. Instead, we 
believe that it is crucial that the code valuation process take place 
with the understanding that the existing work times used in the PFS 
ratesetting process are accurate. We recognize that adjusting work RVUs 
for changes in time is not always a straightforward process and that 
the intensity associated with changes in time is not necessarily always 
linear, which is why we apply various methodologies to identify several 
potential work values for individual codes. However, we reiterate that 
we believe it would be irresponsible to ignore changes in time based on 
the best data available and that we are statutorily

[[Page 65083]]

obligated to consider both time and intensity in establishing work RVUs 
for PFS services. For additional information regarding the use of old 
work time values in our methodology, we refer readers to our discussion 
of the subject in the CY 2017 PFS final rule (81 FR 80273 through 
80274).
    We continue to believe that the nature of the PFS relative value 
system is such that all services are appropriately subject to 
comparisons to one another. Although codes that describe clinically 
similar services are sometimes stronger comparator codes, we do not 
agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk.
    Comment: Commenters disagreed with our proposed work RVU of 3.59 
for CPT code 35600 based on the increment of 0.25 between the RUC-
recommended values of CPT codes 33509 and 35600, and stated that we did 
not list any specific reference codes for this service to support our 
proposed work RVU of 3.59. Commenters also stated that our proposed 
work RVU of 3.59 lowers the intensity to an amount well below that of 
the other surgical add-on procedures, and that the RUC's recommended 
RVU of 4.00 was already leading to a decrease of 19 percent even though 
the surveys supported the same intra and total time for CPT code 35600 
which has a higher valuation of 4.94.
    Response: Although we disagreed with the RUC-recommended work RVU 
for CPT code 35600, we concurred that the relative difference in work 
between CPT codes 33509 and 35600 is equivalent to the recommended 
interval of 0.25 RVUs. Therefore, the work RVU of 3.59 for CPT code 
35600 is valid, based on the recommended interval of a 0.25 increase in 
RVUs above our proposed work RVU of 3.34 for CPT code 33509. Also, as 
stated in our response above, for CPT code 33509, the reference codes 
we used were CPT codes 35686 and 74713. We reiterate that, consistent 
with the statute, we are required to value the work RVU based on the 
relative resources involved in furnishing the service, which include 
time and intensity. We apply various methodologies to identify several 
potential work RVU values for individual codes. We also refer readers 
to the discussion of this subject in the Methodology for Establishing 
Work RVUs section of this final rule (section II.E.2.) for more 
information.
    Comment: Two commenters responded to our request for information 
regarding the RUC's request that the global period for both CPT codes 
33509 and 35600 be an XXX-day global period (that is, global concept 
does not apply) and not a ZZZ-day global period as is customary for 
add-on codes. The commenters both provided very similar information, 
and stated that the rationale for assigning an XXX global period 
instead of a ZZZ add-on global period for CPT codes 33509 and 35600, 
even though these services are almost exclusively performed in 
conjunction with an arterial Coronary arterial bypass graft (CABG) 
procedure, is that an XXX global would allow the individual who 
performs the harvest of an upper extremity artery procedure (often 
separate from the surgeon performing the base CABG procedure and not 
the first assistant) to report it under their National Provider 
Identifier (NPI) number. The societies involved in surveying CPT codes 
33509 and 35600 had also indicated that sometimes a separate physician 
or other qualified health professional (QHP), typically a PA or NP, 
performing these codes is not part of the same practice as the surgeon 
performing the CABG procedure or is not the first assistant at surgery 
for the CABG procedure. Therefore, there would be no established 
mechanism for paying this practitioner for their work.
    Similarly, commenters stated if the physician or QHP who performs 
the upper extremity artery harvest is in the same practice but is not 
the first assistant at surgery for the CABG surgery, they have no 
mechanism to report an add-on code since they are not reporting the 
base arterial CABG code. In both situations, the individual performing 
CPT codes 33509 or 35600 does not have a primary code to report with 
it, which would result in these codes being denied for payment. In many 
cases, even if the individual performing CPT codes 33509 and 35600 is 
the first assistant at surgery and reports an arterial CABG procedure 
with an appropriate assistant at surgery modifier (-80, -82 or -AS), 
the add-on code, which is only reported by the assistant at surgery, is 
not recognized by payers. Commenters noted that by assigning an XXX-day 
global period to these codes and valuing them as ZZZ-day global codes, 
the individual that performs CPT codes 33509 and 35600 can report these 
codes without also having to report an arterial CABG code, thereby 
ensuring that the practitioner performing the service is reimbursed at 
the appropriate rate (for example, physician vs NP or PA). The reason 
that the two codes were surveyed using a reference service list with 
ZZZ-day global codes is to ensure that the codes were valued in the 
same manner as an add-on code with no pre or post service work included 
in the procedure. Commenters stated that this is the case because, as 
CMS points out, they are worded in the same manner as other add-on 
codes and only include the additional work of harvesting the upper 
extremity artery. While these codes are in essence an add-on code, they 
are unique in that the additional intra-operative work represented by 
the procedures is typically performed by individuals that specialize in 
harvesting the grafts for CABG procedures. These individuals may or may 
not be associated with the same practice as the surgeon performing the 
procedure, and it is often the only service that individual provides 
for the case.
    In addition, commenters stated that when referencing that the 
harvest procedure is almost always performed with a CABG procedure, CMS 
noted that ``. . . such codes are designated as add-on procedures and 
are assigned a ZZZ-day global period (that is, a code related to 
another service and is always included in the global period of the 
other service).'' However, commenters stated that is not the case for 
services that are performed by a separate provider than the surgeon 
performing the primary procedure. A relatively recent example of 
services like this are the separate practitioner moderate sedation CPT 
code 99155 (Moderate sedation services provided by a physician or other 
qualified health care professional other than the physician or other 
qualified health care professional performing the diagnostic or 
therapeutic service that the sedation supports; initial 15 minutes of 
intraservice time, patient younger than 5 years of age), 99156 
(Moderate sedation services provided by a physician or other qualified 
health care professional other than the physician or other qualified 
health care professional performing the diagnostic or therapeutic 
service that the sedation supports; initial 15 minutes of intraservice 
time, patient age 5 years or older), and 99157 (Moderate sedation 
services provided by a physician or other qualified health care 
professional other than the physician or other qualified health care 
professional performing the diagnostic or therapeutic service that the 
sedation supports; each additional 15 minutes intraservice time (List 
separately in addition to code for primary service)) which CMS assigned 
an XXX-day global period.
    Response: We solicited comments and requested information that 
could inform why CPT codes 33509 and 35600 should have an XXX-day 
global period instead of the ZZZ-day global period that is customary 
for add-on codes, and received two comments. After reviewing

[[Page 65084]]

the comments, it remains unclear that the solution to a billing issue 
which does not seem to affect the majority of the practitioners billing 
for these add-on services is to revise the global period for CPT codes 
33509 and 35600 in order to bypass our existing standard policies and 
payment procedures. For instance, CPT code 35600 has been in use as a 
ZZZ-day global period code since 2001, and we are unaware of any 
information from stakeholders suggesting that they were unable to get 
their claims paid because of the ZZZ-day global period in the past. We 
are concerned that assigning an XXX-day global period instead of a ZZZ-
day global period for CPT codes 33509 and 35600 would be inconsistent 
with current standard policies and payment procedures. These codes are 
not relative to the other services with an XXX-day global period. We 
find much more clinically coherent similarities with ZZZ-day global 
codes (procedures complementary, and sometimes necessary, to complete a 
larger procedure) than XXX-day global period codes. A ZZZ-day global 
add-on code is a code that is related to another service and is always 
included in the global period of the other service. (Note: Physician 
work is associated with intra-service time and in some instances the 
post service time.) Both commenters also agreed that CPT codes 33509 
and 35600 are, in essence, add-on procedures. Therefore, we believe 
that a ZZZ-day global period is appropriate for both of these codes 
because they would not be done on their own, and would always be 
performed with another surgical procedure. Codes with ZZZ-day global 
periods are always listed separately in addition to the primary 
procedure and included in the global period of the other service, while 
the global period concept does not apply to codes with an XXX-day 
global period. However, we also believe there may be another solution 
to the billing issue described by the two commenters. Instead of 
altering the global periods for these codes, we suggest that 
stakeholders consider coding options that describe when a different 
practitioner is performing the add-on procedure, the same way the 
practitioner performing the preoperative or postoperative care during 
the global period of a surgery can be distinguished from a different 
practitioner who performed that surgery through the use of modifiers. 
This would be similar to the example provided by the commenters who 
highlighted how the separate practitioner moderate sedation CPT codes 
99155, 99156, and 99157 were created. Unlike the descriptions for CPT 
codes 33509 and 35600, the descriptions for CPT codes 99155, 99156, and 
99157 specifically state that these codes identify situations in which 
moderate sedation services are provided by a practitioner who is not 
performing the diagnostic or therapeutic service that the sedation 
supports. Also, we note that while CPT codes 99155 and 99156 both have 
an XXX-day global period, CPT code 99157 has a ZZZ-day global period 
and not an XXX-day global period as stated by the commenters.
    After consideration of the public comments, we are finalizing the 
proposed work RVU of 3.34 for CPT code 33509 with a ZZZ-day global 
period, and the proposed work RVU of 3.59 for CPT code 35600 with a 
ZZZ-day global period. There are no direct PE inputs for this CPT code 
family, as these services are provided exclusively in the facility 
setting.
(10) Needle Biopsy of Lymph Nodes (CPT Code 38505)
    CPT code 38505 (Biopsy or excision of lymph node(s); by needle, 
superficial (eg, cervical, inguinal, axillary)) was identified in 
October 2019 as Harvard Valued with a utilization of over 30,000 
claims. In January 2020, the RUC recommended that the code be surveyed 
for October 2020 RUC meeting. The RUC recommended increasing the work 
RVU to 1.59 which is the survey 25th percentile, acknowledging a change 
in the service, which now involves larger tissue samples, as well as a 
change in technology, and a change in the dominant specialty now 
reporting the service.
    We proposed the RUC-recommended work RVU of 1.59 for CPT code 
38505. We also proposed the RUC-recommended direct PE inputs for this 
code.
    Comment: One commenter suggested that we give the primary 
specialties that use CPT code 38505 time to investigate and identify 
the root cause of the claim submission, provide appropriate education 
to their practitioners regarding appropriate use criteria, and present 
that data to the RUC subcommittee or workgroup for evaluation.
    Response: We believe this comment is directed towards the RUC. We 
will consider any future RUC recommendations for the work RVU for CPT 
code 38505 when they are submitted.
    Comment: Commenters appreciated that CMS proposed the RUC-
recommended work RVU and direct PE inputs for CPT code 38505.
    Response: We thank the commenters for their support.
    After consideration of the public comments, we are finalizing the 
proposed work RVU of 1.59 for CPT code 38505. We are also finalizing 
the RUC-recommended direct PE inputs for code 38505 without refinement.
(11) Drug Induced Sleep Endoscopy (CPT Codes 42975)
    CPT code 42975 (Drug induced sleep endoscopy; with dynamic 
evaluation of velum, pharynx, tongue base, and larynx for evaluation of 
sleep disordered breathing; flexible, diagnostic) is a new code created 
to report drug induced sleep endoscopy (DISE) flexible, diagnostic. The 
RUC recommended, and we agree, that the survey 25th percentile for the 
work RVU of 1.90 accurately reflects the typical physician work 
necessary to perform this service.
    Since this is a drug induced sleep endoscopy, we proposed CPT code 
31575 (Diagnostic laryngoscopy) as the endoscopic base code for CPT 
code 42975 because the description of the proposed CPT code is the same 
as what is described for CPT code 31575 with the additional component 
of the patient being sedated. The procedure is performed with a 
flexible endoscope or laryngoscope. CPT code 42975 is not an add-on 
code, it has a 0-day global period. The endoscopic base code that it is 
using is a specific type of multiple procedure discount that applies to 
some endoscopy codes.
    We proposed the RUC-recommended work RVU of 1.90 for CPT code 
42975. We also proposed the RUC-recommended direct PE inputs for this 
code.
    Comment: Commenters appreciated that CMS proposed the RUC-
recommended work RVU of 1.90 and the RUC-recommended direct PE inputs 
for CPT code 42975.
    Response: We thank commenters for their support.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU of 1.90 and the RUC-recommended direct PE 
inputs for CPT code 42975 as proposed.
(12) Per-Oral Endoscopic Myotomy (POEM) (CPT Codes 43497)
    In May 2020, the CPT Editorial Panel created a new CPT code 43497 
(Lower esophageal myotomy, transoral (i.e., peroral endoscopic myotomy 
[POEM])) to describe a Per-Oral Endoscopic Myotomy (POEM), which 
involves the visualization and dissection of the esophageal muscle 
layers via an endoscope to treat esophageal motility disorders such as 
achalasia. This

[[Page 65085]]

procedure accomplishes a comparable myotomy to what traditional open 
and laparoscopic myotomy (Heller) accomplishes. POEM utilizes an 
endoscope and specially designed dissecting, cutting, and cauterizing 
instruments to create a long submucosal tunnel beginning in the mid-
esophagus and extending several centimeters into the cardia. For CY 
2022, the RUC recommended a work RVU of 15.50 for CPT code 43497.
    We disagreed with the RUC-recommended work RVU for CPT code 43497 
and proposed a work RVU of 13.29 based on a direct work RVU crosswalk 
from CPT code 36819 (Arteriovenous anastomosis, open; by upper arm 
basilic vein transposition). CPT code 36819 has the same 120 minutes of 
intra service time as CPT code 43497, and has 283 minutes of total 
time, which is 2 minutes more than the 281 minutes of total time than 
for 43497. The RUC used CPT codes 43279 (Laparoscopy, surgical, 
esophagomyotomy (Heller type), with fundoplasty, when performed) and 
43180 (Esophagoscopy, rigid, transoral with diverticulectomy of 
hypopharynx or cervical esophagus (e.g., Zenker's diverticulum), with 
cricopharyngeal myotomy, includes use of telescope or operating 
microscope and repair, when performed) as reference codes for CPT code 
43497. However, the intra service time of 150 minutes and total time of 
404 minutes for the RUC reference CPT code 43279, and intra service 
time of 60 minutes and total time of 201 minutes for the RUC reference 
CPT code 43180, are not adequate comparisons since they do not have 
similar time values to those of CPT code 43497. Therefore, we believe 
the proposed work RVU of 13.29 for CPT code 43497 based on a direct 
work RVU crosswalk from CPT code 36819 is a better representation of 
the work being performed and is more appropriate based on the same 
intra service time and similar total time.
    We proposed the RUC-recommended direct PE inputs for CPT code 43497 
without refinement.
    Comment: Commenters disagreed with our proposal to crosswalk the 
work RVU of 13.29 from CPT code 36819 to CPT code 43497. The commenters 
stated that crosswalking to CPT code 36819 based on time alone is 
inappropriate and fails to consider the physician work necessary to 
perform this service. Beyond comparing the time similarities, it is 
unclear whether any other criteria were used to identify the CMS 
recommended work RVU as CMS did not include any clinical comparisons or 
quantifiable inputs. Also, commenters stated that CMS failed to provide 
justification on why the survey data was ignored in the analyses used 
to determine the work RVU for this service. Most importantly, 
commenters noted that CMS does not provide a rationale that would 
warrant the work RVU to fall below the survey 25th percentile from a 
robust survey. They said that a crosswalk based on time alone is not an 
appropriate justification for any code, especially a new code.
    Response: We believe that the proposed work RVU of 13.29 for CPT 
code 43497 is appropriate. CPT code 36819 was reviewed in 2013 and has 
the same intra-service time of 120 minutes and 2 additional minutes of 
total time than the 281 minutes of total time for CPT code 43497, and 
is close to an exact crosswalk. We compared CPT code 43497 to the other 
codes with the same 120 minutes of intra-service time and with total 
times ranging from 271 to 291 minutes. We found the work RVUs ranged 
from a low of 5.90 (represented by CPT code 33220 (Repair of 2 
transvenous electrodes for permanent pacemaker or implantable 
defibrillator) with 276 minutes of total time) to a high of 17.71 
(represented by CPT code 58572 (Laparoscopy, surgical, with total 
hysterectomy, for uterus greater than 250 g) with 271 minutes of total 
time). The RUC recommended RVU of 15.50 was high in comparison to the 
range of RVUs for the comparison CPT codes with the same intra-service 
time and similar total times, therefore we believe this work RVU 
crosswalk from CPT code 36819 to CPT code 43497 is a valid crosswalk. 
Also, the Total Time Ratio of 12.62 between the 2nd key reference code 
of CPT code 43180 and CPT code 43497 supports a value closer to 13.00 
RVUs. The survey data ranged from a minimum value of 5.00 to a maximum 
value of 39.00. We looked at the RUC survey 25th percentile value of 
15.50, which is also the RUC-recommended work RVU. We also looked at 
the 25th percentile value of each of the surveys listed on the RUC 
Summary Report, and note that there was a wide range of 25th percentile 
values shown, ranging from 12.00 to 21.00. Our proposed work RVU 
crosswalk of 13.29 for CPT code 43497 from CPT code 36819 is above the 
lowest 25th percentile value that was provided in the RUC Summary 
Report, and is closer to the Total Time Ratio of 12.62 described above. 
We believe this provides additional support for a work RVU that is 
closer to 13.00, and therefore, our proposed work RVU of 13.29 for CPT 
code 43497 is appropriate.
    Comment: Commenters stated that CPT code 43497 should have a work 
RVU value of 15.50 based on the RUC's 119 survey results and physician 
input, and that a work RVU of 15.50 accurately reflects the physician 
work necessary to perform this service. They noted that the flawed 
crosswalk work RVU of 13.29 for CPT code 43497 creates inconsistencies 
within the RBRVS as the intensity level for CPT code 43180 would be 
higher if the proposed work RVU is accepted.
    Response: We believe the RUC-recommend work RVU of 15.50 for CPT 
code 43497 is high in comparison to the range of work RVUs for the 
comparison CPT codes with the same intra-service time and similar total 
times, and therefore, we believe this work RVU crosswalk from CPT code 
36819 to CPT code 43497 is a valid crosswalk. CPT code 36819 has the 
same intra-service time of 120 minutes and 2 additional minutes of 
total time than the 281 minutes of total time for CPT code 43497, and 
is close to an exact crosswalk. We compared CPT code 43497 to the other 
codes with the same 120 minutes of intra-service time and with total 
times ranging from 271 to 291 minutes. We found the work RVUs ranged 
from a low of 5.90 (represented by CPT code 33220 with 276 minutes of 
total time) to a high of 17.71 (represented by CPT code 58572 with 271 
minutes of total time). Also, the Total Time Ratio of 12.62 between the 
2nd key reference code of CPT code 43180 and CPT code 43497 supports a 
value closer to 13.00 RVUs. Therefore, we believe that the proposed 
work RVU of 13.29 for CPT code 43497 is appropriate.
    Comment: Commenters stated that the reference CPT codes 43279 and 
43180 provided by the RUC were never meant to be crosswalk codes; they 
are reference codes that act as bookends to demonstrate how the value 
of CPT code 43497 falls appropriately between them thereby maintaining 
relativity. It is logical that the survey takers migrated towards CPT 
codes 43279 and 43180 as the top two key reference services based on 
their familiarity with these procedures and the disease states treated 
by these procedures. Commenters stated that the reference codes are 
intended to act as supporting rationale to demonstrate relativity 
within the PFS. Commenters assert that CPT codes 43279 and 43180 are 
representative of this concept in that they demonstrate the validity of 
the 15.50 RVU recommendation for 43497, which falls between the 
established RVUs of CPT code 43279, the longer more intense procedure, 
and CPT code 43180, the shorter less intense procedure. Also, there are 
numerous codes with a similar intra-service time

[[Page 65086]]

and intensity with higher work RVUs that CMS could have selected as a 
more appropriate crosswalk for CPT code 43497. Commenters believe that 
a work RVU of 15.50 most accurately reflects the physician work and 
intensity necessary to perform this service.
    Response: We believe the RUC-recommended work RVU of 15.50 is high. 
We compared CPT code 43497 to the other codes with the same 120 minutes 
of intra-service time and with total times ranging from 271 to 291 
minutes. We found the work RVUs ranged from a low of 5.90 (represented 
by CPT code 33220 with 276 minutes of total time) to a high of 17.71 
(represented by CPT code 58572 with 271 minutes of total time). 
Therefore, we believe the work RVU crosswalk from CPT code 36819 to CPT 
code 43497 is appropriate. CPT code 36819 has the same intra-service 
time of 120 minutes and 2 additional minutes of total time than the 281 
minutes of total time for CPT code 43497, and is close to an exact 
crosswalk. Our reviews of recommended work RVUs and time inputs 
generally include, but have not been limited to, a review of 
information provided by the RUC, the HCPAC, and other public 
commenters, medical literature, and comparative databases, as well as a 
comparison with other codes within the PFS, consultation with other 
physicians and health care professionals within CMS and the Federal 
Government, as well as Medicare claims data. We also assess the 
methodology and data used to develop the recommendations submitted to 
us by the RUC and other public commenters and the rationale for the 
recommendations. In the CY 2011 PFS final rule with comment period (75 
FR 73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalks to key reference or similar codes, and magnitude 
estimation (see the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329) for more information). With regard to the 
invocation of clinically relevant relationships by the commenters, we 
emphasize that we continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes that describe 
clinically similar services are sometimes stronger comparator codes, we 
do not agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk. 
We also refer readers to our discussion of the subject in the 
Methodology for Establishing Work RVUs section of this final rule 
(section II.E.2.)
    Comment: Commenters stated that CMS' recommendation to crosswalk 
CPT code 43497 to 36819 is based only on time and fails to take into 
consideration the difference in intensity between the procedures. CPT 
code 36819 represents one of many codes that CMS could have selected to 
use as a crosswalk based on time. Value is based on multiple factors 
including procedure time, technical skill required, physical effort 
involved, mental effort and judgment, and stress due to the potential 
risks to the patient. Commenters stated that if CMS were to truly have 
considered intensity in addition to time, the selected crosswalk should 
have reflected this consideration by selecting a code with similar 
intensity. A search of the RUC database for 90-day global codes with 
120 minutes of intra- service time yields 235 CPT codes with an intra-
service work per unit of time (IWPUT) ranging from -0.036 to 0.1983. 
CMS' recommended work RVU of 13.29 for CPT code 43497 creates a rank-
order anomaly in the intensities of related procedures.
    Response: We continue to believe that crosswalking the work RVU of 
13.29 from CPT code 36819 to CPT code 43497 is appropriate. CPT code 
36819 has the same intra-service time of 120 minutes and 2 additional 
minutes of total time than the 281 minutes of total time for CPT code 
43497, and is close to an exact crosswalk for CPT code 43497. In 
general, CMS considers a variety of factors when we review the RUC 
recommendations as indicated in the response above. Again, we refer 
readers to our discussion of the subject in the Methodology for 
Establishing Work RVUs section of this final rule (section II.E.2.).
    Comment: Commenters disagreed with crosswalking the work RVU of CPT 
code 36819 to CPT code 43497 and urged CMS to accept the RUC-
recommended RVU of 15.50 for CPT code 43497. CPT code 36819 is an open, 
three-dimensional procedure with a multi-person surgical team using a 
wide field of view, operating on an upper extremity with local 
anesthesia from nerve block. Also, CPT code 36819 is not an endoscopic 
procedure, involves completely different work and has an IWPUT of 
0.0755. The IWPUT of CPT code 43497 is significantly higher at 0.091.
    Response: We continue to believe that the RVU of 13.29 for CPT code 
43497 based on a crosswalk from CPT code 36819 is more appropriate than 
the RUC-recommended work RVU of 15.50. CPT code 36819 has the same 
intra-service time of 120 minutes and 2 additional minutes of total 
time than the 281 minutes of total time for CPT code 43497, and is 
close to an exact crosswalk for CPT code 43497. In more general terms, 
we continue to believe that the nature of the PFS relative value system 
is such that all services are appropriately subject to comparisons to 
one another. Although codes that describe clinically similar services 
are sometimes stronger comparator codes, we do not agree that codes 
must share the same site of service, patient population, or utilization 
level to serve as an appropriate crosswalk.
    After consideration of the public comments, we are finalizing the 
proposed work RVU of 13.29 for CPT code 43497. We are also finalizing 
the RUC-recommended direct PE inputs for CPT code 43497 without 
refinement.
(13) Placement-Removal of Seton (CPT Codes 46020 and 46030)
    For CPT codes 46020 (Placement of seton) and 46030 (Removal of anal 
seton, other marker), we disagree with the RUC-recommended work RVUs of 
3.50 and 2.00, respectively, as we believe these values do not 
adequately reflect the surveyed reductions in physician time for CPT 
code 46020 and the change to a 000-day global period from a 010-day 
global period for these CPT codes. Instead, we proposed a work RVU of 
1.86 for CPT code 46020 and 1.48 for CPT code 46030 based on a reverse 
building block methodology.
    The survey showed that total time and intraservice time are 
decreasing for CPT code 46020 by 26 minutes and 5 minutes, 
respectively. We believe the surveyed decreases in physician time in 
conjunction with the loss of the post-operative visits for CPT code 
46020 merit a decrease in work RVU from the current work RVU.
    We note that the proposed work RVU of 1.48 for CPT code 46030 falls 
between CPT code 57410 (Pelvic examination under anesthesia (other than 
local)), which has a work RVU of 1.75, and CPT code 64487 (Transversus 
abdominis plane (TAP) block (abdominal plane block, rectus sheath 
block) unilateral; by continuous infusion(s) (includes imaging 
guidance, when performed)), which has a work RVU of 1.48. Both of these 
bracketing reference codes have identical intraservice times and 
similar total time values. While we understand that total time is going 
up for CPT code 46030, this increase is a result of significant 
increases to evaluation, positioning, and scrub, dress, wait preservice 
times,

[[Page 65087]]

which is mostly low-intensity physician work.
    We agree with the RUC's recommendation to change CPT codes 46020 
and 46030 to 000-day global period codes from 010-day global period 
codes to account for the highly variable follow-up care for these 
services, but we note that the differences in RUC-recommended work RVUs 
and our proposed work RVUs largely reflect the change in global period 
and loss of physician time to provide the E/M services. The global 
period changes from 010-day to 000-day allow for separately billable E/
M visits relating to CPT codes 46020 and 46030, therefore we removed 
RVUs that we believed were attributable to the currently bundled E/M 
visits totaling 2.04 RVUs for CPT code 46020 and 0.35 RVUs for CPT code 
46030. CPT code 46020 is currently bundled with two post-operative 
follow up office visits, CPT code 99212 (Office or other outpatient 
visit for the evaluation and management of an established patient, 
which requires a medically appropriate history and/or examination and 
straightforward medical decision making. When using time for code 
selection, 10-19 minutes of total time is spent on the date of the 
encounter), and a half hospital discharge CPT code 99238 (Hospital 
discharge day management; 30 minutes or less). CPT code 46030 is 
currently bundled with half of a post-operative follow up office visit, 
CPT code 99212 (Office or other outpatient visit for the evaluation and 
management of an established patient, which requires a medically 
appropriate history and/or examination and straightforward medical 
decision making. When using time for code selection, 10-19 minutes of 
total time is spent on the date of the encounter). We do not believe 
the RUC adequately accounted for the loss of these E/M visits in their 
recommended work RVUs for CPT codes 46020 and 46030.
    The RUC proposed the standard 090-day preservice times for the 
clinical labor activities CA001, CA002, CA003, CA004, and CA005 for CPT 
code 46020 in the facility. We note that the RUC recommended 090-day 
preservice clinical labor times despite surveying the service as a 000-
day service. We disagree with the RUC-recommended 090-day preservice 
clinical labor times as we believe 000-day services should have times 
consistent with 000-day services, not 090-day services. However, we 
recognize there is time needed to coordinate this service. Therefore, 
we proposed the following standard clinical labor times for extensive 
use of clinical staff for a 000-day global code for CPT code 46020 in 
the facility:
     Complete preservice diagnostic and referral forms (CA001) 
5 minutes.
     Coordinate pre-surgery services (including test results) 
(CA002) 10 minutes.
     Schedule space and equipment in facility (CA003) 5 
minutes.
     Provide preservice education/obtain consent (CA004) 7 
minutes.
     Complete pre-procedure phone calls and prescription 
(CA005) 3 minutes.
    We also proposed to refine the direct PE input for Coordinate post-
procedure services (CA038) to 0 minutes from the RUC-recommended 3 
minutes to align with 000-day standards instead of 090-day standards 
for CPT code 46020.
    For CPT code 46030, the RUC recommended the standard 000-day 
extensive use of clinical staff preservice times for clinical 
activities CA001, CA002, CA003, CA004, and CA005 in the facility and 
non-facility settings. Preservice times for 000-day codes are presumed 
to be zero unless there is sufficient justification that preservice 
time is warranted. We do not agree that sufficient justification was 
presented to warrant preservice time in the non-facility setting, 
therefore, we proposed the following standard clinical labor times for 
use of clinical staff in the non-facility setting. We also proposed the 
standards for minimal use of clinical staff in the facility setting, as 
we recognize there is time needed to coordinate this service for CPT 
code 46030:
     Complete preservice diagnostic and referral forms (CA001) 
0 minutes for non-facility and 3 minutes for facility.
     Coordinate pre-surgery services (including test results) 
(CA002) 0 minutes for non-facility and 3 minutes for facility.
     Schedule space and equipment in facility (CA003) 0 minutes 
for non-facility and 3 minutes for facility.
     Provide preservice education/obtain consent (CA004) 0 
minutes for non-facility and 3 minutes for facility.
     Complete pre-procedure phone calls and prescription 
(CA005) 0 minutes for non-facility and 3 minutes for facility.
    We also proposed to refine the direct PE input for Coordinate post-
procedure services (CA038) to 0 minutes from the RUC-recommended 3 
minutes to align with 000-day standards instead of 090-day standards 
for CPT code 46030.
    Comment: Commenters opposed the use of reverse building block 
methodology and stated that the calculations of work RVUs for these CPT 
codes were not transparent. Commenters stated that we removed work RVUs 
based on the CY 2021 E/M increased work RVU of 0.70 for CPT code 99212. 
Commenters also stated that CPT code 46020 was originally misvalued. 
Commenters disagreed with our reference to older work time sources, and 
stated that their use led to the proposal of work RVUs based on flawed 
assumptions. Commenters also stated that it was invalid to draw 
comparisons between the current work times and work RVUs to the newly 
surveyed work time and work RVUs as recommended by the RUC.
    Response: The global period changes from 010-day to 000-day allow 
for separately billable E/M visits relating to CPT codes 46020 and 
46030; therefore, we removed RVUs that we believed were attributable to 
the currently bundled E/M visits totaling 2.04 RVUs (when billed 
separately) for CPT code 46020 and 0.35 RVUs (when billed separately) 
for CPT code 46030 using the reverse building block methodology. 
Reverse building block methodology accounts for the longstanding times 
and work RVU associated with CPT code 99212 (Office or other outpatient 
visit for the evaluation and management of an established patient, 
which requires a medically appropriate history and/or examination and 
straightforward medical decision making. When using time for code 
selection, 10-19 minutes of total time is spent on the date of the 
encounter) for bundled office visits in the surgical global period, 
rather than the increased CY 2021 office/outpatient E/M work RVU of 
0.70 for CPT code 99212, as commenters suggested. The longstanding 
times and work RVUs accounted for in the reverse building block 
methodology are 16 minutes and 0.48 work RVUs for CPT code 99212 and 38 
minutes and 1.28 work RVUs for CPT code 99238. Therefore, we did not 
subtract the increased CY 2021 office/outpatient E/M work RVU of 0.70 
for CPT code 99212 as the commenters suggested. CPT code 46020 is 
currently bundled with two post-operative follow up office visits (CPT 
code 99212) and a half hospital discharge day (CPT code 99238). In CY 
2022, when the currently bundled visits in the global period are 
furnished, practitioners could bill for a total of 2.04 work RVUs, as 
the visits would no longer be bundled in the global period. CPT code 
46030 is currently bundled with half of a post-operative follow up 
office visit, CPT code 99212. In CY 2022, when the currently bundled 
visits in the global period are furnished, practitioners could bill for 
a total of 0.35 work RVUs, as the visit would no longer be bundled in 
the

[[Page 65088]]

global period. We continue to believe that the RUC did not adequately 
account for the removal of these E/M visits as a result of the global 
period changes in their recommended work RVUs for CPT codes 46020 and 
46030.
    We agree with commenters that it is important to use the recent 
data available regarding work times, and we note that when many years 
have passed between when time is measured, significant discrepancies 
can occur. However, we also believe that our operating assumption 
regarding the validity of the existing values as a point of comparison 
is critical to the integrity of the relative value system as currently 
constructed. The work times currently associated with codes play a very 
important role in PFS ratesetting, both as points of comparison in 
establishing work RVUs and in the allocation of indirect PE RVUs by 
specialty. If we were to operate under the assumption that previously 
recommended work times had routinely been underestimated, this would 
undermine the relativity of the work RVUs on the PFS in general, given 
the process under which codes are often valued by comparisons to codes 
with similar times.
    Instead, we believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times 
that have been used in PFS ratesetting are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available, and that we 
are statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the CY 2017 PFS final rule 
(81 FR 80273 through 80274).
    Comment: Some commenters stated that they were concerned about CMS' 
lack of consideration for compelling evidence that services have 
changed. Commenters stated that CMS appeared to dismiss the fact that 
services may change due to technological advances, changes in the 
patient population, shifts in the specialty of physicians providing 
services or changes in the physician work or intensity required to 
perform services. Commenters requested that CMS address the compelling 
evidence submitted with the RUC recommendations when the agency does 
not accept the RUC's recommended work RVUs.
    Response: The concept of compelling evidence was developed by the 
RUC as part of its work RVU review process for individual codes. The 
RUC determines whether there is compelling evidence to justify an 
increase in valuation. The RUC's compelling evidence criteria include 
documented changes in physician work, an anomalous relationship between 
the code and multiple key reference services, evidence that technology 
has changed physician work, analysis of other data on time and effort 
measures, and evidence that incorrect assumptions were made in the 
previous valuation of the service. While we appreciate the submission 
of this additional information for review, we emphasize that the RUC 
developed the concept of compelling evidence for its own review 
process; an evaluation of ``compelling evidence,'' at least as 
conceptualized by the RUC, is not part of our review process, as our 
focus is on the time and intensity of services, in accordance with the 
statute. With that said, we do consider changes in technology, patient 
population, and other compelling evidence criteria, as such evidence 
may affect the time and intensity of a service under review. For 
example, new technology may cause a service to become easier or more 
difficult to perform, with corresponding effects on the time and 
intensity of the service. However, we are under no obligation to adopt 
the same review process or compelling evidence criteria as the RUC. We 
instead focus on evaluating and addressing the time and intensity of 
services when reviewing potentially misvalued codes because 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.
    Based on the aforementioned references and consideration of the 
comments, we are finalizing the work RVUs as proposed for CPT codes 
46020 and 46030 based on the reverse building block methodology. We 
continue to believe the proposed work RVU for CPT code 46020 adequately 
accounts for the 5-minute decrease in intraservice time, 26-minute 
decrease in total time, 51-minute decreased in postservice time, and a 
change to a 000-day global period which will allow for separately 
billable E/M visits as medically necessary. We continue to believe that 
the 1.48 work RVUs for CPT code 46030 adequately accounts for the 3-
minute decrease in intraservice time, 8-minute decrease in post-service 
time, and a change to a 000-day global period which will allow for 
separately billable E/M visits as medically necessary.
    Comment: Some commenters stated that CMS is proposing to refine the 
preservice clinical labor times for major procedures to conform to the 
000-day global period standards despite the RUC recommendation of 
standard 090-day preservice clinical labor times. Commenters stated 
that CPT codes 46020 and 46030 are major procedures performed under 
general anesthesia when performed the facility setting. Commenters 
stated that the change to a 000-day global period was requested to 
account for variable post-operative care and does not change the need 
for clinical staff time typical of 90-day global procedures performed 
in the facility setting. Commenters stated that reassignment of global 
periods for select codes does not negate the fact that a major 
procedure is a major procedure and the pre-service facility clinical 
staff time for a major procedure is independent of the global period 
assignment. Commenters stated that each procedure should be evaluated 
on a case-by-case basis.
    Response: We agree with the commenters that the direct PE inputs 
for each service should be evaluated on a case-by-case basis based on 
our criteria of what would be reasonable and medically necessary in the 
typical case. We reviewed the individual codes in question and 
concluded that the use of 000-day global period standards for 
``Extensive use of clinical staff'' for CPT code 46020 and 000-day 
global period standards for ``Minimal use of clinical staff'' for CPT 
code 46030 in the facility would be most typical in these cases. As we 
noted under the Standardization of Clinical Labor Tasks section 
(section II.B) of this final rule, we continue to believe that setting 
and maintaining clinical labor standards provides greater consistency 
among codes that share the same clinical labor tasks and could improve 
relativity of values among codes.
    We refer readers to section II.B of this final rule, Determination 
of Practice Expense Relative Value Units (PE RVUs), for more 
information regarding the collaborative work of CMS and the RUC in 
improvements in standardizing clinical labor tasks.
    After consideration of the comments, we are finalizing the work 
RVUs as proposed for CPT codes 46020 and 46030. We are also finalizing 
our

[[Page 65089]]

clinical labor inputs as proposed for CPT codes 46020 and 46030.
(14) Periurethral Balloon Continence Device Procedures (CPT Codes 
53451, 53452, 53453, and 53454)
    In October 2020, the CPT Editorial Panel replaced four CPT Category 
III codes with four new CPT Category I codes to report periurethral 
adjustable balloon continence devices. Given the low utilization and 
the low survey response rate for the four new codes, the RUC 
recommended that CMS assign contractor pricing to these procedures. We 
agree with the RUC and we proposed contractor pricing for all four 
codes in the family, CPT codes 53451 (Periurethral transperineal 
adjustable balloon continence device; bilateral insertion, including 
cystourethroscopy and imaging guidance), 53452 (Periurethral 
transperineal adjustable balloon continence device; unilateral 
insertion, including cystourethroscopy and imaging guidance), 53453 
(Periurethral transperineal adjustable balloon continence device; 
removal, each balloon) and 53454 (Periurethral transperineal adjustable 
balloon continence device; percutaneous adjustment of balloon(s) fluid 
volume).
    Comment: Several commenters supported the proposal to assign 
contractor pricing for CPT Codes 53451-53454.
    Response: We appreciate the support for our proposal from the 
commenters.
    After consideration of the comments, we are finalizing our proposal 
of contractor pricing for all four codes in the family.
(15) Intracranial Laser Interstitial Thermal Therapy (LITT) (CPT Codes 
61736 and 61737)
    In October 2020, the CPT Editorial Panel approved the addition of 
two codes to report laser interstitial thermal therapy (LITT) of 
lesion, intracranial, including burr hole(s), with magnetic resonance 
(MR) imaging guidance for a single trajectory for 1 simple lesion and 
multiple trajectories for multiple or complex lesion(s). LITT is a 
novel procedure that involves multiple steps and movements of the 
patient through the hospital for different stages of the procedure. The 
typical facility does not have an interoperative MRI suite (a small 
minority of academic medical centers may), so patient transport is 
necessary.
    The RUC recommended a work RVU of 20.00 for CPT code 61736 (Laser 
interstitial thermal therapy (LITT) of lesion, intracranial, including 
burr hole(s), with magnetic resonance imaging guidance, when performed; 
single trajectory for 1 simple lesion) based on the survey median 
response. CPT code 61736 was surveyed with having one subsequent 
hospital visit, CPT code 99232 (sbsq hospital care/day 25 minutes) and 
40 minutes of immediate postservice time. The RUC noted that although 
the survey median immediate postservice time was 40 minutes, for 61736, 
the CMS 23-Hour Stay Outpatient Surgical Services with Subsequent 
Hospital Visits Policy was applied which resulted in the 99232 visit 
being removed and its 20 minutes of intraservice time being applied to 
the 40 minutes of immediate postservice time resulting in 60 minutes of 
immediate postservice time. See the 2011 PFS final rule (75 FR 73226) 
for an in-depth explanation of the 23-hour policy. We believe the RUC 
partially applied the 23-hr policy when it applied the policy to the 
immediate post service time but not to the work RVU. We believe the 23-
hour policy in its entirety should be applied to CPT code 6173661736 
which includes the work RVUs along with the immediate postservice time.
    Following the valuation methodology we established for 23-hour stay 
services in the CY 2011 PFS final rule, CPT code 61736 will have a work 
RVU of 19.06.
    The steps are as follows:
     Step (1): CPT code 61736 does not have a hospital 
discharge day management service; therefore, we will skip this step.
     Step (2): 20-1.39 ** = 18.61.
     Step (3): 18.61 + (20 minutes x 0.0224)*** = 19.06 RVUs.
    * Value associated with 1/2 hospital discharge day management 
service.
    ** Value associated with an inpatient hospital visit, CPT code 
99232.
    *** Value associated with the reallocated intraservice time 
multiplied by the postservice intensity of the 23-hour stay code.
    Therefore, for CY 2022 we proposed a work RVU of 19.06 for CPT code 
61736.
    In reviewing the RUC-recommended direct PE inputs for 61736 we 
noticed the RUC proposed the standard 090-day preservice times for the 
following clinical labor activities:
     Complete preservice diagnostic and referral forms (CA001) 
5 minutes.
     Coordinate pre-surgery services (including test results) 
(CA002) 20 minutes.
     Schedule space and equipment in facility (CA003) 8 
minutes.
     Provide preservice education/obtain consent (CA004) 20 
minutes.
    Complete pre-procedure phone calls and prescription (CA005) 7 
minutes.
    We note that the RUC recommended 090-day preservice times despite 
surveying the service as a 000-day service. We disagree with the RUC-
recommended 090-day times as we believe this is a 000-day service and 
should have times consistent with 000-day services. However, we 
recognize there is time needed to coordinate this service. Therefore, 
for CY 2022 we proposed the following standard clinical labor times for 
a 000-day extensive:
     Complete preservice diagnostic and referral forms (CA001) 
5 minutes.
     Coordinate pre-surgery services (including test results) 
(CA002) 10 minutes.
     Schedule space and equipment in facility (CA003) 5 
minutes.
     Provide preservice education/obtain consent (CA004) 7 
minutes.
     Complete pre-procedure phone calls and prescription 
(CA005) 3 minutes.
    For CPT code 61737 (Laser interstitial thermal therapy (LITT) of 
lesion, intracranial, including burr hole(s), with magnetic resonance 
imaging guidance, when performed; multiple trajectories for multiple or 
complex lesion(s)), the RUC recommended a work RVU of 24.00 which is 
the survey median. The RUC's recommendation also included 40 minutes of 
immediate postservice time and one hospital visit, CPT code 99233 (sbsq 
hospital care/day visit 35 minutes). We believe it will be appropriate 
to apply the 23-hr policy to CPT code 61737 as well.
    The steps are as follows:
     Step (1): CPT code 61737 does not have a hospital 
discharge day management service. Therefore, we will skip this step.
     Step (2): 24 - 2 ** = 22
     Step (3): 22 + (30 minutes x 0.0224) *** = 22.67 RVUs
    * Value associated with hospital discharge day management service.
    ** Value associated with an inpatient hospital visit, CPT code 
99233.
    *** Value associated with the reallocated intraservice time 
multiplied by the postservice intensity of the 23-hour stay code.
    This results in a work RVU of 22.67, and an immediate post service 
time of 70 minutes. Therefore, for CY 2022 we proposed a work RVU of 
22.67 and 70 minutes of immediate postservice time for CPT code 61737.
    For the direct PE, the RUC proposed identical preservice times for 
CPT codes 61736 and 61737. For the reasons stated above concerning the 
direct PE inputs for CPT code 61736, we proposed the standard clinical 
labor times associated with a 000-day extensive for CPT code 61737 for 
CY 2022.
    Comment: A commenter stated that CMS proposed to apply a formulaic

[[Page 65090]]

reduction to the work RVU attributed to the CMS 23-Hour Stay Outpatient 
Surgical Services with Subsequent Hospital Visits Policy when it 
proposed its work valuation for CPT code 61736. The commenter also 
noted that the LITT codes have 000-day global periods, which typically 
do not allow for an E/M visit on the same day as the procedure. 
However, in its recommendation the RUC applied the CMS 23-hour policy 
related to the post-service time for the base code. Although the median 
survey post-service time for CPT code 61736 was 40 minutes, the CMS 23-
hour stay policy was applied resulting in 60 minutes of immediate post-
service time. The intra-service time was reallocated from the same-day 
E/M code 99232 to the immediate post-service time of the outpatient 
service (adding 20 minutes of intra-service time from 99232). Lastly, 
the commenters stated that mathematically reducing work RVUs, despite a 
valid RUC survey, was not warranted and was not previously implemented 
by CMS when other services eligible for the 23-hour stay policy were 
reviewed.
    Response: As we have stated earlier in this rule and in the CY 2011 
PFS final rule with comment period (75 FR 73328 through 73329), CMS 
uses a variety of methodologies and approaches to develop work RVUs, 
including survey data, building blocks, crosswalk to key reference or 
similar codes, and magnitude estimation. In the CY 2011 PFS final rule, 
we also discussed the 23-hour policy and provided the formula for 
applying the policy to the work RVUs and the times of the outpatient 
service and the same-day E/M code. The commenter's statement reaffirms 
our belief that the RUC partially applied the 23-hour policy in its 
calculation of the recommended RVUs. When the policy is applied 
correctly, a work RVU of 19.06 is the appropriate valuation for CPT 
code 61736.
    We also note, had we used the 25th percentile in the RUC's survey, 
which the RUC frequently recommends for valuing services, CPT code 
61736 would have an RVU of 17.78, which is more than one RVU lower that 
CMS' proposed value. We also note that the RUC-recommended work RVU of 
20.00 for CPT code 61736 is significantly higher than similarly timed 
codes which could imply that the service is overvalued. The commenter 
noted that the LITT codes have 000-day global periods, which typically 
do not allow for an E/M visit on the same day as the procedure. 
However, CPT code 61736 was surveyed as having one same-day E/M visit 
of CPT code 99232. We do not believe it is appropriate to apply select 
portions of the 23-hour policy. As we stated in the proposed rule, the 
23-hour policy, when applied, should be applied in its entirety and 
applying the 23-hour policy in this context resulted in the work RVU of 
19.06 for CPT code 61736. Lastly, we believe we have consistently 
applied the CMS 23-hour stay policy where applicable, in accordance 
with the policy that we finalized in the 2011 PFS final rule (75 FR 
73226).
    Comment: A commenter stated their objection to any proposed 
valuation that uses reverse building block methodology, or any other 
purely formulaic approach, to systematically reduce work RVUs for 
services. In the case of CPT code 61737, the commenter noted that, 
although these codes have 000-day global periods which typically do not 
allow for an E/M visit on the same day as the procedure, code 61737 
typically involves a full 2-midnight admission which justifies the 
same-day E/M visit.
    The commenter also stated when compared to patients undergoing LITT 
for a single lesion, the complexity of code 61737 and the level of 
patient medical instability and risk is greater. The typical number of 
``multiple'' trajectories is two, thus in many aspects the physician 
work is doubled.
    Response: In the CY 2011 PFS final rule we stated we believed that 
the 23-hour stay issue encompasses several scenarios. The typical 
patient under the 23-hour policy is commonly in the hospital for less 
than 24 hours, which often means the patient may indeed stay overnight 
in the hospital. On occasion, the patient may stay longer than a single 
night in the hospital; however, in both cases (one night or more than 
one night), the patient is considered for Medicare purposes to be a 
hospital outpatient, not an inpatient, and our claims data support that 
the typical 23-hour stay service is billed as an outpatient service. 
Accordingly, we believe that the valuation of the codes that fall into 
the 23-hour stay category should not reflect work that is typically 
associated with an inpatient service.
    The RUC surveyed and recommended CPT code 61737 with a CPT code 
99233 subsequent hospital visit. In the CY 2010 PFS proposed rule and 
final rule with comment period (74 FR 33556 and 74 FR 61777, 
respectively), we stated that we believed the use of inpatient E/M 
visit codes for services rendered in the post-service period for 
outpatient 23-hour stay procedures would result in overpayment for pre- 
and post-service work that would not be furnished. In CY 2011, we 
modified our proposed CY 2010 approach and suggested that in the 
future, when the AMA RUC reviews new and potentially misvalued codes 
that are identified as 23-hour stay services, the AMA RUC would apply 
the 23-Hour Stay Outpatient Surgical Services with Subsequent Hospital 
Visits Policy. Therefore, we believe it would be inappropriate to not 
apply the policy we established for services in this scenario.
    With regards to the commenter's statement on the physician's work 
being doubled for CPT code 61737, we note the RUC-recommended a 
difference of four RVUs between CPT codes 61736 and 61737. We proposed 
a work RVU of 19.06 for CPT code 61736 and a work RVU of 22.67 for CPT 
code 61737, which would maintain a 3.61 RVU difference between these 
codes. We believe that a difference of 3.61 RVUs is fairly consistent 
with the RUC's recommendation and values the physician's work 
appropriately.
    Comment: One commenter noted that CMS proposed the standard 
clinical labor times associated with the pre-service time package for 
000-day global ``Extensive use of Clinical Staff'' facility inputs for 
CPT codes 61736 and 61737 while the RUC had recommended time associated 
with 090-day global periods. The commenter stated that it is most 
appropriate for the specialties to be able to advocate for the 
appropriate pre-service time for any given service. The commenters also 
suggested that with evidence some subset of codes may require extensive 
use of clinical staff and has allocated time when appropriate despite 
the assigned global period.
    Response: We agree with the commenter that the direct PE inputs for 
each service should be evaluated on a case-by-case basis based on our 
criteria of what would be reasonable and medically necessary in the 
typical case. We reviewed the individual codes in question and 
concluded that the use of 000-day or 010-day global period standards 
for ``Extensive use of clinical staff'' would be most typical in these 
cases. As we noted under the Standardization of Clinical Labor Tasks 
(section II.B) part of this final rule, we continue to believe that 
setting and maintaining clinical labor standards provides greater 
consistency among codes that share the same clinical labor tasks and 
could improve relativity of values among codes. For additional 
discussion, we direct readers to the individual code families affected 
by our proposed preservice clinical labor times (CPT codes 46020 and 
46030 and CPT codes 61736 and 61737).
    After consideration of the public comments, we are finalizing our

[[Page 65091]]

proposals for CPT codes 61736 and 61737 as proposed.
(16) Arthrodesis Decompression (CPT Codes 63052 and 63053)
    For CPT codes 63052 (Laminectomy, facetectomy, or foraminotomy 
(unilateral or bilateral with decompression of spinal cord, cauda 
equina and/or nerve root[s] [e.g., spinal or lateral recess stenosis]), 
during posterior interbody arthrodesis, lumbar; single vertebral 
segment (List separately in addition to code for primary procedure)) 
and 63053 (Laminectomy, facetectomy, or foraminotomy (unilateral or 
bilateral with decompression of spinal cord, cauda equina and/or nerve 
root[s] [e.g., spinal or lateral recess stenosis]), during posterior 
interbody arthrodesis, lumbar; each additional segment (List separately 
in addition to code for primary procedure)), we disagree with the RUC-
recommended work RVUs of 5.55 and 4.44, respectively, because these 
values are anomalously high in comparison to other similar add-on codes 
that have longer intraservice times, and we proposed a work RVU of 3.08 
for CPT code 63052 and a work RVU of 2.31 for CPT code 63053.
    CPT codes 63052 and 63053 are new add-on codes to report 
decompression when performed in conjunction with posterior interbody 
arthrodesis at the same interspace. The proposed work RVU for CPT code 
63052 is based on an intraservice time ratio between the proposed 40 
minutes of intraservice time for CPT code 63052 and the 45 minutes of 
intraservice time for CPT code 63048 (Laminectomy, facetectomy and 
foraminotomy (unilateral or bilateral with decompression of spinal 
cord, cauda equina and/or nerve root[s], [e.g., spinal or lateral 
recess stenosis]), single vertebral segment; each additional segment, 
cervical, thoracic, or lumbar (List separately in addition to code for 
primary procedure)). We believed that CPT code 63048 was a stronger 
reference code for CPT code 63052 than the RUC-recommended reference 
CPT codes 33924 (Ligation and takedown of a systemic-to-pulmonary 
artery shunt, performed in conjunction with a congenital heart 
procedure (List separately in addition to code for primary procedure)) 
and 22614 (Arthrodesis, posterior or posterolateral technique, single 
level; each additional vertebral segment (List separately in addition 
to code for primary procedure)) because of the similarities in the long 
descriptors, physician time, and intensity of intraservice work for CPT 
codes 63052 and 63048. The intraservice time ratio between CPT codes 
63048 and 63052 equals a work RVU of 3.08 for CPT code 63052 ((40 
minutes/45 minutes) * 3.47 = 3.08). Therefore, we proposed a work RVU 
of 3.08 for CPT code 63052. The intraservice time ratio between CPT 
codes 63048 and 63052 was selected to value CPT code 63052 because of 
the similarities in the descriptions of intraservice work provided in 
the RUC's summary of recommendations for CPT code 63052 and the RUC 
Database for CPT code 63048. We proposed a work RVU of 2.31 for CPT 
code 63053 based on an intraservice time ratio between the proposed 30 
minutes of intraservice time for CPT code 63053 and the proposed 40 
minutes of intraservice time for CPT code 63052 ((30 minutes/40 
minutes) * 3.08 = 2.31), given that the RUC contends that there are 
some efficiencies in providing an additional level of decompression, 
evidenced by the 10 minutes less of intraservice time for CPT code 
63053 compared to CPT code 63052. These work RVU proposals are further 
supported by brackets of other 30 and 40 minute ZZZ codes.
    We note that the proposed work RVU for CPT code 63052 falls between 
CPT code 19294 (Preparation of tumor cavity, with placement of a 
radiation therapy applicator for intraoperative radiation therapy 
(IORT) concurrent with partial mastectomy (List separately in addition 
to code for primary procedure)), which has a work RVU of 3.00, and CPT 
code 37185 (Primary percutaneous transluminal mechanical thrombectomy, 
noncoronary, non-intracranial, arterial or arterial bypass graft, 
including fluoroscopic guidance and intraprocedural pharmacological 
thrombolytic injection(s); second and all subsequent vessel(s) within 
the same vascular family (List separately in addition to code for 
primary mechanical thrombectomy procedure)), which has a work RVU of 
3.28. Both of these bracketing reference codes have identical 
intraservice times as CPT code 63052. The proposed work RVU for CPT 
code 63053 falls between CPT code 43273 (Endoscopic cannulation of 
papilla with direct visualization of pancreatic/common bile duct(s) 
(List separately in addition to code(s) for primary procedure)), which 
has a work RVU of 2.24, and CPT code 22870 (Insertion of interlaminar/
interspinous process stabilization/distraction device, without open 
decompression or fusion, including image guidance when performed, 
lumbar; second level (List separately in addition to code for primary 
procedure)), which has a work RVU of 2.34. Both of these bracketing 
reference codes have identical intraservice times as CPT code 63053. 
When we compared the RUC-recommended work RVU of 5.55 for CPT code 
63052 and 4.44 for CPT code 63053 to other spinal add-on codes in the 
63000 CPT code series in the RUC database, we found that CPT code 63052 
would have the highest work RVU and the second shortest intraservice 
time (with CPT code 63053 having the shortest intraservice time), and 
CPT code 63053 would have the third highest work RVU and shortest 
intraservice time compared to the 10 other nationally-priced spinal 
add-on codes in the 63000 CPT code series. We do not agree that 
decompression when performed in conjunction with posterior interbody 
arthrodesis at the same interspace should have an anomalously high work 
value in comparison to other similar add-on codes in the 63000 CPT code 
series that have longer intraservice times. 6305263053We note that the 
specialty societies did not survey the two new add-on codes with the 
base codes for the January 2021 RUC, which is a standard to provide 
assurance that the respondents followed instruction to only consider 
the work of the add-on codes. CPT codes 63052 and 63053 were reviewed 
again with their base codes at the April 2021 RUC meeting. There were 
also revisions to the base codes' definitions, guidelines, and 
parenthetical instructions, which were approved by the CPT Editorial 
Panel for CY 2022.
    The RUC did not recommend any direct PE inputs for these codes and 
we did not propose any direct PE inputs.
    Comment: Several commenters requested that CMS use the interim RUC 
recommendations from the April 2021 meeting for these add-on codes 
which had previously been reviewed at the January 2021 RUC meeting. 
Commenters stated that the earlier RUC recommendations were made on an 
interim basis and requested an expedited review of the recommendations 
from the April 2021 RUC meeting; the RUC resubmitted its 
recommendations for these code families as part of its comment 
submission.
    Response: We finalized a policy in the CY 2015 PFS final rule to 
make all changes in the work and MP RVUs and the direct PE inputs for 
new, revised, and potentially misvalued services under the PFS by 
proposing and then finalizing such changes through notice and comment 
rulemaking, as opposed to initially finalizing changes on an interim 
final basis (79 FR 67602-67609). As we stated when promulgating the CY 
2015 PFS final rule, this approach has the significant advantage that 
the RVUs

[[Page 65092]]

for all services under the PFS are established using a full notice and 
comment procedure, including consideration of the RUC recommendations, 
before they take effect, providing the public the opportunity to 
comment on a specific proposal prior to it being implemented. We 
continue to believe that this is a far more transparent process which 
assures that we have the full benefit of stakeholder comments before 
establishing values. Since we did not make proposals on the code 
families in question using the RUC's recommendations from the April 
2021 meeting, we would be forced to finalize valuation for these codes 
on an interim final basis, without the opportunity for public comment. 
This would contradict the policy that we finalized in the CY 2015 PFS 
final rule and we do not believe that it would serve the interests of 
transparency. Although we will consider any information submitted by 
stakeholders for valuation during the comment period, as we do for all 
codes which are subject to notice and comment rulemaking, we will 
formally review the recommendations from the April 2021 RUC meeting 
next year as part of the CY 2023 rule cycle.
    Comment: Commenters unanimously disagreed with the intraservice 
time ratio between CPT codes 63048 and 63052, stating that CPT code 
63048 is an inappropriate comparator because of differences in 
procedure and patient elements. Commenters stated that part of the work 
and time involved in CPT code 63048 is that of exposure of bony and 
soft tissue elements of the adjacent level. Commenters stated that CPT 
code 63052 does not require additional work of exposure because it is 
completed as part of the base interbody fusion code, and therefore, CPT 
code 63052 describes only the high intensity, dangerous aspects of 
neural element and spinal cord decompression. Commenters agreed that 
the procedures are similar, but differ in intensity.
    Response: We appreciate the additional information provided by the 
commenters and are compelled to utilize a different methodology than 
the proposed intraservice time ratio between CPT codes 63048 and 63052, 
to value CPT code 63052 because the commenters provided sufficient 
information about how CPT codes 63048 and 63052 differ in intensity.
    After consideration of the public comments regarding CPT code 
63052, we are finalizing a work RVU of 4.25 for CPT code 63052 based on 
a crosswalk to CPT code 22853 (Insertion of interbody biomechanical 
device(s) (e.g., synthetic cage, mesh) with integral anterior 
instrumentation for device anchoring (e.g., screws, flanges), when 
performed, to intervertebral disc space in conjunction with interbody 
arthrodesis, each interspace (List separately in addition to code for 
primary procedure)), which has a work RVU of 4.25 and an intraservice 
time of 45 minutes. CPT code 22853 has only 5 more minutes of 
intraservice time than CPT code 63052, is a spinal procedure, and is an 
add-on code to the same base codes as CPT code 63052. We note that the 
finalized work RVU of 4.25 is supported by the commenters. Commenters 
supported the bracket of key reference service CPT code 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)) and MPC CPT code 
34812 (Open femoral artery exposure for delivery of endovascular 
prosthesis, by groin incision, unilateral (List separately in addition 
to code for primary procedure)). CPT code 22552 has a work RVU of 6.50 
and an intraservice time of 45 minutes, and commenters noted that CPT 
code 22552 has a higher intensity as anticipated for a surgical 
procedure and in comparison, with a lumbar procedure. CPT code 34812 
has a work RVU of 4.13 and 40 minutes of intraservice time, and 
commenters noted that this code involves open femoral artery exposure 
by groin incision and closure of the wound, typically for separately 
reported delivery of an endovascular prosthesis for an asymptomatic 
infrarenal abdominal aortic aneurysm. In comparison, exposure and 
closure for CPT code 63052 are performed as part of the primary 
arthrodesis code and the intraservice time includes higher intensity 
bony and soft tissue resection, therefore, although both codes require 
the same time, the physician work and intensity of CPT code 63052 is 
greater than CPT code 34812.
    After consideration of the public comments regarding CPT code 
63053, we are finalizing a work RVU of 3.19 for CPT code 63053 based on 
an intraservice time ratio between CPT codes 63052 and 63053 ((30 
minutes/40 minutes) * 4.25 = 3.19). As we stated above, we are also 
finalizing a work RVU of 4.25 for CPT code 63052 based on a crosswalk 
to CPT code 22853. The RUC did not recommend any direct PE inputs for 
these codes and we are not finalizing any direct PE inputs.
(17) Hypoglossal Nerve Stimulator Services (CPT Codes 64582, 64583, and 
64584)
    In October 2020, the CPT Editorial Panel added three new CPT 
Category I codes to report open implantation, revision or replacement, 
and removal of hypoglossal nerve stimulator array. These new CPT codes 
replaced three CPT Category III codes which were reported with CPT 
codes 64568 (Incision for implantation of cranial nerve (e.g., vagus 
nerve) neurostimulator electrode array and pulse generator), 64569 
(Revision or replacement of cranial nerve (e.g., vagus nerve) 
neurostimulator electrode array, including connection to existing pulse 
generator) and 64570 (Removal of cranial nerve (e.g., vagus nerve) 
neurostimulator electrode array and pulse generator).
    CPT code 64582 (Open implantation of hypoglossal nerve 
neruostimulator array, pulse generator, and distal respiratory sensor 
electrode or electrode array) was previously reported using the now 
deleted Category III CPT code 0466T (Insertion of chest wall 
respiratory sensor electrode or electrode array, including connection 
to pulse generator (List separately in addition to code for primary 
procedure)) along with CPT code 64568. We did not propose the RUC-
recommendation to use the survey median work RVU of 16.00 for CPT code 
64582. We proposed a work RVU of 14.00 based on the intraservice time 
ratio of CPT code 64568 compared to the RUC-recommended intraservice 
time for CPT code 64582. CPT code 64568 has a work RVU of 9.00, 
intraservice time of 90 minutes and total time of 275 minutes. CPT code 
64582 has a RUC-recommended work RVU of 16.00, intraservice time of 140 
minutes and total time of 294 minutes. Additionally, when we reviewed 
CPT code 64582, we found that the RUC-recommended work RVU was higher 
than other global 90-day codes with similar time values. We did not 
agree that it would be typical to value this code so much higher than 
services with similar work time values. Additionally, we note that the 
proposed work RVU of 14.00 is also the survey 25th percentile. 
Therefore, as previously stated, we believe 14.00 is a more appropriate 
value overall than 16.00 when compared to the range of codes with 
similar work times.
    We did not propose the RUC-recommended work value of 16.50 for CPT 
code 64583 (Revision or replacement of hypoglossal nerve 
neruostimulator array and distal respiratory sensor electrode or 
electrode

[[Page 65093]]

array, including connection to an existing pulse generator), rather we 
proposed a work RVU of 14.50. Although we disagree with the RUC-
recommended work RVU, we concur that the relative difference in work 
between CPT codes 64582 and 64583 is equivalent to the recommended 
increment of 0.50 RVUs. Therefore, we proposed a work RVU of 14.50 for 
CPT code 64583 based on the recommended increment of 0.50 additional 
RVUs above our proposed work RVU of 14.00 for CPT code 64582. We 
believe the use of an incremental difference between these CPT codes is 
a valid methodology for setting values, especially in valuing services 
within a family of codes where it is important to maintain an 
appropriate intra-family relativity. Additionally, we note that the 
proposed work RVU of 14.50 is also nearly identical to the 25th 
percentile survey value for CPT code 64583 of 14.63. Therefore, as 
previously stated, we believe 14.50 is a more appropriate value than 
16.50 to maintain an appropriate intra-family relativity.
    We did not propose the RUC-recommended work value of 14.00 for CPT 
code 64584 (Removal of hypoglossal nerve neruostimulator array, pulse 
generator, and distal respiratory sensor electrode or electrode array), 
rather we proposed a work RVU of 12.00. Although we disagree with the 
RUC-recommended work RVU, we concur that the relative difference in 
work between CPT codes 64582 and 64584 is equivalent to the recommended 
increment of -2.0 RVUs. We believe the use of an incremental difference 
between these CPT codes is a valid methodology for setting values, 
especially in valuing services within a family of codes where it is 
important to maintain an appropriate intra-family relativity. 
Therefore, we proposed a work RVU of 12.00 for CPT code 64584 based on 
the recommended increment of 2.0 RVUs below our proposed work RVU of 
14.00 for CPT code 64582. Additionally, we note that the proposed work 
RVU of 12.00 is also the RUC 25th percentile survey value for CPT code 
64584.
    We proposed the RUC-recommended direct PE inputs without 
refinements for CPT codes 64582, 64583 and 64584.
    Comment: A few commenters including the RUC urged CMS to finalize a 
work RVU of 16.00 for CPT code 64582, 16.50 for CPT code 64583 and 
14.00 for CPT code 64584 based on the survey median. The commenters 
disagreed with CMS calculating intra-service time ratios for valuing 
64582, and also disagreed with CMS utilizing the incremental difference 
for valuing 64583 and 64584. The commenters also indicated that the 
survey median is more appropriate, given the physician work, intensity 
and complexity of the service.
    Response: We disagree with the commenters and continue to believe 
that the use of time ratios is one of several appropriate methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values recommended by the RUC and 
other commenters do not account for survey information that suggests 
the amount of time involved in furnishing the service has changed 
significantly. We reiterate that, consistent with the statute, we are 
required to value the work RVU based on the relative resources involved 
in furnishing the service, which include time and intensity. Therefore, 
when our review of recommended values reveals that changes in time are 
not accounted for in a recommended work RVU, we believe we have an 
obligation to account for that change in establishing work RVUs since 
the statute explicitly identifies time as one of the two elements of 
the work RVUs. We recognize that it would not be appropriate to develop 
work RVUs solely based on time given that intensity is also an element 
of work, but in applying the time ratios, we are using derived 
intensity measures based on current work RVUs for individual 
procedures. Again, we clarify that we do not treat all components of 
physician time as having identical intensity. If we were to disregard 
intensity altogether, the work RVUs for all services would be developed 
based solely on time values and that is definitively not the case, as 
indicated by the many services that share the same time values but have 
different work RVUs. We have responded to concerns about our 
methodology earlier in this section. We disagree with the commenters 
and continue to believe that finalizing a work RVU of 14.00 is more 
appropriate than a work RVU of 16.00 for CPT code 64582 based on the 
intraservice time ratio of CPT code 64568 compared to the RUC-
recommended intraservice time for CPT code 64582. As stated in the 
proposed rule, the AMA RUC surveyed 25th percentile work RVU for CPT 
code 64582 was 14.00. Additionally, we also note that the RUC has also 
used the surveyed 25th percentile work value as a basis to recommend 
the work RVU for a code.
    We believe the use of an incremental difference between the work 
RVUs of codes is a valid methodology for setting values, especially in 
valuing services within a family. Historically, we have frequently 
utilized an incremental methodology in which we value a code based upon 
the incremental work RVU difference between the code and another code 
or another family of codes. We note that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service. We have no evidence to suggest that the use 
of an incremental difference between the work RVUs of codes conflicts 
with the statute's definition of the work component as the resources in 
time and intensity required in furnishing the service. We do consider 
clinical information associated with physician work intensity provided 
by the RUC and other stakeholders as part of our review process, 
although we remind readers again that we do not believe it is necessary 
for codes to share the same site of service, patient population, or 
utilization level to in order to serve as an appropriate crosswalk. 
Therefore, we are finalizing a work RVU of 14.50 for CPT code 64583 
based on the recommended increment of 0.50 additional RVUs above the 
finalized work RVU of 14.00 for CPT code 64582, and we are finalizing a 
work RVU of 12.00 for CPT code 64584 based on the recommended increment 
of 2.0 RVUs below the finalized work RVU of 14.00 for CPT code 64582.
    Comment: A commenter supported CMS' proposal to accept the RUC-
recommended direct PE inputs without refinements for CPT codes 64582, 
64583 and 64584.
    Response: We appreciate the support for our proposed direct PE 
inputs.
    After consideration of public comments, we are finalizing work RVUs 
of 14.00 for CPT code 64582, 14.50 for CPT code 64583 and 12.00 for CPT 
code 64584. We are finalizing the RUC-recommended direct PE inputs 
without refinement for CPT codes 64582, 64583 and 64584.
(18) Destruction by Neurolytic Agent (CPT Codes 64633, 64634, 64635, 
and 64636)
    In September 2014, the Relativity Assessment Workgroup identified a 
work neutrality issue for CPT codes 64633 (Destruction by neurolytic 
agent, paravertebral facet joint nerve(s), with imaging guidance 
(fluoroscopy or CT); cervical or thoracic, single facet joint), 64634 
(Destruction by neurolytic agent, paravertebral facet joint nerve(s), 
with imaging guidance (fluoroscopy or CT); cervical or thoracic, each 
additional facet joint (List separately in addition to code for primary 
procedure)), 64635 (Destruction by neurolytic agent, paravertebral 
facet joint nerve(s), with

[[Page 65094]]

imaging guidance (fluoroscopy or CT); lumbar or sacral, single facet 
joint), and 64636 (Destruction by neurolytic agent, paravertebral facet 
joint nerve(s), with imaging guidance (fluoroscopy or CT); lumbar or 
sacral, each additional facet joint (List separately in addition to 
code for primary procedure)) related to incorrect coding relative to 
how the services were originally valued. In May 2015, the CPT Editorial 
Panel revised the parenthetical instructions for the five codes 
describing paravertebral facet joint nerve destruction to clarify that 
these codes are reported per joint, not nerve. Due to the extensive 
growth and original incorrect assumptions about distribution of 
reporting, the RUC recommended that CPT codes 64633-64636 be surveyed. 
We proposed the RUC-recommended work RVU of 1.32 for CPT code 64634 and 
the RUC-recommended work RVU of 1.16 for CPT code 64636.
    For CPT codes 64633 and 64635, we did not propose the RUC-
recommended work RVU of 3.42 for both codes, as we believe this value 
understates the decrease in physician work time for these codes. An 
analysis of all 010-day global period codes indicates that these 
proposed values will place these codes among the highest valued for 
codes with similar time values. We are instead using a total-time ratio 
methodology to propose work RVUs of 3.31 for CPT code 64633 and 3.32 
for CPT code 64635. We support these values by noting that they fall 
between CPT codes 54164 (Frenulotomy of penis), with a work RVU of 
2.82, and CPT code 68371 (Harvesting conjunctival allograft, living 
donor), with a work RVU of 5.09; these reference codes have total time 
values that are similar to, and intraservice time values that are 
identical to those recommended for CPT codes 64633 and 64635.
    We proposed the RUC-recommended direct PE inputs without 
refinement.
    Comment: Commenters supported the proposal of the RUC-recommended 
work RVUs for the add-on codes, CPT codes 64634 and 64636, and the RUC-
recommended direct PE inputs for all codes. However, many commenters 
opposed the proposed work RVUs for CPT codes 64633 and 64635 and urged 
CMS to finalize the RUC-recommended work RVUs for these codes. 
According to commenters, the proposed values for these codes placed 
these services out of rank order with similar services such as the top 
key reference code, CPT code 64625 (Radiofrequency ablation, nerves 
innervating the sacroiliac joint, with image guidance (ie, fluoroscopy 
or computed tomography) (work RVU = 3.39, 30 minutes intra-service time 
and 98 minutes total time)). Commenters stated that CPT codes 64633 and 
64635 are slightly more intense and complex than CPT code 64625 due to 
the anatomical differences in anatomic locations; while CPT code 64625 
requires more injections, CPT codes 64633 and 64635 are in a much more 
clinically complex location, requiring greater clinical expertise. CPT 
codes 64633 and 64635 also require more total time than 64625 and the 
RUC-recommended median work RVU of 3.42 maintains the proper rank order 
between these services. Commenters stated that CMS' time ratio 
calculation ignored magnitude estimates as indicated by physicians who 
perform these services and compromises the correct relativity of these 
services. Commenters also stated that CMS' calculation also ignored the 
intensity of these services and discounted it by arriving at a value by 
calculation. The RUC requested that CMS provide clinical rationale on 
why CPT codes 64633 and 64635 require less physician work or intensity 
than other similar services. The RUC recommended that the work RVU for 
CPT codes 64633 and 64635 be the same. According to commenters, the CMS 
references to CPT codes 54164 and CPT code 68371 are inappropriate as 
they describe procedures that are too clinically different.
    Response: We disagree that our time ratio calculation is inaccurate 
and we continue to believe that the use of time ratios is one of 
several appropriate methods for identifying potential work RVUs for PFS 
services, particularly when the alternative values recommended by the 
RUC and other commenters do not account for information provided by 
surveys which suggests that the amount of time involved in furnishing 
the service has changed significantly. We have responded to concerns 
about our methodology earlier in this section. For additional 
information regarding the use of old work time values that were 
established many years ago and have not since been reviewed in our 
methodology, we refer readers to our discussion of the subject in the 
Methodology for Establishing Work RVUs section of this final rule 
(section II.E.2.), as well as a detailed discussion in the CY 2017 PFS 
final rule (81 FR 80273 through 80274). We do not agree that the 
proposed work RVU for CPT code 64633 would create a rank order anomaly 
with CPT code 64625, as the proposed value for CPT code 64633 
recognizes that this is a higher intensity procedure than CPT code 
64625. We understand that the RUC asserts that CPT code 64633 and 64635 
describe services of similar intensity, and therefore, we are 
finalizing work RVUs of 3.32 for both codes, rather than 3.31 for CPT 
code 64633 and 3.32 for CPT code 64635 as proposed. Given the identical 
intensity of these two services, we used total time ratios to estimate 
a value that we believe more accurately captures the time as proposed, 
then we used the relative relationship between the two codes to further 
refine the value for 64633 from 3.31 to 3.32. With regard to the 
invocation of clinically relevant relationships by the commenters, we 
emphasize that we continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes that describe 
clinically similar services are sometimes stronger comparator codes, we 
do not agree that they are necessarily more appropriate crosswalks. We 
disagree that our proposed RVUs undervalued these codes in reference to 
other similar procedures, and we note that even considering our 
proposed work RVUs reductions, these codes would still be among the 
highest valued of all 010-day global period codes.
    After consideration of the comments, we are finalizing the proposed 
work RVUs for CPT codes 64634, 64635, and 64636, as proposed. For CPT 
code 64633, we are instead finalizing a work RVU of 3.32 to match the 
work RVU of CPT code 64635. We are also finalizing the RUC-recommended 
direct PE inputs for these codes as proposed without refinement.
(19) Destruction of Intraosseous Basivertebral Nerve (CPT Codes 64628 
and 64629)
    In October 2020, the CPT Editorial Panel added two Category I codes 
to report thermal destruction of intraosseous basivertebral nerve, 
inclusive of all imaging guidance for the first two vertebral bodies 
(lumbar or sacral) and for each additional vertebral body (lumbar or 
sacral).
    We did not propose the RUC-recommended work value of 8.25 for CPT 
code 64628 (Thermal destruction of intraosseous basivertebral nerve, 
inclusive of all imaging guidance; first two vertebral bodies, lumbar 
or sacral). When we reviewed CPT code 64628, we found that the RUC-
recommended work RVU was higher than codes with the same 10-day global 
period, same intraservice time and similar total times. The RUC-
recommended work RVU of 8.25 would value CPT code 64628 at the 90th 
percentile of comparable 10-day global and we do not agree that it will

[[Page 65095]]

be typical to value this code so much higher than services with similar 
work time values. We believed it would be more accurate to propose a 
work RVU of 7.15 based on a crosswalk to CPT code 63650 (Percutaneous 
implantation of neurostimulator electrode array, epidural) with a work 
RVU of 7.15, identical intraservice time of 60, and similar total time 
of 170. We believe the crosswalk to CPT code 63650 serves as a more 
accurate valuation for CPT code 64628.
    We also did not propose the RUC-recommended work value of 4.87 for 
CPT code 64629 (Thermal destruction of intraosseous basivertebral 
nerve, inclusive of all imaging guidance; each additional vertebral 
body, lumbar or sacral (List separately in addition to code for primary 
procedure)). Although we disagree with the RUC-recommended work RVU, we 
concur that the relative difference in work between CPT codes 64628 and 
64629 is equivalent to the recommended increment of -3.38 RVUs. 
However, since the recommended work RVU of code 64628 was higher than 
other codes with the same 10-day global period, same intraservice time, 
and similar total times, we refined the work RVU for code 64629 to 
preserve the incremental difference between the two codes. We believe 
that these refinements maintain the relationship between the two codes 
in the family while better preserving relativity with other similar 10-
day global codes on the wider PFS. We believe the use of an incremental 
difference between these CPT codes is a valid methodology for setting 
values, especially in valuing services within a family of codes where 
it is important to maintain an appropriate intra-family relativity. 
Therefore, we proposed a work RVU of 3.77 for CPT code 64629 based on 
the recommended increment of 3.38 RVUs below our proposed work RVU of 
7.15 for CPT code 64628.
    We proposed the RUC-recommended direct PE inputs without 
refinements for CPT code 64628. CPT code 64629 is an add-on code and 
does not have any direct PE inputs.
    Comment: Several commenters including the RUC urged CMS to finalize 
the RUC-recommended work RVU of 8.25 for CPT code 64628 and 4.87 for 
CPT code 64629 which are both based on the survey 25th percentile. The 
commenters disagreed that the proposed crosswalk to CPT code 63650 
serves as a more accurate valuation for CPT code 64628 and supports the 
RUC's recommendation for code 64628 with comparisons to the reference 
CPT code 22514 (Percutaneous vertebral augmentation, including cavity 
creation (fracture reduction and bone biopsy included when performed) 
using mechanical device (e.g., kyphoplasty), 1 vertebral body, 
unilateral or bilateral cannulation, inclusive of all imaging guidance; 
lumbar) with a work RVU of 7.99, and CPT code 22513 (Percutaneous 
vertebral augmentation, including cavity creation (fracture reduction 
and bone biopsy included when performed) using mechanical device (e.g., 
kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, 
inclusive of all imaging guidance; thoracic) with a work RVU of 8.65. 
The commenters suggested that CMS proposals and methodology consider 
survey data, review by specialty societies and cross-specialty 
comparison. A commenter urged CMS to finalize a work RVU of 9.75 for 
CPT code 64628 and 4.87 for 64629. Another commenter urged CMS to 
finalize a work RVU of 10.40 for the base CPT code 64628, and agreed 
that the additional level code, CPT code 64629, should have a work RVU 
of approximately 50 percent of the base code, and be assigned a work 
RVU of 5.20. A few commenters noted that CMS' proposal does not 
accurately reimburse physicians for their work and that the proposed 
values will negatively impact access to care. For CPT code 64629, 
commenters including the RUC urged CMS to finalize a work RVU of 4.87 
based on the survey 25th percentile for this add-on code. A few 
commenters disagreed with CMS utilizing incremental differences for 
valuing services.
    Response: We appreciate the feedback from commenters, and we are 
sensitive to the need for appropriate payment under the PFS to ensure 
that beneficiaries maintain access to care. However, we disagree with 
the commenters that the RUC's recommended 25th percentile bracketed to 
CPT codes 22514 and 22513 is a more accurate choice than our proposed 
reference code CPT code 63650. We continue to believe that CPT code 
63650 is a more accurate reference code for 64628, and note that the 
CPT Editorial Panel assigned the Destruction of Intraosseous 
Basivertebral Nerve family to the 60000 series.
    We continue to believe that the nature of the PFS relative value 
system is such that all services are appropriately subject to 
comparisons to one another. Although codes that describe clinically 
similar services are sometimes stronger comparator codes, we do not 
agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate code 
comparison or an appropriate crosswalk.
    Additionally, we believe the use of an incremental difference 
between the work RVUs of codes is a valid methodology for setting 
values, especially in valuing services within a family. Historically, 
we have frequently utilized an incremental methodology in which we 
value a code based upon the incremental work RVU difference between the 
code and another code or another family of codes. We note that the RUC 
has also used the same incremental methodology on occasion when it was 
unable to produce valid survey data for a service. We have no evidence 
to suggest that the use of an incremental difference between the work 
RVUs of codes conflicts with the statute's definition of the work 
component as the resources in time and intensity required in furnishing 
the service. We do consider clinical information associated with 
physician work intensity provided by the RUC and other stakeholders as 
part of our review process, although we remind readers again that we do 
not believe that it is necessary for codes to share the same site of 
service, patient population, or utilization level in order to serve as 
an appropriate crosswalk.
    Comment: Some commenters supported CMS proposing the RUC-
recommended direct PE inputs without refinements for CPT code 64628.
    Response: We appreciate the support for our proposed direct PE 
inputs.
    After consideration of the comments, we are finalizing a work RVU 
of 7.15 for CPT code 64628 and 3.77 for CPT code 64629, as proposed. We 
are also finalizing the RUC-recommended direct PE inputs as proposed 
without refinement for CPT code 64628.
(20) Dilation of Aqueous Outflow Canal (CPT Codes 66174 and 66175)
    These services were identified through the New Technology/New 
Services List. In January 2020, the specialty societies submitted an 
action plan and the RUC recommended referral to the CPT Editorial Panel 
in 2020 to possibly revise the descriptor and add exclusionary 
parentheticals for CPT code 66174 (Transluminal dilation of aqueous 
outflow canal; without retention of device or stent). In October 2020, 
the CPT Editorial Panel revised this code to add a parenthetical to 
restrict reporting this code in conjunction with CPT code 65820 
(Goniotomy).
    We did not propose the RUC-recommended work RVUs of 8.53 for CPT 
code 66174 and 10.25 for CPT code 66175 (Transluminal dilation of

[[Page 65096]]

aqueous outflow canal; with retention of device or stent), as we 
believe these values do not adequately reflect the surveyed reductions 
in physician time. These RVUs will rank these codes among the highest 
valued 090-day global period codes of similar time values. We proposed 
a work RVU of 9.34 for CPT code 66175 using a reverse building block 
methodology. We then subtract the incremental difference between the 
two RUC-recommended work RVUs, an increment of 1.72, from our proposed 
work RVU of 9.34 for CPT code 66175 to propose a work RVU of 7.62 for 
CPT code 66174. We believe this approach is consistent with the RUC's 
assumption that the intensity and complexity of CPT code 66174 is the 
same as that of CPT code 66175, the only difference between the two 
procedures being the additional intraservice time associated with 
placement of the stent. As further support for these values, we note 
that they fall between CPT code 66984 (Extracapsular cataract removal 
with insertion of intraocular lens prosthesis (1 stage procedure), 
manual or mechanical technique (e.g., irrigation and aspiration or 
phacoemulsification); without endoscopic cyclophotocoagulation), with 
7.35 work RVUs, and CPT code 15150 (Tissue cultured skin autograft, 
trunk, arms, legs; first 25 sq cm or less), with 9.39 work RVUs.
    We proposed the RUC-recommended PE inputs without refinement.
    Comment: The RUC urged CMS to accept a work RVU of 8.53 for CPT 
code 66174 and 10.25 for CPT code 66175. The RUC disagreed with CMS 
utilizing reverse building block methodology for valuing services and 
stated that both CMS recommended work values are below the survey 25th 
percentile and well below the current values. The RUC stated that the 
reverse building block methodology, or any other purely formulaic 
approach, should not be used as the primary methodology to value 
services. Commenters stated that this was inappropriate as magnitude 
estimation has been used to establish work RVUs for services since the 
publication of the first Medicare PFS in 1992.
    Response: We disagree with the commenter regarding the validity of 
the building block methodology. We note that 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). We believe an alternative 
valuation methodology, in this case the building block methodology, 
more accurately reflects the reductions in physician time values.
    We continue to believe that our proposed values more accurately 
reflect both the surveyed physician time, as well as the relative 
relationship among these codes and other services of similar time 
values as compared to the RUC-recommended values, which would overvalue 
these codes relative to other 090-day global period codes. The proposed 
work RVUs for CPT codes 66174 and 66175 are among the highest of 90-day 
global period codes with these time values. Therefore, we are 
finalizing work RVUs of 7.62 for CPT code 66174 and 9.34 for CPT code 
66175, as proposed. We are finalizing the RUC-recommended direct PE 
inputs without refinement.
(21) Cataract Removal With Drainage Device Insertion (CPT Codes 66989, 
66991, 66982, 66984, 66987, 66988, and 0671T)
    The RUC identified CPT code 0191T (Insertion of anterior segment 
aqueous drainage device, without extraocular reservoir, internal 
approach, into the trabecular meshwork; initial insertion) via the 
Category III codes with High Utilization screen (2018 estimated 
Medicare utilization over 1,000). In January 2020, the RUC recommended 
that the specialty societies develop a coding application for Category 
I status for CPT code 0191T and CPT code 0376T (each additional device 
insertion (List separately in addition to code for primary procedure). 
In October 2020, the CPT Editorial Panel replaced two Category III 
codes (CPT codes 0191T and 0376T) with two new codes, CPT codes 66989 
and 66991, to report extracapsular cataract removal with insertion of 
intraocular lens prosthesis and one Category III code to report 
insertion of anterior segment aqueous drainage device without 
concomitant cataract removal.
    The RUC recommended a work RVU of 12.13 for CPT code 66989 
(Extracapsular cataract removal with insertion of intraocular lens 
prosthesis (1-stage procedure), manual or mechanical technique (e.g., 
irrigation and aspiration or phacoemulsification), complex, requiring 
devices or techniques not generally used in routine cataract surgery 
(e.g., iris expansion device, suture support for intraocular lens, or 
primary posterior capsulorrhexis) or performed on patients in the 
amblyogenic developmental stage; with insertion of intraocular (e.g., 
trabecular meshwork, supraciliary, suprachoroidal) anterior segment 
aqueous drainage device, without extraocular reservoir, internal 
approach, one or more) based on the survey 25th percentile.
    In its recommendation, the RUC noted that the recommended 
intraservice time of 28 minutes for CPT code 66989 is 2 minutes less 
than the intraservice time of 30 minutes associated with CPT code 66982 
(Extracapsular cataract removal with insertion of intraocular lens 
prosthesis (1-stage procedure), manual or mechanical technique (e.g., 
irrigation and aspiration or phacoemulsification), complex, requiring 
devices or techniques not generally used in routine cataract surgery 
(e.g., iris expansion device, suture support for intraocular lens, or 
primary posterior capsulorrhexis) or performed on patients in the 
amblyogenic developmental stage; without endoscopic 
cyclophotocoagulation). The RUC further noted this should not be the 
case, as the insertion of the intraocular lens prosthesis should take 
the same amount of time and be represented by the same relative work 
for both procedures and that it is counterintuitive that the 
intraservice time for CPT code 66989 will be lower than the 
intraservice time for CPT code 66982, as CPT code 66989 includes both 
complex cataract surgery and the insertion of the intraocular anterior 
segment aqueous drainage device. The specialty society that surveyed 
the codes explained that this is likely because the early adopters of 
this new technology service are highly skilled surgeons who will likely 
perform these procedures quickly. They stated that as this procedure 
diffuses into the wider population of ophthalmologic surgeons over the 
next few years, the intraservice time will likely rise above the 
intraservice time associated with CPT codes 66982 and 66984 and will 
come

[[Page 65097]]

in line for both CPT codes 66989 and 66991.
    CPT code 69982 has a work RVU of 10.25, 125 minutes of total time 
and 30 minutes of intraservice time. CPT code 66989 has a RUC-
recommended work RVU of 12.13, 176 minutes of total time and 28 minutes 
of intraservice time. We agree with the RUC assessment that both 
procedures, CPT code 66982 and CPT code 66989, are almost identical in 
time and intensity. However, we disagree with the RUC-recommended work 
RVU of 12.13 for CPT code 66989 noting that CPT code 66982 has a work 
RUV of 10.25. We proposed a work RVU of 10.31 based on the current 
total time ratio of CPT code 66982 compared to the RUC-recommended 
total time for CPT code 66989.
    For CPT code 66991, the RUC recommended a work RVU of 9.23. The RUC 
determined that it would be appropriate to use the increment between 
the 25th percentile work RVU value for CPT code 66989 and the current 
RUC-reviewed work RVU value for CPT code 66982 to build a work RVU 
recommendation for CPT code 66991. The RUC determined that the 
increment between the 25th percentile work RVU value for CPT code 66989 
(work RVU = 12.13) and the current RUC-reviewed work RVU value for CPT 
code 66982 (work RVU = 10.25) will yield an increment between those two 
codes of 1.88. The RUC added the 1.88 increment to 7.35, the current 
work RVU for 66984, which yields a RUC-recommended work RVU value of 
9.23. This comparison results in a work RVU recommendation of 9.23 for 
CPT code 66991. We proposed a work RVU of 7.41, which is the increment 
between the current RUC-reviewed work RVU value for CPT code 66982 and 
CPT code 66984. The increment between CPT code 66982 (work RVU = 10.25) 
and CPT code 66984 (work RVU = 7.35) yields a work RUV of 2.90. We 
subtracted this 2.90 increment from 10.31, to determine our proposed 
work RVU of 7.41 for CPT code 66989.
    We proposed the RUC-recommended indirect PE values for CPT codes 
66989 and 66991.
    We did not propose any new valuations but reaffirmed the work RVUs 
and direct PE inputs that we previously finalized for CPT codes 66982 
(Extracapsular cataract removal with insertion of intraocular lens 
prosthesis (1-stage procedure), manual or mechanical technique (e.g., 
irrigation and aspiration or phacoemulsification), complex, requiring 
devices or techniques not generally used in routine cataract surgery 
(e.g., iris expansion device, suture support for intraocular lens, or 
primary posterior capsulorrhexis) or performed on patients in the 
amblyogenic developmental stage; without endoscopic 
cyclophotocoagulation) and 66984 (Extracapsular cataract removal with 
insertion of intraocular lens prosthesis (1-stage procedure), manual or 
mechanical technique (e.g., irrigation and aspiration or 
phacoemulsification); without endoscopic cyclophotocoagulation). For 
CPT codes 66987 (Extracapsular cataract removal with insertion of 
intraocular lens prosthesis (1-stage procedure), manual or mechanical 
technique (e.g., irrigation and aspiration or phacoemulsification), 
complex, requiring devices or techniques not generally used in routine 
cataract surgery (e.g., iris expansion device, suture support for 
intraocular lens, or primary posterior capsulorrhexis) or performed on 
patients in the amblyogenic developmental stage; with endoscopic 
cyclophotocoagulation) and 66988 (Extracapsular cataract removal with 
insertion of intraocular lens prosthesis (1-stage procedure), manual or 
mechanical technique (e.g., irrigation and aspiration or 
phacoemulsification); with endoscopic cyclophotocoagulation) we 
continue to believe these services should be contractor priced.
    Comment: One commenter urged CMS to finalize its proposed valuation 
for CPT codes 66989 and 66991, stating that these new services are 
overpriced and underperformed.
    Response: We appreciate the commenter's feedback.
    Comment: Commenters requested that CMS finalize the RUC-recommended 
work RVU of 12.13 for CPT code 66989 and the RUC-recommended work RVU 
of 9.23 for CPT code 66991. The commenters urged CMS to consider the 
intensity of CPT code 66989 and to also provide clinical rationale on 
why CPT code 66989 should only be valued 0.06 more work RVUs than CPT 
code 66982. Commenters stated that CMS is only focusing on time and not 
the clinical work and intensity required to perform CPT code 66989. 
Furthermore, this code is more intense than CPT code 66982 because it 
includes both complex cataract surgery and the insertion of the 
intraocular anterior segment aqueous drainage device. The commenters 
stated that CMS' proposed value for CPT code 66991 assumes that the CMS 
proposed value for CPT code 66989 is appropriate and commenters 
disagreed that the proposed value for CPT code 66989 is correct as 
indicated above.
    Response: We appreciate the additional information supplied by 
commenters regarding the clinical work and intensity required to 
perform CPT codes 66989 and 66991, particularly their relationship in 
terms of intensity with CPT code 66982. After consideration of these 
comments, we are not finalizing our proposed work RVUs and will instead 
finalize the RUC-recommended work RVU for both codes.
    Comment: Commenters requested that CMS finalize the RUC-recommended 
work RVU of 13.15 for CPT code 66987 and 10.25 for CPT code 66988. They 
note that these services will be reported more than 7,000 times per 
year and contractor pricing, as proposed, is burdensome.
    Response: We appreciate commenters' feedback. However, we continue 
to believe that CPT codes 66987 and 66988 should be contractor priced. 
We previously finalized the use of contractor pricing in the CY 2020 
PFS final rule due to a lack of survey data and crosswalks to support 
the RUC-recommended work RVUs (84 FR 62751-62753). Since the RUC and 
commenters merely reaffirmed the same work RVUs from CY 2020 without 
providing new information, we continue to believe that contractor 
pricing is the most appropriate choice for these codes.
    Comment: Many commenters expressed concern that the proposed change 
to bundle minimally invasive glaucoma surgery (MIGS) procedures with 
cataract surgery would make the reimbursement rate too low for 
providers to offer the procedure which could impact beneficiary access 
to the service.
    Response: We agree with commenters concerns regarding the payment 
rate of these services. We are concerned that the recommended values of 
these new services might not fit within the family of services as 
currently valued given concerns raised by stakeholders. In 
consideration of stakeholder concerns, including early feedback on how 
the instraservice time for these services may not be reflective of what 
will be considered typical in how these services may be furnished, we 
encourage the RUC and other stakeholders to reconsider the valuation of 
the cataract procedure family as a whole, including the new codes, in 
the near term.
    After consideration of comments we are finalizing the RUC-
recommended work RVUs of 12.13 and 9.23 for CPT codes 66989 and 66991; 
respectively. We are finalizing the proposal to maintain contractor 
pricing for CPT codes 66987 and 66988. We are also finalizing the RUC-
recommended direct PE inputs as proposed for this code family.

[[Page 65098]]

(22) Retinal Detachment Prophylaxis (CPT Codes 67141 and 67145)
    CPT code 67145 (Prophylaxis of retinal detachment (e.g., retinal 
break, lattice degeneration) without drainage, 1 or more sessions; 
photocoagulation (laser or xenon arc)) was identified in October 2019 
as a Harvard Valued service with utilization over 30,000. In January 
2020, the RUC agreed with the specialty societies that surveyed the 
service and recommended that CPT code 67145, as well as its parent CPT 
code 67141 (Prophylaxis of retinal detachment (e.g., retinal break, 
lattice degeneration) without drainage, 1 or more sessions; 
cryotherapy, diathermy), be referred to the CPT Editorial Panel for a 
descriptor and global period change. The codes were edited to remove 
the reference to ``1 or more sessions'' so that the services may be 
valued as a 010-day procedure versus the current 090-day global. At the 
May 2020 CPT Editorial Panel meeting, the Panel approved revision of 
the two codes to remove ``1 or more sessions'' from the descriptors and 
deletion of the Eye and Ocular Adnexa Prophylaxis guidelines.
    For CY 2022, we proposed the RUC-recommended work RVU of 2.53 for 
CPT codes 67141 and 67145. We also proposed the RUC-recommended direct 
PE inputs without refinements.
    Comment: One commenter urged CMS to adopt the 25th percentile 
survey work values reviewed by the RUC and recommended to CMS.
    Response: We appreciate the commenters feedback. For CPT codes 
67141 and 67145, we are finalizing the RUC-recommended work RVU of 2.53 
for CPT codes 67141 and 67145 and the RUC-recommended direct PE inputs 
without refinements, as proposed.
(23) Strabismus Surgery (CPT Codes 67311, 67312, 67314, 67316, 67318, 
67320, 67331, 67332, 67334, 67335, and 67340)
    In April 2020, The RUC recommend that add-on CPT codes 67320, 
67331, 67332, 67334, 67335, and 67340 be surveyed along with the base 
codes in which these services are typically reported (CPT codes 67311, 
67312, 67314, 67316 and 67318). When AMA staff compiled a list of 010-
day and 090-day services for increases in physician work and time 
during the surgical global period, they noticed that several low volume 
codes that were converted to ZZZ global periods in 1999 still included 
office visits (specifically CPT codes 67320, 67331, 67332, 67334, 
67340). It appeared that these office visits may not be appropriate for 
these services. This issue was deferred until October 2020.
    We proposed the RUC-recommended work RVUs for all base codes within 
this family. This includes a work RVU of 5.93 for CPT code 67311 
(Strabismus surgery, recession or resection procedure; 1 horizontal 
muscle), 9.50 for CPT code 67312 (Strabismus surgery, recession or 
resection procedure; 2 horizontal muscles), 5.93 for CPT code 67314 
(Strabismus surgery, recession or resection procedure; 1 vertical 
muscle (excluding superior oblique)), 10.31 for CPT code 67316 
(Strabismus surgery, recession or resection procedure; 2 or more 
vertical muscles (excluding superior oblique)), and 9.80 for CPT code 
67318 (Strabismus surgery, any procedure, superior oblique muscle).
    We also proposed the RUC-recommend work RVUs for all of the add-on 
codes within this family. This includes a work RVU of 3.00 for CPT code 
67320 (Transposition procedure (e.g., for paretic extraocular muscle), 
any extraocular muscle (specify)(List separately in addition to code)), 
2.00 for CPT code 67331 (Strabismus surgery on patient with previous 
eye surgery or injury that did not involve the extraocular muscles 
(List separately in addition to code for primary procedure)), 3.50 for 
CPT code 67332 (Strabismus surgery on patient with scarring of 
extraocular muscles (e.g., prior ocular injury, strabismus or retinal 
detachment surgery) or restrictive myopathy (e.g., dysthyroid 
opthalmopathy) (List separately in addition to code for primary 
procedure)), 2.06 for CPT code 67334 (Strabismus surgery by posterior 
fixation suture technique, with or without muscle recession (List 
separately in addition to code for primary procedure)), 3.23 for CPT 
code 67335 (Strabismus surgery by posterior fixation suture technique, 
with or without muscle recession (List separately in addition to code 
for primary procedure)), and 5.00 for CPT code 67340 (Strabismus 
surgery by posterior fixation suture technique, with or without muscle 
recession (List separately in addition to code for primary procedure)).
    We proposed the RUC-recommended direct PE inputs for this code 
family without refinements.
    Comment: Commenters unanimously opposed the RUC-recommended RVUs 
for every code in this family. Commenters did not agree with the 
reference codes used by the RUC to support their recommended values. 
They stated that they believe it is inappropriate to use reference 
codes to support a valuation that is lower than the 25th percentile 
survey result for CPT code 67311, CPT code 67314, and CPT code 67320, 
while valuing all other CPT codes within the family at the 25th 
percentile. Commenters asked that CMS raise the RVUs for these CPT 
codes to also be the 25th percentile survey result, which would make 
the family consistently valued. Commenters also asked that the 
reduction in RVUs be phased in over a 3 to 5-year timeframe instead of 
the statutory 2 years.
    Response: We generally agree that there should be consistency 
within code families. The recommendations presented to us by the RUC 
for this CPT code family, however, include a review of surveys for time 
changes, intensity, clinical aspects, and a thoughtful review of survey 
results with the intent for the revaluation to minimize rank order 
anomalies and have valuations consistent with and accounting for the 
reductions in intraservice and total times for each CPT code. In 
regards to the possibility of an extended phase-in, section 1848(c)(7) 
of the Act, as added by section 220(e) of the PAMA, 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. CPT codes 67311, 67314, 67320, 67331, 67332, and 
67334 were subject to the phase-in transition and it was applied in 
calculating their proposed RVUs; we direct readers to the Codes Subject 
to Phase-In public use file for the CY 2022 PFS proposed rule for 
additional details. The statute defines the phase-in transition as 
taking place over 2 years. For additional information regarding the 
phase-in of significant RVU reductions, we direct readers to the CY 
2016 PFS final rule with comment period (80 FR 70927 through 70929).
    Comment: Commenters stated that CMS should revise the policy 
finalized in the 2021 PFS final rule (85 FR 84472) that revalued E/M 
office visits but excluded the valuations from 90 and 10-day 
postoperative global surgery packages. Commenters requested the revised 
values be applied to the postoperative visits in global surgery CPT 
code families as well, and they noted this is particularly relevant to 
this and other CPT code families.
    Response: We did not address the exclusion of postoperative office 
visits within global surgery packages from the E/M revaluation for this 
service, or other services, in the proposed rule. Therefore, this 
policy is out of scope for the CY 2022 PFS proposed and final

[[Page 65099]]

rules. We refer readers to our discussion on this topic in the CY 2021 
PFS final rule (84 FR 84472).
    Comment: Commenters raised several concerns about potential impacts 
on clinicians, as well as beneficiaries due to the large reduction in 
work RVUs for each code. Commenters were also concerned about a further 
reduction in the surgical ophthalmology workforce which they say 
suffers an existing shortage. The commenters stated that the further 
reduction could be caused by the proposed reimbursement cuts, low 
reimbursement compared to other ophthalmology services, and lingering 
financial impacts from the PHE. Commenters also stated that a reduction 
will disproportionately impact pediatric beneficiaries, minorities, and 
rural areas. They also stated that it could increase health 
disparities, generally, because the patient population for this service 
is primarily comprised of children insured by Medicaid. Commenters were 
concerned that Medicaid and private insurance payers will follow 
Medicare reimbursement and reduce payment for these services as well.
    Response: We remain committed to minimizing health disparities and 
increasing health equity across all patient populations and 
demographics. We also are committed to minimizing impacts on clinicians 
as they relate to burden and workforce shortage. We acknowledge that 
impacts could potentially occur to special populations outside of 
Medicare as a result of reimbursement cuts to certain covered services. 
We appreciate that stakeholders have raised concerns about these CPT 
codes and we believe that it would be worthwhile for stakeholders, 
including the RUC to review these services in light of the concerns 
that stakeholders presented. We are also interested in engaging with 
stakeholders in light of concerns about beneficiary access to these 
services.
    After consideration of these public comments, we are finalizing the 
work RVUs and direct PE inputs for the Strabismus Surgery CPT code 
family as proposed.
(24) Lacrimal Canaliculus Drug Eluding Implant Insertion (CPT Codes 
68841)
    CPT code 68841 (Insertion of drug-eluting implant, including 
punctal dilation, when performed, into lacrimal canaliculus, each) was 
recommended for RUC review in October 2020 since the CPT Editorial 
Panel replaced CPT Category III (temporary) code 0356T with a new CPT 
Category I code to report the insertion of a drug eluting implant into 
the lacrimal canaliculus. We proposed the RUC-recommended work RVU of 
0.49 for CPT code 68841.
    For the direct PE inputs, we proposed to refine the equipment time 
for the ``lane, screening (oph)'' (EL006) from the RUC-recommended 9 
minutes of equipment time to the 5-minute equipment standard for CPT 
code 68841. Five minutes is the standard equipment time associated with 
EL006 for this procedure. The recommended materials for this code 
family from the RUC state that the screening lane is used for the 
duration of setup, procedure, cleaning, and counselling post procedure 
and that the standard formulas are applied. We believe that the RUC 
inadvertently failed to update the equipment time associated with this 
procedure when CPT code 68841 was reviewed. The recommended materials 
for CPT code 68841 state the standard equipment time formula will be 
typical for this service, which will be 5 minutes in this case (the 
CA013 and CA024 equipment times are included but not the CA035 
equipment time). We proposed to refine the equipment time for the 
equipment item lane, screening (oph) (EL006) from 9 minutes to 5 
minutes to match this change in equipment time and solicited additional 
comments from stakeholders regarding the RUC-recommended non-standard 
equipment time of 9 minutes. We do not agree that it would be typical 
for CPT code 68841 to require an additional 4 minutes of equipment time 
totaling 9 minutes.
    Comment: Several commenters opposed the proposed work RVU of 0.49 
for CPT code 68841, stating that the payment is too low and much lower 
than what they were paid under the temporary CPT category III code 
0356T, when carrier-priced. Commenters suggested that CMS return to 
using the temporary CPT category III code 0356T and its same payments 
for CY 2022.
    Response: Since CPT has established a category I code--CPT code 
68841--to replace the temporary CPT category III code 0356T, this 
temporary code will be replaced by the new category I CPT code 68841, 
so maintaining payment for CPT category III code 0356T is not possible.
    Comment: Commenters urged CMS to withdraw the proposed RUC-
recommended value of 0.49 work RVUs for CPT code 68841 and offered a 
series of other possible CPT codes with higher work RVU values as 
crosswalks for CPT code 68841. Some commenters also asked that the 4 
minutes of equipment time for the ``lane, screening (oph)'' (EL006) be 
restored to the total of 9 minutes. Another commenter thanked CMS for 
correcting the equipment time to 5 minutes.
    Response: After reviewing the procedure itself, its intra-service 
time and the RUC-recommended work RVUs for this service, we believe 
that this work is appropriate and maintains a proper relativity to 
similar codes within the PFS. After considering all the suggestions 
from commenters and reviewing the RUC-recommended work RVUs with the 
RUC-recommended physician times for this CPT code, and re-examining the 
surveyed work RVU of 0.74 at the 25th percentile with 3 minutes of 
intraservice physician time and 11 minutes of total time, we are 
finalizing the work and PE inputs for CPT code 68841 as proposed.
(25) Transcutaneous Passive Implant-Temporal Bone (CPT Codes 69714, 
69717, 69716, 69719, 69726, and 69727)
    In October 2020, the CPT Editorial Panel deleted two codes used for 
mastoidectomy and replaced them with four new codes for magnetic 
transcutaneous attachment to external speech processor. The CPT 
Editorial Panel made additional revisions to differentiate 
implantation, removal, and replacement of the implants.
    We proposed the RUC-recommended work RVU for all six of the codes 
in this family. We proposed a work RVU of 8.69 for CPT code 69714 
(Implantation, osseointegrated implant, skull; with percutaneous 
attachment to external speech processor), a work RVU of 9.77 for CPT 
code 69716 (Implantation, osseointegrated implant, skull; with magnetic 
transcutaneous attachment to external speech processor), a work RVU of 
8.80 for CPT code 69717 (Revision/replacement (including removal of 
existing device), osseointegrated implant, skull; with percutaneous 
attachment to external speech processor), a work RVU of 9.77 for CPT 
code 69719 (Revision/replacement (including removal of existing 
device), osseointegrated implant, skull; with magnetic transcutaneous 
attachment to external speech processor), a work RVU of 5.93 for CPT 
code 69726 (Removal, osseointegrated implant, skull; with percutaneous 
attachment to external speech processor), and a work RVU of 7.13 for 
CPT code 69727 (Removal, osseointegrated implant, skull; with magnetic 
transcutaneous attachment to external speech processor).
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Post-operative visits (total time)'' (CA039) activity 
from the RUC-recommended 108 minutes to 99 minutes for CPT codes 69714 
and 69717. 99 minutes is the clinical labor time associated with one 
Level 2 postoperative office visit and two Level

[[Page 65100]]

3 postoperative office visits; we believe that the RUC inadvertently 
failed to update the clinical labor time associated with these 
postoperative office visits when CPT codes 69714 and 69717 were 
reviewed. We also proposed to refine the equipment time for all 
equipment items other than the basic instrument pack (EQ137) from 108 
minutes to 99 minutes to match this change in clinical labor time.
    Comment: Several commenters stated that they supported the proposed 
work RVUs for all six codes in the family. Commenters noted that the 
work RVUs recommended by the RUC were interim and updated work RVUs 
will be submitted following an upcoming RUC meeting.
    Response: We appreciate the support for our proposed work RVUs; we 
will consider any future RUC recommendations when they are submitted.
    Comment: Several commenters stated that they agreed with the direct 
PE refinements.
    Response: We appreciate the support for our proposed direct PE 
refinements.
    After consideration of the comments, we are finalizing the work 
RVUs and direct PE inputs as proposed for all six of the codes in the 
family.
(26) X-Rays at Surgery Add-On (CPT Code 74301)
    The RUC recommended that CPT code 74301 (Cholangiography and/or 
pancreatography; additional set intraoperative, radiological 
supervision and interpretation (List separately in addition to code for 
primary procedure)) be deleted for October 2020. The specialty 
societies that typically bill for this service submitted a code change 
application to delete CPT code 74301 at the February 2020 CPT meeting. 
However, the specialty societies withdrew the deletion request after 
receiving feedback from the dominant provider of CPT code 74301 
(general surgery), indicating the code is still necessary and should 
not be deleted. The RUC recommended to maintain the work RVU of 0.21 
for CPT code 74301. The specialty societies did not resurvey CPT code 
74301 due to its low utilization (2019 Medicare utilization = 63) and 
the difficulty of obtaining 30 survey responses from service providers 
with experience in the past 12 months. Since there was no survey done, 
there is no new information and the RUC recommended to maintain the 
current value. The work RVU suggested by the RUC is a reaffirmation of 
the current value.
    We proposed the RUC-recommended work RVU of 0.21 for CPT code 
74301. This is an add-on code with no direct PE inputs.
    Comment: The commenters appreciated that CMS proposed the RUC-
recommended work RVU for CPT code 74301.
    Response: We thank the commenters for their support.
    We are finalizing the proposed work RVU of 0.21 for CPT code 74301. 
We did not propose and we are not finalizing any direct PE inputs.
(27) Trabecular Bone Score (TBS) (CPT Codes 77089, 77090, 77091, and 
77092)
    We proposed the RUC-recommended work RVUs of 0.20 for CPT codes 
77089 (Trabecular bone score (TBS), structural condition of the bone 
microarchitecture; using dual X-ray absorptiometry (DXA) or other 
imaging data on gray-scale variogram, calculation, with interpretation 
and report on fracture risk) and 77092 (Trabecular bone score (TBS), 
structural condition of the bone microarchitecture; using dual X-ray 
absorptiometry (DXA) or other imaging data on gray-scale variogram, 
calculation, with interpretation and report on fracture risk 
interpretation and report on fracture risk only, by other qualified 
health care professional). CPT codes 77090 (Trabecular bone score 
(TBS), structural condition of the bone microarchitecture; technical 
preparation and transmission of data for analysis to be performed 
elsewhere) and 77091 (Trabecular bone score (TBS), structural condition 
of the bone microarchitecture; technical calculation only) are PE only 
codes; the RUC did not recommend and we did not propose a work RVU for 
these codes.
    The RUC PE recommendations for CPT codes 77089 and 77091 include a 
new ``TBS iNsight Software'' supply input. The submitted invoice for 
this supply indicates that it is a licensing fee associated with the 
use of the software, which is not typically considered to be a form of 
direct PE under our methodology. Historically, we have considered most 
computer software and associated licensing fees to be indirect costs 
tied to associated costs for hardware considered to be medical 
equipment. However, as we noted in II.B of this final rule, 
stakeholders have routinely expressed concerns with this policy, 
especially for evolving technologies that rely primarily on software 
and licensing fees with minimal costs in equipment or hardware. Most of 
the recommended resource costs for CPT codes 77089 and 77091 are for 
this analysis fee and these costs are not well accommodated by the PE 
methodology since these sorts of technological applications did not 
exist when the data that underlie the PE allocation was last collected 
in 2007 through 2008.
    Therefore, we proposed to value the PE for CPT codes 77089 and 
77091 through the use of a crosswalk to a comparable service, CPT code 
71101 (Radiologic examination, ribs, unilateral; including 
posteroanterior chest, minimum of 3 views), which, for CY 2021, had a 
PE RVU of 0.94. We proposed that the PE RVU for CPT code 77091 equals 
the PE RVU from code 77089 minus the PE RVU from codes 77090 and 77092 
so that the three codes sum to the valuation of code 77089. (CPT code 
77089 is the global code in this family and CPT codes 77090, 77091, and 
77092 must sum together to equal the value of 77089.) CPT code 71101 is 
another type of bone imaging procedure that we believe reflects codes 
77089 and 77091 similar direct PE resource costs as CPT codes 77089 and 
77091. We recognize that the services being performed in this crosswalk 
code are not the same as the services in CPT codes 77089 and 77091, 
however; we believe that the direct resource costs will typically be 
analogous across these codes. We believe that this is the most accurate 
way to incorporate the costs of the software employed in CPT codes 
77089 and 77091 which will not typically be considered direct PE under 
our current methodology. We solicited comments, both on the specific 
proposal for the Trabecular Bone Score codes, as well as our broader 
discussion of this topic in section B of this final rule.
    Comment: Some commenters supported our proposed methodology of 
calculating PE RVU values for CPT codes 77089 and 77091 through the use 
of a crosswalk to CPT code 71101, stating that this is a reasonable 
interim solution until CMS' PE methodology is updated to better account 
for these technologies. Other commenters did not support our proposed 
approach, urging CMS to accept the RUC-recommended direct PE inputs for 
CPT codes 77089 and 77091, which include the TBS iNsight Software 
supply input. These commenters stated that the TBS iNsight Software is 
currently sold ``per click'' or per scan. The invoice submitted by the 
RUC depicts a TBS iNsight 1-year License and covers a total of 100 
scans. The total unit price for the license is $2,500; therefore, the 
cost is estimated to be $25 per patient (or scan). As this is a single-
use item used per patient encounter, the RUC included it as a direct 
expense supply item, not an equipment item, which is typically 
accounted for by minutes used. One commenter disagreed with our 
assertion that software costs would not typically

[[Page 65101]]

be considered direct PE, as there are many codes including ``software'' 
direct inputs, and noted that CMS would therefore not be setting a 
precedent by potentially including software as a direct input in the 
work RVUs for CPT codes 77089 and 77091.
    Response: We are finalizing as proposed the RUC-recommended work 
RVUs of 0.20 for CPT code 77089 and 77092, as well as direct PE inputs 
for CPT codes 77089 and 77091 based on a crosswalk approach to CPT code 
71101. As we stated in the CY 2019 PFS final rule (83 FR 59557), we 
have considered most computer software and associated analysis and 
licensing fees to be indirect costs tied to costs for associated 
hardware that is considered to be medical equipment, and we continue to 
consider that to be the case for these CPT codes 77089 and 77091. We 
refer readers to section II.B of this final rule (the PE section) for a 
comprehensive discussion of our policy for accounting for computer 
software and associated licensing fees in the PE methodology.
(28) Pathology Clinical Consult (CPT Codes 80503, 80504, 80505, and 
80506)
    The Relativity Assessment Workgroup identified CPT code 80500 
(Clinical pathology consultation; limited, without review of patient's 
history and medical records) via the CMS/Other source codes with the 
Medicare utilization over 20,000 screen. In October 2019, the RUC 
referred this issue to the CPT Editorial Panel to define this service 
more specifically as the current descriptor is vague. In October 2020, 
the CPT Editorial Panel replaced CPT codes 80500 and 80502 (Clinical 
pathology consultation; comprehensive, for a complex diagnostic 
problem, with review of patient's history and medical records) with 
four new codes, CPT codes 80503 (Pathology clinical consultation; for a 
clinical problem with limited review of patient's history and medical 
records and straightforward medical decision making. When using time 
for code selection, 5-20 minutes of total time is spent on the date of 
the consultation. (For consultations involving the examination and 
evaluation of the patient, see 99241, 99242, 99243, 99244, 99245, 
99251, 99252, 99253, 99254, 99255)), 80504 (for a moderately complex 
clinical problem, with review of patient's history and medical records 
and moderate level of medical decision making. When using time for code 
selection, 21-40 minutes of total time is spent on the date of the 
consultation), 80505 (for a highly complex clinical problem, with 
comprehensive review of patient's history and medical records and high 
level of medical decision making. When using time for code selection, 
41-60 minutes of total time is spent on the date of the consultation), 
and 80506 (prolonged service, each additional 30 minutes (List 
separately in addition to code for primary procedure)(Use 80506 in 
conjunction with 80505)(Do not report 80503, 80504, 80505, 80506 in 
conjunction with 88321, 88323, 88325) (Prolonged pathology clinical 
consultation service of less than 15 additional minutes is not reported 
separately) (For consultations involving the examination and evaluation 
of the patient, see 99241-99255)) to report pathology clinical 
consultation and creation of guidelines to select and document the 
appropriate level of service.
    The RUC recommended a work RVU of 0.50 for CPT code 80503 based on 
the 25th percentile of the survey. The RUC-recommended 15 minutes of 
intraservice and total times for CPT code 80503 are 2 minutes above the 
current instraservice and total times for CPT code 80500. This 
represents a 15 percent increase in the respective times. However, the 
RUC-recommended work RVU of 0.50 is 35 percent higher than the current 
work RVU of 0.37 for CPT code 80500. We believe that the increase or 
decrease in times should be commensurate with the increase or decrease 
in the work RVU. Therefore, we proposed a work RVU of 0.43. This 
represents the ratio of total time between the current total time of 
CPT code 80500 and the proposed total time of CPT code 80503 (0.15) 
applied to the current value of CPT code 80500 (0.37 x 0.15 = 0.43).
    We proposed the RUC-recommended work RVU of 0.91 without 
refinements for CPT code 80504.
    The RUC recommended a work RVU of 1.80 for CPT code 80505 based on 
the 25th percentile of the survey. The current intraservice and total 
times for CPT code 80502 are 42 minutes. The RUC-recommended times for 
CPT code 80505 are 54 minutes. Similar to the scenario described above 
for CPT code 80503, the intraservice and total times for CPT code 80505 
increased 28.6 percent while the work RVU increased 35 percent. As 
stated above, we believe the increase or decrease in time should be 
commensurate with the increase or decrease in the work RVU. Therefore, 
for CPT code 80505 we proposed a work RVU of 1.71, which is the current 
total time ratio of CPT code 80502 compared to the RUC-recommended 
total time for CPT code 80505.
    We proposed the RUC-recommended work RVU of 0.80 for CPT code 80506 
without refinement.
    For the direct PE inputs of CPT codes 80503, 80504, and 80505, we 
proposed to refine the time associated with the clinical labor activity 
PA001 (Accession and enter information) from the RUC-recommended time 
of 4 minutes to 0 minutes as we believe the time is duplicative with 
clinical labor activity PA008 (File specimen, supplies, and other 
materials).
    The RUC recommended 15, 30, 54, and 30 minutes of equipment time 
for EP024 (microscope, compound) for CPT codes 80503, 80504, 80505, and 
80506, respectively. We note that there is no indication from the code 
descriptors that the pathologist is reviewing physical slides. The code 
descriptor and description of work indicate that the pathologist is 
reviewing paper records and/or electronic health record (EHR), and 
therefore, we proposed to remove the equipment time associated with 
EP024 (microscope, compound) from CPT codes 80503, 80504, 80505, and 
80506.
    Additionally, the proposed Levels of Decision Making for Table for 
Pathology Clinical Consult codes includes ``Assessment requiring an 
independent historian(s)'' as an element of ``Amount and/or Complexity 
of Data to be Reviewed and Analyzed *--Each unique test, order, or 
document contributes to the combination of 2 or combination of 3 in 
Category 1 below.'' Neither the code descriptors nor the descriptions 
of work indicate that this type of assessment is typical in a pathology 
clinical consult as was discussed for the office visit Levels of 
Decision Making table. For these reasons, CMS proposes that this 
element not be included as an element that we will recognize as an 
element of medical decision making. We note that CMS will monitor the 
use of these replacement codes per our usual practice to ensure 
appropriate billing and inform future rulemaking as needed. We also 
solicited comments on how these replacement codes will most typically 
be billed relative to use of existing pathology coding. Such 
information will also inform future rulemaking as needed.
    Comment: A commenter urged CMS to accept the RUC-recommended work 
RVU of 0.50 for 80503 and 1.80 for 80505. The commenter stated CMS' use 
of a total time ratios to value 80503 and 80505 was flawed as the 
predecessor code 80500 was deleted and split out into three base codes 
and one add-on code with different reporting requirements. The 
commenter stated CMS should not compare the time of 80503 to the 
deleted code 80500 because the code descriptor for 80503, in contrast 
to 80500, includes the

[[Page 65102]]

review of patient's history and medical records. The commenter also 
noted that the descriptor for 80502 described a clinical pathology 
consultation for a ``complex diagnostic problem'', whereas new code 
80505 describes a ``highly complex clinical problem''.
    Response: 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, crosswalk to key reference or similar codes, and magnitude 
estimation. As we have previously stated, section 1848(c)(1)(A) of the 
Act requires CMS to consider time and intensity when developing work 
RVUs. Therefore, we believe it is appropriate to compare CPT code 80503 
to CPT code 80500 and CPT code 80505 to code 80502, which CPT code 
80505 replaced, as the PFS is a relative value system. We continue to 
believe that the increases or decreases in work times should be 
commensurate with the increase or decrease in the work RVU, which is 
why we proposed a work RVU of 0.43 for CPT code 80503 and a work RVU of 
1.71 for CPT code 80505 based on the time methodology detailed above.
    Comment: Several commenters disagreed with the proposal to remove 
the equipment time associated with EP024 (microscope, compound) from 
CPT codes 80503, 80504, 80505, and 80506. Commenters noted that the 
RUC's Summary of Recommendation (SOR) states that a patient's medical 
record is reviewed focusing on recent and relevant remote clinical and 
diagnostic findings and all applicable diagnostic material, slides, 
primary analytical data are retrieved/unarchived for the pathologist's 
examination and review. Commenters stated it is typical for a 
consulting pathologist performing CPT codes 80503-80506 to review all 
relevant information about the patient that is available, and a 
physical component of the patient material within the case review is 
the patient's specimen slides. Commenters stated that these slides are 
typically reviewed on a high grade professional microscope at the 
pathologist's workstation and during the service, the microscope itself 
is not available for other personnel to use on other patients, as the 
pathologist may review the slides multiple times during the service. 
Commenters stated that the RUC understood that pathologists require a 
microscope to perform this and numerous other pathology related 
professional services which is why the RUC included equipment time for 
the EP024 compound microscope in its recommendations. Therefore, 
commenters urged CMS to accept and implement the RUC-recommended times 
of 15, 30, 54, and 30 minutes of equipment time for EP024 (microscope, 
compound) for CPT codes 80503, 80504, 80505, and 80506.
    Response: We appreciate the additional information provided by 
commenters. We found the affirmation from commenters that pathologists 
typically review the patient's specimen slides compelling, and we agree 
that the use of the EP024 microscope would be typical for these codes 
based on this additional information. Therefore, we are finalizing a 
policy to restore the RUC-recommended times of 15, 30, 54, and 30 
minutes of equipment time for EP024 (microscope, compound) for CPT 
codes 80503, 80504, 80505, and 80506.
    Comment: Commenters urged CMS to accept and implement the RUC-
recommended time of 4 minutes for clinical labor activity PA001 for CPT 
codes 80503, 80504, and 80505. Commenters stated for these services, 
accessioning and entering information on the patient case is a 
preservice clinical labor task that is not duplicative with the post 
service work of filing specimen slides, filing reports and all relevant 
patient information retrieved for the pathologist to review. The 
preservice clinical labor work here involves the careful documentation 
of the connection between the requesting physician and the pathologist 
onto a worksheet or accession form. The form is used to transcribe the 
request for consult, the primary complaint, patient encounter, and 
other related information so that it becomes part of the patient's EHR. 
This is one of the first steps of the complete service.
    Response: We thank commenters for the additional information. 
However, we believe the majority of the accessioning tasks performed in 
the PA001 activity constitute forms of indirect PE. Although we agree 
that the unique nature of pathology and laboratory services can make 
comparisons across codes more difficult than for other services, we 
believe the comparison of similar clinical labor activities across 
different services is important to maintaining the relativity of the 
direct PE inputs. As we stated in the CY 2017 PFS final rule (81 FR 
80324), we agree with the commenters that patient documentation and 
entering patient data into information systems is an important task, 
and we agree that these would take more than zero minutes to perform. 
However, we continue to believe that these activities are correctly 
categorized as indirect PE as administrative functions, and therefore, 
we do not recognize the entry of patient data as direct PE inputs, and 
we do not consider this task as typically performed by clinical labor 
on a per-service basis. While we do not agree that the data entry tasks 
described in this activity would constitute direct PE, we note that the 
recommended materials for these codes state that multiple existing 
forms of data will need to be identified and incorporated into this 
accession. We believe that these interpretive tasks do constitute a 
form of direct PE as they are individually allocable to a particular 
patient for a particular service. Therefore, we are finalizing 1 minute 
of clinical labor activity associated with PA001 for CPT codes 80503, 
80504, and 80505 to capture the labor performed in these interpretive 
tasks. We note that we have also previously finalized 1 minute for the 
PA001 clinical labor activity in other pathology services such as CPT 
codes 88360 and 88361.
    For CY 2022, we are finalizing the work RVUs of 0.43, 0.91, 1.71, 
and 0.80 for 80503, 80504, 80505, and 80506 as proposed. For the direct 
PE, we are finalizing a policy to restore the RUC-recommended times of 
15, 30, 54, and 30 minutes of equipment time for EP024 (microscope, 
compound) for CPT codes 80503, 80504, 80505, and 80506 and 1 minute of 
clinical labor activity associated with PA001 for CPT codes 80503, 
80504, and 80505 to capture the labor performed in these interpretive 
tasks.
    We reiterate that CMS will monitor the use of these replacement 
codes per our usual practice to ensure appropriate billing and inform 
future rulemaking as needed. We continue to look for stakeholder input 
on how these replacement codes will most typically be billed relative 
to use of existing pathology coding. Such information will also inform 
future rulemaking as needed.
(29) Revaluing End-Stage Renal Disease (ESRD) Monthly Capitation 
Payment Services (MCP) (CPT Code 90954)
    In the CY 2021 PFS final rule (85 FR 84551 through 84554), we 
revalued most, but not all, of the ESRD MCP services. We finalized an 
increase in valuations for those ESRD MCP codes with values tied to the 
values of Outpatient/Office Evaluation and Management (O/O E/M) codes. 
We did not revalue CPT code 90954 (End-stage renal disease (ESRD) 
related services monthly, for patients 2-11 years of age to include 
monitoring for the adequacy of nutrition, assessment of growth and 
development, and counseling of parents; with 4 or more face-to-face 
visits by a physician or other qualified health care

[[Page 65103]]

professional per month) because it was originally valued by a 
crosswalk.
    Stakeholders stated that CPT code 90954 was different from the 
other ESRD MCP codes. Rather than using an O/O E/M code building block 
methodology as had been used originally to value the other ESRD MCP 
codes, CPT code 90954 was valued based upon a crosswalk to CPT code 
99293 (Inpatient pediatric critical care provided for children age 29 
days through 24 months old, per day). When CPT code 99293 was deleted, 
the value of CPT code 90954 was crosswalked to a replacement code, CPT 
code 99471 (Initial inpatient pediatric critical care, per day, for the 
evaluation and management of a critically ill infant or young child, 29 
days through 24 months of age). By crosswalking CPT code 90954 to CPT 
code 99471, the rank order across the ESRD MCP code family at that time 
was preserved.
    Since we finalized the revalued ESRD MCP values for CY 2021, 
stakeholders have requested that we revalue CPT code 90954 because by 
not updating it, we created a rank order anomaly for work RVUs and time 
within the ESRD MCP code family. A stakeholder suggested that we 
address the rank order anomaly by revaluing CPT code 90954 based upon a 
new crosswalk to CPT code 33977 (Removal of a ventricular assist 
device; extracorporeal, single ventricle). The stakeholder stated that 
CPT code 33977 more appropriately represented the time and effort of 
the service provided over one month than the existing crosswalk to CPT 
code 99471 relative to the revalued services within the MCP code 
family.
    In response to stakeholder requests to update the value of CPT code 
90954, we proposed to increase the value of CPT code 90954, a global 
code with a current work RVU of 15.98, by crosswalking it to CPT code 
33977, a 090 day procedural code with a work RVU of 20.86 to preserve 
relativity within the ESRD MCP family. We also solicited comments on 
our proposal to increase the value of CPT code 90954.
    Comment: A few commenters supported our proposal to increase the 
value of the ESRD MCP CPT code 90954.
    Response: We appreciate the support of the commenters.
    Comment: One commenter stated that it was unfair and inconsistent 
to increase the value of CPT code 90954 in order to eliminate a rank 
order anomaly that resulted from our having revalued the other ESRD MCP 
codes in the CY 2021 PFS final rule. The commenter noted that as a 
global code, CPT code 90954 was initially valued based upon magnitude 
estimation with additional negotiations at the RUC. The commenter 
concluded that all the global codes should thus be revalued using the 
same methodology.
    Response: We understand that some commenters disagree with our 
revaluation of CPT code 90954. We maintain that revaluing CPT code 
90954 was important to maintaining rank order within the ESRD MCP 
family. The code identifies ESRD services for our youngest 
beneficiaries, infants and toddlers diagnosed with ESRD. We note that 
CPT code 90954 is not a global code. Nevertheless, we concur with the 
commenter that the group of global codes demands further review and 
possibly revaluation in the future as we come to better understand the 
nature of the services furnished during global periods.
    In response to the majority of commenters and because of our desire 
to eliminate a rank order anomaly, we are finalizing our proposal to 
increase the value of CPT code 90954 to a work RVU of 20.86 in order to 
preserve relativity within the ESRD MCP family. In future rules, we 
will likely revisit the valuing of global codes.
(30) Colon Capsule Endoscopy (CPT Codes 91110, 91111, and 91113)
    In October 2020, the CPT Editorial Panel replaced Category III code 
0355T (Gastrointestinal tract imaging, intraluminal (e.g., capsule 
endoscopy), colon, with interpretation and report) with a new Category 
I code 91113 (Gastrointestinal tract imaging, intraluminal (e.g., 
capsule endoscopy), colon, with interpretation and report) to report 
gastrointestinal tract imaging. CPT codes 91110 (Gastrointestinal tract 
imaging, intraluminal (e.g., capsule endoscopy), esophagus through 
ileum, with interpretation and report) and 91111 (Gastrointestinal 
tract imaging, intraluminal (e.g., capsule endoscopy), esophagus with 
interpretation and report) were added as part of the family and 
surveyed for the January 2021 RUC meeting.
    We proposed the RUC-recommended work RVU for two of the codes in 
this family. We proposed a work RVU of 2.24 for CPT code 91110 and a 
work RVU of 2.41 for CPT code 91113 as recommended by the RUC in both 
cases. For CPT code 91111, we disagree with the RUC-recommended work 
RVU of 1.00 and we proposed a work RVU of 0.90 based on a crosswalk to 
CPT code 95923 (Testing of autonomic nervous system function; 
sudomotor, including 1 or more of the following: quantitative sudomotor 
axon reflex test (QSART), silastic sweat imprint, thermoregulatory 
sweat test, and changes in sympathetic skin potential). CPT code 95923 
is an autonomic nervous system testing procedure that shares the 
identical intraservice work time of 15 minutes with CPT code 91111 and 
has 5 additional minutes of immediate postservice work time. When we 
reviewed CPT code 91111, we noted that the surveyed intraservice work 
time had decreased by 3 minutes, from 18 minutes to 15 minutes, while 
the RUC recommended maintaining the current work RVU of 1.00. 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, decreases in time should typically be reflected in decreases 
to work RVUs. In the case of CPT code 91111, we believe that it will be 
more accurate to propose a work RVU of 0.90 based on a crosswalk to CPT 
code 95923 to account for these decreases in the surveyed work time.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare, set-up and start IV, initial positioning and 
monitoring of patient'' (CA016) activity from the RUC-recommended 9 
minutes to 6 minutes for CPT code 91111. The recommended materials for 
this code family state that the 6 minutes for the CA016 activity are 
used to connect the equipment, fit belt to patient, put data recorder 
on patient, and sync capsule to each sensor on belt. This description 
of this clinical labor activity is identical for CPT codes 91110 and 
91113 and each code has the same recommended time of 6 minutes. 
However, the recommended materials for CPT code 91111 state that 6 
minutes are used to connect the equipment, fit belt, put data recorder 
on patient, sync capsule to each sensor and then an additional 3 
minutes are used to position the patient (assist patient onto table 
lying down on right side and then into a sitting position after the 
capsule is swallowed). We do not agree that it will be typical for CPT 
code 91111 to require an additional 3 minutes for positioning as 
compared with the other codes in the family, particularly in light of 
the clinical similarities between these services. We are refining the 
clinical labor time to 6 minutes for CPT code 91111 to maintain 
relativity within the family.
    We also proposed to refine the equipment time for the capsule 
endoscopy recorder kit (EQ146) from 64 minutes to 61 minutes and the 
exam table (EF023) from 44 minutes to 41 minutes to match this change 
in clinical labor time for CPT code 91111.

[[Page 65104]]

    Comment: A commenter disagreed that the work time had decreased for 
CPT code 91111. The commenter stated that although there was a minor 
reduction in intra-service time, the total time reported by the survey 
takers was 7 minutes greater than the current total time even though 
this time was ultimately not added to pre- and post-service time. 
Therefore, the commenter stated that in practice CPT code 91111 does 
not take less total time than in the past.
    Response: We disagree with the commenter that the work time for CPT 
code 91111 has not decreased. The survey showed a decrease of 3 minutes 
in the intra-service work time from 18 minutes to 15 minutes and the 
RUC recommended maintaining the same pre-service and post-service work 
time of 5 minutes. The RUC routinely makes adjustments to pre-service 
and post-service surveyed work times in its recommendations as it did 
here for CPT code 91111. We agree with the RUC that the typical pre-
service and post-service work time has not increased for CPT code 91111 
which results in an overall decrease for the code.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 0.90 for CPT code 91111 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 1.00. Commenters disagreed 
with the CMS crosswalk to CPT code 95923 and stated that although there 
was a decrease in surveyed work time for CPT code 91111, the intensity 
level required to perform the service has stayed the same. Commenters 
stated that the decrease of 3 minutes of work time for CPT code 91111 
may be due to efficiencies in the healthcare setting, not with the 
overall complexity of delivering the service. Commenters stated that 
the intra-service time, intensity level, and RUC-recommended RVU of 
1.00 properly fell within a relative range compared to similar codes. 
Commenters compared the work of CPT code 91111 to CPT codes 70470 
(Computed tomography, head or brain; without contrast material, 
followed by contrast material(s) and further sections) and 76391 
(Magnetic resonance (e.g., vibration) elastography) and 95819 
(Electroencephalogram (EEG); including recording awake and asleep) to 
support their belief that the intensity relativity is appropriate and 
that the recommended current work value of 1.00 placed the survey code 
well within the relativity of the family.
    Response: We disagree with the commenters and continue to believe 
that the proposed work RVU of 0.90 is a more accurate choice for CPT 
code 91111. As we stated in the proposed rule, since the two components 
of work are time and intensity, decreases in time should typically be 
reflected in decreases to work RVUs. The survey for CPT code 91111 
found that the typical intraservice time required to perform the 
procedure had decreased by 3 minutes and we believe that this decrease 
in work time should be reflected in the work RVU. Even if the decrease 
in work time was due to greater efficiencies in delivering the service, 
this decrease in work time should be reflected in the work RVU for the 
service in question.
    We do not agree with commenters that there has been a corresponding 
increase in intensity for CPT code 91111 which would justify 
maintaining the work RVU at 1.00 despite this surveyed decrease in work 
time. The CPT Editorial Panel did not revise the code descriptor for 
CPT code 91111 and both the survey vignette and the clinical 
description of work remain unchanged for CY 2022. Our proposed work RVU 
of 0.90 maintains the current intensity of the procedure, and we also 
note that the intensity of this procedure would be noticeably higher 
than the rest of the code family at the recommended work RVU of 1.00 
which we do not believe would serve the interests of relativity. We 
also note that our proposed work RVU of 0.90 does reflect a small 
increase in the intensity of this service as compared to its previous 
intensity.
    We also disagree that the work RVU of CPT codes 70470, 76391, or 
95819 would be more appropriate comparisons for CPT code 91111. All of 
these procedures have similar work times but employ more complex forms 
of imaging such as CT imaging or magnetic resonance imaging. For 
example, CPT code 76391 makes use of an MR room (EL008) equipment item 
with a cost over $1.5 million in comparison to the capsule endoscopy 
video system (ES029) used in CPT code 91111 which costs approximately 
$10,000. While we continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another, we believe that CPT code 95923 
is a more accurate crosswalk for CPT code 91111.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the clinical labor time for the ``Prepare, set-up and start IV, 
initial positioning and monitoring of patient'' (CA016) activity from 
the RUC-recommended 9 minutes to 6 minutes for CPT code 91111. 
Commenters stated that there had been a detailed accounting of time for 
clinical labor activities included with the recommended materials for 
the code family. Commenters stated that for capsule endoscopy of the 
esophagus (CPT code 91111), clinical staff position the patient on the 
bed with a pillow (6 cm or 2.5 inches high) under the head to 
facilitate drinking and ingestion. The patient is typically assisted 
from supine to the left side to delay capsule transit across the 
gastroesophageal junction and then into a sitting position after the 
capsule is swallowed. Commenters stated that capsule endoscopy of the 
gastrointestinal tract (CPT code 91110) and colon (CPT code 91113) do 
not require these additional steps for positioning, as noted in the 
recommended materials.
    Response: We appreciate the additional information provided by the 
commenters clarifying the clinical labor tasks taking place during the 
CA016 activity for CPT code 91111. The commenters explained that for 
CPT code 91111 the patient is typically assisted from supine to the 
left side to delay capsule transit across the gastroesophageal junction 
and then into a sitting position after the capsule is swallowed, which 
justifies the additional 3 minutes of clinical labor time recommended 
by the RUC. We are therefore not finalizing our proposed refinement to 
the clinical labor time and will instead finalize the RUC-recommended 
time of 9 minutes for this activity. We are correspondingly also not 
finalizing our proposed refinements the equipment time for the capsule 
endoscopy recorder kit (EQ146) and the exam table (EF023) for CPT code 
91111; we are finalizing the RUC-recommended equipment time of 64 
minutes and 44 minutes respectively.
    After consideration of the comments, we are finalizing our proposed 
work RVUs for all three codes in the family. We are not finalizing our 
proposed direct PE refinements and are instead finalizing the RUC-
recommended direct PE inputs for all three codes.
(31) External Cardiovascular Device Monitoring (CPT Codes 93228 and 
93229)
    For CPT code 93228 (External mobile cardiovascular telemetry with 
electrocardiographic recording, concurrent computerized real time data 
analysis and greater than 24 hours of accessible ECG data storage 
(retrievable with query) with ECG triggered and patient selected events 
transmitted to a remote attended surveillance center for up to 30 days; 
review and interpretation with report by a physician or other qualified 
health care professional), we disagreed with the RUC-recommended work 
RVU of 0.52, and we proposed a

[[Page 65105]]

work RVU of 0.43. The proposed work RVU is based on an intraservice 
time ratio between the current and RUC-recommended intraservice times 
for CPT code 93228 ((10 minutes/12 minutes)*0.52), yielding a work RVU 
of 0.43. This proposed work RVU reflects the decrease in total time and 
is a direct work RVU crosswalk to CPT code 93290 (Interrogation device 
evaluation (in person) with analysis, review and report by a physician 
or other qualified health care professional, includes connection, 
recording and disconnection per patient encounter; implantable 
cardiovascular physiologic monitor system, including analysis of 1 or 
more recorded physiologic cardiovascular data elements from all 
internal and external sensors). CPT code 93290 has the same pre-, 
intra-, and postservice times as the survey times for CPT code 93228 
and was reviewed in October 2016. While we recognize that the number of 
ECG tracings and daily reports have increased because of the increase 
in average wear time from 14 days to 20 days, the specialty societies 
and the RUC contend that this is offset by technology advancements, 
integrations with EHRs, and online portals that make it easier to 
manage and review the data in a chronological and efficient manner. 
Therefore, we proposed a work RVU that accounts for decrease in total 
time to provide this service, given that the increased tracings and 
daily reports are offset by the efficiencies gained by technological 
advancements.
    The RUC recommended 10 minutes for ``Provide education/obtain 
consent'' (CA011) for CPT code 93228, based on a direct crosswalk and 
duplication of CPT code 93229 (External mobile cardiovascular telemetry 
with electrocardiographic recording, concurrent computerized real time 
data analysis and greater than 24 hours of accessible ECG data storage 
(retrievable with query) with ECG triggered and patient selected events 
transmitted to a remote attended surveillance center for up to 30 days; 
review and interpretation with report by a physician or other qualified 
health care professional). We disagree with the RUC-recommended 
duplication of clinical labor to provide education that the patient 
will hear for a second time from the IDTF technician. While we 
understand that the duplication is by design, we do not agree with a 
direct crosswalk from CPT code 93229, because the provider of CPT code 
93229 will likely have more in-depth education, specific to the 
patient, including materials and instructions for the patient to 
review. Therefore, we proposed the standard 2 minutes for CA011 in the 
non-facility for CPT code 93228.
    The RUC recommended the addition of 24 minutes for quality 
assurance ``overread'' done by a second, senior technician, Clinical 
Activity Code CA021, Line 67 on the RUC-recommended PE Spreadsheet, for 
CPT code 93229. This is a new clinical activity for CPT code 93228, and 
we solicited public comments about the typicality of a second senior 
technician. We requested additional information about the IDTF's 
current quality assurance measures and parameters within the ECG 
recording program that should act as some degree of quality assurance. 
We also solicited additional information from IDTFs about the current 
error rate for improperly transmitted tracings to the physician that 
would indicate that it is typical for a second, senior technician to 
perform ``overread.'' We proposed 0 minutes for Clinical Activity Code 
CA021, Line 67 on the RUC-recommended PE Spreadsheet, unless commenters 
could provide compelling information that a second, senior technician 
typically performs quality assurance measures. Otherwise, we agree with 
the RUC-recommended direct PE inputs and proposed the refinements as 
recommended.
    In addition to the proposed work RVU and direct PE input 
refinements, we requested additional information about the acquisition 
costs for equipment item EQ340 Patient Worn Telemetry System. Due to 
the proprietary nature of this equipment, invoices were unattainable to 
update this equipment item. Substantial technological improvements have 
been made to these devices since the last update in 2008, but they are 
proprietary devices, owned and manufactured for each IDTF. We solicited 
public comments on the manufacturing costs and other information to 
help update the equipment item for CY 2022. Second, we requested 
additional information about the useful lifetime of EQ340. We currently 
assign 3 years of useful life to EQ340, but the RUC notes that this is 
the only equipment item and CPT code 93228 is the only CPT code with an 
equipment item that has more than 500 minutes of equipment time and a 
useful life of 3 years or less. We solicited public comments to help 
update the useful life of EQ340, as it has not been updated since 2008, 
and the device has experienced significant technological changes.
    Comment: Commenters disagreed with our use of the intraservice time 
ratio to value CPT code 93228, claiming it disproportionately decreased 
the work RVU by 17 percent, whereas the total time only decreased by 8 
percent. Commenters also disagreed with the choice of reference CPT 
code 93920, stating that CPT code 93920 is often performed parallel to 
a separately reported pacemaker interrogation and wearable 
defibrillator interrogation service, thus making it less intense than 
CPT code 93229, which is usually performed without any separately 
reported services. Commenters stated that treating all components of 
physician time (preservice, intraservice, postservice and post-
operative visits) as having identical intensity is incorrect, and 
inconsistently applying it to only certain services under review 
creates inherent payment disparities in a payment system, which is 
based on relative valuation. Commenters stated that in many scenarios, 
CMS selects an arbitrary combination of inputs to apply rather than 
seeking a valid clinically relevant relationship that would preserve 
relativity. Commenters suggested that CMS determine the work valuation 
for each code based not only on surveyed work times, but also the 
intensity and complexity of the service and relativity to other similar 
services, rather than basing the work value entirely on time.
    Response: We disagree and continue to believe that the use of time 
ratios is one of several appropriate methods for identifying potential 
work RVUs for particular PFS services, particularly when the 
alternative values recommended by the RUC and other commenters do not 
account for information provided by surveys that suggests the intensity 
has not changed or the amount of time involved in furnishing the 
service has changed. We reiterate that, consistent with the statute, we 
are required to value the work RVU based on the relative resources 
involved in furnishing the service, which include time and intensity. 
When our review of recommended values reveals that changes in time have 
been unaccounted for in a recommended RVU, then we believe we have the 
obligation to account for that change in establishing work RVUs since 
the statute explicitly identifies time as one of the two elements of 
the work RVUs. Given the well-established assertion in the RUC 
recommendations that the increased tracings and daily reports from the 
increased average wear time (from 14 to 20 days) is offset by the fact 
that the technology has advanced to make it easier to manage and review 
the data, resulting in a net zero change in intensity, we are obligated 
to account

[[Page 65106]]

for the change in time. We also clarify for the commenters that our 
review process is not arbitrary in nature. Our reviews of recommended 
work RVUs and time inputs generally include, but have not been limited 
to, a review of information provided by the RUC, the HCPAC, and other 
public commenters, medical literature, and comparative databases, as 
well as a comparison with other codes within the PFS, consultation with 
other physicians and health care professionals within CMS and the 
Federal Government, as well as Medicare claims data. We also assess the 
methodology and data used to develop the recommendations submitted to 
us by the RUC and other public commenters and the rationale for the 
recommendations. In the CY 2011 PFS final rule with comment period (75 
FR 73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalks to key reference or similar codes, and magnitude 
estimation (see the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329) for more information). With regard to the 
invocation of clinically relevant relationships by the commenters, we 
emphasize that we continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes that describe 
clinically similar services are sometimes stronger comparator codes, we 
do not agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk.
    Comment: Some commenters stated that the proposed work RVU for CPT 
code 93228 would result in an intensity that is dramatically lower than 
the intensity assigned to a level 1 established patient office visit, 
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.), which does not require the 
presence of a physician or other qualified healthcare professional.
    Response: The RUC-recommended work RVU of 0.52 also assigns CPT 
code 93228 a lower intensity than code CPT code 99211; therefore, we do 
not agree that the proposed work RVU for CPT code 93228 would create a 
rank order anomaly. We agree with the RUC that CPT code 93228 is more 
accurately valued at a lower intensity than CPT code 99211. We also 
agree with the RUC that CPT code 93228 should have a lower intensity 
than key reference CPT codes 93298 (Interrogation device evaluation(s), 
(remote) up to 30 days; subcutaneous cardiac rhythm monitor system, 
including analysis of recorded heart rhythm data, analysis, review(s) 
and report(s) by a physician or other qualified health care 
professional) and 93015 (Cardiovascular stress test using maximal or 
submaximal treadmill or bicycle exercise, continuous 
electrocardiographic monitoring, and/or pharmacological stress; with 
supervision, interpretation and report) from the survey.
    Comment: One commenter stated that while technology has advanced to 
negate some low intensity work, making review and management of data 
more efficient, the RUC-recommended RVU for CPT code 93228 accurately 
reflects the average wear time increasing from 14 to 20 days, the 
number of ECG tracings, and the increased daily reports.
    Response: We agree with the initial statements in the RUC 
recommendations, such as that increased tracings and daily reports from 
the increased average wear time from 14 to 20 days are offset by the 
fact that the technology has advanced to make it easier to manage and 
review the data. The RUC and specialty societies stated that technology 
has advanced to make it easier to manage and review the data, which 
accounts for the reduced intra-service time. The interface for 
physician interaction with the reports has moved from primarily a fax 
and paper-based system, which resulted in large amounts of paper 
reports, to more streamlined digital reports with better organized and 
more easily accessible data. The number of episodes that the physician 
reviews and adjudicates have increased due to the increased wear time 
but the RUC agreed that the increased amount of data and the efficiency 
gained in reviewing that data directly offset each other. This supports 
the assertion that intensity of the service has not changed, given the 
offset discussed in the RUC recommendations. We believe the offset 
yields a net zero change in intensity, which is supported by the RUC 
and specialty societies' statements in the recommendations.
    After consideration of public comments, we are finalizing a work 
RVU of 0.48 for CPT code 93228 based on a total time ratio between the 
current and RUC-recommended total times for CPT code 93228 ((23 
minutes/25 minutes)*0.52). The finalized work RVU addresses commenters' 
concerns that the proposed work RVU was disproportionately decreased 
compared to the decrease in total time. The finalized work RVU also 
maintains the same intensity, which is supported by the statements in 
the RUC's recommendations that the increased amount of data and the 
efficiency gained in reviewing that data offset each other, yielding a 
net zero change in intensity. Based on this well-established assertion 
in the RUC recommendations, we believe it is appropriate to maintain 
the same intensity.
    Comment: One commenter expressed concern with the proposed standard 
2 minutes for ``Provide education/obtain consent'' (CA011) in the non-
facility for CPT code 93228, and recommended a crosswalk of 5 minutes 
for this activity, similar to extended external ECG recording codes 
93225, 93242, and 93246. The commenter stated that they believe the 
standard 2 minutes would be inadequate for clinical staff to explain 
next steps with the IDTF, to obtain the monitor, explain the goals and 
use of the device, and answer technology questions asked by this 
elderly population.
    Response: The RUC recommended 10 minutes for ``Provide education/
obtain consent'' (CA011) for CPT code 93228 based on a direct crosswalk 
and duplication of CPT code 93229. We continue to disagree with the 
RUC-recommended duplication of clinical labor because the patient will 
hear the same information from the IDTF technician and the provider of 
CPT code 93229 will likely have more in-depth education, specific to 
the patient, including materials and instructions for the patient to 
review. We are compelled by the additional information provided by the 
commenter and the provision of 5 minutes of clinal staff time to 
provide education and obtain consent (CA011) in some external extended 
ECG codes, particularly for CPT code 93224 (External 
electrocardiographic recording up to 48 hours by continuous rhythm 
recording and storage; includes recording, scanning analysis with 
report, review and interpretation by a physician or other qualified 
health care professional), as this is a code for review and 
interpretation by a physician or qualified healthcare professional 
similar to CPT code 93228.
    After consideration of public comments, we are finalizing 5 minutes 
for CA011 in the non-facility for CPT code 93228 based on a crosswalk 
to the extended external ECG recording codes.
    Comment: Commenters reiterated that the recommendation of the 
addition of 24 minutes for quality assurance ``overread'' done by a 
second, senior technician, Clinical Activity Code CA021, Line 67 on the 
RUC-recommended PE Spreadsheet, for CPT

[[Page 65107]]

code 93229 was based on two separate training/process documents that 
specifically discuss the role of a ``Senior Monitoring Technician'' and 
the typicality of this clinical labor activity. Commenters also 
corroborated the assertion in the Moran materials that a senior 
technician is contacted when the initial read of the transmitted data 
is unable to confirm the accuracy of the arrhythmias detected by the 
software algorithms. One commenter stated that an ``overread'' by a 
senior technician occurs for well over 50 percent of the services 
provided and that on average, the second ``read'' takes approximately 
25 minutes of clinical staff time. The commenter gave the following two 
examples of when a second ``read'' is necessary: (1) There is enough 
motion artifact to interfere with the algorithm's ability to 
definitively identify arrhythmias; and (2) the occurrence of a complex 
arrhythmia that was not properly identified by the algorithm or the 
initial reviewer is high.
    Response: We appreciate the additional information provided by the 
commenters. After consideration of the public comments, we agree with 
the commenters and are finalizing the RUC-recommended 24 minutes for 
CA021 for CPT code 93229.
    Comment: In response to the request for additional information 
about the acquisition costs and useful life of equipment item EQ340 
Patient Worn Telemetry System, commenters reiterated the uniqueness of 
mobile cardiac telemetry (MCT) and agreed that invoices were 
unattainable because the companies that furnish MCT manufacture their 
own devices and systems, so the equipment is not bought or sold in the 
marketplace. Commenters disagreed with the RUC's assertion that EQ340 
has not been evaluated since 2008 and reiterated that the price was 
adjusted in the 2019 PFS final rule (83 FR 59478). Commenters opined 
that EQ340 has a relatively short life-span because it is worn 
continuously for several weeks, resulting in a high degree of wear, 
tear, damage, and loss. Commenters urged CMS to retain its current 
pricing and useful life for EQ340. One commenter urged consideration of 
the granularity of equipment input in comparison to other patient worn 
cardiac device monitoring systems. Other comments disagreed with the 
recommendation to consider granularity given the uniqueness of CPT code 
93228.
    Response: We believe that the additional information supplied by 
commenters reinforces that the current pricing and useful life of the 
EQ340 equipment item are accurate. We are maintaining the current price 
of $23,494 and useful life of 3 years for the EQ340 equipment item.
    After consideration of the public comments, we are finalizing a 
work RVU of 0.48 for CPT code 93228, which is an increase from our 
proposed work RVU of 0.43. We are finalizing a clinical labor time of 5 
minutes for the CA011 activity for CPT code 93228, an increase from our 
proposed clinical labor time of 2 minutes for this activity. We are 
finalizing the RUC-recommended direct PE inputs for CPT code 93229 
without refinement.
(32) Electrophysiologic Evaluation (CPT Code 93621)
    In October 2019, the RUC identified CPT code 93621 (Comprehensive 
electrophysiologic evaluation including insertion and repositioning of 
multiple electrode catheters with induction or attempted induction of 
arrhythmia; with left atrial pacing and recording from coronary sinus 
or left atrium (List separately in addition to code for primary 
procedure) as a high-growth service. It is an add-on code that can be 
used with several different procedures--base codes or other add-on 
codes, diagnostic, as well as therapeutic. CPT code 93621 is furnished 
in the facility only and thus has no direct PE inputs.
    We disagree with the RUC-recommended work RVU of 1.75 based on a 
crosswalk to CPT code 36483 (Endovenous ablation therapy of incompetent 
vein, extremity, by transcatheter delivery of a chemical adhesive 
(e.g., cyanoacrylate) remote from the access site, inclusive of all 
imaging guidance and monitoring, percutaneous; subsequent vein(s) 
treated in a single extremity, each through separate access sites (List 
separately in addition to code for primary procedure). We proposed a 
work RVU of 1.50 based on a crosswalk to CPT code 16036 (Escharotomy; 
each additional incision). CPT code 16036 is also an add-on code for a 
surgical incision that shares both an identical intraservice work time 
and a total time of 20 minutes with CPT code 93621. While the RUC's 
recommended crosswalk code also has 20 minutes of intraservice and 
total time, CPT code 36483 is more intense than CPT code 93621, whereas 
CPT code 16036 has a similar level of intensity as CPT code 93621.
    The RUC did not recommend and we did not propose any direct PE 
inputs for CPT code 93621.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 1.50 for CPT code 93621 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 1.75. Commenters stated that 
the crosswalk to CPT code 36483 that the RUC recommended was based on 
discussions among the RUC reviewers and accounted for similarities 
between services that both rely upon catheters to execute complex 
maneuvers inside the cardiovascular system. Commenters stated that the 
proposed crosswalk was problematic because CPT code 16036 is completely 
different from cardiac procedures and can be billed multiple times. 
Commenters stated that the RUC-recommended crosswalk code (CPT code 
36483) is a cardiovascular procedure and carries similar intensity of 
work to CPT code 93621.
    Response: We disagree with the commenters that the RUC's 
recommended crosswalk to CPT code 36483 is a more accurate choice than 
our proposed crosswalk to CPT code 16036. We note that all three of the 
codes in question share the identical intraservice and total work time 
of 20 minutes, and therefore, differ only in their work RVUs and 
intensities. Commenters largely objected to the use of CPT code 16036 
as a crosswalk code because it is an escharotomy procedure instead of a 
cardiovascular procedure. However, we continue to believe that the 
nature of the PFS relative value system is such that all services are 
appropriately subject to comparisons to one another. Although codes 
that describe clinically similar services are sometimes stronger 
comparator codes, we do not agree that codes must share the same site 
of service, patient population, utilization level, or (in this case) 
number of times billable per day to serve as an appropriate crosswalk.
    We disagree that CPT code 36483 at a work RVU of 1.75 was the most 
accurate choice to use as a crosswalk for CPT code 93621; though this 
was the RUC's recommended work RVU, using it would have resulted in a 
substantial increase in intensity for CPT code 93621. We note that the 
CPT Editorial Panel did not revise the code descriptor for CPT code 
93621 and the two surveys conducted on this code (at the 2020 April and 
October RUC meetings) both indicated that the work time had decreased 
from 30 minutes to 20 minutes. While we recognize that there have been 
several changes in technique since CPT code 93621 was last surveyed in 
2001, we do not agree that these changes have resulted in a substantial 
increase in the intensity of the service, especially given that the 
work time typically required to perform the service has fallen by a 
third. We were also concerned that the intensity for add-on CPT code 
93621 would potentially be

[[Page 65108]]

higher than the base codes that it is reported with. Although we agree 
that this can occur in some rare cases, we continue to believe that it 
is more accurate to value CPT code 93621 at a work RVU of 1.50. Our 
proposed valuation represents a modest increase in intensity rather 
than the large increase in intensity resulting from the recommended 
work RVU of 1.75, which we believe more accurately captures the typical 
case for this service.
    After consideration of the comments, we are finalizing the proposed 
work RVU of 1.50 for CPT code 93621. The RUC did not recommend and we 
are not finalizing any direct PE inputs for CPT code 93621.
(33) Cardiac Ablation Services Bundling (CPT Codes 93653, 93654, 93655, 
93656, and 93657)
    The technologies and clinical practices associated with Cardiac 
Ablation Services have changed enough over the past decade (since 2011 
when they were first developed) that the specialty societies 
recommended referring theses codes to CPT Editorial Panel to have the 
code descriptors for Cardiac Ablation Services updated to create new 
and more complete descriptors reflecting the fact that many of these 
services are commonly performed together and should be incorporated and 
bundled. In October 2020, the CPT Editorial Panel revised the three 
existing cardiac ablation codes to be bundled with 3D mapping and to 
include ``induction or attempted induction of an arrhythmia with right 
atrial pacing and recording, and catheter ablation of arrhythmogenic 
focus,'' and ``left atrial pacing and recording from coronary sinus or 
left atrium'' and ``intracardiac echocardiography including imaging 
supervision and interpretation'' into their descriptors.
    A survey of the Cardiac Ablation Services was sent out using the 
newly revised CPT code descriptors asking cardiac electrophysiologists 
about the revised language in the existing CPT codes. From the survey 
results, the RUC advisory committee believes that many of the survey 
respondents may not have realized that the code descriptors had been 
substantially revised and that they may not have read the updated code 
descriptors thoroughly enough to understand that services that are 
separately billed, were now combined into the existing codes (since CPT 
did not issue new codes for the revised descriptors). The RUC 
recommended that these services be valued as interim to allow for re-
survey and subsequent review at the April 2021 RUC meeting.
    CPT code 93653 (Comprehensive electrophysiologic evaluation with 
insertion and repositioning of multiple electrode catheters, induction 
or attempted induction of an arrhythmia with right atrial pacing and 
recording, and catheter ablation of arrhythmogenic focus, including 
intracardiac electrophysiologic 3-dimensional mapping, right 
ventricular pacing and recording, left atrial pacing and recording from 
coronary sinus or left atrium, and His bundle recording, when 
performed; treatment of supraventricular tachycardia by ablation of 
fast or slow atrioventricular pathway, accessory atrioventricular 
connection, cavo-tricuspid isthmus or other single atrial focus or 
source of atrial re-entry) (previous work RVU of 14.75 with 000-day 
global) is now bundled with the add-on CPT codes 93613 (Intracardiac 
electrophysiologic 3-dimensional mapping (List separately in addition 
to code for primary procedure)) (work RVU of 5.23 with 90 minutes of 
intraservice time) and the add-on CPT code 93621 (Comprehensive 
electrophysiologic evaluation including insertion and repositioning of 
multiple electrode catheters with induction or attempted induction of 
arrhythmia; with left atrial pacing and recording from coronary sinus 
or left atrium (List separately in addition to code for primary 
procedure)) (work RVU of 2.10 with 30 minutes of intraservice time). 
The RUC-recommended work RVU for CPT code 93653 is 18.49, with 40 
minutes of preservice evaluation, 3 minutes of preservice positioning, 
15 minutes of preservice scrub/dress/wait time, 125 minutes of 
intraservice time and 30 minutes of immediate postservice time.
    Since the two add-on codes are combined with the primary CPT code 
93653, one would expect the intraservice time to have increased or 
remained similar to the current 180 minutes. Instead, the RUC-
recommended intraservice time has decreased to 125 minutes. Accounting 
for changes in technologies and clinical practices from over 10 years 
since this code family's last review, we will expect better 
efficiencies and reductions in work times, but with the addition of two 
add-on codes whose work is mostly, if not all, added to the 
intraservice time, one would not expect a net decrease in minutes. This 
is not what the collected responses from this survey show and it is a 
concern. Some of CPT code 93653 add-on service times may have shifted 
over to the increases in preservice times, but there does appear to be 
a collective misunderstanding in the survey's work RVUs and physician 
work time responses.
    In light of the RUC's intention to resurvey and re-review CPT code 
93653 (and this family of codes) at the April 2021 RUC meeting, and to 
resolve any flaws from the initial survey, such as survey respondents 
probably not realizing that a new descriptor describing the inclusion 
of services is now bundled to the existing CPT code (and not a newly 
issued CPT code), we proposed to maintain the current physician times 
and current work RVU of 14.75, until the AMA RUC returns with a more 
definitive and accurate valuation.
    For CPT code 93654 (Comprehensive electrophysiologic evaluation 
with insertion and repositioning of multiple electrode catheters, 
induction or attempted induction of an arrhythmia with right atrial 
pacing and recording, and catheter ablation of arrhythmogenic focus, 
including intracardiac electrophysiologic 3-dimensional mapping, right 
ventricular pacing and recording, left atrial pacing and recording from 
coronary sinus or left atrium, and His bundle recording, when 
performed; with treatment of ventricular tachycardia or focus of 
ventricular ectopy including left ventricular pacing and recording, 
when performed) (work RVU of 19.75), the RUC recommends 40 minutes of 
preservice evaluation, 3 minutes of preservice positioning, 20 minutes 
of preservice scrub/dress/wait time, 240 minutes of intraservice time 
and 33 minutes of immediate postservice time for a total of 336 
minutes, an increase to the code's current 309 total minutes. Unlike 
CPT codes 93653 and 93656, CPT code 93654 already accounts for the work 
RVUs and physician times for 3-dimensional mapping of add-on CPT code 
93613. The RUC recommended maintaining the current work RVU value of 
19.75. We proposed the RUC-recommended updates to the physician times 
(net increase in total minutes) and to maintain the same work RVUs for 
CPT code 93654 for CY 2022.
    CPT code 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)) has a current work RVU of 7.50 with a physician 
intraservice time of 90 minutes. The RUC recommended a revised 
intraservice time of 60 minutes and 6.50 work RVUs. The primary change 
to CPT code 93655 is the reduction of the intraservice time of

[[Page 65109]]

about 67 percent, which we use as a guide to determine a work RVU. We 
compare add-on CPT code 22854 (Insertion of intervertebral 
biomechanical device(s) (e.g., synthetic cage, mesh) with integral 
anterior instrumentation for device anchoring (e.g., screws, flanges), 
when performed, to vertebral corpectomy(ies) (vertebral body resection, 
partial or complete) defect, in conjunction with interbody arthrodesis, 
each contiguous defect (List separately in addition to code for primary 
procedure)) also with 60 minutes of intraservice and total time and a 
work RVU of 5.50 to CPT code 93655 and we believe that this is a more 
accurate valuation than the RUC's work RVU crosswalk to CPT code 34709 
(Placement of extension prosthesis(es) distal to the common iliac 
artery(ies) or proximal to the renal artery(ies) for endovascular 
repair of infrarenal abdominal aortic or iliac aneurysm, false 
aneurysm, dissection, penetrating ulcer, including pre-procedure sizing 
and device selection, all nonselective catheterization(s), all 
associated radiological supervision and interpretation, and treatment 
zone angioplasty/stenting, when performed, per vessel treated (List 
separately in addition to code for primary procedure)) with a work RVU 
of 6.50 and an intraservice and total time of 60 minutes because the 
proportional reduction in physician time should also reflect a similar 
proportional reduction in work RVUs. We proposed the RUC-recommended 60 
minutes of intraservice and total time, but instead proposed a work RVU 
of 5.50 for CPT code 93655.
    CPT code 93656 (Comprehensive electrophysiologic evaluation 
including transseptal catheterizations, insertion and repositioning of 
multiple electrode catheters with intracardiac catheter ablation of 
atrial fibrillation by pulmonary vein isolation, including intracardiac 
electrophysiologic 3-dimensional mapping, intracardiac echocardiography 
including imaging supervision and interpretation, induction or 
attempted induction of an arrhythmia including left or right atrial 
pacing/recording, right ventricular pacing/recording, and His bundle 
recording, when performed) is now bundled with the add-on CPT codes 
93613 (Intracardiac electrophysiologic 3-dimensional mapping (List 
separately in addition to code for primary procedure)) (work RVU of 
5.23 with 90 minutes of intraservice time) and the add-on CPT code 
93662 (Intracardiac echocardiography during therapeutic/diagnostic 
intervention, including imaging supervision and interpretation (List 
separately in addition to code for primary procedure) (work RVU 
currently carrier-priced with 25 minutes of intraservice time) which 
previously were separately reported add-on services, similar to above 
CPT code 93653 and its add-on codes.
    The RUC-recommended work RVU for CPT code 93656 is 20.00, with 40 
minutes of preservice evaluation, 3 minutes of preservice positioning, 
20 minutes of preservice scrub/dress/wait time, 210 minutes of 
intraservice time and 33 minutes of immediate postservice time, for a 
total of 306 minutes. The current physician times for CPT code 93656 
are 23 minutes of preservice evaluation, 1 minutes of preservice 
positioning, 5 minutes of preservice scrub/dress/wait time, 240 minutes 
of intraservice time, and 40 minutes of immediate postservice time, for 
a total of 309 minutes, which is a net difference of 3 minutes less in 
the total proposed minutes, and the RUC is recommending a work RVU of 
20.00, which is 0.23 more work RVUs than the current work RVU of 19.77.
    In light of the RUC's intention to resurvey and review CPT code 
93653 (and this family of codes) with its new bundling at their April 
2021 RUC meeting to resolve any flaws from the initial survey, where 
many of the survey respondents may not have realized that the code 
descriptors had been substantially revised and that they may not have 
read the updated code descriptors thoroughly enough to respond 
correctly, we believe CPT code 93656 is in the same situation with its 
new bundling thus, we proposed the RUC-recommended updates to the 
physician times (a net decrease of 3 minutes in total time) and to 
maintain the current work RVU of 19.77.
    From the survey of CPT code 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)), a value of 8.00 work RVUs was obtained at the 25th 
percentile for this add-on code. The RUC recommended a work RVU of 
6.50, for the 60 minutes of intraservice and total physician time. The 
current work RVU is 7.50, for 90 minutes of intraservice and total 
physician time.
    We compare add-on CPT code 22854 (Insertion of intervertebral 
biomechanical device(s) (e.g., synthetic cage, mesh) with integral 
anterior instrumentation for device anchoring (e.g., screws, flanges), 
when performed, to vertebral corpectomy(ies) (vertebral body resection, 
partial or complete) defect, in conjunction with interbody arthrodesis, 
each contiguous defect (List separately in addition to code for primary 
procedure)) with 60 minutes of intraservice and total time and 5.50 
work RVUs to CPT code 93657 and we believe that this is a more accurate 
valuation, since the primary change to CPT code 93657 is the reduction 
of the intraservice time of about 67 percent, which we use as a guide 
to determining a work RVU. The RUC-recommended work RVU is crosswalked 
from CPT code 34709 (Placement of extension prosthesis(es) distal to 
the common iliac artery(ies) or proximal to the renal artery(ies) for 
endovascular repair of infrarenal abdominal aortic or iliac aneurysm, 
false aneurysm, dissection, penetrating ulcer, including pre-procedure 
sizing and device selection, all nonselective catheterization(s), all 
associated radiological supervision and interpretation, and treatment 
zone angioplasty/stenting, when performed, per vessel treated (List 
separately in addition to code for primary procedure)) with a work RVU 
of 6.50 and an intraservice and total time of 60 minutes, does not 
reflect the proportional reductions to the intraservice time and work. 
For CPT code 93657, we proposed the RUC-recommended 60 minutes of 
intraservice and total time, and a work RVU of 5.50, crosswalked from 
CPT code 22854.
    There are no direct PE inputs for these facility-only CPT codes.
    Comment: In light of the proposed CY 2022 reductions in payment for 
the Cardiac Ablation codes, commenters were concerned that there will 
be fewer providers of these services, which could cause beneficiaries 
to encounter longer waits for atrial fibrillation treatments as there 
will be fewer Cardiac Electrophysiologists to treat them. Longer waits 
to schedule for the earliest treatments possible are the exact opposite 
scenario to be the most effective in prevent strokes, heart failures, 
acute myocardial infarctions, trachycardia, etc. Some commenters 
requested that CMS and the AMA RUC withdraw their restructuring of 
these codes in their bundling. Commenters explained that in the typical 
progression of Cardiac Ablation treatment services, procedures are 
employed in a series, that services are additive in nature, and that 
subsequent services selected by practitioners are dependent on the 
outcomes of the previous procedures. Different individual patients do 
not necessarily receive the same group of services in every session of 
treatment,

[[Page 65110]]

which is what the bundling of services describes.
    Response: We note that the restructuring of these procedures 
resulted from the AMA CPT deliberative process that CMS does not 
control. This restructuring was developed because of claims evidence 
showing that two or more procedures are observed occurring together on 
the same day, with the same practitioner, for the same beneficiary, 
frequently enough to justify a bundling of services under one new 
procedure code; the CPT panel decided to retain the old procedure code 
and only adjust its descriptor to include the new appended service. 
This appears to have created the misunderstanding with the survey 
respondents that yielded the flawed results and why the AMA RUC 
presented CMS with ``interim'' work RVUs rather than surveyed values. 
At this stage in the development of these codes, unbundling these 
services does not appear possible, so we have decided to maintain the 
current values where we can for another year, until we have new AMA RUC 
recommendations for next year, where stakeholders can comment further.
    Comment: Some commenters stated that since these Cardiac Ablation 
services were going to be reviewed, their work RVUs should be increased 
to reflect more physician time and increases in physician work and work 
intensities. Instead, code bundling has reduced total payments.
    Response: In consideration of concerns about a flaw in the original 
survey for these codes, CMS proposed to maintain the current work RVUs 
for some of the Cardiac Ablation services for CY 2022. We will re-
review the new and revised AMA RUC recommendations for these codes when 
they become available and will consider for future rulemaking.
    Comment: Commenters noted that the AMA RUC was aware of issues with 
the survey for these codes, but submitted work RVUs to CMS as 
recommended ``interim values''. Commenters noted that the AMA RUC 
informed CMS that they also intended to resurvey members of the 
American College of Cardiology & the Heart Rhythm Society, and to re-
review those new survey results in their April 2021 meeting. The new 
results were discussed at that meeting and the updated work RVUs were 
proposed for recommendation to CMS at the conclusion of that meeting. 
The AMA RUC has included those recommendations in comment, and urges 
CMS to implement those corrected work RVUs for CY 2022, replacing the 
``interim values'' first presented in January 2021.
    Response: Stakeholders are aware that in recent years CMS revised 
its review process to align with our rulemaking timelines and to allow 
for consistency and transparency throughout the process. We thank the 
commenters for providing us with information from the April 2021 AMA 
RUC meeting, but note that these values along with recommendations from 
the subsequent October 2021 and January 2022 AMA RUC meetings will be 
considered as part of our CY 2023 PFS rulemaking cycle.
    After consideration of comments on these Cardiac Ablation codes, we 
are finalizing all of the work RVUs as proposed. We did not propose and 
we are not finalizing any direct PE inputs for these facility-only 
codes.
(34) 3D Imaging of Cardiac Structures (CPT Code 93319)
    In May 2020, the CPT Editorial Panel created one new add-on code to 
describe the 3D echocardiographic imaging and postprocessing during 
transesophageal or transthoracic echocardiography for congenital 
cardiac anomalies for the assessment of cardiac structure(s). The 3D 
imaging could be performed as a follow-up to a 2D transthoracic 
echocardiogram.
    We proposed the RUC-recommended work RVU of 0.50 for CPT code 93319 
(3D echocardiographic imaging and postprocessing during transesophageal 
echocardiography, or during transthoracic echocardiography for 
congenital cardiac anomalies, for the assessment of cardiac 
structure(s) (e.g., cardiac chambers and valves, left atrial appendage, 
interatrial septum, interventricular septum) and function, when 
performed (List separately in addition to code for echocardiographic 
imaging).
    While we proposed no refinements to the direct PE inputs, we 
requested additional information about the 3D echocardiography probe 
equipment item. The RUC recommended that a 3D probe was required in 
addition to the base echocardiography machine. We received an invoice 
for $31,754.30 for this equipment item. It was unclear if the invoice 
reflected both the 3D probe and the base echocardiography machine or 
only the probe itself. We solicited additional information to know if 
this equipment item reflected both the 3D probe and the base 
echocardiography machine or only the probe.
    Comment: Several commenters stated that they supported the proposal 
of the RUC-recommended work RVU of 0.50 for CPT code 93319.
    Response: We appreciate the support for our proposed work RVU from 
the commenters.
    Comment: A commenter stated that they had reviewed the submitted 
invoice and was able to confirm that the proposed price of $31,754.30 
is for the 3D echocardiography probe (ER121) itself, not any other 
equipment. Another commenter agreed that the $31,754.30 cost on the 
submitted invoice was for the probe itself and stated that they were 
including additional invoices which reflected a range of costs between 
$34,678.00 to $36,556.44 for 3D probes to support this pricing.
    Response: We appreciate the clarification of the pricing on the 
submitted invoice from the commenters. Unfortunately, we were unable to 
find the additional invoices mentioned by the commenter in their 
submission, and therefore, we were unable to review them for the stated 
range of costs between $34,678.00 to $36,556.44. Commenters are 
encouraged to submit invoices with their public comments or, if outside 
the notice and comment rulemaking process, via email at 
[email protected].
    After consideration of the comments, we are finalizing the proposed 
work RVU of 0.50 and the proposed direct PE inputs for CPT code 93319. 
We are also finalizing the proposed price of $31,754.30 for the 3D 
echocardiography probe (ER121) equipment.
(35) Cardiac Catheterization for Congenital Defects (CPT Codes 93593, 
93594, 93595, 93596, 93597, and 93598)
    In May 2020, the CPT Editorial Panel replaced a family of four 
cardiac catheterization codes with five new codes (CPT codes 93593-
93597) to describe cardiac catheterization for congenital cardiac 
defect(s). The CPT Editorial Panel also replaced two cardiac output 
measurement codes with one new add-on code (CPT code 93598) to report 
cardiac output measurement(s), performed during cardiac catheterization 
for congenital cardiac defects.
    We proposed the RUC-recommended work RVU for two of the codes in 
this family. We proposed a work RVU of 3.99 for CPT code 93593 (Right 
heart catheterization for congenital heart defect(s) including imaging 
guidance by the proceduralist to advance the catheter to the target 
zone; normal native connections) and a work RVU of 6.10 for CPT code 
93594 (Right heart catheterization for congenital heart defect(s) 
including imaging guidance by the proceduralist to advance the catheter 
to the target zone; abnormal native connections) as recommended by the 
RUC in both cases.
    For CPT code 93595 (Left heart catheterization for congenital heart

[[Page 65111]]

defect(s) including imaging guidance by the proceduralist to advance 
the catheter to the target zone, normal or abnormal native 
connections), we disagree with the RUC-recommended work RVU of 6.00 and 
we instead proposed a work RVU of 5.50 based on a crosswalk to CPT code 
32607 (Thoracoscopy; with diagnostic biopsy(ies) of lung infiltrate(s) 
(e.g., wedge, incisional), unilateral). CPT code 32607 is a thorascopy 
procedure with three fewer minutes of intraservice work time (45 
minutes) than CPT code 93595 but a higher total work time of 178 
minutes. CPT code 93595 has similar surveyed work time to CPT code 
93593 but the RUC recommended a work RVU of 3.99 for the first code in 
the family as compared to 6.00 for CPT code 93595. While we agree that 
CPT code 93595 is a more intensive procedure, we do not agree that it 
should be valued more than two full RVUs higher as compared to the 
first code in the family. We believe that it will be more accurate to 
propose a work RVU of 5.50 based on the aforementioned crosswalk to CPT 
code 32607. We note that the intensity of CPT code 93595 remains higher 
than the first two codes in the family at the proposed work RVU of 
5.50.
    For CPT code 93596 (Right and left heart catheterization for 
congenital heart defect(s) including imaging guidance by the 
proceduralist to advance the catheter to the target zone(s); normal 
native connections), we disagree with the RUC-recommended work RVU of 
7.91 and we instead proposed a work RVU of 6.84 based on a crosswalk to 
CPT code 32608 (Thoracoscopy; with diagnostic biopsy(ies) of lung 
nodule(s) or mass(es) (e.g., wedge, incisional), unilateral). CPT code 
32608 is another thorascopy procedure from the same family as CPT code 
32607, with the same 60 minutes of intraservice work time as CPT code 
93596 and a higher total work time of 195 minutes. In the same fashion 
as the previous code, CPT code 93596 has similar surveyed work time to 
CPT code 93594 but the RUC recommended a work RVU of 6.10 for the 
second code in the family as compared to 7.91 for CPT code 93596. While 
we agree that CPT code 93596 is a more intensive procedure, we do not 
agree that it should be valued almost two full RVUs higher as compared 
to the second code in the family. We believe that it will be more 
accurate to propose a work RVU of 6.84 based on the aforementioned 
crosswalk to CPT code 32608. We note that the intensity of CPT code 
93596 remains the highest among the first four codes in the family at 
the proposed work RVU of 6.84. We believe that our proposed RVUs for 
CPT codes 93595 and 93596 better preserve relativity both within the 
family and also with other services on the PFS.
    For CPT code 93597 (Right and left heart catheterization for 
congenital heart defect(s) including imaging guidance by the 
proceduralist to advance the catheter to the target zone(s); abnormal 
native connections), we disagree with the RUC-recommended work RVU of 
9.99 and we instead proposed a work RVU of 8.88 based on the median 
work RVU from the survey. The RUC's recommendation of a work RVU of 
9.99, based on maintaining the prior work RVU of deleted CPT code 93532 
(Combined right heart catheterization and transseptal left heart 
catheterization through intact septum with or without retrograde left 
heart catheterization, for congenital cardiac anomalies), was nearly 
equal to the 75th percentile work RVU from the survey at 10.00. Since 
the RUC recommended the survey median work RVU for the other four non-
measurement codes in the family, we do not understand the 
recommendation of a value for CPT code 93597 that sits within 0.01 RVUs 
of the survey 75th percentile. The survey for CPT code 93597 also 
revealed that it typically requires far less work time to perform as 
compared with predecessor code 93532 (83 minutes of intraservice work 
time as compared to 175 minutes for the predecessor code). Although we 
agree that CPT code 93597 is a more intensive procedure than its 
predecessor code, we do not believe that the work RVU should remain 
unchanged given the greatly reduced work time in the new procedure. 
Since the two components of work are time and intensity, we believe 
that decreases in time should typically be reflected in decreases to 
work RVUs. Therefore, we proposed a work RVU of 8.88 for CPT code 93597 
based on the survey median outcome. We believe that our proposed RVU 
more accurately accounts for these changes in surveyed work time and 
better preserves relativity with the rest of the family.
    For CPT code 93598 (Cardiac output measurement(s), thermodilution 
or other indicator dilution method, performed during cardiac 
catheterization for the evaluation of congenital heart defects), we 
disagree with the RUC-recommended work RVU of 1.75 and we instead 
proposed a work RVU of 1.44 based on a crosswalk to CPT code 37253 
(Intravascular ultrasound (noncoronary vessel) during diagnostic 
evaluation and/or therapeutic intervention, including radiological 
supervision and interpretation; each additional noncoronary vessel). 
CPT code 37253 is an intravascular ultrasound procedure that shares the 
same intraservice work time of 20 minutes as CPT code 93598 and has 1 
additional minute of immediate postservice time. We note that the 
intensity of CPT code 93598 as recommended by the RUC at a work RVU of 
1.75 will be the second-highest in the family, higher than CPT code 
93597 for example. We do not agree that this cardiac output measurement 
code will typically be more intensive to perform than the two types of 
heart catheterization taking place in CPT code 93597.
    We also note that the recommended work RVU for CPT code 93598 was 
higher than the sum of its two predecessor codes. Former CPT codes 
93561 (Indicator dilution studies such as dye or thermodilution, 
including arterial and/or venous catheterization; with cardiac output 
measurement) and 93562 (Indicator dilution studies such as dye or 
thermodilution, including arterial and/or venous catheterization; 
subsequent measurement of cardiac output) had CY 2021 work RVUs of 0.95 
and 0.77 respectively. These two codes sum together to a work RVU of 
1.72 which will be lower than the RUC's recommendation of 1.75 for CPT 
code 93598. The RUC's recommendation suggests that there will be no 
efficiencies gained or savings created in the process of creating CPT 
code 93598; we believe that the survey for the new code indicates 
otherwise, as the predecessor codes had work times of 15 minutes and 12 
minutes respectively (27 minutes total) as compared to 20 minutes of 
surveyed work time for the new code. This lower work time suggests that 
the creation of CPT code 93598 has led to greater efficiencies in the 
service which, under the resource-based nature of the RVU system, lends 
further support for a reduction in the work RVU as compared to a sum of 
the predecessor codes. Therefore, we believe that it will be more 
accurate to a work RVU of 1.44 based on the aforementioned crosswalk to 
CPT code 37253.
    The RUC did not recommend any direct PE inputs for these six codes 
and we did not propose any direct PE inputs.
    Comment: Several commenters disagreed with the proposed valuation 
for the codes in the Cardiac Catheterization for Congenital Defects 
family. Commenters stated that CMS did not address compelling evidence 
for these services. Commenters stated that CMS dismisses the fact that 
services may change due to technological

[[Page 65112]]

advances, changes in the patient population, shifts in the specialty of 
physicians providing services or changes in the physician work or 
intensity required to perform services, and CMS only proposes blanket 
reductions instead of considering how a service may have changed or 
increased. Commenters requested that CMS address the compelling 
evidence that was submitted with the RUC recommendations when the 
agency does not propose the RUC's recommended values.
    Response: As we stated under Methodology for Establishing Work RVUs 
near the beginning of this Valuation of Specific Codes section, 
compelling evidence is a concept developed by the RUC for its review 
process. Compelling evidence is not part of our statutory framework 
which requires that the valuation of codes be based on time and 
intensity. We do consider changes in technology, patient population, 
etc. insofar as they affect the time and intensity of the service under 
review. The RUC's criteria for compelling evidence may overlap with our 
statutory requirement to value services based on time and intensity; 
for example, new technology may cause a service to become easier or 
more difficult to perform, with corresponding effects on the time and 
intensity of the service. However, we are under no obligation to 
specifically address the RUC's compelling evidence criteria in our 
rulemaking since it is outside the purview of the code valuation 
process stipulated by statute. In the context of the codes in the 
Cardiac Catheterization for Congenital Defects family, we discussed the 
intensity of the new services at length in the proposed rule, which 
includes changes that may have been due to technological advances, 
patient population, etc.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 5.50 for CPT code 93595 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 6.00. Commenters stated that 
it was unclear what criteria CMS used to reject the RUC recommendation 
or to select CPT code 32607 as a direct crosswalk. Commenters stated 
that CMS did not provide any clinical foundation for their proposed 
alternate value, did not seem to consider the compelling evidence 
provided in the RUC rationale, and made no acknowledgement that this 
service is typically for pediatric patients with congenital cardiac 
defects.
    Response: As we stated in the proposed rule, CPT code 32607 is a 
thorascopy procedure with three fewer minutes of intraservice work time 
(45 minutes) than CPT code 93595 but a higher total work time of 178 
minutes. We believe that the close match in work times between CPT 
codes 93595 and 32607 makes our proposed crosswalk the most accurate 
choice for valuing CPT code 93595, and also better preserves relativity 
within this family of codes as compared to the RUC's recommendation of 
the survey median work RVU. In more general terms, we continue to 
believe that the nature of the PFS relative value system is such that 
all services are appropriately subject to comparisons to one another. 
Although codes that describe clinically similar services are sometimes 
stronger comparator codes, we do not agree that codes must share the 
same site of service, patient population, or utilization level to serve 
as an appropriate crosswalk. We are aware that the codes in this family 
are typically performed on pediatric patients with congenital cardiac 
defects but this in no way exempts them from comparisons to other 
services on the PFS, each of which has patient populations with their 
own associated risks. We also note that the crosswalk codes recommended 
by the RUC for valuation do not always describe clinically similar 
services, including within this very code family. The RUC recommended 
using a crosswalk to CPT code 36483 to value CPT code 93598 at a work 
RVU of 1.75, even though the former code describes endovenous ablation 
therapy of an incompetent vein while the latter code describes cardiac 
output measurement(s) performed during cardiac catheterization.
    Comment: Several commenters stated that the CMS proposed value for 
CPT code 93595 would produce a rank order anomaly between CPT codes 
93595 and 93594 as the difference in intensities between these two 
services would not be appropriately reflected. Commenters stated that 
risk of arterial catheterization is always high due to risks of stroke, 
bleeding into the brain for infants on heparin, and femoral artery 
injury for infants. Commenters stated that for an abnormal connection 
patient, the procedure is more complex, as doctors are now facing 
crossing arterial shunts or the patent ductus arteriosus (PDA) to 
evaluate the pulmonary arteries, or evaluating other vascular 
structures like major aortopulmonary collateral arteries (MAPCAs), 
which can be multiple. Commenters stated that these procedures require 
a significantly greater level of diagnostic evaluation, catheter and 
wire manipulation, and angiography to identify each and every vessel 
for surgical planning than previously afforded with the non-congenital 
diagnostic codes, and that due to this the physician work intensity is 
very high.
    Response: We agree with the commenters that the catheterization 
services described by CPT code 93595 represent an intensive procedure, 
which is why we proposed a work RVU of 5.50. We agree with the 
commenters that this code should be valued at a higher intensity than 
CPT code 93594, which is why we proposed CPT code 93595 at a higher 
intensity. We do not agree that our proposed valuation creates a rank 
order anomaly, however; as we stated in the proposed rule, we do not 
agree that CPT code 93595 should be valued more than two full RVUs 
higher as compared to the first code in the family. We believe that the 
RUC's recommended work RVU of 6.00 would do more to create rank order 
anomalies within the family, as CPT code 93595 would be valued almost 
identically to CPT code 93594 (6.00 as compared to 6.10) despite having 
12 minutes fewer of intraservice work time (48 minutes as compared to 
60 minutes). At the RUC's recommended work RVU of 6.00, CPT code 93595 
would also be valued 2.01 RVUs higher than the work RVU of 3.99 for CPT 
code 93593 despite having only 3 additional minutes of intraservice 
work time (48 minutes as compared to 45 minutes). While we agree that 
CPT code 93595 is a more intensive code than the first two codes in the 
family, and we therefore proposed a higher intensity for the code, we 
do not agree that this intensity is so high as to merit the RUC-
recommended work RVU of 6.00.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 6.84 for CPT code 93596 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 7.91. Commenters again stated 
that CMS does not provide any clinical foundation for their proposed 
crosswalk to CPT code 32608, did not seem to consider the compelling 
evidence provided in the RUC rationale, and made no acknowledgement 
that this service is typically for pediatric patients with congenital 
defects. Commenters stated that the proposed work RVU would assign CPT 
code 93596 an intensity that is substantially lower than the top two 
key reference codes from the survey, even though 3/4ths of the survey 
respondents that selected those top reference codes indicated that the 
survey code was a more intense service than either reference code.
    Response: As we stated above in the case of CPT code 93595, we 
believe that the close match in work times between

[[Page 65113]]

CPT codes 93596 and 32608 makes our proposed crosswalk the most 
accurate choice for valuing CPT code 93596, and also better preserves 
relativity within this family of codes than the RUC's recommendation of 
the survey median work RVU. We direct readers to our previous 
discussion of compelling evidence and clinical similarity between 
crosswalk codes addressed above. With regards to the two reference 
codes from the survey (CPT codes 93460 and 93461), commenters stated 
that the proposed work RVU of 6.84 would assign CPT code 93596 a lower 
intensity than both reference codes. However, the RUC's recommended 
work RVU of 7.91 for CPT code 93596 also assigns a lower intensity than 
the two reference codes, which indicates that the RUC also believed 
that CPT code 93596 was appropriately valued at a lower intensity 
despite what the survey respondents may have indicated. As we stated in 
the proposed rule, while we agree that CPT code 93596 is a more 
intensive procedure, we do not agree that it should be valued almost 
two full RVUs higher as compared to the second code in the family. 
Commenters did not provide a rationale in their submissions as to why 
CPT code 93596 should be valued so much higher than CPT code 93594. We 
again note that the intensity of CPT code 93596 remains the highest 
among the first four codes in the family at the proposed work RVU of 
6.84 and we continue to believe that our proposed RVUs for CPT codes 
93595 and 93596 better preserve relativity both within the family and 
also with other services on the PFS.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 8.88 for CPT code 93597 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 9.99. Commenters stated that 
CMS did not provide any clinical foundation for their proposed 
alternate value, did not seem to consider the compelling evidence 
provided in the RUC rationale, and made no acknowledgement that this 
service is typically for pediatric patients with congenital defects. 
Commenters stated that the proposed work RVU would assign this service 
a similar intensity to CPT code 93596, even though CPT code 93597 is 
for a more complex patient with an abnormal native connection.
    Response: We did not provide a clinical foundation for the proposed 
work RVU of 8.88 because it was taken from the survey median value; we 
believe that the commenters may have confused our proposed valuation of 
CPT code 93597 with the other codes in this family where we employed a 
crosswalk methodology. We direct readers again to our previous 
discussion of compelling evidence and clinical similarity between 
crosswalk codes addressed above. We agree with the commenters that our 
proposed work RVU of 8.88 would assign CPT code 93597 a similar 
intensity to CPT code 93596. However, we believe that this is 
appropriate because the RUC also recommended a similar intensity 
between the two codes in its own recommendations. The RUC recommended a 
difference in intensity of 0.003 between the two codes while we 
proposed a difference in intensity of 0.002; we believe that this 
provides strong evidence that we are maintaining the relationship 
between these two codes as recommended by the RUC.
    We stated in the proposed rule that the RUC's recommendation of a 
work RVU of 9.99, based on maintaining the prior work RVU of deleted 
CPT code 93532, was nearly equal to the 75th percentile work RVU from 
the survey at 10.00. Since the RUC recommended the survey median work 
RVU for the other four non-measurement codes in the family, we did not 
understand the recommendation of a value for CPT code 93597 that sits 
within 0.01 RVUs of the survey 75th percentile. We noted that the 
survey for CPT code 93597 also revealed that it typically requires far 
less work time to perform as compared with predecessor code 93532 (83 
minutes of intraservice work time as compared to 175 minutes for the 
predecessor code), and although we agreed that CPT code 93597 is a more 
intensive procedure than its predecessor code, we did not believe that 
the work RVU should remain unchanged given the greatly reduced work 
time in the new procedure. Commenters did not address these topics that 
we raised in the proposed rule and did not explain why CPT code 93597 
should be valued within 0.01 RVUs of the survey 75th percentile and 
should maintain the valuation of its predecessor code despite requiring 
substantially less work time to perform. We continue to believe that 
our proposed RVU of 8.88 more accurately accounts for these changes in 
surveyed work time and better preserves relativity with the rest of the 
family.
    Comment: Several commenters disagreed with the CMS proposed work 
RVU of 1.44 for CPT code 93598 and stated that CMS should instead 
finalize the RUC-recommended work RVU of 1.75. Commenters stated that 
CMS did not provide any clinical foundation for their proposed 
alternate value, did not seem to consider the compelling evidence 
provided in the RUC rationale, and made no acknowledgement that this 
service is typically for pediatric patients with congenital defects. 
Commenters stated that the crosswalk code used for valuing CPT code 
93598 (CPT code 37253) is a relatively less intense and less risky 
service typically performed in the lower extremity of an adult patient, 
making it an inappropriate crosswalk. Commenters stated that CPT code 
93598 is a more intense service typically performed on a more complex 
pediatric patient, where a Swan Ganz catheter is introduced from the 
venous sheath, advanced through the right heart, and placed into the 
pulmonary artery for purpose of assessing cardiac output by 
thermodilution.
    Response: As we stated above in the case of CPT codes 93595 and 
93596, we believe that the close match in work times between CPT codes 
93598 and 37253 makes our proposed crosswalk the most accurate choice 
for valuing CPT code 93598, and also better preserves relativity within 
this family of codes than the RUC's recommendation of a crosswalk to 
CPT code 36483. All three of these codes in question (93598 and the two 
crosswalks to 37253 and 36483) share the identical intraservice work 
time of 20 minutes, however we believe that our proposed crosswalk to 
CPT code 37253 is a more accurate choice for valuation. As we stated in 
the proposed rule, the intensity of CPT code 93598 as recommended by 
the RUC at a work RVU of 1.75 would be the second highest in the 
family, higher than CPT code 93597 for example. We do not agree that 
this cardiac output measurement code would typically be more intensive 
to perform than the two types of heart catheterization taking place in 
CPT code 93597. We also noted in the proposed rule that the recommended 
work RVU for CPT code 93598 was higher than the sum of its two 
predecessor codes (CPT codes 93561 and 93562) which had CY 2021 work 
RVUs of 0.95 and 0.77 respectively. These two codes sum together to a 
work RVU of 1.72 which would be lower than the RUC's recommendation of 
1.75 for CPT code 93598. We noted in the proposed rule that the RUC's 
recommendation suggested that there would be no efficiencies gained or 
savings created in the process of creating CPT code 93598, which the 
surveyed work times for the new code indicated otherwise. Commenters 
did not address these topics that we raised in the proposed rule and 
did not explain why CPT code 93598 should have the second-highest 
intensity in the family or why CPT code 93598 should be valued higher 
than the sum of its two predecessor codes. We therefore continue to 
believe a work

[[Page 65114]]

RVU of 1.44 for CPT code 93598 would be more accurate, based on the 
aforementioned crosswalk to CPT code 37253.
    After consideration of the comments, we are finalizing our proposed 
work RVUs for all six codes in the Cardiac Catheterization for 
Congenital Defects family. The RUC did not recommend any direct PE 
inputs for these six codes and we are not finalizing any direct PE 
inputs.
(36) Outpatient Pulmonary Rehabilitation Services (CPT Codes 94625 and 
94626)
    CPT code 94625 (Physician or other qualified health care 
professional services for outpatient pulmonary rehabilitation; without 
continuous oximetry monitoring (per session)) and CPT code 94626 
(Physician or other qualified health care professional services for 
outpatient pulmonary rehabilitation; with continuous oximetry 
monitoring (per session) (Do not report 94625, 94626 in conjunction 
with 94760, 94761)) are two new codes created by the CPT Editorial 
Panel to replace HCPCS G code G0424 (Pulmonary rehabilitation, 
including exercise (includes monitoring), one hour, per session, up to 
two sessions per day), which was created by CMS in 2010. The RUC-
recommended work RVUs for CPT codes 94625 and 946226 were 0.55 and 
0.69, respectively.
    We disagreed with the RUC-recommended work RVUs for both CPT code 
94625 and 94626. Although the pulmonary rehabilitation services as 
described did not change, the RUC recommended an increase in 
intraservice work time for the services.
    Based upon a comparison of intraservice time for the current HCPCS 
code G0424 relative to the RUC-recommended values, we proposed a work 
RVU of 0.36 for CPT code 94625 and a work RVU of 0.56 for CPT code 
94626, both of which represent an increase to the work RVUs from the 
current HCPCS code G0424, the code that these two new codes are 
replacing. Our proposed RVU values reflect a commensurate increase in 
work relative to the increase in intraservice time.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Provide education/obtain consent'' (CA011) activity from 
the RUC-recommended 15 minutes to 2 minutes for both CPT codes 94625 
and 94626. The recommended activities for the two codes include 15 
minutes for the CA011 activity used for education. Education is 
provided at each session and according to RUC documents follows a 
curriculum outlined in the pulmonary rehabilitation guidelines.
    We disagreed that it would be typical for CPT codes 94625 and 94626 
to require an additional 13 minutes for education and consent given 
that the patient is seen two or three times a week for pulmonary 
rehabilitation and the educational activities are covered during those 
sessions. We stated that the educational activities would be done 
during the ``Perform procedure/service--NOT directly related to 
physician work time'' (CA021). Thus, we refined the clinical labor time 
to 2 minutes for both CPT codes 94625 and 94626 to maintain relativity, 
particularly in light of the clinical similarities between the 
services.
    We also proposed to refine the equipment time by lowering the pulse 
oximeter w-printer (EQ211) and exercise equipment (treadmill, bike, 
stepper, UBE, pulleys, balance board) (EQ118) equipment times from 93 
minutes to 80 minutes to match the change in clinical labor time for 
CPT codes 94625 and 94626.
    Finally, we proposed to revise the utilization that is used to set 
rates for CPT code 94626 to reflect our understanding that pulmonary 
rehabilitation is always done with pulse oximetry. Thus, we proposed to 
update our analytic crosswalk to reflect our belief that 100 percent of 
the utilization for the pulmonary rehabilitation services currently 
billed using HCPCS code G0424 will now be billed using CPT code 94626. 
We stated that it is unlikely that the outpatient pulmonary 
rehabilitation services would be billed using CPT code 94625 because it 
is our understanding that pulmonary rehabilitation is typically 
provided with pulse oximetry, and therefore, we expected little or no 
utilization for CPT code 94625. We sought comment from stakeholders on 
our proposal to revise the utilization as stated.
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters expressed concern about the values we proposed 
for the two new outpatient pulmonary rehabilitation codes. They stated 
HCPCS G0424 is not the same service as the two new codes, therefore, 
the intraservice work should not be compared to HCPCS G0424. Commenters 
noted that the more recently developed clinical guidelines for 
pulmonary rehabilitation were not captured or valued in HCPCS code 
G0424. Additionally, the commenters stated that the valuation of HCPCS 
G0424 was based upon incorrect assumptions/flawed methodology of the 
CMS/Other valuation because the code was not surveyed by pulmonary 
medicine physicians.
    Response: We appreciate the concerns of commenters. We understand 
from stakeholders that the services of the two new CPT codes are not 
described exactly the same as the service of HCPCS code G0424. We also 
understand that commenters found our approach to valuing the new codes, 
by using the current value of HCPCS G0424, flawed. We continue to 
believe, however, that the services of all the codes remain 
fundamentally the same, and as such, our use of time ratios is an 
appropriate method for identifying potential work RVUs for particular 
PFS services, especially when alternative recommended values do not 
provide a rationale for the need for additional time. Our review of the 
recommended work RVUs and time inputs included, but was not limited to, 
a review of information provided by the RUC, 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 assessed the methodology and data 
used to develop the recommendations submitted to us by the RUC and the 
rationale for the recommendations.
    Comment: A couple of commenters stated that pulse oximetry may be 
assessed intermittently, as needed, or continuously.
    Response: We thank the commenters for their insights into the 
utilization of the two codes and will consider this information going 
forward.
    After consideration of the comments, we are finalizing the proposed 
values for CPT codes 94625 and 94626 and will delete HCPCS code G0424. 
We are also finalizing the proposed refinements to the direct PE inputs 
and our proposal to update our analytic crosswalk to reflect our belief 
that 100 percent of the utilization for the pulmonary rehabilitation 
services currently billed using HCPCS code G0424 will now be billed 
using CPT code 94626.
(37) Remote Therapeutic Monitoring/Treatment Management (CPT Codes 
98975, 98976, 98977, 98980, and 98981)
    Remote Therapeutic Monitoring (RTM) is a family of five codes 
created by the CPT Editorial Panel in October 2020 and valued by the 
RUC at its January 2021 meeting. The RTM family includes three PE-only 
codes and two codes that include professional work.
    In recent years, we have finalized seven codes in the Remote 
Physiological Monitoring (RPM) family that include

[[Page 65115]]

services similar to the new RTM codes. (See the CY 2021 PFS final rule 
at 85 FR 84542 through 84546 for more information.) Based upon our 
analysis, the services and code structure of RTM resemble those of RPM. 
For example, the RTM codes reflect similar staff and physician work, 
although the specific equipment used is different because the data 
being monitored are non-physiologic rather than physiologic as they are 
with RPM.
    While there are notable similarities between the two sets of code 
descriptors, there are two primary differences. One difference, based 
upon our review of the RUC-recommended valuation materials for these 
codes, is that the primary billers of RTM codes are projected to be 
physiatrists, NPs, and physical therapists. Stakeholders have suggested 
that the new RTM coding was created to allow practitioners who cannot 
bill RPM codes, to furnish and bill for services that are similar to 
those described by the RPM codes. RPM services are considered to be E/M 
services and physical therapists, for example, are not permitted to 
furnish E/M services. In the CY 2020 PFS final rule, we designated the 
two RPM treatment codes (that is, CPT codes 99457 and 99458) as care 
management services (84 FR 62697 through 62698). We designated the 
incident to services in the RPM treatment management codes as care 
management services. As care management services, the clinical labor in 
the PE of the two RPM treatment management codes, CPT codes 99457 and 
99458, can be provided under general supervision rather than direct 
supervision, as required for incident to services.
    In our review of the new RTM codes for the proposed rule, we stated 
that we had identified an issue that we believed would disallow 
therapists and other qualified healthcare professionals from billing 
the RTM codes. Specifically, we were concerned that by modeling the new 
RTM codes on the RPM codes, the clinical labor that is part of the 
direct PE of the PE only code CPT code 98975, as well as the two 
professional work codes, CPT codes 98980 and 98981, could be viewed as 
clinical labor incident to the professional services of the billing 
practitioner. It has been our understanding that there is no incident 
to benefit for therapists (that is, physical therapists, occupational 
therapists, and speech-language pathologists). As a result, we sought 
public comment on how we might remedy the issues related to the RTM 
code construction in order to permit practitioners who are not 
physicians or NPPs to bill and be paid for furnishing RTM services.
    The second primary difference between the RTM and RPM codes is the 
nature of the data to be collected and how the data are collected. 
According to the code descriptors, RTM codes monitor health conditions, 
including musculoskeletal system status, respiratory system status, 
therapy (for example, medication) adherence, and therapy (for example, 
medication) response, and as such, allow non-physiologic data to be 
collected. Reportedly, RTM data can be patient reported, as well as 
digitally uploaded while RPM requires that data be physiologic and be 
digitally uploaded. We note that, for both sets of 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). We sought 
public comment on the typical type of device(s) and associated costs of 
the device(s) that might be used to collect the various kinds of data 
included in the code descriptors (that is, what devices would be used 
to collect data to monitor respiratory system status, musculoskeletal 
status, medication adherence, pain) for the RTM services.
    Based upon our review of the RUC recommendations for these codes, 
we proposed the RUC-recommended work RVU of 0.62 for CPT code 98980 
(Remote therapeutic monitoring treatment management services, 
physician/other qualified health care professional time in a calendar 
month requiring at least one interactive communication with the 
patient/caregiver during the calendar month; first 20 minutes) and the 
RUC-recommended work RVU of 0.61 for its add-on code, CPT code 98981 
(Remote therapeutic monitoring treatment management services, 
physician/other qualified health care professional time in a calendar 
month requiring at least one interactive communication with the 
patient/caregiver during the calendar month; each additional 20 minutes 
(List separately in addition to code for primary procedure)) as a means 
of maintaining parity with the two RPM treatment management codes (CPT 
codes 99457 and 99458) upon which the two RTM codes are based. We 
proposed the RUC-recommended direct PE inputs for the two treatment 
management codes, CPT codes 98980 and 98981, without refinement.
    We proposed to refine the direct PE inputs for the three PE-only 
RTM codes: CPT code 98975 (Remote therapeutic monitoring (e.g., 
respiratory system status, musculoskeletal system status, therapy 
adherence, therapy response); initial set-up and patient education on 
use of equipment), CPT code 98976 (Remote therapeutic monitoring (e.g., 
respiratory system status, musculoskeletal system status, therapy 
adherence, therapy response); device(s) supply with scheduled e.g., 
daily) recording(s) and/or programmed alert(s) transmission to monitor 
respiratory system, each 30 days), and CPT code 98977 (Remote 
therapeutic monitoring (e.g., respiratory system status, 
musculoskeletal system status, therapy adherence, therapy response); 
device(s) supply with scheduled (e.g., daily) recording(s) and/or 
programmed alert(s) transmission to monitor musculoskeletal system, 
each 30 days). We proposed to value the PE for CPT code 98975 by 
crosswalking to the PE RVU for RPM code 99453 upon which the new RTM 
code was based. We also proposed to value the PE for CPT codes 98976 
and 98977 by crosswalking to the PE RVU for comparable RPM code 99454, 
a code that includes payment for the medical device used to collect and 
transmit data. We noted that the only input to CPT code 98976 is a 
monthly fee of $25, which would not be paid as a direct cost under the 
PFS. Historically, we have considered most computer software and 
associated licensing fees to be indirect costs. However, as we noted in 
section II.B. of this final rule (the PE section), stakeholders have 
routinely expressed concern with this policy, especially for evolving 
technologies that rely primarily on software and licensing fees with 
minimal costs in equipment or hardware. As noted in that section of 
this rule, CMS continues to consider how best to reflect such costs 
under our current PE methodology.
    We received many comments from interested stakeholders regarding 
our requests and proposal related to the new Remote Therapeutic 
Monitoring/Treatment Management codes.
    Comment: The majority of commenters disagreed with our 
determination that physical therapists are not permitted to bill remote 
therapeutic monitoring codes. They stated that although the services 
may be performed incident to the services of a billing physician or 
practitioner, they would not represent ``incident to'' services when 
billed by physical therapists. Commenters encouraged us to reevaluate 
our interpretation of the codes to permit physical therapists to bill 
and be paid for these services.
    Response: We appreciate the insights of the commenters and 
understand their concerns. We agree that the new RTM codes are general 
medicine codes. However, we continue to be concerned about the 
construction of the codes.

[[Page 65116]]

    We questioned in the proposed rule whether the RTM codes as 
constructed could be used by therapists because the Medicare benefit 
does not include services provided incident to the services of a 
therapist. We viewed the clinical labor described in the RTM codes as 
being services incident to the billing practitioner's professional 
services. In the proposed rule, we focused on therapists as providers 
of RTM services because we heard from stakeholders that the codes were 
developed in response to the needs of physical therapists. We note 
here, however, that speech-language pathologists, clinical social 
workers, registered dietitians, nutrition professionals, and CRNAs also 
have Medicare benefits that do not include incident to services.
    Despite our concerns about the construction of the codes, we 
believe the services described by the codes are important to 
beneficiaries. Thus, we are finalizing a policy that permits therapists 
and other qualified healthcare professionals to bill the RTM codes as 
described. However, where the practitioner's Medicare benefit does not 
include services furnished incident to their professional services, the 
items and services described by these codes must be furnished directly 
by the billing practitioner or, in the case of a PT or OT, by a therapy 
assistant under the PT's or OT's supervision.
    Comment: Some commenters recommended that we implement the new RTM 
codes as constructed so that non-physicians who cannot bill E/M 
services can bill for RTM services.
    Response: We thank commenters for their recommendation.
    Comment: Commenters identified various issues with the proposed RTM 
codes and offered solutions. For example, commenters described a 
problem with supervision of clinical staff activities. Stakeholders 
noted that the clinical labor in the direct PE of the two RTM treatment 
management codes (that is, CPT codes 98980 and 98981) would have to be 
directly supervised unlike the similar RPM codes (that is CPT code 
99457 and 99458), which as care management codes allow general 
supervision by physicians and NPPs. Commenters expressed concerns that 
physicians and NPPs would be unlikely to use the new RTM codes if they 
had to directly supervise the clinical staff activities associated with 
the codes. To remedy the situation, commenters suggested that CMS 
designate the two RTM treatment management codes as care management 
services. By designating the clinical services of the two codes as care 
management services, physicians and NPPs would be able to supervise 
clinical staff activities under general supervision. Stakeholders 
offered alternatively that CMS develop HCPCS G codes with designated 
care management services to allow general, rather than direct, 
supervision.
    We received other suggestions for developing G codes. Several 
commenters suggested that CMS create new codes that would allow a 
greater array of practitioners to offer RTM services as intended. They 
proposed that HCPCS G codes mirroring CPT codes 98980 and 98981 be 
created just as CMS did with HCPCS codes G2061, G2062, and G2063 for e-
visits. The three e-visit HCPCS G codes mirror the original CPT codes 
for e-visit codes that can be billed only by physicians and NPPs.
    Some commenters suggested that we consider developing HCPCS G codes 
that mirror CPT codes 99457 and 99458 for RPM but construct them 
specifically to allow qualified healthcare professionals such as 
physical therapists to offer RPM treatment management services.
    Response: We thank commenters for their investment in identifying 
issues and solutions related to the construction of the RTM codes. We 
look forward to further discussions about the coding and structure of 
these services. We believe this topic is worthy of ongoing 
collaboration among stakeholders.
    Comment: Several commenters wrote in support of our decision to 
crosswalk the values of CPT codes 98976 and 98977 to the RPM device-
supply code, CPT code 99454. Other commenters urged us to consider 
creating a single temporary HCPCS code similar to CPT code 99454, but 
in addition to CPT codes 98976 and 98977, to serve as a PE-only code to 
facilitate the use of RTM. Commenters offered a list of the types of 
data (for example, motion, gait, balance, breathing regulation, sleep 
patterns, daily symptom reporting) that could be collected if there 
were a general device code available for use.
    Response: We appreciate the support of commenters, as well as the 
descriptions about the value of having a generic code for devices. We 
also thank commenters for the information provided regarding the kinds 
of data that could be collected remotely if a generic code were 
available.
    Comment: Commenters expressed enthusiasm for the new coding and our 
willingness to establish values and pay for the RTM services. The 
commenters requested that we finalize the codes so healthcare 
professionals would be able to provide and bill for RTM services.
    Response: We thank stakeholders for the comments. We note that we 
received comments on topics that were outside the scope for this rule 
and, as a result, we did not address them here. Instead, we may 
consider the comments in future rulemaking.
    After considering the comments, we are finalizing our proposed 
adoption of the RTM codes and our proposed valuations for the services. 
We heard commenters express concern about billing the new RTM codes. 
Comments covered the range of possible outcomes--from accepting the CPT 
codes to revising or developing new codes. Our decision to finalize the 
proposed RTM codes and our proposed valuations for the services strikes 
a balance between supporting beneficiary access to care that these 
services describe and allowing for non-E/M billing practitioners to 
furnish and bill for these services. We acknowledge the major themes 
that emerged in the comments from stakeholders about broadening the 
base of practitioners that could furnish the RTM and RPM services, as 
well as maximizing the efficiency with which these services could be 
furnished.
    In the interest of coding efficiency for these services, we hope to 
continue to engage in dialogue with stakeholders, including the AMA 
CPT, in the immediate future on how best to refine the coding for the 
RTM services to address some of the specific concerns raised by 
stakeholders. We note that as general medicine codes, these codes can 
be billed by physicians and other qualified health care professionals. 
We also note that the five RTM codes will be designated as ``sometimes 
therapy'' codes, which means that the services can be billed outside a 
therapy plan of care by a physician and certain NPPs, but only when 
appropriate. While therapists' services must always be provided under 
therapy plans of care, RTM services that relate to devices specific to 
therapy services, such as the ARIA Physical Therapy device (CPT code 
98977), should always be furnished under a therapy plan of care. We are 
also clarifying that the two device codes, CPT codes 98976 and 98977, 
are not subject to the de minimis standard that establishes the 
threshold for the statutorily required payment adjustment that applies 
to therapy services provided in whole or in part by therapy assistants. 
However, the initial set-up and patient education services represented 
by CPT code 98975 is subject to the de minimis policy. For more 
information about how the de minimis policy is applied for services 
provided in whole or in part by therapy

[[Page 65117]]

assistants, see the Therapy pages at section II.H.1. of this final 
rule.
    We thank the many stakeholders for their thoughtful comments 
regarding the new RTM coding. We will continue to consider the issues 
raised about this set of codes in the context of potential future 
rulemaking.
(38) Principal Care Management and Chronic Care Management (CPT Codes 
99490, 99439, 99491, 99437, 99487, 99489, 99424, 99425, 99426, and 
99427)
    In recent years, we have engaged in efforts to update and improve 
the relative value of care management and coordination services within 
the PFS by identifying gaps in payment and coding. One of those PFS 
services is Chronic Care Management (CCM). CCM services, which include 
management and support services provided by clinical staff under the 
supervision of a physician or NPP or services provided personally by a 
physician or NPP, have received ongoing refinements related to payment 
and coding since CY 2013.
    Beginning in the CY 2014 PFS final rule (78 FR 74414 through 
74427), we noted that physicians and NPPs who furnish care to patients 
with multiple chronic conditions require greater resources than are 
required to support patient care in a typical E/M service. In response, 
we finalized a separately payable HCPCS code, GXXX1 (Chronic Care 
Management (CCM) services furnished to patients with multiple (2 or 
more) chronic condition expected to last at least 12 months, or until 
the death of the patient; 20 minutes or more per in 30 days of chronic 
care management services provided by clinical staff and directed by a 
physician or other qualified health care practitioner). For CY 2015 (79 
FR 67715 through 67730), we refined aspects of the existing CCM 
policies and adopted separate payment for CCM services under CPT code 
99490 (Chronic care management services (CCM), at least 20 minutes of 
clinical staff time directed by a physician or other qualified health 
professional, per calendar month, 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 place the 
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline; Comprehensive care plan 
established, implemented, revised, or monitored). For CY 2017 (81 FR 
80244), we adopted CPT codes 99487 (Complex chronic care management 
(CCCM) 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 place the patient at 
significant risk of death, acute exacerbation/decompensation, or 
functional decline, comprehensive care plan established, implemented, 
revised, or monitored, moderate or high complexity medical decision 
making; first 60 minutes of clinical staff time directed by a physician 
or other qualified health care professional, per calendar month) and 
99489 (CCCM 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 place the patient 
at significant risk of death, acute exacerbation/decompensation, or 
functional decline, comprehensive care plan established, implemented, 
revised, or monitored, moderate or high complexity medical decision 
making; each additional 30 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)). 
Then, in the CY 2019 PFS final rule (83 FR 59577), we adopted a new CPT 
code, 99491 (CCM services, provided personally by a physician or other 
qualified health care professional, at least 30 minutes of physician or 
other qualified health care professional time, per calendar month, 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 place the patient at significant risk 
of death, acute exacerbation/decompensation, or functional decline; 
comprehensive care plan established, implemented, revised, or 
monitored), to describe at least 30 minutes of CCM services performed 
personally by a physician or NPP. In the CY 2020 PFS final rule (84 FR 
62690), we established payment for an add-on code to CPT code 99490 by 
creating HCPCS code G2058 (CCM services, each additional 20 minutes of 
clinical staff time directed by a physician or other qualified 
healthcare professional, per calendar month). We also created two new 
HCPCS G codes, G2064 and G2065 (84 FR 62692 through 62694), 
representing comprehensive services for a single high-risk disease 
(that is, principal care management). In the CY 2021 PFS final rule (85 
FR 84639), we finalized a RUC-recommended replacement code for HCPCS 
code G2058, CPT code 99439, which was given the same valuation and the 
identical descriptor as G2058.
    For CY 2022, the RUC resurveyed the CCM code family, including CCCM 
and Principal Care Management (PCM), and added five new CPT codes: 
99437 (CCM services each additional 30 minutes by a physician or other 
qualified health care professional, per calendar month (List separately 
in addition to code for primary procedure)), 99424 (PCM services for a 
single high-risk disease first 30 minutes provided personally by a 
physician or other qualified health care professional, per calendar 
month), 99425 (PCM services for a single high-risk disease each 
additional 30 minutes provided personally by a physician or other 
qualified health care professional, per calendar month (List separately 
in addition to code for primary procedure), 99426 (PCM, for a single 
high-risk disease first 30 minutes of clinical staff time directed by 
physician or other qualified health care professional, per calendar 
month), and 99427 (PCM services, for a single high-risk disease each 
additional 30 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)).
    The CCM/CCCM/PCM code family now includes five sets of codes, each 
set with a base code and an add-on code. The sets vary by the degree of 
complexity of care (that is, CCM, CCCM, or PCM), who furnishes the care 
(that is, clinical staff or the physician or NPP), and the time 
allocated for the services. The RUC-recommended values for work RVUs 
and direct PE inputs for CY 2022 derive from the recent RUC specialty 
society survey.
    We reviewed the RUC-recommended values for the 10 codes in the CCM 
family and proposed the recommended work values for the codes. We 
proposed the RUC-recommended direct PE inputs without refinements. We 
stated that accepting the updated values was consistent with our goals 
of ensuring continued and consistent access to these crucial care 
management services and acknowledges our longstanding concern about 
undervaluation of care management under the PFS. We solicited comments, 
however, on whether keeping professional PCM and CCM at the same value 
creates an incentive to bill CCM instead of billing PCM when 
appropriate.
    In addition to the proposals on the values for CCM codes, we 
expressed interest in understanding the standard practice used by 
practitioners to obtain beneficiary consent for care management 
services. We stated that we had received questions from stakeholders 
regarding the consent requirements for CCM services. We stated in the 
proposed rule that we

[[Page 65118]]

believed the questions arose because of the many flexibilities allowed 
in response to the PHE for COVID-19. In particular, during the PHE for 
COVID-19, we allowed stakeholders to obtain beneficiary consent for 
certain services under general supervision (85 FR 19230, April 6, 
2020). 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. This requirement is consistent with the 
conditions of payment for this service under the PFS. In considering 
the various policies implemented during the PHE for COVID-19, we 
wondered what policies should remain in effect beyond the PHE. We asked 
how billing practitioners furnishing CCM at different service sites 
(for example, physician office settings, RHCs, FQHCs) obtained 
beneficiary consent over the past year and how different levels of 
supervision impact this activity. We asked for public comment on the 
level of supervision that is necessary to obtain beneficiary consent 
when furnishing care management services and stated we would consider 
such comments in future rulemaking.
    We also proposed to adopt CPT codes 99424 (PCM First 30 minutes 
provided personally by a physician or other qualified health care 
professional, per calendar month) and 99426 (PCM First 30 minutes of 
clinical staff time directed by physician or other qualified health 
care professional, per calendar month) to replace HCPCS codes G2064 and 
G2065 in the calculation of the rate for HCPCS code G0511 for General 
Care Management services billed by RHCs and FQHCs. The payment rate for 
HCPCS code G0511 is calculated based on the average of the national 
non-facility PFS payment rate for care management and general 
behavioral health integration codes (CPT codes 99484, 99487, 99490, and 
99491), as well as HCPCS codes G2064 and G2065 which describe PCM 
services billed under the PFS. The payment rate for HCPCS code G0511 is 
updated annually based on the PFS amounts for these codes.
[GRAPHIC] [TIFF OMITTED] TR19NO21.026

    We received many comments regarding our proposals and request for 
information related the CCM/CCCM/PCM code family. The following 
comments are a summary of the comments we received.
    Comment: The majority of commenters supported our proposal to 
accept the RUC-recommended values for the CC/CCCM/PCM code family.
    Response: We continue to believe that to accept these updated 
values is consistent with our goals of ensuring continued and 
consistent beneficiary access to these crucial care management 
services.
    Comment: Many stakeholders responded to our request for more 
information about obtaining beneficiary consent when furnishing care 
management services. Commenters requested that they be able to continue 
to obtain beneficiary consent under the general supervision of the 
treating physician or NPP, as it has been during the PHE for COVID-19.
    Response: We thank the stakeholders for their insights related to 
this request. We appreciate the comments and will consider them in 
future rulemaking.
    Comment: One commenter stated that keeping professional PCM and CCM 
at the same value would not create an incentive to bill CCM instead of 
PCM. Specialty care practitioners often care for patients with a single 
high-risk disease and do not meet the criteria for reporting other 
types of care management services that require management of multiple 
conditions.
    Response: We thank stakeholders for their comments regarding 
professional PCM and CCM billing.
    Comment: We received several comments that we viewed as out-of-
scope. Topics of the comments included eliminating copayments for care 
management services, reviewing ``30-day'' global codes including care 
management codes, giving CPT code 99072 an active status, and deleting 
HCPCS G0506.
    Response: We may consider these topics in future rulemaking.
    After consideration of the comments, we are finalizing the proposed 
values for the 10 CCM/CCCM/PCM codes, which includes finalizing the 
same values for professional PCM and CCM services.
    We are also finalizing adoption of the CPT codes 99424 (PCM First 
30 minutes provided personally by a physician or other qualified health 
care professional, per calendar month) and 99426 (PCM First 30 minutes 
of clinical staff time directed by physician or other qualified health 
care professional, per calendar month) to replace HCPCS codes G2064

[[Page 65119]]

and G2065 in the calculation of the rate for HCPCS code G0511 for 
General Care Management services billed by RHCs and FQHCs. The payment 
rate for HCPCS code G0511 is calculated based on the average of the 
national non-facility PFS payment rate for care management and general 
behavioral health integration codes (CPT codes 99484, 99487, 99490, and 
99491) and will now include CPT codes 99424 and 99426 which describe 
PCM services billed under the PFS. The payment rate for HCPCS code 
G0511 is updated annually based on the PFS amounts for these codes.
(39) Moderate Sedation (HCPCS Code G0500)
    Following the publication of the CY 2021 PFS final rule, a 
stakeholder contacted us regarding what they believed to be an error in 
the intraservice work time for HCPCS code G0500 (Moderate sedation 
services provided by the same physician or other qualified health care 
professional performing a gastrointestinal endoscopic service that 
sedation supports, requiring the presence of an independent trained 
observer to assist in the monitoring of the patient's level of 
consciousness and physiological status; initial 15 minutes of intra-
service time; patient age 5 years or older (additional time may be 
reported with 99153, as appropriate)). We established HCPCS code G0500 
in CY 2017 to more accurately capture the work of administering 
moderate sedation for gastrointestinal endoscopic procedures for 
patients 5 years of age or older. We based the physician work and time 
for HCPCS code G0500 on data from the 100 gastroenterologists who 
completed the survey of CPT code 99152 (Moderate sedation services 
provided by the same physician or other qualified health care 
professional performing the diagnostic or therapeutic service that the 
sedation supports, requiring the presence of an independent trained 
observer to assist in the monitoring of the patient's level of 
consciousness and physiological status; initial 15 minutes of 
intraservice time, patient age 5 years or older) presented at the 
October 2015 RUC meeting. The survey data for CPT code 99152 showed a 
significant bimodal distribution with data from gastroenterologists 
performing endoscopic procedures demonstrating a markedly different and 
lesser amount of physician work for moderate sedation compared to other 
specialties. The stakeholder stated that the finalization of 12 minutes 
of intraservice work time for HCPCS G0500 appeared to be an error and 
asked CMS to correct it to reflect the 5 minutes of intraservice work 
time indicated by survey data when gastroenterologists performed 
endoscopic procedures.
    While we appreciate the feedback from the stakeholder, we disagreed 
in the proposed rule that the finalization of 12 minutes of 
intraservice work time for HCPCS code G0500 (matching CPT code 99152) 
was an error. The work time for HCPCS code G0500 was proposed and 
finalized at 12 minutes in CY 2017, with the intention that it would 
match the work time for CPT code 99152. This was the rationale behind 
the descriptor for HCPCS code G0500 listing that the code was intended 
for the initial 15 minutes of intraservice time. Furthermore, several 
commenters questioned the work time for HCPCS code G0500 in the CY 2017 
PFS final rule (81 FR 80341) and we stated in response that we expected 
that practitioners would report the appropriate CPT or HCPCS code that 
most accurately described the services performed during a patient 
encounter, including those services performed concurrently and in 
support of a procedural service consistent with CPT guidance. We noted 
that the commenters referred to the time for moderate sedation in the 
survey data, while the time thresholds for the moderate sedation codes 
were intended to match the intraservice time of the procedure itself. 
For a full discussion of this topic, we refer readers to the CY 2017 
PFS final rule (81 FR 80339 through 80349).
    Although we did not propose a change in the work time for HCPCS 
code G0500, we solicited comments on this issue in the interest of 
gaining additional information about the typical use of this procedure. 
We did not receive any comments regarding the work time for HCPCS code 
G0500; we believe that this indicates that we were able to clarify this 
issue in the proposed rule.
(40) Payment for Synthetic Skin Substitutes (HCPCS Codes GXXAB, GXXAC, 
GXXAD, GXXAE, GXXAF, GXXAG, GXXAH, and GXXAI)
    On July 1, 2020, Medicare implemented HCPCS code C1849 (Skin 
substitute, synthetic, resorbable, per square centimeter) and made it 
payable under the OPPS. In the CY 2021 OPPS final rule (85 FR 86064 
through 86067) Medicare finalized payment for C1849--and the associated 
synthetic skin substitute products--allowing it to be billed with graft 
skin substitute procedure CPT codes 15271 through 15278. We note that 
under the OPPS, payment for C1849 is packaged into the payment for the 
graft skin substitute procedure, and its costs are reflected in the 
development of the payment rates for those services. The creation of 
the C-code and the CY 2021 OPPS rulemaking addressed the need for a 
mechanism to pay for graft skin substitute application services 
performed with synthetic graft substitute products in the outpatient 
hospital setting, which is comparable to how Medicare pays for graft 
skin substitute application services performed with graft skin 
substitutes that are regulated by the Food and Drug Administration 
(FDA) under its regulatory framework for human cells, tissues, and 
cellular and tissue-based products (HCT/Ps). We clarify that the 
availability of a HCPCS code for a particular HCT/P does not mean that 
the product is appropriately regulated solely under section 361 of the 
PHS Act and the FDA regulations in 21 CFR part 1271. Manufacturers of 
HCT/Ps should consult with the FDA Tissue Reference Group (TRG) or 
obtain a determination through a Request for Designation (RFD) on 
whether their HCT/Ps are appropriately regulated solely under section 
361 of the PHS Act and the regulations in 21 CFR part 1271 (85 FR 
86058). We note that in a response to the CY 2021 OPPS proposal, a 
commenter noted that the use of a C-code meant that synthetic graft 
skin substitute products would only be payable under the OPPS, and 
would not be able to be reported for graft skin substitute services 
using a synthetic product in the physician office setting (85 FR 
86066).
    Currently, graft skin substitute application services are paid 
separately from the HCT/Ps skin substitutes under the PFS. 
Specifically, when a physician or NPP furnishes a surgical service to 
apply a (HCT/Ps) skin substitute in a non-facility setting, they may 
bill Medicare for the surgical service (as described by CPT codes 15271 
through 15278), and separately bill for the (HCT/Ps) skin substitute. 
For CY 2022, in order to reconcile the gap in payment for synthetic 
products in the physician office setting, we proposed to create ten 
HCPCS codes (parallel to the aforementioned existing surgical codes) 
that would include the synthetic graft skin substitute product as a 
supply cost in determining the PFS rate. We indicated that we believe 
it would be appropriate to consider these products as incident to 
supplies in the office setting, and as such they should be built in as 
a supply cost in calculating the PFS rate. Therefore, we proposed to 
consider these products as incident to supplies in the office setting.

[[Page 65120]]

    The codes and long descriptors for the proposed synthetic graft 
skin substitute services are:
     HCPCS Code GXXAB: Application of synthetic skin substitute 
graft to trunk, arms, legs, total wound surface area up to 100 sq cm, 
including provision of synthetic skin substitute; first 25 sq cm or 
less wound surface area.
     HCPCS Code GXXAC: Application of synthetic skin substitute 
graft to trunk, arms, legs, total wound surface area up to 100 sq cm, 
including provision of synthetic skin substitute; each additional 25 sq 
cm wound surface area, or part thereof (List separately in addition to 
code for primary procedure).
     HCPCS Code GXXAD: Application of synthetic skin substitute 
graft to trunk, arms, legs, total wound surface area greater than or 
equal to 100 sq cm, including provision of synthetic skin substitute; 
first 100 sq cm wound surface area, or 1% of body area of infants and 
children.
     HCPCS Code GXXAE: Application of synthetic skin substitute 
graft to trunk, arms, legs, total wound surface area greater than or 
equal to 100 sq cm, including provision of synthetic skin substitute; 
each additional 100 sq cm wound surface area, or part thereof, or each 
additional 1% of body area of infants and children, or part thereof 
(List separately in addition to code for primary procedure).
     HCPCS Code GXXAF: Application of synthetic skin substitute 
graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, 
hands, feet, and/or multiple digits, total wound surface area up to 100 
sq cm, including provision of synthetic skin substitute; first 25 sq cm 
or less wound surface area.
     HCPCS Code GXXAG: Application of synthetic skin substitute 
graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, 
hands, feet, and/or multiple digits, total wound surface area up to 100 
sq cm, including provision of synthetic skin substitute; each 
additional 25 sq cm wound surface area, or part thereof (List 
separately in addition to code for primary procedure).
     HCPCS Code GXXAH: Application of synthetic skin substitute 
graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, 
hands, feet, and/or multiple digits, total wound surface area greater 
than or equal to 100 sq cm, including provision of synthetic skin 
substitute; first 100 sq cm wound surface area, or 1% of body area of 
infants and children.
     HCPCS Code GXXAI: Application of synthetic skin substitute 
graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, 
hands, feet, and/or multiple digits, total wound surface area greater 
than or equal to 100 sq cm, including provision of synthetic skin 
substitute; each additional 100 sq cm wound surface area, or part 
thereof, or each additional 1% of body area of infants and children, or 
part thereof (List separately in addition to code for primary 
procedure).
    We proposed contractor pricing for these codes for CY 2022; we note 
that there is limited data available on the cost of synthetic skin 
substitute products in physician offices, so we also solicited comments 
and documentation regarding the appropriate values for these services 
for consideration of national pricing in future rulemaking.
    Though we proposed contractor pricing, we also considered an 
alternative approach that would use crosswalks to value these services 
in the physician office setting in a way that is commensurate with the 
rates paid under the OPPS. Though there is only limited data on the 
cost of graft synthetic skin substitute products in physician offices, 
hospitals began reporting costs associated with synthetic skin 
substitute products in CY 2020 after C1849 became effective and payable 
under the OPPS starting in July, 2020. We analyzed CY 2020 OPPS claims 
data and estimate HOPD costs for graft synthetic skin substitute 
products averaged $1500. We note that under the OPPS, outpatient 
departments are paid separately for the primary surgical application 
codes (CPT codes 15271, 15273, 15275, 15277), and the costs associated 
with the synthetic products, as well as the add-on services (described 
by CPT codes 15272, 15274, 15276, 15278) are packaged into the payment 
for the primary procedure.
    Under this alternative, we considered following an approach similar 
to that use under the OPPS where the cost of the supply would be 
included in the primary codes (described by HCPCS GXXAB, GXXAD, GXXAF, 
and GXXAH) and not the add-on codes (described by HCPCS GXXAC, GXXAE, 
GXXAG, and GXXAI), though the add-on would continue to be reported and 
paid separately. Specifically, we would use direct crosswalks for the 
work RVUs, MP RVUs, and facility PE RVUs from the current surgical 
application codes (that is, CPT codes 15271 through 15278) as we 
believe that these payment components for the synthetic graft skin 
substitute services, described by the aforementioned HCPCS codes, would 
be similar.
    However, with regard to the non-facility PE RVUs, we recognize that 
there are significant supply costs associated with synthetic skin 
substitute products. As described previously, we estimate that 
hospitals face average costs associated with synthetic skin substitute 
products of $1500. We note that the PE methodology, which relies on the 
allocation of indirect costs based on the magnitude of direct costs, 
may not be appropriate for these types of services because the 
specialists that typically furnish these types of services do not 
typically have significant supply costs within the methodology. As 
such, we used the hospital reported costs and we looked to other codes 
where specialists frequently have similarly high supply costs in order 
to crosswalk the non-facility PE RVUs. We considered services that have 
a significant proportion of supply costs and are furnished by 
specialists who typically have higher supply costs as potential 
crosswalks for the non-facility PE RVUs. For example, we considered a 
crosswalk to CPT code 21461 (Open treatment of mandibular fracture; 
without interdental fixation) for HCPCS codes GXXAB and GXXAF, and a 
crosswalk to CPT code 21462 (Open treatment of mandibular fracture; 
with interdental fixation) for HCPCS codes GXXAD and GXXAH. As an 
estimate of non-facility PE, we believe these would be appropriate 
codes for crosswalking non-facility PE RVUs.
    As previously discussed in the proposed rule, for the purposes of 
the work RVUs, MP RVUs, and facility PE RVUs, we believed direct 
crosswalks to the current surgical application codes would be 
appropriate as those values would generally not be impacted by the 
addition of a synthetic skin substitute product. We realized this 
alternative considered would follow a similar coding and payment 
approach established under the OPPS, and that potential adoption of 
this alternative would mean that the cost of the products is included 
in the primary codes and not included in the add-on codes. We welcomed 
feedback on our proposal to treat synthetic skin substitute products as 
incident to supplies in the physician office, the proposal to have 
contractor pricing for these codes, and other ways we could obtain 
detailed and reliable cost information on synthetic skin substitutes 
that are furnished in the non-facility setting. We also solicited 
comment on the alternative approach that we considered (using 
crosswalks to value these services in the physician office setting). 
Additionally, we solicited comment on potential ways to reconcile these 
coding and payment differences across settings to yield a more 
consistent and rational payment approach for synthetic and HCT/P graft 
skin substitutes.

[[Page 65121]]

    Comment: One commenter agreed with the proposal to create eight 
HCPCS codes for these services citing their previous position regarding 
high-cost disposable supplies, and that they had urged CMS to consider 
separately identifying and paying for services with disposable supplies 
over $500. The commenter disagreed with the proposed alternatives 
considered whereby instead of contractor pricing, we could 
alternatively utilize crosswalks to value these services in the 
physician office setting in a way commensurate with the rates paid 
under the OPPS. The commenter asserted that any use of the relativity 
of hospital charge data to determine the relativity of practice costs 
within the physician office setting is inconsistent with the statutory 
provisions articulated in Medicare statutory authority for the PFS. The 
commenter stated that the new procedure codes need to go through the 
CPT and RUC processes like all other services.
    Response: With regard to the commenter's concerns regarding the 
proposed alternatives considered, we note that section 1848(c)(2)(N) of 
the Act authorizes us to use alternative approaches to establishing or 
adjusting PE RVUs using cost, charge, or other data from suppliers or 
providers of services in order to ensure accurate valuation of services 
under the PFS. Additionally, we reiterate that we continually engage 
with stakeholders, including the RUC, with regard to our approach for 
accurately valuing codes, and as we prioritize our obligation to value 
new, revised, and potentially misvalued codes. We continue to welcome 
feedback from all interested parties regarding valuation of services 
for consideration through our rulemaking process.
    Comment: One commenter requested clarification on how CMS intends 
to determine payment for proposed synthetic skin substitutes.
    Response: We note that we discussed in the proposed rule that the 
eight new HCPCS codes would be contractor priced, and also discussed an 
alternative approach we considered whereby we would use direct 
crosswalks to the current surgical application codes for the work RVUs, 
MP RVUs, and facility PE RVUs as those generally would not be impacted 
by the addition of a synthetic skin substitute product; and with regard 
to the proposal to determine the non-facility PE RVUs for the eight new 
proposed HCPCS codes we would use crosswalks to other codes for which 
there are frequently similarly high supply costs.
    Comment: Several commenters stated that they appreciate CMS' 
recognition of the need to develop appropriate payment mechanisms for 
synthetic skin substitute products in the physician office setting; 
however, the commenters urged CMS to not finalize the proposal to treat 
synthetic skin substitutes as incident to supplies in the physician 
office setting, and to instead adopt a uniform and consistent policy to 
treat all skin substitutes, including synthetic skin substitutes, in 
the same manner. Specifically, the commenters stated that CMS should 
pay separately for the procedure using the existing graft skin 
substitute application codes (CPT codes 15271-15278) and establish 
specific HCPCS codes for each distinct synthetic skin substitute 
product; some commenters noted that new synthetic skin substitutes will 
have variable costs and pricing and for that reason they believe unique 
HCPCS coding is necessary to provide identification to payers on 
claims, and track each product's cost. Some commenters also stated that 
synthetic skin substitutes are not supplies and mention that all other 
skin substitutes are not considered incident to supplies in any setting 
including the physician office setting. Therefore, they believe it is 
illogical that CMS would propose that synthetic skin substitutes be 
treated as incident to supplies in the physician office. The commenters 
stated that the proposal would create inconsistencies across treatment 
settings, and any policy differences between the OPPS and PFS will 
cause considerable confusion and unnecessary administrative burden. A 
few commenters stated that alternatively, CMS could mirror the 
methodology used in the outpatient department setting by assigning 
synthetic skin substitutes to a high or low-cost category and establish 
a single payment rate for each category, which would also require CMS 
to develop unique HCPCS coding for each synthetic skin substitute 
product.
    Response: We thank commenters for their thoughtful comments and 
note that they highlighted several important factors that must be 
addressed as we consider payment for synthetic skin substitutes. We 
appreciate that there is a great deal of information and additional 
considerations we need to further examine in order to more 
comprehensively address our goal of establishing a consistent and 
rational payment approach for synthetic (as well as HCT/P) graft skin 
substitutes across settings. After consideration of the public 
comments, we acknowledge that the policy as proposed could contribute 
to continued differing treatment of synthetic skin substitutes in the 
physician office setting as compared to the hospital setting. However, 
we also recognize that currently there is no payment mechanism which 
makes use of synthetic skin substitute products payable under the PFS, 
and we acknowledge the need to reconcile the gap in payment for 
synthetic products in the physician office setting without delay. 
Therefore, in order to address this need, and to be responsive to the 
feedback we received from commenters, we are establishing a unique 
HCPCS Level II code for each of 10 products for which we have received 
a HCPCS Level II coding application and then, though this final rule, 
finalizing that these products will be payable in the physician office 
setting as contractor priced products that are billed separately from 
the procedure to apply them. The ten products are as follows: NovoSorb 
SynPath, Restrata Wound Matrix, Symphony, InnovaMatrix AC, Mirragen 
Advanced Wound Matrix, bio-ConneKt Wound Matrix, TheraGenesis, 
XCelliStem, Microlyte Matrix, and Apis. We note that we are taking a 
closer look at our approach to HCPCS Level II coding for a broad range 
of skin substitute products, also referred to as wound dressings, and 
that our decision on the ten applications for synthetic skin 
substitutes noted above is part of that ongoing work. These ten 
applications were received over the course of several quarterly and 
biannual coding cycles in 2020 and 2021. With the exception of the 
timing, the process we used to decide that we will establish a unique 
HCPCS Level II code for each the ten products that we are announcing in 
this final rule was the same process we currently use to decide other 
HCPCS Level II coding applications submitted during our quarterly and 
biannual coding cycles. Under that process, CMS staff review and make 
recommendations to agency leadership regarding whether to approve the 
applications. We post our coding decisions for drugs and biologicals on 
a quarterly basis. For our quarterly cycles for drugs and biologicals, 
we do not routinely review those applications at a HCPCS public 
meeting. For non-drugs and non-biologicals, we post our coding 
decisions on a biannual basis. For our biannual cycles for non-drugs 
and non-biologicals, we post preliminary coding decisions, then invite 
stakeholders to react to those preliminary coding decisions at a 
biannual HCPCS public meeting. After the HCPCS public meetings, we post 
the final coding decisions. We do not have a formal

[[Page 65122]]

process for consulting with an outside committee as part of our 
evaluation of HCPCS Level II coding applications. Around early November 
2021, we will post information about these new HCPCS Level II codes on 
our website at https://www.cms.gov/medicare/coding/medhcpcsgeninfo. We 
are finalizing a policy to allow these HCPCS codes to be billed as add-
on codes to the appropriate existing surgical application codes (CPT 
codes 15271-15278); this is consistent with the current treatment for 
other skin substitutes under the PFS. This approach differs from the 
original proposal in that the payment for the product is coded 
separately from the procedure to apply it, and it is consistent with 
the approach several of the commenters urged us to adopt instead. This 
approach will allow us to address the gap in payment for synthetic skin 
substitutes under the PFS, while also allowing us to take the necessary 
additional time to determine the most appropriate way to handle skin 
substitutes more comprehensively under the Medicare program. We 
anticipate addressing this matter more extensively in future 
rulemaking.
    Comment: A few commenters stated that several refinements would be 
needed if the proposed G-codes are finalized. One commenter noted that 
the proposed alternative crosswalks for HCPCS codes GXXAB, GXXAD, GXXAF 
and GXXAH were inadequate, and provided alternate potential crosswalks 
for consideration. Additionally, a few commenters stated that CMS 
should not package payment for add-on codes, as proposed--whereby the 
cost of the supply would be included in the primary codes but not the 
add-on codes. The commenters also expressed that they believe this 
approach is also inappropriate under the OPPS where it was previously 
finalized, some stating that it overpays for treatment of smaller 
wounds and creates barriers to treating larger wounds in the HOPD. The 
commenters reference the August 23, 2021 Advisory Panel on Hospital 
Outpatient Payment stating that the panel unanimously approved 
recommendations to allow for payment for the existing skin substitute 
application add-on codes, and to assign similar APCs for skin 
substitute applications regardless of anatomical location on the body. 
The commenters stated that prior to adopting the proposed G-codes for 
payment in the physician office setting, these recommendations would 
need to be taken into consideration.
    Response: As stated above, we are not finalizing the proposal to 
create G-codes that would treat the synthetic skin substitutes as 
incident to supplies, and instead are finalizing a modification to our 
proposal whereby we will establish product specific HCPCS codes that 
will be payable in the physician office setting. We appreciate the 
information regarding the recommendation to allow for payment of skin 
substitute application add-on codes under the OPPS, and will consider 
it in our ongoing review of all skin substitutes.
    Comment: A few commenters urged CMS to re-evaluate the CY 2021 
decision to issue HCPCS code C1849 for payment for synthetic skin 
substitute products under the OPPS and replace that generic code with 
unique product specific Q-codes similar to what occurs for all other 
skin substitutes.
    Response: This comment regarding a policy finalized under the OPPS 
for CY 2021 is outside of the scope of this final rule.
    Comment: One commenter stated that CMS had consistent policy for 
skin substitutes across the PFS and OPPS prior to CY 2014 when all 
products were paid separately as biologicals, and beginning in CY 2014 
CMS began a policy of packaging skin substitutes under the OPPS while 
continuing to make separate payment under the PFS. The commenter stated 
that CMS could re-establish the old policy by reverting to separate 
payment for skin substitutes as CMS did prior to CY 2014.
    Response: We appreciate the commenter's feedback, though the 
comment with regard to a policy established under the OPPS in CY 2014 
is outside of the scope of this final rule; however, we would refer 
interested parties to the CY 2014 OPPS/ASC final rule with comment 
period (78 FR 74938) for the discussion regarding how the policy to 
package skin substitutes was part of a broader policy to package all 
drugs and biologicals that function as supplies when used in a surgical 
procedure.
    Comment: One commenter stated that they agree with the proposal to 
establish G-codes for synthetic skin substitutes in the office setting 
and if the proposed G-codes incorporate a high enough reimbursement 
level that considers the application of small to larger sizes and is 
also inclusive of existing in-office site preparation codes currently 
utilized today, then the proposed G-codes would be a positive step 
forward. The commenter stated that they do not agree with the industry 
commentary to consider utilization of Q-codes during the early adoption 
of such policy.
    Response: We appreciate the commenters feedback regarding our 
proposal.
    Comment: One commenter stated that the miscellaneous HCPCS code 
Q4100 could be used for the synthetic skin substitute product until 
specific HCPCS codes can be established through the usual HCPCS coding 
process that all other skin substitute products go through, and could 
be billed along with the existing application codes.
    Response: We appreciate the commenter's feedback. As previously 
discussed, we are finalizing a policy to make synthetic skin substitute 
products payable under the PFS.
    Comment: One commenter stated that there is no universal definition 
of what constitutes a synthetic product and that neither CMS nor the 
industry have clearly defined what a synthetic product is. The 
commenter noted that they believe a definition is a critical first step 
in determining the cost and other benefits to patients of new and 
advanced technology. Another commenter stated that synthetic skin 
substitute manufacturers should be given the opportunity to apply for a 
unique HCPCS codes as has been the process for all non-synthetic 
products rather than establish new HCPCS codes. The commenter stated 
that as the codes are evaluated by the HCPCS committee, the product 
should meet the significant therapeutic distinction criterion and 
demonstrate that the product heals wounds with statistical 
significance, and not simply act as a dressing or barrier for normal 
healing, and is only used when wounds become chronic. The commenter 
stated that the current proposal does not adequately account for 
variations in technology, stating that creating different coding and 
reimbursement methodologies does not account for the increasing 
intersection between biological, bioengineered, and synthetic 
components, as skin substitutes are a heterogenous group and that the 
materials used to produce skin substitutes are either natural, 
synthetic, or both. The commenter indicated that CMS previously 
assigned HCPCS code Q4117 to a product considered to be a synthetic 
skin substitute, which demonstrates that synthetic skin substitutes can 
function within the current coding under both the PFS and OPPS 
frameworks. The commenter stated that it would be better for CMS to 
judiciously assign HCPCS codes to synthetic products that meet the 
HCPCS coding application requirements of significant therapeutic 
distinction. The commenter also stated that the proposed introduction 
of eight new HCPCS codes would be confusing because if materials used 
to produce the skin substitute are either natural, synthetic, or both 
it would be difficult

[[Page 65123]]

for the provider to know which skin substitutes are synthetic and which 
are not, or if the product has both synthetic and natural components; 
and these uncertainties may cause potential delays or errors for 
providers and may have unintentional effect of increased patient 
responsibility if not coded correctly.
    Response: We will take these comments into consideration for 
possible future rulemaking as we continue our work to address payment 
for all skin substitutes across settings, taking into account the 
intersection between biological, bioengineered, and synthetic 
components of these products. We also plan to further evaluate these 
components of products with an existing Q-code for future rulemaking 
to, in a similar manner, address payment policies for all skin 
substitutes across settings in a consistent manner along with products 
discussed in this rule. As indicated above we are finalizing a policy 
to create product specific HCPCS Level II codes that will be payable 
under the PFS. Additionally, we note that the definition of skin 
substitutes was clarified in the CY 2021 OPPS/ASC final rule with 
comment period (85 FR 86058), but we certainly appreciate that the 
definitional issues raised in a comment on the CY 2022 PFS proposed 
rule are challenging, and we acknowledge that it will be important to 
develop the appropriate terminology for these products going forward. 
We expect this to be an evolving issue as we address this topic in 
future rulemaking.
    Comment: One commenter stated that the proposed synthetic skin 
substitute HCPCS codes should include both resorbable, and non-
resorbable synthetic skin substitutes, as well as resorbable and non-
resorbable bio-synthetic skin substitutes. The commenter stated that 
the G-code descriptors should be modified to include ``bio-synthetic'' 
and clarify that the proposed G-codes can be reported for both 
synthetic and bio-synthetic skin substitute products that are either 
resorbable or non-resorbable. The commenter also stated that if CMS 
would like to distinguish between resorbable and non-resorbable, as 
well as bio-synthetic, that CMS should create several code sets that 
would make these distinctions.
    Response: We appreciate the commenter's feedback and will take 
these comments into consideration for future rulemaking as we continue 
our work to address payment for all skin substitutes across settings.
    Comment: A few commenters questioned the inclusion of the language 
which had previously been included in the CY 2021 OPPS/ASC final rule 
(85 FR 86058) stating that manufacturers of human cells, tissues, and 
cellular and tissue-based products should consult with the FDA Tissue 
Reference Group or obtain a determination through a Request for 
Designation on whether their HCT/Ps are appropriately regulated solely 
under section 361 of PHS Act and the regulations in 21 CFR part 1271. 
The commenters questioned why this information was included relating to 
synthetic resorbable skin substitutes since most of them have gone 
through the FDA's 510(k) process and received 510(k) clearance, and 
they are not considered HCT/Ps and thus should not be required to 
obtain another determination from the FDA TRG or RFD from FDA. The 
commenters stated that CMS should provide additional clarification and 
state which products must obtain a determination from the TRG or an RFD 
from FDA and remove any reference regarding consulting with the FDA TRG 
or obtaining a determination through an RFD from the discussion of 
synthetic skin substitutes since this information is not pertinent to 
these products.
    Response: As indicated in the preamble to the CY 2022 PFS proposed 
rule (86 FR 39177), CMS established a policy with regard to payment for 
graft skin substitute application services performed with synthetic 
graft substitute products under the OPPS that is comparable to the way 
Medicare pays for graft skin substitute application services performed 
with HCT/P skin substitutes. We included the information about HCT/P 
skin substitutes in order to provide background and context for the 
policies we proposed when synthetic graft substitute products are 
furnished in the physician office setting. Similarly, our statement 
about consulting with the FDA TRG and the RFD process was intended to 
provide further background on CMS' overall approach to skin substitute 
products, and should not be interpreted as applying to products that 
received 510(k) clearance.
    After consideration of the public comments, in order to address the 
need to establish a payment mechanism for synthetic skin substitutes in 
the physician office setting without further delay, and to be 
responsive to the feedback we received from commenters, we are creating 
the following unique HCPCS Level II codes for the following products: 
NovoSorb SynPath, Restrata Wound Matrix, Symphony, InnovaMatrix AC, 
Mirragen Advanced Wound Matrix, bio-ConneKt Wound Matrix, TheraGenesis, 
XCelliStem, Microlyte Matrix, and Apis; and are also finalizing that 
these synthetic skin substitutes will be payable with physician 
services in the office setting. Around early November 2021, CMS will 
post information about these new HCPCS Level II codes on its website at 
https://www.cms.gov/medicare/coding/medhcpcsgeninfo. These HCPCS Level 
II codes may be billed as add-on codes to the appropriate existing 
surgical application codes (CPT codes 15271-15278), and will be 
contractor priced.
(41) External Extended ECG Monitoring (CPT Codes 93241, 93242, 93243, 
93244, 93245, 93246, 93247, and 93248)
    In the CY 2021 PFS proposed rule (85 FR 50164), we proposed to 
adopt the RUC recommendations for CPT codes 93241 (External 
electrocardiographic recording for more than 48 hours up to 7 days by 
continuous rhythm recording and storage; includes recording, scanning 
analysis with report, review and interpretation), 93242 (External 
electrocardiographic recording for more than 48 hours up to 7 days by 
continuous rhythm recording and storage; recording (includes connection 
and initial recording)), 93243 (External electrocardiographic recording 
for more than 48 hours up to 7 days by continuous rhythm recording and 
storage; scanning analysis with report), 93244 (External 
electrocardiographic recording for more than 48 hours up to 7 days by 
continuous rhythm recording and storage; review and interpretation), 
93245 (External electrocardiographic recording for more than 7 days up 
to 15 days by continuous rhythm recording and storage; includes 
recording, scanning analysis with report, review and interpretation), 
93246 (External electrocardiographic recording for more than 7 days up 
to 15 days by continuous rhythm recording and storage; recording 
(includes connection and initial recording)), 93247 (External 
electrocardiographic recording for more than 7 days up to 15 days by 
continuous rhythm recording and storage; scanning analysis with 
report), and 93248 (External electrocardiographic recording for more 
than 7 days up to 15 days by continuous rhythm recording and storage; 
review and interpretation).
    We noted that the recommendations for this family of codes contain 
one new supply item, the ``extended external ECG patch, medical 
magnetic tape recorder'' (SD339). We did not receive a traditional 
invoice to establish a price for this supply item. Instead we received 
pricing information from two sources: A weighted median of claims data 
with the cost of the other direct PE inputs removed, and a top-down 
approach calculating the cost of the supply per service based on 
summing

[[Page 65124]]

the total costs of the health care provider and dividing by the total 
number of tests furnished. The former methodology yielded a supply 
price of approximately $440 while the latter methodology produced an 
estimated supply price of $416.85. Stakeholders also submitted a series 
of invoices from the clinical study marketplace with a price of $595, 
which we rejected as we typically require an invoice representative of 
commercial market pricing to establish a national price for a new 
supply or equipment item.
    After consideration of the information, we proposed to employ a 
crosswalk to an existing supply for use as a proxy price until we 
received pricing information to use for the ``extended external ECG 
patch, medical magnetic tape recorder'' item. We proposed to use the 
``kit, percutaneous neuro test stimulation'' (SA022) supply as our 
proxy item at a price of $413.24. We believed the kit to be the closest 
match from a pricing perspective to employ as a proxy until we would be 
able to arrive at an invoice that is representative of commercial 
market pricing. We welcomed the submission of invoices or other 
additional information for use in pricing the ``extended external ECG 
patch, medical magnetic tape recorder'' supply. In response to our 
proposal, we received conflicting information from commenters and in 
the CY 2021 PFS final rule (85 FR 84631), we ultimately finalized 
contractor pricing for CY 2021 for the four codes that include this 
supply input (CPT codes 93241, 93243, 93245, and 93247) to allow 
additional time to receive more pricing information.
    We note that stakeholders have continued to engage with CMS and the 
MACs on payment for this service. We remain concerned that we continue 
to hear that the supply costs as initially considered in our CY 2021 
PFS proposal are much higher than they should be. At the same time, we 
also have heard that the resource costs, as reflected in the contractor 
based payments do not adequately cover the incurred cost for the SD339 
supply that is used to furnish these services. In consideration of 
continued access to these services for Medicare beneficiaries, we once 
again solicited public comments and information to support CMS' future 
rulemaking to establish a uniform national payment that appropriately 
reflects the PE that are used to furnish these services. As previously 
stated, invoices or other additional information, including for 
example, which proxy supply items could be used to establish cost for 
the SD339 supply, information on use/application and potential 
alternatives (as appropriate) to the supply items, will be ideal for us 
to use in establishing fair and stable pricing for these services. We 
note that in the absence of such additional and actionable information 
(that is, information that provides further context to information that 
has already been considered) we proposed to maintain contractor pricing 
for these services.
    Comment: Many commenters supported establishing national payment 
rates in CY 2022 for CPT codes 93241, 93243, 93245, and 93247. 
Commenters stated that the establishment of national payment rates 
would enable Medicare beneficiaries to access these technologies at 
fair and stable rates representing relative resources typically used to 
furnish these services. Commenters detailed the clinical benefits 
associated with the use of extended ECG monitoring and stated that the 
establishment of national pricing would ensure payment stability and 
increase beneficiary access to this form of care.
    Response: We agree with the commenters that establishing national 
payment rates for CPT codes 93241, 93243, 93245, and 93247 would help 
remove disparities in pricing for these services and could potentially 
increase access to extended ECG monitoring services. However, we were 
previously unable to determine accurate pricing for the ``extended 
external ECG patch, medical magnetic tape recorder'' (SD339) supply due 
to conflicting information. Because this supply makes up a 
disproportionate amount of the costs associated with CPT codes 93241, 
93243, 93245, and 93247, we were unable to finalize national payment 
rates in CY 2021. We believe that we require accurate pricing of the 
relative resource costs associated with this supply item before we can 
finalize national payment for these services. Additionally, we note 
that we did not receive public comments requesting that CMS maintain 
contractor pricing for these codes.
    Comment: Several commenters submitted invoices for use in pricing 
the SD339 supply item. We received ten invoices in total describing 
several different types of patches that commenters stated were 
analogous to the pricing of the SD339 supply. These invoices averaged 
out to a price of $200.15. Some commenters requested that CMS use the 
submitted invoices to establish appropriate national payment for CPT 
codes 93241, 93243, 93245, and 93247; other commenters requested that 
CMS identify an appropriate proxy supply item from a list of supplies 
that they provided. One commenter suggested crosswalking the price of 
the SD339 supply to the catheter, balloon, esophageal or rectal (graded 
distention test) (SD214) supply at its CY 2021 price of $325.98.
    Response: We appreciate the submission of invoices and additional 
information for use in pricing the SD339 supply from the commenters. 
Based on the information in the submitted invoices, we are finalizing 
an updated price of $200.15 for the extended external ECG patch, 
medical magnetic tape recorder'' (SD339) supply based on the average of 
the ten invoices we received. We believe that the invoice data for this 
supply item, which ranged from a minimum price of $179.80 to a maximum 
price of $241.99, suggests that our updated price of $200.15 is more 
accurate than the suggested crosswalk to the SD214 supply at a price of 
$325.98.
    Comment: Several commenters requested that CMS add additional 
clinical labor and equipment time to CPT codes 93241, 93243, 93245, and 
93247 above what the RUC recommended and CMS proposed in CY 2021. 
Commenters stated that the clinical labor inputs recommended by the RUC 
and proposed by CMS understate what is needed to perform the data 
analysis and report generation for extended ECG monitoring and 
requested additional clinical labor time to review the data obtained 
during the service. Commenters also stated that the equipment time 
recommended by the RUC and proposed by CMS understated the proprietary 
software and visualization technologies used to improve the accuracy 
and reproducibility of the human work. One commenter requested adding 
104 minutes of equipment time for both the CEM system (EQ297) and the 
EEG analysis software (EQ013) equipment. A different commenter 
requested an increase to the equipment costs by using as proxies the 
equipment costs used in other cardiac monitoring and described by the 
Holter analysis system (EQ309) and the patient worn telemetry system 
(EQ340).
    Response: We do not agree with the commenters that there are 
additional clinical labor and equipment costs above what the RUC 
recommended and we proposed in CY 2021 for CPT codes 93241, 93243, 
93245, and 93247. In the CY 2022 PFS proposed rule, we requested 
invoices or other additional information regarding supply costs, 
including for example which proxy supply items could be used to 
establish cost for the SD339 supply, for use in

[[Page 65125]]

establishing fair and stable pricing for these services; we did not 
request information regarding clinical labor or equipment inputs. We 
continue to believe that the other direct PE inputs proposed in CY 2021 
are accurate for CPT codes 93241, 93243, 93245, and 93247; for a full 
discussion of this topic, we direct readers to the CY 2021 PFS proposed 
rule (85 FR 50164) and our responses to commenters in the CY 2021 PFS 
final rule (85 FR 84631).
    After consideration of the comments, we are finalizing an updated 
price of $200.15 for the extended external ECG patch, medical magnetic 
tape recorder'' (SD339) supply based on the average of the 10 invoices 
we received. Although we did request and receive pricing information as 
requested from stakeholders, we note that these services have a high 
utilization, and as a result any changes to the PE for these services 
would noticeably impact our BN adjustments for CY 2022. We believe that 
in light of a potential impact to payment for other services under the 
PFS, a proposal to establish national payment for these services based 
on this new pricing information should take into account broader 
stakeholder feedback. Therefore, we are not finalizing national pricing 
at this time and are finalizing our proposal to maintain contractor 
pricing for CPT codes 93241, 93243, 93245, and 93247 for CY 2022. 
However, we encourage stakeholders to continue to provide feedback 
regarding invoices or other additional information which could be used 
to establish pricing for the SD339 supply to assist CMS in setting 
national prices for these CPT codes for the CY 2023 rulemaking cycle. 
Stakeholders are encouraged to submit invoices with their public 
comments or, if outside the notice and comment rulemaking process, via 
email at [email protected].
(42) Comment Solicitation for Impact of Infectious Disease on Codes and 
Ratesetting
    During the PHE for COVID-19, several stakeholders have contacted 
CMS with concerns about the additional costs borne by physician and 
NPPs due to the pandemic that may impact the professional services 
furnished to Medicare beneficiaries. For example, we have heard from 
stakeholders about higher costs due to additional supplies, such as 
personal protective equipment, and increased time that physicians, NPPs 
and their clinical staff may spend with patients to mitigate further 
spread of infection when, for example, stakeholders are working to rule 
out a COVID-19 infection, or furnishing other services to a patient 
with a confirmed COVID-19 infection. While costs such as these may 
diffuse into Medicare payment rates over a period of time, our payment 
systems, including the PFS, are not generally designed to accommodate 
more acute increases in resource costs, even if they are widespread. We 
acknowledge the circumstances stakeholders have identified that may 
lead to additional costs borne by physicians and NPPs during the PHE, 
and we have developed and implemented policies, as appropriate and 
where possible, to maintain beneficiary access to necessary services 
during the PHE. We are continuing to think broadly about the concerns 
raised, and specifically about the types of resource costs that may not 
be fully reflected in payment rates for existing services, or costs 
that could be accounted for by establishing new payment rates for new 
services. We were interested in feedback from stakeholders about 
additional strategies to account for PHE-related costs, including 
feedback on the specific types of services and costs that may benefit 
from further review, such as infectious disease control measures, 
research-related activities and services, or PHE-related preventive or 
therapeutic counseling services. We were interested in detailed 
feedback from stakeholders to help inform whether we should consider 
making changes to payments for services or develop separate payments 
for such services in future rulemaking.
    Comment: Many commenters suggested the use of a new modifier that 
infectious disease physicians and other clinicians could append to 
current E/M codes that would help ensure that resources are available 
for the increased work associated with care during an outbreak. 
Commenters noted that the use of a modifier would provide CMS with two 
useful safeguards: (1) CMS could set documentation requirements 
regarding the existence of the outbreak (for example, parameters 
associated with the timeframe that public health officials have 
declared an infectious disease/public health emergency (PHE) or 
reporting associated diagnosis codes); and (2) CMS could set 
documentation requirements to justify the enhanced services that were 
provided during the outbreak (for example, evidence in the medical 
record that one or more of the aforementioned activities were delivered 
or influenced care). Commenters noted that there are other mechanisms 
that could achieve the same policy goals, but a mechanism such as a 
modifier would allow CMS to more narrowly tailor the directing of 
resources based on cases where the enhanced care is delivered in a way 
that supports program integrity. Commenters stated that a payment 
modifier would ensure that physicians, regardless of specialty 
designation, receive reimbursement commensurate with the atypical 
activities associated with treating patients during an outbreak or 
pandemic.
    Commenters noted that a permanent mechanism or ``outbreak 
activation'' policy to reimburse clinicians for critical activities 
associated with managing future infectious disease outbreaks would 
promote certainty for both physicians and CMS, and facilitate rapid 
responses at the beginning of an outbreak when speed is critical to 
stop the spread of infections and save lives. Commenters noted that the 
payment enhancements made to address the current resource challenge 
were not predictable, were temporary in nature, and are specific to the 
COVID-19 outbreak, and therefore, cannot be used as a base for a 
permanent mechanism.
    Response: We appreciate the commenters' feedback and will consider 
this feedback in the context of potential future rulemaking.
    Comment: Many commenters urged CMS to implement and pay for CPT 
code 99072 (Additional supplies, materials, and clinical staff time 
over and above those usually included in an office visit or other non-
facility service(s), when performed during a Public Health Emergency, 
as defined by law, due to respiratory-transmitted infectious disease) 
to compensate practices for the additional staffing and personal 
protection equipment (PPE) and other supplies needed during the COVID-
19 pandemic, without patient cost-sharing or BN adjustments. Some 
commenters expressed urgency as physicians continue to incur increased 
expenses in an effort to safely care for patients during the PHE, and 
the commenters encouraged the issuance of an interim final rule to 
separately pay for CPT code 99072. Other commenters stated that CPT 
code 99072 does not capture the myriad of activities and tasks that are 
required of hospitalists and other types of physicians during a 
pandemic and that even if CMS were to assign a value to this code, it 
still would not meet the needs of the physician community as it would 
not account for specific services provided during a pandemic. One 
commenter suggested that CPT code 99483 (Assessment of and care 
planning for a patient with cognitive impairment, requiring an 
independent historian, in the office or other outpatient, home or 
domiciliary or

[[Page 65126]]

rest home, with all of the following required elements: Cognition-
focused evaluation including a pertinent history and examination; 
Medical decision making of moderate or high complexity; Functional 
assessment (e.g., basic and instrumental activities of daily living), 
including decision-making capacity; Use of standardized instruments for 
staging of dementia (e.g., functional assessment staging test [FAST], 
clinical dementia rating [CDR]); Medication reconciliation and review 
for high-risk medications; Evaluation for neuropsychiatric and 
behavioral symptoms, including depression, including use of 
standardized screening instrument(s); Evaluation of safety (e.g., 
home), including motor vehicle operation; Identification of 
caregiver(s), caregiver knowledge, caregiver needs, social supports, 
and the willingness of caregiver to take on caregiving tasks; 
Development, updating or revision, or review of an Advance Care Plan; 
Creation of a written care plan, including initial plans to address any 
neuropsychiatric symptoms, neuro-cognitive symptoms, functional 
limitations, and referral to community resources as needed (e.g., 
rehabilitation services, adult day programs, support groups) shared 
with the patient and/or caregiver with initial education and support. 
Typically, 50 minutes are spent face-to-face with the patient and/or 
family or caregiver.), HCPCS code G2064 (Comprehensive care management 
services for a single high-risk disease, e.g., principal care 
management, at least 30 minutes of physician or other qualified health 
care professional time per calendar month with the following elements: 
One complex chronic condition lasting at least 3 months, which is the 
focus of the care plan, the condition is of sufficient severity to 
place patient at risk of hospitalization or have been the cause of a 
recent hospitalization, the condition requires development or revision 
of disease-specific care plan, the condition requires frequent 
adjustments in the medication regimen, and/or the management of the 
condition is unusually complex due to comorbidities), and HCPCS code 
G0108 (Diabetes outpatient self-management training services, 
individual, per 30 minutes) would be appropriate crosswalk codes for 
valuation and inputs.
    Response: We appreciate the commenters' feedback and will consider 
this feedback in the context of potential future rulemaking.
    Comment: One commenter suggested separate, additional payment for 
pandemic costs that are free from BN considerations. The commenter 
noted that CMS could pay for CPT code 99072, or create a pandemic 
``pack'' of standardized inputs for services, similar to the E/M supply 
pack.
    Response: We appreciate the commenters' feedback and will consider 
this feedback and our regulatory and statutory authority in future 
rulemaking.
(43) Comment Solicitation on Separate PFS Coding and Payment for 
Chronic Pain Management
    Adequate treatment of pain is a significant public health 
challenge. Centers for Disease Control and Prevention (CDC) data 
indicate 50 million adults in the United States have chronic daily 
pain, with nearly 20 million experiencing high impact pain that 
interferes with daily life or work. Pain is the most common reason 
individuals seek medical care, and more than 20 percent of office 
visits are associated with pain.\3\ In the United States, 42.6 percent 
of adults report having pain on some days in the past 6 months,\4\ and 
chronic pain and high-impact chronic pain are experienced by 20.4 
percent and 8 percent of adults, respectively.\5\ The high prevalence 
of pain exacts a substantial economic toll: Medical expenditures and 
lost productivity related to pain result in a cost to the United States 
estimated at up to $635 billion.\6\
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    \3\ Daubresse M, Chang HY, Yu Y, Viswanathan S, Shah ND, 
Stafford RS, Kruszewski SP, Alexander GC. Ambulatory diagnosis and 
treatment of non-malignant pain in the United States, 2000-2010. 
Medical care. 2013 Oct;51(10).
    \4\ Erratum: Vol. 66, No. 29. MMWR Morb Mortal Wkly Rep 
2017;66:1238. DOI: http://dx.doi.org/10.15585/mmwr.mm6644a10external 
icon.
    \5\ Dahlhamer J, Lucas J, Zelaya, C, et al. Prevalence of 
Chronic Pain and High-Impact Chronic Pain Among Adults--United 
States, 2016. MMWR Morb Mortal Wkly Rep 2018;67:1001-1006. DOI: 
http://dx.doi.org/10.15585/mmwr.mm6736a2.
    \6\ Gaskin DJ, Richard P. The economic costs of pain in the 
United States. The Journal of Pain. 2012 Aug 1;13(8):715-24.
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    In 2010, HHS, through the National Institutes of Health (NIH), 
contracted with the Institute of Medicine to make recommendations ``to 
increase the recognition of pain as a significant public health problem 
in the United States.'' In its 2011 report entitled Relieving Pain in 
America: A Blueprint for Transforming Prevention, Care, Education, and 
Research, the Institute of Medicine, through a study mandated by 
Congress, recommended significant improvements in pain prevention, 
care, education, and research and development of a population health-
level strategy to address pain care.\7\ The report described that the 
unique experience of pain requires a combination of person-centered 
therapies and coping techniques influenced by genes, cultural 
attitudes, stress, depression, ability to understand health 
information, and other behavioral, cultural, and emotional factors. It 
noted that individualized care can require adequate extra time to 
counsel patients and caregivers, promote self-management, and consult 
with other health care providers, but current reimbursement systems are 
not designed to efficiently pay for this approach. HHS subsequently 
convened an expert committee to oversee creation of the National Pain 
Strategy (NPS), issued in 2016.\8\ The NPS addressed six key areas of 
care: Population research, prevention and care, disparities, service 
delivery and payment, professional education and training, and public 
education/communication. In this report, NPS' vision is to ``decrease 
the prevalence of pain across its continuum from acute to high-impact 
chronic pain and its associated morbidity and disability across the 
lifespan,'' and aim ``to reduce the burden of pain for individuals, 
their families, and society as a whole.''
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    \7\ https://www.nap.edu/catalog/13172/relieving-pain-in-america-a-blueprint-for-transforming-prevention-care.
    \8\ https://www.iprcc.nih.gov/national-pain-strategy-overview/national-pain-strategy-report.
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    This work was followed by HHS' 2019 release of its Pain Management 
Best Practices Inter-Agency Task Force Report: Updates, Gaps, 
Inconsistencies, and Recommendations (PMTF Report).\9\ The PMTF Report 
focuses on the development of patient-centered pain treatment plans to 
establish diagnosis and set measurable outcomes such as improvements in 
quality of life, function, and activities of daily living. It 
emphasized multi-modal, multi-disciplinary approaches that include 
various modalities for acute and chronic pain. The PMTF Report also 
identified five broad treatment categories: Medications including 
opioids and non-opioids, restorative therapies, interventional 
approaches, behavioral approaches, and complementary and integrative 
health. It stressed the importance of special populations including 
older adults and persons with relapsing conditions, Veterans, and 
people who receive palliative care. The PMTF Report recognized the 
importance of proper opioid stewardship for individuals who need 
opioids to effectively manage their pain. As the Task Force noted, 
there are ongoing concerns regarding suicide and suicidal ideation due 
to pain, and a lack of

[[Page 65127]]

access to pain treatment, including appropriate access to opioid 
medications. The PMTF Report noted that management of pain conditions 
often requires multidisciplinary coordination among health care 
professionals, and that the experience of pain can intensify other 
health issues such as delayed recovery from surgery, or exacerbate 
behavioral health conditions. Many health care professionals, including 
primary care providers, have opted out entirely in treating pain, 
worsening an existing shortage of pain specialists and making chronic 
pain care hard to access, including for people who frequently 
experience disparities in pain care such as rural dwellers, racial/
ethnic minorities, and people with disabilities. The COVID-19 PHE has 
also had an impact on the ability of many older adults and people with 
disabilities' access to care, although telehealth modalities have shown 
promise in broadening access to services and supports.
---------------------------------------------------------------------------

    \9\ https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf.
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    At the same time individuals are experiencing difficulties finding 
pain care, the country is also coping with a worsening opioid and SUD 
crisis. The current environment involves shifting ``waves'' of overdose 
deaths associated with heroin, synthetic opioids, and prescription 
drugs, and intensifying stimulant and polysubstance use. Preliminary 
Centers for Disease Control and Prevention data released in April 2021 
show a 29 percent rise in overdose deaths from October 2019 through 
September 2020--the most recent data available--compared with the 
previous 12-month period.\10\ Illicitly manufactured fentanyl and other 
synthetic opioids were the primary drivers, although many fatal 
overdoses have also involved stimulant drugs, particularly 
methamphetamine. In December 2020, the Substance Abuse and Mental 
Health Services Administration (SAMHSA) released a preliminary report 
from its Drug Abuse Warning Network, which captures data on emergency 
department (ED) visits related to recent substance use and misuse such 
as alcohol use, illicit drug use, suicide attempts, and nonmedical use 
of pharmaceuticals. Most commonly associated with ED visits in the 
participating hospitals are illicit substances and central nervous 
system agents. Among illicit drugs, stimulants (including 
methamphetamine and illicit amphetamine) are the most common, followed 
by cannabinoids (including marijuana and synthetic cannabinoids).\11\
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    \10\ https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
    \11\ https://www.samhsa.gov/data/report/preliminary-dawn-data-review.
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    The PMTF Report urged clinicians to use a comprehensive, 
individualized, person-centered approach to the diagnosis and treatment 
of pain featuring multiple therapeutic modalities. The uptake of this 
approach is an urgent concern as growing numbers of older adults are 
enrolling in Medicare. Some estimates indicate about half of older 
adults have pain that interferes with function. Primary care clinicians 
and specialists are already facing challenges in treating pain and 
associated chronic disease in the Medicare population, where conditions 
such as arthritis, bone/joint disorders, back and neck pain, cancer and 
other conditions that inform and at times inhibit employing the full 
spectrum of pain management therapies are common. We believe untreated 
and inappropriately treated pain may translate to increased costs to 
the Medicare program as more beneficiaries experience functional 
decline, incapacitation, and frailty. Additional risks in untreated 
pain include individuals using illicit drugs such as cannabis; 
inadequate treatment of mental disorders such as depression and 
anxiety, misuse of prescription drugs, alcohol and other drug use 
disorder, and increased suicide risk and suicide.
    In 2019 HHS issued the Guide for Clinicians on the Appropriate 
Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics (the 
Guide) to support the thoughtful, deliberative, and measured 
discontinuation of long-term opioid analgesics, and mitigate harm and 
risk to patients who are working with their clinicians to undergo 
appropriate tapering or discontinuation.\12\ The Guide notes that 
decisions to continue or reduce opioid medications for pain should be 
collaborative and based on the individual patient's goals and 
circumstances and clinicians should consider, for example, whether 
opioid medications continue to support patients meeting treatment 
goals; if opioids are exposing the person to an increased risk for 
serious adverse events or an opioid use disorder; and whether benefits 
continue to outweigh risks of opioids. Whether or not opioids are used 
in treatment, safe and effective non-opioid treatments can be 
integrated into patients' pain management plans based on an 
individualized assessment of benefits and risks, and considering the 
patient's diagnosis, goals and circumstances.\13\ Unique needs and 
coordination across the health care team is critical and clinicians and 
care teams have a responsibility to provide, or arrange for, 
coordinated management of patients' pain including any medication-
related issues. The system of care should not ultimately result in 
patient abandonment. The FDA issued a safety announcement in 2019, 
advising--including through required updates to opioid analgesic 
prescribing information--that health care professionals should not 
abruptly discontinue opioids in patients who are physically dependent 
and that patient-specific plans should be created to gradually taper 
off opioids, in part due to the risk of adverse events including abrupt 
withdrawal symptoms, increased pain, mood changes, mental health 
impact, psychosocial impact, and importantly, suicide risk.\14\
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    \12\ https://www.hhs.gov/opioids/sites/default/files/2019-10/Dosage_Reduction_Discontinuation.pdf.
    \13\ https://www.cdc.gov/drugoverdose/pdf/assessing_benefits_harms_of_opioid_therapy-a.pdf.
    \14\ https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes.
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    In 2020 the National Academy of Medicine, as part of its ``Action 
Collaborative to Countering the U.S. Opioid Epidemic,'' began an effort 
to understand more about the state of chronic pain management, and to 
bring greater awareness to any intended and unintended consequences of 
opioid prescribing metrics as they pertain to the delivery, access, and 
coordination of chronic pain management and care. CMS is one of the 
sponsors of this work. The aim of this project is to visually 
illustrate the chronic pain management journey and accelerate the 
uptake of a range of pain treatments by outlining approaches to 
effective communication that leads to strong clinical relationships and 
optimal quality of life for people with pain.\15\
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    \15\ https://nam.edu/event/living-with-chronic-pain-perspectives-from-persons-with-lived-experience/.
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    The SUPPORT Act (Pub. L. 115-271, October 24, 2018) outlines 
national strategies to help address America's opioid and substance use 
disorders (SUD) crisis, and advances policies to improve the treatment 
of pain and SUD. The SUPPORT Act recognizes the importance of opioid-
related medication management, as well as the overall need to identify 
SUD in the Medicare beneficiary population. Sections 2002 and 6086 of 
the SUPPORT Act are of particular importance regarding pain management. 
For beneficiaries with chronic pain, section 2002 of the

[[Page 65128]]

SUPPORT Act amended sections 1861(ww) and (hhh)(2) of the Act to 
include a review of any current opioid prescriptions in conjunction 
with the initial preventive physical examination (the ``Welcome to 
Medicare'' visit) and annual wellness visit (AWV). The opioid 
prescription review is to include a review of the potential risk 
factors to the individual for opioid use disorder, an evaluation of the 
individual's pain severity and current treatment plan, the provision of 
information on non-opioid treatment options, and referral to a 
specialist, if appropriate. Section 2002 also amended sections 1861(ww) 
and (hhh)(2) of the Act to add a screening for potential SUDs to the 
Welcome to Medicare visit and the AWV, and to add referral to a 
specialist, as appropriate, to the AWV.
    Section 6086 of the SUPPORT Act, the Dr. Todd Graham Pain 
Management Study, will provide HHS and CMS with key information about 
services delivered to Medicare beneficiaries with acute or chronic 
pain, help in understanding the current landscape of pain relief 
options for Medicare beneficiaries, and inform decisions around payment 
and coverage for pain management interventions, including those that 
minimize the risk of SUD. CMS has worked with the Agency for Healthcare 
Research and Quality, which has undertaken three topic briefs and two 
systematic reviews to inform Medicare coverage for the treatment of 
acute and chronic pain. CMS has also worked with HHS' Office of the 
Secretary for Planning and Evaluation to write a Report on the Study, 
which will be submitted to Congress. CMS will post a completed copy of 
the Report on our website. The Report will address questions regarding 
coverage and payment for evidence-based interventions for acute and 
chronic pain in Medicare, barriers to access, costs and benefits of 
expanding or revising benefits not currently covered, and legislative 
and administrative options to improve pain interventions.
    We believe it is important to highlight the role of a person-
centered approach to pain care. The National Quality Forum, which as 
its core work defines measures and health care practices as the best, 
evidence-based approaches to improving care, has defined person-
centered planning as ``a facilitated, individual-directed, positive 
approach to the planning and coordination of a person's services and 
supports based on individual aspirations, needs, preferences, and 
values,'' and stated that the ``goal of person-centered planning is to 
create a plan that will optimize the person's self-defined quality of 
life, choice, and control, and self-determination through meaningful 
exploration and discovery of unique preferences and needs and wants in 
areas including, but not limited to, health and well-being, 
relationships, safety, communication, residence, technology, community, 
resources, and assistance.'' \16\ These general principles should also 
apply in the treatment of individuals with pain, where clinicians 
confirm and affirm the individual's recovery and/or maintenance goals, 
and focus on those, where treatment is a means to an end.\17\ For 
example, one goal might be to not rely on aiming to reduce a simple 
pain score, such as a numeric or visual score, but to evaluate function 
for example, through a tool such as the Defense and Veterans Pain 
Rating scale,\18\ which integrates functional status, and then aim to 
optimize physical function and mental function in the beneficiary with 
chronic pain.
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    \16\ https://www.qualityforum.org/Home.aspx.
    \17\ https://www.qualityforum.org/ProjectMaterials.aspx?projectID=89422.
    \18\ https://www.va.gov/painmanagement/resources.asp.
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    We recognize that there are no existing codes that specifically 
describe the work of the clinician involved in performing the tasks 
necessary to perform pain management care. We believe there are 
complexities in treating pain management patients that could include 
lifestyle discussion, ongoing medication management (such as opioid 
tapering or discontinuation, when appropriate), behavioral health care, 
preparation and updating of a care plan, consideration of Federal and 
other opioid prescribing limits and guidelines, Prescription Drug 
Monitoring Program checks, electronic prescribing requirements, special 
licensing requirements (controlled substance licenses; buprenorphine 
``X-waivers''), interdisciplinary interactions, prescription drug 
coverage, CMS high-prescriber oversight, consideration of out-of-pocket 
costs, and other issues. As one example, decreasing or discontinuing 
opioid treatment requires careful, person-centered consideration of all 
of these aspects of providing care. These unique challenges often 
adversely impact the delivery of care, and subsequent access to care, 
for beneficiaries with chronic pain. Current Medicare payment 
methodologies such as Chronic Care Management (CCM) support chronic 
disease management, though may not provide adequate payment to health 
care providers or systems to holistically care for beneficiaries with 
chronic pain; we believe the complexity and resources required for safe 
and effective pain management may not be adequately captured and paid 
through these codes.
    We believe that creating separate or add-on payment for care and 
management for people with pain might provide opportunities to better 
leverage services furnished using telecommunications technology and non 
face-to-face care while expanding access to treatment for pain. Such an 
additional payment could potentially be effective in preventing or 
reducing the need for acute services such as fall avoidance, and reduce 
the need for treatment for mental disorders such as depression, 
anxiety, and sleep disorders which may occur in some individuals with 
pain. There is also reason to believe that addressing chronic pain (for 
example, pain that lasts more than 3 months) early in its course may 
result in averting the development of ``high-impact'' chronic pain in 
some individuals, where they experience at least one major activity 
restriction (for example, unable to work, go to school, perform 
household chores). These individuals report more severe pain, more 
difficulty with self-care, and higher health care use than others with 
chronic pain. From a social determinants of health perspective, Blacks, 
Native Americans, persons of Asian/Indian descent, older adults, and 
people with less education, and single individuals report more high 
impact chronic pain.\19\
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    \19\ https://www.nccih.nih.gov/research/research-results/prevalence-and-profile-of-high-impact-chronic-pain.
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    In 2019, 12.2 million individuals were enrolled in both Medicaid 
and Medicare, including people age 65 and older and younger 
beneficiaries with disabilities. Many have multiple chronic conditions, 
physical disabilities, behavioral health conditions, and cognitive 
impairments and on average, use more services and supports than those 
enrolled in only Medicaid or Medicare, with higher per capita costs. 
Dually eligible beneficiaries often have multiple social risk factors 
such as housing insecurity and homelessness, food insecurity, 
inadequate access to transportation, and low health literacy. A 2019 
study \20\ on dually eligible beneficiaries using ``high dose'' opioids 
to treat pain between 2006 through 2015 indicated that the common 
conditions in beneficiaries studied were chronic pain, migraine, 
rheumatoid arthritis,

[[Page 65129]]

osteoporosis, HIV/AIDS, viral hepatitis, and SUD.\21\
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    \20\ https://www.macpac.gov/wp-content/uploads/2020/06/Chapter-1-Integrating-Care-for-Dually-Eligible-Beneficiaries-Background-and-Context.pdf.
    \21\ https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/DataStatisticalResources/Downloads/OpioidsDataBrief_2006-2015_10242018.pdf.
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    We solicited comment on whether we should consider creating 
separate coding and payment for medically necessary activities involved 
with chronic pain management and achieving safe and effective dose 
reduction of opioid medications when appropriate, or whether the 
resources involved in furnishing these services are appropriately 
recognized in current coding and payment. These activities could 
include, but are not limited to the following:
     Diagnosis;
     Assessment and monitoring;
     Administration of a validated rating scale(s);
     Development and maintenance of a person-centered care 
plan;
     Overall treatment management;
     Facilitation and coordination of any needed behavioral 
health treatment;
     Medication management;
     Patient education and self-management;
     Crisis care;
     Specialty care coordination such as complementary and 
integrative pain care, and SUD care; and
     Other aspects of pain and/or behavioral health services, 
including care rendered through telehealth modalities.
    We indicated in the proposed rule that we are interested in 
feedback regarding whether the resource costs involved in furnishing 
these activities will be best captured through an add-on code to be 
billed with an E/M visit or a standalone code. To price such a code, we 
could consider using a crosswalk to the valuation and inputs for 
reference codes such as CPT code 99483 (Assessment of and care planning 
for a patient with cognitive impairment), HCPCS code G2064 
(Comprehensive care management services for a single high-risk disease, 
e.g., principal care management, at least 30 minutes of physician or 
other qualified health care professional time per calendar month), 
HCPCS code G0108 (Diabetes outpatient self-management training 
services, individual, per 30 minutes), or other services paid under the 
PFS with similar resource costs.
    We also solicited information on the health care settings in which 
safe and effective pain management care is occurring, as well as what 
types of practitioners furnish these services. We solicited comments on 
whether the specific activities we identify above are appropriate, and 
whether there are other activities that should be included. We are 
interested in stakeholder feedback regarding how we could define and 
value separate coding or an E/M add-on code. We solicited comments on 
whether any components of the service could be provided ``incident to'' 
the services of the billing physician who is managing the beneficiary's 
overall care similar to the structure of the Behavioral Health 
Integration (BHI) codes, which can include BHI services that are not 
delivered personally by the billing practitioner and delivered by other 
members of the care team (except the beneficiary), under the direction 
of the billing practitioner on an incident to basis (as an integral 
part of services delivered by the billing practitioner), subject to 
applicable State law, licensure, and scope of practice. The other care 
team members are either employees or working under contract to the 
practitioner who bills for BHI services.
    We welcome feedback from stakeholders and the public on potential 
separate coding or an E/M add-on code for chronic pain management for 
our consideration for CY 2022 or for future rulemaking
    We received over 1,900 public comments on potential separate coding 
for chronic pain management. The following is a brief summary of the 
comments we received and our responses.
    Comment: Generally, commenters agreed that efforts are needed to 
effectively support the complex needs of beneficiaries with chronic 
pain. Many commenters supported the creation of separate coding and 
payment for chronic pain management under the PFS. One commenter 
suggested that CMS either clarify or modify existing codes so they can 
support services for patients with chronic pain or significant acute 
pain, as well as beneficiaries with a chronic disease or behavioral 
health condition, stating that using the existing codes would avoid any 
concerns about overpayment for patients with both a chronic disease and 
pain, while also making it more feasible for small practices to employ 
care management staff and provide customized care management services 
for all the patients who need them. Some commenters recommended 
creating stand-alone codes rather than E/M add-on codes and several 
commenters included feedback about what specific activities should be 
included in such codes. One commenter recommended that ``CMS establish 
a multi-stakeholder working group to determine operational details and 
resource allocation'' and requested that CMS ``establish a pilot 
program using innovative payment methodologies.''
    Response: We thank the commenters for all of the information 
submitted in recognizing the needs of beneficiaries with pain. We will 
carefully consider this feedback for future rulemaking.
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BILLING CODE 4120-01-C

F. Evaluation and Management (E/M) Visits

    Over the past several years, CMS has engaged with the AMA and other 
stakeholders in a process to update coding and payment for office/
outpatient evaluation and management (E/M) visits, with recent changes 
taking effect January 1, 2021 (see 85 FR 84548 through 84574). In light 
of these changes, we are engaged in an ongoing review of other E/M 
visit code sets and proposed a number of refinements to our current 
policies. The following section discusses several policies we proposed 
regarding split (or shared) visits, critical care services, and 
teaching physician visits.
1. Split (or Shared) Visits
a. Background
    A split (or shared) visit refers to an E/M visit that is performed 
(``split'' or ``shared'') by both a physician and an NPP who are in the 
same group. Because the Medicare statute provides a higher PFS payment 
rate for services furnished by physicians than services furnished by 
NPPs, we need to address whether and when the physician can bill for 
split (or shared) visits. For visits in the non-facility (for example, 
office) setting for which the physician and NPP each perform portions 
of the visit, the physician can bill for the visit rather than the NPP, 
as long as the visit meets the conditions of payment in our regulations 
at Sec.  410.26(b)(1) for services furnished ``incident to'' a 
physician's professional services. However, for visits furnished under 
similar circumstances in facility settings (for example, in a 
hospital), our current regulations provide for payment only to the 
physician or NPP who personally performs all elements of the service, 
and no payment is made for services furnished ``incident to'' the 
billing professional's services.
    As stated in our regulation at Sec.  410.26(b)(1), Medicare Part B 
pays for services and supplies furnished ``incident to'' a physician's 
(or other practitioner's) professional services if those services and 
supplies are furnished in a noninstitutional setting to 
noninstitutional patients. In certain institutional (or ``facility'') 
settings, our longstanding split (or shared) billing

[[Page 65151]]

policy allows a physician to bill for an E/M visit when both the 
billing physician and an NPP in their group each perform portions of 
the visit, but only if the physician performs a substantive portion of 
the visit. When the physician bills for such a split (or shared) visit, 
in accordance with section 1833(a)(1)(N) of the Act, the Medicare Part 
B payment is equal to 80 percent of the payment basis under the PFS, 
which, under section 1848(a)(1) of the Act, is the lesser of the actual 
charge or the fee schedule amount for the service. In contrast, if the 
physician does not perform a substantive portion of such a split (or 
shared) visit and the NPP bills for it, in accordance with section 
1833(a)(1)(O) of the Act, the Medicare Part B payment is equal to 80 
percent of the lesser of the actual charge or 85 percent of the fee 
schedule rate.
    Previously, our policy for billing these split (or shared) visits 
was reflected in several provisions of our Medicare Claims Policy 
Manual (sections 30.6.1(B), 30.6.12, and 30.6.13(H)) which were 
withdrawn effective May 9, 2021, in response to a petition under the 
Department's Good Guidance regulations at 45 CFR 1.5 (see Transmittal 
10742 available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Transmittals/r10742cp). In the 
absence of these manual provisions, the Medicare statute and various 
broadly applicable regulations continue to apply. In addition to 
withdrawing the manual provisions, we issued our response to the 
petition and an accompanying enforcement instruction on May 26, 2021, 
available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/Evaluation-and-Management-Visits). In those documents, we indicated that we intend to address 
split (or shared) visits and critical care services (addressed below) 
through rulemaking; and that until we do, we will limit review to the 
applicable statutory and regulatory requirements for purposes of 
assessing payment compliance.
    The list of applicable statutory and regulatory requirements 
includes the CY 2021 PFS final rule (85 FR 84549), where CMS generally 
adopted new CPT prefatory language and code descriptors for office/
outpatient E/M visits. The new CPT guidelines for E/M services 
introduced a CPT definition of a split (or shared) visit for the first 
time, effective January 1, 2021. This new CPT definition was part of 
CPT's new guidelines indicating how to select the visit level based on 
time, which can be done for all office/outpatient E/M visits starting 
in 2021. The CPT guidelines that we are referring to are published in 
the CPT Codebook, in a section titled ``Evaluation and Management 
Services (E/M) Guidelines.'' \22\ In this section of our final rule, we 
use the term ``CPT E/M Guidelines'' to refer to this material.
---------------------------------------------------------------------------

    \22\ 2021 CPT Codebook, p.5.
---------------------------------------------------------------------------

    In the CY 2021 PFS final rule (85 FR 84549), we stated that we are 
generally adopting the CPT E/M Guidelines for the new office/outpatient 
E/M visit codes. However, the CPT E/M Guidelines do not address many 
issues that arise in the context of PFS payment for split (or shared) 
visits, such as which practitioner should report the visit when 
elements of the visit are performed by different practitioners; whether 
a substantive portion of the visit must be performed by the billing 
practitioner; whether practitioners must be in the same group to bill 
for a split (or shared) visit; or the settings of care where split (or 
shared) visits may be furnished and billed. The CPT E/M Guidelines 
simply state, ``A split or shared visit is defined as a visit in which 
a physician and other qualified health care professional(s) jointly 
provide the face-to-face and non-face-to-face work related to the 
visit. When time is being used to select the appropriate level of 
services for which time-based reporting of shared or split visits is 
allowed, the time personally spent by the physicians and other 
qualified health care professional(s) assessing and managing the 
patient on the date of the encounter is summed to define total time. 
Only distinct time should be summed for split or shared visits (that 
is, when two or more individuals jointly meet with or discuss the 
patient, only the time of one individual should be counted).'' \23\
---------------------------------------------------------------------------

    \23\ 2021 CPT Codebook, p.7.
---------------------------------------------------------------------------

    In contrast, to ensure appropriate PFS payment, our policy for 
split (or shared) visits, as expressed in the recently withdrawn manual 
provisions, is that the physician may bill for a split (or shared) 
visit only if they perform a substantive portion of the visit, and the 
practitioners must be in the same group and furnishing the visit in 
specified settings in order to bill for a split (or shared) visit. Our 
manual also limited billing for split (or shared) visits to services 
furnished to established patients. In our proposed rule, we made a 
number of proposals to address the recently withdrawn manual sections 
and improve transparency and clarity regarding our policies on billing 
for split (or shared) visits, to update them to account for recent 
revisions to E/M visit coding and payment, and to revise our 
regulations to reflect these policies.
    We received many public comments on our proposals for split (or 
shared) visits. In general, the commenters appreciated the need to 
clarify and refine our policies, although some were worried about 
increased administrative burden, disruption to current practice 
patterns, or perceived disadvantages to physicians or NPPs. There was 
no consensus on what the substantive portion of a split (or shared) 
visit should be, although many commenters recommended we find a way to 
recognize medical decision-making (MDM) as the substantive portion. The 
following is a summary of the comments we received and our responses.
b. Definition of Split (or Shared) Visits
    We proposed to define a split (or shared) visit as an E/M visit in 
the facility setting that is performed in part by both a physician and 
an NPP who are in the same group, in accordance with applicable laws 
and regulations. We proposed to add this definition to a new section of 
our regulations at 42 CFR 415.140.
    Additionally, we proposed to define split (or shared) visits as 
those that:
     Are furnished in a facility setting by a physician and an 
NPP in the same group, where the facility setting is defined as an 
institutional setting in which payment for services and supplies 
furnished incident to a physician or practitioner's professional 
services is prohibited under our regulation at Sec.  410.26(b)(1).
     Are furnished in accordance with applicable law and 
regulations, including conditions of coverage and payment, such that 
the E/M visit could be billed by either the physician or the NPP if it 
were furnished independently by only one of them in the facility 
setting (rather than as a split (or shared) visit).
    We proposed to revise our regulations at Sec.  415.140 to codify 
this definition.
    We believed that limiting the definition of split (or shared) 
visits to include only E/M visits in institutional settings, for which 
``incident to'' payment is not available, would allow for improved 
clarity, and clearly distinguish, the policies applicable to split (or 
shared) visits, from the policies applicable to services furnished 
incident to the professional services of a physician. We did not see a 
need for split (or shared) visit billing in the office setting, because 
the ``incident to'' regulations govern situations where an NPP works 
with a physician who bills

[[Page 65152]]

for the visit, rather than billing under the NPP's own provider number.
    We also proposed to modify our policy to allow physicians and NPPs 
to bill for split (or shared) visits for both new and established 
patients, and for critical care and certain Skilled Nursing Facility/
Nursing Facility (SNF/NF) E/M visits. We proposed these modifications 
to the current policy and conditions of payment for split (or shared) 
visits, discussed below, to account for changes that have occurred in 
medical practice patterns, including the evolving role of NPPs as part 
of the medical team.
    Comment: While most commenters were generally supportive of our 
definition and appreciative of clarifications to current policy, a few 
commenters recommended that we allow billing of split (or shared) 
visits in all settings, both institutional and non-institutional. 
Commenters noted that split (or shared) visit billing might be 
appropriate or necessary for new patient visits in the office setting, 
since payment for services furnished incident to the services of 
physicians and other clinicians is only available for established 
patients.
    Response: We have been reviewing this aspect of our ``incident to'' 
policy, independent of its relationship to split (or shared) visit 
billing. Since we are considering addressing requirements for new and 
established patients in future rulemaking in a broader context, and 
this is the only situation raised by commenters where ``incident to'' 
payment would not be available in a non-institutional setting, we do 
not believe we should address it through split (or shared) visit 
policies. We will continue to consider this issue in the context of 
potential future rulemaking. We are finalizing our definition of split 
(or shared) visits as proposed, and codifying it in a new section of 
our regulations at Sec.  415.140, as proposed.
c. Definition of Substantive Portion
(1) More Than Half of the Total Time
    As stated earlier, we proposed that only the physician or NPP who 
performs the substantive portion of the split (or shared) visit would 
bill for the visit. We proposed to define ``substantive portion'' as 
more than half of the total time spent by the physician and NPP 
performing the split (or shared) visit. We noted that our withdrawn 
manual instructions contained a few definitions of ``substantive 
portion.'' For example, one section defined substantive portion as any 
face-to-face portion of the visit, while another section defined it as 
one of the three key components of an E/M visit-- either the history of 
present illness (HPI), physical exam, and/or MDM. Given recent changes 
in the CPT E/M Guidelines, HPI and physical exam are no longer 
necessarily included in all E/M visits, because as noted above, for 
office/outpatient E/M visits, the visit level can now be selected based 
on either MDM or time, and history and exam are performed only as 
medically appropriate. Accordingly, defining ``substantive portion'' as 
one of these three key components is no longer a viable approach. 
Similarly, MDM is not easily attributed to a single physician or NPP 
when the work is shared, because MDM is not necessarily quantifiable 
and can depend on patient characteristics (for example, risk). We 
believed that time is a more precise factor than MDM to use as a basis 
for deciding which practitioner performs the substantive portion of the 
visit.
    We also did not believe it would be appropriate to consider the 
performance of any portion of the visit--with or without direct patient 
contact--as a substantive portion. For instance, we did not believe it 
would be appropriate to consider a brief or minor interaction, with or 
without direct patient contact, such as where the physician merely 
``pokes their head'' into the room, to be a substantive portion of the 
visit. Therefore, we proposed to define ``substantive portion'' as more 
than half of the total time spent by the physician and NPP performing 
the split (or shared) visit. We proposed to revise our regulation at 
Sec.  415.140 to codify this definition.
    We recognized that the billing practitioner, who would be the 
practitioner providing the substantive portion of the visit, could 
select the level for the split (or shared) visit based on MDM, but we 
nonetheless proposed to base the definition of substantive portion on 
the amount of time spent by the physician and NPP providing the visit. 
We recognized that this policy would necessitate the practitioners' 
tracking and documenting the time they spent for these visits. However, 
we believed that practitioners are likely to increasingly time their 
visits for purposes of visit level selection independent of our split 
(or shared) visit policies, given recent changes to the CPT E/M 
Guidelines, and the fact that critical care visits are already timed. 
Accordingly, we did not believe this would comprise a substantial new 
burden.
    Comment: The commenters agreed that the individual who performs the 
substantive portion should bill for the visit. Approximately half of 
the commenters supported our proposal, noting that it was appropriate 
and would provide a clear rule. However, approximately half of the 
public comments recommended alternative definitions of substantive 
portion, including:
     A lower percentage of time (25 to 30 percent of the total 
time) (several comments).
     MDM (several comments).
     Some portion of MDM, such as a majority or critical 
element of MDM, more than half of the time or the portion of the visit 
in which the MDM is performed, or physician involvement in the MDM 
(several comments).
     Choice of MDM or time, for example, based on whichever is 
used to select visit level (several comments).
     One of the three key components of history, exam, or MDM, 
at least until the AMA completes changes for E/M visit coding and the 
CPT E/M Guidelines that the commenters expect for 2023 (several 
comments).
     Some combination of the above, for example, more than half 
of the MDM or more than half of total time (several comments).
     Working with the CPT Editorial Panel to develop a policy 
(several comments).
    The commenters who recommended using MDM (or part thereof) were 
concerned that using only time to determine the substantive portion 
implies that MDM and non-patient-facing work is less significant than 
time, and that time spent in front of the patient is most critical. The 
commenters were also concerned that tracking time would result in an 
administrative burden, or remove their ability to use MDM to select 
visit level. Some commenters were concerned about disrupting current 
practice patterns. Some commenters noted that using time would 
disadvantage physicians, because NPPs receive significantly less 
education, training, and certification than osteopathic and allopathic 
(DOs and MDs) physicians, making physicians more skilled, efficient, 
and proficient than NPPs. They stated that MDM is used more often to 
determine visit level. Commenters also noted, in many instances, the 
activities performed by the physician, which are the key portion of the 
visit, take less time than the activities that are required to provide 
the additional information needed for MDM and the plan of care. The 
commenters stated that an NPP may be involved in tasks that require 
significant time, such as preparing the medical record, taking a 
history, performing a physical exam, inputting orders, obtaining lab or 
test results, requesting consultations, and doing

[[Page 65153]]

preliminary documentation. However, synthesizing the patient's symptoms 
and other information such as test results and then devising the plan 
of care are the substance of the visit and typically are done by a 
physician.
    Response: Regarding recommendations to consider the substantive 
portion to be a lower percentage of time, having reviewed our current 
policy, we do not believe that the higher physician payment rate under 
the PFS should be made when a physician performs less than half of the 
visit, such as a quarter or a third of the total time or less than half 
of the MDM.
    We do not believe MDM is necessarily the most critical or central 
component of E/M visits, and it is not the only service component 
included in the PFS payment for the service. We are also not clear how 
it could be known that MDM is used most often to determine visit level. 
PFS payment rates incorporate and assume a certain amount of physician 
time per visit, reflected in the assigned RVUs and reflected annually 
in our physician time files. PFS payment rates reflect the typical 
amount of time spent on visits, and the Act requires us to reflect both 
time and intensity of work (physician and practitioner) in our payment 
rates. We do not believe this in any way devalues the unique education, 
training, experience, or expertise of physicians, but rather that both 
time and expertise are important and included in payment under the PFS.
    We continue to believe that MDM cannot be readily attributed to 
only the physician or the NPP, or definitively divided between them. 
MDM has three parts: the number and complexity of problem(s) that are 
addressed during the encounter; the amount and/or complexity of data to 
be reviewed and analyzed; and the risk of patient management decisions 
made at the visit.\24\ Both the physician and the NPP would be 
addressing the same problem(s) during the encounter, and both are 
likely to be reviewing and analyzing data. No key or critical portion 
of MDM is identified by CPT. Therefore, we do not see how MDM (or its 
critical portion, or other component part) can be attributed to only 
one of the practitioners, or how we could distinguish these for 
purposes of assigning appropriate payment when visits are shared.
---------------------------------------------------------------------------

    \24\ 2021 CPT Codebook, p. 14.
---------------------------------------------------------------------------

    We believe the commenters overestimate the administrative burden of 
tracking and attributing time, given the advent of EHRs and new E/M 
visit coding structures. However, we understand that an adjustment 
period may be needed to establish systems to track and attribute time 
for split (or shared) visits, especially since the coding for E/M 
visits in many facility settings will not use MDM or time to 
distinguish visit levels until 2023. Therefore, we are finalizing our 
definition of substantive portion for split (or shared) visits as 
proposed (more than half of the total time spent by the physician and 
NPP performing the split (or shared) visit) beginning January 1, 2023. 
However, we are modifying our proposed policy for one transitional 
year. For CY 2022, except for critical care visits, the substantive 
portion will be defined as 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). In other 
words, for CY 2022, the practitioner who spends more than half of the 
total time, or performs the history, exam, or MDM can be considered to 
have performed the substantive portion and can bill for the split (or 
shared) E/M visit. We wish to be clear that practitioners can still use 
MDM to select visit level for the E/M split (or shared) visit, as 
proposed. We also are clarifying that when one of the three key 
components is used as the substantive portion in 2022, the practitioner 
who bills the visit must perform that component in its entirety in 
order to bill. For example, if history is used as the substantive 
portion and both practitioners take part of the history, the billing 
practitioner must perform the level of history required to select the 
visit level billed. If physical exam is used as the substantive portion 
and both practitioners examine the patient, the billing practitioner 
must perform the level of exam required to select the visit level 
billed. If MDM is used as the substantive portion, each practitioner 
could perform certain aspects of MDM, but the billing practitioner must 
perform all portions or aspects of MDM that are required to select the 
visit level billed.
    For visits that are already timed (that is, critical care 
services), the substantive portion will not be based on performance of 
the history, exam, or MDM. For critical care visits, starting for 
services furnished in CY 2022, the substantive portion will be more 
than half of the total time, as proposed. A unique listing of 
qualifying activities for purposes of determining the substantive 
portion of critical care visits will apply, as proposed (see section 
II.F.2. of this final rule where we discuss critical care).
    We are codifying this definition of substantive portion for split 
(or shared) visits in our regulations at Sec.  415.140. We will 
continue to review and consider any future changes by the AMA/CPT 
Editorial Panel to the CPT E/M Guidelines for split (or shared) visits. 
We also intend to monitor the claims data for split (or shared) visits, 
such as how frequently practitioners use or rely upon this billing 
construct, and what specialties they represent (see modifier 
requirement below). We summarize our final policies in Table 26.
[GRAPHIC] [TIFF OMITTED] TR19NO21.048


[[Page 65154]]


(2) Distinct Time
    We proposed that the distinct time of service spent by each 
physician or NPP furnishing a split (or shared) visit would be summed 
to determine total time and who provided the substantive portion (and 
therefore, bills for the visit). This would be consistent with the CPT 
E/M Guidelines stating that, for split (or shared) visits, when two or 
more individuals jointly meet with or discuss the patient, only the 
time of one individual should be counted.\25\ For example, if the NPP 
first spent 10 minutes with the patient and the physician then spent 
another 15 minutes, their individual time spent would be summed to 
equal a total of 25 minutes. The physician would bill for this visit 
since they spent more than half of the total time (15 of 25 total 
minutes). If, in the same situation, the physician and NPP met together 
for five additional minutes (beyond the 25 minutes) to discuss the 
patient's treatment plan, that overlapping time could only be counted 
once for purposes of establishing total time and who provided the 
substantive portion of the visit. The total time would be 30 minutes, 
and the physician would bill for the visit since they spent more than 
half of the total time (20 of 30 total minutes).
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    \25\ 2021 CPT Codebook (Evaluation and Management (E/M) Services 
Guidelines), p. 7.
---------------------------------------------------------------------------

    Comment: One commenter stated it would be burdensome for 
practitioners to track how much of their time was spent jointly meeting 
with or discussing the patient, as opposed to time spent individually. 
However, a number of commenters recommended generally that we should 
align our split (or shared) visit policies with the CPT E/M Guidelines 
to reduce administrative burden.
    Response: We believe that we should align with the CPT E/M 
Guidelines on this point, to reduce administrative burden, and are 
finalizing as proposed that, for split (or shared) visits, when two or 
more individuals jointly meet with or discuss the patient, only the 
time of one individual can be counted.
(3) Qualifying Time
    Drawing on the CPT E/M Guidelines, we proposed a listing of 
activities that could count toward total time for purposes of 
determining the substantive portion. For visits that are not critical 
care services, we proposed the CPT listing of activities that can count 
when time is used to select an E/M visit level, specifically the 
following activities, when performed and regardless of whether or not 
they involve direct patient contact:
     Preparing to see the patient (for example, review of 
tests).
     Obtaining and/or reviewing separately obtained history.
     Performing a medically appropriate examination and/or 
evaluation.
     Counseling and educating the patient/family/caregiver.
     Ordering medications, tests, or procedures.
     Referring and communicating with other health care 
professionals (when not separately reported).
     Documenting clinical information in the electronic or 
other health record.
     Independently interpreting results (not separately 
reported) and communicating results to the patient/family/caregiver.
     Care coordination (not separately reported).
    Practitioners would not count time spent on the following:
     The performance of other services that are reported 
separately.
     Travel.
     Teaching that is general and not limited to discussion 
that is required for the management of a specific patient.\26\
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    \26\ 2021 CPT Codebook, p. 8, as clarified in the CPT 2021 
Errata and Technical Corrections dated June 7, 2021 and available on 
the AMA website at https://www.ama-assn.org/system/files/2021-06/cpt-corrections-errata-2021.pdf.
---------------------------------------------------------------------------

    Since critical care services can include additional activities that 
are bundled into the critical care visit code(s), we proposed a 
different listing of qualifying activities, discussed in our section 
below on split (or shared) critical care services. Additionally, we 
solicited public comments on whether there should be a different 
listing of qualifying activities for purposes of determining the total 
time and substantive portion of split (or shared) emergency department 
(ED) visits, since those visits also have a unique construct.
    Comment: The commenters were generally supportive of our proposal 
to use the CPT E/M Guidelines listing of qualifying activities for 
time. We received mixed comments about applying it to ED visits. Some 
commenters noted our proposed listing could apply equally to office/
outpatient and ED visits. Other commenters noted that the CPT Editorial 
Panel should weigh in on this issue and develop a consensus on whether 
for ED visits, there should be a different listing of qualifying 
activities. One commenter recommended several revisions to our proposed 
listing, to remove time-based activities and to better represent MDM as 
the driving force determining the substantive portion of an ED visit, 
specifically:
     Obtaining and/or reviewing separately obtained history.
     Performing and/or reviewing a medically appropriate 
examination and/or evaluation.
     Formulation of a differential diagnosis.
     Reviewing and amending (as appropriate) clinical 
information in the electronic or other health record.
     Ordering medications, tests, or procedures.
     Independently interpreting results (not separately 
reported) and communicating results to the patient/family/caregiver.
     Consulting with other health care professionals as 
appropriate.
     Counseling and educating the patient/family/caregiver.
     Formulating and instituting a final treatment plan.
     Determining appropriate disposition.
    Practitioners would not count the following activities:
     The performance of other services that are reported 
separately.
     Teaching that is general and not limited to discussion 
that is required for the management of a specific patient.
    Response: Having reviewed the public comments and consulted with 
our medical officers, we do not believe that an alternative listing for 
ED visits is the best approach at this time. As we discussed above, 
only for 2022, we will allow history, or exam, or MDM, or more than 
half of the total time (inclusive of activities on the finalized 
listing), to comprise the substantive portion of any E/M visit 
(including ED visits) except critical care. Starting in 2023, the 
finalized listing of qualifying activities will apply to all split (or 
shared) E/M visits except critical care, for purposes of determining 
the substantive portion. (Critical care will have a different listing 
of qualifying activities, discussed in the critical care section 
below). We would expect all aspects of MDM to be included or reflected 
in the listing of qualifying activities. Many of the additions 
recommended by the ED physicians' association (for example, formulating 
and instituting a final treatment plan, determining appropriate 
disposition, formulation of a differential diagnosis) appear to be more 
detailed descriptions of MDM activities that could be interpreted as 
already included in the current CPT listing of qualifying activities. 
Perhaps additional levels of detail or specificity should be considered 
by the CPT Editorial Panel for inclusion in its listing of qualifying

[[Page 65155]]

activities. However, we agree with the commenters who noted that a 
consensus should be reached at CPT before we adopt alternative 
language. Regarding suggested deletions from the listing, we do not 
believe it is necessary to exclude travel, even though ED visits do not 
involve travel, as long as there is one listing applicable for all E/M 
visit code families (other than critical care, as discussed below). 
Finally, we recognize the related, controversial issue of whether or 
not all ED visits should include time (not just split or shared ED 
visits). Therefore, starting in 2023, our final policy for ED visits 
will be to use the CPT listing of qualifying activities for time, as 
proposed. Meanwhile, we will continue to monitor any related changes 
that may be made by the CPT Editorial Panel.
    Comment: Several commenters asked us to clarify whether our intent 
in our proposed rule was to require both practitioners to have face-to-
face contact with the patient, or only one of them. These commenters 
were concerned that the CPT language could be interpreted to mean that 
both practitioners do not need to perform face-to-face work, which they 
believed would reduce transparency, harm quality assessment, and reduce 
program integrity.
    Response: The current CPT E/M Guidelines state, ``The E/M services 
for which these guidelines apply require a face-to-face encounter with 
the physician or other qualified health care professional. For office 
or other outpatient services, if the physician's or other qualified 
health care professional's time is spent in the supervision of clinical 
staff who perform the face-to-face services of the encounter, use 
99211. A shared or split visit is a visit in which a physician and 
other qualified health care professional(s) jointly provide the face-
to-face and non-face-to-face work related to the visit.'' \27\ The list 
of qualifying activities for time do not specify whether each activity 
is face-to-face or not. To our knowledge, CPT has not defined the terms 
``face-to-face'' and ``non-face-to-face,'' but in this context we 
interpret face-to-face to mean in-person. We note that certain 
prolonged service CPT codes use the terms ``with direct patient 
contact'' and ``without direct patient contact'' instead of ``face-to-
face.''
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    \27\ 2021 CPT Codebook, p.7.
---------------------------------------------------------------------------

    Our intent was that only one of the practitioners must perform the 
in-person part of an E/M visit when it is split (or shared), although 
either or both can do so. We acknowledge that Medicare policy on this 
was not clear in the past, since one manual section defined substantive 
portion as any face-to-face portion of the encounter, and another 
section defined it as a key component (which could have included, for 
example, MDM). We are finalizing as proposed that the substantive 
portion can be comprised of time that is with or without direct patient 
contact. Since by 2023 (except for critical care visits), the physician 
must perform more than half of the total time in order to bill a split 
(or shared) visit, we believe our final policy ensures enough physician 
involvement to support their billing for the service, even though the 
physician might not have direct patient contact. Our final policy is 
that for all split (or shared) visits, one of the practitioners must 
have face-to-face (in-person) contact with the patient, but it does not 
necessarily have to be the physician, nor the practitioner who performs 
the substantive portion and bills for the visit. The substantive 
portion could be entirely with or without direct patient contact, and 
will be determined by the proportion of total time, not whether the 
time involves direct or in-person patient contact. We will continue to 
consider this issue going forward and any changes or clarifications 
that may be made by the CPT Editorial Panel on this topic.
(4) Application to Prolonged Services
    For office/outpatient E/M visits, as discussed in our CY 2021 PFS 
final rule (85 FR 84572), HCPCS code G2212 can be used to report 
prolonged services in 15-minute increments of time beyond the maximum 
time for a level 5 office/outpatient E/M visit. For all other E/M 
visits (except critical care and emergency department visits), CPT 
codes 99354-9 can be used to report prolonged time with or without 
direct patient contact, when required time increments above the typical 
time is spent (see CY 2017 PFS final rule, 81 FR 80228-80230 and the 
Medicare Claims Processing Manual (Pub. 100-02), chapter 12, section 
30.6.15 available on our website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf).
    Our withdrawn manual provisions instructed that practitioners 
cannot bill prolonged services as a split (or shared) visit. Having 
reviewed this policy, we believed that codes that are billed as add-on 
codes for prolonged service time for an E/M visit, which could be 
furnished and billed as a split (or shared) visit under our proposed 
policy, should be considered to be part of that E/M visit. Therefore, 
we proposed to change our policy to allow a practitioner to bill for a 
prolonged E/M visit as a split (or shared) visit. Specifically, the 
physician or practitioner who spent more than half the total time (that 
is, performed the substantive portion described above) would bill for 
the primary E/M visit and the prolonged service code(s) when the 
service is furnished as a split (or shared) visit, if all other 
requirements to bill for the services were met. The physician and NPP 
would sum their time together, and whomever furnished more than half of 
the total time, including prolonged time, (that is, the substantive 
portion) would report both the primary service code and the prolonged 
services add-on code(s), assuming the time threshold for reporting 
prolonged services is met. We noted that for critical care visits, the 
practitioner would not bill prolonged E/M services because the 
practitioners would instead aggregate their time, as proposed below, to 
report additional units of critical care services.
    Comment: We did not receive many comments specifically on this 
proposed policy, and the comments we received were supportive of our 
proposal.
    Response: We thank the commenters for their support. Starting in 
2023, our policy will be as proposed. Specifically, the physician or 
practitioner who spent more than half the total time (the substantive 
portion starting in 2023) will bill for the primary E/M visit and the 
prolonged service code(s) when the service is furnished as a split (or 
shared) visit, if all other requirements to bill for the services are 
met. The physician and NPP will add their time together, and whomever 
furnished more than half of the total time, including prolonged time, 
(that is, the substantive portion) will report both the primary service 
code and the prolonged services add-on code(s), assuming the time 
threshold for reporting prolonged services is met.
    The same policy will apply for services furnished in the 2022 
transition year when practitioners use a majority of total time as the 
substantive portion; but when practitioners use a key component as the 
substantive portion, there will need to be different approaches for 
office/outpatient E/M visits than other kinds of E/M visits. For shared 
office/outpatient visits where practitioners use a key component as the 
substantive portion, prolonged services can be reported by the 
practitioner who reports the primary service, when the combined time of 
both practitioners meets the threshold for reporting prolonged office/
outpatient services (HCPCS code G2212). For all other types of E/M 
visits (except ED and critical care visits), prolonged services can be 
reported by the practitioner who reports the primary service, when the

[[Page 65156]]

combined time of both practitioners meets the threshold for reporting 
prolonged E/M services other than office/outpatient E/M visits (60 or 
more minutes beyond the typical time in the CPT code descriptor of the 
primary service). (We remind readers that ED and critical care visits 
are not reported as prolonged services). While this is a complex 
approach for the CY 2022 transition year, we note that prolonged 
services historically are not frequently reported. We summarize these 
policies in Table 27.
[GRAPHIC] [TIFF OMITTED] TR19NO21.049

d. New and Established Patients, and Initial and Subsequent Visits
    Our withdrawn manual provisions stated that when an E/M service is 
furnished as a split or shared encounter, between a physician and an 
NPP (that is, an NP, PA, CNS or CNM), the service is considered to have 
been performed ``incident to'' if the requirements for ``incident to'' 
are met and the patient is an established patient. This provision was 
generally interpreted to mean that split (or shared) visits cannot be 
billed for new patients. The withdrawn manual provisions also did not 
specify whether the practitioner who bills for the split (or shared) 
visit could bill for initial, versus subsequent, split (or shared) 
visits in the facility setting. After conducting an internal review, 
including consulting our medical officers, in our proposed rule we 
stated our belief that the practice of medicine has evolved toward a 
more team-based approach to care, and greater integration in the 
practice of physicians and NPPs, particularly when care is furnished by 
practitioners in the same group in the facility setting. Given this 
evolution in medical practice, the concerns that may have been present 
when we issued the manual instructions may no longer be as relevant. We 
understand that there have been changes in the practice of medicine 
over the past several years, some facilitated by the advent of EHRs and 
other systems, toward a more team-based approach to care. There has 
also been an increase in alternative payment models that employ a more 
team-based approach to care. After considering and reevaluating our 
policy, we saw no reason to preclude the physician or NPP from billing 
for split (or shared) visits for a new patient, in addition to an 
established patient, or for initial and subsequent split (or shared) 
visits. Therefore, we proposed to permit the physician or NPP to bill 
for split (or shared) visits for both new and established patients, as 
well as for initial and subsequent visits. We believed this approach 
would also be consistent with the CPT E/M Guidelines for split (or 
shared) visits, which does not exclude these types of visits from being 
billed when furnished as split (or shared) services.
    Comment: We received many comments on this proposal, all in support 
of it.
    Response: We thank the commenters for their support. After 
consideration of public comments, we are finalizing as proposed.
e. Settings of Care
    The concept of split (or shared) visits was developed as an analog 
in the facility setting to payment policies for services and supplies 
furnished incident to a physician's or an NPP's professional services 
in the non-institutional setting. Section 410.26(a)(6) of our 
regulations defines the non-institutional setting as all settings other 
than a hospital or SNF. We proposed to allow billing of split (or 
shared) visits, including critical care visits, when they are performed 
in any institutional setting and proposed to codify the definition of 
facility setting in the regulation at Sec.  415.140. We discuss our 
proposals regarding billing for critical care split (or shared) E/M 
services below (see section II.F.2. of this final rule).
    Our withdrawn manual provisions did not allow practitioners to bill 
for split (or shared) visits that are critical care services or SNF/NF 
visits. The manual stated that the split (or shared) E/M policy did not 
apply to critical care services or procedures, and that a split (or 
shared) E/M service performed by a physician and a qualified NPP of the 
same group (or employed by the same employer) cannot be reported as a 
critical care service. It also stated that a split (or shared) E/M 
visit cannot be reported in the SNF/NF setting. We proposed to define 
split (or shared) visits to be limited to services furnished in 
institutional settings, as discussed above. As discussed below, we did 
not see any reason to preclude billing for split (or shared) visits for 
critical care services, although we sought public comment on this issue 
in particular. We understand that there have been changes in the 
practice of medicine over the past several years, some facilitated by 
the advent of EHRs and other systems, toward a more team-based approach 
to care. There has also been an increase in alternative payment models

[[Page 65157]]

that employ a more team-based approach to care. Where a physician and 
NPP in the same group take a team approach to furnishing care, as would 
be the case for split (or shared) visits, even for new patients, 
initial visits, critical care visits, or SNF/NF visits, we were less 
concerned about potential disruptions in continuity of care than we 
might once have been. Rather, we believed that when a visit is shared 
between a physician and an NPP in the same group, there would be close 
coordination and an element of collaboration in providing care to the 
beneficiary.
    We did not see any reason to preclude billing for split (or shared) 
visits for the subset of SNF/NF visits that are not required by our 
regulations to be performed in their entirety by a physician. Under our 
current policy, no E/M services can be furnished and billed as split 
(or shared) visits in the SNF setting. We refer readers to our 
Conditions of Participation in 42 CFR 483.30 for information regarding 
the SNF/NF visits that are required to be performed in their entirety 
by a physician. That regulation requires that certain SNF/NF visits 
must be furnished directly and solely by a physician. Therefore, our 
proposal would not apply to the SNF/NF visits that are required to be 
performed in their entirety by a physician; any SNF/NF visit that is 
required to be performed in its entirety by a physician cannot and 
would not be able to be billed as a split (or shared) visit. However, 
for other visits to which the regulation at Sec.  483.30 does not 
apply, there is no requirement for a physician to directly and solely 
perform the visit. We proposed that those visits could be furnished and 
billed as split (or shared) visits.
    Comment: We received many comments on this proposal, all in support 
of it.
    Response: We thank the commenters for their support. After 
consideration of the public comments, we are finalizing as proposed.
f. Same Group
    In accordance with the current policy outlined in the withdrawn 
manual provisions, we proposed that a physician and NPP must be in the 
same group in order for the physician and NPP to bill for a split (or 
shared) visit. We believed that in circumstances when a split or 
(shared) visit is appropriately billed, a physician and NPP are working 
jointly to furnish all of the work related to the visit with the 
patient. However, if a physician and NPP are in different groups, we 
would expect the physician and NPP to bill independently, and only for 
the services they specifically and fully furnish. Further, consistent 
with our withdrawn manual guidance, we noted that Medicare does not pay 
for partial physician's visits, so CPT modifier -52 (reduced services) 
could not be used to report split (or shared) visits. Thus, if a 
physician and an NPP who are in different groups each furnished part of 
an E/M service, but not all of it, then we would not consider either 
service to be a billable service. Similarly, if two physicians, each in 
their own private practice, both saw the same patient in the hospital, 
but neither one fully furnished a billable service--there would be no 
basis on which to combine their efforts or minutes of service into one 
billable E/M visit.
    We sought public comment on whether we should further define 
``group'' for purposes of split (or shared) visit billing. While we did 
not propose a definition in the proposed rule, we considered several 
options, such as requiring that the physician and NPP must be in the 
same clinical specialty, in which case we would use the approach 
outlined in the CPT E/M Guidelines; that is the NPP is considered to be 
in the same specialty and subspecialty as the physician with whom they 
are working.\28\ We were also considering an approach under which we 
would align the definition of ``group'' with the definition of 
``physician organization'' at Sec.  411.351. The term ``physician 
organization'' is defined at Sec.  411.351 for purposes of section 1877 
of the Act and our regulations in 42 CFR part 411, subpart J 
(collectively, the physician self-referral law), and explained further 
in frequently asked questions available on the CMS website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Downloads/FAQs-Physician-Self-Referral-Law.pdf. Another approach would be to 
consider practitioners with the same billing tax identification number 
(TIN) as being in the same group. We were concerned that this 
particular approach may be too broad in multi-specialty groups or 
health care systems that include many practitioners who do not 
typically work together to furnish care to patients in the facility 
setting. We noted that some of these approaches may not align with the 
definition of ``group'' used for purposes of Medicare enrollment.
---------------------------------------------------------------------------

    \28\ 2021 CPT Codebook, p. 6, ``When advanced practice nurses 
and physician assistants are working with physicians, they are 
considered as working in the exact same specialty and exact same 
subspecialties as the physician.''
---------------------------------------------------------------------------

    Comment: We did not receive comments disagreeing with our proposal 
that the physician and NPP should be in the same group. Commenters 
agreed that the appropriate definition of group in the context of split 
(or shared) visits is a complex issue. Some commenters did not 
recommend that we further define ``group'' in this context, suggesting 
that the liability to a physician taking on the responsibility of 
billing for an NPP's work under their NPI, or assuming supervisory 
responsibility for an NPP, will only split (or share) visits with NPPs 
in whom they have confidence.
    Some other commenters recommended various ways to define group. 
These included:
     Having the same TIN.
     Being an employee or independent contractor of the same 
entity.
     Being in the same clinical specialty or clinical specialty 
practice.
     Working as part of the team that provides the same 
clinical services. For example, if an NPP is working with a group of 
orthopedic surgeons to treat the patient, the NPP should be considered 
part of the orthopedic surgery group when determining whether split (or 
shared) visits can be provided.
     Being members of a care team working in the same practice.
     Presence of a supervisory or liability relationship 
between the physician and NPP.
     Professional service agreements that the physician has 
with the institution, or other care-coordination models under the 
Quality Payment Program.
     Aligning with the CPT E/M Guidelines in which the NPP is 
considered to be in the same specialty and subspecialty as the 
physician with whom they are working.
    One commenter objected to classifying NPPs as being in the same 
specialty or subspecialty of the physician with whom they work. The 
commenter stated that split (or shared) visits across specialties are 
important for multidisciplinary care (for example, a PA specializing in 
cardiology should be able to split (or share) critical care services 
with a pulmonologist in the same group practice to provide the most 
appropriate, interdisciplinary care to manage life threatening illness 
or injury). However, another commenter noted that requiring different 
specialties may have the unintended consequence of NPPs always being in 
different specialties than the physicians with whom they work under the 
PFS specialty taxonomy.
    A few commenters stated that using the definition of physician 
organization at Sec.  411.352 would be too burdensome, prescriptive, 
and extensive. These commenters stated that under this

[[Page 65158]]

definition, a solo physician with NPP(s) in their practice (as is 
common in rural areas) would be disadvantaged, because the group would 
be required to have at least two physicians who are members of the 
group (whether employees or direct or indirect owners).
    Several commenters stated that the definition should include TIN 
but also professional service agreements that the physician has with 
the institution, or other care-coordination models under the Quality 
Payment Program that could include multiple TINs. Commenters 
acknowledged that a given TIN could encompass a health system or 
multiple specialties.
    One commenter recommended that being in the same group should mean 
being employed by, or an independent contractor affiliated with, the 
same entity, or an independent contractor who is billing through the 
same entity, or where the physician is obligated to perform the 
supervisory service for that particular NPP on the patient's date of 
service for the particular split (or shared) visit regardless of the 
billing entity status. The commenters noted it would be important for 
the physician to be legally responsible for the care being provided by 
the NPP.
    Some commenters recommended that we work with the AMA Workgroup on 
E/M to create a proposal to the CPT Editorial Panel to address this 
issue and to clarify the reporting in CPT E/M Guidelines. One commenter 
stated that the physician and NPP do not necessarily need to be the 
same specialty, but should be practicing as part of a team providing 
coordinated clinical care. The commenter stated that the definition of 
initial and subsequent E/M visits for 2023 will include guidance that 
aligns with the clinical team concept.
    Response: After consideration of the public comments, we are 
finalizing as proposed that the physician and NPP must be in the same 
group, but we are not further defining ``group'' at this time. We 
intend to monitor our claims data, and we thank the commenters for 
their recommendations and insights into current practice, which we may 
consider for future rulemaking.
g. Medical Record Documentation
    To ensure program integrity and quality of care, we proposed that 
documentation in the medical record must identify the two individual 
practitioners who performed the visit. The individual who performed the 
substantive portion (and therefore, bills the visit) would be required 
to sign and date the medical record. We proposed to revise our 
regulation at Sec.  415.140 to reflect the conditions of payment for 
split (or shared) visits as discussed in this section.
    We received public comments on the medical record documentation. 
The following is a summary of the comments we received and our 
responses.
    Comment: We did not receive many comments to our documentation 
proposal. A few commenters supported our proposal. Several other 
commenters did not support it, because they believe each practitioner 
should document what they perform or, in the inpatient setting, sign, 
date, and time their documentation in the medical record. A few 
commenters recommended that we work with the AMA/CPT to develop 
consensus on a single set of clarifying guidelines. One commenter 
opposed the requirement that the billing provider sign and date the 
medical record, stating that this is a needless administrative 
requirement that will not support program integrity.
    Response: Recently, we finalized a policy through notice and 
comment rulemaking that any individual who is authorized under Medicare 
law to furnish and bill for their professional services, whether or not 
they are acting in a teaching role, may review and verify (sign and 
date) the medical record for the services they bill, rather than re-
document notes in the medical record made by physicians, residents, 
nurses, and students (including students in therapy or other clinical 
disciplines), or other members of the medical team (85 FR 84594 through 
84596). We emphasized that, while any member of the medical team may 
enter information into the medical record, only the reporting clinician 
may review and verify notes made in the record by others for the 
services the reporting clinician furnishes and bills.
    We continue to believe that we should only require the reporting 
clinician to review and verify medical records documenting the services 
provided by themselves and other individuals during an E/M visit for 
which they bill, because the reporting clinician assumes responsibility 
for those services by signing off on the medical record. It may be 
helpful for each practitioner providing the split (or shared) visit to 
directly document and time their activities in the medical record, to 
track and attribute time, in order to determine who performed the 
substantive portion and should therefore bill. However, we believe we 
should leave it to the discretion of individual practitioners and the 
groups they work in to decide how time will be tracked. For split (or 
shared) visits, we continue to believe that documentation in the 
medical record needs to identify the two individual practitioners who 
split (or shared) the visit. Therefore, after consideration of public 
comments, we are finalizing as proposed that documentation in the 
medical record must identify the two individual practitioners who 
performed the visit. The individual who performed the substantive 
portion (and therefore, bills the visit) must sign and date the medical 
record. We are revising our regulation at Sec.  415.140 to include 
these requirements.
h. Claim Identification
    We proposed to create a modifier to describe split (or shared) 
visits, and we proposed to require that the modifier must be appended 
to claims for split (or shared) visits, whether the physician or NPP 
bills for the visit. Currently, we cannot identify through claims that 
a visit was performed as a split (or shared) visit, which means that we 
could know that a visit was performed as a split (or shared) visit only 
through medical record review. We believed it is important for program 
integrity and quality considerations to have a way to identify who is 
providing which E/M services, and how often we are paying at the 
physician rate for services provided in part by NPPs. (Please see the 
documentation section above for additional information). The modifier 
would give CMS insight, directly through our claims data instead of 
only through medical record review, into the specific circumstances 
under which these split (or shared) visits are furnished. Such 
information would be helpful to CMS for program integrity purposes, and 
could be instructive in considering whether we may need to offer 
additional clarification to the public, or further revise the policy 
for these E/M visits in future rulemaking.
    We proposed to revise our regulation at Sec.  415.140 to reflect 
the conditions of payment for split (or shared) visits as discussed in 
this section.
    Consistent with our current policy, Medicare does not pay for 
partial E/M visits for which all elements of the service are not 
furnished. Therefore, we proposed that the modifier identified by CPT 
for purposes of reporting partial services (modifier -52 (reduced 
services)) could not be used to report partial E/M visits, including 
any partial services furnished as split (or shared) visits. We noted 
that we were also considering whether it is necessary to amend our 
regulations to explicitly state that Medicare does not pay for partial 
E/M visits and were interested in public comments on this issue.
    We received public comments on the claim identification and partial 
visit

[[Page 65159]]

policy proposals. The following is a summary of the comments we 
received and our responses.
    Comment: Many commenters were supportive of a modifier to identify 
split (or shared) visits on claims. Several commenters stated that this 
would allow for tracking the contributions of NPPs more easily, 
increasing transparency and allowing providers, employers, and CMS to 
better evaluate those contributions. These commenters stated that 
accurate attribution of services is needed for quality assessment, 
resource utilization determinations, and future policy considerations. 
However, many commenters opposed the adoption of a modifier to identify 
split (or shared) visits because they believe it will increase 
administrative burden. One association recommended a one-year delay, to 
allow for practitioner education. Another commenter noted that we did 
provide a sufficient rationale, and asked about the agency's program 
integrity experience with split (or shared) services.
    Response: We agree with commenters that accurate attribution of 
services is needed for transparency and program integrity, quality 
assessment, resource utilization determinations, and future policy 
considerations. We agree with the commenters that, given the 
differential PFS payment rates for physicians and NPPs, we need to be 
able to identify when visits are furnished by these different types of 
practitioners to improve payment accuracy.
    We disagree that reporting a modifier on a claim comprises a 
substantial administrative burden, and believe that any potential 
burden is outweighed by policy considerations of quality, payment 
accuracy and program integrity, as described above.
    After consideration of the public comments, we are finalizing as 
proposed that, for services furnished beginning in CY 2022, we will 
require a modifier to be reported on the claim to identify split (or 
shared) visits as such.
    Comment: We received few public comments on our proposal that the 
modifier identified by CPT for purposes of reporting partial services 
(modifier -52 (reduced services)) could not be used to report partial 
E/M visits, including any partial services furnished as split (or 
shared) visits. One commenter agreed with our view that PFS payment is 
not made for partial E/M visits, and did not believe that an explicit 
prohibition needs to be codified. Another commenter stated that split 
(or shared) visits should not be defined as partial or incomplete 
services, because they are neither.
    Response: We thank the commenters for their support. In this final 
rule, we are clarifying that Medicare does not pay for partial E/M 
visits, and that the modifier identified by CPT for purposes of 
reporting partial services (modifier -52 (reduced services)) cannot be 
used to report partial E/M visits, including any partial services 
furnished as split (or shared) visits.
2. Critical Care Services (CPT Codes 99291-99292)
    As stated previously, in light of updates that we previously 
finalized for coding and payment for office/outpatient E/M visits, we 
proposed a number of refinements to other E/M code sets including 
critical care. Historically, our policy for billing critical care 
services was reflected in several provisions in the Medicare Claims 
Processing Manual (sections 30.6.1(B), 30.6.12, and 30.6.13(H)) that 
were withdrawn effective May 9, 2021, in response to a petition under 
the Department's Good Guidance regulation at 45 CFR 1.5 (see 
Transmittal 10742 available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Transmittals/r10742cp). 
In the absence of these manual provisions, Medicare statute and various 
broadly applicable regulations continue to apply. In addition to 
withdrawing the manual provisions, we issued our response to the 
petition and accompanying enforcement instruction issued on May 26, 
2021, available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/Evaluation-and-Management-Visits.
    In those documents, we indicated that we intend to address split 
(or shared) visits (see the previous section) and critical care 
services (addressed in this section) through rulemaking and that until 
we do, we will limit review to the applicable statutory and regulatory 
requirements for purposes of assessing payment compliance. The list of 
applicable statutory and regulatory requirements includes the CY 2021 
PFS final rule (85 FR 84549), where CMS generally adopted new CPT 
prefatory language and code descriptors for office/outpatient E/M 
visits. Therefore, we proposed to update our critical care E/M visit 
policies to improve transparency and clarity, and to account for recent 
revisions to E/M visit coding and payment.
    Specifically, we made a number of proposals related to critical 
care visits in the CY 2021 PFS proposed rule (86 FR 39207 through 
39211). The CPT 2021[supreg] Professional Codebook (hereafter, CPT 
Codebook) provides guidelines for critical care services in the CPT E/M 
Guidelines on pp. 5-9 and in prefatory language, code descriptors, and 
parentheticals on pp. 31-33. We proposed to adopt the CPT prefatory 
language for critical care services as currently described in the CPT 
Codebook, except as otherwise specified. Should CPT make changes to the 
guidance for critical care services in a subsequent edition of the CPT 
Codebook, we could revisit these policies in future rulemaking.
    We proposed to clarify our definition of critical care visits, as 
well as requirements governing how critical care visits are reported 
under various circumstances, including when:
     A single practitioner furnishes critical care.
     More than one practitioner or specialty furnishes critical 
care visits.
     A critical care visit is furnished as a split (or shared) 
visit.
     A critical care visit and another E/M visit occur on the 
same day.
     Critical care is furnished in the context of global 
surgery.
     Documenting critical care visits.
a. Definition of Critical Care
    Critical care visits are described by CPT codes 99291 (Critical 
care, evaluation and management of the critically ill or critically 
injured patient; first 30-74 minutes) and 99292 (each additional 30 
minutes (List separately in addition to code for primary service). The 
CPT 2021[supreg] Professional Codebook (hereafter, CPT Codebook) 
defines critical care services in prefatory language on pp. 31-33.
    Critical care services were defined in the withdrawn provisions of 
the Medicare Claims Processing Manual (IOM). The IOM definition tracked 
closely with the CPT Codebook prefatory language regarding critical 
care services. To improve transparency and clarity, we proposed to 
adopt the CPT prefatory language as the definition of critical care 
visits. The CPT prefatory language states that critical care is the 
direct delivery by a physician(s) or other qualified healthcare 
professional (QHP) of medical care for a critically ill/injured patient 
in which there is acute impairment of one or more vital organ systems, 
such that there is a probability of imminent or life-threatening 
deterioration of the patient's condition.\29\ It involves high 
complexity decision-making to treat single or multiple vital organ 
system failure and/

[[Page 65160]]

or to prevent further life-threatening deterioration of the patient's 
condition. In the proposed rule, we stated our belief that the CPT 
Codebook appropriately delineates coding and definitions for critical 
care services in order to distinguish them as more intense services 
that are valued relatively higher than other E/M services. Thus, we 
proposed to adopt the CPT prefatory language as the definition of 
critical care visits and referred readers to the CPT Codebook for 
additional details.
---------------------------------------------------------------------------

    \29\ 2021 CPT Codebook, p.31.
---------------------------------------------------------------------------

    We stated that, under current Medicare policy, a QHP is an 
individual who is qualified by education, training, licensure/
regulation (when applicable), facility privileging (when applicable), 
and the applicable Medicare benefit category to perform a professional 
service within their scope of practice and independently report that 
service (see, for example, 80 FR 70957; 85 FR 84543, 84593). Because 
the CPT Codebook provides that critical care services can be delivered 
by a physician or QHP, we proposed that critical care services may be 
reported by a physician or NPP who is a QHP (as explained above). In 
this section of our final rule, we refer to such an individual as an 
NPP.
    In our proposed rule, we also noted that the CPT prefatory language 
specifies that critical care may be furnished on multiple days, and is 
typically furnished in a critical care area, which can include an 
intensive care unit or emergency care facility. CPT prefatory language 
also states that critical care requires the full attention of the 
physician or NPP, and therefore, for any given time period spent 
providing critical care services, the practitioner cannot provide 
services to any other patient during the same period of time. We 
proposed to adopt this CPT prefatory language to improve transparency 
and clarity of our policy for critical care for Medicare billing 
purposes.
    CPT prefatory language also provides billing and coding guidance. 
The guidance bundles several services into critical care visits 
furnished by a given practitioner when performed during the critical 
period by the practitioners providing critical care. We proposed to 
adopt CPT's listing of bundled services that are part of critical care 
visits: Interpretation of cardiac output measurements (CPT codes 93561, 
93562), chest X rays (CPT codes 71045, 71046), pulse oximetry (CPT 
codes 94760, 94761, 94762), blood gases, and collection and 
interpretation of physiologic data (for example, ECGs, blood pressures, 
hematologic data); gastric intubation (CPT codes 43752, 43753); 
temporary transcutaneous pacing (CPT code 92953); ventilator management 
(CPT codes 94002-94004, 94660, 94662); and vascular access procedures. 
As a result, these codes would not be separately billable by a 
practitioner during the time-period when the practitioner is providing 
critical care for a given patient. We also proposed to adopt the CPT 
prefatory language stating that time spent performing separately 
reportable procedures or services should be reported separately and 
should not be included in the time reported as critical care time.
    Comment: The public comments were supportive of our proposed 
definition of critical care. Several commenters expressed concern about 
the services that are bundled into the critical care codes. In 
particular, they disagreed with the inclusion of vascular access 
procedures in the bundled services. The commenters stated that bundling 
all of the vascular access procedures (not merely peripheral access, 
but also central venous and arterial lines) into critical care billing 
is not advisable because of the significant additional risk potential 
of central venous and arterial access procedures. The commenters added 
that the central venous and arterial access procedures require 
significant additional procedural training and skill on the part of the 
practitioner and that not all those who practice critical care have 
this additional competency. The commenters suggested the peripheral 
vascular access procedures could be bundled into critical care 
services, but not the central venous/arterial access procedures.
    Response: We appreciate the commenters' support of our proposed 
definition of critical care. For administrative simplicity, we believe 
we should adopt the CPT listing of bundled services. We note that we 
included vascular access procedures in the list of bundled services 
because page 31 of the CPT Codebook states that vascular access 
procedures are included in critical care bundle when performed during 
the critical period by the physician(s) providing clinical care. 
Therefore, we are finalizing as proposed the CPT listing of services 
bundled into critical care. We will review and consider any future 
changes made by CPT to the listing of bundled services, if future 
changes are made by the CPT Editorial Panel.
    After consideration of public comments, we are finalizing our 
proposal to adopt the CPT definition of critical care services and the 
current CPT listing of bundled services.
b. Critical Care by a Single Physician or NPP
    Our withdrawn manual provisions and the prefatory language in the 
CPT Codebook both describe the time duration for the correct reporting 
of critical care services by a single physician or NPP. To improve 
transparency and clarity of our policy, we proposed to adopt the CPT 
prefatory language. Under our proposal, the physician or NPP would 
report CPT code 99291 for the first 30-74 minutes of critical care 
services provided to a patient on a given date. The CPT Codebook 
indicates that CPT code 99291 should be used only once per date even if 
the time spent by the practitioner is not continuous on that date. 
Thereafter, the physician or NPP would report CPT code 99292 for 
additional 30-minute time increments provided to the same patient. The 
prefatory language states that CPT codes 99291 and 99292 are used to 
report the total duration of time spent by the physician or QHP (NPP) 
providing critical care services to a critically ill or critically 
injured patient, even if the time spent by the practitioner on that 
date is not continuous; and that non-continuous time for medically 
necessary critical care services may be aggregated. We proposed to 
adopt these rules for critical care services furnished by a single 
physician or NPP. We noted that the prefatory language does not 
indicate how practitioners should report critical care when a service 
lasts beyond midnight. We solicited public comments about how 
practitioners should report CPT codes 99291 and 99292 when critical 
care services extend beyond midnight to the following calendar day. We 
referred readers to the CPT Codebook (page 32) for examples of the 
total duration of critical care visits.
    Comment: We received a few comments regarding this proposal. 
Commenters expressed support for allowing time to be aggregated when 
reporting the total duration of time spent by a physician or NPP 
providing critical care services, even if the time spent by the 
practitioner on that date is not continuous. Several commenters 
submitted suggestions for how practitioners might report CPT codes 
99291 and 99292 when a service extends beyond midnight to the following 
calendar date. One commenter urged us to work with the AMA to develop 
guidance to be added to the CPT prefatory language, so that consistent 
guidance exists across payers. Other commenters recommended that

[[Page 65161]]

when critical care extends over midnight, the entire period be 
attributed to the calendar day the critical care service was initiated. 
Another commenter suggested that the practitioner should conclude the 
distinct episode of critical care provision, tally the time, and 
attribute the service to the initial date. One other commenter 
recommended that, when critical care services extend beyond midnight, 
we should adopt the same rule that applies in the Outpatient 
Prospective Payment System (OPPS): Critical care services should be 
billed with the date of service they began.
    Response: We thank the commenters for their support and 
suggestions. After consideration of public comments, we are finalizing 
as proposed that the physician or NPP will report CPT code 99291 for 
the first 30-74 minutes of critical care services provided to a patient 
on a given date. CPT code 99291 will be used only once per date even if 
the time spent by the practitioner is not continuous on that date. 
Thereafter, the physician or NPP will report CPT code 99292 for 
additional 30-minute time increments provided to the same patient. CPT 
codes 99291 and 99292 will be used to report the total duration of time 
spent by the physician or NPP providing critical care services to a 
critically ill or critically injured patient, even if the time spent by 
the practitioner on that date is not continuous; and non-continuous 
time for medically necessary critical care services may be aggregated.
    Regarding critical care crossing midnight, since the publication of 
the CY 2022 PFS proposed rule, we identified CPT guidance that defines 
how a service is to be billed when the service extends across calendar 
dates. According to CPT introductory language, ``Some services measured 
in units other than days extend across calendar dates. When this 
occurs, a continuous service does not reset and create a first hour. 
However, any disruption in the service does create a new initial 
service. For example, if intravenous hydration (96360, 96361) is given 
from 11 p.m. to 2 a.m., 96360 would be reported once and 96361 twice. 
For continuous services that last beyond midnight (that is, over a 
range of dates), report the total units of time provided continuously'' 
(CPT Codebook, page xvii). We are adopting this rule for critical care 
being furnished by a single physician or NPP when the critical care 
crosses midnight.
c. Critical Care Visits Furnished Concurrently by Different Specialties
    The CPT Codebook does not provide special instruction about how to 
report critical care visits furnished concurrently by more than one 
physician or practitioner, whether in a split (or shared) visit context 
or other contexts that might be relevant given the unique nature of 
critical care and the long timeframes over which patients may receive 
these services. The CPT E/M Guidelines state broadly that concurrent 
care is the provision of similar services (for example, hospital 
visits) to the same patient by more than one physician or other QHP on 
the same day. The CPT E/M Guidelines state that when concurrent care is 
provided, no special reporting is required.\30\ The CPT E/M Guidelines 
also state broadly that when time is being used to select the 
appropriate level of services for which time-based reporting of split 
(or shared) visits is allowed), the time personally spent by the 
physician and other QHP(s) assessing and managing the patient on the 
date of the encounter is summed to define total time; and that only 
distinct time should be summed for split (or shared) visits (that is, 
when two or more individuals jointly meet with or discuss the patient, 
only the time of one individual should be counted).\31\
---------------------------------------------------------------------------

    \30\ 2021 CPT Codebook (Evaluation and Management (E/M) Services 
Guidelines), p.8.
    \31\ 2021 CPT Codebook (Evaluation and Management (E/M) Services 
Guidelines), p.7.
---------------------------------------------------------------------------

    In the context of critical care services, our withdrawn manual 
provisions provided guidance on concurrent care, and stated that there 
are situations where physicians or NPPs within a group provide coverage 
or follow-on care for one another on a single day. The manual also 
stated that critically ill or injured patients may require the care of 
more than one practitioner from more than one specialty (regardless of 
group affiliation), and this work could transpire simultaneously or 
could overlap.
    Consistent with our current policy, and to improve transparency and 
clarity of our policy for critical care services, we proposed that 
concurrent care occurs where more than one physician or qualified NPP 
furnishes services to the same patient on the same day. Medicare policy 
for physicians' services is that concurrent care exists where more than 
one physician renders services more extensive than consultative 
services during a period of time.\32\ The reasonable and necessary 
services of each physician rendering concurrent care could be covered 
where each is required to play an active role in the patient's 
treatment (for example, because of the existence of more than one 
medical condition requiring diverse specialized medical services). In 
our proposed rule, we noted that, in the context of critical care 
services, a critically ill patient may have more than one medical 
condition requiring diverse specialized medical services and thus 
requiring more than one practitioner having different specialties to 
play an active role in the patient's treatment. Thus, we proposed that 
critical care visits may be furnished as concurrent care (or 
concurrently) to the same patient on the same date by more than one 
practitioner in more than one specialty (for example, an internist and 
a surgeon, allergist and a cardiologist, neurosurgeon and NPP), 
regardless of group affiliation, if the service meets the definition of 
critical care and is not duplicative of other services. Additionally, 
as for most Medicare-covered services, these critical care visits would 
need to be medically reasonable and necessary for the diagnosis or 
treatment of illness or injury or to improve the functioning of a 
malformed body member. We solicited public comments on our proposal to 
better understand current clinical practice for critical care, and when 
it would be appropriate for more than one physician or NPP of the same 
or different specialties, and within the same or a different group, to 
provide critical care services.
---------------------------------------------------------------------------

    \32\ Medicare Benefit Policy Manual (Pub. 100-04) Chapter 15, 
Section 30.D.
---------------------------------------------------------------------------

    Comment: We received a few comments, all in support of our 
proposal.
    Response: We thank commenters for their support, and are finalizing 
as proposed.
d. Critical Care Furnished Concurrently by Practitioners in the Same 
Specialty and Same Group (Follow-Up Care)
    Physician(s) or NPP(s) in the same specialty and in the same group 
may provide concurrent follow-up care, such as a critical care visit 
subsequent to another practitioner's critical care visit. This may be 
as part of continuous staff coverage or follow-up care to critical care 
services furnished earlier in the day on the same calendar date.
    According to CPT coding and billing conventions, a practitioner who 
furnishes a timed service such as a critical care visit would typically 
need to report the primary service or procedure code before reporting 
an add-on code. However, we stated that because practitioners in the 
same specialty and same group cover for one another, we believed the 
total time for

[[Page 65162]]

critical care services furnished to a patient on the same day by the 
practitioners in the same group with the same specialty should be 
reflected as if it were a single set of critical care services 
furnished to the patient. We proposed that, when critical care is 
furnished concurrently, by two or more practitioners in the same 
specialty and in the same group, to the same patient on the same date, 
the individual physician(s) or NPP(s) providing the follow-up or 
subsequent care would report their time using the code for subsequent 
time intervals (CPT code 99292), and would not report the primary 
service code (CPT code 99291). CPT code 99291 would not be reported 
more than once for the same patient on the same day by these 
practitioners. This proposal recognizes that multiple practitioners in 
the same specialty and the same group can maintain continuity of care 
by providing follow-up care for the same patient on the same day, and 
is consistent with our current policy as described in the withdrawn 
manual provisions.
    We proposed that in the situation where a practitioner furnishes 
the initial critical care service in its entirety and reports CPT code 
99291, that the practitioner(s) reporting subsequent critical care 
services would report CPT code 99292. This proposal recognizes that 
multiple practitioners in the same specialty and group can furnish 
critical care services concurrently to a patient on a single day.
    We also proposed that when one practitioner begins furnishing the 
initial critical care service, but does not meet the time required to 
report CPT code 99291, another practitioner in the same specialty and 
group can continue to deliver critical care to the same patient on the 
same day. We stated that the total time spent by the practitioners 
could be aggregated to meet the time requirement to bill CPT code 
99291. Under this proposal, once the cumulative required critical care 
service time is met to report CPT code 99291, CPT code 99292 could not 
be reported by a practitioner in the same specialty and group unless 
and until an additional 30 minutes of critical care services are 
furnished to the same patient on the same day (74 minutes + 30 minutes 
= 104 total minutes).
    Finally, we stated that the aggregated time spent on critical care 
visits must be medically necessary and each visit must meet the 
definition of critical care in order to add the times for purposes of 
meeting the time requirement to bill CPT code 99291.
    Comment: Several comments supported our proposal to aggregate time 
for critical care furnished concurrently by practitioners in the same 
specialty and same group (Follow-Up Care). A couple of commenters noted 
our math miscalculation (86 FR 39209). We incorrectly stated that 70 
minutes + 34 minutes = 114 minutes when in fact it equals 104 minutes.
    Response: We appreciate the support of commenters and thank them 
for letting us know about our addition error. We have revised the total 
number of minutes.
    After consideration of public comments, we are finalizing our 
proposal for aggregating time when critical care is furnished 
concurrently, by two or more practitioners in the same specialty and in 
the same group, to the same patient on the same date (follow-up care).
e. Split (or Shared) Critical Care Visits
    Under current CMS policy, critical care services cannot be billed 
as split (or shared) E/M services. As previously discussed in section 
II.F.1. of this final rule for split (or shared) visits, we believe the 
practice of medicine has evolved toward a more team-based approach to 
care, and greater integration in the practice of physicians and NPPs, 
particularly when care is furnished by clinicians in the same group in 
the facility setting. Given this evolution in medical practice, the 
concerns that may have been present when we issued current policy may 
no longer be as relevant. We understand that there have been changes in 
the practice of medicine over the past several years, some facilitated 
by the advent of EHRs and other systems, toward a more team-based 
approach to care. There has also been an increase in alternative 
payment models that employ a more team-based approach to care. In 
considering and reevaluating this policy, we believed it would be 
appropriate to revise our policy to allow critical care services to be 
reported when furnished as split (or shared) services. Therefore, we 
proposed that critical care visits may be furnished as split (or 
shared) visits. The proposals described for other types of split (or 
shared) visits would apply (except for the listing of qualifying 
activities for determining the substantive portion, discussed below), 
and service time would be counted for CPT code 99292 in the same way as 
for prolonged E/M services. In other words, we proposed that the total 
critical care service time provided by a physician and NPP in the same 
group on a given calendar date to a patient would be summed, and the 
practitioner who furnishes the substantive portion of the cumulative 
critical care time would report the critical care service(s).
    Since unlike other types of E/M visits, critical care services can 
include additional activities that are bundled into the critical care 
visits code(s), we proposed a different listing of qualifying 
activities for split (or shared) critical care. These qualifying 
activities are described in prefatory language on pp. 31-32 of the 2021 
CPT Codebook. When critical care services are furnished as a split (or 
shared) visit, we proposed to define the substantive portion as more 
than half the cumulative total time in qualifying activities that are 
included in CPT codes 99291 and 99292.
    Similar to our proposal for split (or shared) prolonged visits, the 
billing practitioner would first report CPT code 99291 and, if 75 or 
more cumulative total minutes were spent providing critical care, the 
billing practitioner could report one or more units of CPT code 99292. 
We would require practitioners to include the proposed split (or 
shared) visit modifier on the claim, and the same documentation rules 
would apply as for other types of split (or shared) E/M visits. We 
noted that, in contrast to our proposals regarding concurrent critical 
care services, when a critical care service is furnished as a split (or 
shared) visit, when two or more practitioners spend time jointly 
meeting with or discussing the patient, the time could be counted only 
once for purposes of reporting the split (or shared) critical care 
visit. This is consistent with our proposed policy for all split (or 
shared) visits. It is also consistent with the CPT E/M Guidelines 
stating that, for split (or shared) visits, when two or more 
individuals jointly meet with or discuss the patient, only the time of 
one individual should be counted).\33\
---------------------------------------------------------------------------

    \33\ 2021 CPT Codebook (Evaluation and Management (E/M) Services 
Guidelines), p.7.
---------------------------------------------------------------------------

    We sought public comment on these proposals to ensure they reflect 
a clinically appropriate approach, and to help us assess whether we 
should instead require that an individual physician or NPP directly 
perform the entirety of each critical care visit. We sought public 
comment to better understand current clinical practice for critical 
care, and when it would be appropriate for more than one physician or 
NPP of the same or different specialties, and within the same or a 
different group, to provide critical care to a patient.
    Comment: We did not receive any public comments opposing any aspect 
of our proposals regarding split (or shared) critical care visits.
    Response: We thank the commenters for their support. After 
consideration of

[[Page 65163]]

the public comments, we are finalizing as proposed.
f. Critical Care Visits and Same-Day Emergency Department, Inpatient or 
Office/Outpatient Visits
    The CPT Codebook states that critical care and other E/M services 
may be provided to the same patient on the same date by the same 
individual. However, our general policy as described in the Medicare 
Claims Processing Manual states that physicians in the same group who 
are in the same specialty must bill and be paid for services under the 
PFS as though they were a single physician. If more than one E/M visit 
is provided on the same day to the same patient by the same physician, 
or by more than one physician in the same specialty in the same group, 
only one E/M service may be reported unless the E/M services are for 
unrelated problems. Instead of billing separately, the physicians 
should select a level of service representative of the combined visits 
and submit the appropriate code for that level.\34\
---------------------------------------------------------------------------

    \34\ Medicare Claims Processing Manual (Pub. 100-02), Chapter 
12, Section 30.6.5, Physicians In Group Practice.
---------------------------------------------------------------------------

    This policy is intended to ensure that multiple E/M visits for a 
patient on a single day are medically necessary and not duplicative. 
With respect to office/outpatient E/M visits specifically, our current 
manual instructs, ``As for all other E/M services except where 
specifically noted, the Medicare Administrative Contractors (MACs) may 
not pay two E/M office visits billed by a physician (or physician of 
the same specialty from the same group) for the same beneficiary on the 
same day unless the physician documents that the visits were for 
unrelated problems in the office, off campus-outpatient hospital, or on 
campus-outpatient hospital setting which could not be provided during 
the same encounter.'' \35\
---------------------------------------------------------------------------

    \35\ Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, 
Section 30.6.7.B., available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf.
---------------------------------------------------------------------------

    For hospital visits and hospital ED visits furnished on the same 
day as critical care services, the Medicare Claims Processing Manual 
states, ``When a hospital inpatient or office/outpatient E/M service 
are furnished on a calendar date at which time the patient does not 
require critical care and the patient subsequently requires critical 
care both the critical care services (CPT codes 99291 and 99292) and 
the previous E/M service may be paid on the same date of service. 
Hospital ED services are not paid for [on] the same date as critical 
care services when provided by the same physician to the same 
patient.'' \36\
---------------------------------------------------------------------------

    \36\ Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, 
Section 30.6.9.B., available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf.
---------------------------------------------------------------------------

    We expressed concern about adopting the CPT rule that states that 
critical care and other E/M visits may be furnished to the same patient 
on the same date by the same practitioner. We stated in the past that 
we believe multiple E/M visits by the same practitioner, or by 
practitioners in the same specialty within a group, on the same day as 
another E/M service ordinarily would not be medically necessary (83 FR 
59639). We noted that the CPT rule allowing billing for critical care 
and other E/M visits on the same day, by practitioners in the same 
group and of the same specialty, could lead to duplicative payment, 
particularly given the frequently long duration of critical care 
services, the CPT prefatory language indicating that time spent 
furnishing critical care may be non-continuous, and the relatively 
higher valuation of critical care services compared to other E/M 
services. Thus, we proposed that no other E/M visit can be billed for 
the same patient on the same date as a critical care service when the 
services are furnished by the same practitioner, or by practitioners in 
the same specialty in the same group.
    We suggested several alternative approaches to addressing our 
concerns about medical necessity and duplicative payment for E/M 
services furnished to a patient on the same day by the same 
practitioner or a practitioner in the same group. We previously 
considered an MPPR for standalone office/outpatient E/M visits that 
occur on the same day as a procedure. An MPPR would address 
efficiencies (for example, in preservice and postservice clinician work 
and PE) that are not accounted for in the current payment rates (83 FR 
59639). These visits could be identified on the claim with modifier -25 
(significant, separately identifiable E/M service by the same physician 
on the same day of the procedure or other service) and CMS could assign 
a reduced payment rate to one of the visits. CMS could also require 
documentation to support the medical necessity and non-duplicative 
nature of a claim for critical care services on the same calendar date 
as another E/M visit provided to a patient by the same practitioner or 
practitioner of the same specialty in a group.
    We recognized that our proposal not to allow an E/M visit to be 
billed for the same patient on the same date as a critical care service 
when the services are furnished by the same practitioner, or by 
practitioners in the same specialty within a group, might be 
appropriate only in certain clinical situations. For example, it is 
possible that a patient might not require critical care services at the 
time of an ED visit, but then be admitted to the hospital on the same 
calendar date as the ED visit and require care that meets the 
definition of critical care services. It is also possible that the 
practitioner who furnished the ED visit might provide the critical care 
services to the same patient on the same calendar date. Thus, we 
solicited public comments on our proposal to better understand clinical 
practice for critical care when E/M services are furnished on the same 
date as critical care services and the services are furnished by the 
same practitioner or practitioners in the same specialty in the same 
group, while also reducing the potential for duplicative payment.
    Comment: We received many public comments on our proposal regarding 
critical care visits and same-day emergency department, inpatient or 
office/outpatient E/M visits. Many commenters opposed the proposal. 
These commenters stated that the proposal was contrary to the CPT 
Codebook which states that critical care and other E/M services may be 
provided to the same patient on the same date by the same individual. 
Other commenters stated that same-day emergency department, inpatient 
or office/outpatient visits are separate services that can be 
independent of critical care services. Many commenters offered examples 
where an E/M visit might occur on the same day as critical care 
services and concluded by stating that there may be instances when a 
patient would need both types of services on the same day. Commenters 
stated that we should maintain enough flexibility around provision of 
these services to allow practitioners to bill an E/M visit on the same 
date as a critical care service in those instances where it is 
clinically appropriate and for which there is documentation of the 
specific services provided by each practitioner.
    Response: We appreciate the many comments we received on this 
proposal. We remain concerned about adopting the CPT rule that states 
that critical care and other E/M visits may be furnished to the same 
patient on the same date by the same practitioner. As we have stated in 
the past, we believe that multiple E/M visits by the same practitioner 
or practitioners in the same specialty within a group, on the same date 
as another E/M service would not seem to

[[Page 65164]]

be medically necessary (83 FR 59639). We appreciate the examples that 
commenters sent describing situations where a patient might require a 
same-day E/M visit, as well as critical care services, and understand 
that in certain circumstances the E/M visit could be independent of the 
critical care services. We also agree that flexibility is important; 
although, we do not presume the billing of critical care with other E/M 
visits on the same day as a typical situation. We note that the CPT 
rule allowing billing for critical care and other E/M visits on the 
same day, by practitioners in the same group and of the same specialty, 
could lead to duplicative payment, particularly given the frequently 
long duration of critical care services.
    After consideration of the public comments, we are finalizing a 
policy similar to the policy in our withdrawn manual. Specifically, as 
long as the physician documents that the E/M service was provided prior 
to the critical care service at a time when the patient did not require 
critical care, that the service is medically necessary, and that the 
service is separate and distinct, with no duplicative elements from the 
critical care service provided later in the day, practitioners may bill 
for both services. Practitioners must use modifier -25 on the claim 
when reporting these critical care services. We may consider in future 
rulemaking a payment adjustment similar to our MPPR that would more 
broadly apply to same-day E/M visits and procedures.
g. Critical Care Visits and Global Surgery
    Critical care visits are sometimes needed during the global period 
of a procedure, whether pre-operatively, on the same day or during the 
post-operative period. In many cases, preoperative and postoperative 
critical care visits are included in procedure codes that have a global 
surgical period. In the CY 2015 PFS final rule, we discussed our 
concerns related to accurately accounting for the number of visits 
included in the valuation of 10- and 90-day global packages (79 FR 
67548, 67582). The 10- and 90-day global packages can include critical 
care visits. finalized a policy to change all global periods to 0-day 
global periods, as well as to allow separate payment for post-operative 
E/M visits.
    Our concerns were based on a number of key points including: The 
lack of sufficient data on the number of visits typically furnished 
during the global periods, questions about whether we would be able to 
adjust values on a regular basis to reflect changes in the practice of 
medicine and health care delivery, and concerns about how our global 
payment policies could affect services that are actually furnished. 
Section 1848(c)(8)(B) of the Act, which was added by section 523(a) of 
the Medicare Access and CHIP Reauthorization Act (MACRA), required us 
to collect data to value surgical services. Because critical care 
visits are included in some 10- and 90-day global packages, we proposed 
to bundle critical care visits with procedure codes that have a global 
surgical period. We noted that this proposal differs from current 
policy as described in the Medicare Claims Processing Manual which 
states that critical care visits are unbundled from procedures with a 
global surgical period as long as the critical care service was 
unrelated to the procedure.\37\ As we have made clear in previous 
rulemaking, we are continuing to assess values for global surgery 
procedures (84 FR 2452), including the number and level of preoperative 
and postoperative visits, which can include critical care services. 
Because this work is still ongoing, we proposed to bundle critical care 
visits with procedure codes that have a global surgical period.
---------------------------------------------------------------------------

    \37\ Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, 
Section 40.2.A.9, available on the CMS website.
---------------------------------------------------------------------------

    Comment: We received many public comments on our proposal to bundle 
critical care services with procedure codes with a global surgical 
period. Many commenters opposed our proposal. These commenters stated 
that this policy, if finalized, would have a significant negative 
impact on the quality and safety of patient care, health system 
resiliency, health equity, and the surgical workforce. Most commenters 
recommended that we continue to pay separately for critical care 
services that are billed with surgical procedures that do not contain 
critical care services as part of a global surgical package. A few 
commenters wrote in favor of maintaining modifiers -24 (Unrelated E/M 
service by the same physician during a postoperative period) and -25 
(Significant, separately identifiable E/M service by the same physician 
on the same day of the procedure or other service) to indicate that the 
critical care service was unrelated to the surgical procedure and can 
be billed and paid at full value when unrelated to the procedure.
    Response: We appreciate the many informative comments shared by 
stakeholders on this topic. We found the detailed comments about how 
our proposal would negatively impact the quality and safety of patient 
care, health system resiliency, health equity, and the surgical 
workforce especially compelling. Thus, after considering public 
comments, we are choosing not to finalize our proposal to always bundle 
critical care visits with procedure codes that have a global surgical 
period. Instead, we are maintaining our current policy that critical 
care visits may be separately paid in addition to a procedure with a 
global surgical period, as long as the critical care service is 
unrelated to the procedure. Preoperative and/or postoperative critical 
care may be paid in addition to the procedure if the patient is 
critically ill (meets the definition of critical care) and requires the 
full attention of the physician, and the critical care is above and 
beyond and unrelated to the specific anatomic injury or general 
surgical procedure performed (for example, trauma, burn cases). We are 
creating a new modifier that we will require on such claims to identify 
that the critical care is unrelated to the procedure. If care is fully 
transferred from the surgeon to an intensivist (and the critical care 
is unrelated), modifiers -54 (surgical care only) and -55 
(postoperative management only) must also be reported to indicate the 
transfer of care. The surgeon will report modifier -54. The intensivist 
accepting the transfer of care will report both modifiers -55 and the 
new unrelated modifier. As usual, medical record documentation must 
support the claims. We may consider in future rulemaking an MPPR-like 
adjustment that would be used to identify critical care that is billed 
in conjunction with a global surgical procedure, and would discount one 
of the services rather than paying for both in their entirety.
h. Medical Record Documentation Requirements
    Because critical care is a time-based service, we proposed to 
require practitioners to document in the medical record the total time 
that critical care services were provided by each reporting 
practitioner (not necessarily start and stop times). We stated that 
documentation would need to indicate that the services furnished to the 
patient, including any concurrent care by the practitioners, were 
medically reasonable and necessary for the diagnosis or treatment of 
illness or injury or to improve the functioning of a malformed body 
member. To support coverage and payment determinations regarding 
concurrent care, we indicated that services would need to be 
sufficiently documented to allow a medical reviewer to determine the 
role

[[Page 65165]]

each practitioner played in the patient's care (that is, the condition 
or conditions for which the practitioner treated the patient). We 
stated that, in order to support coverage and payment determinations 
regarding split (or shared) critical care services, documentation 
requirements for all split (or shared) E/M visits would apply to 
critical care visits also (see section II.F.1. of this final rule).
    Comment: We received a few public comments in support of our 
proposed documentation requirements. Commenters stated that critical 
care time should include total time, not a range or threshold met, that 
services must be medically reasonable and necessary to treat a critical 
condition, and that documentation should demonstrate the role played by 
the medical practitioner (especially if there is split or shared 
billing).
    Response: We agree with the commenters that medical record 
documentation is especially important for split (or shared) critical 
care visit billing, as well as same-day multiple visits and billing of 
critical care in conjunction with a global surgical procedure, 
discussed above. After consideration of public comments, we are 
finalizing the documentation requirements for critical care time as 
proposed. We also refer readers to the sections above on critical care 
billed the same day as other E/M visits, and critical care billed in 
conjunction with a global surgical procedure, for additional discussion 
of documentation requirements in support of services billed.
3. Payment for the Services of Teaching Physicians
    As part of the CPT office/outpatient E/M visit coding framework 
that we finalized beginning for CY 2021 (85 FR 84548 through 84574), 
practitioners can select the office/outpatient E/M visit level to bill, 
based either on the total time personally spent by the reporting 
practitioner or MDM. Stakeholders have asked us how teaching physicians 
who involve residents in furnishing care should consider time spent by 
the resident in selecting the office/outpatient E/M visit level.
    For teaching physicians, section 1842(b) of the Act specifies that 
in the case of physicians' services furnished to a patient in a 
hospital with a teaching program, the Secretary shall not provide 
payment for such services unless the physician renders sufficient 
personal and identifiable physicians' services to the patient to 
exercise full, personal control over the management of the portion of 
the case for which payment is sought.
    Regulations regarding PFS payment for teaching physician services 
are codified in 42 CFR part 415. In general, under Sec.  415.170, 
payment is made under the PFS for services furnished in a teaching 
hospital setting if the services are personally furnished by a 
physician who is not a resident, or the services are furnished by a 
resident in the presence of a teaching physician, with exceptions as 
specified in subsequent regulatory provisions in part 415. Medicare 
separately pays for the time spent by the resident through direct 
graduate medical education (GME) under Medicare Part A.
a. General Policy for Evaluation and Management Visits
    Under our regulation at Sec.  415.172 and absent a public health 
emergency (PHE), if a resident participates in a service furnished in a 
teaching setting, a teaching physician can bill for the service only if 
they are present for the key or critical portion of the service. For 
residency training sites that are located outside a metropolitan 
statistical area, PFS payment may also be made if a teaching physician 
is present through audio/video real-time communications technology 
(that is, ``virtual presence''). In the case of E/M services, the 
teaching physician must be present during the portion of the service 
that determines the level of service billed.
    We proposed that when total time is used to determine the office/
outpatient E/M visit level, only the time that the teaching physician 
was present can be included. We believe it is appropriate to include 
only the time of the teaching physician because the Medicare program 
makes separate payment for the program's share of the graduate medical 
training program, which includes time spent by a resident furnishing 
services with a teaching physician, under Medicare Part A. During the 
PHE, the time of the teaching physician when they are present through 
audio/video real-time communications technology may also be included in 
the total time considered for visit level selection. We noted that, 
outside the circumstances of the COVID-19 PHE, the teaching physician 
presence requirement can be met virtually, through audio/video, real-
time communications technology, only in residency training sites that 
are located outside of a metropolitan statistical area.
    This proposal is consistent with our previously finalized policy 
that practitioners can use total time personally spent by the reporting 
practitioner on the date of the encounter to select office/outpatient 
E/M visit level. It is also consistent with our regulation at Sec.  
415.172 that states that PFS payment is made when a teaching physician 
involves a resident in providing care only if the teaching physician is 
present for the key or critical portions of the service, including the 
portion that is used to select the visit level.
    We received public comments on the general policy for E/M visits. 
The following is a summary of the comments we received and our 
responses.
    Comment: Commenters overwhelmingly supported our proposed 
clarification concerning the specific portion of total time that can be 
used to determine separate payment for teaching physician services 
under the PFS for an office/outpatient (O/O) E/M visit involving 
residents. These commenters supported our clarification that since the 
Medicare program already pays for a resident's care as part of a 
graduate medical education (GME) training program, only the time 
personally spent by the teaching physician furnishing services should 
be used to select the level of O/O E/M visits services that are 
separately billed under the Medicare Part B PFS for teaching physician 
services. Medicare Part A payment for graduate medical training 
programs includes the time that a resident spends furnishing services 
with a teaching physician.
    Response: We appreciate the overall support for our proposal and 
the consensus that it is a reasonable approach to prevent duplicative 
program payment for services furnished by teaching physicians involving 
residents. Our proposal is also consistent with our approach to the 
primary care exception discussed below.
    Comment: One commenter disagreed with our proposal to make separate 
payment under the Medicare Part B PFS only to teaching physicians and 
not residents, opining it will cause a hardship for organizations that 
accept residents but are not recipients of the Medicare Part A GME 
payment. The commenter stated that such organizations rely on billing 
and separate payment under the Medicare PFS to a teaching physician for 
the total time spent for an O/O E/M visit to compensate for the time 
and effort of training a resident.
    Response: We appreciate that organizations that are not hospitals 
with a teaching program or teaching hospital primary care centers may 
accept residents and provide education and training opportunities for 
such individuals. However, if an organization

[[Page 65166]]

other than a teaching hospital with an accredited GME program ``accepts 
residents'' for training, it would either be a ``non-hospital site'' 
associated with a teaching hospital's GME program (in which case the 
hospital presumably would count and be paid for the FTE resident time 
spent there), or the ``resident'' would not be performing services as 
part of the GME program at all--they would be ``moonlighting.'' Program 
regulations at 42 CFR 410.200 state that services furnished in 
hospitals by residents in approved GME programs are specifically 
excluded from being paid as ``physician services'' defined in Sec.  
414.20. We also note that program regulations at Sec.  415.208(b)(4) 
state that no payment is made for teaching physician services 
associated with services furnished by a moonlighting resident.
    Comment: One commenter requested clarity on what specific teaching 
physician activities count toward the time the teaching physician was 
present, as well as whether face-to-face time is required or if non-
face-to-face time as described in Current Procedural Terminology (CPT) 
guidelines counts. However, the commenter urged CMS to delay making 
changes or clarifications to this policy until 2023, when CPT could 
make substantial changes to E/M codes as it continues to review and 
revise the E/M code set.
    Response: We appreciate the commenters' suggestion. At this time, 
the qualifying activities for selecting office/outpatient E/M visit 
level using the reporting practitioner's time are specified by CPT. 
Earlier this year, the CPT Editorial Panel published an erratum or 
technical correction to the 2021 CPT E/M Guidelines which addressed 
teaching physician time by excluding time spent in ``teaching that is 
general and not limited to discussion that is required for the 
management of a specific patient.'' \38\ Therefore, we are clarifying 
that only time spent by the teaching physician performing qualifying 
activities listed by CPT (with or without direct patient contact on the 
date of the encounter), including the time the teaching physician is 
present when the resident is performing such activities, may be counted 
for purposes of visit level selection. This excludes teaching time that 
is general and not limited to discussion that is required for the 
management of a specific patient. As CPT reviews and revises the E/M 
visit code set, we will consider in future rulemaking any pertinent 
changes that may be made by the CPT Editorial Panel on this topic, and 
whether further clarifications or changes may be needed to the current 
regulations at Sec.  415.172 regarding the billing requirements for 
teaching physician services.
---------------------------------------------------------------------------

    \38\ 2021 CPT Codebook, p. 8, as clarified in the CPT 2021 
Errata and Technical Corrections dated June 7, 2021 and available on 
the AMA website at https://www.ama-assn.org/system/files/2021-06/cpt-corrections-errata-2021.pdf.
---------------------------------------------------------------------------

    Comment: Several commenters urged CMS to make permanent beyond the 
COVID-19 pandemic, the ability of teaching physicians to include in the 
total time considered for visit level selection, their virtual presence 
through audio/video, real-time communications technology, when billing 
for office/outpatient E/M visits in residency training centers located 
inside, as well as outside of a metropolitan statistical area (MSA).
    Response: We appreciate the commenters' recommendation. However, 
the issue of making the virtual presence flexibility permanent beyond 
the COVID-19 pandemic and extending this flexibility to include 
residency training centers located inside an MSA was not part of our 
proposal for general primary care office/outpatient E/M visit level 
selection.
    Comment: A few commenters requested that CMS use ``provider-
neutral'' language in all regulatory rulemaking, including in the 
definition of ``teaching physician services'' to reflect the full 
spectrum of healthcare professionals delivering care to their 
communities. A commenter encouraged CMS to clarify that physician 
assistants (PAs) and advanced practice registered nurses (APRNs) can 
count the total time they were present with residents, students, and 
other trainees toward selecting the E/M visit level.
    Response: Payment is made under the Medicare PFS for teaching 
physicians' services as described in part 415 of our regulations. We 
define a teaching physician in Sec.  415.152 as a physician other than 
a resident who involves residents in the care of their patients. 
Additionally, teaching physicians are involved in training residents as 
part of an approved GME residency program in a teaching hospital, which 
includes only programs in medicine, osteopathy, dentistry, or podiatry. 
For each of these program areas under a GME residency program, section 
1861(r) of the Act uses the term ``physician'' in connection with the 
performance of any function or action by a doctor of medicine or 
osteopathy, a doctor of dental surgery or dental medicine, and a doctor 
of podiatric medicine. NPPs are not included under the statutory 
definition of a physician.
    After considering the public comments, we are finalizing our 
proposal that only the teaching physician's total time is counted when 
total time is used to determine the office/outpatient E/M visit level, 
not including the time spent by the resident furnishing care without 
the presence of the teaching physician. We are clarifying that only 
time spent by the teaching physician performing qualifying activities 
listed by CPT (with or without direct patient contact on the date of 
the encounter), including time the teaching physician is present when 
the resident is performing those activities, may be counted for 
purposes of visit level selection. This excludes teaching time that is 
general and not limited to discussion that is required for the 
management of a specific patient.
b. Primary Care Exception Policy
    The regulation at Sec.  415.174 sets forth an exception to the 
conditions for PFS payment for services furnished in teaching settings 
in the case of certain E/M services furnished in certain primary care 
centers. Under the so-called ``primary care exception,'' Medicare makes 
PFS payment in certain teaching hospital primary care centers for 
certain services of lower and mid-level complexity furnished by a 
resident without the physical presence of a teaching physician. We 
expanded the list of services that residents could furnish without the 
physical presence of the teaching physician for the duration of the PHE 
to include all levels of an office/outpatient E/M visit, among other 
services. Upon the conclusion of the PHE, levels 4-5 office/outpatient 
E/M visits will no longer be included in the primary care exception (85 
FR 84585 through 84590).
    Section 415.174(a)(3) requires that the teaching physician must not 
direct the care of more than four residents at a time, and must direct 
the care from such proximity as to constitute immediate availability 
(that is, provide direct supervision), and must review with each 
resident during or immediately after each visit, the beneficiary's 
medical history, physical examination, diagnosis, and record of tests 
and therapies. Section 415.174(a)(3) also requires that the teaching 
physician must have no other responsibilities at the time, assume 
management responsibility for the beneficiaries seen by the residents, 
and ensure that the services furnished are appropriate.
    We proposed that under the primary care exception, only MDM can be 
used to select office/outpatient E/M visit level. The intent of the 
primary care exception as described in Sec.  415.174 is that E/M visits 
of lower and mid-level complexity furnished by residents are simple 
enough to permit a teaching

[[Page 65167]]

physician to be able to direct and manage the care of up to four 
residents at any given time and direct the care from such proximity as 
to constitute immediate availability. In the context of teaching 
hospital primary care centers that are staffed by residents and 
teaching physicians, we believe that MDM will be a more accurate 
indicator of the complexity of the visit as opposed to time. Because 
residents are in training, they may need more time than is reflected in 
the code descriptor to furnish a visit that has a low-level of medical 
decision making. For example, CPT code 99213 (Office or other 
outpatient visit for the evaluation and management of an established 
patient, which requires a medically appropriate history and/or 
examination and low level of medical decision making. When using time 
for code selection, 20-29 minutes of total time is spent on the date of 
the encounter) involves a low level of MDM and between 20-29 minutes of 
total time. If time was used for level selection instead of MDM, it is 
possible that residents may need more than 20-29 minutes of time, 
including any conferring with the teaching physician, to furnish CPT 
code 99213. Thus, residents may be less efficient relative to a 
teaching physician in furnishing care.
    Office/outpatient E/M visits requiring 30 or more minutes of total 
time are described by visit levels 4-5. After the expiration of the 
COVID-19 PHE, office/outpatient levels 4-5 will no longer be included 
in the primary care exception. In the CY 2021 PFS final rule, we 
expressed concern that the teaching physician may not be able to 
maintain sufficient personal involvement in all of the care to warrant 
PFS payment for the services being furnished by up to four residents 
when some or all of the residents might be furnishing services that are 
more than lower and mid-level complexity. We noted that when the 
teaching physician is directing the care of a patient that requires 
moderate or higher medical decision-making, the ability to be 
immediately available to other residents could be compromised, 
potentially putting patients at risk (85 FR 84586). Thus, to guard 
against the possibility of residents furnishing visits that are of more 
than lower and mid-level complexity, we proposed that only MDM may be 
used for office/outpatient E/M visit level selection for services 
furnished by residents under the primary care exception.
    We acknowledge that under the new CPT office/outpatient E/M visit 
coding framework, it is possible that time is an accurate indicator of 
the complexity of the visit. Thus, we solicited public comments on this 
proposal, including our assumption that MDM is a more accurate 
indicator of the appropriate level of the visit relative to time in the 
context of the primary care exception for services furnished by 
residents and billed by teaching physicians in primary care centers. We 
also solicited comments on whether time is an accurate indicator of the 
complexity of the visit and how teaching physicians might select 
office/outpatient E/M visit level using time when directing the care of 
a patient that is being furnished by a resident in the context of the 
primary care exception.
    We received public comments on the primary care exception policy. 
The following is a summary of the comments we received and our 
responses.
    Comment: Most of the commenters support and concur with our 
proposal to use medical decision making (MDM) only to select the visit 
level for office/outpatient E/M visits under the primary care 
exception.
    Response: We appreciate the commenters' support for our approach.
    Comment: Several commenters opposed our proposal to use MDM 
exclusively to select the office/outpatient E/M visit level for 
services furnished under the primary care exception. These commenters 
were concerned that the exclusive use of MDM may create incentives for 
physicians to quickly move residents from patient to patient, rather 
than furnish the appropriate clinical care. They stated that without 
evidence that MDM is a more accurate indicator than time in selecting 
the E/M visit level under the primary care exception, both time and MDM 
should be allowed as options for visit level selection. The commenters 
noted that time spent by the teaching physician reviewing the chart, 
looking at images, discussing with consultants, etc., should all still 
count in determining the E/M level, just as it does in a non-teaching 
situation.
    Response: We acknowledge the commenters' opposition to our proposal 
to allow MDM as the only option for E/M visit level selection under the 
primary care exception. However, under our primary care exception 
policy, we believe that using MDM to inform office/outpatient E/M visit 
level selection rather than time is appropriate given our concerns 
about the accuracy of counting time spent by residents in training to 
inform office/outpatient E/M visit level selection. We believe that the 
use of MDM is far more practical and less burdensome, because it allows 
for the likelihood that residents in training might take more time to 
perform services because they are potentially less efficient. As a 
result, time is not necessarily an accurate reflection of the visit 
level. Also, under the primary care exception, the teaching physician 
is allowed to participate simultaneously in the services furnished by 
up to four residents and bill separately for teaching physician 
services under the PFS for each of these residents. Under these 
circumstances, when a teaching physician must direct and manage the 
care of up to four residents at a given time and direct the care from 
such proximity as to constitute immediate availability, it is difficult 
to discern which time should be counted.
    Comment: We received some comments that are outside the scope of 
the teaching physician proposals and comment solicitation we included 
in the proposed rule. One of these comments stated that the increased 
investment in primary care expected from the 2021 E/M visit code 
revaluation has not materialized in many cases, expressing the view 
that this is because the employers of many family physicians are not 
reflecting the increased RVUs or Medicare payment allowances in their 
employment contracts. The other commenter suggested that CMS should 
adjust the values of the E/M postoperative visits included in the 10- 
and 90-day global codes to reflect the 2021 updates to the office/
outpatient E/M code payment increases.
    Response: We will not be addressing the concerns raised in these 
comments in this final rule because they are not within the scope of 
topics addressed in this CY 2022 PFS rulemaking.
    After considering public comments, we are finalizing our proposal 
that MDM is used to determine the visit level for office/outaptient E/M 
visits furnished under the primary care exception.

G. Billing for Physician Assistant (PA) Services

    Under the respective Medicare statutory benefit categories for the 
services of PAs, nurse practitioners (NPs), and clinical nurse 
specialists (CNSs), these nonphysician practitioners (NPPs) are 
authorized to furnish services that would be physicians' services if 
they were furnished by a physician, and which they are legally 
authorized to perform by the State in which the services are furnished; 
and such services that are provided incident to these NPPs' 
professional services (but only if no facility or other provider 
charges or is paid any amount for the services). Additionally, the 
payment amount for the services of PAs, NPs, and CNSs, as specified 
under section 1833(a)(1)(O) of

[[Page 65168]]

the Act, is equal to 80 percent of the lesser of the NPP's actual 
charge or 85 percent of the amount that would be paid to a physician 
under the PFS. However, while NPs and CNSs are authorized to bill the 
Medicare program and be paid directly for their professional services, 
section 1842(b)(6)(C)(i) of the Act has required since the inception of 
the PA benefit (with a narrow exception not relevant here), that 
payment for PA services must be made to the PA's employer. Accordingly, 
our regulation at Sec.  410.74(a)(2)(v) specifies that PA services are 
covered under Medicare Part B only when billed by the PA's employer. 
Our regulation that addresses to whom Medicare Part B payment is made, 
at Sec.  410.150(b)(15), further provides that payment is made to the 
qualified employer of a PA, and specifies that the PA could furnish 
services under a W-2 employment relationship, an employer-employee 
relationship, or as an independent contractor through a 1099 employment 
relationship. The regulation also specifies that a group of PAs that 
incorporate to bill for their services is not a qualified employer. 
Given the statutory requirement that we make payment to the PA's 
employer, PAs are precluded from directly billing the Medicare program 
and receiving payment for their services, and do not have the ability 
to reassign Medicare payment rights for their services to any employer, 
facility, or billing agent.
    Section 403 of the Consolidated Appropriations Act, 2021 (CAA) 
(Pub. L. 116-260, December 27, 2020), amended section 1842(b)(6)(C)(i) 
of the Act to remove the requirement to make payment for PA services 
only to the employer of a PA effective January 1, 2022. With the 
removal of this requirement, PAs will be authorized to bill the 
Medicare program and be paid directly for their services in the same 
way that NPs and CNSs do. Effective with this amendment, PAs also may 
reassign their rights to payment for their services, and may choose to 
incorporate as a group comprised solely of practitioners in their 
specialty and bill the Medicare program, in the same way that NPs and 
CNSs may do. We note that the amendment made by section 403 of the CAA 
changed only the statutory billing construct for PA services. It 
changed neither the statutory benefit category for PA services, 
including the requirement that PA services are performed under 
physician supervision, at section 1861(s)(2)(K)(i) of the Act, nor the 
statutory payment percentage applicable to PA services specified in 
section 1833(a)(1)(O) of the Act. However, with the amendments to the 
PA physician supervision requirement under Sec.  410.74(a)(2)(iv) made 
beginning in CY 2020, PAs have flexibility to meet the statutory 
physician supervision requirement through collaborating with physicians 
and forming partnerships as long as this is in accordance with their 
State scope of practice laws. Now that PAs are authorized to bill 
Medicare directly, we believe that PAs will furnish more services under 
collaborative relationships with physicians, likely in rural areas or 
underserved communities where Medicare beneficiaries may have less 
direct access to care by physicians because of a lack of physicians.
    We proposed to amend pertinent sections of our regulations to 
reflect the amendment made by section 403 of the CAA. Specifically, we 
proposed to amend Sec.  410.74(a)(2)(v) to specify that the current 
requirement that PA services must be billed by the PA's employer in 
order to be covered under Medicare Part B is effective only until 
December 31, 2021. We also proposed to amend Sec.  410.150(b) to 
redesignate the current requirements in paragraph (b)(15) as Sec.  
410.150(b)(15)(i), and to provide that Medicare payment is made for PA 
services to the qualified employer of the PA for services furnished 
prior to January 1, 2022. In Sec.  410.150, we further proposed to add 
a new paragraph (b)(15)(ii) to state that, effective for services 
furnished on or after January 1, 2022, payment is made to a PA for 
their professional services, including services and supplies provided 
incident to their services. We proposed to conform this new paragraph 
with the regulation at Sec.  410.150(b)(16) regarding to whom payment 
is made for NP or CNS services. As such, the new paragraph at Sec.  
410.150(b)(15)(ii) would provide that payment is made to a PA for 
professional services furnished by a PA in all settings in both rural 
and non-rural areas; and that payment is made only if no facility or 
other provider charges or is paid any amount for services furnished by 
a PA. We would also update our program manual instructions to reflect 
the statutory change made by section 403 of the CAA and the changes to 
our regulations.
    We received public comments on these proposals to amend the current 
requirements. The following is a summary of the comments we received 
and our responses.
    Comment: Overall, the commenters supported this proposal that 
authorizes PAs to bill the Medicare program and be paid directly for 
their services. Commenters stated that this billing authorization 
simplifies the billing process for PAs in that it does not tie billing 
for PA services directly to employment which eliminates an 
administrative burden for employers; and, it provides billing parity 
between PAs and other NPPs such as NPs and CNSs, which may help to 
increase access to PA services, particularly in rural areas. 
Additionally, these commenters expressed their appreciation for this 
new billing authority that makes PAs eligible for the option to 
reassign payment for their services to their employer, independent 
contractor, or group practice and, to incorporate as a group of PAs and 
bill the Medicare program for PA services.
    Response: We appreciate that commenters support the changes we 
proposed to implement section 403 of the CAA effective January 1, 2022.
    Comment: A few commenters opposed our proposals to implement 
section 403 of the CAA. These commenters disapprove of the change to 
the statutory billing construct that authorizes PAs to bill the 
Medicare Part B program directly beginning January 1, 2022. Instead, 
these commenters support continued third-party payment to the PA's 
employer or independent contractor for PA services furnished 
collaboratively with physicians to deliver care led by physicians in 
integrated practice arrangements.
    Response: While we appreciate the commenters' concerns, section 403 
of the CAA amended the statute effective January 1, 2022. Our proposals 
simply implement the amended Medicare law.
    Comment: Several commenters expressed concerns that this direct 
billing authority for PAs might undermine the proven physician-led-team 
based care model under which PAs, NPs and CNSs are integral team 
members, and instead encourage independent practice by these NPPs. 
These commenters requested that CMS establish oversight of PA billing 
practices to ensure that PAs are practicing in accordance with State 
law and scope of practice rules; that quality of care for Medicare 
beneficiaries is maintained; and, that the Medicare Trust Fund is 
protected.
    Response: We do not anticipate that this change will impact the 
participation of NPPs as vital team members of physician-directed-team 
care models, or otherwise diminish the quality of health care furnished 
to Medicare beneficiaries. As provided in Medicare law at section 
1861(s)(2)(K)(i) of the Act, PA services must be furnished under the 
supervision of a physician and, also in our regulation at Sec.  
410.74(a), PA services are covered

[[Page 65169]]

only when furnished in accordance with State law and scope of practice 
rules.
    Comment: One commenter suggested that allowing PAs to bill the 
Medicare program directly would require updates to Medicare enrollment 
and billing for PAs, and that the program should consider adopting a 
grace period to allow CMS to implement revisions to the CMS-855I, CMS-
855R and related enrollment forms.
    Response: We appreciate the concerns the commenter raised about the 
time required to update necessary reassignment and enrollment forms. 
However, we have prepared to update these forms to accommodate the 
change to allow direct billing by PAs effective January 1, 2022.
    After considering public comments, we are finalizing our proposals 
to implement section 403 of the CAA as proposed.

H. Therapy Services

1. Payment for Outpatient PT and OT Services Furnished by Therapy 
Assistants
    We are implementing the third and final part of the amendments made 
by section 53107 of the Bipartisan Budget Act (BBA of 2018) (Pub. L. 
115-123, February 9, 2018). The BBA of 2018 added a new section 1834(v) 
of the Act. Section 1834(v)(1) of the Act requires CMS to make a 
reduced payment for physical therapy and occupational therapy services 
furnished in whole or in part by PTAs and OTAs at 85 percent of the 
otherwise applicable Part B payment for the service, effective January 
1, 2022.
    Section 1834(v)(2) of the Act requires that: (1) By January 1, 
2019, CMS must establish a modifier to indicate that a therapy service 
was furnished in whole or in part by a PTA or OTA; and, (2) beginning 
January 1, 2020, each claim for a therapy service furnished in whole or 
in part by a PTA or an OTA must include the modifier. Section 
1834(v)(3) of the Act requires CMS to implement these amendments 
through notice and comment rulemaking.
    In the CY 2019 PFS final rule (83 FR 59654 through 59660), we 
established the CQ and CO modifiers that were required to be used by 
the billing practitioner or therapy provider to identify therapy 
services provided in whole or in part by PTAs and OTAs, respectively, 
beginning January 1, 2020. We require these payment modifiers to be 
appended on claims for therapy services, alongside the GP and GO 
therapy modifiers which are used to indicate the services are furnished 
under a physical therapy or occupational therapy plan of care, 
respectively. The payment modifiers are defined as follows:
     CQ modifier: Physical therapy services furnished in whole 
or in part by PTAs.
     CO modifier: Occupational therapy services furnished in 
whole or in part by OTAs.
    In the CY 2019 PFS final rule (83 FR 59654 through 59660), we did 
not finalize our proposed definition of ``furnished in whole or in part 
by a PTA or OTA'' as a service for which any minute of a therapeutic 
service is furnished by a PTA or OTA. Instead, in response to public 
comments, we finalized a de minimis standard under which a service is 
considered to be furnished in whole or in part by a PTA or OTA when 
more than 10 percent of the service is furnished by the PTA or OTA.
    In the CY 2019 PFS proposed and final rules (83 FR 35850 through 
35852, and 83 FR 59654 through 59660, respectively), we explained that 
the CQ and CO modifiers would not apply to claims for outpatient 
therapy services that are furnished by, or incident to, the services 
of, physicians or NPPs including NPs, PAs, and CNSs. This is because 
our outpatient physical and occupational therapy services regulations 
require that the individual who performs outpatient therapy services 
incident to the services of a physician or NPP must meet the 
qualifications and standards for a therapist (other than State 
licensure). As such, only therapists, and not therapy assistants, can 
perform outpatient therapy services incident to the services of a 
physician or NPP (83 FR 59655 through 59656); and the modifiers to 
describe services furnished in whole or in part by a PTA or OTA are not 
applicable to the claim for a therapy service billed by a physician or 
NPP incident to their professional services. We indicated that we would 
add this distinction in the provision of the Medicare Benefit Policy 
Manual (MBPM) Chapter 15 that discusses therapy services furnished 
incident to the physician's or NPP's services at section 230.5, as well 
as the sections that discuss PTA and OTA services at sections 230.1 and 
230.2, respectively.
    In the CY 2020 PFS proposed and final rules (84 FR 40558 through 
40564 and 62702 through 62708, respectively), we explained that the CQ/
CO modifiers and the de minimis policy would apply to both untimed and 
timed codes. The untimed codes are evaluation and reevaluation codes, 
group therapy and supervised modalities, and when these are billed, 
only one unit is reflected in the ``units'' portion of the claim. When 
the PTA/OTA provides more than 10 percent of the service, the code is 
billed with a CQ/CO modifier. For timed codes, that is, those codes 
defined in 15-minute increments, the services are typically performed 
in multiple units of the same and/or different codes for a patient on 
one treatment day. We explained that under our policy, the therapist or 
therapy assistant needs to find the total time of all these 15-minute 
timed codes in order to determine the number of units that can be 
billed for that day. For example, if the PT/OT and/or the PTA/OTA, as 
appropriate, furnished between 8 minutes through 22 minutes, one unit 
can be billed; if 23 minutes through 37 minutes are provided, 2 units 
can be billed; if 38 minutes through 52 minutes are furnished, 3 units 
can be billed. Once the total number of units to bill is determined, 
the qualified professional (therapist or assistant) then needs to 
decide whether the CQ/CO modifier is applicable.
    In the CY 2020 PFS proposed rule (84 FR 40558 through 40564), we 
proposed that the time the PTA/OTA spent together with the PT/OT in 
performing a service, as well as the time the PTA/OTA spent independent 
of the PT/OT treating the patient, is considered time for which the 
service is furnished in whole or in part by the PTA/OTA. As explained 
in the CY 2020 PFS final rule (84 FR 62702 through 62708), many 
commenters objected to our proposal to include as time that the therapy 
service is furnished ``in whole or in part'' by the PTA/OTA both the 
minutes spent by the PTA/OTA concurrently with and separately from the 
therapist. These commenters also expressed concerns that this policy 
would unfairly discount services that are fully furnished by 
therapists, and in which the therapy assistant supports them while they 
provide a service. We were persuaded by commenters to finalize a policy 
to not include as minutes furnished in whole or in part by a PTA/OTA 
the minutes in which the PTA/OTA worked concurrently with the PT/OT. We 
agreed with the commenters that when a therapy assistant and therapist 
furnish care to a patient at the same time, the patient requires both 
professionals, and this reflects a clinical scenario where the 
assistant is helping the therapist to provide a highly skilled 
procedure or one in which both professionals are needed for safety 
reasons. We modified our proposed regulation text at Sec. Sec.  410.59 
(outpatient occupational therapy), 410.60 (physical therapy), and 
410.105 (for PT and OT Comprehensive

[[Page 65170]]

Outpatient Rehabilitation Facility (CORF) services) accordingly.
    For purposes of deciding whether the 10 percent de minimis standard 
is exceeded, we offered two different ways to compute this.
     The simple method: Divide the total of the PTA/OTA + PT/OT 
minutes by 10, round to the nearest integer then add 1 minute to get 
the number of minutes needed to exceed the de minimis standard at and 
above which the CQ/CO modifier applies.
     The percentage method: Divide the PTA/OTA minutes by the 
sum of the PTA/OTA and therapist minutes and then multiply this number 
by 100 to calculate the percentage of the service that involves the 
PTA/OTA, if this number is greater than 10 percent the CQ/CO modifier 
applies.
    Hypothetical examples of each of these methods are included later 
in this section. In response to our proposal that all the units of one 
service needed to be considered when determining if the de minimis is 
applied, commenters requested that we consider each 15-minute unit 
instead--noting that they would be able to apply the CQ/CO modifier on 
one claim line for a service that was provided by the PTA/OTA and 
report another claim line without the CQ/CO for the service provided by 
the PT/OT. We were persuaded by stakeholders, and finalized a policy 
under which the de minimis standard is applied for each 15-minute unit 
of a service. This allows the separate reporting, on two different 
claim lines, of the number of 15-minute units of a code to which the 
therapy assistant modifiers do not apply, and the number of 15-minute 
units of a code to which the therapy assistant modifiers do apply. 
However, we neglected to modify the text of our regulations to reflect 
this final policy for applying the de minimis standard; therefore, we 
proposed to revise our regulation text to specify that the de minimis 
rule is applied to each 15-minute unit of a service, rather than to all 
the units of a service at Sec. Sec.  410.59(a)(4)(iii)(B), 
410.60(a)(4)(iii)(B), and 410.105(d)(3)(ii). The specific revisions are 
discussed below.
    To recap, we finalized a de minimis standard to identify when the 
CQ/CO modifiers apply and when they do not apply as follows:
     Portions of a service furnished by the PTA/OTA independent 
of the physical therapist/occupational therapist, as applicable, that 
do not exceed 10 percent of the total service (or 15-minute unit of a 
service) are not considered to be furnished in whole or in part by a 
PTA/OTA, so are not subject to the payment reduction;
     Portions of a service that exceed 10 percent of the total 
service (or 15-minute unit of a service) when furnished by the PTA/OTA 
independent of the therapist must be reported with the CQ/CO modifier, 
alongside of the corresponding GP/GO therapy modifier; are considered 
to be furnished in whole or in part by a PTA/OTA, and are subject to 
the payment reduction; and
     Portions of a service provided by the PTA/OTA together 
with the physical therapist/occupational therapist are considered for 
this purpose to be services provided by the therapist.
    In the CY 2020 PFS proposed rule (84 FR 40558 through 40564), we 
proposed to adopt a documentation requirement that a short phrase or 
statement must be added to the daily treatment note to explain whether 
the therapy assistant modifier was or was not appended for each therapy 
service furnished. We also sought comment on whether it would be 
appropriate to also require documentation of the minutes spent by the 
therapist or therapy assistant along with the CQ/CO modifier 
explanation as a means to avoid possible additional burden associated 
with a contractor's medical review process conducted for these 
services. Many commenters stated that: (1) The statute does not require 
documentation to explain why a modifier was or was not applied for each 
code; (2) the proposed documentation requirements are exceedingly 
burdensome and conflict with the agency's ``Patients over Paperwork 
Initiative''; (3) the proposed documentation requirement that calls for 
a narrative phrase in the treatment note and requires documentation of 
the minutes is duplicative of current requirements that requires adding 
the total timed code minutes and total treatment time (includes timed 
and untimed codes) to the daily treatment note; and, (4) the Medicare 
Benefit Policy Manual (MBPM) already includes extensive documentation 
requirements. In response to the feedback, we did not finalize the 
proposed documentation requirement; nor did we finalize a requirement 
that the therapist and therapy assistant minutes be included in the 
documentation. Instead, we reminded therapists and therapy providers 
that correct billing requires sufficient documentation in the medical 
record to support the codes and units reported on the claim, including 
those reported with and without an assistant modifier. Further, in 
agreement with many commenters, we clarified that we would expect the 
documentation in the medical record to be sufficient to know whether a 
specific service was furnished independently by a therapist or a 
therapist assistant, or was furnished ``in part'' by a therapist 
assistant, in sufficient detail to permit the determination of whether 
the 10 percent standard was exceeded.
    In the CY 2020 PFS proposed rule, we also provided multiple typical 
clinical billing scenarios to illustrate when the CQ/CO modifier would 
and would not be applicable. Because these clinical scenarios did not 
convey our finalized policies as modified in response to public 
comments, we indicated in the CY 2020 PFS final rule that we would 
provide further detail regarding the clinical scenario examples to 
illustrate how to use the therapy assistant modifiers through 
information we would post on the cms.gov website. We clarified that our 
revised finalized policy applied generally in the same way as 
illustrated in those examples, except for the difference in the minutes 
of time that are counted toward the 10 percent standard (not counting 
the minutes furnished together by a therapist and therapy assistant), 
the application of the 10 percent standard to each billed unit of a 
timed code rather than to all billed units of a timed code, and the 
billing on two separate claim lines of the units of a timed code to 
which the therapy assistant modifiers do and do not apply.
    In early March 2021, we posted on our Therapy Services website at 
https://www.cms.gov/Medicare/Billing/TherapyServices general guidance 
on how to assign the CQ/CO modifiers for multiple billing scenarios. In 
the guidance, we provided general examples for 8 different billing 
scenarios in which multiple units of 15-minute codes are provided by 
PTs/OTs and PTAs/OTAs and one billing example that used the untimed 
code for group therapy performed for equal minutes by a PT and a PTA.
    We noted that prior to applying our rules to determine appropriate 
application of the CQ/CO modifiers, the PTA/OTA or PT/OT first needs to 
determine how many 15-minute units can be billed in a single treatment 
day for a patient. For information on this topic, we referred readers 
to the chart in section 20.2.C of Chapter 5 of the Medicare Claims 
Processing Manual (MCPM) that describes how to count minutes for timed 
codes defined by 15-minute units, since the therapist or assistant 
should use the same counting rule, commonly known as the ``8-minute 
rule,'' that they have used previously.
    Once the therapist or therapy assistant has identified the number 
of 15-minute units that can be billed for a patient on

[[Page 65171]]

a single treatment day, we provided the following information to 
clarify how to apply our policy for application of the CQ and CO 
modifiers, as follows:
    Step 1. Identify the Timed HCPCS Codes Furnished for 15 Minutes or 
More: List the code numbers of each of the services furnished along 
with the number of minutes in total done by the PT, PTA, OT, or OTA. 
When a PT, PTA, OT, or OTA provides at least 15 minutes and less than 
30 minutes of a service on a single treatment day, assign 1 unit; when 
multiples of 15 minutes are furnished, for example, 30 minutes (assign 
2 units) and 45 minutes (assign 3 units), etc. This needs to be the 
first step whenever it is applicable to the billing scenario. When any 
of these services, that is, full 15-minute increments, are provided by 
a PTA/OTA, the CQ/CO modifiers apply.
    Step 2. Identify Services for Which the PT/OT and PTA/OTA Provide 
Minutes of the Same HCPCS Code: After applying Step 1, where 
applicable, identify any minutes (including remaining minutes from Step 
1) performed by a PT/OT and PTA/OTA for the same service/code. Add the 
minutes furnished by the PT/OT and the PTA/OTA together, then divide 
the total by 10 and round to the nearest integer--this is the 10 
percent de minimis time standard. Then add 1 minute to get the fewest 
number of minutes performed by the PTA/OTA that would exceed the 10 
percent time standard for that service--if the PTA/OTA minutes meet or 
exceed this number, the CQ/CO modifier would be appended. This is the 
``simple'' method for calculating the de minimis number of minutes.
    Step 3. Identify Services Where the PT/OT and PTA/OTA Furnish 
Services of Two Different Timed HCPCS Codes: After applying Step 1 for 
each service, compare the remaining minutes furnished by the PT/OT for 
one service with the remaining minutes furnished by the PTA/OTA for a 
different service. Assign the CQ/CO modifier to the service provided by 
the PTA/OTA when the time they spent is greater than the time spent by 
the PT/OT performing the different service. The CQ/CO modifier does not 
apply when the minutes spent delivering a service by the PT/OT are 
greater than the minutes spent by the PTA/OTA delivering a different 
service.
    Step 4. Identify the Different HCPCS Codes Where the PT/OT and the 
PTA/OTA Each Independently Furnish the Same Number of Minutes: Once 
Step 1 is completed for each service (when applicable), and when the 
remaining minutes for each service--one provided by the PT/OT and the 
other provided by the PTA/OTA--are the same, either service may be 
billed. If the service provided by the PT/OT is billed, the CQ/CO 
modifier does not apply. However, if the service provided by the PTA/
OTA is billed, the CQ/CO modifier does apply.
    The below two examples are taken from our guidance on the CMS 
website. These are examples of when the PT and PTA provide minutes of 
the same service:
Example #1
PTA--23 minutes 97110
PT--13 minutes 97110
PT--30 minutes 97140
Total = 66 minutes--qualifies for billing 4 units (53 minutes through 
67 minutes)

    Billing Explanation:
     First Step: Assign units to services based on those that 
have at least 15 minutes or codes that were provided in multiples of 15 
minutes. For 97110, assign one unit of 97110 with the CQ modifier 
because the PTA furnished at least 15 minutes of 97110 (therapeutic 
exercise). Then, assign two units of 97140 without the modifier, 
because the PT furnished the full 30 minutes of manual therapy.
     Second Step: Determine if the PTA furnished more than 10 
percent of the remaining minutes of the 97110 service. To do this via 
the simple method: Add the PTA's 8 remaining minutes to the PT's 13 
minutes for a total time of 21 minutes. Divide the total by 10 to get 
2.1 minutes and round to the nearest integer, which is 2 minutes (the 
10 percent time standard for this service). Add 1 minute to find the 
threshold number of minutes that would exceed the de minimis standard, 
which in this example is 3 minutes. Using the percentage method, divide 
the PTA's remaining 8 minutes by the total 21 minutes of the service (8 
PTA + 13 PT = 21 minutes) to get 0.38, then multiply the result x 100 = 
38 percent.
    Final Step: Because 8 minutes meets or exceeds the 3-minute 
threshold, and 38 percent is greater than 10 percent, a second unit of 
97110 is billed with the CQ modifier.
Example #2
PTA--19 minutes of 97110
PT--10 minutes of 97110
Total = 29 minutes--two units of 97110 can be billed (23 minutes 
through 37 minutes).

    Billing Explanation:
     First Step: Bill one unit of 97110 with the CQ modifier 
because a full 15 minutes was provided by the PTA, with 4 minutes 
remaining.
     Second Step: Determine if the PTA's 4 remaining minutes 
exceed the 10 percent de minimis standard. Simple method: Add together 
the PTA's 4 remaining minutes and the 10 PT minutes to get the total 
time of 14 minutes and divide by ten to get 1.4 minutes and round to 
the nearest integer = 1 minute to get the 10 percent de minimis 
standard. Then add 1 minute to get a threshold minimum of 2 minutes for 
PTA time. If the PTA minutes are at or above the threshold, the CQ 
modifier applies. Percentage method: Divide the PTA's 4 remaining 
minutes by the total time of 14 to get 0.29 then multiply by 100 = 29 
percent. If the resulting percentage is greater than 10 percent, the 
PTA modifier applies.
     Final Step: Bill another unit of 97110 with the CQ 
modifier since 4 minutes is greater than the 2-minute threshold minimum 
and 29 percent is greater than 10 percent.
    After reviewing the information posted on the CMS Therapy Services 
web page, therapy stakeholders reached out to CMS to express concern 
that certain aspects of the billing scenarios described in the guidance 
contradict their interpretation of our de minimis policy, especially as 
it applies to a final unit of a multiple-unit timed service. The 
therapy stakeholders suggested that the guidance we offered would lead 
to confusion for the same-service billing scenarios (including examples 
#1 and #2 above). We consider the unit of measure for a timed therapy 
service code to be 15 minutes. In billing scenarios with multiple 
units, we would consider the combined time for same or different 
services in 15-minute unit increments.
    The stakeholders agree that the de minimis standard is applied to 
the last unit of a timed therapy service code in two separate cases. 
The first case happens when the PTA/OTA and the PT/OT each furnish less 
than 8 minutes for that final unit of a service. For example, if the 
PTA/OTA provided 7 minutes and the PT/OT furnished 5 minutes--using the 
simple method: 12 minutes divided by 10 equals 1.2, rounded to the 
nearest integer is 1, plus 1 equals 2--if the PTA/OTA provides 2 or 
more minutes, the CQ/CO modifier is applied. The second case occurs 
when the PTA/OTA provides 8 or more minutes and the PT/OT furnishes 
less than 8 minutes--in which event, the de minimis standard is 
exceeded and the CQ/CO modifier is applied.
    We note that the therapy stakeholders' interpretation of when the 
de minimis policy applies for a final 15-minute unit of a multiple unit 
timed service is based on what is commonly termed the ``8-minute rule'' 
which recognizes a unit of a 15-minute timed therapy service code

[[Page 65172]]

as 8 minutes (more than the midpoint of the service or 7.5 minutes), 
but only when it applies to the final unit billed. Applied to the above 
two examples, the stakeholders informed us that they believe the second 
unit of CPT code 97110 in both examples should not be billed with an 
assistant modifier because the therapist provided enough minutes of the 
service on their own, that is, 8 minutes or more, to bill for the last 
unit without the assistant's additional minutes. The stakeholders 
indicated that the therapist would have a financial incentive to not 
have the PTA/OTA provide the additional minutes at all if the CQ or CO 
modifier would apply. We note that, in addition to the two cases 
discussed above, there is another billing scenario to address in the 
context of our de minimis policy--specifically, where the PT/OT and 
PTA/OTA each furnish between 9 and 14 minutes of a 15-minute timed 
service when the total time of therapy services furnished in 
combination by the PTA/OTA and PT/OT is at least 23 but no more than 28 
minutes, and there are two remaining units left to be billed. These 
``two remaining unit'' cases with time ranges between 9 and 14 minutes 
include the following PTA/OTA:PT/OT (or vice versa) time splits: 9:14, 
10:13, 11:12, 12:12, 12:13, 12:14, 13:13; 13:14; and 14:14.
    We believe that the stakeholder's interpretation of the de minimis 
standard is not consistent with the de minimis policy we finalized in 
the CY 2020 PFS final rule (84 FR 62702 through 62708). However, in 
working through the billing scenarios with the stakeholders, we 
identified where we could make refinements to our policy to address 
some of the confusion and concerns expressed by stakeholders and to 
address the ``two remaining unit'' cases noted above. These refinements 
may also avoid implementing a payment policy that could be perceived to 
penalize the provision of additional care by a therapy assistant when 
those minutes of service would lead to a reduced payment for a unit of 
a service. The stakeholders criticized the finalized de minimis policy 
because they believed it provides an inherent financial incentive for 
the therapist to ensure that PTAs/OTAs provide services in exactly 15-
minute intervals--to avoid any leftover PTA/OTA minutes that could 
necessitate application of the CQ/CO modifier, and reduced payment, for 
the service that the therapist is also providing--without regard to the 
clinical needs of the individual patient. The stakeholders suggested 
that if we were to recognize their ``8-minute rule'' and recommended 
policy, we would remove the incentive for the therapist to avoid 
providing appropriate minutes of therapy services performed by the PTA/
OTA.
    To address the concerns expressed by the stakeholders and the ``two 
remaining unit'' cases we identified in our review, we proposed to 
modify our existing policy, specifically for billing scenarios when 
only one unit of a timed therapy service remains to be billed (the 
majority of all billing scenarios) and the ``two remaining unit'' cases 
described above. As shown in Table 28, this policy requires the 
application of the CQ/CO modifier when the PTA/OTA provides at least 8 
minutes or more and the PT/OT provides less than 8 minutes of the 
service; or, when both the PT/OT and the PTA/OTA provide less than 8 
minutes of the same service.
[GRAPHIC] [TIFF OMITTED] TR19NO21.050

    Under this modification, the CQ/CO modifier would not apply when 
the PT/OT furnishes 8 minutes or more, or both the PT/OT and the PTA/
OTA furnish 8 minutes or more, of a timed service. This ``midpoint 
rule'' policy was suggested to us by the therapy stakeholders. We agree 
that since, in this circumstance, the PT/OT provided enough minutes of 
the service on their own to bill the last unit of the service, the 
additional minutes of service performed by the PTA/OTA are not 
material, and thus, should be disregarded, as shown in the examples in 
Table 29.
[GRAPHIC] [TIFF OMITTED] TR19NO21.051


[[Page 65173]]


    With these policy adjustments, the CQ/CO modifiers apply when the 
PTA/OTA provides all the minutes of a timed service, and to some 
services (as illustrated in Table 28) when the PTA/OTA and PT/OT each, 
independent of the other, furnish portions of the same timed service. 
The CQ/CO modifiers also apply if the portion of an untimed code 
furnished by the PTA/OTA exceeds the de minimis standard. The CQ/CO 
modifiers do not apply when the PTA/OTA and the PT/OT furnish different 
services. Time spent by the PT/OT and PTA/OTA providing services 
together is considered time spent by the PT/OT for purposes of applying 
the de minimis standard. Finally, we proposed to modify our policy so 
that the CQ/CO modifiers would not apply when the PT/OT provides enough 
minutes of the service on their own to bill for the last unit of a 
timed service, (more minutes than the midpoint or 8 minutes of a 15-
minute timed code) regardless of any additional minutes for the service 
provided by the PTA/OTA.
    Examples of Billing Scenarios using the CQ/CO modifiers when the de 
minimis standard applies, and the proposed policy for the last billed 
unit of a service:
Example #A
PTA--10 minutes of 97110
PT--5 minutes of 97110
Total = 15 minutes--qualifies to bill one 15-minute unit (8 minute to 
22 minutes).

    Analysis: Bill one unit of 97110 with the CQ modifier because the 
PTA provided 8 minutes or more and the PT provided less than 8 minutes. 
The de minimis standard applies in these cases.
Example #B
PTA--5 minutes of 97110
PT--6 minutes of 97110
Total = 11 minutes--qualifies to bill one 15-minute unit (8 minute 
through 22 minutes).

    Analysis: Bill one unit of 97110 with the CQ modifier because the 
PTA and the PT both provided less than 8 minutes. In this case, the PT 
provided 6 minutes and the PTA furnished 5 minutes independent of each 
other. The de minimis standard applies in these cases.
Example #C
PTA-22 minutes of 97110
PT--23 minutes of 97110
Total = 45 minutes--qualifies to bill three 15-minute units (38 minutes 
through 52 minutes).

    Analysis:
     Apply Step One of the general policy rules and bill one 
unit of 97110 with the CQ modifier because the PTA provided 15 full 
minutes with 7 minutes remaining.
     Apply Step One to the PT's 23 minutes and bill one unit 
without the assistant modifier with 8 minutes remaining.
     The third unit of 97110 is billed without the assistant 
modifier because the therapist provided enough minutes (8 or more 
minutes) without the PTAs minutes to bill the final unit.
Example #D--Also See the Below Regulatory Proposal Using This `Two 
Remaining Unit' Example
PT--12 minutes of 97110
PTA--14 minutes of 97110
PT--20 minutes of 97140
Total = 46 minutes--qualifies to bill three units (38 minutes through 
52 minutes)

    Analysis:
     Apply Step One of the general policy rules and bill one 
unit of 97140 without the CQ modifier because the PT provided 15 full 
minutes of one unit with 5 minutes remaining.
     Two units remain to be billed and the PT and the PTA each 
provided between 9 and 14 minutes independent of one another with a 
total time between 23 and 28 minutes--in these ``two remaining unit'' 
scenarios, one unit is billed with the CQ modifier for the PTA and the 
other unit is billed without it for the PT.
     The PT's 5 remaining minutes of 97140 are counted towards 
the total timed minutes but are not billable in this scenario.
Example #E
OTA--11 minutes of 97535
OT--11 minutes of 97530
Total = 22 minutes--qualifies to bill one (1) unit (8 minutes through 
22 minutes)

    Billing Analysis: Since two different services were furnished for 
an equal number of minutes--the ``tie-breaker'' scenario applies. 
Either code 97530 by the OT or code 97535 by the OTA can be billed in 
accordance with a billing example in the MCPM, Chapter 5, section 
20.2.C. Either one unit of 97530 is billed without the CO modifier or 
one unit of 97535 is billed with the CO modifier.
Example #F: Untimed Code--1 Unit Is Billed for All Untimed Codes 
Including Evaluations, Reevaluations, Supervised Modalities, and Group 
Therapy
OTA--20 minutes 97150 independent of the OT
OT--20 minutes 97150 independent of the OTA
Total = 40 minutes of Group Therapy = 1 unit of 97150 is billed for 
each group member

    Billing Analysis: One unit of group therapy 97150 is billed with 
the CO modifier because the OTA provided more than the 10 percent time 
standard in this example. Either method can be used to determine if the 
OTA's time exceeded the 10 percent time standard for this clinical 
scenario, see below:
     The simple method: First add the OTA's 20 minutes to the 
OT's 20 minutes to get 40, then divide by 10 to get 4.0 and add 1 to 
equal 5 minutes. The OTA's 20 minutes is equal to or greater than 5 
minutes so the CO modifier is required on the claim.
     The percentage method: Divide the number of minutes that 
an OTA independently furnished a service by the total number of minutes 
the service was furnished as a whole--20 divided by 40 equals 0.50. 
Then multiple by 100 to get 50 percent, which is greater than 10 
percent. The CO modifier is applied to 97150.
     Tie breaker: The tie breaker does not apply in this 
scenario because the example does not contain two different timed codes 
described in 15-minute intervals. For ``tie breaker'' see Example #F 
above.
    As noted above and illustrated in Example #D, there are a finite 
number of cases where there are two 15-minute units left to bill. In 
these ``two remaining unit'' cases, the PTA/OTA and the PT/OT each 
provide between 9 and 14 minutes with a total time of at least 23 
minutes through 28 minutes. Under our proposed policy, one unit of the 
service would be billed with the CQ/CO modifier for the minutes 
furnished by the PTA/OTA (who furnished between 9 and 14 minutes of the 
service), and one unit would be billed without the CQ/CO modifier for 
the service provided by the PT/OT (who also furnished between 9 and 14 
minutes of the same service). This is because the PTA/OTA and the PT/OT 
each independently furnished part of each unit of the same service, and 
these cases are not addressed by the proposed midpoint rule that would 
apply when there is only one single unit left to bill. We proposed to 
amend our regulation to address the scenario where there are two 
remaining 15-minute units of the same service for which the PTA/OTA and 
the PT/OT each provided between 9 and 14 minutes with a total time of 
at least 23 minutes and no more than 28 minutes. In this scenario, we 
proposed that one unit of the service will be billed with the CQ/CO 
modifier and the other unit of the service will be billed without

[[Page 65174]]

the assistant modifier. We proposed to add this policy to our 
regulations at Sec. Sec.  410.59(a)(4)(v) and 410.60(a)(4)(v) for 
outpatient occupational therapy and physical therapy services, 
respectively and at Sec.  410.105(d)(3)(iv) for CORF services.
    As noted previously, when we finalized the policy to consider each 
15-minute unit of a service for purposes of determining whether the de 
minimis standard applies, we neglected to revise our regulations at 
Sec. Sec.  410.59, 410.60 and 410.105 to reflect this change. As such, 
we proposed to amend the regulations at Sec. Sec.  410.59(a)(4)(iii)(B) 
and 410.60(a)(4)(iii)(B) for outpatient occupational therapy and 
physical therapy services, respectively, and at Sec.  410.105(d)(3)(ii) 
for CORF services to specify that we consider a service to be furnished 
in part by a PTA or an OTA when the PTA/OTA furnishes a portion of a 
service, or in the case of a 15-minute timed code, a portion of a unit 
of a service, separately from the portion of the service or unit of 
service furnished by the therapist such that the minutes for that 
portion of a service or a unit of a service furnished by the PTA/OTA 
exceed 10 percent of the total minutes for that service or unit of a 
service.
    To accommodate the proposed refinement of the de minimis policy, we 
proposed to amend the same regulations at Sec. Sec.  410.59(a)(4)(iv) 
and 410.60(a)(4)(iv) for outpatient occupational therapy and physical 
therapy services, respectively, and at Sec.  410.105(d)(3)(iii) for 
CORF services to provide that, for the final 15-minute unit billed for 
a patient for a date of service, when the PT/OT provides more than the 
midpoint (at least 8 minutes) of a service such that they could bill 
for the service without any additional minutes being furnished by the 
PTA/OTA, the service may be billed without a CQ or CO modifier, and any 
remaining minutes of service furnished by the PTA/OTA are considered 
immaterial.
    Beginning January 1, 2022, therapy services furnished in whole or 
in part by a PTA or OTA will be identified based on the inclusion by 
the billing therapy services provider (whether a therapist in private 
practice or therapy provider) of the CQ or CO modifier, respectively, 
on claim lines for therapy services, and the payment for those services 
will be adjusted as required by section 1834(v)(1) of the Act. Per our 
usual system update process, we plan to issue instructions in a change 
request to prepare our shared systems and Medicare Administrative 
Contractors (MACs) to pay the reduced amount for therapy services 
furnished in whole or in part by a PTA or OTA. We will issue a Medlearn 
Learning Network[supreg] (MLN) article once the CR is released, after 
the CY 2022 PFS final rule is issued.
    When we identified a limited number of cases in which there are two 
15-minute units left to bill and the PTA/OTA and the PT/OT each provide 
between 9 and 14 minutes with a total time of 23 through 28 minutes, 
where we proposed that one unit is billed with an assistant modifier 
and one unit is billed without it, we have identified four additional 
examples of PTA/OTA:PT/OT (or vice versa) time splits that we would 
like to acknowledge--these instances include 10:14, 11:13, 11;14, and 
13:12. The full complement of these time splits are: 9:14, 10:13, 
10:14, 11:12, 11:13, 11:14, 12:12, 12:13, 12:14, 13:12, 13:13, 13:14, 
and 14:14.
    We are making a technical correction to the proposed regulation 
text at Sec.  410.105(d)(3)(iii) that appeared in the CY 2022 PFS 
proposed rule, to remove an extra parenthesis ``('' as it appeared in 
``((ii)'' so that the CORF regulation at Sec.  410.105(d)(3)(iii) 
correctly reads as ``(iii) Paragraph (d)(3)(ii)''.
    We solicited comment on all of our proposals.
    We received over 12,000 public comments on our proposals. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters, including the major therapy stakeholders, 
expressed appreciation that we updated the interpretation of the de 
minimis standard to take into account the ``8-minute rule'' for the 
final unit billed. One commenter conveyed their belief that this policy 
is sound and will ensure that therapists and therapy providers are not 
paid less for providing more care. A few commenters also supported our 
explanation and proposal to bill one unit of a service with the CQ/CO 
modifier and one unit without a CQ/CO modifier when the PTA/OTA and the 
PT/OT each provide between 9 and 14 minutes of a 15-minute timed 
service with a total time of 23 to 28 minutes where there are two units 
left to bill.
    Response: We appreciate that commenters are supportive that we 
revised our de minimis policy in response to specific requests from the 
major therapy stakeholders regarding the ``8-minute rule'' for the 
final unit billed; and, thank the commenter for their remark about the 
soundness of this policy that permits therapists and therapy providers 
to furnish proper care without being paid less for the service. We also 
appreciate that others specifically supported our proposal to further 
refine our de minimis policy for those limited number of cases where 
there are 2 15-minute units remaining to be billed.
    Comment: Many commenters supported and welcomed the refinement to 
the de minimis standard; however, many others requested that CMS delay 
implementation of the therapy assistant payment policy until CY 2023 so 
that: (a) Therapists and therapy assistants would have the time to 
implement the final policy changes; (b) we have additional time to 
provide education and technical assistance to providers on what some 
term as a complex policy; (c) electronic medical record (EMR) vendors 
have time to program, test, and finalize their systems; and (d) 
therapists in private practice and therapy providers have time to 
recover financially from the coronavirus pandemic. We also received 
several positive comments regarding the implementation of the therapy 
assistant payment policy, effective January 1, 2022.
    In requesting the one-year delay of the 15 percent payment 
reduction for services furnished in whole or in part by PTAs, one 
commenter noted that the reduction alone would be a challenge in non-
pandemic times, and stated that the total reduction in payment to 
physical therapists and therapy providers will total nearly 28 percent 
in the midst of the ongoing pandemic. The commenter described the 
nearly 28 percent reduction as the cumulative 27.75 percent reduction 
in payment that includes the 15 percent reduction for services 
furnished in whole or in part by PTAs, plus the 3.75 percent reduction 
in Medicare payment, and a 7 percent (on average) reduction in payment 
due to the MPPR, and the 2 percent Medicare sequester that is scheduled 
to return in CY 2022. The commenter cited these reductions in 
combination with the ongoing effects of the PHE for COVID-19 as support 
to delay the implementation of the 15 percent PTA payment differential 
until January 1, 2023.
    Response: We are not able to change the implementation date as the 
statute at section 1834(v)(1) of the Act specifies that the payment 
adjustment for physical therapy and occupational therapy services 
furnished in whole or in part by PTAs and OTAs begins January 1, 2022. 
The revision we proposed to incorporate, the ``8-minute rule'' for the 
final 15-minute unit billed, according to discussions with the major 
therapy association stakeholders, reflects typical billing for some 
private insurers. We plan to add billing scenarios to our Therapy 
Services website located at https://www.cms.gov/Medicare/Billing/TherapyServices that

[[Page 65175]]

are similar to or the same as the above Billing Scenarios #A through #F 
we discussed in the proposed rule. We will also include the general 
rules and steps involved with applying these rules to the various 
billing scenarios.
    Comment: A majority of commenters asked that we provide an 
exemption of the 15 percent payment differential for rural and 
underserved areas, where they stated that a disproportionate amount of 
therapy services are provided by OTAs and PTAs. Some of these 
commenters noted that physical and occupational therapists, together 
with their therapy assistants, work as teams to play a critical role in 
assisting access to care in rural areas where they report a shortage of 
therapists exist.
    One commenter told us that implementing the payment differential 
for services provided in whole or in part by PTAs and OTAs in January 
2022 will further increase existing health disparities in rural areas. 
The commenter stated that they agree with the two mechanisms that were 
recommended by congressional members in a May 14, 2021 letter to help 
mitigate potential harm to rural beneficiaries from the 15 percent 
payment reduction for PTA/OTA services. Although the letter containing 
the recommendations from congressional members was not submitted as a 
comment to our CY 2022 PFS proposed rule, we note that the 
recommendations are the same as those that the commenter shared 
directly with us as a public comment to the CY 2020 PFS proposed rule. 
Those recommendations were for us to use our discretionary authority to 
help mitigate potential harm to rural beneficiaries from the 15 percent 
payment reduction for PTA/OTA services through one of two means based 
on provisions of section 1848 of the Act: (a) Create a class-specific 
geographic index for physical and occupational therapy services 
furnished by PTAs and OTAs; or (b) establish incentive payments for RVU 
data collected from physical and occupational therapists practicing in 
rural areas.
    Response: While we empathize with commenters about a shortage of 
therapists and other healthcare workers in rural areas, section 
1834(v)(1) of the Act does not provide us with statutory authority to 
exempt rural areas or other underserved areas from the 15 percent 
payment differential for therapy services provided in whole or in part 
by PTAs and OTAs. The suggested methods to mitigate the effects of the 
reduced payment amounts involving section 1848 of the Act cannot be 
used to supersede the requirements of section 1834(v)(1) of the Act 
that requires CMS to make the reduced payment for physical and 
occupational therapy services furnished in whole or in part by PTAs and 
OTAs in all areas at 85 percent of the otherwise applicable PFS amount. 
We are hopeful that the revised de minimis standard will improve the 
access issues in rural areas and underserved communities.
    Comment: Many commenters requested that we change the requirement 
that PTs and OTs provide direct supervision of PTAs and OTAs in the 
private practice setting, claiming that the requirement is burdensome 
and inconsistent with CMS supervision requirements in all other 
settings where general supervision is allowed. Many commenters stated 
that the direct supervision requirement is more restrictive than the 
majority of State practice acts for physical and occupational 
therapists, does not allow therapists to practice within the full scope 
of their license, and that this impedes employment opportunities for 
PTAs and OTAs. Commenters also told us that changing the private 
practice direct supervision requirement to general supervision that 
allows audio-only contact between the PT/OT and the PTA/OTA, 
respectively, would also help to ensure continued patient access to 
needed therapy services, especially in rural and underserved areas 
where beneficiaries rely on assistant services to access therapy, 
assist in the ongoing recovery from the COVID-19 pandemic, and provide 
support for small outpatient therapy businesses that are facing the 15 
percent cut to services provided by therapist assistants beginning in 
CY 2022. Many commenters informed us that they would support 
permanently allowing direct supervision via audio/video communications 
that they have appreciated using during the PHE, if we could not change 
the direct supervision requirement to general; however, they also 
reminded us to consider that some patients in rural and underserved 
areas may not have access to broadband, which may not allow patients to 
receive therapy services in their homes under this requirement.
    Response: We did not address supervision requirements for PTAs and 
OTAs in the CY 2022 PFS proposed rule. As such, it would not be 
appropriate to modify those requirements in this final rule. We also 
received other comments raising issues that were well outside the scope 
of the issues we discussed in the CY 2022 PFS proposed rule, and for 
that reason, we decline to address those comments here.
    While we are still reviewing the comments received in response to 
our comment solicitation about whether the flexibility we adopted to 
permit direct supervision through virtual presence should be continued, 
as discussed in section II.D. of this final rule, we want to 
acknowledge that the virtual presence definition for direct supervision 
is effective until the later of the end of the calendar year in which 
the PHE ends or December 31, 2021. The presence of the supervising 
practitioner includes virtual presence through audio/video, real-time 
communications technology (excluding audio-only). This allows the 
private practice therapist to provide direct supervision of therapy 
assistants through virtual presence via real-time audio/video 
communications technology (excluding audio-only).
    Comment: Several commenters requested that we confirm the order of 
claims processing for therapy services billed with a CQ or CO modifier. 
Some questioned whether the 15 percent reduction is taken before or 
after the therapy MPPR. While some commenters thanked us for clarifying 
in the proposed rule that the 15 percent reduction for PTA/OTA services 
does not impact the beneficiary's 20 percent coinsurance, two 
commenters requested that we verify that the 20 percent beneficiary 
copay was not impacted, as they believed was suggested by the 
ratesetting formula we used to estimate the volume discount factor of 
88 percent for services provided by PTAs and OTAs billed with a CQ or 
CO modifier that appeared in the PE section of the CY 2022 PFS proposed 
rule (86 FR 39112).
    Response: In the CY 2022 PFS proposed rule (86 FR 39112), we 
clarified that the 15 percent payment reduction applicable to some PTA/
OTA services applies to the 80 percent of the lesser of the actual 
charge or applicable fee schedule amount and that the remaining 20 
percent is the beneficiary copayment. We explained that for therapy 
services to which the 15 percent reduction applies, payment will be 
made at 85 percent of the 80 percent of allowed charges, or 68 percent 
of allowed charges. We confirm that the beneficiary's copayment for a 
therapy service is deducted right after the application of the MPPR to 
the PE payment. CMS applies the MPPR to ``always therapy'' codes (as 
explained below), which occurs right before the 15 percent reduction is 
applied to 80 percent of the lesser of the actual charge or applicable 
fee schedule amount for claims with a CQ or CO modifier.
    For the majority of therapy claims, the beneficiary copay is less 
than the 20

[[Page 65176]]

percent PFS allowed amount because it is always determined after the 
application of the therapy MPPR that applies to all ``always therapy'' 
codes. ``Always therapy'' codes include almost all therapy applicable 
codes in the Physical Medicine and Rehabilitation section of the 2021 
CPT Professional Codebook with the exception of the codes for active 
wound care management (which are not ``always therapy'' codes). When 
therapy claims have more than one unit of a service or two or more 
``always therapy'' codes, and they also have a CQ or CO modifier for 
each unit or code, the beneficiary's deductible (where it applies) is 
calculated first, then the MPPR is applied to the PE payment, and then 
the 20 percent coinsurance is deducted, as per the usual process. After 
that, the 15 percent reduction is taken for PTA/OTA services, followed 
by the 2 percent sequestration that is always last (when applicable).
    Comment: We received many comments objecting to our determination 
(see section II.E.37. of this final rule) that physical therapists are 
not able to bill for the Remote Therapeutic Monitoring (RTM) codes 
because services cannot be billed incident to the services of a 
physical therapist (86 FR 39173 through 39174). The commenters maintain 
that, when billed by physical therapists, the RTM services would not be 
considered ``incident to'' as they are when billed by physicians. The 
commenters urged us to reconsider our interpretation of the RTM codes 
to permit physical therapists to bill and be paid for these services.
    Response: The RTM codes addressed in section II.E.37. of this final 
rule were intended to be furnished by physical therapists and other 
practitioners who do not bill for E/M visits. (Please see section 
II.E.37. of this final rule for full discussion of the RTM codes and 
their use by therapists.) Payment for these RTM codes is being 
finalized for CY 2022, and we are now designating the five RTM CPT 
codes as ``sometimes therapy'' codes. (Please refer to section II.E.37. 
of this final rule for the discussion on code valuation for these RTM 
services.) As sometimes therapy codes, the RTM services can be billed 
outside a therapy plan of care when provided by a physician and certain 
NPPs, but only when appropriate. While therapists' services must always 
be provided under therapy plans of care, RTM services that relate to an 
RTM device that is specific to therapy services, such as the ARIA 
Physical Therapy device supply in CPT code 98977, must also be 
furnished under a therapy plan of care when furnished by physicians and 
NPPs. RTM services must be provided under direct supervision when not 
directly performed by physicians, NPPs, or therapists; and RTM services 
delegated by PTs and OTs to PTAs and OTAs, respectively, are subject to 
the de minimis standard.
    The RTM codes we are finalizing as described in section II.E.37. of 
this final rule include two 20-minute codes, which is a different time 
interval from the existing 15-minute timed therapy codes. To 
accommodate the two 20-minute CPT codes 98980 and 98981 under our de 
minimis policy, we are making a technical amendment to the regulatory 
text to recognize this 20-minute time interval (or any other potential 
time intervals that may arise in the future) as an ``other time 
interval.'' Specifically, we will add ``or other time interval'' after 
the ``15-minute'' term in our de minimis regulations at Sec. Sec.  
410.59(a)(4)(iii)(B) (for outpatient occupational therapy), 
410.60(a)(4)(iii)(B) (for outpatient physical therapy) and 
410.105(d)(3)(ii) for CORF physical and occupational therapy services.
    We are also providing a billing example to illustrate how the de 
minimis standard would be applied for the RTM treatment management 
services that describe the interactive communications between the 
therapist and/or therapy assistant and the patient/caregiver during the 
calendar month. CPT code 98980 represents the first 20 minutes provided 
in the month while CPT code 98981 reflects each additional full 20-
minute unit, so the midpoint rule is not applicable to these codes.
    Billing Scenario #AA: The PT and PTA independently provide a total 
of 80 minutes of RTM services during the month.
    For purposes of billing 98980: The first full 20 minutes were 
provided by the PT--therefore, CPT code 98980 is billed without a CQ 
modifier.
    For purposes of bulling CPT code 98981, the remaining 60 minutes 
qualifies for billing three 20-minute units, they were furnished as 
follows:

PTA--23 minutes of 98981
PT--37 minutes of 98981
Total = 60 minutes of 98981 (qualifies to bill three 20-minute units)

    Billing Analysis: The 60 total minutes allows three full 20-minute 
units of CPT code 98981 to be billed:
     One unit is billed with the CQ modifier for 20 minutes of 
the 23 minutes provided by the PTA (with 3 minutes leftover).
     One unit is billed without the CQ modifier for the PT's 20 
minutes of the 37 minutes--(with 17 minutes left over).
     The final 20-minute unit is billed with a CQ modifier 
because the PTA's 3 minutes is greater than 10 percent of the 20-minute 
total--that is, 3 minutes divided by 20 equals 15 percent which is 
greater than the 10 percent standard of 2 minutes.
    The two device codes, CPT codes 98976 and 98977, are not subject to 
the de minimis standard, but, the devices' initial set up and patient 
education on its use represented by CPT code 98975 is subject to the de 
minimis policy as an untimed code.
    Comment: We heard from many commenters on issues of interest to 
PTs, OTs, and SLPs, most relating to services included on the Medicare 
telehealth services list that are primarily provided by PTs, OTs, and 
SLPs (see section II.D. of this final rule). We also received several 
comments addressing issues other than those related to the reduced 
payment for services furnished in whole or in part by a PTA/OTA, such 
as requests to modify the plan of care certification requirement and 
recognize PTs as eligible to furnish and bill the CPT codes 20560 and 
20561 for needle insertion without injection--a prohibition that falls 
under the Acupuncture NCD (NCD 30.3.3).
    Response: These comments are outside of the scope of policies 
addressed in the CY 2022 PFS proposed rule, and therefore, we decline 
to address the comments here.
    After consideration of public comments, we are implementing the 
final requirement of the amendments made by section 53107 of the BBA of 
2018 to make payment for physical and occupational therapy services 
furnished in whole or in part by PTAs and OTAs at 85 percent of the 
otherwise applicable PFS payment amount for dates of service on and 
after January 1, 2022. We are finalizing our regulations as proposed at 
Sec. Sec.  410.59(a)(4)(iii)(B) and 410.60(a)(4)(iii)(B) for outpatient 
occupational and physical therapy services, respectively, and at Sec.  
410.105(d)(3)(iii) for CORF occupational and physical therapy services 
to specify that the de minimis rule is applied to each 15-minute unit 
of a service, rather than to all the units of a service. We are also 
finalizing amendments to these sections of the regulations to account 
for the 20-minute codes for RTM services--specifically we are adding 
the phrase ``or other timed'' after ``each 15-minute'' and before 
``unit'' such the phrase will correctly read as ``to specify that the 
de minimis rule is applied to each 15-minute or other timed unit of a 
service.'' We are also finalizing our regulations as proposed at 
Sec. Sec.  410.59(a)(4)(iv) and

[[Page 65177]]

410.60(a)(4)(iv) for outpatient occupational and physical therapy 
services, respectively, and at Sec.  410.105(d)(3)(ii) for CORF 
occupational and physical therapy services to note that the de minimis 
rule is not applied when the OT/PT provides more than the midpoint of a 
15-minute timed code, that is, 8 or more minutes, regardless of any 
minutes for the same service furnished by the OTA or PTA. We are also 
finalizing our regulations as proposed at Sec. Sec.  410.59(a)(4)(v) 
and 410.60(a)(4)(v) for outpatient occupational and physical therapy 
services, respectively, and Sec.  410.105(d)(3)(iv) for CORF services 
to clarify the two remaining unit scenarios, to allow one unit to be 
billed with a CO/CQ modifier and the other unit to be billed without 
the CO/CQ modifier when the OTA/PTA and the OT/PT each provide between 
9 and 14 minutes, independent of one another, with a total time between 
23 and 28 minutes. We plan to add Billing Scenarios to our Therapy 
Services website located at https://www.cms.gov/Medicare/Billing/TherapyServices that are similar to or the same as the above Billing 
Scenarios #A through #F that we discussed in the proposed rule. We plan 
to add a de minimis example of the 20-minute RTM services defined by 
CPT codes 98980 and 98981. We will also include the general rules and 
steps involved with applying the rules to the various billing 
scenarios.
2. Therapy KX Modifier Threshold Amounts
    The KX modifier thresholds were established through section 50202 
of the Bipartisan Budget Act (BBA) of 2018. Formerly referred to as 
therapy caps, these KX modifier thresholds are a permanent provision of 
the statute, meaning that the statute does not specify an end date. 
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 Medicare 
Economic Index (MEI). Specifically, these amounts are calculated by 
updating the previous year's amount by the MEI for the upcoming 
calendar year and rounding to the nearest $10.00. Increasing the CY 
2021 KX modifier threshold amount of $2,110 by the CY 2022 MEI of 2.1 
percent and rounding to the nearest $10.00 results in a CY 2022 KX 
threshold amount of $2,150 for PT and SLP services combined and $2,150 
for OT services.
    Section 1833(g)(7)(B) of the Act was also added by section 50202 of 
the BBA of 2018 and it retains the targeted medical review process, but 
at a lower threshold amount of $3,000 (until CY 2028 when it is updated 
by the MEI). Accordingly, for CY 2022, the MR threshold is $3,000 for 
PT and SLP services combined and $3,000 for OT services. Under the 
established targeted review process, some, but not all, claims 
exceeding the MR threshold amount are subject to review. Information on 
the targeted manual medical review process is available at https://www.cms.gov/ResearchStatistics-Data-and-Systems/MonitoringPrograms/Medicare-FFSCompliancePrograms/Medical-Review/TherapyCap.html.
    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.
    We apply the same PFS-rate accrual process noted above to 
outpatient therapy services furnished by critical access hospitals 
(CAHs), 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).
    When the expenses incurred for the beneficiary's outpatient therapy 
services for the year have exceeded one or both of the KX modifier 
thresholds, therapy suppliers and providers use the KX modifier on 
claims for subsequent medically necessary services. By using 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.

I. Changes to Beneficiary Coinsurance for Additional Procedures 
Furnished During the Same Clinical Encounter as Certain Colorectal 
Cancer Screening Tests

    Section 122 of Division CC of the Consolidated Appropriations Act 
(CAA) of 2021, Waiving Medicare Coinsurance for Certain Colorectal 
Cancer Screening Tests, amends section 1833(a) of the Act to offer a 
special coinsurance rule for screening flexible sigmoidoscopies and 
screening colonoscopies, regardless of the code that is billed for the 
establishment of a diagnosis as a result of the test, or for the 
removal of tissue or other matter or other procedure, that is furnished 
in connection with, as a result of, and in the same clinical encounter 
as the colorectal cancer screening test. The reduced coinsurance will 
be phased-in beginning January 1, 2022. Currently, the addition of any 
procedure beyond a planned colorectal cancer screening test (for which 
there is no coinsurance), results in the beneficiary having to pay 
coinsurance.
    Section 1861(pp) of the Act defines ``colorectal cancer screening 
tests'' and, under sections 1861(pp)(1)(B) and (C) of the Act, 
identifies ``screening flexible sigmoidoscopy'' and ``screening 
colonoscopy'' as two of the recognized procedures. During the course of 
either one of these two procedures, removal of tissue or other matter 
may become necessary for diagnostic purposes. Among other things, 
section 1861(pp)(1)(D) of the Act authorizes the Secretary to include 
in the definition other tests or procedures and modifications to the 
tests and procedures described under this subsection, with such 
frequency and payment limits as the Secretary determines appropriate, 
in consultation with appropriate organizations. Section 1861(s)(2)(R) 
of the Act includes colorectal cancer screening tests in the definition 
of the medical and other health services that fall within the scope of 
Medicare Part B benefits described in section 1832(a)(1) of the Act. 
Section 1861(ddd)(3) of the Act includes colorectal cancer screening 
tests within the definition of ``preventive services.'' In addition, 
section 1833(a)(1)(Y) of the Act provides for payment for a preventive 
service under the PFS at 100 percent of the lesser of the actual charge 
or the fee schedule amount for these colorectal cancer screening tests, 
and under the OPPS at 100 percent of the OPPS payment amount, when the 
preventive service is recommended by the United States Preventive 
Services Task Force (USPSTF) with a grade of A or B. As such, there is 
no beneficiary coinsurance for recommended colorectal cancer screening 
tests as defined in section 1861(pp)(1) of the Act.
    Under these statutory provisions, we have issued regulations 
governing payment for colorectal cancer screening tests at Sec.  
410.152(l)(5). We pay 100 percent of the Medicare payment amount 
established under the applicable payment methodology for the setting 
for providers and suppliers, and beneficiaries are not required to pay 
Part B coinsurance for colorectal cancer screening tests (except for 
barium

[[Page 65178]]

enemas, which are not recommended by the USPSTF with a grade of A or 
B).\39\
---------------------------------------------------------------------------

    \39\ We refer readers to the CY 2022 OPPS final rule for a 
detailed discussion of Changes to Beneficiary Coinsurance for 
Colorectal Cancer Screening Tests in outpatient and ambulatory 
surgical settings.
---------------------------------------------------------------------------

    In addition to colorectal cancer screening tests, which typically 
are furnished to patients in the absence of signs or symptoms of 
illness or injury, Medicare also covers various diagnostic tests (see 
Sec.  410.32). In general, diagnostic tests must be ordered by the 
physician or practitioner who is treating the beneficiary and who uses 
the results of the diagnostic test in the management of the patient's 
specific medical condition. Under Part B, Medicare may cover flexible 
sigmoidoscopies and colonoscopies as diagnostic tests when those tests 
are reasonable and necessary as specified in section 1862(a)(1)(A) of 
the Act. When these services are furnished as diagnostic tests rather 
than as screening tests, patients are responsible for the Part B 
coinsurance (20 or 25 percent depending upon the setting) associated 
with these services.
    We define colorectal cancer screening tests in our regulation at 
Sec.  410.37(a)(1) to include ``flexible screening sigmoidoscopies'' 
and ``screening colonoscopies, including anesthesia furnished in 
conjunction with the service.'' Under our current regulations, we 
exclude from the definition of colorectal screening services, 
colonoscopies and sigmoidoscopies that begin as screening services, but 
where a polyp or other growth is found and removed as part of the 
procedure. The exclusion of these services from the definition of 
colorectal cancer screening tests is based upon longstanding provisions 
under sections 1834(d)(2)(D) and (d)(3)(D) of the Act dealing with the 
detection of lesions or growths during procedures (see CY 1998 PFS 
final rule at 62 FR 59048, 59082 for a more detailed explanation).
    Prior to the enactment of section 122 of the CAA, section 
1834(d)(2)(D) of the Act provided that if, during the course of a 
screening flexible sigmoidoscopy, a lesion or growth is detected which 
results in a biopsy or removal of the lesion or growth, payment under 
Medicare Part B shall not be made for the screening flexible 
sigmoidoscopy, but shall be made for the procedure classified as a 
flexible sigmoidoscopy with such biopsy or removal. Similarly, prior to 
the recent legislative change, section 1834(d)(3)(D) of the Act 
provided that if, during the course of a screening colonoscopy, a 
lesion or growth is detected that results in a biopsy or removal of the 
lesion or growth, payment under Medicare Part B shall not be made for 
the screening colonoscopy but shall be made for the procedure 
classified as a colonoscopy with such biopsy or removal. In these 
situations, Medicare pays for the flexible sigmoidoscopy and 
colonoscopy tests as diagnostic tests rather than as screening tests 
and the 100 percent payment rate for recommended preventive services 
under section 1833(a)(1)(Y) of the Act, as codified in our regulation 
at Sec.  410.152(l)(5), has not applied. As such, beneficiaries 
currently are responsible for the usual coinsurance that applies to the 
services (20 or 25 percent of the cost of the services depending upon 
the setting).
    Under section 1833(b) of the Act, before making payment under 
Medicare Part B for expenses incurred by a beneficiary for covered Part 
B services, beneficiaries must first meet the applicable deductible for 
the year. Section 4104 of the Affordable Care Act (that is, the Patient 
Protection and Affordable Care Act (Pub L. 111-148, March 23, 2010), 
and the Health Care and Education Reconciliation Act of 2010 (Pub. L. 
111-152, March 30, 2010), collectively referred to as the ``Affordable 
Care Act'') amended section 1833(b)(1) of the Act to make the 
deductible inapplicable to expenses incurred for certain preventive 
services that are recommended with a grade of A or B by the USPSTF, 
including colorectal cancer screening tests as defined in section 
1861(pp) of the Act. Section 4104 of the Affordable Care Act also added 
a sentence at the end of section 1833(b)(1) of the Act specifying that 
the exception to the deductible shall apply with respect to a 
colorectal cancer screening test regardless of the code that is billed 
for the establishment of a diagnosis as a result of the test, or for 
the removal of tissue or other matter or other procedure that is 
furnished in connection with, as a result of, and in the same clinical 
encounter as the screening test. Although amendments made by the 
Affordable Care Act addressed the applicability of the deductible in 
the case of a colorectal cancer screening test that involves biopsy or 
tissue removal, they did not alter the coinsurance provision in section 
1833(a) of the Act for such procedures. Public commenters encouraged 
the agency to eliminate the coinsurance in these circumstances; 
however, the agency found that statute did not provide for elimination 
of the coinsurance (75 FR 73170 at 73431).
    Beneficiaries have continued to contact us noting their concern 
that a coinsurance percentage applies (20 or 25 percent depending upon 
the setting) under circumstances where they expected to receive only a 
colorectal screening test to which coinsurance does not apply. Instead, 
these beneficiaries received what Medicare considers to be a diagnostic 
procedure because, for example, polyps were discovered and removed 
during the procedure. Similarly, physicians have expressed concern 
about the reactions of beneficiaries when they are informed that they 
will be responsible for coinsurance if polyps are discovered and 
removed during a procedure that they had expected to be a screening 
procedure to which coinsurance does not apply.
    Section 122 of the CAA addresses this coinsurance issue by 
successively reducing, over a period of years, the percentage amount of 
coinsurance for which the beneficiary is responsible. Ultimately, for 
services furnished on or after January 1, 2030, the coinsurance will be 
zero.
    To implement the amendments made by section 122 of the CAA, we 
proposed to modify our regulations to reflect the changes to Medicare 
statute. As amended, the statute effectively provides that, for 
services furnished on or after January 1, 2022, a flexible 
sigmoidoscopy or a colonoscopy can be considered a screening flexible 
sigmoidoscopy or a screening colonoscopy test even if an additional 
procedure is furnished to remove tissue or other matter during the 
screening test. Specifically, section 122(a)(3) of the CAA added a 
sentence to the end of section 1833(a) of the Act to include as 
colorectal screening tests described in section 1833(a)(1)(Y) of the 
Act, a colorectal cancer screening test, regardless of the code that is 
billed for the establishment of a diagnosis as a result of the test, or 
for the removal of tissue or other matter or other procedure that is 
furnished in connection with, as a result of, and in the same clinical 
encounter as the screening test. We noted that only flexible screening 
sigmoidoscopies and screening colonoscopies are recognized currently as 
colorectal cancer screening tests that might involve removal of tissue 
or other matter. This new sentence added under section 1833(a) of the 
Act uses the same language that was used to amend the statute at 
section 1833(b)(1) of the Act and to broaden the scope of colorectal 
cancer screening tests to which a deductible does not apply. Section 
122(b)(1) of the CAA then limits application of the 100 percent 
Medicare payment rate (that is, no beneficiary coinsurance) under 
section 1833(a)(1)(Y) of the Act for the additional colorectal cancer 
screening

[[Page 65179]]

tests (those that are not screening tests ``but for'' the new sentence 
at the end of section 1833(a) of the Act) by making payment for them 
subject to a new section 1833(dd) of the Act. Section 1833(dd) of the 
Act provides for a series of increases in the Medicare payment rate 
percentage for those services over successive periods of years through 
CY 2029. Thereafter, section 1833(dd) of the Act has no effect, so 
payment for all colorectal cancer screening tests would be made at 100 
percent under section 1833(a)(1)(Y) of the Act.
    To codify the amendments made by section 122 of the CAA in our 
regulations, we proposed to make two modifications to current 
regulations.
    At Sec.  410.37, we proposed to modify our regulation where we 
define conditions for and limitations on coverage for colorectal cancer 
screening tests by adding a new paragraph (j). That paragraph would 
provide that, effective January 1, 2022, when a planned colorectal 
cancer screening test, that is, screening flexible sigmoidoscopy or 
screening colonoscopy test, requires a related procedure, including 
removal of tissue or other matter, furnished in connection with, as a 
result of, and in the same clinical encounter as the screening test, it 
is considered to be a colorectal cancer screening test.
    At Sec.  410.152(l)(5), we also proposed to modify our regulation. 
Here we describe payment for colorectal cancer screening tests. 
Effective January 1, 2022, we proposed to provide for an increase in 
the Medicare payment percentage that is phased in over time. As the 
Medicare payment percentage increases, the beneficiary coinsurance 
percentage decreases. We proposed to revise Sec.  410.152(l)(5) to 
provide that Medicare payment in a specified year is equal to a 
specified percent of the lesser of the actual charge for the service or 
the amount determined under the fee schedule that applies to the test. 
The phased in Medicare payment percentages for colorectal cancer 
screening services described in the proposed regulation at Sec.  
410.37(j) (and the corresponding reduction in coinsurance) are as 
follows:
     80 percent payment for services furnished during CY 2022 
(with coinsurance equal to 20 percent);
     85 percent payment for services furnished during CY 2023 
through CY 2026 (with coinsurance equal to 15 percent);
     90 percent payment for services furnished during CY 2027 
through CY 2029 (with coinsurance equal to 10 percent); and
     100 percent payment for services furnished from CY 2030 
onward (with coinsurance equal to zero percent).
    Thus, between CYs 2022 and 2030, the coinsurance required of 
Medicare beneficiaries for planned colorectal cancer screening tests 
that result in additional procedures furnished in the same clinical 
encounter will be reduced over time from the current 20 or 25 percent 
to zero percent beginning CY 2030 and will remain at zero percent 
thereafter.
    We received several public comments on our proposed modifications 
to the regulations. The following is a summary of the comments we 
received and our responses.
    Comment: Overall, commenters expressed support for our proposals to 
implement, as required, section 122 of Division CC of the CAA of 2021.
    Response: We thank commenters for supporting our proposals to 
implement the amendments made by section 122 of the CAA.
    Comment: One commenter expressed concern about the length of the 
phase-in period for the reduction in the beneficiary's coinsurance 
percentage, and asked whether it could be changed to next year.
    Response: We proposed to implement the amendments made by section 
122 of the CAA. Those amendments clearly specify the applicable 
coinsurance percentages for each calendar year, and we do not have 
discretion to modify them.
    Comment: A commenter requested that the beneficiary should not be 
responsible for coinsurance for anesthesia services when a screening 
flexible sigmoidoscopy or a screening colonoscopy becomes a diagnostic.
    Response: In the CY 2015 PFS final rule (79 FR 67730 through 
67732), we amended the definition of colorectal cancer screening tests 
that are colonoscopies at Sec.  410.37(a)(1)(iii) to include anesthesia 
that was furnished in conjunction with screening colonoscopies. We did 
not make a corresponding modification to the definition of colorectal 
cancer screening tests that are flexible sigmoidoscopies at Sec.  
410.37(a)(1)(ii). Section 122 of the CAA did not change these 
regulatory definitions of colorectal cancer screening tests and we did 
not propose to modify them in the CY 2022 PFS proposed rule. Therefore, 
we are not making any changes in the regulation with respect to 
anesthesia with screening flexible sigmoidoscopy in this final rule. 
However, we will take these public comments into consideration for 
possible future rulemaking.
    Comment: A commenter requested that we allow suppliers to waive the 
coinsurance even earlier than 2030 if they elect to do so without fear 
of violating any CMS rules.
    Response: Through this rulemaking we are adopting Medicare 
regulations regarding beneficiary coinsurance that reflect the 
decreasing beneficiary financial obligations over time as established 
by statute. Prior to the complete phaseout of Medicare coinsurance 
amounts for colorectal cancer screening tests in CY 2030, suppliers may 
waive coinsurance amounts only if they comply with applicable law, 
including the Federal Anti[hyphen]Kickback Statute and the civil 
monetary penalty provision prohibiting inducements to 
beneficiaries.\40\
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    \40\ For further information see the OIG website at https://oig.hhs.gov/compliance/physician-education/fraud-abuse-laws/.
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    Comment: A commenter urged CMS to conduct patient education and 
outreach about the changes to their coinsurance when a screening 
becomes a diagnostic.
    Response: We agree it is important for Medicare beneficiaries to 
understand the changes that will affect their coinsurance percentage 
for certain colorectal cancer screening services and expect to develop 
articles and update other media to announce and explain the changes.
    We received several comments that were outside the scope of the 
proposals made in the CY 2022 PFS proposed rule. Comments included 
questions about coverage of bowel preparation products, coverage of 
non-invasive screening tests that require a follow-up colonoscopy, and 
cost-sharing for new colorectal screening technologies. Although we are 
not summarizing and responding to these comments in this final rule, we 
will take them into consideration for possible future healthcare 
provider education or rulemaking.
    After considering public comments, we are finalizing the proposals 
made in the CY 2022 PFS proposed rule to implement section 122 of the 
CAA without modification.

J. Vaccine Administration Services: Medicare Payments for Administering 
Preventive Vaccines

    As we discussed in the CY 2022 PFS proposed rule (86 FR 39220), on 
January 31, 2020, under section 319 of the Public Health Service (PHS) 
Act (42 U.S.C. 247d), the Secretary of the Department of Health and 
Human Services (the Secretary) determined that a public health 
emergency (PHE) as a result of confirmed cases of 2019 Novel

[[Page 65180]]

Coronavirus exists nationwide and has existed since January 27, 2020 
(hereafter referred to as the PHE for COVID-19). The Secretary has 
since renewed this declaration for successive 90-day periods, the 
latest on October 18, 2021.
    The PHE for COVID-19 has reinforced the important and positive 
impact that preventive vaccines can have on the health of Medicare 
beneficiaries and the broader public. At the time of publishing this 
final rule, the PHE for COVID-19 declaration is still in effect and the 
United States is in the middle of a national effort to vaccinate as 
many people against COVID-19 as quickly as possible. This national 
effort has at least temporarily altered the landscape for vaccines and 
vaccine administration by, for example, encouraging existing providers 
and suppliers to dramatically expand their vaccination capabilities and 
by encouraging new (and new types) of providers and suppliers to 
furnish vaccines.
    Over the past several years, stakeholders have expressed concerns 
about the reduction in Medicare payment rates for the service to 
administer preventive vaccines covered by Medicare Part B under section 
1861(s)(10) of the Act, including the influenza, pneumococcal, and 
hepatitis B virus (HBV) vaccines. In the last two PFS rulemaking cycles 
(that is, for CY 2020 and CY 2021), we have attempted to address some 
of these concerns and these efforts are discussed in more detail below. 
However, CY 2021 payment rates for administration of these vaccines by 
suppliers including physicians, NPPs, and mass immunizers remain the 
same as in CY 2019: A national average rate of $16.94, which is 
geographically adjusted. In the CY 2022 PFS proposed rule (86 FR 
39221), we requested feedback on how we should update the payment rate 
for administration of these preventive vaccines under Medicare Part B.
1. Medicare Part B Payment for Vaccines
    As we discussed in the CY 2022 PFS proposed rule (86 FR 39220 
through 39224), under section 1861(s)(10) of the Act, Medicare Part B 
covers both the vaccine and its administration for the preventive 
vaccines specified--the influenza, pneumococcal, HBV, and COVID-19 
vaccines. Under sections 1833(a)(1)(B) and (b)(1) of the Act, there is 
no applicable beneficiary coinsurance, and the annual Part B deductible 
does not apply for these vaccinations or the services to administer 
them. In CY 2021, payment for these vaccines is based on 95 percent of 
the Average Wholesale Price (AWP) for a particular vaccine product 
except where furnished in the settings for which payment is based on 
reasonable cost, such as a HOPD, RHC, or FQHC. For example, for the 
2020-2021 influenza season, payment limits for adult influenza vaccine 
products range from about $19 to $61 per adult dose. We noted that most 
other preventive vaccines not specified for Medicare Part B coverage 
under section 1861(s)(10) of the Act, such as the shingles vaccine, are 
covered and paid for under Medicare Part D.
    Section 3713 of the Coronavirus Aid, Relief, and Economic Security 
Act (CARES Act) (Pub. L. 116-136) added the COVID-19 vaccine and its 
administration to section 1861(s)(10)(A) of the Act in the same 
subparagraph as the influenza and pneumococcal vaccines and their 
administration. We implemented this change through an interim final 
rule with comment period (November 4th COVID-19 IFC (85 FR 71145 
through 71150)) which established that payments for COVID-19 vaccines 
and vaccine administration would be made in the same manner as payments 
for the influenza and pneumococcal vaccines. The IFC specifically 
amended Sec. Sec.  414.707(a)(2)(iii) and 414.904(e)(1) to include the 
COVID-19 vaccine in the list of vaccines with payment limits calculated 
using 95 percent of the AWP (85 FR 71147). We noted that Medicare does 
not pay providers and suppliers for the vaccine product when the 
Federal Government purchases it and gives it to the provider or 
suppliers for free, as has been the case for all COVID-19 vaccines as 
of the publication of the proposed rule.
    We noted that the vaccine administration services described under 
section 1861(s)(10) of the Act are not technically valued or paid under 
the PFS, as they are not included within the statutory definition of 
physicians' services in section 1848(j)(3) of the Act. Despite this, we 
have historically based payment rates for the administration of these 
preventive vaccines by suppliers such as physicians, NPPs, and mass 
immunizers on an evaluation of the resource costs involved in 
furnishing the service, which is similar to the methodology that we use 
to establish payment rates for the PFS. We noted further that we also 
assign a payment rate for administering these preventive vaccines under 
the Outpatient Prospective Payment System (OPPS), and those payment 
rates are for hospitals and home health agencies for preventive vaccine 
administration. Certain other types of providers and suppliers, such as 
RHCs, FQHCs and critical access hospitals (CAHs), are paid based on 
reasonable cost for vaccine administration. We also noted that payments 
for the administration of the preventive vaccines by suppliers such as 
physicians, NPPs, and mass immunizers are geographically adjusted based 
on the provider's wage index.
    As discussed in the CY 2021 PFS proposed rule (85 CFR 50162), many 
stakeholders raised concerns about the reductions in payment rates for 
the preventive vaccine administration services that had occurred over 
the past several years. We generally have established payment rates for 
the three Healthcare Common Procedural Coding System (HCPCS) codes 
G0008, G0009, and G0010--which describe the services to administer an 
influenza, pneumococcal and HBV vaccines, respectively, based on a 
direct crosswalk to the PFS payment rate for CPT code 96372 
(Therapeutic, prophylactic, or diagnostic injection (specify substance 
or drug); subcutaneous or intramuscular). Because we proposed and 
finalized reductions in valuation for that code for CY 2018, the 
payment rate for the vaccine administration codes was concurrently 
reduced. Further, because the reduction in RVUs for CPT code 96372 was 
significant enough to be required to be phased in over several years 
under section 1848(c)(7) of the Act, the reductions in overall 
valuation for the vaccine administration codes were likewise subject to 
reductions over several years. As we noted in the CY 2022 PFS proposed 
rule (86 FR 39222) in Table 21, Table 30 shows the national payment 
rate for administering these preventive vaccines has declined more than 
30 percent since 2015.

[[Page 65181]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.052

    We explained that we have attempted to address the reduction in 
payment rates for these vaccine administration HCPCS codes in the last 
two PFS rulemaking cycles. In the CY 2020 PFS final rule, we 
acknowledged that it is in the public interest to ensure appropriate 
resource costs are reflected in the valuation of the immunization 
administration services that are used to deliver these vaccines, and 
noted that we planned to review the valuations for these services in 
future rulemaking. For CY 2020, we maintained the CY 2019 national 
payment amount for immunization administration services described by 
HCPCS codes G0008, G0009 and G0010.
    In the CY 2021 PFS proposed rule, we proposed to crosswalk G0008, 
G0009 and G0010 to CPT code 36000 (Introduction of needle or 
intracatheter, vein) (85 FR 50163). In the proposed rule, we noted that 
CPT code 36000 is a service with a similar clinical vignette, and that 
the additional clinical labor, supply, and equipment resources 
associated with furnishing CPT code 36000 were similar to costs 
associated with these vaccine administration codes. We also noted that 
this crosswalk would have resulted in a payment rate for vaccine 
administration services that is approximately the same as the CY 2017 
rate (as noted in Table 30) that was in place prior to the revaluation 
of CPT code 96372 (the original crosswalk code). In the CY 2021 PFS 
final rule, we did not finalize the proposed policy, and instead 
finalized a policy to maintain the CY 2019 payment amount for G0008, 
G0009 and G0010 (85 FR 84628). In the final rule, we also noted that we 
continued to seek additional information that specifically identifies 
the resource costs and inputs that should be considered to establish 
payment for vaccine administration services on a long-term basis.
    As noted above, section 3713 of the CARES Act added the COVID-19 
vaccine and its administration to the preventive vaccines covered under 
Medicare Part B under section 1861(s)(10)(A) of the Act in the same 
subparagraph as the influenza and pneumococcal vaccines and their 
administration. We noted in the CY 2022 PFS proposed rule (86 FR 39222) 
that section 3713 of the CARES Act allows us to implement the 
amendments made by that section through ``program instruction or 
otherwise.'' In implementing section 3713 of the CARES Act in the 
November 4th COVID-19 IFC (85 FR 71147), we indicated that we would 
establish specific coding and payment rates for the COVID-19 vaccine 
and its administration through technical direction to Medicare 
Administrative Contractors (MACs) and information posted publicly on 
the CMS website.
    In December 2020, we publicly posted the applicable CPT codes for 
the Pfizer-BioNTech and Moderna COVID-19 vaccines and initial Medicare 
payment rates for administration of these vaccines upon the FDA's 
authorization of these vaccines. We announced an initial Medicare 
payment rate for COVID-19 vaccine administration of $28.39 to 
administer single-dose vaccines. For a COVID-19 vaccine requiring a 
series of two or more doses--for example, for both the Pfizer-BioNTech 
and Moderna products--we announced a payment rate for administration of 
the initial dose(s) of $16.94, which was based on the Medicare payment 
rate for administering the other preventive vaccines under section 
1861(s)(10) of the Act. We also announced a payment rate for 
administering the second dose of $28.39, which was based on the payment 
rate that was proposed, but not finalized, for administration of the 
other preventive vaccines under section 1861(s)(10) of the Act in the 
CY 2021 PFS proposed rule, discussed in more detail above.
    On March 15, 2021, we announced an increase in the payment rate for 
administering a COVID-19 vaccine to $40 per dose, effective for doses 
administered on or after March 15, 2021, which means the payment rate 
is $40 to administer a single dose product, and $40 each to administer 
the first and second dose in a two-dose regime ($80 total).

[[Page 65182]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.053

    As discussed above, payment rates for suppliers such as physicians, 
NPPs, and mass immunizers for administering the Part B covered 
preventive vaccines (other than for COVID-19) have generally been based 
on a direct crosswalk to CPT code 96372 (Therapeutic, prophylactic, or 
diagnostic injection (specify substance or drug); subcutaneous or 
intramuscular). The service described by this crosswalk code is paid 
under the PFS, and Medicare's process to value codes under the PFS 
relies in part on recommended resource inputs provided by the AMA RUC 
and steps to translate those recommended inputs into national RVUs.
    In 2020, the RUC resubmitted its 2009 valuation recommendation for 
vaccine administration services described by CPT codes, including CPT 
codes 90460 (Administration of first vaccine or toxoid component 
through 18 years of age with counseling), 90471 (Administration of 1 
vaccine), and 90473 (Administration of 1 nasal or oral vaccine). The 
AMA RUC also recently provided valuation recommendations for the CPT 
codes that describe the service to administer the COVID-19 vaccines.
    As noted earlier, we also assign a payment rate for administering 
preventive vaccines under the OPPS by assigning each service to an 
ambulatory payment classification (APC) based on clinical and resource 
cost similarity to other services assigned to the APC. Geometric mean 
costs, which are generally used in establishing the prospective OPPS 
payments for each APC, are calculated using historical claims and cost 
report information. In CY 2021, CMS assigned HCPCS codes G0008, G0009 
and G0010 to APC 5691 (level 1 drug administration), which has a 
national payment rate of $40 for CY 2021.
    In the CY 2022 PFS proposed rule (86 FR 39223), we explained that 
our practice of setting payment rates for preventive vaccine 
administration services described by HCPCS codes G0008, G0009 and G0010 
for physicians, NPPs, and mass immunizers by using the PFS approach 
(for example, a crosswalk to an existing CPT code) means that costs 
incorporated into the rate primarily reflect costs of furnishing the 
service in a physician office setting. It also means that the payment 
rate can be affected by other aspects of the PFS rate-setting 
methodology, such as the allocation of indirect PE, and broader changes 
to PFS codes and rates, including the multi-year phase-in of 
significant reductions in RVUs discussed earlier. We noted that we have 
not historically collected or used information from other providers and 
suppliers, including pharmacies which are commonly enrolled as mass 
immunizers to furnish vaccines and vaccine administration services, for 
purposes of establishing a rate for these codes.
    We requested feedback from stakeholders that would support the 
development of an accurate and stable payment rate for administration 
of the preventive vaccines described in section 1861(s)(10) of the Act 
for physicians, NPPs, mass immunizers and certain other providers and 
suppliers. We invited commenters to submit their detailed feedback to 
the following questions and requests that we believe may assist us in 
establishing payment rates for these services that could be appropriate 
for use on a long-term basis.
     What are the different types of providers and suppliers 
that furnish preventive vaccines, and have these types of providers/
suppliers changed as a result of the PHE for COVID-19? (We noted that 
our claims data reflect the type of Medicare enrollment for those 
billing for the vaccine administration, but we are particularly 
interested in understanding additional, specific characteristics of the 
providers and suppliers that may not be distinguishable under the more 
general Medicare enrollment data.) Do different providers and suppliers 
furnish different aspects of the vaccine administration for the same 
beneficiary?
     What are the differences in incurred costs of furnishing 
influenza, pneumococcal and HBV vaccines compared to furnishing COVID-
19 vaccines? Are there differences in the costs (per dose or otherwise) 
of furnishing a one-dose vaccine product vs. a two-dose vaccine 
product? Also, are there differences in cost of administering 
preventive vaccines furnished under the Part D benefit, such as the 
shingles vaccines, compared to those furnished under Part B?
     What are the resource costs that physicians, NPPs, mass 
immunizers and certain other suppliers incur when furnishing vaccines 
safely and effectively? Specifically, what are the costs related to 
staffing/labor, infrastructure, patient onboarding/enrollment, vaccine 
storage and handling, vaccine procurement and coordination, supplies, 
CDC and State reporting requirements, patient counseling about safety 
and efficacy, and other costs we may not have considered? We also 
sought information on specific resource costs per vaccine dose within 
each cost category, if that is available.
     What are the impacts of the PHE for COVID-19 on resource 
costs incurred by vaccination providers, and do stakeholders envision 
that these impacts will continue after the PHE has ended? Following the 
end of the PHE, do you expect that the same types of vaccination 
providers and suppliers will continue to administer vaccines, or do you 
envision that this will change (if so,

[[Page 65183]]

how, and what would be the primary factors driving the change)?
     How should Medicare assess costs associated with 
furnishing these preventive vaccines outside of the physician office 
setting, such as in pharmacies, mass immunization sites, mobile vaccine 
clinics or other locations? In addition, as we noted in the CY 2022 PFS 
proposed rule (86 FR 39224), we understand that there could be 
administrative burden associated with the routine collection of cost 
data to support more accurate rate-setting for suppliers that are 
vaccinating patients. Are there other ways to update and validate costs 
for a broader range of entities using existing data?
     Payment rates for vaccine administration currently vary by 
setting. For HCPCS codes G0008, G0009 and G0010, the CY 2021 national 
average payment rate for physicians, practitioners and other suppliers 
is $16.94, which is geographically adjusted, while for HOPDs it is $40. 
However, for COVID-19 vaccine administration, Medicare now pays $40 per 
administration in all settings, unless the vaccine in administered 
under certain circumstances in the home or residence (as discussed in 
more detail below). Should Medicare continue to pay differently for 
non-COVID-19 preventive vaccines furnished in certain settings or under 
certain conditions? If not, what factors contribute to higher costs for 
administration of non-COVID-19 vaccines that are not currently 
reflected in the Medicare payment rates?
     Should CMS use a different process to update the payment 
rates for administration of the preventive vaccines described in 
section 1861(s)(10) of the Act on an annual basis?
     In the last few years we have also crosswalked vaccine 
administration CPT codes 90460 (Administration of first vaccine or 
toxoid component through 18 years of age with counseling), 90461 
(Administration of vaccine or toxoid component through 18 years of age 
with counseling), 90471 (Administration of 1 vaccine), 90472 
(Administration of vaccine), 90473 (Administration of 1 nasal or oral 
vaccine), and 90474 (Administration of nasal or oral vaccine) to the 
same rate used by G0008, G0009 and G0010. How should Medicare address 
payment rates for these CPT codes under the PFS?
     Are there major differences between what Medicare pays 
physicians, NPPs and mass immunizers for non-COVID-19 preventive 
vaccine administration and what commercial insurers pay? To the extent 
possible, we also sought comments on the specific rates used by other 
insurers.
    We received feedback from a wide variety of stakeholders in 
response to our comment solicitation on payment rates for the 
administration of COVID-19 vaccines and other preventive vaccines 
covered under the Medicare Part B vaccine benefit. Commenters 
overwhelmingly emphasized the importance of vaccination in achieving 
positive health outcomes for Medicare beneficiaries and the broader 
American public. At the same time, they observed that immunization 
rates overall continue to fall short of national objectives, and that 
troubling disparities exist with respect to vaccination among racial 
and ethnic minorities. Commenters also confirmed that many different 
types of healthcare providers have contributed to the vaccination 
effort in the United States, and provided detailed feedback on the 
challenges and resource costs experienced by these vaccine providers, 
especially in the context of the COVID-19 public health emergency. In 
what follows, we summarize the comments that we received on these 
topics, and explain how they have informed the policies we are adopting 
in this final rule.
    Comment: The comments we received are a testament to the complex 
landscape of vaccination that has emerged in the wake of the COVID-19 
pandemic. We received feedback from representatives of many different 
types of healthcare providers who stated that they significantly 
increased their vaccination capabilities in an effort to immunize as 
many Americans as possible against COVID-19. These include primary care 
physicians, NPs, pharmacies, urgent care centers, podiatrists, 
community health centers, Urban Indian Organizations, and schools of 
nursing. Commenters cited Federal financial assistance and 
flexibilities, in particular the March 2020 Declaration under the 
Public Readiness and Emergency Preparedness (PREP) Act (Division C of 
Pub. L. 109-148), as factors that have enabled a broader scope of 
healthcare providers to participate in the COVID-19 vaccination effort. 
In addition, commenters noted that healthcare providers such as 
hospitals, pharmacies and FQHCs have sought to expand the reach of 
their vaccination campaigns by establishing mobile and outreach 
clinics, as well as operating mass immunization sites in their 
communities.
    We also received numerous responses to our request for feedback on 
the specific types of expenses incurred by healthcare providers of 
COVID-19 and other preventive vaccines, including the ways in which 
these expenses have evolved as a result of the COVID-19 PHE. Many 
commenters indicated that the costs of administering the COVID-19 
vaccines are higher than those associated with other preventive 
vaccines, citing factors such as the needs for ultra-cold storage, 
manual filling of syringes, scheduling for subsequent doses, post-
injection monitoring, stocking of EPI pens, distribution of CDC fact 
sheets, disposal and logging of wasted doses, and State and Federal 
reporting obligations, which in turn have required hiring of additional 
staff and various software and IT enhancements. With respect to the 
specific impacts of the pandemic on resource costs, commenters cited 
the need for personal protective equipment, increased sanitization 
measures, community outreach efforts, and high patient volumes combined 
with staffing shortages. One commenter added that costs and 
administrative burdens have increased because patients do not want to 
go to provider locations to risk other illnesses. In addition, several 
commenters pointed specifically to misinformation and vaccine hesitancy 
as factors that have impeded the national immunization effort, and 
recommended that payment rates should take into consideration the time 
required to counsel and educate patients, including in the event that a 
patient ends up declining the vaccine. A few commenters indicated that 
they expect the effects of the pandemic to persist into CY 2022 and 
beyond, and that we should therefore maintain the $40 payment rate for 
COVID-19 vaccines for the foreseeable future.
    Finally, commenters also provided feedback on the expenses 
associated with setting up outreach clinics and mass immunization 
sites, which require significant upfront infrastructure investments, as 
well as back-end costs to break down these operations when they are 
concluded. Specific expenses associated with such ventures include 
tents, generators, portable restrooms, relocation of computers and 
other equipment, security services, and staffing. Some commenters 
recommended that the payment rate for mass community vaccination events 
organized by FQHCs be increased from $40 to at least $120 per dose to 
reflect these additional costs incurred by FQHCs.
    One commenter representing pharmacists stated that cost reporting 
would be the best approach to valuing vaccine administration at 
pharmacies, and that the current crosswalk to the PFS does not 
accurately reflect the costs incurred by pharmacies in furnishing

[[Page 65184]]

these services. The commenter cited costs including vaccine packaging 
and storage, ancillary supplies such as syringes and gloves, patient 
outreach and counseling, staffing and training, reporting requirements, 
seasonal fluctuations in patient volume, and reporting requirements. In 
response to our inquiry about the differences in costs of administering 
preventive vaccines furnished under the Part B and Part D benefits, a 
couple of commenters noted that the Part B claims submission process is 
more complex and labor-intensive than the process under Part D and 
results in greater costs for pharmacies.
    Given the various expenses outlined above, commenters generally 
applauded CMS for establishing a payment rate for COVID-19 vaccines of 
$40 per dose as of March 15, 2021, with several commenters noting that 
this amount accurately reflects the resource costs involved in COVID-19 
vaccine administration. On the other hand, a majority of commenters 
also expressed concern regarding the payment rate for other Part B 
preventive vaccines, that is, influenza, pneumococcal, and HBV 
vaccines--which, as noted above, currently stands at $16.94. Commenters 
stated that this amount does not take full account of the expenses 
associated with administering these vaccines, and that, as a result, 
many healthcare providers, especially smaller, independent practices 
and those in underserved areas, might be discouraged from offering 
vaccines to their patients. Indeed, many commenters cited adequate 
reimbursement as one of the principal factors that contribute to higher 
immunization rates, and several cited a recent survey in which 80 
percent of respondents indicated that increasing vaccine administration 
payment rates would help overcome vaccination barriers and costs 
created by the pandemic.\41\ A couple of commenters added that Medicare 
payment rates impact the rates paid by Medicaid and private payers, 
with one commenter asserting that some regional and private payers pay 
as little as half of the Medicare rate. One commenter therefore 
commended CMS for taking efforts to ensure appropriate, predictable and 
stable payment for vaccines and their administration as a key lever to 
improving immunization rates among Medicare beneficiaries. Another 
commenter added that contracting influenza concurrently with COVID-19 
may increase the risk of adverse health outcomes, and recommended 
increasing payment rates for influenza vaccines for this reason.
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    \41\ Belowich, E., Pratt, K., Fifer, S., Solis, P., & Hughes IV, 
R. (2020, December 9). Increased Reimbursement May Help Overcome 
Barriers To Administration Of Seasonal And Routine Vaccines [verbar] 
Health Affairs. Health Affairs. https://www.healthaffairs.org/do/10.1377/hblog20201208.111539/full/.
---------------------------------------------------------------------------

    Commenters generally recommended that payment rates for the 
influenza, pneumococcal and HBV vaccines should be updated and that 
payment for the administration of these vaccines and of the COVID-19 
vaccines should be determined using consistent methodologies, as 
discussed below. One group of commenters recommended that CMS pay for 
these services on the basis of resource-based relative value scale 
(RBRVS) principles using recommendations submitted by the AMA RUC. In 
May 2021, the RUC submitted its recommendations for Immunization 
Administration codes 90460, 90461, 90471, 90472, 90473, 90474, G0008, 
G0009 and G0010. In particular, the RUC recommended that CMS crosswalk 
HCPCS codes G0008-10 to CPT code 90471, using inputs that would result 
in a payment of approximately $21 per dose.
    Furthermore, in December 2020, the RUC submitted recommendations 
for CPT codes 0001A, 0002A, 0011A, 0012A, and 0031A (the first and 
second doses of the Pfizer-BioNTech and Moderna COVID-19 vaccines and 
the first dose of the Janssen vaccine, respectively). Specifically, the 
RUC recommended crosswalking these codes to CPT code 90460, which would 
result in a payment of approximately $30 for the vaccine administration 
codes, and additionally recommended that for the duration of the PHE 
CMS approve payment of approximately $10 for new CPT code 99072 
(Additional supplies, materials, and clinical staff time over and above 
those usually included in an office visit or other non-facility 
service(s), when performed during a Public Health Emergency, as defined 
by law, due to respiratory-transmitted infectious disease) to reflect 
the additional PEs associated with administration of the COVID-19 
vaccines during the PHE. The RUC submitted similar recommendations for 
the third doses of the Pfizer and Moderna vaccines in August 2021. 
Thus, using the RUC recommendations would result in a payment for 
COVID-19 vaccine administration of approximately $35-$40 per dose 
during the PHE, and approximately $25-$30 after the PHE is terminated.
    Another group of commenters recommended decoupling payment for 
preventive vaccine administration from the crosswalk to a code valued 
under the PFS. These commenters generally supported a site-neutral 
payment of $40 per dose for administration of all Part B preventive 
vaccines, in line with the current payment rate for COVID-19 vaccine 
administration and with the payment rate for administration of all 
preventive vaccines under the OPPS. Several commenters who supported 
this recommendation stated that equal payment for COVID-19 and other 
preventive vaccines would be appropriate, since the work involved in 
administering the different types of vaccines is essentially the same. 
A few commenters also stated that costs associated with vaccine 
administration do not vary significantly across different sites of 
service, with some adding that a site-neutral payment would help 
address inequities across healthcare provider settings and maximize 
access to the vaccines. Additionally, a few commenters stated that, if 
CMS does not decouple payment for vaccine administration from the PFS 
and adopt a payment rate of $40 per dose as discussed above, then an 
acceptable alternative would be to value these services by means of a 
crosswalk to CPT code 36000 (Introduction of needle or intracatheter, 
vein), as originally proposed in the CY 2021 PFS proposed rule. As 
explained in the CY 2021 PFS proposed rule (85 FR 50163), CPT code 
36000 is a service with a similar clinical vignette, and the additional 
clinical labor, supply, and equipment resources associated with 
furnishing CPT code 36000 are similar to costs associated with these 
vaccine administration codes. This proposal, which was not finalized, 
would have resulted in a payment for Part B vaccine administration 
services of approximately $28.39 per dose.
    One commenter suggested that CMS base payment for vaccine 
administration services on average rates paid by commercial payers or 
on the 2015 Medicare rate adjusted for inflation to 2022. Another 
commenter provided data indicating that rates set by commercial payers 
for CPT code 90471 (Immunization, initial) and CPT code 90472 
(Immunization administration, each additional vaccine) are about 41 
percent and 23 percent higher than rates set by Medicare, respectively.
    Response: We appreciate the feedback received from the wide range 
of providers and suppliers that furnish preventive vaccinations. We 
agree with commenters on the need to establish stable payment rates 
that take into account the costs associated with administering the 
preventive vaccines included in the Part B vaccine benefit. In 
particular, we agree that the payment

[[Page 65185]]

rates for administration of the influenza, pneumococcal and hepatitis B 
vaccines are too low and need to be adjusted to reflect the costs 
incurred by healthcare providers. Furthermore, we agree with commenters 
who stated that we should decouple payment for these vaccine 
administration services from the crosswalk to the PFS and treat them 
independently. We took a number of factors into consideration in 
developing our final policy.
    First, we considered the impact of the pandemic on the costs 
associated with vaccine administration, as well as the specific costs 
associated with administration of the COVID-19 vaccines. We generally 
agree with the commenters who stated that the service to administer 
these vaccines is essentially the same and does not vary significantly 
across different types of healthcare providers. At the same time, we 
recognize that the PHE has posed and continues to pose unique 
challenges for vaccination providers, particularly with respect to the 
administration of vaccines for COVID-19. For example, we anticipate 
that healthcare providers will continue to experience unusual costs 
associated with staffing, scheduling, and reporting requirements as 
increasing numbers of patients receive additional doses and boosters of 
the COVID-19 vaccines in the near future, and as health care providers 
adapt their vaccine delivery infrastructure accordingly. After the PHE, 
however, we anticipate that these costs will go down as patient volumes 
stabilize and as healthcare providers incorporate tasks such as 
scheduling and reporting into their routine clinical practice. In 
addition, we note that healthcare providers will have already made 
certain capital investments associated with the COVID-19 vaccines, such 
as ultra-cold storage freezers and software upgrades, during the course 
of the PHE, and thus after the PHE such investments will no longer 
represent a significant additional cost over and above the costs of 
administering other preventive vaccines. At the same time, we recognize 
that the formal termination of the PHE will not necessarily coincide 
with an immediate return to pre-pandemic circumstances, and that some 
of the additional costs mentioned above may persist while conditions 
normalize. For these reasons, we believe that it is appropriate to 
establish a single, consistent payment rate for the administration of 
all Part B preventive vaccines following the end of the calendar year 
in which the PHE expires. That is, effective January 1 of the year 
following the year in which the PHE ends, the $40 payment rate for 
administration of the COVID-19 vaccines will be adjusted to equal the 
payment rate for the administration of other Part B preventive 
vaccines.
    We also considered the empirical data sources available to us for 
establishing an appropriate vaccine-neutral payment. On the one hand, 
we considered the recommendations submitted by the AMA RUC, which, as 
noted above, would result in payment rates of approximately $21 for 
administration of the influenza, pneumococcal and hepatitis B vaccines, 
and approximately $25-$30 for administration of the COVID-19 vaccine 
following the end of the PHE. On the other hand, we considered the 
payment rate for vaccine administration services established using the 
APC methodology under the hospital OPPS, which currently stands at 
approximately $40. Finally, we considered the recommendation made by 
commenters who stated that we should base the payment rate on a 
crosswalk to CPT code 36000, which would result in a payment rate of 
approximately $30 after adjusting the CY 2021 rate of $28.39 for 
inflation. Based on these data and on the feedback we received from 
commenters, we believe that $30 is the most appropriate payment rate 
for administration of Part B preventive vaccines. Specifically, this 
amount is approximately equivalent to the CY 2021 valuation of CPT code 
36000 adjusted for inflation to CY 2022, and also near the upper range 
of the approximate payment rates that would result if we adopted the 
RUC recommendations for administration of the COVID-19 vaccines.
    Based on the history and status of payment for preventive vaccine 
administration discussed above and given the concerns gathered through 
the comment solicitation we believe that we need to act expeditiously 
to update payment rates for the administration of preventive vaccines 
paid under Medicare Part B, effective January 1, 2022. In addition, we 
believe that the timing is appropriate for establishing a predictable 
payment rate for preventive vaccine administration since the PHE has 
ignited a hypervigilance for infectious diseases.
    In setting the payment rate for administration of preventive 
vaccines, we carefully considered how to move forward with what we 
believe is the appropriate payment mechanism that would align with the 
goal of vaccinating as many Medicare beneficiaries as possible each 
year in an effort to prevent illnesses that are known to lead to 
negative outcomes. For example, we considered the value of establishing 
a site-neutral payment rate versus recognition that cost structures are 
different between an office, hospital, or temporary remote COVID-19 
vaccination administration site. We concluded that establishing payment 
rates that are intended to address the unique costs experienced across 
the wide variety of providers and suppliers that administer 
vaccinations would require the development of an unnecessarily complex 
payment methodology and potentially delay implementation.
    We also recognize the value of a site-neutral payment rate, 
especially with regard to vaccine administration, since the procedure 
itself is practically the same across settings. However, we are unable 
to establish a single Medicare program payment rate that is site-
neutral since there are several settings in which different Medicare 
payment methodologies dictate different payment rates for vaccine 
administration under Part B. Payment rates for administration of 
preventive vaccines by suppliers such as physicians, NPPs, and mass 
immunizers historically have been based on an evaluation of the 
resource costs involved in furnishing the service, which is analogous 
to the methodology that we use to establish payment rates under the 
PFS. We also assign a payment rate under the OPPS for administration of 
preventive vaccines by hospitals. Certain other types of providers and 
suppliers, such as RHCs, FQHCs and CAHs, are paid on a reasonable cost 
basis for vaccine administration.
    We believe we have gathered sufficient resource cost data that can 
be used to set an appropriate payment rate for suppliers such as 
physicians, NPPs, and mass immunizers, who administer the majority of 
preventive vaccines to Medicare beneficiaries. In addition, we believe 
a stable vaccine-neutral payment rate is appropriate in this space so 
providers and suppliers that furnish preventive vaccinations can rely 
on predictable payments for this service, which we anticipate would 
allow them to forecast their business plans and engage in activities 
that could continue to build and sustain robust vaccination programs. 
As we discuss above, we recognize there are cost differentials that 
exist with regard to the COVID-19 vaccine versus the other preventive 
vaccines at the time of this final rule and that those may continue to 
exist into and potentially throughout CY 2022. Therefore, beginning for 
services furnished in CY 2022, we are finalizing a uniform payment rate 
of $30 for the administration of an influenza, pneumococcal or HBV 
vaccine covered

[[Page 65186]]

under the Medicare Part B preventive vaccine benefit at section 
1861(s)(10) of the Act.
    The AMA RUC develops recommended valuations for services by 
contemplating the typical case and then deciding how many minutes the 
typical case takes and what supplies are typically used. The RUC 
developed specific estimates for COVID-19 vaccine administration and 
for pediatric and other immunizations, but not for the Part B 
preventive vaccines. The RUC recommendations would produce a payment 
for COVID-19 vaccine administration of approximately $35-$40 per dose 
during the PHE, and approximately $25-$30 after the PHE is terminated. 
The best cost data we have available comes from the hospital outpatient 
setting, which, as mentioned above, suggests a cost of approximately 
$40 for administration of a preventive vaccine. However, most 
immunizers will not have a cost structure similar to an acute care 
hospital. As such, we believe it is appropriate to finalize a payment 
rate that approximates the RUC's estimates of the costs involved in the 
typical case of COVID-19 vaccine administration after the PHE, (that 
is, $30).
    In addition, as explained above, we will maintain the current 
payment rate of $40 per dose for the administration of the COVID-19 
vaccines through the end of the calendar year in which the PHE ends; 
effective January 1 of the year following the year in which the PHE 
ends, the payment rate for COVID-19 vaccine administration will be set 
at a rate that aligns with the per dose payment rate for administration 
of other Part B preventive vaccines. We recognize that it is difficult 
to predict when resource costs relating to COVID-19 vaccination will 
align with those for other vaccinations after the PHE ends, as we 
believe the scale of this PHE is unique in recent Medicare payment 
history. We will continue to actively monitor vaccination utilization 
and may consider refinements in the future.
    We note that the administration of the preventive vaccines 
described under section 1861(s)(10) of the Act is not included within 
the statutory definition of physicians' services, that the payment 
rates finalized above are independent of the PFS, and that these 
payment rates will be updated as necessary independently of the 
valuation of any specific codes under the PFS. We believe that the 
payment rates finalized above accurately reflect the resource costs 
involved in the administration of Part B preventive vaccines, and that 
a payment differential limited to the duration of the PHE recognizes 
the additional costs involved in the administration of the COVID-19 
vaccines in the context of the pandemic.
    Comment: Some commenters, while supporting payment rates based on 
AMA RUC recommendations for CY 2022, encouraged CMS to consider whether 
it would be more effective and sustainable to develop a payment 
methodology for vaccine administration that considers the value of 
preventive vaccinations instead of only considering the cost of 
furnishing these services, and whether such an approach might boost 
vaccination rates among Medicare beneficiaries. Commenters who 
advocated for this approach stated that cost-based reimbursement has 
been ineffective, whereas moving away from a cost-based methodology 
would give vaccine providers more flexibility to furnish additional 
counseling services or implement innovative clinical workflows to 
optimize vaccination among their patients.
    Response: We thank the commenters for their suggestion. We plan to 
monitor immunization rates among Medicare beneficiaries after the 
payment rates for vaccine administration services finalized in this 
final rule go into effect, and will continue to engage with members of 
the public on potential refinements to our policies.
    As we stated above, we believe we have gathered sufficient resource 
cost data to set a payment rate for vaccine providers such as 
physicians, NPPs, and mass immunizers, who administer the majority of 
preventive vaccines to Medicare beneficiaries. Therefore, beginning 
January 1, 2022, these providers and suppliers will be paid $30 for the 
administration of an influenza, pneumococcal or HBV vaccine under the 
Medicare Part B vaccine benefit. In addition, through the end of the 
year in which the COVID-19 PHE ends, we will maintain the current 
payment rate of $40 per dose for the administration of the COVID-19 
vaccines; following the end of the year in which the PHE ends, the 
payment rate for COVID-19 vaccine administration will be set at a rate 
that aligns with the rate for other preventive vaccines.
    Comment: A couple of commenters provided feedback in response to 
our inquiry about the process to update the payment rates for 
administration of preventive vaccines on an annual basis. One commenter 
suggested that incremental updates should be made to the payment rate 
each year. Another commenter stated that annual updates to the vaccine 
administration payment rates based on OPPS claims data would be a 
reliable and data-based method for updating the payment rate and would 
prevent the issues that have occurred in the past with the crosswalk to 
CPT code 96372.
    Response: We thank the commenters for their suggestions. We 
continue to seek feedback on an appropriate mechanism for updating 
these payments on a yearly basis by, for example, applying an annual 
inflation factor, for example the MEI, to the payment rate in order to 
reflect increases in costs faced by providers and suppliers that 
furnish the service, and plan to address updating the payment rate for 
Part B preventive vaccine administration in future rulemaking.
    Comment: We received feedback from several commenters who 
emphasized the role of primary care physicians in vaccinating Medicare 
beneficiaries and the general public. The commenters cited a study 
indicating that primary care practices provide over half of all vaccine 
administration services for Medicare beneficiaries,\42\ and noted that 
these healthcare professionals are an important resource for addressing 
vaccine hesitancy and encouraging patients to receive vaccinations. On 
the other hand, commenters expressed concern that inadequate payment 
rates may discourage small family practices with limited resources from 
offering vaccines, and that patients may be less likely to follow 
through on their physician's advice to receive a vaccine if it is not 
immediately available onsite.
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    \42\ Wilkinson, E., Jetty, A., Petterson, S., Jabbarpour, Y., & 
Westfall, J. M. (2021). Primary Care's Historic Role in Vaccination 
and Potential Role in COVID 19 Immunization Programs. Annals of 
Family Medicine, 19 (4), 351. 355. https://doi.org/10.1370/AFM.2679.
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    Several commenters emphasized the role of pharmacists in providing 
both routine seasonal vaccines and vaccines against COVID-19, and 
anticipated that pharmacies will continue to play a leading role in 
immunization efforts after the PHE is over and COVID-19 becomes 
endemic. Commenters pointed to the widespread presence of pharmacies in 
local communities across the country, with one commenter asserting that 
pharmacists are the most accessible healthcare professionals, 
interacting regularly with patients and providing education and 
recommendations that may have a positive impact on a person's decision 
to receive a vaccine.
    Response: We appreciate the contributions that primary care 
physicians and pharmacists make in the national immunization effort, 
including their role in educating patients on the issue of vaccines. We 
believe that the payment rates for vaccine administration services 
finalized in this

[[Page 65187]]

final rule more accurately reflect the costs incurred by primary care 
physicians, pharmacists and other healthcare providers in furnishing 
vaccines.
    Comment: We also received comments related to payment to FQHCs for 
COVID-19 vaccine administration services, vaccination efforts among 
American Indian/Alaska Native (AI/AN) populations and payment for 
vaccine administration to Indian health care providers, suggestions on 
ways to promote effective and equitable distribution of preventive 
vaccines, and potential barriers to access that may prevent 
beneficiaries from receiving vaccines covered under the Medicare Part D 
benefit.
    Response: We appreciate the commenters' feedback. However, we did 
not discuss or include proposals on these issues in the CY 2022 PFS 
proposed rule. As such, these comments are outside the scope of this 
rulemaking, but we will take these comments into consideration for the 
future.
2. Payment for COVID-19 Vaccine Administration in the Home
    As we discussed in the CY 2022 PFS proposed rule (86 FR 39224), 
effective June 8, 2021, we announced a new add-on payment with a 
national rate of $35.50 when a COVID-19 vaccine is administered in the 
home.\43\ Under this policy, 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 (0001A, 0002A, 0011A, 0012A, 0031A) 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). Providers and 
suppliers administering a COVID-19 vaccine in the home will be paid a 
national average payment $75.50 dollars per dose ($40 for COVID-19 
vaccine administration and $35.50 for the additional payment for 
administration in the home, and both payments are geographically 
adjusted).
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    \43\ https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
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    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. More specifically, 
for purposes of this additional payment for administration of the 
COVID-19 vaccine in the home, we established that Medicare will make 
this payment when either of these situations applies:
     The patient has difficulty leaving the home to get the 
vaccine, which could mean any of these:
    (1) 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;
    (2) They have a condition that makes them more susceptible to 
contracting a pandemic disease like COVID-19; or
    (3) 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. We also specified that payment is made 
for HCPCS code M0201 if the sole purpose of the visit is to administer 
the COVID-19 vaccine. However, 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.
    For purposes of this add-on payment for in-home COVID-19 vaccine 
administration, we announced that 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, or a patient's home that is 
made provider-based to a hospital during the PHE for COVID-19. As such, 
a home may be a domiciliary or rest home, meaning a facility, which 
provides room, board, and other personal assistance services (for 
example, an assisted living facility).
    We also announced that the following locations are not considered 
to be the patient's home for purposes of the add-on payment for COVID-
19 vaccine administration: Communal spaces of a multi-unit living 
arrangement; hospitals; Medicare SNFs, and Medicaid NFs, regardless of 
whether they are the patient's permanent residence; assisted living 
facilities participating in the CDC's Pharmacy Partnership for Long-
Term Care Program when their residents are vaccinated through this 
program. In the CY 2022 PFS proposed rule (86 FR 39224), we clarified 
that an institution is not considered to be a patient's home if the 
institution 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.\44\
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    \44\ 42 CFR 409.42(a).
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    Additionally, we established that assisted living facilities 
participating in the CDC Pharmacy Partnership for Long-Term Care 
Program partnership would not be eligible for this higher payment for 
COVID-19 vaccine administration in the home when their residents were 
vaccinated through this program.
    In addition, we established that the COVID-19 vaccine 
administration service must be furnished 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. We established that communal spaces 
of, or related to, congregate living arrangements (such as a communal 
area of an apartment or condominium complex, assisted living facility, 
group home) were not considered a home for purposes of this add-on 
payment because multiple people could be vaccinated and monitored 
either simultaneously or in tandem in such communal spaces.
    As noted in the code descriptor for HCPCS code M0201, this code 
could be billed only once per individual home per date of service. In 
situations where more than one Medicare beneficiary lives in the same 
individual home, the additional payment for COVID-19 vaccine 
administration in the home was limited to one time in that home on that 
day, while any additional COVID-19 vaccine administration services for 
other individuals in that same home would be paid at the generally 
applicable rate of approximately $40 without the additional in-home 
add-on payment amount.
    We established the payment amount for HCPCS code M0201 for in-home 
vaccination to reflect the additional costs associated with 
administering the vaccine in the home, such as upfront administration 
costs like scheduling, the additional clinical time needed for post 
administration monitoring of a single patient, and public health 
reporting requirements. To identify an appropriate payment rate for 
HCPCS code M0201, we used the home health low utilization payment 
adjustment add-on factor for skilled nursing as a proxy for the 
increased resource costs, above those reflected in the base payment 
rate for COVID-19 vaccine administration, involved in arranging

[[Page 65188]]

and furnishing COVID-19 vaccine administration services in the home. 
For home health services, we make a low utilization payment adjustment 
(LUPA) when, during a 30-day period of home health care (or prior to 
January 1, 2020, a 60-day episode of home health care) a patient 
receives minimal services (less visits than a predetermined threshold) 
and the home health agency is paid per visit rather than the full 30-
day (previously 60-day) bundled payment amount (see 42 CFR 484.230). As 
stated in the CY 2008 HH PPS proposed rule, after the HH PPS went into 
effect we received comments and correspondence stating that the LUPA 
per-visit payment rates do not adequately account for the front-loading 
of costs in an episode. Commenters suggested that because of the small 
number of visits in a LUPA episode, HHAs have little opportunity to 
spread the costs of lengthy initial visits over a full episode (72 FR 
25424). As such, under the Medicare home health payment system, LUPA 
add-on payments are made to account for the upfront fixed costs and 
prolonged visit lengths in a LUPA period/episode compared to those for 
non-LUPA periods/episodes. We believe the LUPA add-on factor for 
skilled nursing is an appropriate proxy for the upfront fixed costs and 
prolonged visit lengths that exemplify and constitute the increased 
resource costs involved in arranging and furnishing COVID-19 vaccine 
administration services in the home.
    The CY 2021 LUPA add-on factor for skilled nursing is 1.8451, and 
we applied this to the base rate for COVID-19 vaccine administration of 
$40 per dose (effective March 15, 2021). This calculation results in a 
total proxy payment rate for in-home COVID-19 vaccine administration of 
approximately $74. Subtracting the $40 base rate for COVID-19 vaccine 
administration, which applies across most other settings, results in an 
additional proxy payment rate of roughly $34. To expedite access to 
this service and ensure consistency in payment rates for HCPCS code 
M0201 between health care professionals, other suppliers, and 
institutional providers, we established a payment rate that corresponds 
to the proxy we calculated based on the LUPA add-on factor using a 
reference to another proxy payment rate under the hospital OPPS. 
Specifically, we looked to APC payment amounts under the hospital OPPS 
that were similar to the $34 proxy amount and could be implemented with 
speed under the COVID-19 vaccine benefit (which relies on both 
institutional and professional claims processing systems). We 
identified New Technology APC 1494 under the hospital OPPS with a 
national payment rate of $35.50 as an appropriate reference payment 
amount for this service for most providers and suppliers, and 
established that amount as the national payment rate for HCPCS code 
M0201. That is, the national payment rate for HCPCS code M0201 is 
$35.50 for all providers and suppliers not paid reasonable cost. 
Although we announced a payment rate of approximately $35 on June 8, 
2021, in order to accelerate implementation of the new payment for 
claims processing purposes, it was expedient to choose a proxy payment 
rate that was already in place under the OPPS.
    In announcing the add-on payment for in-home COVID-19 vaccine 
administration, 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 continue to evaluate the needs 
of Medicare patients and these policies, and will address them in the 
future, as needed.'' \45\
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    \45\ https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
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    On August 24, 2021, after the publication of the CY 2022 PFS 
proposed rule, we announced a number of changes to our policies. 
Effective August 24, 2021, communal spaces of a multi-unit or communal 
living arrangement, as well as assisted living facilities participating 
in the CDC's Pharmacy Partnership for Long-Term Care Program when their 
residents are vaccinated through this program, can qualify as a 
Medicare patient's home for purposes of the additional in-home payment 
amount. Furthermore, effective August 24, 2021, 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.\46\
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    \46\ https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
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    We used the proposed rule as a way to collect feedback on our 
policies and potential future changes.
     We sought feedback on our requirements, including the 
definition of the ``home'' and the types of clinical and non-clinical 
circumstances that make it difficult for a beneficiary to receive a 
COVID-19 vaccine outside the home. Do these requirements strike the 
appropriate balance of ensuring access to vaccines for vulnerable 
beneficiaries while also protecting against potential fraud? Should we 
maintain these requirements during the PHE as-is, and if not, what 
changes should we consider? Outside of the circumstances of the PHE 
that create a need for beneficiaries to be vaccinated as quickly and 
broadly as possible, under what circumstances do health care providers, 
suppliers, or others find particular need to vaccinate people at home 
rather than periodically in association with routine in-person visits?
     As noted, we established an add-on payment of $35.50, 
which is based on applying the LUPA add-on factor for skilled nursing 
to the national $40 payment rate for the base service as a proxy to 
reflect the additional resources involved in furnishing services in the 
home setting. What are the costs associated with furnishing COVID-19 
vaccines in the home, and how do these costs differ from costs of 
furnishing vaccines in traditional locations, such as a physician's 
office or mass immunization site?
     What other steps should we take related to program 
integrity and beneficiary protection with this new add-on payment for 
administering the COVID-19 vaccine in the home? What documentation 
should providers and suppliers that furnish vaccines in the home be 
required to maintain and/or provide?
    As we noted in the CY 2022 PFS proposed rule (86 FR 39225), this 
add-on payment of $35.50 only applies when providers or suppliers 
furnish the COVID-19 vaccine in the home, and is not billable when 
providers and suppliers furnish a different preventive vaccine 
(influenza, pneumococcal, HBV) in the home. Furthermore, we explained 
that we believe the additional payment is only appropriate for COVID-19 
vaccines due to the unique circumstances of the PHE, as well as the 
upfront fixed costs and prolonged visit lengths that exemplify and 
constitute the increased resource costs involved in arranging and 
furnishing COVID-19 vaccine administration services in the home. 
However, we sought feedback on whether the same barriers that could 
prevent a beneficiary from obtaining a COVID-19 vaccine would also 
prevent them from obtaining other preventive vaccines, whether Medicare 
should make a similar add-on vaccine administration payment in those 
circumstances, and whether the costs to furnish other preventive 
vaccines in the home would be consistent with the costs to furnish the 
COVID-19 vaccine.
    Comment: We received numerous comments in support of our policy to 
provide an additional payment in the

[[Page 65189]]

amount of $35.50 when a COVID-19 vaccine is administered in the home 
under certain circumstances. Commenters overwhelmingly recommended that 
we continue making the additional payment beyond the end of the PHE, 
and many commenters also supported extending the payment to other 
preventive vaccines, either permanently or until the end of the 
pandemic. In support of this policy, commenters emphasized the 
importance of increasing vaccination rates and making the vaccines 
available to vulnerable homebound beneficiaries, who face barriers 
including chronic illness, financial and social precarity, and lack of 
access to digital resources. Several commenters stated that the same 
circumstances that currently prevent a beneficiary from leaving their 
home to receive a COVID-19 vaccine apply to other preventive vaccines 
as well and will continue beyond the end of the PHE. With respect to 
the specific resource costs involved in providing vaccine services in 
the home, commenters cited travel, vaccine storage and handling 
requirements, scheduling challenges, security, and sanitization; some 
commenters observed that similar costs apply to the administration of 
both the COVID-19 and other preventive vaccines in a beneficiary's 
home. A few commenters agreed that the Home Health LUPA is a reasonable 
proxy for the additional resource costs involved with administering 
COVID-19 vaccines in the home, while others asserted that the current 
payment amount of $35.50 is too low.
    Response: We agree with the feedback that we received regarding the 
need to incentivize providers to administer COVID-19 vaccines in the 
home during the PHE, and especially with commenters who cited the need 
to protect beneficiaries who would be at increased risk of contracting 
COVID-19 and developing a serious illness if exposed. We also thank 
suppliers such as family physicians who have gone to great lengths to 
vaccine hard-to-reach populations under the difficult circumstances of 
the pandemic.
    Given the commenters' concurrence with the added costs and 
compelling needs that led CMS to adopt the in-home add-on payment, we 
believe this policy is an appropriate one. In addition, since we do not 
expect those needs or costs to diminish immediately with the end of the 
PHE, we believe it would be appropriate to leave the in-home add-on 
payment rate in place through the end of the CY in which the PHE ends. 
For example, we anticipate that additional booster doses will be 
needed. In addition, we believe that that this policy would set clear 
expectations for vaccine providers and suppliers and allow for a more 
gradual transition to a permanent payment policy.
    Therefore, we are finalizing our policy to continue making the 
additional payment of $35.50 when a COVID-19 vaccine is administered in 
a beneficiary's home under certain circumstances until the end of the 
year in which the PHE expires. We believe that this extension will 
maximize access to COVID-19 vaccines for vulnerable homebound 
beneficiaries during the gradual return to normal conditions following 
the formal termination of the PHE. At the same time, it will afford CMS 
the opportunity to monitor vaccine uptake data. We also note that a 
policy to continue this payment in place through the end of the year in 
which the PHE ends is in keeping with our policies outlined elsewhere 
regarding the payment rate of $40 for COVID-19 vaccine administration, 
as well as the coverage and payment of COVID-19 monoclonal antibody 
therapies for COVID-19 under the Part B vaccine benefit.
    We note that for purposes of this add-on payment for in-home COVID-
19 vaccine administration, we are maintaining the policy that 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, or a patient's home that is made provider-based to a hospital 
during the PHE for COVID-19; however, an institution is not considered 
to be a patient's home if the institution meets the requirements of 
sections 1861(e)(1), 1819(a)(1), or 1919(a)(1) of the Act, which 
includes hospitals and SNFs, as well as most nursing facilities under 
Medicaid.
    We are grateful for the additional feedback we received from 
commenters who advocated maintaining the additional payment for in-home 
COVID-19 vaccination beyond the PHE and extending it to other 
preventive vaccines, and we will continue to engage with stakeholders 
on this topic.
    Comment: Several commenters expressed concern that our policies 
regarding eligibility for the additional in-home payment are too 
restrictive, and encouraged CMS to consider incorporating flexibilities 
that would make this payment available under a greater variety of 
circumstances. Among the restrictions cited most frequently by 
commenters was our policy that Medicare does not pay the additional 
payment if another Medicare service is provided in the same home on the 
same date. For example, one commenter observed that home providers are 
not eligible to receive the additional payment if they offer the 
vaccine during an E/M visit or in conjunction with an influenza 
vaccine.
    Another commenter stated that it is important for CMS to consider 
the unique cultural dynamics in households in Indian Country and 
provide flexibility to consider the family size composition and 
intergenerational living arrangements that are common in AI/AN 
communities; specifically, the commenter urged CMS to provide the 
additional payment when services are furnished to other family members 
in the same household. Commenters also cited restrictions on the number 
of vaccine administration services that may be furnished during a 
single visit and in a single home unit or communal space, as well as on 
the types of providers that are eligible to receive the additional 
payment. In addition, one commenter requested that CMS classify mobile 
vaccination as a patient's ``home'' to reflect the increased costs of 
safely vaccinating patients in this setting.
    Response: We thank the commenters and will take their feedback into 
consideration if we contemplate any future changes to our policy 
concerning COVID-19 vaccine administration in the home.
    Comment: One commenter urged CMS to offer explicit guidance on how 
the concept of ``home'' should be documented in individual patient 
medical records to reflect the various circumstances supported by 
COVID-19 vaccination payment policies as outlined on the CMS 
website.\47\ The commenter also requested that CMS clarify whether the 
10-patient limit applies to the capacity of the living facility or 
whether it is based on the number of patients given vaccination on a 
date of service.
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    \47\ https://www.cms.gov/medicare/covid-19/coding-covid-19-vaccine-shots.
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    Response: We have not established any specific medical record 
documentation requirements for the additional in-home COVID-19 
vaccination payment. We have issued guidance explaining the 
circumstances under which the payment is available; and vaccine 
providers should ensure that the medical record documentation is 
sufficient support payment. We note that the documentation should 
additionally support the beneficiary's appropriateness for home 
vaccination as

[[Page 65190]]

indicated in the CMS Coronavirus vaccination toolkit.\48\
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    \48\ https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
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    In response to the second part of the commenter's question, we are 
clarifying that, effective August 24, 2021, Medicare pays 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. When 10 or more Medicare patients 
receive a COVID-19 vaccine dose at a group living location on the same 
day, the additional payment can only be billed once per home (whether 
the home is an individual living unit or a communal space). We are 
further clarifying that the limit applies to the number of patients who 
receive a COVID-19 vaccine dose on the same day, regardless of the 
total number of patients residing at the location or the total capacity 
of the facility. For example, if 8 Medicare patients all reside in a 
location that houses 100 patients total, and those 8 Medicare patients 
receive a COVID-19 vaccine dose on the same day at that location, then, 
effective August 24, 2021, Medicare pays approximately $497.50 (5 x 
$35.50 for the in-home vaccine administration, plus 8 x $40 for each 
dose of the COVID-19 vaccine). On the other hand, if 12 Medicare 
patients all reside in a location that houses 100 patients total, and 
those 12 Medicare patients receive a COVID-19 vaccine dose on the same 
day at that location, then, effective August 24, 2021, Medicare pays 
approximately $515.50 (12 x $40 for each dose of COVID-19 vaccine, and 
1 x $35.50 for one in-home vaccine administration--only one home add-on 
payment is billable in this circumstance because 10 or more Medicare 
patients were vaccinated at the same group living location on the same 
date).
    Comment: One commenter stated that most COVID-19 vaccinations in 
the home have been administered by community pharmacists, and requested 
retroactive payment for pharmacists and other providers who 
administered the vaccine in communal spaces and other previously 
ineligible locations prior to the new flexibilities effective as of 
August 24, 2021.
    Response: The additional flexibilities effective on August 24, 
2021, were introduced, among other reasons, in order to enable a 
greater number of healthcare providers to furnish vaccine services to 
Medicare beneficiaries in their homes. We are grateful to community 
pharmacists and other healthcare providers who furnished these services 
in communal spaces and other ineligible locations prior to August 24, 
2021, but we are not adopting the commenter's suggestion to make 
additional payments to providers retroactively.
3. Monoclonal Antibodies Used To Treat COVID-19
    As we discussed in the CY 2022 PFS proposed rule (86 FR 39226), on 
November 9, 2020, the FDA issued an Emergency Use Authorization (EUA) 
for bamlanivimab monotherapy.\49\ On November 21, 2020 the FDA issued 
an EUA for casirivimab and imdevimab, which are administered 
together.\50\ On February 9, 2021, the FDA issued an EUA for 
bamlanivimab and etesevimab, which are administered together and which 
are also authorized for post-exposure prophylaxis for certain high risk 
patients.\51\ On April 16, 2021, the FDA revoked the EUA for 
bamlanivimab monotherapy.\52\ On May 26, 2021, the FDA issued an EUA 
for sotrovimab monotherapy.\53\ On June 3, 2021, the FDA revised the 
EUA for casirivimab and imdevimab, which revised the dosing regimen 
from 2,400 mg (1200 mg of casirivimab and 1 200 mg of imdevimab) to 1 
200 mg (600 mg of casirivimab and 600 mg of imdevimab), authorized the 
addition of a new presentation consisting of a single vial of 
casirivimab and imdevimab co-formulated in a 1:1 ratio, and also 
authorized casirivimab and imdevimab to be administered together via 
subcutaneous injection in certain limited circumstances.\54\ On June 
24, 2021, the FDA issued an EUA for tocilizumab monotherapy.\55\ We 
explained that under the EUAs, all of these products, except for 
tocilizumab could be used for certain high-risk patients with mild-to-
moderate COVID-19 with the goal of preventing further deterioration and 
hospitalization. Tocilizumab is authorized for hospitalized patients 
who are receiving systemic corticosteroids and require supplemental 
oxygen, non-invasive or invasive mechanical ventilation, or 
extracorporeal membrane oxygenation (ECMO).
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    \49\ https://www.fda.gov/media/143602/download.
    \50\ https://www.fda.gov/media/143891/download.
    \51\ https://www.fda.gov/media/145801/download.
    \52\ https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab.
    \53\ https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-monoclonal-antibody-treatment-covid-19.
    \54\ https://www.regeneron.com/downloads/treatment-covid19-eua-fda-letter.pdf.
    \55\ https://www.fda.gov/media/150319/download.
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    When these products were granted EUAs during the PHE for COVID-19, 
we made the determination to cover and pay for them under the COVID-19 
vaccine benefit in section 1861(s)(10) of the Act. When we announced 
this approach, we also indicated that we would address ``potential 
refinements to payment for administering monoclonal antibody products 
to treat COVID-19 through future notice-and-comment rulemaking''.\56\
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    \56\ https://www.cms.gov/medicare/covid-19/monoclonal-antibody-covid-19-infusion.
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    We make a separate payment for the products (when not given to the 
provider or supplier for free by the government) and for the service to 
administer them. We noted that as of June 30, 2021, the monoclonal 
antibody products authorized by the FDA under an EUA include two 
products involving drugs administered together, casirivimab and 
imdevimab and bamlanivimab and etesevimab, sotrovimab monotherapy, and 
tocilizumab monotherapy. All four products may be administered through 
intravenous (IV) infusion, and casirivimab and imdevimab may be 
administered via subcutaneous injection in certain limited 
circumstances under the updated June 3rd EUA.
    Initially, we established a national payment rate of $309.10 for 
the service to administer (through IV infusion only at the time) these 
products, which was based on one hour of infusion and post-infusion 
monitoring in the hospital outpatient setting. We noted that while 
these products are typically infused over a period of roughly one hour, 
the EUA for casirivimab and imdevimab allows the product to be infused 
over a shorter time-period, such as 20 minutes, when appropriate. We 
noted that, as of June 15, 2021, the EUAs require at least one hour of 
post-infusion monitoring for all of the products available. On May 6, 
2021, we increased the payment rate for administration of these 
products to $450.00 and established a separate payment rate of $750.00 
when a monoclonal antibody product used to treat COVID-19 is 
administered in a home or residence.\57\
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    \57\ https://www.cms.gov/newsroom/press-releases/cms-increases-medicare-payment-covid-19-monoclonal-antibody-infusions.
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    As we further explained in the CY 2022 PFS proposed rule (86 FR 
39226), the decision to cover and pay for monoclonal antibody products 
used to treat COVID-19 under the COVID-19 vaccine benefit prioritized 
access to

[[Page 65191]]

these products during the COVID-19 pandemic by allowing almost all 
Medicare enrolled providers and suppliers, as permitted by State law 
and consistent with the terms of the EUA, to furnish and bill for 
administering these products across settings of care. Covering and 
paying for these services under the COVID-19 vaccine benefit also means 
that beneficiaries are not responsible for any cost sharing for the 
product or the service to administer it. We noted that Medicare 
considers other monoclonal antibody products--that is, monoclonal 
antibody products used in the treatment of other health conditions--
``biologicals'' and pays for them based on the methodology in section 
1847A of the Act when they are furnished in physician offices, 
ambulatory infusion clinics and under a similar methodology under the 
hospital OPPS. We also noted that, for these care settings, we 
typically rely on the applicable AMA CPT codes to describe and pay for 
drug administration services performed by providers and suppliers.
    As noted above, bamlanivimab monotherapy and casirivimab and 
imdevimab, administered together, were authorized in late 2020. At that 
time, we made the determination to cover and pay for them under the 
vaccine benefit in section 1861(s)(10) of the Act, and this decision 
prioritized beneficiary access for purposes of addressing the PHE for 
COVID-19. Since that time, the EUA for bamlanivimab monotherapy has 
been revoked, the EUA for casirivimab and imdevimab administered 
together has been revised to include a new presentation, a new dosing 
regimen, and a new route of administration (in certain limited 
circumstances) and post-exposure prophylaxis for certain high-risk 
patients, sotrovimab monotherapy has been authorized and tocilizumab 
monotherapy has been authorized. In the CY 2022 PFS proposed rule (86 
FR 39226) we stated that it was also becoming clear that, as more 
products enter the market, the Federal Government might not purchase 
them for distribution to providers and suppliers for free, as is the 
case with sotrovimab monotherapy and tocilizumab monotherapy. We note 
that subsequent to the issuance of the CY 2022 PFS proposed rule, the 
Federal Government has purchased sotrovimab and will be directing the 
distribution of the product beginning mid-October, 2021.
    Given these fast-moving changes, we solicited feedback on our 
approach to coverage and payment for COVID-19 monoclonal antibody 
products under the COVID-19 vaccine benefit. We explained that we are 
considering whether we should align payment and coverage for these 
products with our approach for other monoclonal antibody products 
following the end of the PHE. We further explained that we believe the 
context in which these products are furnished to beneficiaries after 
the end of the PHE may more closely resemble the circumstances under 
which similar drugs and biologics are ordinarily furnished, 
specifically to a more targeted patient population outside of a 
pandemic. Outside the context of the PHE, we believe treating these 
products like other drugs and biologics paid under section 1847A of the 
Act may better align Medicare coverage and payment policies for COVID-
19 monoclonal antibody products with other monoclonal antibody 
products, which are purchased by providers and suppliers through 
similar channels and administered using similar modalities. As noted 
above, coverage and payment for COVID-19 monoclonal antibodies under 
the COVID-19 vaccine benefit has meant that Medicare beneficiaries are 
not responsible for any cost-sharing, which is typically 20 percent of 
the allowed amount in most settings. We noted that if Medicare were to 
pay for COVID-19 monoclonal antibody products under the methodologies 
in 1847A of the Act, it would mean that beneficiary co-insurance would 
apply, similar to the way it applies to other drugs and biologics that 
are not paid for under a preventive vaccine benefit.
    We also noted that tocilizumab--typically sold under the brand name 
Actemra[supreg]--was previously approved by the FDA for several 
indications.\58\ As a result, during the PHE for COVID-19, Medicare has 
separate coding and payment rules for tocilizumab when it is furnished 
to patients with COVID-19 and in a manner consistent with the terms of 
the EUA, and for when tocilizumab is used for other clinical purposes. 
This may be confusing for hospital providers and we believe that 
treating these monoclonal antibody products like other drugs and 
biologics paid under section 1847A of the Act may help clarify these 
inconsistencies. We invited feedback on these issues.
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    \58\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125472s044lbl.pdf.
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    We also invited additional feedback on the resource costs to 
administer COVID-19 monoclonal antibody products, such as costs 
associated with infrastructure, clinical labor, and equipment, 
including personal protective equipment. We recognize that 
administering monoclonal antibodies used to treat COVID-19 may be 
complex due the need to interact with beneficiaries that have active 
infections and manage the potential for spreading disease. We requested 
information on how the costs to furnish monoclonal antibodies used to 
treat COVID-19 compare with infusions of other complex biologics, and 
how the costs to furnish these products may be different when these 
products are administered in the home.
    Comment: Commenters offered diverging opinions in response to our 
request for information on the coverage of monoclonal antibodies for 
the treatment of COVID-19 under the Medicare Part B vaccine benefit. 
Several commenters urged CMS to extend payment for COVID-19 monoclonal 
antibodies as vaccines beyond the end of the PHE. A few commenters 
cited continuing uncertainty regarding the pandemic and the emergence 
of new variants as reasons why CMS should defer any changes to its 
current policy to future rulemaking cycles, while others emphasized the 
importance of maintaining beneficiary access to these treatments, 
especially among minority communities. In addition, several commenters 
pointed to the development of monoclonal antibodies used for pre-
exposure prophylaxis against COVID-19, stating that such products are 
functionally equivalent to vaccines and should therefore be covered 
under the COVID-19 statutory vaccine benefit in section 1861(s)(10) of 
the Act. On the other hand, we also received comments supporting a 
transition to regular Part B payment for COVID-19 monoclonal antibody 
treatments following the end of the PHE, including payment for the 
products themselves as biologics under section 1847A of the Act. In 
particular, several commenters recommended a transition to payment for 
COVID-19 monoclonal antibody therapies as biologics following the end 
of the year in which the PHE expires, as long as CMS provides clear 
guidance about the process and takes steps to mitigate out-of-pocket 
expenses for Medicare beneficiaries. One commenter recommended an 
extension beyond the PHE of at least two calendar quarters and urged 
CMS provide clear guidance to manufacturers on ASP reporting 
obligations.
    With respect to the specific expenses incurred by providers of 
monoclonal antibodies, commenters observed that the current infusion 
infrastructure is tailored to non-infectious patients, and indicated 
that increased costs for administration of COVID-19 monoclonal antibody 
therapies result primarily from measures necessary to mitigate risk and 
isolate infectious

[[Page 65192]]

patients. Specific resource costs cited by respondents include: 
Isolation of infectious patients in separate rooms or infusion suites; 
personal protective equipment for staff; staff training and 
implementation of new clinical workflows; reporting requirements; and, 
sometimes, increased pharmacy labor to deal with inconsistent product 
packaging and labeling.
    While several commenters encouraged CMS to extend the additional 
payment and associated flexibilities for administration of COVID-19 
monoclonal antibody therapies in the home beyond the end of the PHE, 
other commenters recommended against in-home administration of these 
products, citing concerns over patient safety and the potential for 
adverse reactions.
    Response: We agree with commenters who recommended CMS transition 
to treating COVID-19 monoclonal antibody therapies as biologicals that 
are paid using methodologies under section 1847A of the Act following 
the end of the calendar year in which the PHE expires. In particular, 
we believe that the public health needs that prompted coverage of these 
products as vaccines will gradually restabilize following the end of 
the PHE, and that extending the current payment approach to the end of 
the year will give healthcare providers adequate time to prepare for 
the change in payment methodology while continuing to maximize access 
to beneficiaries, including those who receive these treatments in the 
home. Similar to the continuation policies we are adopting for the $40 
payment rate and the in-home add-on payment for COVID-19 vaccine 
administration, given the commenters' concurrence with the added costs 
and compelling needs that led CMS to provide payment and coverage for 
COVID-19 monoclonal antibody therapies under the Medicare Part B 
vaccine benefit, we believe this policy is an appropriate one. In 
addition, since we do not expect those needs or costs to diminish 
immediately with the end of the PHE, we believe it would be appropriate 
to continue to provide payment and coverage for COVID-19 monoclonal 
antibody therapies under the Medicare Part B vaccine benefit in place 
through the end of the CY in which the PHE ends. We recognize that once 
the COVID-19 PHE declaration is terminated, EUAs issued under that 
declaration will no longer remain in effect,\59\ which may affect the 
availability of some products either for the diagnosis, treatment, or 
prevention of COVID-19, because they will need to have the requisite 
marketing authorization to remain on the market. To the extent there 
are products that would no longer have the requisite marketing 
authorization to remain on the market after a revocation of an EUA, we 
believe a transition period would be appropriate to allow for 
adjustments, as needed, to care plans that included such products.
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    \59\ https://www.fda.gov/media/97321/download.
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    Therefore, we are finalizing a policy to continue to pay for COVID-
19 monoclonal antibody therapeutic products as vaccines under section 
1861(s)(10) of the Act until the end of the calendar year in which the 
PHE expires. During this interim time, we will continue to pay 
providers and suppliers for the products themselves at 95 percent of 
Average Wholesale Price (AWP) except when they are provided for free by 
the government; we will also maintain the $450 payment rate for 
administering a COVID-19 monoclonal antibody in a healthcare setting, 
as well as the payment rate of $750 for administering a COVID-19 
monoclonal antibody therapy in the home. Starting at the beginning of 
the calendar year following the year in which the PHE ends, we will 
treat COVID-19 monoclonal antibody therapies as biologics paid under 
section 1847A of the Act, and discontinue the unique payment rates of 
$450 and $750 for administering a COVID-19 monoclonal antibody product, 
which were established to ensure access during the PHE. We note that 
under section 1847A of the Act, physicians and suppliers furnishing 
COVID-19 monoclonal antibody therapies typically will be paid based on 
Average Sales Price (ASP) + 6 percent. In addition, providers and 
suppliers will be paid under the applicable payment system, and using 
the appropriate coding and payment rates, for administering COVID-19 
monoclonal antibodies similar to the way they are paid for 
administering other complex biological products.
    Comment: A few commenters stated that CMS should continue to make 
enhanced payments for COVID-19 monoclonal antibodies even after 
transitioning to regular coverage of these services under Medicare Part 
B as discussed above. One commenter stated that if payment for COVID-19 
monoclonal antibodies is aligned with that for other monoclonal 
antibody products, then additional work and PE costs must be factored 
in, and CMS must address steep reductions in drug administration 
services due to clinical labor pricing update proposal, for example by 
providing an enhanced payment when a COVID-19 diagnosis is present on a 
claim. Another commenter recommended a $300 COVID-19 therapy modifier 
to offset what they described as grossly undervalued professional 
service payments for infusion centers.
    Response: We believe that the public health needs that prompted 
enhanced payments for COVID-19 monoclonal antibodies and administration 
services will gradually restabilize following the end of the PHE. As 
described in the previous section, extending the current payment 
approach to the end of the year in which the PHE ends will give 
healthcare providers adequate time to prepare for the change in payment 
methodology while continuing to maximize access to beneficiaries.
    Comment: One commenter stated that CMS should adjust the 
eligibility standards for home-based administration of COVID-19 
monoclonal antibodies to align with the more flexible standards that 
apply when determining eligibility for the additional payment when a 
COVID-19 vaccine is administered in a beneficiary's home. That is, in 
order to qualify as homebound for purposes of receiving monoclonal 
antibody services in the home, a beneficiary would need to meet the 
requirements set forth in the CMS COVID-19 vaccination toolkit.
    Response: We thank the commenter for their feedback and will take 
it into consideration if we contemplate any future changes to our 
policy concerning in-home administration of COVID-19 monoclonal 
antibodies.
    Comment: We received several comments pertaining to the role of 
specific provider types in administering and billing for COVID-19 
monoclonal antibodies.
    One commenter stated that pharmacists are well-positioned to 
increase awareness of and expand access to monoclonal antibody 
therapies, and urged CMS to consider supplemental funding for community 
pharmacies to develop the infrastructure to administer monoclonal 
antibodies onsite. Additionally, the commenter stated that a 
significant barrier to maximizing the use of pharmacists to develop 
these treatments is inadequate reimbursement for administrative costs 
and delays in the processing of claims by Medicare; the commenter 
therefore urged CMS to issue pharmacist/pharmacy specific guidance on 
pharmacy billing for these therapies outlining specific, rapid turn-
around of Medicare reimbursements for MACs that covers the entirety of 
administration costs in a pharmacy setting.
    One commenter emphasized the role of urgent care centers in 
furnishing

[[Page 65193]]

monoclonal antibody treatment, and stated that simplification of 
administrative and reporting requirements would improve urgent care 
centers' ability to offer these services.
    Another commenter urged CMS to establish a protocol allowing long-
term care pharmacies (LTCPs) to bill independently for the procurement, 
preparation and reporting of monoclonal antibody treatment administered 
by a long-term care facility (LTCF). The commenter stated that 
splitting this fee is currently allowed by CMS, but the division is 
conducted as a private, two-party contract between LTCFs and LTCPs, and 
that providing a mechanism to reimburse each party for their efforts 
would provide CMS with better data related to the use of monoclonal 
antibodies to combat COVID-19 and other public health threats.
    In addition, one commenter emphasized the role of home infusion 
pharmacies in providing monoclonal antibody treatment, both in 
beneficiaries' homes and in pharmacy-owned infusion suites. The 
commenter observed that, after the PHE, administration of monoclonal 
antibodies for COVID-19 in the home would not be covered under the 
standard Part B benefit without additional flexibilities, and 
therefore, urged CMS to maintain coverage of these products as vaccines 
until the establishment of a similar benefit that allows a licensed 
home infusion pharmacy to provide COVID-19 treatments in the home or in 
a pharmacy-owned and operated infusion suite at the current payment 
rates for each site of care.
    Response: We believe that, following the end of the PHE, the public 
health needs that prompted coverage and payment of COVID-19 monoclonal 
antibody therapies (and their administration) under the Part B vaccine 
benefit will gradually restabilize. As discussed in the previous 
section, extending the current payment approach to the end of the year 
in which the PHE ends will give healthcare providers adequate time to 
prepare for the change in payment methodology while continuing to 
maximize access to beneficiaries, including those who receive these 
therapies in the home.
    Comment: Several commenters urged CMS to update the FQHC cost 
report to ensure adequate reimbursement for monoclonal antibody 
infusions at 100 percent of reasonable cost.
    Response: We appreciate the commenters' feedback. However, we did 
not discuss or include proposals on FQHC cost reports in the CY 2022 
PFS proposed rule. As such, these comments are outside the scope of 
this rulemaking, but we will take these comments into consideration for 
the future.
4. Summary
    We have taken several steps to promote broad and timely access to 
COVID-19 vaccines, including monoclonal antibody products used to treat 
COVID-19 paid for as vaccines, during the PHE for COVID-19. We 
appreciate the feedback we have received from the public on these 
important issues regarding preventive vaccine administration, vaccine 
administration in the home, and administration of monoclonal antibody 
products used to treat COVID-19.
    In summary, for CY 2022, we are finalizing the following policies:
Administration of Preventive Vaccines
    Effective January 1, 2022, CMS will pay $30 per dose for the 
administration of the influenza, pneumococcal and hepatitis B virus 
vaccines. In addition, CMS will maintain the current payment rate of 
$40 per dose for the administration of the COVID-19 vaccines through 
the end of the calendar year in which the ongoing PHE ends. Effective 
January 1 of the year following the year in which the PHE ends, the 
payment rate for COVID-19 vaccine administration will be set at a rate 
to align with the payment rate for the administration of other Part B 
preventive vaccines.
In-Home Administration of COVID-19 Vaccines
    CMS will continue the additional payment of $35.50 for COVID-19 
vaccine administration in the home under certain circumstances through 
the end of the calendar year in which the PHE ends.
COVID-19 Monoclonal Antibody Products
    CMS will continue to pay for COVID-19 monoclonal antibodies under 
the Medicare Part B vaccine benefit through the end of the calendar 
year in which the PHE ends. During this interim time, we will maintain 
the $450 payment rate for administering a COVID-19 monoclonal antibody 
in a healthcare setting, as well as the payment rate of $750 for 
administering a COVID-19 monoclonal antibody therapy in the home. 
Effective January 1 of the year following the year in which the PHE 
ends, CMS will pay physicians and other suppliers for COVID-19 
monoclonal antibody products as biological products paid under section 
1847A of the Act; healthcare providers and practitioners will be paid 
under the applicable payment system, and using the appropriate coding 
and payment rates, for administering COVID-19 monoclonal antibodies 
similar to the way they are paid for administering other complex 
biological products.
    Table 32 summarizes the policy changes finalized in this final 
rule.

[[Page 65194]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.054

K. Payment for Medical Nutrition Therapy Services and Related Services

    Section 105 of the Medicare, Medicaid, and SCHIP Benefits 
Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554, 
December 21, 2000) added section 1861(vv)(1) to the Act which provided 
Medicare coverage under Part B for Medical Nutrition Therapy (MNT) 
services when performed by registered dietitians and nutrition 
professionals pursuant to a referral from a physician.
    Under section 1842(b)(18)(C) of the Act, registered dietitians and 
nutrition professionals are included in the list of NPPs that may bill 
Medicare and be paid directly for their services, effective January 1, 
2002. To submit claims for MNT services, the registered dietitian or 
nutrition professional must enroll as such in accordance with our 
regulations at 42 CFR 414.64 and 424.510. Like other NPPs listed in 
section 1842(b)(18)(C) of the Act, registered dietitians and nutrition 
professionals who are employees or independent contractors of hospitals 
or physician groups may reassign their rights to receive payment to 
that hospital or physician group, as appropriate. The Medicare 
specialty code for ``dietitian/nutritionist'' is 71.
    Under section 1833(a)(1)(T) of the Act, we were originally required 
to pay for MNT services at 80 percent of the lesser of the actual 
charge for the services or 85 percent of the amount determined under 
the PFS for the same services if the services had been furnished by a 
physician. We established payment regulations for MNT in our regulation 
at Sec.  414.64 in the CY 2002 PFS final rule (66 FR 55278 through 
55281 and 55332).
    MNT services are defined as nutritional diagnostic, therapeutic, 
and counseling services that are furnished by a registered dietitian or 
nutrition professional for the purpose of managing diabetes or a renal 
disease. These practitioners use three CPT[supreg] codes to bill for 
MNT assessment and intervention services with the referral of a 
physician. In cases where there is a second physician referral for MNT 
for the same patient within a calendar year (for example, based on a 
change in the patient's condition, diagnosis, or treatment regimen), 
the furnishing practitioner uses two other HCPCS codes to report these 
episodes. We have worked with stakeholders over the years to establish 
values for the services described by the five MNT codes.
    The importance of MNT services for managing diabetes or renal 
disease, as well as the underutilization of the benefit by Medicare 
beneficiaries were discussed in the proposed rule at section III.I. (86 
FR 39259 through 39261). More recently, stakeholders who were concerned 
about the low utilization rate for the services have requested that CMS 
make changes geared toward making MNT services more accessible to 
Medicare beneficiaries. These stakeholders believe the underutilization 
of MNT services is due to multiple factors. Some of these factors and 
our proposals to address them are discussed elsewhere in this final 
rule (see section III.I.), including proposals to remove the 
requirement that the MNT referral be made by the ``treating physician'' 
and update the glomerular filtration rate (GFR) eligibility criteria to 
reflect current medical practice. First, stakeholders recommended that 
we modify the Medicare Claims Processing Manual (MCPM) to increase the 
visibility of MNT services by moving the provisions that address these 
services to appear near the provisions addressing other preventive 
services. (We note that MNT services are included in the definition of 
preventive services under section 1861(ddd)(3)(A) of the Act). Second, 
the stakeholders recommended that we revise our Medicare Benefit Policy 
Manual to address registered dietitians and nutrition professionals, 
and the MNT services they furnish, in a way that aligns with the 
provisions addressing other types of practitioners and the services 
they furnish.
    We established the MNT regulations in the CY 2002 PFS final rule at 
Sec.  410.130 through Sec.  410.134 and Sec.  414.64. There have since 
been two significant changes to payment for MNT services, which are 
discussed in more detail below: (1) We added MNT services to the 
Medicare telehealth services list and recognized that registered 
dietitians and nutrition professionals can furnish and bill for these 
services as distant site practitioners; and (2) section 4104 of the

[[Page 65195]]

Affordable Care Act (ACA) amended the statute to remove application of 
the Medicare Part B deductible and coinsurance for MNT services 
effective January 1, 2011. In the CY 2006 PFS final rule (70 FR 70155 
through 70157), we amended our regulation to add registered dietitians 
and nutrition professionals to the list of distant site practitioners 
for telehealth services at Sec.  410.78(b)(2)(viii), and to add the 
three individual MNT services to the Medicare telehealth services list 
by adding ``individual medical nutrition therapy'' to Sec.  
414.65(a)(1). In the CY 2011 PFS final rule, we also added one of the 
group MNT codes (97804) to the Medicare telehealth services list (75 FR 
73314 through 73315). Although the codes for individual MNT services 
were recognized as telehealth services beginning in CY 2006, a recent 
claims query (prior to the PHE for COVID-19) showed low utilization of 
MNT services via telehealth by registered dietitians and nutrition 
professionals.
    In the CY 2011 PFS final rule, (75 FR 73412 through 73430), we 
implemented the amendments made by section 4104 of the ACA, which were 
designed to remove financial barriers that may have prevented 
beneficiaries from obtaining certain preventive services. Section 4104 
of the ACA amended section 1833(a)(1) of the Act by adding a new 
subparagraph (Y), which provides for Medicare Part B payment at 100 
percent for preventive services described in section 1861(ddd)(3)(A) of 
the Act that are recommended with a grade of A or B by the United 
States Preventive Services Task Force (USPSTF); and, amended section 
1833(b)(1) of the Act to specify that the annual Medicare Part B 
deductible does not apply to preventive services with a recommended 
grade of A or B by the USPSTF. Section 1861(ddd)(3) of the Act defines 
``preventive services'' and includes MNT services as a preventive 
service through a cross reference to section 1861(ww)(2) of the Act. 
Additionally, section 4104 of the ACA amended section 1833(a)(1)(T) of 
the Act to specify that Medicare Part B payment is made at 100 percent 
(instead of 80 percent) of the lesser of the actual charge or 85 
percent of the PFS payment amount for these services if they are 
recommended with an A or B rating by the USPSTF, thereby removing 
beneficiary coinsurance for these services. In the CY 2011 PFS final 
rule, we listed all preventive services and their recommended ratings 
from the USPSTF in Table 66 (66 FR 73420 through 73430), noting that 
all 5 MNT services received a grade of B from the USPSTF; and the last 
column in the table noted that the coinsurance and deductible are not 
applicable to these services beginning January 1, 2011. We codified the 
coinsurance exception for MNT services at Sec.  410.152(l)(7) to 
indicate that Medicare Part B pays 100 percent of the Medicare payment 
amount; and codified the exception for the Medicare Part B deductible 
at Sec.  410.160(b)(11).
    At that time, the preventive services coinsurance and deductible 
changes were implemented through Change Request 7012 (Transmittal 864); 
however, we neglected to update the payment regulation for MNT services 
at Sec.  414.64(a). As a result, we proposed in the CY 2022 PFS 
proposed rule to modify the regulation at Sec.  414.64(a) to clarify 
that MNT services, with their USPSTF recommended B rating, are paid at 
100 percent of the lesser of the actual charges or 85 percent of the 
PFS amount. In the proposed regulation text at Sec.  414.64(a), we made 
an inadvertent typographical error, using ``or'' instead of ``of.'' We 
are correcting the error here in this final rule so that Sec.  
414.64(a) provides that payment is made at 80 percent, or 100 percent 
if the service is recommended by the United States Preventive Services 
Task Force with a grade of A or B, ``of'' the lessor of the actual 
charge or 85 percent of the physician fee schedule amount.
    Because the registered dietitian and nutrition professional are the 
only practitioner types listed at section 1842(b)(18)(C) of the Act 
without a specific regulatory provision addressing them as a type of 
practitioner and specifying payment policies for their services, we 
proposed to create a new section at Sec.  410.72 to reflect these 
practitioners and related payment policies. We proposed to include in 
the regulation at Sec.  410.72 a cross reference to the regulation at 
Sec.  410.134 that addresses the qualifications for registered 
dietitians and nutrition professionals. For covered services described 
at Sec.  410.72(b), we proposed as a condition of coverage to refer to 
medical nutrition therapy services as defined at Sec.  410.130, and 
also to refer to the conditions for coverage of MNT services at Sec.  
410.132(a). Section 410.132(a) requires a referral for MNT services 
from a physician (an M.D. or D.O.), and that MNT services are performed 
by the registered dietitian or nutrition professional in a face-to-face 
encounter except when those services are furnished as a telehealth 
service as provided in Sec.  410.78 of our regulations.
    Because registered dietitians and nutrition professionals are also 
the primary specialty that furnishes diabetes self-management training 
(DSMT) services, we proposed to include DSMT at Sec.  410.72(b)(2) as 
an ``other service'' that registered dietitians and nutrition 
professionals can provide in cases where the registered dietitian or 
nutrition professional is a certified provider of DSMT services as 
specified at section 1861(qq)(2)(A) of the Act; and they have submitted 
necessary documentation to, and are accredited by, a CMS-approved 
accreditation organization, as specified in Sec.  410.141(e) for DSMT 
services. We also proposed to address in the regulation at Sec.  
410.72(b)(2) the current requirement that, as specified in the 
regulation at Sec.  410.141(b)(1), DSMT services require a referral 
from the physician or qualified NPP (as defined in Sec.  410.32(a)(2)) 
who is treating the beneficiary's diabetes condition. We also proposed 
to specify in the regulation at Sec.  410.72(b)(3) that MNT and DSMT 
services cannot be furnished together on the same date of service as 
detailed in the national coverage determination for MNT services (see 
https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?ncdid=252); and, that neither MNT nor DSMT services can be 
furnished incident to the professional services of a physician or other 
practitioner. For MNT services, we proposed to clarify that MNT 
services cannot be provided incident to the services of a billing 
physician. As a distinct, stand-alone benefit under Medicare Part B at 
section 1861(s)(2)(V) of the Act, MNT services cannot be furnished 
incident to a physician's professional service that is separately 
specified at section 1861(s)(2)(A) of the Act. Further, if a physician 
also meets the qualifications to bill Medicare as a registered 
dietitian or nutrition professional (although not necessarily enrolled 
as one), they would have to personally provide any MNT services as 
explained above, meaning that those services could not be furnished by 
auxiliary personnel incident to their own professional services. For 
DSMT services, we also proposed to clarify that DSMT services cannot be 
provided incident to the services of a billing physician or 
practitioner. DSMT is a distinct benefit under Medicare Part B, as 
specified in a stand-alone statutory provision at section 1861(s)(2)(S) 
of the Act. Approved DSMT entities are separately recognized programs, 
rather than individuals or practitioners, that provide DSMT services in 
accordance with their accreditation from a CMS-approved organization 
under Sec.  410.142, indicating that the entity meets a set of quality 
standards described in

[[Page 65196]]

Sec.  410.144. Even when the DSMT services are billed by a physician or 
other practitioner, such as the DSMT certified provider, the physician 
or other practitioner could not provide DSMT services directly, unless 
they themselves are also an approved DSMT entity. If a physician or 
practitioner is an approved entity, the DSMT services must be provided 
in accordance with the requirements to furnish such services. For these 
reasons, we proposed to add at Sec.  410.72(b)(3)(ii) that neither MNT 
nor DSMT may be furnished and billed incident to the professional 
services of a physician or practitioner, where applicable.
    Given the foregoing, we proposed to add at Sec.  410.72(d) that the 
registered dietitian or nutrition professional can be paid for their 
professional services only if those services have been personally 
performed by them. Section 1861(vv) of the Act clearly indicates that 
MNT services are only provided by registered dietitians and nutrition 
professionals; and this was reiterated at Sec.  410.134 as established 
in the CY 2002 PFS final rule (66 FR 55331). In addition, the 
regulation at Sec.  410.132(a) specifies that MNT services consist of 
face-to-face nutritional assessments and interventions in accordance 
with nationally accepted dietary or nutritional protocols. After we 
issued the CY 2022 PFS proposed rule, we reviewed the proposed 
regulation text at Sec.  410.72(d) regarding the requirement that 
professional services of registered dietitians and nutrition 
professionals must be ``personally performed'' by them. We noted that 
the term, ``personally performed'' is used in 42 CFR part 410 of the 
regulations to describe services furnished both directly and incident 
to the services of other types of practitioners that are authorized by 
the statute to furnish and bill Medicare for covered services incident 
to their own professional services. Registered dietitians and nutrition 
professionals are not authorized by the statute to furnish and bill 
Medicare for services incident to their professional services. Upon 
further reflection, we are concerned that the reference to ``personally 
performed'' in the proposed regulation text at Sec.  410.72(d) could 
potentially be confusing when applied to services of registered 
dietitians and nutrition professionals. To avoid any potential 
confusion, we are clarifying that registered dietitians and nutrition 
professionals may bill Medicare only for professional services that 
they furnish directly to the beneficiary. For the same reasons, we are 
also modifying and finalizing our proposed regulation text to 
substitute ``directly'' for ``personally'' in Sec.  410.72(d).
    In the CY 2022 PFS proposed rule, we included proposed regulation 
text at Sec.  410.72(g) to specify that MNT and DSMT services may be 
provided as telehealth services (meeting the requirements in Sec.  
410.78) when registered dietitians or nutrition professionals act as 
distant site practitioners. While we did explain as noted above that 
registered dietitians and nutrition professionals were added to the 
list of distant site practitioners for telehealth services in Sec.  
410.78 of our regulation in the CY 2006 PFS final rule, we neglected to 
discuss the proposed regulation text at Sec.  410.72(g) in the preamble 
to the CY 2022 PFS proposed rule. The proposed regulation text at Sec.  
410.72(g) essentially provides a cross-reference to longstanding policy 
codified in Sec.  410.78 beginning in CY 2006. We received no comments 
on this proposed regulation text. We also discovered typographical 
errors in the proposed regulation text at Sec.  410.72(g) after the CY 
2022 PFS proposed rule was issued. The DSMT acronym was misspelled as 
``DMST'' and we left out the ``s'' at the end of ``telehealth 
services.'' In this final rule, we are correcting these two errors and 
otherwise finalizing the regulation text at Sec.  410.72(g) as 
proposed.
    In the CY 2002 PFS final rule (which we cited correctly but 
inadvertently misidentified in the CY 2022 PFS proposed rule as the CY 
2001 PFS final rule), we discussed that registered dietitians and 
nutrition professionals who are enrolled in Medicare could furnish 
services in various settings including private practices and outpatient 
hospitals, but that separate payment for MNT services would not be made 
when beneficiaries are inpatients in Part A stays in hospitals and SNFs 
(66 FR 55279). We explained that our payment to hospitals and SNFs 
includes payment for MNT services. We established these conditions of 
payment in the regulation at Sec.  414.64(e) (which we inadvertently 
cited incorrectly in the CY 2022 PFS proposed rule as Sec.  414.64(c)). 
We proposed to add these conditions of payment to our regulation at 
Sec.  410.72(c)(1) and (2), to address payment for services of 
registered dietitians and nutrition professionals when beneficiaries 
are inpatients of hospitals and SNFs. Also, in the CY 2002 PFS final 
rule, we finalized, in accordance with section 1861(s)(2)(V)(ii) of the 
Act, that there is no coverage for MNT services available for 
beneficiaries who are receiving maintenance dialysis for which payment 
is made under section 1881 of the Act, that is, services from an end-
stage renal disease (ESRD) facility. We codified this policy at Sec.  
410.132(b) of our regulations. We proposed to add this rule to our 
regulation at Sec.  410.72(c)(3) through a cross-reference to Sec.  
410.132(b).
    In accordance with section 1842(b)(18)(B) of the Act, the 
registered dietitian or nutrition professional must accept assignment, 
meaning that they must accept the payment amount Medicare approves as 
payment in full and collect nothing from the beneficiaries for those 
services for which Medicare pays 100 percent of the Medicare approved 
amount or only collect the difference between the Medicare approved 
amount and the Medicare Part B payment in accordance with Sec.  424.55. 
We proposed to add at Sec.  410.72(f) that the services of a registered 
dietitian or nutrition professional are provided on an assignment-
related basis. Because Medicare pays 100 percent of the Medicare 
approved amount for MNT covered services, this means that beneficiaries 
cannot be billed any amount for MNT covered services. For other 
services, including DSMT, for which the Medicare Part B coinsurance 
percentage is 20 percent, a registered dietitian or nutrition 
professional must not collect amounts in excess of the limits specified 
in Sec.  424.55 of our regulation, and if they do, they must refund the 
full amount of the impermissible charge to the beneficiary. Finally, we 
noted that the proposed regulatory text for Sec.  410.72(f) is 
consistent with the text in existing regulations for other types of 
NPPs at Sec. Sec.  410.74(d)(2), 410.75(e)(2), 410.76(e)(2) and 
410.77(d)(2). We also considered whether alternate regulatory text that 
cross-references the assignment requirements in Sec.  424.55 would 
provide additional clarity. Specifically, we considered whether to 
specify within Sec.  410.72(f) that the services of a registered 
dietitian or nutrition professional are provided on an assignment-
related basis; the registered dietitian or nutrition professional may 
not charge a beneficiary in excess of the amounts permitted under 42 
CFR 424.55; and if a beneficiary has made payment for a service in 
excess of these limits, the registered dietitian or nutrition 
professional must refund the full amount of the impermissible charge to 
the beneficiary.
    To ensure maximum consistency in our regulations, we stated that if 
we finalize the alternate regulatory text for Sec.  410.72(f), we would 
also make corresponding revisions to Sec. Sec.  410.74(d)(2), 
410.75(e)(2), 410.76(e)(2) and 410.77(d)(2). We

[[Page 65197]]

solicited public comments on the clearest language to describe the 
assignment requirements, as well as the rest of our proposals.
    We received public comments on our proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters appreciated and commended our proposal 
to clarify and codify payment for MNT services at Sec.  414.64(a) to 
reflect that MNT services, with their USPSTF recommended B rating, are 
paid at 100 percent of the PFS amount, rather than 80 percent.
    Response: We thank the commenters for their support.
    Comment: Some commenters offered support for all the proposed 
changes to regulations related to the Part B MNT benefit and expressed 
their agreement with our reasons for proposing the changes. Other 
commenters expressed support for the proposed regulatory text that 
includes specific payment policies for registered dietitians and 
nutrition professionals who are recognized to bill Medicare directly 
for the MNT services they provide.
    Response: CMS appreciates the many commenters' support.
    Comment: One commenter asked whether a physician (MD or DO) can 
``co-sign'' an MNT referral made by an NPP they are supervising, for 
example, when the physician and NP or PA are practicing under a 
collaborative practice agreement as required by State law. The 
commenter added that NPPs manage and coordinate care for many 
individuals with diabetes and earlier stages of chronic kidney disease 
(CKD) in both urban and rural areas--suggesting that it would be 
appropriate to permit these NPPs to refer patients for MNT. We also 
received several comments about the possibility of expanding the 
referral requirement for MNT services to include other physicians such 
as optometrists and certain NPPs, including PAs and NPs.
    Response: As discussed in the proposed rule, section 1861(vv)(1) of 
the Act expressly requires that the referral for MNT services must be 
from a physician--an M.D. or D.O. as defined in section 1861(r)(1) of 
the Act. We interpret this requirement to mean that the MNT referral 
must come directly from an M.D. or D.O., and not through a 
``cosignature'' on a referral from another type of physician or 
practitioner. Therefore, we are not expanding the referral requirement 
to include other physicians or practitioners as these commenters 
requested.
    Comment: One commenter requested that we provide clarification for 
our statement in the proposed rule regarding limitations on payment to 
registered dietitians and nutrition professionals at Sec.  410.72(c). 
The commenter specifically asked us to explain our statement that the 
payment CMS makes to hospitals and SNFs for their Medicare 
beneficiaries who are inpatients includes payment for MNT services.
    Response: We appreciate the commenter's interest in payment for MNT 
services under the PFS and the opportunity to clarify our statement. In 
developing the proposed regulation at Sec.  410.72, we included the 
restrictions on separate payment for MNT as discussed in the CY 2002 
PFS final rule and codified at Sec.  414.64(e), which specifies that 
separate payment for MNT services is made only if the beneficiary is 
not an inpatient of a hospital, SNF, nursing home or hospice; and is 
not receiving services in an RHC, FQHC or ESRD facility. We did not 
propose to revise our policy in this regard; only to reiterate it under 
the proposed new regulation at Sec.  410.72 that pertains to registered 
to dietitians and nutrition professionals and the services they 
furnish.
    Comment: We received comments from several organizations that were 
supportive of our proposals to reduce barriers and improve access to 
MNT services, but expressed the view that the proposals did not go far 
enough to achieve those goals. They noted that Medicare Advantage plans 
often cover MNT for other conditions in addition to the Medicare 
coverage of MNT for patients with diabetes and CKD, and urged us to 
expand access to MNT for other conditions as appropriate, including 
mental health conditions (such as eating disorders).
    Response: Currently, section 1861(s)(2)(V) of the Act provides a 
benefit for MNT services only for beneficiaries with diabetes or a 
renal disease. The scope of the statutory Medicare Part B benefit for 
MNT does not allow for expansion to additional diagnoses/conditions.
    Comment: We received other comments that were not specific to the 
discussion and proposals made in the CY 2022 PFS proposed rule. For 
example, a few commenters requested that we provide additional clarity 
in the Medicare Claims Processing and Benefit Policy Manuals on 
coverage and billing procedures for MNT and DSMT services under the PFS 
in all settings, including hospital clinics, FQHCs, RHCs, and CAHs; and 
one commenter wanted CMS and Congress to address multiple access 
barriers to the DSMT benefit.
    Response: We thank the commenters for their feedback and will take 
this information into consideration for the future. We look forward to 
working with stakeholders to consider and work toward increasing 
appropriate access to MNT and DSMT services. However, these comments 
are outside the scope of this rulemaking, and we decline to respond to 
them here.
    We did not receive comments in response to our request for comments 
on the clearest language to describe the assignment requirements for 
registered dietitians and nutrition professionals. As noted in the 
proposed rule and specified at section 1842(b)(18)(B) of the Act, 
registered dietitians and nutrition professionals are required to 
provide services on an assignment-related basis. We proposed to add 
regulation text at the new Sec.  410.72(f) that mirrors the current 
regulation text to reflect the requirements for payment on an 
assignment-related basis for other types of NPPs in Sec. Sec.  
410.74(d)(2), 410.75(e)(2), 410.76(e)(2) and 410.77(d)(2). We also 
indicated that we were considering whether to adopt alternate 
regulation text at Sec.  410.72(f) that would reflect the requirements 
for payment on an assignment-related basis through a cross-reference to 
the regulation at Sec.  424.55, and whether that approach would provide 
greater clarity. Specifically, we said we were considering whether to 
specify in Sec.  410.72(f) that the services of a registered dietitian 
or nutrition professional are provided on an assignment-related basis, 
and the registered dietitian or nutrition professional may not charge a 
beneficiary in excess of the amounts permitted under Sec.  424.55; and 
that if a beneficiary has made payment for a service in excess of these 
limits, the registered dietitian or nutrition professional must refund 
the full amount of the impermissible charge to the beneficiary. We 
stated that if we finalized the alternate approach to regulation text 
for Sec.  410.72(f), to ensure maximum consistency across our 
regulations, we would make corresponding revisions to the regulations 
at Sec. Sec.  410.74(d)(2), 410.75(e)(2), 410.76(e)(2), and 
410.77(d)(2). After further reflection, we believe that alternate text 
that cross-refers to the assignment requirements at Sec.  424.55 
provides greater clarity, and helpfully cross-refers to the current 
regulation that specifies the requirement for billing on an assignment-
related basis. Therefore, we are adopting the alternate approach we 
described in the proposed rule and finalizing alternate

[[Page 65198]]

regulatory text to specify that the registered dietitian's or nutrition 
professional's services are provided on an assignment-related basis, 
and the registered dietitian or nutrition professional may not charge a 
beneficiary in excess of the amounts permitted under 42 CFR 424.55. 
Additionally, the registered dietitian or nutrition professional must 
refund the full amount of the impermissible charge to the beneficiary, 
if a beneficiary has made payment for a service in excess of these 
limits.
    Given that we are finalizing the alternate regulatory text for 
Sec.  410.72(f), as we noted in describing the alternate approach to 
the regulation text at Sec.  410.72(f) in our proposed rule, to ensure 
consistency in our regulations, we are also finalizing conforming 
revisions to Sec. Sec.  410.74(d)(2), 410.75(e)(2), 410.76(e)(2) and 
410.77(d)(2), of our regulations for PAs, NPs, CNSs, and certified 
nurse mid-wives, respectively.
    After consideration of public comments, we are finalizing our 
proposals, with modifications explained above, to amend the regulation 
at Sec.  414.64(a) to reflect that MNT services are paid at 100 percent 
(instead of 80 percent) of 85 percent of the Medicare PFS approved 
amount without cost sharing; and to add the regulation at Sec.  410.72 
to address registered dietitians and nutrition professionals and 
payment for their services. We are also finalizing revisions to the 
regulations at Sec. Sec.  410.74(d)(2), 410.75(e)(2), 410.76(e)(2) and 
410.77(d)(2) to remove current language addressing the requirements of 
payment on an assignment-related basis and to instead cross-refer to 
those requirements as specified in the current regulation at Sec.  
424.55.

III. Other Provisions of the Proposed Rule

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

1. Background
a. RHC and FQHC Payment Methodologies
    As discussed in 42 CFR part 405, subpart X, RHC and FQHC visits 
generally are 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 with a shortage of home health agencies. A 
Transitional Care Management (TCM) service can also be paid by Medicare 
as an RHC or FQHC visit. In addition, a Diabetes Self-Management 
Training (DSMT) service or a Medical Nutrition Therapy (MNT) service 
furnished by a certified DSMT or MNT program may also be considered an 
FQHC visit 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 a payment limit for the AIR, and 
this limit will be determined for each RHC in accordance with section 
130 of the Consolidated Appropriations Act, 2021 as described below.
    FQHCs were paid under the same AIR methodology until October 1, 
2014. Beginning that date, in accordance with section 1834(o) of the 
Act (as added by section 10501(i)(3) of the Affordable Care Act), they 
began to transition to an 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 for 
the complexity of the patient health care needs, the length of the 
visit, or the number or type of practitioners involved in the patient's 
care.
2. Payment Methodology for RHCs
a. Background
    As we discussed previously, under Medicare Part B, payment to RHCs 
for services (defined in Sec.  405.2411) furnished to beneficiaries is 
made on the basis of an all-inclusive payment methodology subject to a 
maximum payment per-visit (discussed in section III.A.3. of this final 
rule) and annual reconciliation. Our regulations at Sec.  405.2470 
provides that RHCs are required to submit cost reports to allow the 
Medicare Administrative Contractor (MAC) to determine payment in 
accordance with 42 CFR part 405, subpart X, and instructions issued by 
CMS. The statutory payment requirements for RHC services are set forth 
at section 1833(a)(3) of the Act, (as amended by the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 \60\), 
which states that RHCs are paid reasonable costs * * * less the amount 
a provider may charge as described in clause of section 1866(a)(2)(A) 
of the Act, but in no case may the payment exceed 80 percent of such 
costs. The beneficiary is responsible for the Medicare Part B 
deductible and coinsurance amounts. Section 1866(a)(2)(A)(ii) of the 
Act and implementing regulations at Sec.  405.2410(b) establish 
beneficiary coinsurance at an amount not to exceed 20 percent of the 
clinic's reasonable charges for covered services.
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    We explain in Sec.  405.2464(a) the AIR is determined by the MAC at 
the beginning of the cost reporting period. The MAC calculates the AIR 
that will apply for the upcoming cost reporting period for each RHC by 
dividing the estimated total allowable costs by estimated total visits 
for RHC services. The MAC also periodically reviews the AIR throughout 
the cost reporting period to assure that payments approximate actual 
allowable costs and visits and may adjust the rate. Productivity, 
payment limits, and other factors are also considered in the 
calculation. Allowable costs must be reasonable and necessary and may 
include practitioner compensation, overhead, equipment, space, 
supplies, personnel, and other costs incident to the delivery of RHC 
services (Sec.  405.2468).
    Medicare payment for RHC services are ultimately determined at cost 
report settlement. That is, during the annual reconciliation as 
explained in Sec.  405.2466, MACs determine the total reimbursement 
amount due the RHC for

[[Page 65199]]

covered services furnished to Medicare beneficiaries based on the 
reporting period. The total reimbursement amount due is compared with 
total payments made to the RHC for the reporting period, and the 
difference constitutes the amount of the reconciliation. If the total 
reimbursement due to the RHC exceeds the payments made for the 
reporting period, the MAC makes a lump-sum payment to the RHC to bring 
total payments into agreement with total reimbursement due the RHC. If 
the total payments made to an RHC for the reporting period exceed the 
total reimbursement due the RHC for the period, the MAC arranges with 
the RHC for repayment.
    In the event a new RHC is in its initial reporting period, and the 
MAC does not have a cost report to set its AIR, the RHC provides the 
MAC an estimate of what it expects its costs to be for its initial 
reporting period. In the Provider Reimbursement Manual (Pub. 15-2), 
chapter 46, section 4600,\61\ we explain that for an RHC's initial 
reporting period, the clinic completes the cost report's worksheets 
with estimates of costs and visits and other information required by 
the reports. The MAC uses these estimates to determine an interim rate 
of payment for the RHC. This interim rate may be adjusted throughout 
the reporting period. Following the end of the RHC's reporting period, 
the RHC is required to submit its worksheets, using data based on its 
actual experience for the reporting period. The AIR for the following 
year will then be based on the RHC's actual experience.
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    As discussed in Pub. 100-02, Chapter 13, section 80.2,\62\ when 
RHCs are part of the same organization with more than one RHC, they may 
elect to file consolidated cost reports rather than individual cost 
reports. Under this type of reporting, each RHC in the organization 
need not file individual cost reports. Rather, the group of RHCs may 
file a single report that accumulates the costs and visits for all RHCs 
in the organization. In order to qualify for consolidation reporting, 
all RHCs in the group must be owned, leased, or through any other 
agreement, controlled by one organization.
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3. RHC Payment Limit Per-Visit
a. Background
    Prior to the Balanced Budget Act of 1997 \63\ (BBA), the payment 
methodology for an RHC depended on whether it was ``provider-based'' or 
``independent.'' Specifically, payment to provider-based RHCs for 
services furnished to Medicare beneficiaries was made on a reasonable 
cost basis by the provider's MAC in accordance with the regulations at 
42 CFR part 413; whereas payment to independent RHCs for services 
furnished to Medicare beneficiaries was made on the basis of a uniform 
all-inclusive rate payment methodology in accordance with 42 CFR part 
405, subpart X. In addition, payment to independent RHCs also was 
subject to a maximum payment per visit (also referred to as a ``payment 
limit per-visit'', ``upper payment limit per-visit'', or ``cap'') as 
set forth in section 1833(f) of the Act. This national statutory 
payment limit was set at $46 and was adjusted annually based on the 
Medicare Economic Index (MEI) described in section 1842(b)(3) of the 
Act.
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    Section 1833(f) of the Act was further amended by section 4205(a) 
of the BBA) (Pub. L. 105-33) to permit an exception to the national 
statutory payment limit for RHCs based in rural hospitals with less 
than 50 beds. Our guidance directed Medicare intermediaries to use the 
bed definition at Sec.  412.105(b) and the rural definition at Sec.  
412.62(f)(1) to determine which RHCs are eligible for the exception. 
The hospital bed definition was based on available bed days and the 
rural definition was based on the Office of Management and Budget's 
metropolitan statistical area (MSA) method.
    Section 224 of the Medicare, Medicaid and SCHIP Benefits 
Improvement and Protection Act of 2000 (Appendix F of Consolidated 
Appropriations Act of 2001) (BIPA) \64\ (Pub. L. 106-554, December 21, 
2000) further amended section 1833(f) of the Act by expanding the 
eligibility criteria for receiving an exception to the national 
statutory payment limit for RHCs. Specifically, this section of BIPA 
extended the exemption to RHCs based in small, urban hospitals. 
Effective July 1, 2001, all hospitals of less than 50 beds were 
eligible to receive an exception from the per visit payment limit for 
their RHCs.
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    As discussed in Change Request 1958, Transmittal A-01-138 issued on 
December 6, 2001, following the implementation of the BBA provision, 
CMS announced an alternative bed size definition for very rural, sole 
community hospitals with seasonal fluctuations in patient census. The 
MAC reviews the number of beds twice a year to determine whether the 
provider-based RHC meets the exception, during the Desk Review process 
and during the interim rate process (that is, determining the RHC's 
AIR). The provider-based RHC continues to receive the exception until 
the hospital which they are affiliated with submits a cost report with 
more than 50 beds. However, in the May 8, 2020 Federal Register, in 
response to the PHE for COVID-19, we published the ``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'' interim final rule 
with comment period (85 FR 27550) (May 8, 2020 IFC). In the May 8, 2020 
IFC, we implemented, on an interim basis, a change to the period of 
time used to determine the number of beds in a hospital at Sec.  
412.105(b) for purposes of determining which provider-based RHCs are 
subject to the payment limit (85 FR 27569). That is, for the duration 
of the PHE, we adopted an interim final policy to use the number of 
beds from the cost reporting period prior to the start of the PHE as 
the official hospital bed count for application of this policy. As 
such, RHCs with provider-based status that were exempt from the 
national statutory payment limit in the period prior to the effective 
date of the PHE (January 27, 2020) would continue to be exempt from the 
bed count requirement for the duration of the PHE for the COVID-19 
pandemic, as defined at Sec.  400.200, even if the hospital raised its 
bed count above 50. Once the PHE for COVID-19 ends, hospitals need to 
lower their bed count to less than 50 beds to utilize an RHC policy 
that has such a requirement.
b. Section 130 of the Consolidated Appropriations Act, 2021
    In the CY 2022 PFS proposed rule (86 FR 39231 through 39232), we 
discussed section 130 of the Consolidated Appropriations Act, 2021 (CAA 
2021) (Pub. L. 116-260, December 27, 2020), which updated section 
1833(f) of the Act by restructuring the payment limits for RHCs 
beginning April 1, 2021. We noted that section 2 of H.R. 1868 (Pub. L. 
117-7), enacted April 14, 2021, provided a technical correction to

[[Page 65200]]

section 1833(f) of the Act. The amendments made by this technical 
correction take effect as if included in the enactment of the 
Consolidated Appropriations Act of 2021 (Pub. L. 116-260).
    We explained that section 1833(f)(2) of the Act, as added by 
section 130 of the CAA 2021, states that beginning April 1, 2021, RHCs 
will begin to receive an increase in their payment limit per visit over 
an 8-year period, with a prescribed amount for each year from 2021 
through 2028. Then, in a subsequent year, at the limit established for 
the previous year increased by the percentage increase in the MEI 
applicable to primary care services furnished as of the first of such 
subsequent year. This provision also subjects all new RHCs (including 
provider-based RHCs in a hospital with less than 50 beds and enrolled 
in Medicare after December 31, 2020) to the national statutory payment 
limit.
    The national statutory payment limit for RHCs over an 8-year period 
is as follows:
     In 2021, after March 31, at $100 per visit;
     In 2022, at $113 per visit;
     In 2023, at $126 per visit;
     In 2024, at $139 per visit;
     In 2025, at $152 per visit;
     In 2026, at $165 per visit;
     In 2027, at $178 per visit; and
     In 2028, at $190 per visit.
    In addition, in the CY 2022 PFS proposed rule (86 FR 39231), we 
stated that beginning April 1, 2021, provider-based RHCs that met the 
qualifications in section 1833(f)(3)(B) of the Act, as added by section 
130 of the CAA 2021 and amended by Public Law 117-7, were entitled to 
special payment rules, as described in section 1833(f)(3)(B) of the 
Act. That is, a provider-based RHC must meet the following criteria to 
have its payment limit established based on its per visit payment 
amount (or AIR):
     As of December 31, 2020, was in a hospital with less than 
50 beds and after December 31, 2020 in a hospital that continues to 
have less than 50 beds (not taking into account any increase in the 
number of beds pursuant to a waiver during the PHE for COVID-19); and 
one of the following circumstances:
    ++ As of December 31, 2020, was enrolled in Medicare (including 
temporary enrollment during the PHE for COVID-19); or
    ++ Submitted an application for enrollment in Medicare (or a 
request for temporary enrollment during the PHE for COVID-19) that was 
received not later than December 31, 2020.
    Specifically, beginning April 1, 2021, for provider-based RHCs that 
had a per visit payment amount (or AIR) established for services 
furnished in 2020, the payment limit per visit shall be set at an 
amount equal to the greater of: (1) The per visit payment amount 
applicable to such RHC for services furnished in 2020, increased by the 
percentage increase in the MEI applicable to primary care services 
furnished as of the first day of 2021; or (2) the national statutory 
payment limit for RHCs per visit. We stated that the details of the 
most recent MEI rebasing and revising are discussed in the CY 2011 PFS 
final rule with comment period (75 FR 73262). The MEI increase for an 
update year is based on historical data through the second quarter of 
the prior calendar year. For example, the 2021 update reflects data 
through the second quarter 2020. 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, 
https://ihsmarkit.com/index.html.
    We explained that in a subsequent year (that is, after 2021), the 
provider-based RHC's payment limit per visit shall be set at an amount 
equal to the greater of: (1) The payment limit per visit established 
for the previous year, increased by the percentage increase in the MEI 
applicable to primary care services furnished as of the first day of 
such subsequent year; or (2) the national statutory payment limit for 
RHCs. We stated that the proposed CY 2022 MEI update was 1.8 percent 
based on the IGI 1st quarter 2021 forecast of the MEI and productivity 
adjustment, which reflects historical MEI data through 4th quarter 2020 
and historical MFP data through 2019. As is our general practice, we 
proposed that if more recent data became available after the 
publication of the proposed rule and before the publication of this 
final rule (for example, a more recent estimate of the MEI percentage 
increase or productivity adjustment), we would use such data, if 
appropriate, to determine the final CY 2022 MEI update.
    Based on the more recent data available for this CY 2022 PFS final 
rule (that is, IGI's third quarter 2021 forecast of the 2006-based MEI 
with historical data through the second quarter of 2021 and historical 
MFP data through 2020), we estimate that the CY 2022 MEI update is 2.1 
percent.
    In the CY 2022 PFS proposed rule (86 FR 39231), we explained for 
provider-based RHCs that meet certain requirements, but did not have a 
per visit payment amount (or AIR) established for services furnished in 
2020, the payment limit per visit shall be at an amount equal to the 
greater of: (1) The per visit payment amount applicable to the 
provider-based RHC for services furnished in 2021; or (2) the national 
statutory payment limit for RHCs.
    In a subsequent year (that is, after 2022), the provider-based RHCs 
payment limit per visit will be the greater of: (1) The payment limit 
per visit established for the previous year, increased by the 
percentage increase in MEI applicable to primary care services 
furnished as of the first day of such subsequent year; or (2) the 
national statutory payment limit for RHCs.
    We stated that a provider-based RHC that meets the qualifications 
of section 1833(f)(3)(B) of the Act, as corrected by Public Law 117-7 
will lose this designation if the hospital does not continue to have 
less than 50 beds, beyond the exemptions provided for the PHE for 
COVID-19. If this occurs, the provider-based RHC will be subject to the 
statutory payment limit per visit applicable for such year and not able 
to regain the specified provider-based payment limit.
    Lastly, we stated that provider-based RHCs that are newly enrolled 
beginning January 1, 2021, and after are subject to the national 
statutory payment limit applicable for such year for RHCs.
c. Implementation of Section 130 of the Consolidated Appropriations 
Act, 2021
    In the CY 2022 PFS proposed rule (86 FR 39232 through 39233), we 
stated that prior to this legislation, the CY 2020 national statutory 
payment limit for RHCs was $86.31. We noted that due to this timing, 
for calendar year 2021, there are two sets of payment rules for RHCs. 
That is, for the period before March 31, 2021, independent RHCs and 
provider-based RHCs that did not meet specified requirements were 
subject to the payment limit of $87.52 that CMS announced in Change 
Request 12035, Transmittal 10413 issued on October 29, 2020.\65\ 
Provider-based RHCs that met specified requirements were not subject to 
a payment limit for the first quarter of calendar year 2021. However, 
beginning April 1, 2021, in accordance with section 130 of the CAA 
2021, all RHCs are now subject to a payment limit. For example, 
beginning April 1, 2021 through December 31, 2021 the national 
statutory payment limit for RHCs is $100.00. We explained in the 
proposed rule that in order to prepare for this change in payment 
limits during the calendar year, Change Request 12185, Transmittal 
10679 was issued on March 16, 2021, to implement an

[[Page 65201]]

increase in the RHC statutory payment limit per visit and establish the 
provider-based RHC payment limits per visit, which went in effect on 
April 1, 2021. We noted Change Request 12185, Transmittal 10679, was 
rescinded and replaced by Transmittal 10780 issued on May 4, 2021 to 
reflect the technical corrections in section 2 of H.R. 1868 (Pub. L. 
117-7). We also noted that this provision does not impact the way 
beneficiary coinsurance is calculated as described in Sec.  
405.2410(b)(1).
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i. Specified Provider-Based RHCs
    In section III.A.3.b. of the CY 2022 PFS proposed rule (86 FR 
39232) and section III.A.3.b. of this final rule, we discuss the 
qualifications specified in section 1833(f)(3)(B) of the Act, as 
amended by Public Law 117-7, that determine if a provider-based RHC is 
entitled to the special payment rules described in section 
1833(f)(3)(A) of the Act. To determine if an RHC was in a hospital with 
less than 50 beds as of December 31, 2020, we stated that we would 
review each provider-based RHC using the existing bed count review 
process, as described previously, to determine if this criterion is 
met. In addition, we explained that this process generally includes 
ongoing review by the MACs two times a year. The beds to be counted for 
purposes of this criterion are described in Sec.  412.105(b), in 
accordance with existing policy.
    In the CY 2022 PFS proposed rule (86 FR 39232), we discussed our 
intent to continue with our existing policy and in accordance with 
section 1833(f)(3)(B)(i) of the Act which states that ``as of December 
31, 2020, was in a hospital with less than 50 beds and after such date 
such hospital continues to have less than 50 beds'' an RHC will retain 
its specified provider-based status until the hospital which they are 
affiliated submits a cost report with more than 50 beds. An RHC will no 
longer retain its specified provider-based status nor be eligible for 
specified status in the future once the hospital which they are 
affiliated submits a cost report with more than 50 beds. However, in 
response to the PHE for COVID-19 and in accordance with section 
1833(f)(3)(B)(I) of the Act, we stated that we would apply the policy 
that allows for increased hospital bed counts, as described in the May 
8, 2020 IFC, for purposes of determining this bed count criterion for 
specified provider-based RHC status. That policy specified that for the 
duration of the PHE, we would use the number of beds from the cost 
reporting period prior to the start of the PHE as the official hospital 
bed count. We noted that the criteria specified in section 
1833(f)(3)(B)(i) of the Act specified in a hospital with less than 50 
beds, therefore, beginning April 1, 2021, we would apply the bed 
definition at Sec.  412.105(b) exclusively.
    In the CY 2022 PFS proposed rule (86 FR 39232), we discussed 
section 1833(f)(3)(B)(ii) of the Act, as added by section 2 of Public 
Law 117-7, which requires that these specified provider-based RHCs as 
of December 31, 2020 are ``enrolled under section 1866(j) of the Act 
(including temporary enrollment during such emergency period for such 
emergency period),'' or ``submitted an application for enrollment under 
section 1866(j) of the Act (or a request for such a temporary 
enrollment for such emergency period) that was received not later than 
December 31, 2020.'' We proposed that the RHC's effective date of 
enrollment (as established under existing regulations) would be used in 
our determination as to whether an RHC is enrolled under section 
1866(j) of the Act as of December 31, 2020. In addition, with regard to 
an application for enrollment under section 1866(j) of the Act or a 
request for temporary enrollment, we proposed to use the date an 
application or request was received to determine if the RHC met the 
qualification. We explained that RHCs that established temporary 
locations for the purpose of responding to the PHE for COVID-19, in 
accordance with their State pandemic response plan, are permitted to 
enroll and receive temporary Medicare billing privileges. When the PHE 
for COVID-19 ends, an RHC that had been temporarily enrolled under the 
flexibilities described previously must submit a complete CMS-855 
enrollment application in order to establish full Medicare billing 
privileges. Failure to do so will result in the deactivation of the 
RHC's temporary billing privileges. No payments can be made for 
services provided while the temporary billing privileges are 
deactivated. For RHCs enrolled through the temporary enrollment process 
that will need to submit a complete CMS-855 enrollment application, we 
proposed, regardless of when the temporarily enrolled RHC is fully 
enrolled, that the RHC would be entitled to the special payment rules 
as long as it was temporarily enrolled as of December 31, 2020 or a 
temporary enrollment request was received by December 31, 2020, and it 
meets the bed count requirement.
    As we stated in the CY 2022 PFS proposed rule (86 FR 39233), 
section 1833(f)(3)(A) of the Act instructs Medicare to set payment 
limits per visit for these specified provider-based RHCs under certain 
payment rules. Specifically, beginning April 1, 2021, a payment limit 
per visit shall be set at an amount equal to the greater of: (1) The 
per visit payment amount applicable to such RHC for services furnished 
in 2020, increased by the percentage increase in the MEI applicable to 
primary care services furnished as of the first day of 2021 or; (2) the 
statutory payment limit per visit as described in section 1833(f)(2) of 
the Act. For subsequent years, in accordance with section 
1833(f)(3)(A)(ii) of the Act, that payment amount is increased by the 
percentage increase in the MEI or the statutory payment limit described 
in section 1833(f)(2) of the Act, whichever is greater.
    As we explained in the CY 2022 PFS proposed rule (86 FR 39233), we 
interpreted the ``per visit payment amount'' to align with the interim 
rate process the MACs use in determining an RHC's AIR. That is, as 
explained in Sec.  405.2464(a) the AIR is determined by the MAC using 
the most recently available cost report. Therefore, with regard to 
``services furnished in 2020'' we interpreted this to mean the period 
at which the services were furnished in 2020 and that costs for those 
services were reported. We understand that there may be more than one 
cost report that reports costs for services furnished in calendar year 
2020. However, since section 130 of the CAA 2021 states that the ``per 
visit payment amount'' is to be increased by the CY 2021 MEI, if a 
provider has a cost reporting period that differs from a calendar year 
time-period then the MACs should use data based on the relevant cost 
report period ending in 2020.
    Finally, in the CY 2022 PFS proposed rule (86 FR 39233), we 
acknowledged that certain RHCs file consolidated cost reports. We 
stated that for specified provider-based RHCs, existing RHCs that are 
independent, and existing RHCs that are in a hospital with greater than 
50 beds, we will continue to use the parent RHCs' cost reports to 
determine the payment limit per visit (for multi-facility RHC systems), 
as consolidated cost reporting reduces the reporting burden and cost 
report preparation time for RHCs. We noted that combining multiple 
individual RHC cost reports into a consolidated cost report allows RHCs 
to take advantage of administrative efficiencies and economies of scale 
that do not exist otherwise.
    However, we explained that in accordance with section 1833(f)(2) of 
the Act, all new provider-based RHCs and independent RHCs enrolled, as 
of January 1, 2021, shall have a payment limit established at the 
national

[[Page 65202]]

statutory payment limit for RHCs. Therefore, beginning with RHCs 
enrolled in Medicare as of January 1, 2021, we would no longer allow 
new RHCs to file consolidated cost reports.
ii. All Other RHCs
    In the CY 2022 PFS proposed rule (86 FR 39233), we explained that 
while there are criteria that allow for specified provider-based RHCs 
to be eligible for certain payment rules, all other RHCs are subject to 
payment limits as described in section 1833(f)(2) of the Act. We stated 
that while there may be new RHCs that are ``in a hospital with less 
than 50 beds'' and ``enrolled under section 1866(j) [of the Act]'', 
they will not have met these criteria by December 31, 2020. Thus, any 
new RHCs will also be subject to the national statutory payment limits 
as described in section 1833(f)(2) of the Act.
    We noted that though the payment limit is described, these RHCs 
will still have an AIR per visit determined based on their allowable 
costs for each year going forward. The payment limit that is 
established will be the maximum amount that an RHC will be paid by 
Medicare per visit. At the time of reconciliation, if an RHC's costs 
per visit are above the AIR, they will be paid an amount that reflects 
these additional costs, not to exceed the payment limit. If an RHC's 
costs per visit are below the AIR, then CMS would collect any 
overpayment for that visit. In addition, we noted that to implement 
this provision beginning April 1, 2021, CMS instructed the MACs to 
increase the payment limits to $100 per visit.
    In the CY 2022 PFS proposed rule (86 FR 39233), we stated that 
while the payment limit per-visit as set forth in section 1833(f) of 
the Act was implemented in administrative instructions issued to the 
MACs in Change Request 12185, we proposed revisions to Sec.  405.2462 
to reflect the provisions set forth in section 1833(f)(2) and (3) of 
the Act. We solicited comment on these revisions and on our proposals 
regarding the implementation of section 130 of the CAA 2021.
    The following is a summary of the comments we received and our 
responses.
    Comment: While commenters supported the increased upper payment 
limit for independent RHCs, some commenters expressed concern about how 
the payment limit per visit is established for specified provider-based 
RHCs. To be appropriately reflective of an individual clinic's true 
costs, one commenter stated that grandfathered, clinic specific, upper 
payment limits should be based on the final cost settled amount for 
cost reporting periods that end in 2020, or 2021 (for grandfathered 
RHCs that do not have cost reporting period that end in 2020), not an 
interim rate. If an interim final rate is necessary for the time period 
before final cost settled rates are adjudicated, the commenter 
suggested that CMS set interim clinic-specific upper limits only until 
such time that a final rate is established.
    Response: We agree with the commenter and believe that what the 
commenter describes is aligned with the statute and how we implemented 
the payment limit per visit for specified provider-based RHCs through 
Change Request 12185, Transmittal 10780, issued on May 4, 2021. That 
is, in accordance with section 1833(f)(3)(A) of the Act, specified 
provider-based RHCs that had a per visit payment amount (or AIR) 
established for services furnished in 2020, had their payment limit per 
visit based on their AIR determined from their final settled cost 
report ending in 2020 increased by the percentage increase in the MEI 
applicable to primary care services furnished as of the first day of 
2021 (CY 2021 MEI of 1.4 percent). However, if the product of these two 
numbers (AIR established for services furnished in 2020 * 1.014) were 
less than the national statutory payment limit of $100, their payment 
limit per visit was established at $100.
    With regard to a specified provider-based RHC that does not have an 
AIR established for services furnished in 2020 and is receiving an 
interim rate until the MAC accepts and finalizes the RHC's initial cost 
report, we again agree with the commenter. We believe that what the 
commenter describes also aligns with the statute and how we implemented 
the payment limit per visit for these specified provider-based RHCs 
through Change Request 12185, Transmittal 10780, issued on May 4, 2021. 
That is, in accordance with section 1833(f)(3)(A) of the Act, specified 
provider-based RHCs that did not have an AIR established for services 
furnished in 2020, will have their payment limit per visit established 
based on their AIR determined by MACs using the RHC's final settled 
cost report ending in 2021. The interim rate estimate will be 
reconciled at cost report settlement for the cost reporting period 
ending in 2021 which is used to establish the RHC's payment limit per 
visit for services furnished in 2021.
    Comment: One commenter noted that while the law and the CY 2022 PFS 
proposed rule is a significant improvement for independent RHCs, they 
are concerned that implementing the rule for provider-based RHCs will 
have devastating consequences for the future of the provider-based RHC 
program and rural health more broadly. The commenter suggested that CMS 
monitor impacts of the provider-based RHC upper-payment limit changes 
on access for rural beneficiaries and encouraged CMS to implement the 
statute in a manner that limits the impact on current and future 
provider-based RHCs. The commenter further expressed concern that there 
are differing interpretations on the updated statute regarding the 
provision that allows those entities who had submitted their CMS-855A 
applications by December 31, 2020 to be eligible for grandfather status 
by the regional MAC. Therefore, the commenter urged CMS to implement 
the statute in a manner allowing all provider-based RHCs who had 
submitted an CMS-855A application by December 31, 2020, to be eligible 
for grandfathered rates.
    Another commenter requested that CMS confirm that provider-based 
RHCs whose enrollment application was received by CMS as of December 
31, 2020, will not be required to complete their certification process 
by the end of 2021 since completing this process can take as long as 6 
months under normal circumstances and even longer during the PHE. One 
commenter requested that CMS expand the definition of ``existing RHCs'' 
to include hospital-based clinics that can provide proof of material 
efforts to establish a new RHC before December 31, 2020.
    Response: We appreciate the commenter notifying us that they 
believe that the regional MACs may have differing interpretations of 
the statute and the accompanying Change Request 12185, Transmittal 
10780, issued on May 4, 2021 that CMS issued to implement the 
provisions required under section 130 of the CAA, 2021. In conjunction 
with the issuance of this final rule, we expect to issue guidance that 
clarifies what date is used to determine if a provider-based RHC is 
entitled to the special payment rules described in section 
1833(f)(3)(B)(ii) of the Act. The date CMS receives the application or 
request is the date used to determine whether the RHC met the 
qualifications.
    Regarding the comment requesting that CMS confirm that provider-
based RHCs whose enrollment application was received by CMS as of 
December 31, 2020 will not be required to complete their certification 
process by the end of 2021, we confirm there is no requirement on the 
timing of when the certification process needs to be

[[Page 65203]]

complete after the enrollment application is received by CMS.
    With regard to the comment requesting that CMS expand the 
definition of ``existing RHCs'' to include hospital-based clinics that 
can provide proof of material efforts to establish a new RHC before 
December 31, 2020, we believe that the statute was clear that to be 
eligible for special payment consideration, the provider-based RHC 
needed to be, as of December 31, 2020, enrolled in Medicare (including 
temporary enrollment during the PHE for COVID-19) or have submitted an 
application for enrollment in Medicare (or a request for temporary 
enrollment during the PHE for COVID-19) that was received not later 
than December 31, 2020. We do not believe that hospital-based clinics 
that can provide proof of material efforts to establish a new RHC 
before December 31, 2020 meets that criteria.
    With regard to the comment suggesting that CMS monitor the impacts 
of the provider-based RHC upper-payment limit changes on access for 
rural beneficiaries, we agree with the commenter and CMS plans to 
monitor the policy changes for potential health equity impacts, 
including utilization and access to care for rural beneficiaries.
    Comment: One commenter requested that CMS clarify whether a 
hospital with an existing provider-based RHC may temporarily increase 
capacity to 50 or more beds in response to any future localized or 
national PHE without being penalized by losing its existing RHC status. 
The commenter also requested that CMS reduce the administrative burden 
on both MACs and hospitals by determining a hospital's bed count once a 
year, based on that year's Medicare cost report.
    Response: We appreciate the commenter's suggestion regarding future 
PHE flexibilities as it relates to the exception for RHCs based in 
rural hospitals with less than 50 beds. However, it is out of scope for 
this proposal. For the duration of the COVID-19 PHE, we adopted an 
interim final policy to use the number of beds from the cost reporting 
period prior to the start of the COVID-19 PHE as the official hospital 
bed count for application of this policy. As such, RHCs with provider-
based status that were exempt from the national statutory payment limit 
in the period prior to the effective date of the COVID-19 PHE (January 
27, 2020) would continue to be exempt from the bed count requirement 
for the duration of the PHE for the COVID-19 pandemic, as defined at 
Sec.  400.200, even if the hospital raised its bed count above 50. Once 
the COVID-19 PHE ends, hospitals need to lower their bed count to less 
than 50 beds to utilize the RHC exception. In addition, protocols are 
already in place to determine how the MACs establish the bed count. The 
MAC reviews the number of beds twice a year to determine whether the 
provider-based RHC meets the exception, during the Desk Review process 
and during the interim rate process (that is, determining the RHC's 
AIR).
    As described in Chapter 13 of the Medicare Benefit Policy Manual, 
the MACs review is not an additional burden for the purpose of this 
rule. We note that it is impossible to predict in advance the extent, 
severity and impact of a future public health emergency, and not every 
public health emergency, even a localized one, might require us to 
provide the bed count flexibility the commenter seeks in order to 
assure patients' access to services. We recognize that many interim 
policies and waivers established during the COVID-19 PHE provided 
needed flexibilities for Medicare providers and suppliers, and we 
continue to study the effectiveness of these waivers in providing 
patient access in the event of a future PHE.
    Comment: One commenter requested that CMS not retroactively recoup 
any potential overpayments that may accrue as a result of an audit 
adjustment of a hospital's initial cost report, but instead incorporate 
the audit adjustments into the RHCs AIR prospectively for future years.
    Response: We do not believe that it would be necessary or 
appropriate for CMS to incorporate the audit adjustments into the RHCs 
AIR prospectively for future years. Applying audit adjustments 
prospectively seems to imply that there should be forgiveness of any 
errors in the cost report that determines the base rate. RHCs are 
required to submit a cost report that is correct and in compliance with 
provisions of the health care services laws and regulations, as are the 
MACs. If an adjustment is proposed and the provider appeals the 
adjustment, the appeal would be handled like any other appeal that 
impacts subsequent years. While appeals have taken some years to 
resolve, the Provider Reimbursement Review Board (PRRB) has implemented 
new rules to make it easier to settle some appeals and, thereby, reduce 
the time to resolve appeal and reduce the backlog of cases.
    Comment: One commenter requested that CMS not punish any provider-
based RHC who may make updates to their facilities by removing their 
grandfathered status. A provider-based RHC should be able to update 
their facility or move facilities without losing their specified 
provider-based status. Another commenter requested that CMS clarify 
that if an existing RHC needs to change its address or alter its 
enrollment application, it will not negate the RHC's existing status, 
subjecting it to the national statutory payment limit. Another 
commenter requested that the policies regarding grandfathering status 
following an RHC change of address or change of ownership be explicitly 
addressed in CMS guidance, as the statute is clear that these RHCs 
should maintain their grandfathered status and clinic specific upper 
payment limit in these scenarios.
    Response: If an RHC undergoes a change of ownership (CHOW) and the 
acquiring owner accepts assignment of the Medicare agreement, all 
things associated with the agreement carries over to the new owner. 
This would include the CMS certification number (CCN), any financial 
obligations/repayments, the ``grandfather'' provision located at 42 CFR 
491.5(b), which applies to location requirements, and the 
qualifications specified in section 1833(f)(3)(B) of the Act, as 
amended by Public Law 117-7, that determine if a provider-based RHC is 
entitled to the special payment rules described in section 
1833(f)(3)(A) of the Act.
    Regarding a change of address, updates to a facility (for example, 
cosmetic improvements), or altering of a specified provider-based 
enrollment record, we do not believe that this would impact their 
eligibility, as long as the RHC continues to meet the location 
requirements of section 1861(aa)(2) of the Act and part 491 of this 
chapter concerning RHC services and conditions for approval, and has 
filed an agreement with CMS that meets the requirements in Sec.  
405.2402 to provide RHC services under Medicare. We note that RHCs are 
intended to provide services in rural areas.
    Comment: A few commenters suggested that CMS revise the proposal to 
no longer allow new RHCs to file consolidated reports. One commenter 
suggested that CMS revise this proposal to only prohibit consolidated 
cost reports when grandfathered and non-grandfathered RHCs are combined 
and allow new RHCs to file consolidated cost reports with other RHCs 
who are also subject to the national statutory payment limit. Another 
commenter requested that CMS clarify whether a hospital who acquires a 
new RHC that is subject to the lower national statutory payment limit 
may still include the RHC on the consolidated cost report as long as 
the RHC is reported using a separate

[[Page 65204]]

cost reporting line number. They stated that this solution will reduce 
the administrative burden on both hospitals and MACs while achieving 
CMS' goal of segregating the cost to provide care in existing RHCs from 
new RHCs.
    Response: We appreciate the commenters' feedback on the 
flexibilities for RHCs to file consolidated cost reports. We were 
persuaded by the commenters' suggestion to reconsider the benefits that 
consolidated cost reporting provides for RHCs, such as administrative 
efficiencies. At the time of the proposed rule, we had not contemplated 
allowing only new RHCs that are subject to the national statutory 
payment limit to file consolidated cost reports. However, we agree that 
there are situations where new RHCs could file consolidated cost 
reports with other RHCs to reduce their administrative burden. We 
analyzed potential outcomes based on the different statuses of RHCs. We 
compared provider-based RHCs that have or will have their payment limit 
per-visit established based on their applicable AIR to RHCs that have 
their payment limit per visit based on the national statutory payment 
limit (that is, existing provider-based RHCs that are in a hospital 
with greater than 50 beds, independent RHCs, and new RHCs).
    We note that flexibility in requiring consolidated cost reports has 
been a longstanding CMS policy. We have historically allowed multi-
facility RHC systems to file consolidated cost reports because often 
sites under common ownership have integrated functions such as 
bookkeeping and purchases (for example, medical supplies) in an effort 
to operate more efficiently. We do not want to inadvertently cause a 
disruption in the data reporting that is in place for RHCs or cause 
undue burden for new RHCs that may be a part of a multi-facility RHC 
system with other new RHCs.
    Therefore, new RHCs (that is, enrolled under section 1866(j) of the 
Act on or after January 1, 2021) are permitted to file consolidated 
cost reports with:
     New RHCs that are provider-based,
     New RHCs that are independent,
     Existing independent RHCs, and/or
     Existing provider-based RHCs that are in a hospital that 
has greater than 50 beds.
    For reasons stated above, we believe that RHCs that have the same 
national statutory payment limit should have the flexibility to file a 
consolidated cost report and each of the types of RHCs listed above 
will have a payment limit per-visit as described in section 1833(f) of 
the Act.
    We agree with commenters with regard to the types of RHCs that 
should not be permitted to file consolidated cost reports. 
Specifically, we will not permit specified provider-based RHCs to file 
a consolidated cost report with a new RHC. We believe that it would not 
be appropriate to allow a new RHC that the statute specifies should 
have a payment limit per-visit set to the national statutory payment 
limit provided at section 1833(f)(2) of the Act to file a consolidated 
cost report with an RHC that otherwise has a payment limit per-visit 
established on their applicable AIR.
    Regarding the comment requesting CMS to clarify whether a hospital 
that acquires a new RHC that is subject to the national statutory 
payment limit may still include the new RHC on the consolidated cost 
report, we agree that the hospital cost report provides this ability. 
That is, hospitals have the ability to identify a group of RHCs as 
consolidated and identify an individual RHC. More information on 
identifying provider-based RHCs on the hospital cost report (FORM CMS-
2552-10) is available in PRM 15-2, Chapter 40, section 4010.
    After consideration of the public comments, we are finalizing our 
proposal to codify Sec.  405.2462 as proposed to reflect the provisions 
set forth in section 1833(f)(2) and (3) of the Act.
3. Payment for Attending Physician Services Furnished by RHCs or FQHCs 
to Hospice Patients
a. Background
    In the Fiscal Year (FY) 2021 Hospice Payment Rate Update final rule 
(85 FR 47070) we explain that hospice care is a comprehensive, holistic 
approach to treatment that recognizes the impending death of a 
terminally ill individual and warrants a change in the focus from 
curative care to palliative care for relief of pain and for symptom 
management. Palliative care is at the core of hospice philosophy and 
care practices, and is a critical component of the Medicare hospice 
benefit. The goal of hospice care is to help terminally ill individuals 
continue life with minimal disruption to normal activities while 
remaining primarily in the home environment.
    A hospice uses an interdisciplinary approach to deliver medical, 
nursing, social, psychological, emotional, and spiritual services 
through a collaboration of professionals and other caregivers, with the 
goal of making the beneficiary as physically and emotionally 
comfortable as possible. As referenced in our regulations at Sec.  
418.22(b)(1), to be eligible for Medicare hospice services, the 
patient's attending physician (if any) and the hospice medical director 
must certify that the individual is ``terminally ill,'' as defined in 
section 1861(dd)(3)(A) of the Act and our regulations at Sec.  418.3; 
that is, the individual's prognosis is for a life expectancy of 6 
months or less if the terminal illness runs its normal course.
    Section 1861(dd)(3)(B) of the Act defines the term ``attending 
physician'' to mean, with respect to an individual, the physician, the 
NP or PA who may be employed by a hospice program, whom the individual 
identifies as having the most significant role in the determination and 
delivery of medical care to the individual at the time the individual 
makes an election to receive hospice care.
    As explained in Pub. 100-02, chapter 9, section 20.1,\66\ the 
attending physician is a doctor of medicine or osteopathy who is 
legally authorized to practice medicine or surgery by the State in 
which he or she performs that function, an NP, or PA, and is identified 
by the individual, at the time he or she elects to receive hospice 
care, as having the most significant role in the determination and 
delivery of the individual's medical care. An NP is defined as a 
registered nurse who performs such services as legally authorized to 
perform (in the State in which the services are performed) in 
accordance with State law (or State regulatory mechanism provided by 
State law) and who meets training, education, and experience 
requirements described in Sec.  410.75. A PA is defined as a 
professional who has graduated from an accredited PA educational 
program who performs such services as he or she is legally authorized 
to perform (in the State in which the services are performed) in 
accordance with State law (or State regulatory mechanism provided by 
State law) and who meets the training, education, and experience 
requirements as the Secretary may prescribe. The PA qualifications for 
eligibility for furnishing services under the Medicare program can be 
found in the regulations at Sec.  410.74(c).
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    \66\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c09.pdf.
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    RHCs and FQHCs are not authorized under the statute to serve in the 
role of an attending physician. However, a physician, NP, or PA who 
works for an RHC or FQHC may provide hospice attending physician 
services during a time when they are not working for the RHC or FQHC 
(unless prohibited by their RHC or FQHC contract or

[[Page 65205]]

employment agreement). These services would not be considered RHC or 
FQHC services since they are not being provided by an RHC or FQHC 
practitioner during RHC or FQHC hours. The physician, NP, or PA would 
bill for services under Part B using their own provider number/NPI. In 
addition, any service provided to a hospice beneficiary by an RHC or 
FQHC practitioner must comply with Medicare prohibitions on 
commingling. Further information regarding commingling is available in 
Pub. 100-02, Chapter 13, section 100.\67\
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    \67\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c13.pdf.
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b. Section 132 of the Consolidated Appropriations Act 2021
    In the CY 2022 PFS proposed rule (86 FR 39234), we discussed that 
section 132 of the CAA 2021 amended section 1834(o) of the Act and 
added a new section 1834(y) to the Act, to provide the authority for 
both FQHCs and RHCs, respectively, to receive payment for hospice 
attending physician services. Specifically, when a designated attending 
physician employed by or working under contract with an FQHC or RHC 
furnishes hospice attending physician services (as described in section 
1812(d)(2)(A)(ii) of the Act) on or after January 1, 2022, the FQHC or 
RHC is eligible to receive payment under the FQHC PPS or RHC AIR, 
respectively.
    Therefore, beginning January 1, 2022, a physician, NP, or PA who is 
employed by or working under contract with an RHC or FQHC may provide 
hospice attending physician services during a time when they are 
working for the RHC or FQHC. The RHC or FQHC would bill for these 
services as they would for any other qualified service to be paid the 
RHC AIR or the FQHC PPS rate, respectively. When the RHC/FQHC furnishes 
a hospice attending physician service that has a TC, the provider 
furnishing the TC would go to the hospice for payment as discussed in 
the Medicare Claims Processing Manual at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c11.pdf.
    We proposed to codify the new statutory provisions as described in 
section 132 of the CAA 2021 in 42 CFR 405, subpart X, specifically:
     At Sec.  405.2411, Scope of benefits, we are amending 
Sec.  405.2411(b) to reflect that hospice attending physician services 
are covered when furnished during a patient's hospice election only 
when provided by an RHC/FQHC physician, NP, or PA designated by the 
patient at the time of hospice election as his or her attending 
physician and employed or under contract with the RHC or FQHC at the 
time the services are furnished.
     At Sec.  405.2446, Scope of services, we are amending 
Sec.  405.2446(c) to include that FQHC services are covered when they 
are hospice attending physician services furnished during a hospice 
election.
    We received public comments on the proposal to codify the new 
statutory provisions as described in section 132 of the CAA 2021. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters were supportive of our proposal to codify 
the new statutory provision as described in section 132 of the CAA 2021 
in 42 CFR part 405, subpart X. One commenter noted that the new 
statutory provision would remove an unnecessary barrier to the 
efficient provision of hospice care for Medicare beneficiaries. Another 
commenter stated that allowing RHC/FQHC providers to continue to care 
for their patients who elect the hospice benefit should enhance the 
quality of care and coordination of care.
    A few commenters requested that CMS clarify that hospice patients 
could change their attending physician to an RHC/FQHC provider after 
their initial hospice election and expressed concern that the proposed 
language in Sec.  405.2411(b)(3) limits this payment to RHC/FQHC 
providers whom patients choose as their attending provider at the time 
they elect to receive hospice care. Commenters stated that under 
current Medicare rules, hospice patients are permitted to change their 
attending provider after they have made their initial election to 
receive hospice benefits, and that nothing in section 132 of the CAA 
2021 would prohibit RHC/FQHC providers from serving as attending 
providers for patients who select them after making their initial 
hospice election. Commenters requested that the phrase ``at the time of 
election'' be removed from the regulatory text. Several commenters 
requested that CMS align FQHC policies with other Medicare providers 
and permit patients to change their attending provider after they have 
made their initial election to receive hospice benefits. Commenters 
stated that CMS has the authority to provide more flexibility for 
health center patients to ensure they have the provider of their choice 
during every step of hospice care.
    Response: Regarding the concerns that CMS align policies with other 
Medicare providers and permit patients to change their attending 
physician after they have made their initial election to receive 
hospice benefits, we agree. The regulations at Sec.  418.24(g) provide 
authority for changing the attending physician, and states ``to change 
the designated attending physician, the individual (or representative) 
must file a signed statement with the hospice that states that he or 
she is changing his or her attending physician.'' Since hospice 
beneficiaries can change their attending physician at any time during 
their hospice election and we believe that this would also permit a 
beneficiary to change from their attending physician designated at 
their election to an RHC or FQHC practitioner, if they preferred. 
Therefore, we will remove the phrase ``at the time of election'' stated 
in our proposed regulation text at Sec.  405.2446(c).
    After consideration of the comments received, we are finalizing our 
proposal to codify the new statutory provision as described in section 
132 of the CAA in 42 CFR 405, subpart X with a revision to the proposed 
regulation text at Sec.  405.2446(c) to provide flexibility since 
hospice patients are permitted to change their attending provider after 
they have made their initial election.
    Comment: One commenter stated that ``CMS did not specify in the 
proposed rule which revenue code(s) RHCs can use when billing for these 
encounters'' and requested that CMS provide clarity.
    Response: We would point the commenter to subregulatory guidance 
published in Transmittal 10907, Change Request 12357 on August 10, 
2021. In exploring how to implement this policy, we found that there is 
a HCPCS modifier, -GV, defined as ``attending physician not employed or 
paid under arrangement by the patient's hospice provider'' currently in 
existence and this modifier provides the necessary information for RHCs 
and FQHCs to bill. Therefore, we believed that a new revenue code was 
not needed.
    Comment: We received one comment that was out of scope for this 
rule. While supportive of our proposal to codify the new statutory 
provision as described in section 132 of the CAA 2021 in 42 CFR 405, 
subpart X, the commenter recommended that CMS authorize PAs employed by 
a hospice to prescribe medications to Medicare hospice patients, 
similar to hospice-employed physicians and NPs. The commenter noted 
that CMS should allow a beneficiary to have the option to select a PA 
employed by a hospice when the patient does not have a previously 
established attending physician.
    Response: We appreciate the feedback; however, this comment is

[[Page 65206]]

considered to be out of scope of the proposed rule, and therefore, we 
are not addressing in this final rule.
4. Concurrent Billing for Chronic Care Management Services (CCM) and 
Transitional Care Management (TCM) Services for RHCs and FQHCs
a. Background
    In the CY 2013 PFS final rule (77 FR 68978 through 68994), we 
authorized Medicare payment for TCM services furnished by an RHC or 
FQHC practitioner, effective January 1, 2013, consistent with the 
effective date of payment for TCM services under the PFS. We adopted 
two CPT codes (99495 and 99496) to report physician or qualifying NPP 
care management services for a patient following a discharge from an 
inpatient hospital or SNF, an outpatient hospital stay for observation 
or partial hospitalization services, or partial hospitalization in a 
community mental health center. As a condition for receiving TCM 
payment, a face-to-face visit was required.
    In the CY 2016 PFS final rule with comment period (80 FR 71080 
through 71088), we finalized policies for payment of CCM services in 
RHCs and FQHCs. Payment for CCM services in RHCs and FQHCs was 
effective beginning on January 1, 2016, for RHCs and FQHCs that furnish 
a minimum of 20 minutes of qualifying CCM services during a calendar 
month to patients with multiple (two or more) chronic conditions that 
were expected to last at least 12 months or until the death of the 
patient, and that would place the patient at significant risk of death, 
acute exacerbation/decompensation, or functional decline. Payment was 
made for CCM services when CPT code 99490 was billed alone or with 
other payable services on an RHC or FQHC claim, and the rate was based 
on the PFS national average non-facility payment rate. The requirement 
that RHC or FQHC services be furnished face-to-face was waived for CCM 
services furnished to an RHC or FQHC patient because CCM describes non-
face-to-face services.
    In the CY 2018 PFS final rule, (82 FR 53172 through 53180), we 
finalized a policy permitting payment for CCM, general Behavioral 
Health Integration (BHI), and the psychiatric collaborative care model 
(CoCM) services furnished by RHCs or FQHCs on or after January 1, 2018, 
described by HCPCS codes G0511 and G0512. HCPCS code G0511 is 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. HCPCS code G0512 is a psychiatric CoCM code for use 
by RHCs or FQHCs when at least 70 minutes of initial psychiatric CoCM 
services or 60 minutes of subsequent psychiatric CoCM services are 
furnished to a patient in a calendar month. The payment amount for 
HCPCS code G0511 is set at the average of the three national non-
facility PFS payment rates for the CCM and general BHI codes and 
updated annually based on the PFS rates. The three codes are 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). The payment amount for HCPCS code G0512 is set 
at the average of the two national non-facility PFS payment rates for 
the CoCM codes and is updated annually based on the PFS rates. The two 
codes are CPT code 99492 (70 minutes or more of initial psychiatric 
CoCM services) and CPT code 99493 (60 minutes or more of subsequent 
psychiatric CoCM services).
    In the CY 2019 PFS final rule (83 FR 59687), we finalized a policy 
that effective January 1, 2019, the payment rate for HCPCS code G0511 
(General Care Management Services) is set at the average of the 
national non-facility PFS payment rates for CPT codes 99490, 99487, 
99484, and 99491.
    In the CY 2020 PFS final rule with comment period (84 FR 62692), we 
added HCPCS code G2064 (30 minutes of PCM services furnished by 
physicians or NPPs) and G2065 (30 minutes or more of PCM services 
furnished by clinical staff under the direct supervision of a physician 
or NPP) as a general care management service and included it in the 
calculation of HCPCS code G0511. Beginning January 1, 2021, the payment 
for HCPCS code G0511 is set at the average of the national non-facility 
PFS payment rates for CPT codes 99490, 99487, 99484, and 99491, and 
HCPCS codes G2064 and G2065, and is updated annually based on the PFS 
rates. Additional information on CCM requirements is available on the 
CMS Care Management web page \68\ and on the CMS RHC \69\ and FQHC \70\ 
web pages.
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    \68\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/Care-Management.html.
    \69\ https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html.
    \70\ https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
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    Currently, RHCs and FQHCs may not bill for TCM services for a 
beneficiary if another practitioner or facility has already billed for 
CCM services for the same beneficiary during the same time-period.
b. Concurrent Billing for Chronic Care Management Services and TCM 
Services for RHCs and FQHCs
    As discussed in the CY 2022 PFS proposed rule (86 FR 39235), we 
finalized a policy in the CY 2020 PFS final rule (84 FR 62687) allowing 
suppliers paid under the PFS to concurrently bill care management codes 
that were previously restricted from being billed with TCM for services 
billed under the PFS. This included allowing concurrent billing of TCM 
with 14 HCPCS codes, as well as CPT codes 99490 and 99491, which 
describe CCM services furnished under the PFS. However, we did not 
extend this policy to care management services furnished in RHCs or 
FQHCs at that time.
    Consistent with changes made in the CY 2020 PFS final rule for care 
management services billed under the PFS, in the CY 2022 PFS proposed 
rule (86 FR 39235) we proposed to allow RHCs and FQHCs to bill for TCM 
and other care management services furnished for the same beneficiary 
during the same service period, provided that all requirements for 
billing each code are met. This would include the services described by 
HCPCS codes G0511 (General Care Management for RHCs and FQHCs only) and 
G0512 (Psychiatric CoCM code for RHCs and FQHCs only), which both 
describe a service period of one calendar month. We stated that when 
medically necessary, these services may complement each other rather 
than substantially overlapping or duplicating services since TCM 
services are furnished once within 30 days of a patient's discharge, 
whereas CCM services require a more comprehensive care management plan, 
care coordination and ongoing clinical care, and CoCM services describe 
care management services specifically for behavioral health conditions. 
We noted that under this proposal, time and effort could not be counted 
more than once.
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters supported the proposal to allow RHCs and FQHCs 
to bill for TCM and other care management services furnished for the 
same beneficiary during the same service period, provided that all 
requirements for billing each code are met. Commenters agreed that 
patients receiving TCM services after discharge would benefit from the 
more comprehensive care management plan developed under CCM, as well as 
the

[[Page 65207]]

behavioral health-specific care management included in the Psychiatric 
Collaborative Care Management (CoCM) when furnished simultaneously.
    Response: We appreciate the commenters' support and feedback on our 
proposal to allow RHCs and FQHCs to concurrently bill TCM with other 
care management services.
    After consideration of the public comments, we are finalizing our 
proposal to allow RHCs and FQHCs to bill for TCM and other care 
management services furnished for the same beneficiary during the same 
service period, provided all requirements for billing each code are 
met.
5. Conforming Technical Changes to 42 CFR 405.2466
    In the November 6, 2020 Federal Register, we published the 
``Additional Policy and Regulatory Revisions in Response to the COVID-
19 Public Health Emergency'' interim final rule with request for 
comment (85 FR 71145 through 71147) (hereinafter referred to as the 
November 6, 2020 IFC). In the November 6, 2020 IFC, we implemented 
section 3713 of the CARES Act (Pub. L 116-136, March 27, 2020), which 
established Medicare Part B coverage and payment for a COVID-19 vaccine 
and its administration.
    As we discussed in that rule (85 FR 71147), section 3713 of the 
CARES Act added the COVID-19 vaccine and administration to section 
1861(s)(10)(A) of the Act in the same subparagraph as the influenza and 
pneumococcal vaccines and their administration. Therefore, the Medicare 
allowed amount and billing processes for COVID-19 vaccinations are 
similar to those in place for influenza and pneumococcal vaccinations 
across provider/supplier settings. The amendments made to section 
1861(s)(10)(A) of the Act were effective on the date of enactment, that 
is, March 27, 2020, and apply to a COVID-19 vaccine beginning on the 
date that such vaccine is licensed under section 351 of the PHS Act (42 
U.S.C. 262). A list of vaccines and their effective dates are updated 
as they are available and located on the CMS website at https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies. Although there were regulations 
updated to reflect the changes set forth by the CARES Act, we 
inadvertently did not revise the specific regulation text that applies 
to RHCs and FQHCs.
    Therefore, in the CY 2022 PFS proposed rule (86 FR 39235) 
consistent with the changes described previously, we proposed to make 
conforming technical changes to the applicable RHC and FQHC regulations 
in 42 CFR part 405, subpart X, specifically:
     At Sec.  405.2466, Annual reconciliation, we proposed to 
amend paragraph (b)(1)(iv) to include the COVID-19 vaccine in the list 
of vaccines and their administration that would be paid at 100 percent 
of Medicare reasonable cost.
    We did not receive public comments on this provision, and 
therefore, we are finalizing as proposed.

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

1. Revising the Definition of an RHC and FQHC Mental Health Visit
a. Payment Rules for RHC and FQHC Visits and for Medicare Telehealth 
Services
    Section 1861(aa)(1) of the Act defines RHC services as physicians' 
services and such services and supplies that are furnished as an 
incident to a physician's professional service, and items and services, 
as well as certain vaccines and their administration. It also includes 
services furnished by a PA, NP, clinical psychologist, or clinical 
social worker and services and supplies furnished as incident to these 
services as would otherwise be covered if furnished by a physician or 
incident to a physician's service. In the case of an RHC in an area 
with a home health agency shortage, part-time or intermittent nursing 
care and related medical supplies may be furnished by a registered 
professional nurse or licensed practical nurse to a homebound 
individual under certain conditions. Section 1861(aa)(3) of the Act 
defines FQHC services to include the specified RHC services and 
preventive services, as well as required primary preventive health 
services.
    As previously stated, RHC and FQHC visits are defined as medically-
necessary, face-to-face encounters between a patient and an RHC or FQHC 
practitioner, during which time one or more RHC or FQHC qualifying 
services are furnished. Services furnished must be within the 
practitioner's State scope of practice, and only services that require 
the skill level of the RHC or FQHC practitioner are considered RHC or 
FQHC visits. The RHC and FQHC payment is based on the costs of all 
services, except in certain circumstances, such as vaccines and their 
administration.
    RHCs are paid an all-inclusive rate (AIR) for medically-necessary 
primary health care services, and qualified preventive health services, 
furnished by an RHC practitioner. Medicare pays 80 percent of the RHC 
AIR, subject to a payment limit. Services furnished incident to an RHC 
professional service are included in the AIR and are not billed as a 
separate visit. The PC of a procedure is usually a covered service, but 
is not a stand-alone billable visit. The costs of covered services 
provided incident to a billable visit may be included on the RHC cost 
report.
    FQHCs are paid 80 percent of the lesser of the FQHC's charge or the 
FQHC PPS payment rate. Except for grandfathered tribal FQHCs, the FQHC 
PPS payment rate reflects a base rate that is the same for all FQHCs, a 
geographic adjustment based on the location where services are 
furnished, and other applicable adjustments. The FQHC PPS rate was 
established based on the aggregate of FQHC total costs, and is updated 
yearly by the productivity-adjusted FQHC market basket increase.
    Under the PFS, Medicare makes payment to professionals and other 
suppliers for physician's services, certain diagnostic tests, and some 
preventive services. Section 1834(m) of the Act specifies for Medicare 
telehealth services paid under the PFS, the payment amounts and 
circumstances under which Medicare makes payment for a discrete set of 
services, all of which must ordinarily be furnished in-person, when 
they are instead furnished using interactive, real-time 
telecommunication technology. When furnished under the telehealth 
rules, many of these specified Medicare telehealth services are still 
reported using codes that describe ``face-to-face'' services but are 
furnished using audio/video, real-time communication technology instead 
of in-person (82 FR 53006). Section 1834(m) of the Act also specifies 
conditions related to which professionals can be paid by Medicare for 
their professional services furnished via telehealth (referred to as 
distant site practitioners) and the originating site (both setting of 
care and geography) where a beneficiary is located while receiving 
telehealth services furnished remotely by the physician or practitioner 
through a telecommunications system. The regulation text at 42 CFR 
410.78(f) describes a process for adding or deleting services to the 
list of Medicare telehealth services through the annual PFS rulemaking 
process and defines what technology may be used to furnish the service.
    Under the statutory authority set out under section 
1834(m)(4)(C)(ii) of the Act, RHCs and FQHCs, like hospitals, physician 
offices, and other sites, are

[[Page 65208]]

authorized to serve as originating sites for eligible telehealth 
services. As defined in section 1834(m)(4)(C)(i) of the Act, the 
originating site is where the eligible telehealth individual is located 
at the time the service is furnished via a telecommunications system. 
As defined in section 1834(m)(4)(A) of the Act, the distant site is 
where the physician or practitioner is located at the time the service 
is provided via a telecommunications system. Originating sites are paid 
an originating site facility fee that is billed using HCPCS code Q3014 
and is assigned a rate of $27.02 for CY 2021.
    Section 3704 of the Coronavirus Aid, Relief, and Economic Security 
Act (the CARES Act) (Pub. L. 116-136, March 27, 2020) directs the 
Secretary to establish Medicare payment for telehealth services 
provided by RHCs and FQHCs serving as a distant site (that is, where 
the practitioner is located) during the public health emergency (PHE) 
for COVID-19. Separately, section 3703 of the CARES Act expanded CMS' 
emergency waiver authority to allow for a waiver of any of the 
statutory telehealth payment requirements under section 1834(m) of the 
Act for telehealth services furnished during the PHE. Specifically, 
section 1834(m)(8)(B) of the Act, as added by the CARES Act, requires 
that the Secretary develop and implement payment methods for FQHCs and 
RHCs that serve as a distant site during the PHE for the COVID-19 
pandemic. The payment methodology outlined in the CARES Act requires 
that rates shall be based on rates that are similar to the national 
average payment rates for comparable telehealth services under the 
Medicare PFS. CMS established rates based on the average amount for all 
PFS telehealth services on the telehealth list, weighted by volume. 
RHCs and FQHCs bill for these Medicare telehealth services using HCPCS 
code G2025 and the rate for CY 2021 is $99.45. The temporary authority 
under section 1834(m)(8) of the Act to pay RHCs and FQHCs for 
furnishing distant site Medicare telehealth services expires when the 
PHE for the COVID-19 pandemic is terminated. While they will continue 
to be able to serve as an originating site for Medicare telehealth 
services, the payment mechanism for the professional services of RHC 
and FQHC practitioners will be FQHC and RHC payments under the 
established methodology, that is the RHC AIR or the FQHC PPS.
b. Adoption of Telehealth Technologies for Mental Health Care
    While not specific to RHC and FQHC telehealth services provided 
during the PHE, according to MedPAC's report, Telehealth in Medicare 
after the Coronavirus Public Health Emergency,\71\ there were 8.4 
million telehealth services paid under the PFS in April 2020, compared 
with 102,000 in February 2020. MedPAC also reported that during focus 
groups held in the summer of 2020, clinicians and beneficiaries 
supported continued access to telehealth visits with some combination 
of in-person visits. They cited benefits of telehealth, including 
improved access to care for those with physical impairments, increased 
convenience from not traveling to an office, and increased access to 
specialists outside of a local area. In their annual beneficiary 
survey, over 90 percent of respondents who had a telehealth visit 
reported being ``somewhat'' or ``very satisfied'' with their video or 
audio visit, and nearly two-thirds reported being ``very satisfied.''
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    \71\ http://medpac.gov/docs/default-source/reports/mar21_medpac_report_ch14_sec.pdf?sfvrsn=0.
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    Widespread use of telecommunications technology to furnish services 
during the PHE has illustrated interest within the medical community 
and among Medicare beneficiaries in furnishing and receiving care 
through the use of technology beyond the PHE. During the PHE for COVID-
19 pandemic, RHCs and FQHCs, much like other provider types, have had 
to change how they furnish care in order to meet the needs of their 
patients, and use of the temporary authority to bill Medicare for PFS 
telehealth services has been widely utilized by RHCs and FQHCs during 
the PHE. This shift in how care is furnished has prompted us to 
reevaluate the regulations regarding visit requirements for encounters 
between an RHC or FQHC patient and an RHC or FQHC practitioner to 
ensure that they reflect contemporary medical practice.
    Recently enacted legislation modified the circumstances under which 
Medicare makes payment for mental health services furnished via 
telehealth technology under the PFS following the PHE. Division CC, 
section 123 of the Consolidated Appropriations Act of 2021 (CAA) (Pub. 
L. 116-260, December 27, 2020) removed the domestic geographic 
originating site restrictions and added the home of the individual as a 
permissible originating site for telehealth services billed under the 
PFS when furnished for the purposes of diagnosis, evaluation, or 
treatment of a mental health disorder. This change correlates with a 
growing acceptance of the use of technology in the provision of mental 
health care. Clinicians furnishing telepsychiatry services at 
Massachusetts General Hospital Department of Psychiatry during the PHE 
observed several advantages of the virtual format for furnishing 
psychiatric services, noting that patients with psychiatric pathologies 
that interfere with their ability to leave home (for example, 
immobilizing depression, anxiety, agoraphobia, and/or time-consuming 
obsessive-compulsive rituals) were able to access care more 
consistently since eliminating the need to travel to a psychiatry 
clinic can increase privacy, and therefore, decrease stigma-related 
barriers to treatment, potentially bringing care to many more patients 
in need, as well as enhanced ease of scheduling, decreased rate of no-
shows, increased understanding of family and home dynamics, and 
protection for patients and practitioners with underlying health 
conditions.\72\
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    \72\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7347331/.
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    These findings are consistent with our analysis of Medicare claims 
data that indicate that use of interactive communication technology for 
mental health care is likely to continue to be in broad use beyond the 
circumstances of the pandemic. According to our analysis of Medicare 
Part B claims data for services furnished via Medicare telehealth under 
the PFS during the PHE, use of telehealth for many professional 
services spiked in utilization around April 2020 and diminished over 
time; however, utilization was still higher than it was prior to the 
PHE. In contrast, Medicare claims data suggests that for mental health 
services both permanently and temporarily added to the Medicare 
Telehealth list, subsequent to April 2020, the trend is toward 
maintaining a steady state of usage over time. Given this information, 
broad acceptance in the public and medical community, and the 
relatively stable Medicare utilization of services during the entire 
COVID-19 pandemic, we believe use of interactive communication 
technology in furnishing mental health care is becoming an established 
part of medical practice, very likely to persist well after the COVID-
19 pandemic, and available across the country under Medicare statute 
for the range of professionals furnishing mental health care and paid 
under the PFS.
c. Revising the Definition of an RHC and FQHC Mental Health Visit
    In the 2022 PFS proposed rule (86 FR 39237), we stated that 
beneficiaries receiving mental health services from

[[Page 65209]]

RHC and FQHC practitioners should have the same access to mental health 
care delivered via telecommunications technology as beneficiaries 
receiving services from practitioners paid under the PFS. We believed 
that disruptions in access to mental health care from trusted 
practitioners can be particularly problematic for Medicare 
beneficiaries, especially when it results in fragmented care. However, 
absent changes in the definition of mental health visits, RHCs and 
FQHCs would no longer be paid by Medicare for mental health care 
services delivered via telecommunications technology and would likely 
resume furnishing solely in-person, face-to-face mental health visits 
after the PHE, thereby removing the ability for beneficiaries to be 
able to receive these services from RHC/FQHC practitioners if furnished 
via interactive communication technology.
    Because the definitions of RHC and FQHC services, as specified in 
sections 1861(aa)(1) and (3) of the Act, respectively, refer 
specifically to physicians' services, and services that would be 
physicians' services, but are instead furnished by certain other types 
of practitioners, we felt it would be consistent to align policies to 
provide access to services furnished by RHCs and FQHCs similar to PFS 
services, where appropriate and within statutory requirements. To 
ensure that beneficiaries could access services furnished by RHCs and 
FQHCs in a manner similar to mental health services under the PFS after 
the PHE, we stated that it would be appropriate to consider modifying 
our regulatory definition of a mental health visit to provide for 
remote access to RHC and FQHC services. Therefore, to avoid both the 
inequities in access to modes of care, and to avoid potentially 
problematic interruptions to care or the negative consequences of 
fragmented care, for CY 2022, we proposed to revise 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 to also include encounters furnished 
through interactive, real-time telecommunications technology, but only 
when furnishing services for the purposes of diagnosis, evaluation, or 
treatment of a mental health disorder.
    Additionally, similar to the discussion of mental health services 
furnished under the PFS, as described in section II.D. of this final 
rule, we believe that mental health telehealth services furnished via 
audio-only communications technology would increase access to care, 
especially in areas with poor broadband infrastructure and among 
patient populations that either are not capable of, or do not consent 
to, the use of devices that permit a two-way, audio/video interaction. 
Therefore, in order to align with proposals related to use of audio-
only telecommunications technology to furnish similar mental health 
services under the PFS, we proposed to allow RHCs and FQHCs to furnish 
mental health visits using audio-only interactions in cases where 
beneficiaries were not capable of, or did not consent to, the use of 
devices that would permit a two-way, audio/video interaction. We noted 
that the decision related to a service being furnished via 
telecommunications technology should be a patient-centered choice and 
that providers/practitioners should not force or impose services being 
furnished via telecommunications technology on beneficiaries who prefer 
to receive the services in-person. Additionally, some patients may have 
preferred a hybrid whereby some mental health services are in person, 
but other times they are done using telecommunications technology. We 
stated that this decision should be based on the clinical judgment of 
the practitioner, in consideration of patient needs and preferences.
    This change would allow 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. This expansion of payable modes of mental health 
services furnished by RHCs and FQHCs corresponds with the expanded 
availability for professionals paid for Medicare telehealth services 
under the PFS authorized by section 123 of the CAA and using the 
technology available for use for corollary services when paid under the 
PFS. This revision would not allow RHCs or FQHCs to report visits 
furnished using asynchronous communications like email exchanges. 
Rather, RHCs and FQHCs would continue to report and be paid for 
furnishing medically necessary virtual communications services in 
accordance with the requirements for HCPCS code G0071 (83 FR 59686). 
Also, this change would not allow RHCs and FQHCs to report Medicare 
telehealth services under section 1834(m) of the Act or be paid under 
the PFS since RHCs and FQHCs are not authorized to serve as distant 
site practitioners for Medicare telehealth services once the PHE for 
the COVID-19 pandemic has been terminated. In order to track 
utilization of mental health visits furnished using communication 
technology, we proposed that RHCs and FQHCs would append the 95 
modifier (Synchronous Telemedicine Service Rendered via Real-Time 
Interactive Audio and Video Telecommunications System) in instances 
where the service was furnished using audio-video communication 
technology or a new service level modifier in cases where the service 
was furnished audio-only.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: We received many public comments that were supportive of 
the proposal to revise the current regulatory language for RHC or FQHC 
mental health visits to include visits furnished using interactive, 
real-time telecommunications technology. Some commenters pointed out 
that rural residents often face significant barriers to accessing 
mental health services, which result in significant disparities in care 
and that patients in rural areas often must travel long distances to 
receive specialized care such as mental health services. Commenters 
stated that being able to access these services through local RHCs and 
FQHCs via telecommunications technology would help to increase the 
frequency in which rural residents can access mental health services. 
Some commenters noted that patients without reliable transportation, 
internet, or the necessary technology will still face difficulties 
accessing services after the PHE ends.
    One commenter stated that allowing RHCs to be reimbursed at the AIR 
reduces administrative burden and ensures that providing equitable 
mental health care remains a component of RHC provided care. A few 
commenters requested that this flexibility be extended to medical 
visits furnished at RHCs and FQHCs, not just mental health visits. 
Additionally, MedPAC commented that FQHC and RHC-provided telehealth 
services should be paid at rates comparable to those under the PFS.
    Response: After consideration of the public comments, we are 
finalizing our proposal to revise the current regulatory language for 
RHC or FQHC mental health visits to include visits furnished using 
interactive, real-time telecommunications technology and for 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. Since the flexibilities 
authorized by the CARES Act will expire at the end of the PHE,

[[Page 65210]]

we do not believe we currently have the authority to pay RHCs and FQHCs 
for services that would be paid under the AIR or PPS at the PFS rates 
outside of the PHE. We note that payment for virtual communications and 
care management services furnished at RHCs and FQHCs are paid based on 
PFS rates; however, these services describe non-face-to-face encounters 
between a patient and an RHC or FQHC practitioner and are paid outside 
of the AIR or PPS. Therefore, we are finalizing for CY 2022 that RHCs 
and FQHCs will be paid for mental health visits furnished via 
telecommunications technology at the same rate they are paid for in-
person mental health visits (that is, the AIR or FQHC PPS).
    In response to comments that this flexibility be extended to 
medical visits furnished at RHCs and FQHCs, not just mental health 
visits, we note that the use of telecommunications technology to 
furnish medical visits at RHCs and FQHCs was not within the scope of 
this proposal.
    We received public comments on allowing RHCs and FQHCs to furnish 
mental health visits using 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. The following 
is a summary of the comments we received and our responses.
    Comment: Many commenters supported the inclusion of audio-only 
communications technology in this proposal and stated that this 
flexibility especially benefits rural patients with poor broadband 
structure. Several commenters stated that Medicare beneficiaries 
receiving services through these facilities should have the same access 
to mental and behavioral health services as those being treated by 
providers practicing independently.
    Response: After consideration of public comments, we are finalizing 
our proposal to allow RHCs and FQHCs to furnish mental health visits 
using 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. We are also finalizing our proposal for 
RHCs and FQHCs to append the 95 modifier (Synchronous Telemedicine 
Service Rendered via Real-Time Interactive Audio and Video 
Telecommunications System) in instances where the service was furnished 
using audio-video communication technology and to append a new service 
level modifier in cases where the service was furnished audio-only. 
This will allow us to track utilization of mental health visits 
furnished using telecommunication technology at RHCs and FQHCs in order 
inform future rulemaking.
    Additionally, we noted in the proposed rule that section 123 of the 
CAA also requires that there be an in-person service within 6 months 
prior to the furnishing of the telehealth service and at intervals 
thereafter as specified by the Secretary for mental health services 
furnished via Medicare telehealth under the PFS. We solicited comment 
on whether we should consider a similar requirement for mental health 
services furnished by RHCs and FQHCs via telecommunications technology, 
or whether this requirement may be especially burdensome for 
beneficiaries receiving treatment at RHCs and FQHCs, particularly in 
rural areas. In establishing a similar requirement for RHC and FQHC 
mental health services, we would consider the changes described for 
Medicare telehealth services described in section II.D. of this final 
rule that there be an in-person service within 6 months prior to the 
furnishing of the telecommunications service and that an in-person 
service (without the use of telecommunications technology) be provided 
at least every 6 months while the beneficiary is receiving services 
furnished via telecommunications technology for diagnosis, evaluation, 
or treatment of mental health disorders, which would be documented in 
the patient's medical record, or whether we should defer to the 
clinical judgment of the practitioner on how often an in-person visit 
would be appropriate.
    We received public comments on whether we should consider a similar 
requirement for mental health services furnished by RHCs and FQHCs via 
telecommunications technology, or whether this requirement may be 
especially burdensome for beneficiaries receiving treatment at RHCs and 
FQHCs, particularly in rural areas. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters were opposed to imposing an in-person 
service requirement for telehealth mental health visits. A few 
commenters described that existing evidence does not support the need 
for such a requirement, which could negatively impact access to care 
for beneficiaries and recommended CMS defer to the clinical judgment of 
the practitioner on how often an in-person visit would be appropriate 
and additionally noting that existing studies suggest low-income 
patients and those living in rural communities face more transportation 
barriers compared to other patients, and therefore, it is likely that 
in-person requirements would more profoundly impede access to care for 
the populations that RHCs and FQHCs serve. Other commenters encouraged 
CMS to provide maximum flexibility for FQHCs implementing in-person 
service requirements for patients receiving mental health services 
furnished via telecommunications technology. One commenter recommended 
that CMS provide a robust set of exceptions for patients unable or 
unwilling to fulfill the once every six months in-person visit 
requirement.
    However, a few commenters supported requiring an in-person visit 
every 6 months, asserting that these requirements ensure some level of 
physical proximity between the patient and provider which is valuable 
in the event of in-person mental health care needs. Some commenters 
stated that this requirement would protect the integrity of the benefit 
and aligns with FFS provider in-person requirements and that ensuring 
that patients in rural areas receive mental health care via 
telecommunications technology in a location reasonably situated to 
where they receive in-person care would provide the most comprehensive 
option in meeting patient needs. Several commenters stated that if CMS 
had to establish an interval for subsequent in-person visits, it should 
be at least 12 months, noting that even that would present a hardship 
for rural patients and patients with disabilities.
    Response: We appreciate all the comments received on this topic. We 
are persuaded by the comments related to ensuring access in the event 
of in-person needs and alignment with requirements under Medicare FFS. 
Therefore, we are finalizing that there must be an in-person mental 
health service furnished within 6 months prior to the furnishing of the 
telecommunications service and that in general, there must be an in-
person mental health service (without the use of telecommunications 
technology) must be provided at least every 12 months while the 
beneficiary is receiving services furnished via telecommunications 
technology for diagnosis, evaluation, or treatment of mental health 
disorders. Consistent with policies finalized for mental health 
services furnished via telehealth under the PFS, the in-person service 
requirements apply only to telehealth services furnished to a patient 
receiving the service at home. However, in response to commenters' 
concerns regarding the requirement that an in-person, non-telehealth 
visit be furnished every 12 months, we agree with

[[Page 65211]]

commenters that there may be specific circumstances when an in-person 
visit within 12 months of each mental health visit furnished via 
telecommunications technology may be inadvisable or impracticable for 
an individual beneficiary. Therefore, we are finalizing a policy that 
will allow for limited exceptions to the requirement that there be an 
in-person, non-telehealth service every 12 months based on beneficiary 
circumstances, in which case the basis for that decision should be 
documented in the patient's medical record. Specifically, if the 
patient and practitioner consider the risks and burdens of an in-person 
service and agree that, on balance, these outweigh the benefits, and 
the practitioner documents the basis for that decision in the patient's 
medical record, then the in-person visit requirement is not applicable 
for that 12-month period. Situations in which the risks and burdens 
associated with an in-person service may outweigh the benefit could 
include, but are not limited to, instances when an in-person service is 
likely to cause disruption in service delivery or has the potential to 
worsen the patient's condition(s). The risks and burdens associated 
with an in-person service could also outweigh the benefit if a patient 
receiving services is in partial or full remission and only requires a 
maintenance level of care. Other justifications include the clinician's 
professional judgment that the patient is clinically stable and/or that 
an in-person visit has the risk of worsening the beneficiary's 
condition, creating undue hardship on self or family, or if it is 
determined that the patient is at risk for disengagement with care that 
has been effective in managing the illness. We note that the 12-month 
in-person visit requirement is not intended to dictate how often a 
provider and patient should meet in person; rather, patients and 
providers should determine the frequency of in-person meetings as 
driven by clinical needs. This is consistent with the policies for 
Medicare telehealth services furnished under PFS, as required by 
section 123 of the CAA and as finalized in Section II.D of this final 
rule. Given that this requirement may pose more of a challenge for 
beneficiaries in rural areas, we will monitor the impact of this 
requirement to determine whether it presents a disruption in access to 
mental health care in the RHC/FQHC setting.
d. Regulatory Changes
    We proposed to revise the regulation at Sec.  405.2463, to revise 
paragraph (a)(1)(i) to state that a mental health visit is a face-to-
face (that is, in person) encounter (or, for mental health visits only, 
an encounter that meets the requirements under paragraph (b)(3)) 
between an RHC patient and an RHC practitioner. We proposed to revise 
paragraph (b)(3) to define a mental health visit as a face-to-face 
encounter or an encounter where services are furnished using 
interactive, real-time, audio and video telecommunications technology 
or audio-only interactions in cases where beneficiaries are not capable 
of, or do not consent to, the use of devices that permit a two-way, 
audio/video interaction for the purposes of diagnosis, evaluation or 
treatment of a mental health disorder. We also proposed to revise Sec.  
405.2469, FQHC supplemental payments, to revise paragraph (d) by adding 
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.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: We received many public comments that were supportive of 
the proposal to revise the current regulatory language for RHC or FQHC 
mental health visits to include visits furnished using interactive, 
real-time telecommunications technology.
    Response: After consideration of public comments, we are finalizing 
our proposal to revise the regulation at Sec. Sec.  405.2463 and 
405.2469, as described above. Additionally, at Sec.  405.2463, we are 
revising paragraph (b)(3) 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. We are also 
revising Sec. Sec.  405.2463(b)(3) and 405.2469(d) to allow an 
exception for a particular 12-month period when 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. At Sec.  405.2469, FQHC supplemental 
payments, we are revising paragraph (d) to describe the same in-person 
visit requirement referenced above.

C. Federally Qualified Health Centers (FQHCs) Payment for Tribal 
FQHCs--Comment Solicitation

1. Health Services to American Indians and Alaska Natives (AI/AN)
    There is a special government-to-government relationship between 
the Federal Government and Federally-recognized tribes based on U.S. 
treaties, laws, Supreme Court decisions, Executive Orders and the U.S. 
Constitution. This government-to-government relationship forms the 
basis for Federal health services to American Indians/Alaska Natives 
(AI/AN) in the U.S. In 1976, the Indian Health Care Improvement Act 
(IHCIA) (Pub. L. 94-437, September 30, 1976) amended the statute to 
permit payment by Medicare and Medicaid for services provided to AI/ANs 
in Indian Health Service (IHS) and tribal health care facilities that 
meet the applicable requirements. Under this authority, Medicare 
services to AI/ANs may be furnished by IHS operated facilities and 
programs and tribally-operated facilities and programs under Title I or 
Title V of the Indian Self Determination Education Assistance Act, as 
amended (ISDEAA) (Pub. L 93-638, January 4, 1975). According to the IHS 
Profile,\73\ the IHS healthcare delivery system currently consists of 
46 hospitals, with 24 of those hospitals operated by the IHS and 22 of 
them operated by tribes under the ISDEAA, as well as 492 health 
centers, 75 operated by IHS and 417 operated by tribes under the 
ISDEAA.
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    \73\ https://www.ihs.gov/newsroom/factsheets/ihsprofile/.
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    Payment rates for outpatient medical care (also referred to as 
outpatient hospital services) furnished by the IHS and tribal 
facilities is set annually by the IHS under the authority of sections 
321(a) and 322(b) of the Public Health Service Act (the PHS Act) (42 
U.S.C. 248 and 249(b)) (Pub. L. 83-568 (42 U.S.C. 2001(a)), and the 
IHCIA, based on the previous year cost reports from Federal and tribal 
hospitals. The IHCIA provided the authority for CMS (then HCFA) to pay 
IHS and tribal facilities for its outpatient hospital services to 
Medicare eligible patients, using an

[[Page 65212]]

outpatient per visit rate (also referred to as the Medicare all-
inclusive payment rate (AIR).
2. Federally Qualified Health Centers (FQHCs) Prospective Payment 
System (PPS)
    FQHCs were established in 1990 by section 4161 of the Omnibus 
Budget Reconciliation Act of 1990 (OBRA 90) (Pub. L. 101-508, November 
5, 1990), and were effective beginning on October 1, 1991. They are 
facilities that furnish services that are typically furnished in an 
outpatient clinic setting. The statutory requirements that FQHCs must 
meet to furnish services to Medicare beneficiaries are in section 
1861(aa)(4) of the Act. All FQHCs are subject to Medicare regulations 
at 42 CFR part 405, subpart X, and 42 CFR part 491. Based on these 
provisions, the following three types of organizations that are 
eligible to enroll in Medicare as FQHCs:
     Health Center Program grantees: Organizations receiving 
grants under section 330 of the PHS Act (42 U.S.C. 254b).
     Health Center Program ``lookalikes'': Organizations that 
have been identified by the Health Resources and Services 
Administration as meeting the requirements to receive a grant under 
section 330 of the PHS Act, but which do not receive section 330 grant 
funding.
     Outpatient health programs or facilities operated by a 
Tribe or tribal organization under the ISDEAA, or by an urban Indian 
organization receiving funds under Title V of the IHCIA.
    FQHCs are also entities that were treated by the Secretary, for 
purposes of Medicare Part B, as a comprehensive Federally funded health 
center as of January 1, 1990 (see section 1861(aa)(4)(C) of the Act). 
Section 1834 of the Act was amended in 2010 by section 10501(i)(3)(A) 
of the Affordable Care Act by adding a new subsection (o), 
``Development and Implementation of Prospective Payment System'' for 
FQHCs. Section 1834(o)(1)(A) of the Act requires that the system 
include a process for appropriately describing the services furnished 
by FQHCs, and establish payment rates based on such descriptions of 
services, taking into account the type, intensity, and duration of 
services furnished by FQHCs. It also stated that the new system may 
include adjustments (such as geographic adjustments) as determined 
appropriate by the Secretary. Section 1833(a)(1)(Z) of the Act, as 
added by the Affordable Care Act, requires that Medicare payment for 
FQHC services under section 1834(o) of the Act be 80 percent of the 
lesser of the actual charge or the PPS amount determined under section 
1834(o) of the Act.
    In accordance with the requirements in the statute, as amended by 
the Affordable Care Act, beginning on October 1, 2014, payment to FQHCs 
is based on the lesser of the national encounter-based FQHC PPS rate, 
or the FQHC's total charges, for primary health services and qualified 
preventive health services furnished to Medicare beneficiaries. The 
FQHC PPS rate is adjusted by the FQHC geographic adjustment factor 
(GAF), which is based on the Geographic Practice Cost Index used under 
the PFS. The FQHC PPS rate is also adjusted when the FQHC furnishes 
services to a patient that is new to the FQHC, and when the FQHC 
furnishes an IPPE or an AWV. Payment to the FQHC for a Medicare visit 
is the lesser of the FQHC's charges (as established by the G-code), or 
the PPS rate. The CY 2021 FQHC PPS rate is $176.45.
3. Grandfathered Tribal FQHCs
    In the November 16, 2015 Federal Register, we published a final 
rule, entitled ``Medicare Program; Revisions to Payment Policies Under 
the Physician Fee Schedule and Other Revisions to Part B for CY 2016 
(referred to as CY 2016 PFS final rule). In that rule, we discuss the 
payment methodology and requirements finalized for grandfathered tribal 
FQHCs (80 FR 71089 through 71096). We stated that tribal facilities 
that met the conditions of Sec.  413.65(m) on or before April 7, 2000, 
and had a change in their status on or after April 7, 2000, from IHS to 
tribal operation, or vice versa, or the realignment of a facility from 
one IHS or tribal hospital to another IHS or tribal hospital, such that 
the organization no longer met the Medicare Conditions of Participation 
(CoPs) for Medicare-participating hospitals at Sec.  482.12, the 
``governing body'' of the facility could nevertheless seek to become 
certified as a grandfathered tribal FQHC.
    In CY 2016 PFS final rule, we explained that a different structure 
was needed to maintain access to care for AI/AN populations served by 
the hospitals and clinics impacted by the provider-based rules at Sec.  
413.65, while also ensuring that the tribal clinics are in compliance 
with our health and safety rules. We recognized that a tribal clinic 
billing under an IHS hospital's CMS Certification Number (CCN), without 
any additional administrative or clinical relationship with the IHS 
hospital, could put that hospital at risk for noncompliance with their 
CoPs because the clinic had a separate governing body although still 
provider-based. We explained that the FQHC program provided an 
alternative structure that met the needs of these tribal clinics and 
the populations they served, while also ensuring the IHS hospitals were 
not at risk of being cited for non-compliance with the requirements 
with their CoPs (80 FR 71090).
    As stated in Sec.  405.2462(d)(1) a ``grandfathered tribal FQHC'' 
is a FQHC that is operated by a tribe or tribal organization under the 
ISDEAA; was billing as if it were provider-based to an IHS hospital on 
or before April 7, 2000 and is not currently operating as a provider-
based department of an IHS hospital. We refer to these tribal FQHCs as 
``grandfathered tribal FQHCs'' to distinguish them from freestanding 
tribal FQHCs that are currently being paid the lesser of their charges 
or the adjusted national FQHC PPS rate, and from provider-based tribal 
clinics that may have begun operations subsequent to April 7, 2000. 
Currently, there are 7 ``grandfathered tribal FQHCs''.
    Under the authority in section 1834(o) of the Act to include 
adjustments determined appropriate by the Secretary, we revised 
Sec. Sec.  405.2462 and 405.2464 to pay these grandfathered tribal 
FQHCs on the Medicare outpatient per visit rate as set annually by the 
IHS, that is, the AIR and not the FQHC PPS payment rates (80 FR 71089). 
Payment rates for outpatient medical care (also referred to as 
outpatient hospital services) furnished by the IHS and tribal 
facilities is set annually by the IHS under the authority of sections 
321(a) and 322(b) of the Public Health Service Act (the PHS Act) (42 
U.S.C. 248 and 249(b)) (Pub. L. 83-568 (42 U.S.C. 2001(a)), and the 
IHCIA, based on the previous year cost reports from Federal and tribal 
hospitals. The outpatient per visit rate is only applicable for those 
IHS or tribal facilities that meet the definition of a provider-based 
department as described at Sec.  413.65(m), or a ``grandfathered'' 
tribal FQHC as described at Sec.  405.2462(d)(1). There is an 
outpatient per visit AIR for Medicare visits in Alaska and a separate 
outpatient per visit AIR for Medicare visits in the lower 48 States. 
For CY 2021, the outpatient per visit rate for Medicare visits in 
Alaska is $662 and $414 in the lower 48 States (85 FR 86940). There are 
no grandfathered tribal FQHCs in Alaska because the tribes operate the 
hospitals, not IHS. We note that IHS does not operate any hospitals or 
facilities in Hawaii or the territories, and thus, no rates are set in 
those localities.

[[Page 65213]]

    As we discussed in CY 2016 PFS final rule, the payment rate is not 
adjusted by the FQHC GAF; for new patients, annual wellness visits, or 
initial preventive physical examinations; or annually by the 
productivity-adjusted FQHC PPS market basket increase, as further 
adjustments would be unnecessary and/or duplicative of adjustments 
already made by IHS in deriving the rate. Comparatively, the FQHC PPS 
rate established by CMS is $176.45. The reimbursement is the lesser of 
the charges or the IHS AIR rate. We stated as part of the CY 2016 PFS 
final rule that we would monitor future costs and claims data of these 
tribal clinics and reconsider options as appropriate.
4. Paying all IHS- and Tribally-Operated Outpatient Clinics the AIR
    As we discussed in the CY 2022 PFS proposed rule (86 FR 39239), CMS 
established a Tribal Technical Advisory Group (TTAG) in 2004 to provide 
advice and input to CMS on policy and program issues impacting AI/AN 
populations served by CMS programs. Although not a substitute for 
formal consultation with Tribal leaders, the TTAG enhances the 
government-to-government relationship and improves increased 
understanding between CMS and Tribes. The TTAG has subject specific 
subcommittees that meet on a regular basis in order to be more 
effective and perform in-depth analysis of Medicare, Medicaid, CHIP, 
and the Health Insurance Marketplace policies that have Tribal 
implications. The TTAG is comprised of 17 representatives: An elected 
Tribal leader, or an appointed representative from each of the 12 
geographic areas of the IHS delivery system and a representative from 
each of the national Indian organizations headquartered in Washington, 
DC--the National Indian Health Board, the National Congress of American 
Indians, and the Tribal Self-Governance Advisory Group. Section 
5006(e)(1) of the American Recovery and Reinvestment Act of 2009, which 
became effective July 1, 2009, mandates that TTAG shall be maintained 
within CMS and added two new representative's positions: A 
representative and alternate from a national urban Indian health 
organization (National Council of Urban Indian Health); and a 
representative and alternate from the IHS.
    In the CY 2022 PFS proposed rule (86 FR 39239), we stated that the 
TTAG has requested \74\ that CMS amend its Medicare regulations to make 
all IHS and tribally-operated outpatient facilities eligible for 
payment at the IHS Medicare outpatient per visit rate/AIR. The TTAG 
explained that outpatient clinics, which are otherwise similar to 
grandfathered tribal FQHCs, are paid at different rates depending upon 
whether they meet the requirements as a ``provider based facility,'' a 
``grandfathered tribal FQHC,'' a non-grandfathered tribal FQHC, or none 
of the above. They believe that the rates vary based on the Medicare 
regulatory definition, rather than the actual costs of the outpatient 
clinic. There are varying payment differentials among Medicare enrolled 
providers and suppliers under the authorities of the SSA. For example, 
ASCs are paid differently than HOPDs; which are paid differently 
whether they are under the under the outpatient prospective payments 
system or a located in a critical access hospital.
---------------------------------------------------------------------------

    \74\ https://www.nihb.org/tribalhealthreform/wp-content/uploads/2020/06/TTAG-letter-to-CMS-requesting-IHS-rate-for-all-tribal-clinics-06.10.2020.pdf.
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    The TTAG also questioned the need for grandfathered tribal FQHCs to 
file cost reports. Specifically, the TTAG stated that the FQHC cost 
reports have no relationship to the IHS Medicare outpatient per visit 
rate/AIR paid to grandfathered tribal FQHCs, as they use hospital cost 
reports in setting the rate. Therefore, they stated, the FQHCs should 
only need to file a cost report to the extent necessary to support 
payment for non-FQHC services that are reimbursed outside the Medicare 
outpatient per visit rate/AIR. We noted that under section 1815(a) of 
the Act, providers participating in the Medicare program are required 
to submit financial and statistical information to achieve settlement 
of costs relating to health care services rendered to Medicare 
beneficiaries. Under the FQHC PPS, Medicare payment for FQHC services 
is the lesser of the FQHC PPS rate or the charges on the claim. In the 
establishment of the FQHC PPS, the statute does not exempt FQHCs from 
submitting cost reports. In addition, Medicare payments for the 
reasonable costs of the influenza and pneumococcal vaccines and their 
administration, allowable graduate medical education costs, and bad 
debts are determined and paid through the cost report. The FQHC market 
basket also uses information from the FQHC cost report to determine the 
cost share weights, which reflect the relative costs of input expenses 
that FQHCs face in order to provide FQHC services. Having a full 
picture of the costs of providing care by grandfathered FQHCs is 
important so that CMS can be sure that payments are adequate.
5. Solicitation for Input and Comment
    In the CY 2022 PFS proposed rule (86 FR 39240), we expressed 
appreciation for the TTAG's concerns with ensuring that CMS make 
appropriate payments among the clinics for similar services and the 
impact this has on tribal Medicare beneficiaries and ensuring that 
access to healthcare is available and equitable and we take these 
concerns seriously, but noted that we had insufficient information 
necessary to evaluate the costs and benefits of potential changes to 
these policies. Therefore, we solicited comments on the TTAG's request 
for CMS to amend its Medicare regulations to make all IHS- and 
tribally-operated outpatient facilities/clinics eligible for payment at 
the Medicare outpatient per visit rate/AIR, regardless of whether they 
were owned, operated, or leased by IHS.
    We solicited information on the kinds of and number of facilities 
or clinics that could potentially enroll in Medicare as an FQHC, or are 
already an FQHC paid under the FQHC PPS, and if these clinics are 
freestanding or provider-based to expand on information provided by the 
IHS Profile.
    We solicited information regarding the relative operating costs of 
IHS- and tribally-operated outpatient clinics compared to non-tribal 
FQHCs, stakeholder feedback and supporting evidence to address whether 
or why payment set at the IHS AIR would be more appropriate than 
payment rate under the FQHC PPS.
    Further, we solicited comment on how the IHS AIR, which is based 
upon a limited number of hospital cost reports, relates to costs in 
such clinics and the kinds of services that the clinics furnish.
    Finally, we solicited comment on the concerns that the AI/AN 
community may have on issues regarding access or inequity care in 
situations where a payment differential exists.
    We noted that although we have information on grandfathered tribal 
FQHCs and the outpatient hospital cost reports, we did not have any 
information specific to the composition of IHS and tribal facilities. 
For example, if the facility is not enrolled in Medicare as an FQHC or 
is not provider based to a hospital, is it a physician practice? It 
would be helpful to know how the facilities are organized and related. 
Are there other options for enrolling as different types of providers 
or suppliers?
    As increasing the rate would increase payments from the Medicare 
Trust

[[Page 65214]]

Fund, we also requested comment on the magnitude of that payment change 
and whether any program integrity concerns would be present with the 
increased payment.
    We also requested comments on FQHC services that are paid through 
the cost report, like influenza, pneumococcal, and COVID-19 
vaccinations and GME and how that impacts the request to not file cost 
reports.
    As stated previously, we believed that having a full picture of the 
costs of providing care was important to ensure adequate payments.
    We also solicited input on other potential uses of the adjustment 
authority under section 1834(o)(1)(A) of the Act which provides that 
the FQHC PPS may include adjustments determined appropriate by the 
Secretary. For example, should we consider TTAG's request on the 
expansion of the payment policy finalized in the CY 2016 PFS final rule 
for grandfathered tribal FQHCs to all Tribally-operated outpatient 
clinics. Alternatively, should we develop a payment adjustment 
applicable to IHS- and tribally-operated outpatient clinics based on 
the cost differential reported in their cost reports when compared to 
non-IHS outpatient clinics, or non-provider-based clinics, if such 
differentials exist and would be interested in specific comments about 
appropriate adjustments to the FQHC PPS rate for clinics that are 
enrolled as FQHCs.
    Finally, we requested information on other potential ways to 
determine whether the costs associated with furnishing services to AI/
AN are uniquely greater than other clinics within the confines of the 
FQHC PPS outlined in section 1834(o)(1) of the Act.
    We received several comments on these questions. Below, we provide 
a summary of the comments we received and our response.
    Comment: Commenters stated CMS should exercise its authority to 
authorize all IHS clinics to bill at the same IHS AIR as a matter of 
health equity. One commenter noted it is of particular importance in 
fulfilling the Indian Self-Determination education Assistance Act 
(ISDEAA) and preventing Tribes from being penalized for having assumed 
control over their own clinics. Several commenters stated that there is 
an equity issue when a facility's Medicare designation determines the 
rate they will be reimbursed as IHS clinics are heavily reliant on 
third-party reimbursements to fund operations. Commenters also noted 
that the request for information regarding the make-up, structure, and 
costs of IHS/Tribal clinics needed to evaluate the costs and benefits 
of potential changes to Medicare policies was irrelevant to the issue. 
Commenters did not agree that billing as an FQHC is the only or best 
solution, especially since so few clinics elect to enroll as an FQHC 
due to the burden of submitting cost reports, and suggested changes to 
the tribal provider-based rules at Sec.  413.65(m) and an umbrella rule 
providing that all outpatient Indian health programs qualify for 
reimbursement at the AIR regardless of how they are enrolled in 
Medicare. Commenters also proposed changes that would amend 42 CFR part 
405. In addition, one commenter stated that allowing all Indian health 
clinics to bill at the IHS AIR would have zero impact on program 
integrity, especially since the IHS AIR is already available to some 
Tribal clinics.
    Response: Although we did not receive specific information on costs 
or specific types of clinics, we will consider the commenters' requests 
for CMS to amend its Medicare regulations to make all IHS- and 
tribally-operated outpatient facilities/clinics eligible for payment at 
the Medicare outpatient per visit rate/AIR, regardless of whether they 
were owned, operated, or leased by IHS. We understand the commenters' 
concerns and note that commenters do not agree that wholesale 
enrollment as Medicare FQHCs is the preferred outcome. We would like to 
continue these discussions to evaluate the impact of the commenters' 
proposed changes to the current Medicare payment policies and will 
consider these recommendations for future rulemaking.

D. Requiring Certain Manufacturers To Report Drug Pricing Information 
for Part B and Determination of ASP for Certain Self-Administered Drug 
Products

1. Requiring Certain Manufacturers To Report Drug Pricing Information 
for Part B (Sec. Sec.  414.802 and 414.806)
a. Overview and Summary
    Section 1927(b)(3)(A)(iii)(I) of the Act requires manufacturers 
with a Medicaid drug rebate agreement to report Average Sales Price 
(ASP) data as specified in section 1847A of the Act. Some manufacturers 
without Medicaid drug rebate agreements voluntarily submit ASP data for 
their single source drugs or biologicals that are payable under Part B; 
however, other manufacturers without Medicaid drug rebate agreements do 
not voluntarily submit such data. Without manufacturer reported ASP 
data, CMS cannot calculate the ASP payment limit, and consequently, 
payment is typically based on Wholesale Acquisition Cost (WAC).
    Consistent with section 1847A(c)(3) of the Act and our regulations 
at Sec.  414.804(a)(2), the ASP is net of price concessions. However, 
consistent with the definition of WAC at section 1847A(c)(6)(B) of the 
Act, the WAC is not net of price concessions, and thus is nearly 
always, and sometimes significantly, higher than ASP. Drugs with 
payment allowances based on WAC may have greater ``spreads'' between 
acquisition costs and payment than drugs for which there is an ASP-
based payment allowance, which, in turn, may: (1) Incent the use of the 
drug based on its spread rather than on purely clinical considerations; 
(2) result in increased payments under Medicare Part B; and (3) 
increase beneficiary cost sharing.
    Section 401 of Division CC, Title IV of the CAA, 2021 (for the 
purposes of this section of this proposed rule, hereinafter is referred 
to as ``section 401'') amended section 1847A of the Act to add new 
section 1847A(f)(2) of the Act, which requires manufacturers without a 
Medicaid drug rebate agreement to report ASP information to CMS for 
calendar quarters beginning on January 1, 2022, for drugs or 
biologicals payable under Medicare Part B and described in sections 
1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of the Act, including 
items, services, supplies, and products that are payable under Part B 
as a drug or biological. Section 401(b)(2) also amended section 
1847A(c)(6)(A) of the Act to permit the Secretary to exclude 
repackagers \75\ from the definition of ``manufacturer'' for purposes 
of the ASP reporting requirement in section 1847A(f)(2) of

[[Page 65215]]

the Act, if the Secretary determines appropriate.
---------------------------------------------------------------------------

    \75\ The FDA has defined ``repackag[ing],'' for purposes of drug 
establishment registration, as ``the act of taking a finished drug 
product or unfinished drug from the container in which it was placed 
in commercial distribution and placing it into a different container 
without manipulating, changing, or affecting the composition or 
formulation of the drug.'' 21 CFR 207.1. The FDA has defined 
``repack[ager]'' for purposes of drug establishment registration as 
the person who owns or operates an establishment that repacks a drug 
or drug package.'' Id. For more information about repackaging, 
please see FDA guidance documents, including a January 2017 Guidance 
for Industry titled, ``Repackaging of Certain Human Drug Products by 
Pharmacies and Outsourcing Facilities,'' available at https://www.fda.gov/media/90978/download and the FDA's January 2018 Guidance 
for Industry titled, ``Mixing, Diluting, or Repackaging Biological 
Products Outside the Scope of an Approved Biologics License 
Application,'' available at https://www.fda.gov/files/drugs/
published/Mixing_Diluting-or-Repackaging-Biological-Products-
Outside-the-Scope-of-an-Approved-Biologics-License-Application.pdf.
---------------------------------------------------------------------------

    Section 401(b)(1) also adds provisions to section 1847A of the Act 
addressing confidentiality, audit and verification provisions; civil 
money penalties for misrepresentation, late reporting, and reporting of 
false information; and increasing oversight and enforcement provisions. 
These provisions largely track the statutory provisions in section 
1927(b) of the Act that apply to the reporting of ASP by manufacturers 
with Medicaid drug rebate agreements. Additionally, section 401(d) 
requires HHS Office of the Inspector General (OIG) to submit a report 
on the accuracy of ASP submissions to Congress by January 1, 2023.
    Finally, section 401 amended section 1927(b) of the Act to clarify 
that for Part B ASP reporting, drugs would include items, services, 
supplies, and products that are payable under Medicare Part B as a drug 
or biological.
    In the CY 2022 PFS proposed rule, we proposed regulatory changes to 
implement the new reporting requirements at 42 CFR, part 414, subpart 
J.
b. Reporting Requirements for Manufacturers Without a Medicaid Drug 
Rebate Agreement
    Starting with calendar quarters beginning on January 1, 2022, 
manufacturers will be required to report ASP for drugs and biologicals 
payable under Medicare Part B consistent with the statutory 
requirements of section 1847A(f) of the Act, regardless of whether they 
have Medicaid drug rebate agreements. Our existing regulations at 42 
CFR part 414, subpart J implement the ASP reporting requirements 
referenced in section 1847A(f)(1) of the Act, that is, the requirements 
of section 1927(b)(3) of the Act. Thus, the existing regulations at 
subpart J already set forth requirements for manufacturers with 
Medicaid drug rebate agreements to report their ASP information (and if 
required to make payment, WAC) each quarter.
    Many manufacturers without Medicaid drug rebate agreements 
voluntarily submit ASP data consistent with these requirements. Whether 
obligated to report or voluntarily reporting, manufacturers are 
accustomed to the existing regulatory requirements at subpart J, and 
indeed, the methodology for reporting ASP reflected in these 
regulations does not currently distinguish between manufacturers with 
Medicaid drug rebate agreements and those without these agreements.
    Because new section 1847A(f)(2) of the Act, as noted previously, 
largely parallels section 1927(b)(3) of the Act, and thus both 
manufacturers with Medicaid drug rebate agreements, as well as those 
without such agreements, will be subject to requirements already 
reflected in the existing regulations at subpart J, we did not believe 
it was necessary to propose substantial changes to the regulation text. 
For these reasons, our proposal to amend the regulations to reflect the 
new requirements of section 1847A(f)(2) of the Act sought to preserve 
the status quo to the extent possible.
c. Definitions
    As noted previously, the new section 1847A(f)(2) of the Act, as 
added by section 401(a), requires manufacturers without a Medicaid drug 
rebate agreement to report ASP information to CMS for calendar quarters 
beginning on January 1, 2022 for drugs or biologicals payable under 
Medicare Part B and described in sections 1842(o)(1)(C), (E), or (G) or 
1881(b)(14)(B) of the Act, including items, services, supplies, and 
products that are payable under Part B as a drug or biological. Section 
401 also made a conforming amendment to the ASP reporting requirements 
applicable to manufacturers with Medicaid drug rebate agreements at 
section 1927(b)(3)(A)(iii) of the Act to specify that those reporting 
requirements also apply to items, services, supplies, and products that 
are payable under Part B as a drug or biological.
    To implement this change, we proposed to amend the definition of 
the term ``drug'' at Sec.  414.802 to mean a drug or biological, and 
includes an item, service, supply, or product that is payable under 
Medicare Part B as a drug or biological.
    We received public comments on amending the definition of the term 
``drug'' at Sec.  414.802 to mean a drug or biological, and includes an 
item, service, supply, or product that is payable under Medicare Part B 
as a drug or biological. The following is a summary of the comments we 
received and our responses.
    Comment: Some commenters suggested that CMS provide more clarity or 
be more specific in the definition of the term ``drug'' to further 
describe which products, or groups of products, are subject to 
requirement in section 401.
    Response: We disagree that further clarification is needed for this 
definition. The requirements in section 401 apply to drugs or 
biologicals described in section 1842(o)(1)(C), (E), or (G) of the Act 
or section 1881(b)(14)(B) of the Act, including items, services, 
supplies, or products that are payable under [Medicare Part B] as a 
drug or biological. That is, if a particular item, service, supply, or 
product of any kind, is payable as a drug or biological under Part B, 
then it is subject to the ASP reporting requirements.
    Comment: One commenter requested that CMS confirm that 
radiopharmaceuticals that do not currently report ASPs will be excluded 
from this proposal. The commenter stated that ASPs are not currently 
reported for all radiopharmaceuticals, and requiring ASP reporting for 
all radiopharmaceuticals will require CMS to clarify how ASPs should be 
calculated under circumstances that are unique to radiopharmaceuticals. 
For these reasons, the commenter suggested that any proposal that 
requires ASP reporting for all radiopharmaceuticals should be delayed 
to allow CMS to provide sufficient information to radiopharmaceutical 
manufacturers to allow for accurate ASP reporting, and to allow 
radiopharmaceutical manufacturers to prepare.
    Response: Consistent with section 303(h) of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) 
(Pub. L. 108-173, December 8, 2003), radiopharmaceuticals are not paid 
under section 1847A of the Act. Section 401 requires manufacturers 
without Medicaid drug rebate agreements to report ASP to the same 
extent that manufacturers with Medicaid drug rebate agreements must do. 
It does not change the scope of drugs and biologicals for which ASP 
must be reported other than to clarify that the ASP reporting 
requirements apply to items, services, supplies, and products that are 
payable under Part B as a drug or biological and are described in 
section 1842(o)(1)(C), (E) of the Act, or (G) or 1881(b)(14)(B) of the 
Act.
    Comment: One commenter generally expressed support of the proposal 
to modify the definition of ``drug'' at Sec.  414.802 to include any 
item, service, supply or product that is payable under Part B as a drug 
or biological.
    Response: We thank the commenter for their feedback.
    After consideration of public comments, we are finalizing the 
definition of the term ``drug'' at Sec.  414.802 as proposed.
    Section 1847A(c)(6)(A) of the Act incorporates the definition of 
manufacturer at section 1927(k)(5) of the Act, except that section 
401(b)(2) permits the Secretary to exempt repackagers from the 
definition of

[[Page 65216]]

manufacturer, as determined appropriate, for purposes of section 
1847A(f)(2) of the Act. However, no such exemption is provided for 
manufacturers with Medicaid drug rebate agreements (see the definition 
of manufacturer at Sec.  447.502). Consequently, the current ASP data 
reporting includes submissions by repackagers.
    In the CY 2022 PFS proposed rule (86 FR 39241 through 39242), we 
discussed Medicare Payment Advisory Commission's (MedPAC's) assertion 
in their June 2017 report (available at http://medpac.gov/docs/default-source/reports/jun17_ch2.pdf) that many repackagers currently do not 
report ASP data. We explained that we conducted an analysis to estimate 
the proportion of repackaged products in our existing ASP data because 
we believed it could inform our consideration of whether we should 
propose to exclude repackagers from the definition of manufacturers for 
purposes of section 1847A(f)(2) of the Act. If our existing ASP data do 
not contain an appreciable proportion of repackaged products, it may be 
appropriate to exclude repackagers from the definition of manufacturer 
for this limited purpose. However, if repackaged products comprise an 
appreciable proportion of our existing ASP data, we would reasonably 
anticipate this trend to follow under the new requirements, and in such 
a scenario, it would not be appropriate to exclude repackagers from the 
definition of manufacturer for purposes of section 1847A(f)(2) of the 
Act because excluding their sales could distort the ASP.
    To effectuate this analysis, we obtained a list of National Drug 
Codes (NDCs) of repackaged drugs from the United States Food and Drug 
Administration (FDA).\76\ We also obtained a list of labeler codes for 
which the manufacturers have Medicaid drug rebate agreements.\77\ We 
then performed a crosswalk both of these to our composite file of ASP 
data submissions to segregate our composite file of ASP data 
submissions into four categories:
---------------------------------------------------------------------------

    \76\ https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory. We note that this list only includes 
prescription drugs approved under a New Drug Application (NDA) or 
Abbreviated NDA (ANDA) and does not include biological products 
approved under a Biologics License Application (BLA) or devices.
    \77\ https://data.medicaid.gov/Uncategorized/Drug-Manufacturer-Contacts/uex2-n56q/data. This link has all labeler codes with 
effective date and termination date, if applicable. If there is a 
termination date, the code was not active as of that date.
---------------------------------------------------------------------------

    (1) Repackaged products for which ASP data submissions were 
required (that is, manufacturers with Medicaid drug rebate agreements);
    (2) Repackaged products for which ASP data submissions were 
voluntary (that is, for manufacturers without Medicaid drug rebate 
agreements);
    (3) Non-repackaged products for which ASP data submissions were 
required; and
    (4) Non-repackaged products for which ASP data submissions were 
voluntary.
    We estimated that, of all 6319 products for which we currently 
receive ASP data submissions (the sum of categories (1) through (4) 
above), repackaged products accounted for 271 (4.29 percent) of these 
products. Additionally, repackaged products accounted for 137 (2.51 
percent of) products for which ASP data submissions were required, and 
134 (15.23 percent of) products for which ASP data were voluntarily 
submitted.
    Additionally, we conducted another analysis to estimate: (1) The 
number of new ASP submissions we can expect as a result of the new 
requirements under section 401; and (2) the proportion of those 
submissions that involve repackaged products. To effectuate this 
analysis, we obtained a crosswalk of NDCs and Healthcare Common 
Procedure Coding System (HCPCS) codes that includes the NDCs and HCPCS 
codes of items for which ASP reporting is not currently required.\78\ 
We supplemented this crosswalk by adding HCPCS codes with NDCs that are 
payable under Part B, but not already reflected in the crosswalk.\79\ 
We then identified \80\ and removed from the crosswalk all of the 
products contained in our composite file of ASP data submissions and 
those HCPCS codes that are non-covered under Medicare Part B. Adding 
the results of this analysis to the results of categories two and four 
from the prior analysis (that is, repackaged and non-repackaged 
products for which ASP submissions were voluntary), we estimated there 
will be 6,994 total products for which manufacturers will now be 
required to submit ASP data. We then compared this number to FDA's list 
of repackaged products in the previous analysis, and found that of the 
6,994 products for which manufacturers will be required to submit ASP 
data, 223 (3.19 percent) are repackaged products. Further, we estimated 
6,114 products for which their manufacturers did not previously 
(voluntarily) submit ASP data and will now be required to do so under 
the new reporting requirements of section 401. Of these, 89 (1.46 
percent) are repackaged products.
---------------------------------------------------------------------------

    \78\ https://www.dmepdac.com/palmetto/PDACv2.nsf/DID/FFYLYC1WVL 
Accessed April 12, 2021, using the April 2021 files.
    \79\ We note that such products were spread across the second 
and fourth categories in the prior analysis.
    \80\ We used the April 2021 Alpha-Numeric HCPCS codes files 
available at https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update. We selected HCPCS codes 
with a coverage code of S (column AE), which indicates that the 
product is non-covered by the Medicare statute.
---------------------------------------------------------------------------

    These data did not persuade us that it was necessary to exempt 
repackagers from the new reporting requirements under section 401 at 
this time. Our current operational process to verify the accuracy of 
manufacturers' reported ASP data does not distinguish: (1) Products on 
the basis of repackaging; and (2) manufacturers who are required to 
report ASP data from those who do so voluntarily.
    Each month, we review ASP data submissions at the NDC level (and 
for products without NDCs, the manufacturer's product code). 
Previously, we have not required manufacturers to identify which 
products are repackaged as part of these submissions. Exempting 
repackagers from the new requirements of section 1847A(f)(2) of the Act 
would significantly increase our administrative burden because we would 
have to undergo an additional quality check for each NDC from a 
different database for which data are submitted as part of our 
operational process to verify the accuracy of manufacturers' reported 
ASP data. Moreover, for products without NDCs, our ability to determine 
if these products are repackaged (without manufacturer attestation) to 
that effect is significantly limited. Finally, any such attestation 
would require a data source for us to verify the accuracy of the 
attestation, and no such data source currently exists.
    These additional checks could, in turn, significantly increase the 
time it takes for us to calculate and display on our website the 
volume-weighted ASP payment limits. Additionally, we were concerned 
that exempting repackagers from the new reporting requirements could 
lead to a gap in ASP reporting, meaning that ASPs could be distorted to 
the extent that certain sales are carved out of the reporting 
requirement through the use of repackagers. Consequently, in order to 
maintain consistency and integrity of the ASP data for those 
manufacturers with and without Medicaid drug rebate agreements, we did 
not believe it was appropriate to exclude repackagers from the 
requirements of section 401 at this time. However, we stated that we 
may

[[Page 65217]]

propose to exempt repackagers in the future, if warranted.
    We solicited comment on this approach.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter suggested that CMS exclude repackagers from 
the proposed ASP reporting requirements. They stated that requiring all 
repackagers to report would likely be duplicative and increase the 
burden on all parties without providing tangible benefit. In addition, 
they stated that, generally, most reporting requirements are simply not 
applicable to repackagers, whose business is generally outside of the 
scope of the proposed requirements. They recommend repackagers who 
already report ASP data continue to do so, but that CMS not require 
repackagers, as a group, to be subject to the reporting requirements at 
this time.
    Response: We are not persuaded that repackagers should be excluded 
at this time. As previously stated in this section, in order to 
maintain consistency and integrity of the ASP data for those 
manufacturers with and without Medicaid drug rebate agreements, and for 
operational reasons, we do not believe it is appropriate to exclude 
repackagers from the ASP reporting requirements. If warranted, we could 
revisit this in future rulemaking.
    Comment: One commenter concluded that CMS' analysis and proposal 
not to exclude repackagers without a rebate agreement from reporting 
ASP data is reasonable. The commenter stated that given that 
repackagers with a rebate agreement are required to report ASP data, it 
is reasonable not to exclude repackagers without a rebate agreement 
from the requirements of section 401. They added that having ASP data 
from repackagers with and without rebate agreements could also permit 
future analysis of the effect of repackagers' ASP submissions on 
Medicare Part B payment rates.
    Response: We agree it is reasonable not to exclude repackagers 
without a Medicaid drug rebate agreement and thank the commenter for 
their feedback.
    After consideration of public comments, we are not excluding 
repackagers from the definition of manufacturers for purposes of 
section 1847A(f)(2) of the Act.
    In summary, we proposed to modify the definition of drug at Sec.  
414.802 to include any item, service, supply or product that is payable 
under Part B as a drug or biological. We did not propose to exclude 
repackagers from the definition of manufacturer for purposes of the 
reporting requirements at section 1847A(f)(2) of the Act and are 
finalizing the definition of drug at Sec.  414.802 as proposed.
d. Civil Money Penalties
    As amended by section 401(b), section 1847A(d)(4)(A) of the Act 
specifies the penalties associated with misrepresentations in the 
reporting of the manufacturer's ASP for a drug or biological. 
Consistent with our existing regulation at Sec.  414.806, if the 
Secretary determines that a manufacturer has made a misrepresentation 
in the reporting of ASP data, a civil money penalty in an amount of up 
to $10,000 may be applied for each price misrepresentation and for each 
day in which the price misrepresentation was applied.
    New sections 1847A(d)(4)(B) and (C) of the Act, as added by section 
401(b), apply civil money penalties for failure to report timely and 
accurate ASP data for manufacturers without Medicaid drug rebate 
agreements, consistent with the civil money penalties found at sections 
1927(b)(3)(C)(i) and (ii) of the Act for manufacturers with Medicaid 
drug rebate agreements. Our current regulations at Sec.  414.806 refer 
to section 1927(b)(3)(C) of the Act, as amended by section 303(i)(4) of 
the MMA, as specifying the penalties associated with a manufacturer's 
failure to submit timely information or the submission of false 
information.
    We proposed to amend Sec.  414.806 to reflect the new provisions 
specifying penalties for manufacturers without Medicaid drug rebate 
agreements and to provide some technical changes to streamline the 
regulations text. Specifically, we proposed to do the following:
     Add paragraph (a), labeled as ``Misrepresentation'', 
moving the existing regulatory language at Sec.  414.806 specific to 
misrepresentation to this paragraph;
     Remove the sentence which reads, ``If the Secretary 
determines that a manufacturer has made a misrepresentation in the 
reporting of ASP data, a civil money penalty in an amount of up to 
$10,000 may be applied for each price misrepresentation and for each 
day in which the price misrepresentation was applied,'' since the 
previous sentence in the regulations text already references the 
statutory provision for this language;
     Add paragraph (b), labeled as ``Failure to provide timely 
information or the submission of false information'';
     Add paragraph (b)(1) to clarify that the existing language 
at Sec.  414.806 regarding civil money penalties for failure to submit 
timely information or for the submission of false information applies 
to manufacturers with a Medicaid drug rebate agreement;
     Remove the phrase ``as amended by section 303(i)(4) of the 
MMA''; and
     Add paragraph (b)(2) to reflect new sections 
1847A(d)(4)(B) and (C) of the Act regarding civil money penalties for 
failure to submit timely information or for the submission of false 
information for manufacturers without a Medicaid drug rebate agreement.
    We welcomed comments on these proposals.
    We received one public comment on these proposals. The following is 
a summary of the comment we received and our response.
    Comment: One commenter stated that it fully supported CMS' proposed 
revisions to the regulations at Sec.  414.806 to mirror the enforcement 
provisions of the statute. In addition, the commenter expressed concern 
that the current civil monetary penalties may not sufficiently ensure 
that all manufacturers fully comply with the express requirements of 
the new ASP reporting provisions and suggested that CMS address other 
enforcement options it may use if manufacturers fail to comply with the 
ASP reporting requirements. Specifically, the commenter suggested that 
CMS could pursue action under the False Claims Act (31 U.S.C. 3729-
3733), elect to not reimburse certain products of a manufacturer that 
does not report ASP, or adopt alternative reimbursement schemes for 
certain products.
    Response: We appreciate the commenter's support in finalizing these 
proposals. We also appreciate the feedback regarding other methods of 
enforcement; however, these are outside the purview of codifying and 
implementing section 401.
    After consideration of public comments, we are finalizing 
amendments to Sec.  414.806 as proposed.
e. Summary of All Proposals
    In summary, to implement the new reporting requirements for 
manufacturers without Medicaid drug rebate agreements, we proposed to 
modify:
     The definition of drug at Sec.  414.802; and
     The regulations describing civil money penalties at Sec.  
414.806.
    We welcomed comments on these proposals.
    We received public comments on these proposals as described in 
sections (c) and (d) above. We received several comments of general 
support of section 401 implementation. The following is a

[[Page 65218]]

summary of these comments and our responses.
    Comment: Several commenters expressed general support of section 
401 and its implementation. They commended Congress and CMS for taking 
the necessary steps to resolve the inconsistent treatment of similarly 
situated products under the Medicare Part B program and support efforts 
to require manufacturers to provide CMS with regular and accurate ASP 
data for drugs and biological products payable under Medicare Part B as 
a means to ensure accurate payment.
    Response: We thank these commenters and appreciate their feedback. 
We also received several comments that were not specifically related to 
the proposals. The following is a summary of these comments and our 
responses.
    Comment: We received several comments requesting that CMS publish 
an ASP payment limit in the ASP Drug Pricing File for all billing and 
payment codes for which there are products reporting ASP data. These 
commenters stated that this would create a level field for all 
manufacturers, prevent overbilling to Medicare due to reimbursement 
based on WAC prices, decrease beneficiary financial responsibility, and 
ensure that clinicians select products based on clinical efficacy. 
Commenters also stated that CMS has lacked transparency by not 
publishing ASP payment limits for all billing and payment codes for 
which there are products reporting ASP data. They suggested that 
billing and payment codes with a published ASP payment limit have an 
advantage over those that do not and that providers are hesitant to 
prescribe products that do not appear on the ASP Drug Pricing File. In 
addition, one commenter suggested that if an ASP payment limit is not 
published in the ASP Drug Pricing File, then the Medicare payment 
should be based on invoice pricing only, rather than basing payment on 
the WAC. Two commenters suggested that CMS should expand the list of 
published ASP payment limits to include all items separately payable 
under Part B as done in Addendum B for the hospital outpatient setting.
    Response: Section 401 does not address the ASP Drug Pricing File, 
nor does it specify which products should be published on the file, and 
the proposed rule did not include any proposals pertaining to the ASP 
Drug Pricing File. CMS does not publish an ASP payment limit or 
crosswalk for every product for which ASP data is reported.
    Similarly, section 401 does not address MACs' discretion to use 
WAC-based pricing or invoice pricing to determine payment amounts in 
the absence of a published ASP payment limit, and the proposed rule did 
not include any proposals pertaining to this discretion.
    Comment: Some commenters recommended that CMS address the proper 
treatment of lagged price concessions in the ASP for products that are 
newly reporting ASP and that CMS confirm that manufacturers submitting 
ASP data for the first time are estimating the price concessions based 
on the most recent 12-month period for which data is available.
    Response: Manufacturers that are newly reporting ASP data to CMS 
must do so in the same manner as those who are already reporting ASP 
data.
    Specific information about calculating and reporting lagged price 
concessions is available in the December 1, 2006 Federal Register (71 
FR 69666), the September 16, 2004 Federal Register (69 FR 55763), and 
the regulation text at Sec.  414.804(a)(3).
    Comment: A few commenters requested that CMS consider deferring the 
implementation of this requirement to provide more specific guidance 
for manufacturers newly reporting ASP data.
    Response: Section 401 requires manufacturers without a Medicaid 
drug rebate agreement to report ASP information to CMS for calendar 
quarters beginning on January 1, 2022, for drugs or biologicals payable 
under Medicare Part B and described in sections 1842(o)(1)(C), (E), or 
(G) or 1881(b)(14)(B) of the Act, including items, services, supplies, 
and products that are payable under Part B as a drug or biological. CMS 
does not have the authority to defer the statutory implementation date.
    Comment: One commenter suggested that manufacturers should disclose 
actual material and production costs to regulators, as well as research 
and development costs contributing to a drug's pricing.
    Response: We thank the commenter for their feedback; however, 
manufacturers' reporting of actual material, production, research, and 
development costs are outside the scope of this rule.
    After consideration of public comments, we are finalizing these 
proposals as proposed.
2. Determination of ASP for Certain Self-administered Drug Products 
(Sec.  414.904)
a. Background
    Drugs and biologicals payable under Medicare Part B fall into three 
general categories: those furnished incident to a physician's services 
(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(s)(6) of the Act), and others as 
specified by statute (for example, certain vaccines described in 
sections 1861(10)(A) and (B) of the Act). Payment limits for most drugs 
and biologicals 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 ASP plus a statutorily mandated 6 percent add-
on. Most drugs payable under Part B are paid under the ``incident to'' 
benefit under section 1861(s)(2) of the Act, which includes drugs and 
biologicals not usually self-administered by the patient.
    Paragraphs (4)(A) and (6) of sections 1847A(b) of the Act require 
that the Medicare Part B payment amount for a single-source drug or 
biological be determined using all of the NDCs assigned to it. Section 
1847A(b)(5) of the Act further states that the payment limit shall be 
determined without regard to any special packaging, labeling, or 
identifiers on the dosage form or product or package. In 2007, CMS 
issued a program instruction (available at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_annoucement.pdf), as permitted under section 
1847A(c)(5)(C) of the Act, stating that the payment limit for a single 
source drug or biological will be based on the pricing information for 
products produced or distributed under the applicable FDA approval 
(such as a New Drug Application (NDA) or Biologics License Application 
(BLA)). Therefore, all versions of a single source drug or biological 
product (or NDCs) marketed under the same FDA approval number (for 
example, NDA or BLA, including supplements) are considered the same 
drug or biological for purposes of payments made under section 1847A of 
the Act and are crosswalked to the same billing and payment code. This 
means that a self-administered version marketed under the same FDA 
approval is subject to the ASP reporting requirements and is not 
excluded from the payment limit calculation, even though Medicare does 
not make separate Part B payment for it. This is consistent with our 
longstanding policy on the scope of the ASP reporting

[[Page 65219]]

requirements. (Please see our final rule titled, ``Medicare Program; 
Revisions to Payment Policies, Five-Year Review of Work Relative Value 
Units, Changes to the Practice Expense Methodology Under the Physician 
Fee Schedule, and Other Changes to Payment Under Part B; Revisions to 
the Payment Policies of Ambulance Services Under the Fee Schedule for 
Ambulance Services; and Ambulance Inflation Factor Update for CY 
2007,'' published in the December 1, 2006 Federal Register (71 FR 
69675)). The price of a drug or biological product that may be 
administered by the patient (that is, self-administered) may differ 
from versions that are administered incident to a physician's service, 
which may affect the ASP-based payment limit for drug or biological 
product's billing and payment code.
    The HHS OIG conducted studies 81 82 of payment-limit 
calculations for certain drugs paid under section 1847A of the Act. The 
OIG identified two highly utilized biological products for which there 
are both Part-B-covered (versions administered incident to a 
physician's service) and non-covered versions (those identified to be 
self-administered) for which the NDCs were marketed under the same FDA 
approval number. OIG's studies found that when the ASPs of the self-
administered versions are included in the payment limit calculation, 
the resulting payment limit is substantially higher than if the ASPs of 
only the incident-to versions had been included.
---------------------------------------------------------------------------

    \81\ https://www.oig.hhs.gov/oei/reports/oei-12-17-00260.pdf, 
accessed March 15, 2021.
    \82\ https://www.oig.hhs.gov/oei/reports/OEI-BL-20-00100.pdf, 
accessed March 15, 2021.
---------------------------------------------------------------------------

    The OIG studies concluded that as a result, Medicare payment 
amounts were inflated, causing the program and its beneficiaries to pay 
an additional $366 million from 2014 through 2016 and $497 million from 
2017 through 2018. They recommended that legislative changes be made to 
provide CMS the flexibility to determine when certain versions of a 
drug identified to be self-administered should be included in ASP 
payment limit calculations.
    Section 405 of Division CC, Title IV of the CAA, 2021 (for the 
purposes of this section, referred to as ``section 405''), amended 
section 1847A of the Act by redesignating existing subsection (g) as 
subsection (h) and adding new subsection (g), which describes the 
Medicare Part B ASP payment-limit adjustment for certain drugs and 
biological products for which NDCs have been identified by the OIG to 
be self-administered and not covered under Medicare Part B. The new 
section 1847A(g)(1) of the Act directs OIG to conduct periodic studies 
to identify NDCs for drug or biological products that are identified to 
be self-administered for which payment may not be made under Part B 
pursuant to section 1861(s)(2) of the Act and that OIG determines 
should be excluded from the determination of the payment amount under 
section 1847A of the Act.
    New section 1847A(g)(2) of the Act specifies that if the OIG 
identifies an NDC under section 1847A(g)(1) of the Act, it must inform 
the Secretary at such times as the Secretary may specify. Then the 
Secretary shall, to the extent appropriate, apply as the payment limit 
for the applicable billing and payment code the lesser of: (1) The 
payment allowance that would be determined under section 1847A of the 
Act if the NDC for the identified drug or biological product were 
excluded from the calculation; or (2) the payment limit otherwise 
determined under section 1847A of the Act without application of 
section 1847A(g) of the Act. In other words, the Medicare payment limit 
for a drug or biological product's billing and payment code in these 
circumstances would be the lesser of the payment limit determined 
including the NDCs identified to be self-administered and the payment 
limit determined after excluding the NDCs identified to be self-
administered (hereinafter referred to as the ``lesser-of payment 
methodology'').
    Although section 1847A(g)(1) of the Act provides us with discretion 
in whether to apply the lesser-of methodology to billing and payment 
codes that include self-administered versions identified by the OIG 
(because we are directed to apply the methodology to the extent deemed 
appropriate), new section 1847A(g)(3) of the Act, requires the 
application of the lesser-of methodology to the two billing and payment 
codes identified in the OIG's July 2020 report titled, ``Loophole in 
Drug Payment Rule Continues To Cost Medicare and Beneficiaries Hundreds 
of Millions of Dollars,'' (available at https://oig.hhs.gov/oei/reports/OEI-BL-20-00100.asp) (hereinafter referred to as ``OIG's July 
2020 report'')) beginning July 1, 2021. To meet the implementation date 
required by this provision, we applied the lesser-of methodology to the 
payment limit calculations for the billing and payment codes 
representing Cimzia[supreg] (certolizumab pegol) and Orencia[supreg] 
(abatacept), details on these calculations are described in this 
section. In a memorandum providing supplemental information on the OIG 
July 2020 report, the OIG provided specific NDCs that the report 
identified: 00003-2188-11, 00003-2188-51, 00003-2814-11, 00003-2818-11, 
50474-0710-79, 50474-0710-81. The lesser-of methodology was applied to 
these billing and payment codes for the July 2021 ASP Drug Pricing 
Files and crosswalks along with program instructions in a change 
request (CR) at https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/2021-asp-drug-pricing-files.
    In the CY 2022 PFS proposed rule (86 FR 39244), we proposed to 
codify the new requirements of section 1847A(g) of the Act at Sec.  
414.904. Our proposals sought to specify when the application of the 
lesser-of methodology would be appropriate, describe how we would apply 
the lesser-of payment methodology to billing and payment codes that OIG 
has identified pursuant to studies described in section 1847A(g)(1) of 
the Act, and how to codify the approach we used for the certolizumab 
pegol and abatacept billing and payment codes.
b. Identification of Billing and Payment Codes to Which the Lesser-of 
Policy Will Be Applied
    As noted previously, section 1847A(g)(1) of the Act directs OIG to 
conduct periodic studies to identify NDCs for drug or biological 
products that are self-administered and for which payment is not made 
under Part B. Section 1847A(g)(2) of the Act specifies that if OIG 
makes an identification under section 1847A(g)(1) of the Act, OIG 
informs CMS at such times as we may specify, and in such an event, we 
apply the lesser-of methodology to the extent deemed appropriate. In 
the CY 2022 PFS proposed rule (86 FR 39244), we proposed that when the 
OIG conducts a periodic study, they would inform us at the time the 
study becomes publicly available. CMS would then obtain the NDCs 
identified by the OIG study described in section 1847A(g)(1) of the 
Act. However, if the specific NDCs were not available in the OIG study 
report, we would request OIG provide documentation of the identified 
NDCs to CMS.
    To allow operational time for assessment and application of the 
lesser-of methodology, we stated it was reasonable that the application 
of the lesser-of methodology be reflected beginning in the ASP pricing 
file two quarters following the OIG study publication. For example, if 
the OIG study became available to the public in the first quarter of 
the calendar year, the lesser-of methodology would be applied to the 
payment limit calculation of the applicable billing and payment code in 
the third quarter ASP pricing file (in

[[Page 65220]]

other words, the July ASP pricing file) and each quarter thereafter.
    We received public comments on the identification of billing and 
payment codes to which the lesser-of methodology will be applied. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters expressed concern regarding the OIG 
studies described in new section 1847A(g)(1) of the Act. Specifically, 
there is concern that neither CMS nor the OIG has specified details 
about future OIG studies, what criteria the OIG will use to initiate a 
study, how often such studies will be conducted, or if external 
stakeholders will be able to request a study. Commenters suggested that 
CMS offer a timeframe under which the OIG would be expected to produce 
such reports and work with the OIG to ensure transparency of factors 
used to determine which NDCs are considered ``self-administered'' and 
address study methodology. Another commenter urged the OIG to be 
thoughtful and transparent in the factors that it will use when 
determining which NDCs are ``self-administered.''
    Response: The proposed rule did not include any proposals 
pertaining to how, when, or under what conditions the OIG would produce 
study reports as described in section 1847A(g)(1) of the Act. The 
statute assigns to the OIG, and not to CMS, the determination of self-
administration for purposes of these studies, as well as study 
methodology.
    Comment: One commenter expressed concern that CMS does not 
specifically define the term ``self-administered'' for purposes of the 
lesser-of methodology. The commenter inquired whether CMS and/or the 
OIG will refer to contractor self-administered drug (SAD) lists to 
determine if a drug should be studied and the ``lesser-of'' methodology 
be applied and, if so, if the drug will have to be on all contractor 
SAD lists for the drug eligible for an OIG study.
    Response: Section 1847A(g)(1) of the Act states the Inspector 
General shall conduct periodic studies to identify which NDCs for drug 
or biological products are self-administered and should be excluded 
from the determination of the payment amount under this section. Such 
studies shall be based on the same or similar methodologies to the 
methodologies used in OIG's July 2020 report \83\ or in the November 
2017 final report of the Inspector General entitled ``Excluding 
Noncovered Versions When Setting Payment for Two Part B Drugs Would 
Have Resulted in Lower Drug Costs for Medicare and its Beneficiaries.'' 
\84\ Methodologies for these studies are described in detail in each 
report. As noted previously, the statute puts these determinations in 
the OIG's purview.
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    \83\ https://oig.hhs.gov/oei/reports/OEI-BL-20-00100.pdf; 
accessed September 22, 2021.
    \84\ https://www.oig.hhs.gov/oei/reports/oei-12-17-00260.pdf; 
accessed September 22, 2021.
---------------------------------------------------------------------------

c. Calculation of Payment Allowance Using the Lesser-of Payment 
Methodology
    Sections 1847A(g)(2) and (g)(3) of the Act set forth the lesser-of 
payment methodology for applicable billing and payment codes with NDCs 
for certain drug or biological products identified by the OIG as self-
administered products for which payment may not be made under this part 
because such products are not covered under section 1861(s)(2) of the 
Act. In the CY 2022 PFS proposed rule (86 FR 39244), we proposed to 
codify this methodology, which we currently use for the billing and 
payment codes that describe certolizumab pegol and abatacept, and which 
we also proposed to use for billing and payment codes for which OIG 
identifies a drug or biological product with NDCs identified to be 
self-administered as described in section 1847A(g)(1) of the Act.
    The ASP payment limit calculation is described in section 
1847A(b)(6) of the Act and codified at Sec.  414.904(b)(2)(ii) and 
(c)(2)(ii), which specifies that for a billing and payment code, the 
volume-weighted average of the ASPs reported by the manufacturer is 
determined by:
     Computing the sum of the products (for each NDC assigned 
to such drug products) of:
    ++ The manufacturer's ASP determined by the Secretary without 
dividing such price by the total number of billing units for the NDC 
for the billing and payment code; and
    ++ The total number of units sold; and
     Dividing the sum determined under (A) by the sum of by the 
sum of the products (for each NDC assigned to such drug products) of
    ++ The total number of units specified sold; and
    ++ The total number of billing units for the NDC for the billing 
and payment code.
    When applying the lesser-of methodology described in 1847A(g)(2) 
and (g)(3) of the Act, we proposed to make two calculations as 
described in section 1847A(b)(6) of the Act: (1) The ASP payment limit 
for the billing and payment code, excluding the NDCs that have been 
identified by the OIG study (that is, excluding the ASPs for those 
NDCs, as well as the units of such NDCs sold in the quarter); and (2) 
the ASP payment limit for the billing and payment code, including such 
NDCs' ASPs and units sold. The calculation resulting in the lower 
payment limit would be used as the payment limit for the applicable 
billing and payment code for that quarter's ASP pricing files. We 
proposed to apply the lesser-of methodology to the billing and payment 
codes containing OIG-identified products each quarter when determining 
ASP payment limits.
    New section 1847A(g) of the Act did not change ASP reporting 
requirements, and consistent with section 1847A(f)(1) of the Act and, 
beginning January 1, 2022, section 1847A(f)(2) of the Act, 
manufacturers must continue to report ASP data for all NDCs of the drug 
or biological product. Under new section 1847A(g) of the Act, ASP data 
for all NDCs under the same FDA approval application (for example, NDA 
or BLA, including any supplements) are required to carry out the 
lesser-of calculations for the purposes of determining the payment 
limit for the billing and payment code. Even if the resulting payment 
limit does not reflect the ASPs or units sold of self-administered 
versions of a product identified by the OIG, the manufacturer must 
continue to report those versions' ASPs and units sold to the 
Secretary.
    The implementation of the lesser-of methodology is not expected to 
be associated with substantial administrative costs and we incorporated 
the methodology in the current operational process used to determine 
ASP payment limits each quarter. The OIG found that Medicare and its 
beneficiaries would have saved a combined $497 million on certolizumab 
pegol and abatacept over 2 years (2017 through 2018) if such a 
methodology had been in place.
    We did not receive public comments on this provision, and 
therefore, we are finalizing as proposed.
d. Exceptions
    In the CY 2022 PFS proposed rule (86 FR 39245), we further proposed 
that the application of the lesser-of methodology was deemed 
appropriate in all cases in which OIG identifies a drug or biological 
product in a periodic study described in section 1847A(g)(1) of the Act 
and made publicly available, unless the drug or biological product is 
in short supply.\85\ As stated in the OIG's July

[[Page 65221]]

2020 report, CMS expressed concern about the potential impact on 
beneficiary access if certain versions identified to be self-
administered were excluded from the ASP payment limit calculation. 
Because of the potential for drug shortages that may affect patient 
care, beneficiary and provider access, and drug prices for providers, 
we will consider it not appropriate to apply the lesser-of methodology 
when a drug is in short supply. Similar to the average manufacturer 
price (AMP) price substitution provision in section 1847A(d)(3)(C) of 
the Act (codified in Sec.  [thinsp]414.904(d)(3)), we proposed to add 
Sec.  414.904(d)(4)(ii) to specify that we would not apply the lesser-
of methodology (that is, we would determine the payment allowance 
including all NDCs of the drug or biological product) if the drug and 
dosage form(s) represented by the billing and payment code are reported 
by the Drug Shortage list established under section 506E of the Federal 
Food, Drug, and Cosmetic Act (FFDCA) (Pub. L. 75-717) at the time that 
ASP payment limits are being finalized for the next quarter. However, 
we proposed that this exception to the application of the lesser-of 
methodology would not apply in the case of the billing and payment 
codes for certolizumab pegol and abatacept because section 1847A(g)(3) 
of the Act does not provide us with the same discretion as section 
1847A(g)(2) of the Act. Thus, for these applicable billing and payment 
codes we will always apply the lesser-of methodology. We recognized 
that NDCs identified by an OIG study described in section 1847A(g)(1) 
or (g)(3) of the Act may change. In the event that the manufacturer of 
an OIG-identified product simply redesignates the NDC for its product, 
we stated the new NDC also would meet the same criteria defined in the 
OIG study. In this circumstance, we expected that the product labeling 
would not contain substantial changes regarding the redesignated NDC. 
Therefore, we proposed to add Sec.  414.904(d)(4)(iv) to codify the 
application of the lesser-of methodology such that the manufacturer-
reported pricing data associated with redesignated NDCs would be used 
in the lesser-of methodology in the same way as the original OIG-
identified NDC.
---------------------------------------------------------------------------

    \85\ Our regulation at Sec.  414.904(d)(3)(ii)(C) in reference 
to AMP price substitution refers to drugs ``identified by FDA as 
being in short supply.'' The current AMP price substitution policy 
for shortages is consistent with the policy discussed here, as we 
interpret the phrase ``identified by FDA as being in short supply'' 
at Sec.  414.904(d)(3)(ii)(C) to mean the list in effect under 
section 506E of the Federal Food, Drug, and Cosmetic Act.
---------------------------------------------------------------------------

    Once an OIG study identifies self-administered versions of a drug 
or biological product, there may be subsequent FDA approvals of other 
products with the same active ingredient, such as new syringe sizes, 
new types of injector syringes, generic formulations, biosimilar 
biological products, or interchangeable biological products. For 
example, this would include the situation in which the current 
manufacturer of certolizumab pegol or abatacept obtains a supplemental 
FDA approval for a new version of the product. Similarly, this would 
also include the situation in which another manufacturer gains FDA 
approval of a product with the same active ingredient as an OIG-
identified self-administered version. We stated that we believe that 
provisions at new section 1847A(g) of the Act would require a new OIG 
study as described in section 1847A(g)(1) of the Act in order for us to 
apply the lesser-of methodology to the drug or biological product.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter expressed support of the proposal to not 
apply the lesser-of payment methodology to drugs or biological products 
for which there is a shortage. The commenter stated that ensuring 
patient access to needed medicines is critical both for individuals and 
for our health care system more broadly, and not applying the lesser-of 
payment methodology to products in short supply should help to improve 
access.
    Response: We appreciate the commenters feedback and agree that not 
applying the lesser-of methodology to products in short supply will 
help improve access.
    After consideration of public comments, we are finalizing Sec.  
414.904(d)(4)(ii) as proposed.
e. Summary
    In summary, to implement new section 1847A(g) of the Act, we 
proposed to:
     Add Sec.  414.904(d)(4) to codify the lesser-of payment 
methodology and define when the application of the lesser-of 
methodology would first be reflected in the ASP pricing file following 
the OIG study publication; and
     Describe the lesser of methodology at Sec.  
414.904(d)(4)(iv).
     Describe exceptions to application of the lesser-of 
methodology at Sec.  414.904(d)(4)(ii).
     Clarify application of the lesser-of methodology for 
billing and payment code described under section 1847A(g)(3) of the Act 
at Sec.  414.904(d)(4)(iii).
     Describe the application of the lesser-of methodology to 
redesignated NDCs of those identified in the OIG studies at Sec.  
414.904(d)(4)(v).
    We solicited comments on these proposals.
    We received other general comments on section 405. The following is 
a summary of the comments we received and our responses.
    Comment: One commenter stated that they oppose the application of 
the lesser-of methodology to certolizumab pegol and abatacept billing 
and payment codes as they may negatively impact patient access to the 
most appropriate treatment for their disease. They expressed that 
certain products with separate formulations, such as those administered 
by subcutaneous versus intravenous routes, are distinct with 
sufficiently unique indications, risks, and target patient populations. 
To make an appropriate medical decision, providers follow the standards 
of medical practice and incorporate the patient's unique medical 
history.
    The commenter disputed the OIG report's assertion that providers 
are monetarily incentivized to administer certolizumab pegol and 
abatacept over other therapies and stated that providers select the 
most appropriate treatment for their patients without any consideration 
of financial incentives. The commenter suggested that CMS not implement 
OIG's recommendation of excluding self-administered formulations of 
certolizumab pegol and abatacept from ASP payment limit calculations.
    Response: Section 1847A(g)(3) of the Act requires the application 
of the lesser-of methodology to certolizumab pegol and abatacept 
billing and payment codes. This section states that, for NDCs 
identified by OIG's July 2020 report, the lesser-of methodology shall 
be applied beginning July 1, 2021. As required by this statutory 
provision, we have implemented section 1847A(g)(3) of the Act as 
reflected in the July 2021 ASP Drug Pricing File and quarterly files 
thereafter (https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/2021-asp-drug-pricing-files).
    Comment: One commenter encouraged CMS to abandon the lesser-of 
methodology in favor of a model that works to provide appropriate 
reimbursement for all drugs. They suggested that CMS consider the 
alternative approaches that maintain balanced market incentives for 
competition among physician-administered drugs with the goal of 
protecting patient access.

[[Page 65222]]

    They stated that there is a need to broaden the current thinking 
beyond the studied ``loophole'' where the OIG finding is based on two 
specific drugs where the self-administered versions reported appear to 
increase the volume-weighted ASP creating a financial incentive for the 
use of these products while leading to increased cost and limiting 
access for patients. Likewise, there needs to be consideration that 
including non-covered NDCs may reduce the volume-weighted ASP leading 
to disincentives in the marketplace for those drugs and again impacting 
patient access. Furthermore, they stated that approval of same drug 
within one NDA or BLA versus multiple NDAs or BLAs should not lead to a 
different reimbursement paradigm for covered and non-covered drugs.
    Response: As stated in the previous response, section 1847A(g)(3) 
of the Act requires the application of the lesser-of methodology with 
respect to these drugs and does not give CMS the discretion to decline 
to apply it.
    As explained in the background section, paragraphs (4)(A) and (6) 
of sections 1847A(b) of the Act require that the Medicare Part B 
payment amount for a single-source drug or biological be determined 
using all of the NDCs assigned to it and section 1847A(b)(5) of the Act 
further states that the payment limit shall be determined without 
regard to any special packaging, labeling, or identifiers on the dosage 
form or product or package. In 2007, CMS issued a program instruction 
(available at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_annoucement.pdf), as permitted under section 
1847A(c)(5)(C) of the Act, stating that the payment limit for a single 
source drug or biological will be based on the pricing information for 
products produced or distributed under the applicable FDA approval 
(such as an NDA or BLA). Therefore, all versions of a single source 
drug or biological product (or NDCs) marketed under the same FDA 
approval number (for example, NDA or BLA, including supplements) are 
considered the same drug or biological, for payments made under section 
1847A of the Act and are crosswalked to the same billing and payment 
code.
    Comment: One commenter expressed general support of the proposal to 
utilize the lesser-of payment methodology for all self-administered 
NDCs identified by the future OIG studies. They stated that the lesser-
of methodology eliminates the potential for non-covered self-
administered forms of a product to inflate Medicare Part B payment 
rates and results in savings for beneficiaries and taxpayers.
    Response: We thank the commenter and appreciate their feedback.
    After consideration of public comments, we are finalizing these 
proposals as proposed.

E. Medicare Part B Payment for Drugs Approved Through the Pathway 
Established Under Section 505(b)(2) of the Federal Food, Drug, & 
Cosmetic Act

1. Background
    As we discussed in the CY 2022 PFS proposed rule (86 FR 39245 
through 39246), for most drugs that are payable under Medicare Part B, 
payment-limit amounts are determined using the methodology in section 
1847A of the Act. In many cases, the payment-limit amount is based on 
the ASP plus a statutorily mandated 6 percent add-on. Additionally, 
small molecule drugs payable under Medicare Part B using the 
methodology in section 1847A of the Act fall into two broad, mutually 
exclusive categories: (1) Multiple source drugs, and (2) single source 
drugs. These terms are defined in sections 1847A(c)(6)(C) and (D) of 
the Act, respectively.
    In most cases, the distinction between multiple source drugs and 
single source drugs is straightforward. We published program 
instructions in 2007 (available at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_annoucement.pdf) that address 
how these distinctions are made. However, a subset of drugs that are 
approved by the FDA under New Drug Applications (NDAs) are approved 
through the pathway established under section 505(b)(2) of the FFDCA 
(Pub. L. 75-717, June 25, 1938) (hereinafter referred to as ``section 
505(b)(2) drug products''). For section 505(b)(2) drug products, the 
distinction between multiple source drugs and single source drugs can 
be less straightforward.
    The drug approval pathway established under section 505(b)(2) of 
the FFDCA (hereinafter referred to as ``the section 505(b)(2) 
pathway'') provides an avenue for applications that contain full 
reports of investigations of safety and effectiveness, where at least 
some of the information needed for an approval comes from studies not 
conducted by or for the applicant, and for which the applicant has not 
obtained a ``right of reference or use'' \86\. An application submitted 
under the section 505(b)(2) pathway (hereinafter referred to as a 
``section 505(b)(2) application'') may rely either on the FDA's 
findings of safety, effectiveness, or both, for an already-FDA-approved 
drug product or on published literature, provided that: (1) Such 
reliance is scientifically justified, and (2) the section 505(b)(2) 
application complies with applicable statutory and regulatory 
requirements, including, but not limited to, patent certification, if 
appropriate. Unlike a generic drug product approved under an 
Abbreviated New Drug Application (ANDA), a section 505(b)(2) drug 
product is not required to have the same FDA-approved labeling as the 
labeling for the already-FDA-approved drug product(s) upon which the 
section 505(b)(2) application relied. (For more information, see the 
FDA's May 2019 guidance titled, ``Determining Whether to Submit an ANDA 
or a 505(b)(2) Application,'' available at https://www.fda.gov/media/124848/download.)
---------------------------------------------------------------------------

    \86\ Regulations at 21 CFR 314.3 define ``Right of Reference or 
Use'' to mean the authority to rely upon, and otherwise use, an 
investigation for the purpose of obtaining approval of an NDA, 
including the ability to make available the underlying raw data from 
the investigation for FDA audit, if necessary.
---------------------------------------------------------------------------

    We noted that the number of section 505(b)(2) drug products 
approved each year has been growing, from about 40 per year from 2011 
to 2016, to about 60 to 70 per year from 2017 to 2020. Approximately 10 
to 20 percent of these section 505(b)(2) drug products are payable 
under Medicare Part B. Of these, some section 505(b)(2) drug products 
share substantial portions of the FDA-approved labeling with the 
approved drug product(s) upon which the section 505(b)(2) application 
relied, for example prescribing information on safety, efficacy, and 
pharmacokinetics. In some cases, the section 505(b)(2) drug product 
even shares substantial portions of labeling with generic drug products 
that are payable under Part B as multiple source drugs. Medicare Part B 
claims data from 2020 indicate that spending for some of these section 
505(b)(2) drug products (that is, those that could be assigned to a 
multiple source drug code under the framework described below, but are 
instead currently assigned to a single source drug code) is 
substantially greater than that for the corresponding generic drug 
products assigned to a multiple source drug code. One example is a 
sterile injectable drug that was first approved as a lyophilized powder 
for reconstitution in a vial and later was approved through the section 
505(b)(2) pathway as a concentrated liquid in a vial. Another example 
is a drug available as a lyophilized powder for reconstitution in a 
vial that was then approved through the section 505(b)(2) pathway as a 
ready-to-use intravenous (IV) solution in a bag. Analysis of 2020

[[Page 65223]]

claims data for the separately coded section 505(b)(2) drug product 
(that is, the ready-to-use IV solution) shows that Medicare spending 
per service unit was approximately eight times that of the 
corresponding products in the multiple source drug code. Moreover, in 
the July 2021 ASP Pricing File (available at https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/2021-asp-drug-pricing-files), the payment limit for the section 505(b)(2) drug 
product is 17.2 times the payment limit for the multiple source code, 
when adjusted for the different dose descriptors of each code. In 
another example, there were approximately 7.54 million allowed service 
units, representing approximately $1.38 million of allowed charges, for 
a multiple source drug code, but for the separately coded section 
505(b)(2) drug product, over the same time-period there were 
approximately 1.08 million allowed service units, representing 
approximately $2.13 million in allowed charges. Calculating the allowed 
charges per allowed service unit, each service unit of the section 
505(b)(2) drug product cost Medicare 10.78 times that of the 
corresponding products assigned to the multiple source drug code, 
costing Medicare an additional $1.93 million. In the July 2021 ASP 
Pricing File, the payment limit for the section 505(b)(2) drug product 
is 21.3 times the payment limit for the multiple source code.
    In the CY 2022 PFS proposed rule (86 FR 39246) we indicated that 
based on these observed data points, we plan to perform additional 
analysis of spending on section 505(b)(2) drug products and potential 
savings to Medicare and Medicare beneficiaries that may be realized if 
certain section 505(b)(2) drug products were to be assigned to multiple 
source drug codes based on the framework described in section III.E.3 
of the proposed rule. The framework is also provided below in section 
III.E.3 of this final rule.
2. CY 2021 Proposal
    In the CY 2022 PFS proposed rule (86 FR 39246), we discussed that 
in the CY 2021 PFS proposed rule, we proposed to codify our long-
standing approach to determine whether a section 505(b)(2) drug product 
is described by an existing multiple source drug code, or if the 
section 505(b)(2) drug product would be assigned to a single source 
drug code. In that proposal, we explained generally how information 
about the section 505(b)(2) drug product's active ingredient(s), drug 
product name (this refers to nomenclature of the drug product as found 
in the United States Pharmacopeia--National Formulary (USP-NF) and 
nomenclature as found in title of the FDA-approved labeling), and 
description; labeling information; and ordering (prescribing) and 
clinical use would factor into a determination. Commenters on our 
proposal in the CY 2021 PFS proposed rule (primarily manufacturers) 
stated that the proposal conflicted with both the Medicare statute and 
the FDA's therapeutic equivalence (TE) ratings,87 88 and 
would impair access for patients, underpay providers, and stifle 
innovation. Several commenters from beneficiary advocate and provider 
organizations generally repeated the same points, although some 
commenters expressed support for curbing drug prices, particularly if 
the proposal did not affect patient access. Several commenters appeared 
to take a middle ground that conditionally supported the proposals, 
particularly if more detail could be provided and if effects on patient 
access were considered. Several commenters supported the proposals 
without conditions. Several commenters expressed that we should provide 
more detail about the decision framework and the determination process.
---------------------------------------------------------------------------

    \87\ As published in the FDA's ``Orange Book: Approved Drug 
Products with Therapeutic Equivalence Evaluations'' available at 
https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm.
    \88\ See also 21 CFR 314.3(b) for definitions of ``therapeutic 
equivalents'' and related terms, as well as https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface.
---------------------------------------------------------------------------

    Some commenters on the CY 2021 PFS proposed rule requested that we 
provide more details about the process by which certain section 
505(b)(2) drug products would be assigned to multiple source drug 
codes. Commenters requested that we include more detail on how factors 
described in the CY 2021 PFS proposal, (for example, differences in the 
active ingredient and labeling) may be interpreted and which drug 
products might be affected. Commenters also requested that we provide 
the public more time to assess a more detailed proposal, as well as an 
opportunity, such as through future rulemaking, for public input both 
on the proposal and on decisions about specific drug products.
    Several commenters stated that if we move forward with the CY 2021 
proposal, we should exclude products with ``meaningful differences'' 
from the policy and encouraged us to continue an approach ``that allows 
for innovation, competition, and ultimately more therapeutic choices 
for Medicare beneficiaries.'' We noted that we recognize some section 
505(b)(2) drug products have clear differences in factors such as 
safety, efficacy, or pharmacokinetics, which would not result in the 
assignment of the product to the existing multiple source drug code. We 
stated that the framework discussed in section III.E.3 of the CY 2022 
PFS proposed rule (86 FR 39247) would address situations in which a 
section 505(b)(2) drug product is not described by an existing multiple 
source drug code, and therefore, would not be assigned to the existing 
multiple source drug code.
    We explained in the CY 2022 PFS proposed rule (86 FR 39247) that in 
response to commenters' requesting more detail about our proposed 
approach and to delay finalizing a decision, we did not finalize our 
proposals in the CY 2021 PFS proposed rule regarding section 505(b)(2) 
drug products. We stated that the delay would allow time for CMS to 
further consider this issue. Therefore, as part of our further 
consideration, we solicited comment on a more detailed framework 
(hereinafter referred to as ``the framework'') for determining when a 
section 505(b)(2) drug product is a multiple source drug under section 
1847A(c)(6)(C) of the Act.
    The framework is consistent with program instruction published in 
2007, which addressed how we would assign ``single source drugs'' and 
``biological products'' using a multi-step process. However, this 
program instruction did not expressly address how we would assign 
multiple source drugs. The program instruction uses the term ``drug'' 
at the billing and payment code level when discussing single source 
drugs in the same way that the discussion in this preamble uses the 
term ``drug'' in reference to multiple source drugs. Development of 
standards for identifying multiple source drugs (that is, the 
framework) would add to the 2007 program instruction and provide detail 
about an approach to Medicare Part B payment for section 505(b)(2) drug 
products.
    We stated that the framework described in section III.E.3 in the CY 
2022 PFS proposed rule (86 FR 39247) aims to build off the current CMS 
policy for assigning drug products to billing and payment codes by 
describing detailed standards for determining whether a section 
505(b)(2) drug product corresponds to an existing multiple source drug 
code. While we did not propose to adopt the framework, we instead 
sought comment on the framework to inform future policy making.

[[Page 65224]]

3. The Framework
    As we described in the CY 2022 PFS proposed rule (86 FR 39247), the 
framework is a determination process to identify when section 505(b)(2) 
drug products without an FDA TE rating to an existing drug product 
payable under Part B correspond to an existing multiple source drug 
code for the purpose of payment under Medicare Part B. The framework 
would provide additional detail about the decision-making process and 
increase transparency about potential determinations resulting from the 
framework.
    The first portion of the framework would compare certain qualities 
of the section 505(b)(2) drug product with drug products already 
assigned to an existing multiple source drug code.\89\ This includes 
comparison of the: (1) Active ingredient(s); (2) dosage form (if part 
of the drug product name); (3) salt form; and (4) other ingredients in 
the drug product formulation. The drug product assessment could result 
in a match or non-match designation. Section 505(b)(2) drug products 
receiving a match designation in the first portion of the framework 
would continue to a verification step. This step would compare the 
pharmacokinetic and clinical studies of the section 505(b)(2) drug 
product's FDA-approved labeling with those of the drug products already 
assigned to an existing multiple source code. Finally, a determination 
would be made as to whether the section 505(b)(2) drug product could be 
assigned to the existing multiple source code.
---------------------------------------------------------------------------

    \89\ These assignments are published as part of the ASP NDC-
HCPCS Crosswalk Files available at https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/2021-asp-drug-pricing-files.
---------------------------------------------------------------------------

    For full details on the framework, please see https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.
    We solicited comment on the following:
     The framework and how it aligns with the statutory 
definitions of single source and multiple source drugs in section 
1847A(c)(6)(C) and (D) of the Act, respectively;
     How the framework distinguishes situations in which a 
section 505(b)(2) drug product is not described by an existing multiple 
source drug code; and
     The potential impacts of the framework on Medicare 
beneficiaries, the government, and other stakeholders.
    We received public comments on the framework, a determination 
process to identify when section 505(b)(2) drug products without an FDA 
TE rating to an existing drug product payable under Part B correspond 
to an existing multiple source drug code for the purpose of payment 
under Medicare Part B. The following is a summary of the comments we 
received and our response.
    Comment: Overall, we received 27 comments on the framework approach 
to assigning certain section 505(b)(2) drug products to existing 
multiple source codes. A majority of commenters were pharmaceutical 
manufacturers; other commenters included MedPAC, and professional 
associations representing stakeholder interests.
    We received 14 comments on the framework and how it aligns with the 
statutory definitions of single source and multiple source drugs. 
Several commenters noted that CMS lacks the statutory basis for the 
framework. The commenters stated that the framework does not align with 
the statutory definition for multiple source drug.
    We received six comments on how the framework distinguishes 
situations in which a section 505(b)(2) drug product is not described 
by an existing multiple source drug code. Some commenters stated that 
framework does detect meaningful differences between drug products. 
However, some commenters stated that the framework is not robust enough 
and does not consider all of the important elements that would make two 
drug products meaningfully different. Other commenters suggested 
modifications to the framework.
    We received comments on the potential impacts of the framework on 
Medicare beneficiaries, the government, and other stakeholders. Several 
commenters expressed concern about potential impacts of the framework 
on manufacturers' use of the section 505(b)(2) pathway. Commenters 
stated that implementation of the framework approach would slow 
innovation by discouraging or disincentivizing manufacturers from using 
the section 505(b)(2) pathway for drug approval. The commenters also 
stated that payment for section 505(b)(2) drug products as multiple 
source drugs could result in inadequate reimbursement, and 
subsequently, may limit access to patients in the physician office 
setting.
    Lastly, we received comments in support of the framework and the 
assignment of certain section 505(b)(2) drug products to existing 
multiple source codes. One commenter agreed that drugs approved under 
the section 505(b)(2) pathway should be considered for definition as a 
multiple source drug. The commenter stated that defining some section 
505(b)(2) drug products as multiple source drugs, and potentially 
assigning lower payment limit, would generate cost savings. MedPAC 
reiterated their 2021 PFS comment, which supported CMS codifying its 
longstanding process for assigning certain section 505(b)(2) drug 
products into multiple source billing and payment codes. A third 
commenter expressed concern regarding the price of legacy drugs 
approved through the section 505(b)(2) pathway.
    Response: We thank all the commenters for providing feedback on 
this comment solicitation regarding the framework and how it aligns 
with the statutory definitions of single source and multiple source 
drugs; how the framework distinguishes situations in which a section 
505(b)(2) drug product is not described by an existing multiple source 
drug code; and potential impacts of the framework on Medicare 
beneficiaries, the government, and other stakeholders. We will take 
these comments into consideration for future rulemaking.

F. Appropriate Use Criteria for Advanced Diagnostic Imaging

    Section 218(b) of the Protecting Access to Medicare Act (Pub. L. 
113-93, April 1, 2014) (PAMA) amended Title XVIII of the Act to add 
section 1834(q) of the Act directing us to establish a program to 
promote the use of appropriate use criteria (AUC) for advanced 
diagnostic imaging services. We have taken steps to implement this 
program over several years, 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, which has been extended 
through CY 2021.
    The CY 2016 PFS final rule with comment period (80 FR 70886) 
addressed the initial component of the new Medicare AUC program, 
specifying applicable AUC. In the CY 2016 PFS final rule with comment 
period, we established an evidence-based process and transparency 
requirements for the development of AUC, defined provider-led entities 
(PLEs) and established the process by which PLEs may become qualified 
to develop, modify or endorse AUC. The first list of qualified PLEs was 
posted on the CMS website at the end of June 2016 at which time their 
AUC libraries became specified applicable AUC for purposes of section 
1834(q)(2)(A) of the Act.
    The CY 2017 PFS final rule (81 FR 80170) addressed the second 
component

[[Page 65225]]

of this program, specification of qualified clinical decision support 
mechanisms (CDSMs). In the CY 2017 PFS final rule, we defined CDSM, 
identified the requirements CDSMs must meet for qualification, 
including preliminary qualification for mechanisms documenting how and 
when each requirement is reasonably expected to be met, and established 
a process by which CDSMs may become qualified. We also defined 
applicable payment systems under this program, specified the first list 
of priority clinical areas, and identified exceptions to the 
requirement that ordering professionals consult specified applicable 
AUC when ordering applicable imaging services. The first list of 
qualified CDSMs was posted on the CMS website in July 2017.
    The CY 2018 PFS final rule (82 FR 53190) addressed the third 
component of this program, the consultation and reporting requirements. 
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. 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, and furnishing professionals must report AUC consultation 
information on the Medicare claim. We further specified that the AUC 
program will begin on January 1, 2020 with a year-long educational and 
operations testing period during which time AUC consultation 
information is expected to be reported on claims, but claims would not 
be denied for failure to include proper AUC consultation information. 
We also established a voluntary period from July 2018 through the end 
of 2019 that ordering professionals who are ready to participate in the 
AUC program may consult specified applicable AUC through qualified 
CDSMs and communicate the results to furnishing professionals; and 
furnishing professionals who are ready to do so may report AUC 
consultation information on the claim at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10481.pdf.
    Additionally, to incentivize early use of qualified CDSMs to 
consult 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 (hereinafter ``CY 2018 
Quality Payment Program 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 the CY 2019 PFS final rule (83 FR 59452), we made further 
additions and clarifications to the AUC program requirements. We added 
independent diagnostic testing facility (IDTF) to the definition of 
applicable settings under Sec.  414.94(b). We also clarified that the 
furnishing professionals (including provider or supplier entities 
furnishing advanced diagnostic imaging services in an applicable 
setting, paid for under an applicable payment system) are required to 
report AUC consultation information on the claims as specified under 
Sec.  414.94(k). We established significant hardship exception criteria 
and process under Sec.  414.94(i)(3) to be specific to the AUC program 
and independent of other Medicare programs. We specified under Sec.  
414.94(j)(2) that when delegated by the ordering professional, clinical 
staff under the direction of the ordering professional may perform the 
AUC consultation with a qualified CDSM. Finally, we announced our 
intention to use G-codes and modifiers to report AUC consultation 
information on the Medicare claims. In 2020, in response to the Public 
Health Emergency (PHE) for the Coronavirus Disease 2019 (COVID-19) (PHE 
for COVID-19), the educational and operations testing period was 
extended through CY 2021.
1. Background
    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). Evidence-based AUC for imaging 
can assist clinicians in selecting the imaging study that is most 
likely to improve health outcomes for patients based on their 
individual clinical presentation. For purposes of this program, AUC is 
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.
    AUC need to be integrated as seamlessly as possible into the 
clinical workflow. 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 
EHRs. Ideally, practitioners would interact directly with the CDSM 
through their primary user interface, thus minimizing interruption to 
the clinical workflow.
2. Statutory Authority
    Section 218(b) of the PAMA added a new section 1834(q) of the Act 
entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging 
Services,'' which directed the Secretary to establish a program to 
promote the use of AUC. Section 1834(q)(4) of the Act requires ordering 
professionals to consult with specified applicable AUC through a 
qualified CDSM for applicable imaging services furnished in an 
applicable setting and paid for under an applicable payment system; and 
payment for such service may only be made if the claim for the service 
includes information about the ordering professional's consultation of 
specified applicable AUC through a qualified CDSM.
3. Discussion of Statutory Requirements
    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 for services furnished after January 1, 
2017 (section 1834(q)(5) of the Act). We did not identify mechanisms 
for consultation by April 1, 2016. Therefore, we did not require 
ordering professionals to consult CDSMs or furnishing professionals to 
report information on the consultation by the January 1, 2017 date.
a. Establishment of AUC
    In the CY 2016 PFS final rule with comment period, we addressed the 
first component of the Medicare AUC program under section 1834(q)(2) of 
the Act--the requirements and process for establishment and 
specification of applicable AUC, along with relevant aspects of the 
definitions under section 1834(q)(1) of the Act. This included defining 
the term ``provider-led entity'' and finalizing requirements for the 
rigorous, evidence-based process by which a PLE would develop AUC, upon 
which qualification is based, as provided in section 1834(q)(2)(B) of 
the Act and in the CY 2016 PFS final rule with comment period. Using 
this process, once a PLE is qualified by us, the AUC that are 
developed, modified or endorsed by the qualified PLE are

[[Page 65226]]

considered to be specified applicable AUC under section 1834(q)(2)(A) 
of the Act. We defined PLE to include national professional medical 
societies, health systems, hospitals, clinical practices and 
collaborations of such entities such as the High Value Healthcare 
Collaborative or the National Comprehensive Cancer Network. Qualified 
PLEs may collaborate with third parties that they believe add value to 
their development of AUC, provided such collaboration is transparent. 
We expect qualified PLEs to have sufficient infrastructure, resources, 
and the relevant experience to develop and maintain AUC according to 
the rigorous, transparent, and evidence-based processes detailed in the 
CY 2016 PFS final rule with comment period.
    In the same rule, we established a timeline and process under Sec.  
414.94(c)(2) for PLEs to apply to become qualified. Qualified PLEs are 
listed at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/PLE.html (OMB 
Control Number 0938-1288).
b. Mechanism for AUC Consultation
    In the CY 2017 PFS final rule, we addressed the second major 
component of the Medicare AUC program--the specification of qualified 
CDSMs for use by ordering professionals for consultation with specified 
applicable AUC under section 1834(q)(3) of the Act, along with relevant 
aspects of the definitions under section 1834(q)(1) of the Act. This 
included defining the term CDSM and finalizing functionality 
requirements of mechanisms, upon which qualification is based, as 
provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS 
final rule. We defined CDSM as an interactive, electronic tool for use 
by clinicians that communicates AUC information to the user and assists 
them in making the most appropriate treatment decision for a patient's 
specific clinical condition. Tools may be modules within or available 
through certified EHR technology (as defined in section 1848(o)(4) of 
the Act) or private sector mechanisms independent from certified EHR 
technology or a mechanism established by the Secretary.
    In the CY 2017 PFS final rule, we established a timeline and 
process in Sec.  414.94(g)(2) for CDSM developers to apply to have 
their CDSMs qualified. Qualified CDSMs are listed at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html (OMB Control 
Number 0938-1315).
c. AUC Consultation and Reporting
    In the CY 2018 PFS final rule, we addressed the third major 
component of the Medicare AUC program--consultation with applicable AUC 
by the ordering professional and reporting of such consultations under 
section 1834(q)(4) of the Act. We established a January 1, 2020 
effective date for the AUC consultation and reporting requirements for 
this program. We also established a voluntary period during which early 
adopters could begin reporting limited consultation information on 
Medicare claims from July 2018 through December 2019. During the 
voluntary period, there is no requirement for ordering professionals to 
consult AUC or furnishing professionals to report information related 
to the consultation. On January 1, 2020, the program began with an 
educational and operations testing period and during this time, we have 
continued to pay claims whether or not they correctly include AUC 
consultation information. Ordering professionals must consult specified 
applicable AUC through qualified CDSMs for applicable imaging services 
furnished in an applicable setting, paid for under an applicable 
payment system and ordered on or after January 1, 2020; and furnishing 
professionals must report the AUC consultation information on the 
Medicare claim for these services ordered on or after January 1, 2020.
    Consistent with section 1834(q)(4)(B) of the Act, we also 
established that the following information must be reported on Medicare 
claims for advanced diagnostic imaging services as specified in section 
1834(q)(1)(C) of the Act and defined in Sec.  414.94(b), furnished in 
an applicable setting as defined in section 1834(q)(1)(D) of the Act, 
paid for under an applicable payment system as defined in section 
1834(q)(4)(D) of the Act, and ordered on or after January 1, 2020: (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).
    Section 1834(q)(4)(C) of the Act provides for exceptions to the AUC 
consultation and reporting requirements 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. In the CY 2017 PFS final rule, 
we adopted a regulation at Sec.  414.94(h)(1)(i) to specify the 
circumstances under which AUC consultation and reporting requirements 
are not applicable and in the CY 2019 PFS final rule, we updated the 
significant hardship exception criteria to be specific to the AUC 
program and independent of other programs. An ordering professional 
experiencing any of the following when ordering an advanced diagnostic 
imaging service is not required to consult AUC using a qualified CDSM, 
and the claim for the applicable imaging service is not required to 
include AUC consultation information. Significant hardship exceptions 
under Sec.  414.94(i)(3) include: Insufficient internet access; EHR or 
CDSM vendor issues; or extreme and uncontrollable circumstances.
    We remind readers that, consistent with section 1834(q)(4)(A) of 
the Act, ordering professionals must consult AUC for every applicable 
imaging service furnished in an applicable setting and paid under an 
applicable payment system unless a statutory exception applies.
    Section 1834(q)(4)(D) of the Act specifies the applicable payment 
systems for which AUC consultation and reporting requirements apply. In 
the CY 2017 PFS final rule, we defined applicable payment system to 
reflect the statutory requirements in Sec.  414.94(b) as: (1) The PFS 
established under section 1848(b) of the Act; (2) the PPS for HOPD 
services under section 1833(t) of the Act; and (3) the ASC payment 
system under section 1833(i) of the Act.
    Section 1834(q)(1)(D) of the Act specifies the applicable settings 
in which AUC consultation and reporting requirements apply: A 
physician's office, a HOPD (including an emergency department), an ASC, 
and any other ``provider-led outpatient setting determined appropriate 
by the Secretary.'' In the CY 2017 PFS final rule, we added this 
definition to Sec.  414.94(b). As noted above, we expanded that 
definition to add an IDTF in the CY 2019 PFS final rule.
d. Identification of Outliers
    The fourth component of the Medicare AUC program is specified in 
section 1834(q)(5) of the Act, Identification of Outlier Ordering 
Professionals. The identification of outlier ordering professionals 
under this paragraph facilitates a prior authorization requirement that 
applies for outlier professionals beginning

[[Page 65227]]

January 1, 2020, as specified under section 1834(q)(6) of the Act. 
Because we established a start date of January 1, 2020 for AUC 
consultation and reporting requirements, we did not identify any 
outlier ordering professionals by that date. As such, implementation of 
the prior authorization component is delayed. However, we did finalize 
in the CY 2017 PFS final rule the first list of priority clinical areas 
to guide identification of outlier ordering professionals as follows:
     Coronary artery disease (suspected or diagnosed).
     Suspected pulmonary embolism.
     Headache (traumatic and non-traumatic).
     Hip pain.
     Low back pain.
     Shoulder pain (to include suspected rotator cuff injury).
     Cancer of the lung (primary or metastatic, suspected or 
diagnosed).
     Cervical or neck pain.
    We will use future rulemaking to establish the methodology for the 
identification of outlier ordering professionals who would eventually 
be subject to a prior authorization process when ordering advanced 
diagnostic imaging services.
4. Continuing Implementation
a. Clarification of AUC Program Scope
i. Modified Orders
    Updates or modifications to orders for advanced diagnostic imaging 
services may be warranted in certain situations once the beneficiary is 
under the care of the furnishing professional. Unless they are also 
serving as the ordering professional, furnishing professionals may not 
consult AUC on behalf of or in place of the ordering professional. The 
Medicare Benefit Policy Manual (BPM) (Pub. L. 100-02) addresses 
situations where the furnishing professional performs imaging services 
that differ from ordered services in chapter 15, sections 80.6.1-4 
(hereafter in this section, ``the BPM''). The BPM on modified orders 
state that when an interpreting physician determines that a different 
or additional imaging service not included on the order should be 
performed, the interpreting physician or testing facility generally may 
not perform the test until a new order from the treating physician/
practitioner has been received. If the treating physician/practitioner 
cannot be reached to change or obtain a new order, the interpreting 
physician or testing facility may furnish the additional imaging 
service under the following circumstances, as documented in the 
patient's medical record: The treating physician/practitioner could not 
be reached, the ordered test is performed and an additional diagnostic 
test is medically necessary because of the abnormal result of that 
test, delaying performance of the additional test would have an adverse 
effect on the patient's care, the result of the additional test is 
communicated to and used by the treating physician/practitioner in the 
patient's treatment, and the interpreting physician/practitioner 
documents in the report the reasons for the additional testing.
    When the furnishing professional performs additional imaging 
services not reflected on the order under these circumstances, we do 
not believe it would be appropriate to consider them to be acting as an 
ordering professional such that an AUC consultation would be needed. 
Instead, we believe the furnishing professional in these situations is 
the interpreting physician/practitioner who is exercising their 
professional judgment to provide the ordering professional with 
additional diagnostic test results for use in managing the patient's 
care. Additionally, they are doing so only because, after performing 
the ordered test and determining that additional testing is expedient 
given the results of that test, the ordering professional cannot be 
reached to request a modified or additional order. Given the conditions 
under which these additional imaging services are performed, we 
proposed that when the furnishing professional for an advanced 
diagnostic imaging service performs one or more additional services 
under the circumstances described in chapter 15, section 80.6.2-4 of 
the BPM, neither the ordering professional nor the furnishing 
professional are required to consult AUC for the additional service(s). 
In these situations, the AUC consultation information from the original 
order is to be reported on the claim line for the additional 
service(s). Where the furnishing professional modifies the order for an 
advanced diagnostic imaging service without obtaining a new order from 
the ordering professional, the AUC consultation information provided by 
the ordering professional with the original order should be reflected 
on the Medicare claim to demonstrate that the requisite AUC 
consultation occurred. Because the BPM states that the interpreting 
physician or testing facility generally may not perform a modified or 
new test until a new order from the treating physician/practitioner has 
been received, we expect situations where AUC consultations do not 
occur for new or modified orders to be infrequent.
    We received public comments on the proposal and discussions related 
to modified orders above. The following is a summary of the comments we 
received and our responses.
    Comment: One commenter stated that CMS does not provide enough data 
to substantiate that modified orders are infrequent.
    Response: We make this statement at the end of the discussion above 
and after referring to the existing language in the BPM (Chapter 15, 
sections 80.6.2-4). The BPM states that when an interpreting physician 
determines that a different or additional imaging service not included 
on the order should be performed, the interpreting physician or testing 
facility generally may not perform the test until a new order from the 
treating physician/practitioner has been received and, if the treating 
physician/practitioner cannot be reached to change or obtain a new 
order, only then may the interpreting physician or testing facility 
furnish the additional imaging service under certain circumstances. 
Because the expectation is that, except under narrow circumstances, a 
new or additional order to be placed by the ordering professional, we 
expect situations where the ordering professional is completely 
uninvolved, and thus, where we proposed that another AUC consultation 
would not be performed, to be infrequent. This is not based on 
information generated from claims or other data as, to the best of our 
knowledge, claims for modified orders (additional or replacement) do 
not include unique, identifying information. If orders are in fact 
being modified frequently, it would suggest to us that practitioners 
may not be familiar with the provisions of the BPM regarding modified 
orders.
    Comment: Two commenters stated that the proposal conflicts with a 
response to public comments in the CY 2018 PFS final rule addressing 
order modifications. These commenters stated that in the CY 2018 PFS 
final rule, CMS provided guidance that when furnishing professionals 
must update or modify the order, the AUC consultation information 
provided by the ordering professional with the original order should be 
reflected on the claim. These commenters further stated that EHRs 
implement functionality that automatically applies AUC information from 
an original order to the modified order without any verification that 
the requirements for order modification were met. These commenters 
requested that CMS allow providers to append

[[Page 65228]]

modifier MH (indicating that the imaging service was not subject to the 
AUC program requirements) when the furnishing professional determines a 
new or modified order should be performed without first requesting the 
new or modified order to submitted by the original ordering 
professional.
    Response: We disagree that the above proposal conflicts with the 
guidance included in the CY 2018 PFS final rule, but rather believe it 
provides further clarification. These commenters did not reference the 
CMS response in its entirety which stated that we do not believe it was 
the intent of section 218(b) of the PAMA to reverse the rules specified 
in Chapter 15, sections 80.6.2-4 of the Medicare BPM, and we expect 
furnishing professionals and facilities to continue to adhere to them. 
After this statement, we then addressed instances when the furnishing 
professional must update or modify the order and stated that for these 
situations, the AUC consultation information provided by the ordering 
professional with the original order should be reflected on the 
Medicare claim to demonstrate that the requisite AUC consultation 
occurred. While the language cited by commenters, when taken out of 
context of the entire response, appears to instruct practitioners to 
append the original AUC consultation information to the claim without 
consideration of ordering professionals submitting an updated order, 
such interpretation is inconsistent with the whole response which 
states that we expect furnishing professionals to maintain compliance 
with the provisions of Chapter 15, sections 80.6.2-4 of the Medicare 
BPM. As such, the proposals in this year's proposed rule are consistent 
with prior guidance in rulemaking and existing guidance in the BPM. 
Additionally, we disagree with the commenter's suggestion that it would 
be appropriate to append a modifier to claims for such services, 
indicating that they are not subject to the AUC program requirements. 
We maintain that when the furnishing professional is unable to reach 
the ordering professional to obtain a new order and proceeds with 
additional or different imaging as described in the BPM, the AUC 
consultation information for the original order is to be appended to 
the claim for the service(s) ultimately furnished.
    Comment: One commenter stated that the proposals for modified 
orders are confusing and CMS should develop other solutions for how AUC 
data should be reported on claims for revised/additional advanced 
diagnostic imaging orders. This commenter further stated that the 
proposals appear to require furnishing professionals to report 
erroneous information about the consultation on the claim which could 
potentially negatively impact the ordering professional when the 
program moves into the outlier identification and prior authorization 
component. This commenter requested that CMS clarify how AUC data 
should be reported on claims for revised/additional imaging orders and 
how CMS might mitigate negative downstream effects on ordering 
professionals whose CDSM data were erroneously reported on claims to 
accommodate this scenario. Another commenter also requested 
clarification around the applicability and documentation for modified 
orders.
    Response: While we recognize that the claims processing solutions 
to fully implement the AUC program are imperfect, particularly since 
our claims processing systems do not have the capability to fully 
automate claims processing for advanced diagnostic imaging services 
subject to the AUC program, we believe the proposal specific to 
modified orders is clear, appropriate and does not in fact require the 
reporting of erroneous information on the Medicare claim.
    First, the proposal is that, in the event a different or additional 
service is furnished than was originally ordered under the 
circumstances described in the BPM, the furnishing professional would 
report on the claim for the imaging service(s) ultimately furnished the 
AUC information communicated with the original order by the ordering 
professional. In these situations, no other AUC consultations take 
place since, under our proposal, the furnishing professional is not 
originally and does not become the ordering professional. As such, the 
only AUC consultation information pertinent to the specific patient in 
question and for the specific clinical scenario in question was 
obtained when the ordering professional consulted AUC for the original 
order, and thus this is the only AUC consultation information that 
could be appended to the claim. In instances where the furnishing 
professional determines additional or replacement imaging services 
should be performed and he or she is able to reach the ordering 
professional for a new order, then the ordering professional will 
consult AUC for the new order(s) and provide that information with the 
new order(s) for inclusion on the claim.
    Second, these services, when furnished in an applicable setting and 
paid under an applicable payment system, are not excepted from the AUC 
program, so appending a modifier to indicate that they are, would be 
erroneous.
    Third, we disagree with the suggestion that this approach would 
result in negative downstream effects for ordering professionals 
specific to outlier identification and prior authorization as inclusion 
of the original consultation information on the claim would meet the 
requirements for the claim to process and communicate the original 
consultation information to indicate the level of adherence of the 
order placed by the ordering professional with AUC. This suggestion 
raises the question whether the modified order parameters set forth in 
the Medicare BPM are consistently followed. CMS does not have the 
authority to establish an exception to the reporting requirements. CMS 
may consider in subsequent rulemaking whether an additional modifier 
should be appended to all modified orders (additional and/or revised) 
for which new orders are not submitted by the original ordering 
professional to ensure that furnishing professionals are not furnishing 
advanced diagnostic imaging services unilaterally and without the 
acknowledgement of the ordering professional. An additional modifier to 
identify these situations could be useful to mitigate any unintended 
consequences during the outlier identification and prior authorization 
component. We note that the AUC program is designed to improve ordering 
patterns of ordering professionals by further educating them on 
appropriate use of advanced diagnostic imaging services and this may 
not be achieved if orders are frequently modified without the 
involvement of the ordering professional.
    Comment: Some commenters expressed general support for the 
proposal. One commenter expressed agreement with the proposal, in the 
conditions outlined in the proposed rule, that the ordering 
professional would not be required to consult AUC for imaging studies 
that need to be modified once under the care of the furnishing 
professional. Another commenter specifically expressed support for the 
proposal to except modified orders from the AUC consultation 
requirement when a different test is clinically appropriate, additional 
testing may be needed, and the ordering professional is not available 
to provide a new order. One commenter stated that furnishing 
professionals should be able to modify the order without obtaining a 
new order from the ordering professional and use the original AUC on 
the claim for

[[Page 65229]]

modified orders when a radiologist deems it necessary to change the 
original exam based on best clinical judgement for decisions regarding 
contrast/non-contrast or scans on contiguous body parts.
    Response: We appreciate the comments and remind readers of the 
specifications in the BPM discussed above.
    After consideration of public comments we are finalizing our 
proposal without change so that furnishing professionals that modify an 
order for advanced diagnostic imaging services with a replacement and/
or additional imaging service, and are unable to reach the ordering 
professional for a new order as described in Chapter 15, sections 
80.6.2-4 of the Medicare BPM, are to append to the Medicare claim for 
the service(s) the AUC consultation information provided by the 
ordering professional specific to the original order.
ii. Extreme and Uncontrollable Circumstances Hardship Exception
    In the CY 2019 PFS final rule, we describe extreme and 
uncontrollable circumstances to include disasters, natural or man-made, 
that have a significant negative impact on healthcare operations, area 
infrastructure or communication systems. We also explain these may 
include areas where events occur that have been designated by FEMA as a 
major disaster or a public health emergency declared by the Secretary. 
To further clarify, these circumstances are events that are entirely 
outside the control of the ordering professional that prevent the 
ordering professional from consulting AUC through a qualified CDSM. We 
believe the hardship criteria under this program are similar to other 
programs such as the Promoting Interoperability performance category of 
the Merit-based Incentive Payment System (MIPS), particularly the 
flexibility that is given to clinicians to identify what they consider 
to be extreme and uncontrollable circumstances.
    The PHE for COVID-19 has been in effect since January 27, 2020. 
Stakeholders have described challenges in continuing to prepare for the 
payment penalty phase of the AUC program due to resource reallocation 
resulting from the PHE. Some stakeholders have explained that all 
health technology projects unrelated to the PHE were halted, including 
projects that impact establishing or updating health IT systems that 
enable AUC consultation through qualified CDSMs. Stakeholders have also 
indicated that human resources were reallocated to focus on responding 
to the PHE. Additionally, we recognize that practitioners have been 
heavily impacted in their own practice of medicine to respond to the 
PHE and provide treatment to patients which may have prevented them 
from focusing on and participating in the educational and operations 
testing period to prepare for the payment penalty phase. While we are 
continuing to move forward in implementing the AUC program, we want to 
assure stakeholders that they may attest to a significant hardship 
under the AUC program due to extreme and uncontrollable circumstances 
due to the PHE for COVID-19, and such an attestation may be used as 
needed by ordering practitioners throughout the PHE. Furthermore, as 
the AUC program progresses into the payment penalty phase, self-
attestation for a significant hardship exception will continue to be 
available for ordering professionals experiencing extreme and 
uncontrollable circumstances due to the PHE. We also recognize that 
ordering professionals may experience significant hardships related to 
or resulting from the PHE that extend beyond the date the PHE expires 
and note that AUC program exceptions will continue to be available for 
such significant hardships as defined at Sec.  414.94(i)(3).
    We received public comments on the extreme and uncontrollable 
significant hardship exception along with comments on other exceptions. 
The following is a summary of the comments we received and our 
responses.
    Comment: Some commenters agreed with our clarification that the PHE 
for COVID-19 is a significant hardship and significant hardships due to 
the PHE may extend beyond the date the PHE expires. Another commenter 
agreed that the PHE for COVID-19 is a proper circumstance for an 
extreme and uncontrollable circumstance exception even after the start 
of the payment penalty phase of the AUC program if the PHE or effects 
of the PHE impact ordering professionals. Other commenters requested 
that CMS allow providers to use the extreme and uncontrollable 
circumstances exemption for at least one year following the start of 
the payment penalty phase because of the PHE.
    Response: We appreciate the support of the commenters. As 
significant hardship exceptions under the AUC program are self-
attested, we did not propose, and decline to specify time frame 
parameters around experiencing an extreme and uncontrollable 
circumstances significant hardship due to the PHE for COVID-19.
    Comment: One commenter requested that CMS harmonize the hardship 
exceptions with the Quality Payment Program (QPP) hardship exceptions 
and allow ordering professionals and furnishing professionals to 
annually attest to hardship rather than on every claim. One commenter 
stated that significant hardship exemptions should be included for 
furnishing professionals.
    Response: As discussed in the CY 2019 PFS final rule, the AUC 
program requires real time reporting of information on the Medicare 
claims for payment purposes while the QPP is not a real time program, 
but instead uses data from prior performance years to determine status 
and potential payment adjustments in future years. We explained in that 
final rule that this difference along with the statutory differences 
between the programs necessitates a separate significant hardship 
exception approach and process for the AUC program. In that final rule, 
we further discuss that the real time self-attestation process (as 
opposed to a blanket exception for a predetermined period of time) 
ensures that clinicians have the ability and flexibility to use the 
significant hardships allowable under the program. We also noted that 
applying a blanket exception for a specific period of time for ordering 
professionals based on a single significant hardship attestation would 
introduce a level of complexity and burden to the process whereby 
furnishing professionals would need to keep track of which ordering 
professionals had attested to a significant hardship and over what 
applicable period of time every time an order is received and a claim 
is prepared, submitted and processed. We also note that the statute 
provides for significant hardships for ordering professionals for whom 
consultation with AUC would result in a significant hardship but the 
statute does not provide for significant hardships specific to 
furnishing professionals.
    Comment: One commenter requested that, like QPP, the AUC program 
include an exception for new physicians for one year and for low volume 
of Medicare patients.
    Response: As discussed in the CY 2019 PFS final rule, we do not 
have the authority to include exceptions to the AUC program beyond the 
scope of those specified in section 1834(q)(4)(C) of the Act. As 
explained in that final rule, we believe that significant hardships are 
reflective of situations that would impede clinicians from consulting 
AUC through a CDSM and we do not agree

[[Page 65230]]

that ordering professionals in practices with a low volume of Medicare 
patients would be impeded from consulting AUC. Similarly, we stated 
that we do not believe being a new physician would cause the act of 
consulting AUC to be particularly difficult or challenging for ordering 
professionals.
    Comment: Two commenters requested exceptions for providers in 
value-based care models and two commenters requested exceptions for 
physicians and practices that are already taking on financial risks in 
advanced payment models (APMs).
    Response: The statute does not except participants in certain types 
of models or initiatives from the AUC program requirements.
    Comment: Several commenters requested CMS address how second 
opinions are to be handled under the AUC program. One commenter stated 
that it is important to exempt second opinions of already performed and 
interpreted imaging studies to prevent additional imaging, ensure 
timely access for patients and limit barriers to evaluation by 
subspecialty radiologists. Another commenter specifically requested 
guidance on whether a consulting professional must also consult AUC and 
how to indicate that consultation was performed particularly if it does 
not result in a new order and, when it does result in a new order, 
whether the consulting professional should order the second imaging 
service and whether the ordering professional must consult AUC a second 
time. One commenter specifically requested clarification around how the 
AUC requirements apply to second opinions and how orders that are 
placed contra-AUC for legitimate clinical reasons are to be identified.
    Response: We believe the AUC consultation and reporting 
requirements apply to second opinions in the same way they apply to 
original patient assessments and resulting orders for advanced 
diagnostic imaging serves. If an additional PC is submitted for an 
imaging services due to a second opinion, the AUC consultation 
information specific to the advanced diagnostic imaging services that 
was furnished (the original order) would be appended to the claim for 
the PC. If, based upon this second opinion, further tests must be 
ordered, they would require separate and additional AUC consultation as 
they are new/additional orders. We note that, as introduced by 
commenters, second opinions are different from modified orders, so if 
new or additional orders result from the second opinion review, these 
would be new, subsequent orders and thus be subject to the AUC program 
requirements as such. We expect second opinions to proceed as they 
normally would, but with the inclusion of AUC consultation and 
subsequent reporting on the Medicare claims for and new or additional 
orders for advanced diagnostic imaging services. When reporting, the 
appropriate modifier indicating the outcome of the AUC consultation 
should be appended to the claim, even if the order ultimately placed 
would not adhere to the AUC consulted albeit for legitimate clinical 
reasons.
    Comment: Some commenters asked if the AUC requirements apply to 
imaging ordered pursuant to a clinical trial protocol, what modifier 
should be appended and how to indicate on the claim that the service 
was pursuant to a clinical trial. Commenters also requested that 
imaging services performed as part of a clinical trial be excluded from 
the AUC program and that a separate HCPCS modifier be established to 
identify such claims.
    Response: As discussed above in section III.F.3.c. of this final 
rule, section 1834(q)(4)(C) of the Act provides for exceptions to the 
AUC consultation and reporting requirements and these exceptions are 
codified in our regulations in Sec.  414.94(h)(1)(i). We disagree that 
advanced diagnostic imaging services furnished pursuant to or as a part 
of a clinical trial qualify for an exception as specified in the 
statute and regulations and described above in section III.F.3.c. of 
this final rule; therefore, we are unable to exclude or except claims 
for these imaging services. The AUC consultation information relevant 
to the imaging service that is ordered should be appended on the claim 
to accurately communicate information about the consultation. Because 
these services are subject to the AUC program requirements, we do not 
see a need to establish a separate modifier to identify these services. 
We note that claims for many clinical trials covered by Medicare must 
include the national clinical trial (NCT) identifier number, HCPCS 
modifiers Q0 (zero) or Q1 (one) and also ICD-10 diagnosis code Z00.6, 
so there are other ways to track claims submitted as part of clinical 
trials if necessary.
b. Claims Processing
    As we move ahead to implement the payment penalty phase of this 
program, we must address additional operational and administrative 
issues. We explain these issues here, and our assessments and proposals 
for addressing them. We solicited comments on whether additional 
scenarios require our consideration, and whether the proposed solutions 
adequately address issues raised by stakeholders. We solicited any 
additional information stakeholders may offer to assist us in 
developing claims processing system edits or other measures to ensure 
that only appropriate claims are subject to AUC claims processing 
edits. The AUC program will be fully implemented when we have the 
necessary edits established in the claims processing system and we 
begin using those edits to deny Medicare claims that fail to report the 
required AUC consultation information. The identification of claims 
that are or are not subject to the Medicare AUC Program must be precise 
to avoid inadvertently denying claims that should be paid. Because 
implementation of this program establishes edits for advanced 
diagnostic imaging claims, the inadvertent denial of claims would 
disproportionately impact radiologists, HOPDs and freestanding imaging 
centers. Also, as we have noted previously, the AUC program is unique 
in that the burden of consulting AUC and providing AUC consultation 
information to the furnishing professional falls on the ordering 
professional, yet the claims that are denied for failing to report AUC 
consultation information are for services furnished and billed by the 
professionals and facilities that furnish advance diagnostic imaging.
    Two main Medicare claim types are subject to claims processing 
edits in the AUC program. These are the CMS-1500 and its electronic 
equivalent (referred to here as the practitioner claim) submitted by 
physicians and practitioners, ASCs, and IDTFs, and the UB- 04, also 
called the CMS-1450, (referred to here as the institutional claim) 
submitted by HOPDs and on-campus and off-campus provider-based 
departments. These claim types differ in the data elements they 
contain; therefore, claims processing edits will not be identical 
across claim types.
    We have already issued partial claims processing instructions 
(CR11268, Transmittal 2404) \90\ to support the educational and 
operations testing period. We established HCPCS Level III G-codes for 
furnishing professionals to report which CDSM was consulted on a 
separate claim line. We also established HCPCS modifiers for furnishing 
professionals to report adherence, non-adherence and not applicable AUC 
consultation responses on the same claim line as the advanced 
diagnostic

[[Page 65231]]

imaging HCPCS code. We established additional HCPCS modifiers for 
furnishing professionals to report situations in which the ordering 
professional is not required to consult AUC, which are also reported on 
the same claim line as the advanced diagnostic imaging HCPCS code. Both 
G-codes and modifiers are applicable to practitioner and institutional 
claims. We also established a procedure code list that identifies the 
advanced diagnostic imaging codes that are subject to the AUC program. 
Based on a review of CY 2020 Medicare claims (noting for readers that 
during this year the AUC program was only in the education and 
operations testing phase with no payment penalties), we estimate 
between 9-10 percent of all claims subject to the AUC program reported 
information sufficient to be considered compliant with the program. 
This means that 90-91 percent of claims would not be considered 
compliant with AUC program requirements because they do not include 
either the required AUC consultation information (including the 
ordering professional NPI, G-code identifying the qualified CDSM 
consulted, and the modifier specifying the appropriateness of the 
order) or a modifier indicating an applicable exception to the AUC 
consultation information reporting requirements. In other words, if the 
claims processing systems edits had been in place for the payment 
penalty phase, only 9-10 percent of claims subject to the AUC program 
would have been paid as opposed to being denied or rejected. An 
additional 6-7 percent of claims subject to the AUC program included 
some relevant information, which demonstrates an awareness of the AUC 
program among these billing entities; but the claims did not include 
all of the necessary AUC consultation information that will ultimately 
be required for the claim to be paid.
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    \90\ https://www.cms.gov/files/document/r2404otn.pdf.
---------------------------------------------------------------------------

i. Ordering Professional NPI
    There are locations on both the practitioner and institutional 
claim types to report the NPI of the ordering professional. The 
institutional claim uses the K3 segment and the practitioner claim uses 
the referring professional field. However, to fully implement the AUC 
program, we must establish a claims processing edit to require these 
fields to be populated on all advanced diagnostic imaging claims 
subject to the AUC program.
    In addition, there currently are situations in which multiple 
advanced diagnostic imaging services ordered by more than one ordering 
professional may be reported on a single claim. This would not be 
workable for purposes of reporting AUC consultation information because 
the referring professional field is reported at the claim-level and not 
at the claim line- or service-level for professional claims. Therefore, 
the furnishing professional will need to submit separate claims for the 
services ordered by each referring or ordering professional. In other 
words, only one ordering professional can be reported per claim.
    We received comments on this discussion. The following is a summary 
of the comments we received and our responses.
    Comment: One commenter, referencing different sections of the 837 
professional claim, requested confirmation that practitioner claims are 
unable to accommodate line-level identification of the ordering 
professional NPI as discussed above. This commenter stated that while 
the referring professional is a claim level element in ASC 5010 837 
Professional Claim Loop 2310A, there is also a line-item element for 
referring professional in Loop 2420F. This commenter requested further 
clarification in terminology used by CMS, noting that there are 
different fields on the claim forms for ``ordering'' and ``referring'' 
professionals and whether CMS is placing limitations on the ``ordering 
professional'' or ``referring professional'' elements and how that 
dictates claims be split. This commenter requested CMS be completely 
clear on which fields are to be populated with the NPI of the 
practitioner that ordered the service and whether services for one 
beneficiary ordered by more than one practitioner must be split into 
separate claims.
    Response: Upon further review of the 837P form, we agree that the 
practitioner who orders the advanced diagnostic imaging service can be 
identified at the line level and we will proceed with implementation 
accordingly. We expect this means the 837P claims will not be required 
to be submitted separately for each practitioner who orders advanced 
diagnostic imaging services (the ``ordering professional'' as defined 
under the AUC program). We will continue to evaluate which line-item 
field is most appropriate to populate (the ordering or referring 
professional fields on the claim).
    Comment: One commenter stated that one ordering clinician per claim 
is not overly burdensome in most situations and another commenter noted 
that splitting claims is not ideal, but can be done and should not hold 
up the AUC program. This commenter stated that a significant amount of 
manual intervention will likely be required. One commenter stated that 
submitting separate claims to accommodate different ordering 
professionals will be difficult because their current system groups 
ordering professional encounters for the same date of service on the 
same institutional claim. This commenter explained that separate claims 
will require separate registrations which is more burdensome for 
registration staff and may dissatisfy patients. Furthermore, this 
commenter stated that two or more account numbers with the same date of 
service may increase error for documentation and charging. This 
commenter asked if Medicare will be able to process two separate 
ordering professional claims with the same date of service.
    Response: As noted in the response above, we believe the 837P claim 
can identify different practitioners that order advanced diagnostic 
imaging services at the line level so splitting claims will not be 
necessary, which will also minimize burden. As we proceed with 
establishing claims processing instructions for the payment penalty 
phase of the program, we will continue to explore opportunities to 
minimize burden.
    After consideration of public comments, we will move forward with 
developing claims processing instructions that allow more than one 
practitioner that orders advanced diagnostic imaging services to be 
reported on the practitioner claim.
ii. Critical Access Hospitals
    As discussed in the CY 2018 PFS final rule with comment period (82 
FR 53192), advanced diagnostic imaging services furnished in an 
outpatient department of a critical access hospital (CAH) are not 
subject to the AUC program because, in accordance with section 
1833(q)(1)(D) of the Act, a CAH is not an applicable setting under the 
program. Therefore, we must identify these advanced diagnostic imaging 
services and allow them to bypass the AUC program claims processing 
edits. For institutional claims, we intend to apply the AUC program 
claims processing edits to type of bill 13x, which is used only for 
outpatient hospital settings. CAHs submit outpatient claims using type 
of bill 85x, rather than type of bill 13x.
    In the CY 2019 PFS final rule (83 FR 59694), we further explained 
that because section 1834(q)(4)(B) of the Act clearly includes all 
claims paid under applicable payment systems without exclusion, the 
claims from both furnishing professionals and facilities must include 
AUC consultation

[[Page 65232]]

information. We revised our regulation at Sec.  414.94(k) to specify 
that AUC consultation information must be reported on Medicare claims 
for advanced diagnostic imaging services furnished in an applicable 
setting and paid under an applicable payment system. Prior to this 
revision, Sec.  414.94(k) required furnishing professionals to report 
AUC consultation on the claim, without also specifying that facility 
claims must include the AUC consultation information. In the CY 2019 
PFS final rule, we explained that the AUC consultation information 
would be included on the practitioner's claim for the PC of the service 
and on the provider's or supplier's claim for the facility portion or 
TC of the service. Under Sec.  414.94(k), the requirement to report AUC 
consultation information on the claim applies to both the PC and TC of 
the imaging services that are furnished in an applicable setting and 
paid under an applicable payment system. Section 1834(q)(4)(B) of the 
Act further specifies that the requirement to report AUC consultation 
information is specific to claims for advanced diagnostic imaging 
services furnished in an applicable setting and paid under an 
applicable payment system. We believe that all claims for advanced 
diagnostic imaging services, both the PC and TC, must include the AUC 
consultation information when they are furnished both in an applicable 
setting and paid under an applicable payment system. However, if 
advanced diagnostic imaging services are not entirely furnished in an 
applicable setting, we believe that neither the PC nor TC claim should 
be required to include AUC consultation information. This ensures 
consistent application of the AUC consultation requirements across 
claims submitted for advanced diagnostic imaging services even when the 
PC and TC components of the service are furnished by different 
furnishing professionals. As such, we proposed that claims submitted by 
physicians or practitioners for the PC of an advanced diagnostic 
imaging service when the TC was not furnished in an applicable setting 
will not be subject to the AUC program since the setting where the TC 
of the imaging service is furnished is not subject to the AUC program 
consultation and reporting requirements. If a physician or practitioner 
submits a claim for the PC of an advanced imaging service for which the 
TC was performed as an outpatient CAH service, there currently is not a 
systems-based way for us to recognize that the TC of the service was 
furnished by a CAH. Place of service codes reported on practitioner 
claims are not specific enough. We have not yet identified a way to 
segregate these claims and automatically allow them to bypass AUC 
program claims processing edits. Therefore, as discussed below, we 
proposed to establish a separate HCPCS modifier that will be used to 
identify practitioner claims for advanced diagnostic imaging services 
that are not subject to the AUC program and that are not otherwise 
identified using the other AUC program modifiers designated to identify 
specific situations where the claims are not subject to the AUC 
program.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Some commenters supported the proposal that the PC for an 
advanced diagnostic imaging service for which the TC was furnished by a 
CAH would also not require AUC consultation information appended to the 
claim. One commenter also supported applying this proposal for any 
other non-applicable sites. One commenter expressed support for 
excluding services when the TC is not furnished in an applicable 
setting. One commenter agreed with the proposal to identify these 
situations using a modifier on the claim.
    Response: We appreciate the comments. We prefer to automate the 
identification of these claims whenever possible and will continue to 
search for a mechanism. For example, we recently determined that a CAH 
can be identified in the CCN by a number 1 in third position and a 
number 3 in the fourth position. We will explore whether we can 
automate an edit in the claims processing system to identify CAH claims 
using the CCN.
    Comment: Some commenters urged CMS to extend the exemption to 
ordering professionals that order advanced diagnostic imaging services 
in CAHs as CAHs have limited resources.
    Response: As discussed in section III.F.3.c. of this final rule, 
section 1834(q)(4)(C) of the Act provides for exceptions to the AUC 
consultation and reporting requirements and these exceptions are 
codified in our regulations in Sec.  414.94(h)(1)(i). We disagree that 
ordering professionals that order advanced diagnostic imaging services 
in a CAH qualify for an exception as specified in the statute and 
regulations and described above in section III.F.3.c. of this final 
rule.
    Comment: Two commenters stated that the MH modifier does not 
describe this situation so a new modifier would need to be created. One 
of these commenters further noted that using modifier MH for CAH 
related claims will impact data integrity by combining CAH providers 
with those that do not provide AUC consultation information.
    Response: We appreciate this comment and further discuss modifier 
MH in section III.F.4.b.viii. of this final rule.
    After consideration of public comments, we are finalizing this 
proposal that claims submitted by physicians or practitioners for the 
PC of an advanced diagnostic imaging service when the TC was not 
furnished in an applicable setting not be subject to the AUC program 
since the setting where the TC of the imaging service is furnished is 
not subject to the AUC program consultation and reporting requirements. 
We are also finalizing the proposal to use a modifier to identify 
practitioner claims for advanced diagnostic imaging services that are 
not subject to the AUC program, like those submitted for advanced 
diagnostic imaging services furnished in a CAH, and that are not 
otherwise identified using the other AUC program modifiers designated 
to identify specific situations where the claims are not subject to the 
AUC program. We further discuss this modifier in section 
III.F.4.b.viii. of this final rule.
iii. Maryland Total Cost of Care Model
    Section 1834(q)(4)(D) of the Act specifies that the applicable 
payment systems for which AUC consultation and reporting requirements 
apply are the PFS, the hospital OPPS and the ASC payment system. We 
define applicable payment system consistent with statute at Sec.  
414.94(b) and, as noted above, require AUC consultation information to 
be reported on Medicare claims for advanced diagnostic imaging 
services, both the PC and TC, furnished in an applicable setting and 
paid under an applicable payment system at Sec.  414.94(k). Section 
1834(q)(4)(B) of the Act specifies that the requirement to report AUC 
consultation information is specific to claims for advanced diagnostic 
imaging services furnished in an applicable setting and paid under an 
applicable payment system. We believe that all claims for the advanced 
diagnostic imaging services, both the PC and TC, must include the AUC 
consultation information when they are furnished both in an applicable 
setting and paid under an applicable payment system. Therefore, if both 
the PC and TC for advanced diagnostic imaging services are not paid 
under an applicable payment system, neither the PC nor TC claim is 
required to include

[[Page 65233]]

AUC consultation information. This ensures consistent application of 
the AUC consultation requirements across claims submitted for advanced 
diagnostic imaging services even when the PC and TC components of the 
service are furnished by different furnishing professionals. Similar to 
claims for the PC of services for which the TC is furnished outside of 
an applicable setting, and because both practitioner and institutional 
claims are subject to the AUC program as discussed above, when the 
practitioner or institutional claim for the advanced imaging service is 
not subject to the AUC program (for example, payment is not made under 
an applicable payment system), the corresponding practitioner or 
institutional claim for the same imaging service is also not subject to 
the AUC program.
    Stakeholders alerted CMS to concerns about whether advanced 
diagnostic imaging services furnished in hospitals participating in the 
Maryland Total Cost of Care Model would be subject to the AUC program. 
We appreciated that this was brought to our attention and we solicited 
comments on other models. Advanced diagnostic imaging services 
furnished in outpatient departments of Maryland hospitals that 
participate in the Hospital Payment Program within the Maryland Total 
Cost of Care Model are not subject to the AUC program because these 
services are not paid under an applicable payment system (Maryland 
hospitals that receive payments under the Hospital Payment Program 
within the Maryland Total Cost of Care Model are not paid under the 
OPPS). Because these services are not subject to the AUC program 
requirements when furnished in a hospital paid under the Hospital 
Payment Program within the Maryland Total Cost of Care Model, as 
opposed to an applicable payment system, we propose that the PCs of 
these advanced diagnostic imaging services, when billed separately, are 
also not required to include AUC consultation information. We believe 
we can identify all institutional claims from a hospital that is paid 
under the Hospital Payment Program within the Maryland Total Cost of 
Care Model based on their CMS Certification Number (CCN) and allow 
those claims to bypass AUC program claims processing edits. We 
understand that when the TC and PC of advanced diagnostic imaging 
services are billed separately, the professional claim must identify in 
box 32 the location where the TC of the imaging service was furnished 
to the patient. Therefore, we believe we will have the ability to 
identify situations in which the imaging service was furnished in a 
hospital that is paid under the Hospital Payment Program within the 
Maryland Total Cost of Care Model and exclude those claims from being 
subject to AUC program claims processing edits. We believe this can be 
accomplished by using the CCN and will continue to work to determine if 
a list of CCNs can be used as the source of our edits in addition to 
determining the frequency that the list will be updated.
    Note that advanced diagnostic imaging services furnished in 
applicable settings in the State of Maryland and paid under an 
applicable payment system are subject to the AUC program--the above 
discussion applies only to the outpatient departments of hospitals that 
are paid under the Hospital Payment Program within the Maryland Total 
Cost of Care Model.
    We received comments on the Maryland Total Cost of Care Model 
related proposals. The following is a summary of the comments we 
received and our responses.
    Comment: One commenter expressed concerns with excluding Maryland 
outpatient hospital departments under the Maryland Total Cost of Care 
Model from the AUC program requirements and instead recommended that 
all Maryland ordering professionals be excluded. The commenter stated 
that excluding outpatient hospital departments under the model will 
have negative unintended consequences. These include acting as an 
incentive for ordering professionals to send Medicare patients to 
hospitals instead of non-hospital entities like imaging centers and 
IDTFs creating a major competitive disadvantage for imaging centers, 
IDTFs and other non-hospital imaging providers in Maryland. The 
commenter stated that it may disrupt existing referral patters and 
continuity of care, is likely to increase cost to Medicare and patients 
through higher out of pocket expenses at high priced hospital 
facilities, will inconvenience patients through longer travel times, 
scheduling delays resulting from higher demand for hospital based 
imaging and limited access due to COVID and related staffing shortages. 
The commenter requested that if Maryland Total Cost of Care Model 
participating outpatient departments are excluded from the AUC program, 
CMS explore ways to restore competitive balance between Maryland 
outpatient departments and non-hospital imaging providers like giving 
ordering professionals more flexibility in meeting AUC consultation 
requirements and/or making AUC a required performance metric under the 
Maryland model. The commenter further requested CMS clarify if 
hospital-owned imaging centers, whether on-campus or off-campus, that 
are paid for advanced diagnostic imaging services according to the PFS 
or OPPS, regardless of provider tax ID number used for billing, are 
still subject to the AUC program.
    Response: We appreciate this comment and understand the concerns 
expressed, however we are unable to modify the AUC requirements and 
applicability in the State of Maryland given the statutory provisions 
that AUC consultation and reporting is required for advanced diagnostic 
imaging services furnished in an applicable setting and paid for under 
an applicable payment system. Since services furnished under the 
Maryland Total Cost of Care Model are not paid under an applicable 
payment system, the advanced diagnostic imaging services furnished 
under the model are not subject to the program requirements. We are 
unable to create an exception for other locations or providers in 
Maryland to offset the potential impact of the model on settings or 
providers that are not included in the model. The AUC program 
requirements apply to advanced diagnostic imaging services furnished in 
an applicable setting and paid under an applicable payment system as 
specified in Sec.  414.94 without exclusion of sites based on ownership 
or the provider tax ID used for billing.
    After consideration of public comments, we will continue to work to 
set up claims processing edits using the CCN in box 32 to identify 
advanced diagnostic imaging services furnished under the Maryland Total 
Cost of Care Model, the claims for which, as discussed above, are not 
subject to the AUC program requirements.
iv. Inpatients Converted to Outpatients
    While uncommon, there are situations in which a beneficiary's 
hospital inpatient status is changed to outpatient. Certain criteria 
must be met for this to occur and, if met, condition code 44 (inpatient 
admission changed to outpatient) is appended to the institutional claim 
(https://www.cms.gov/regulations-and-guidance/guidance/transmittals/downloads/r299cp.pdf). We proposed to allow institutional claims with 
condition code 44 to bypass AUC claims processing edits. We made this 
proposal because, at the time advanced diagnostic imaging services were 
ordered and furnished, they were ordered for and furnished to a 
beneficiary who was in inpatient status. As such, the AUC consultation

[[Page 65234]]

requirement would not have applied at that time. We believe that any 
professional claims would include place of service code 21 (inpatient 
hospital) since the expectation, until just prior to discharge, would 
be that the patient is in an inpatient status. We expect less than half 
of one percent of claims will include condition code 44.
    We received comments on our proposal to allow institutional claims 
with condition code 44 to bypass AUC claims processing edits. The 
following is a summary of the comments we received and our responses.
    Comment: Some commenters agreed with this proposal. Two commenters 
supported the proposal but noted that not all patients moved from 
inpatient to outpatient will be captured with condition code 44 so CMS 
should create an exception for any inpatient order for advanced 
diagnostic imaging services furnished within a short period after the 
inpatient discharge and use a new modifier for these instances where 
inpatient imaging orders are performed in the outpatient setting 
shortly after discharge. One commenter requested that in addition to 
excepting ``inpatient to outpatient''/condition code 44 claims, CMS 
should also except inpatient part A claims that are self-denied or 
denied by an auditor and then rebilled to part B, usually with a 131 or 
121 claim since imaging services were furnished to an inpatient at the 
time.
    Response: We appreciate the comments and disagree that a modifier 
is needed to capture relevant claims. In section III.F.4.b.ix. of this 
final rule, we discuss proposals around what type of bill would be 
subject to the AUC program edits and do not include type of bill 121 
which is used for Medicare Part A/B rebillings for services that 
occurred during the inpatient period. Type of bill 131 is an outpatient 
bill type and is included in the type of bill to which we proposed, and 
are finalizing, to limit claims processing edits. As discussed below, 
we are finalizing this proposal.
    After consideration of public comments, we are finalizing the 
proposal to allow institutional claims with condition code 44 to bypass 
AUC claims processing edits.
v. Deny or Return Claims That Fail AUC Claims Processing Edits
    As discussed above, claims that do not properly include AUC 
consultation information will not be paid once we fully implement the 
AUC claims processing edits. We are considering whether claims that do 
not pass the AUC claims processing edits, and therefore, will not be 
paid, should be initially returned to the health care provider so they 
can be corrected and resubmitted, or should be denied so they can be 
appealed. On one hand, we expect there will be some errors in reporting 
AUC consultation information on claims, especially early on, and health 
care providers might find it helpful to have the opportunity to correct 
claims. However, there may be situations in which the health care 
provider would prefer the claim be denied so they have an earlier 
opportunity to appeal. We requested comments to help us better 
understand which path would be most appropriate once we fully implement 
the AUC program claims edits. Additionally, we requested comments on 
whether the payment penalty phase should begin first with returning 
claims and then transition to denying claims after a period of time, 
which may be helpful to furnishing professionals and facilities as they 
become more proficient in submitting claims under the AUC program.
    We received public comments on which path would be most appropriate 
once we fully implement the AUC program claims edits and whether the 
payment penalty phase should begin first with returning claims and then 
transition to denying claims after a period of time. The following is a 
summary of the comments we received and our responses.
    Comment: Some commenters recommended that claims be returned for 
correction instead of being denied. Some of these commenters noted that 
returning claims affords practitioners the opportunity to correct and 
resubmit which is a faster, easier and less costly process than denying 
and appealing. Other commenters suggested claims be returned at least 
initially for similar reasons. Two of these commenters suggested 
returning claims for the first year of the payment penalty phase and 
then transition to denials, one supported transitioning to denials but 
did not identify a timeframe within which to transition, and two 
commenters suggested revisiting the approach at some point in the 
future to determine if it should be revised. One commenter recommended 
that CMS should allow for correction of claims without complete 
information on the front-end by indicating the claim cannot be accepted 
for processing until it contains necessary information. One commenter 
stated that if CMS decides to deny claims, the denials should be for 
the line-item if AUC information is not present instead of denying the 
whole claim. One commenter suggested that instead of deciding whether 
to deny or return claims, CMS should ensure the program does not result 
in substantial number of claims submission issues for furnishing 
provider claims.
    Response: We appreciate the recommendations and perspectives shared 
by commenters and assure commenters that we working to establish claims 
processing solutions amenable to the practitioners and providers 
impacted by this program to the best of our ability given the 
constraints of the claims processing systems and specifications set 
forth in statute.
    Comment: Two commenters requested CMS clearly outline the claim 
denial process and how it pertains to ordering and furnishing 
providers. One commenter requested further detail and elaboration of 
criteria used in claims processing and auditing as soon as possible so 
institutions can incorporate internal review prior to claims 
submissions.
    Response: We remind readers that the reporting requirements are 
specific to the furnishing professionals as AUC consultation 
information is required on the claim for the advanced diagnostic 
imaging service. Since the ordering professional, unless they are also 
the furnishing professional, does not submit a claim for the advanced 
diagnostic imaging service, the claim denial process would not impact 
them. As we proceed through the process of establishing claims 
processing systems edits and instructions, we will post those documents 
on the AUC website: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program.
    After consideration of public comments, we agree that returning 
claims for correction and resubmission when the payment penalty phase 
begins would be most appropriate. If needed, we may revisit whether 
claims denials are appropriate at some point in the future once 
practitioners become more comfortable with the claims processing 
requirements.
vi. Medicare as a Secondary Payer
    We understand based on feedback from stakeholders that, in some 
EHRs, the primary payer information is readily available and known to 
the ordering professional; however, secondary payer information 
typically is not available. Additionally, it is possible that when 
Medicare is the secondary payer that no Medicare payment would be made 
at all after the primary payer makes payment. Medicare is reported as 
the secondary payer for approximately 1.5 percent of advanced 
diagnostic imaging services

[[Page 65235]]

that are subject to the AUC program. Because the secondary payer 
information for a patient generally is not available to the ordering 
professional, and because no Medicare payment may be involved at all 
when Medicare is the secondary payer, we proposed to exclude claims 
that identify Medicare as the secondary payer from application of the 
AUC consultation and reporting requirements. Specifically, we proposed 
to allow claims that identify Medicare as the secondary payer (using 
block 1 or the electronic equivalent of the practitioner claims and 
using FL 50/51 or the electronic equivalent of institutional claims) to 
bypass the AUC program claims processing edits.
    We received public comments on excluding claims that identify 
Medicare as the secondary payer from application of the AUC 
consultation and reporting requirements. The following is a summary of 
the comments we received and our responses.
    Comment: Several commenters agreed with the proposal to exclude 
claims that identify Medicare as the secondary payer from the AUC 
consultation and reporting requirements. Two commenters stated that if 
this proposal is implemented, it would change how primary and secondary 
payer information is captured in health information technology (HIT) so 
HIT systems would need sufficient advance notice to update accordingly. 
One commenter specified that HIT systems would need a minimum of 18 
months to scope, develop, test and implement new requirements.
    Response: We appreciate the comments and will work to issue claims 
processing instructions as expeditiously as possible.
    Comment: One commenter asked if Medicare Managed Care claims 
require AUC consultation information.
    Response: The AUC program requirements under our regulations are 
specific to fee-for-service Medicare, so Medicare Advantage 
organizations (MAOs) are not required to follow the AUC program 
requirements, and the requirements do not apply to Medicaid. However, 
MAOs might require their contracted providers to follow Medicare AUC 
program procedures, so you would need to contact the MAOs (and any 
other types of plans) for more information about their requirements 
specific to AUC.
    After consideration of public comments, we are finalizing as 
proposed to allow claims that identify Medicare as the secondary payer 
(using block 1 or the electronic equivalent of the practitioner claims 
and using FL 50/51 or the electronic equivalent of institutional 
claims) to bypass the AUC program claims processing edits.
vii. Date of Service and Date of Order
    We will specify a start date for the AUC program claims processing 
edits to take effect. Medicare claims include a date of service but do 
not allow for the date of an imaging order to be recorded. Because we 
cannot identify the order date for an advanced imaging service based on 
claims, we proposed that the AUC program claims processing edits for 
the payment penalty phase will be applicable for advanced imaging 
services furnished on or after the effective date of the claims edits. 
For imaging services ordered prior to, but furnished on or after the 
effective date of the AUC program claims processing edits, the 
furnishing professional would apply the separate HCPCS modifier 
discussed in section III.F.4.b.ii. (Critical Access Hospitals) of this 
final rule to indicate that the claim is not subject to the AUC claims 
processing edits.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Two commenters disagreed with this proposal and instead 
recommended that for services ordered prior to the penalty phase but 
furnished after it begins, CMS should have a grace period within the 
penalty phase for these services which would eliminate the burden 
associated with returning claims. This commenter suggested soft edits 
to establish the end of the grace period based on a decrease in 
potential returns. Some commenters supported this proposal and agreed 
with denoting these claims with a separate modifier.
    Response: Because the time over which advanced diagnostic imaging 
services are ordered for patients with chronic or ongoing conditions 
necessitating repeat imaging is different for each patient, we disagree 
that establishing a grace period to account for these situations is a 
viable option. We believe allowing these claims to instead bypass edits 
based on the presence of a modifier is more appropriate, particularly 
since all other advanced diagnostic imaging services will be subject to 
payment penalties when the payment penalty phase begins. This approach 
would essentially extend the educational and operations testing period 
further.
    After consideration of public comments, we are finalizing as 
proposed our proposal to identify claims for imaging services ordered 
prior to, but furnished on or after the effective date of the AUC 
program claims processing edits, using the separate HCPCS modifier we 
will create to identify claims that are not subject to AUC claims 
processing edits.
viii. HCPCS Modifiers
    We established two primary sets of HCPCS modifiers for this 
program. In the proposed rule we erroneously stated that the first set 
of modifiers, which report whether the imaging service adheres to the 
AUC consulted (modifier ME), does not adhere to the AUC (modifier MF), 
or the qualified CDSM does not contain AUC that applies to the order 
(modifier MG), is to be included on the same claim line as the G-code 
identifying the CDSM that was consulted. This is incorrect and we are 
correcting this mistake with the following revised description of 
modifier placement, consistent with the previously released MLN Matters 
article 11268. The first set, modifiers ME, MF and MG, is to be 
included on the same claim line as the CPT code for the advanced 
diagnostic imaging service. We intend for these modifiers to continue 
to be used when the program enters the payment penalty phase. 
Additionally, reporting of these modifiers should be limited to one per 
qualified CDSM G-code (listed on a separate claim line) since these 
modifiers are mutually exclusive.
    The second set of HCPCS modifiers is available for use when the 
ordering professional does not consult a qualified CDSM. On these 
claims, providers would not add a G-code for a CDSM because a 
consultation did not take place, and the HCPCS modifier would be 
included on the same line as the procedure code for the advanced 
diagnostic imaging service that was furnished. These HCPCS modifiers 
include the three that were created to describe significant hardship 
exceptions (insufficient internet access (modifier MB), EHR or CDSM 
vendor issues (modifier MC) and extreme and uncontrollable 
circumstances (modifier MD)). Additionally, section 1834(q)(4)(C) of 
the Act includes an exception for services ordered for an individual 
with an emergency medical condition and modifier MA is available to 
identify claims for patients with a suspected or confirmed emergency 
medical condition. This set of codes is mutually exclusive and we 
expect only one to be reported per procedure code-level claim line.
    Modifier QQ was created for use during the voluntary period, before 
more detailed modifiers and codes were created, to indicate that an 
ordering professional consulted a qualified CDSM for the service and 
related AUC consultation information was provided

[[Page 65236]]

to the furnishing professional. The descriptor for this code explains 
that the ordering professional consulted a qualified CDSM for this 
service and the related information was provided to the furnishing 
professional. Modifier QQ continues to be available for use through the 
educational and operations testing period, but we intend to end the use 
of that modifier and not carry it forward into the payment penalty 
phase since we have established and will require the use of distinct 
modifiers to communicate specific AUC consultation information.
    Modifier MH was created for use during the educational and 
operations testing phase to identify claims for which AUC consultation 
information was not provided to the furnishing professional and 
furnishing facility. When the AUC program enters the payment penalty 
phase, we will no longer have a need for this modifier because claims 
will be required to include AUC consultation information or indicate a 
reason the information is not required in order to avoid AUC program 
claims processing edits. Beginning for services furnished on and after 
the effective date of the AUC program claims processing edits, we 
proposed to redefine modifier MH to describe situations in which the 
ordering professional is not required to consult AUC and the claim is 
not required to report AUC consultation information. For example, we 
proposed to repurpose modifier MH to be used in the scenarios described 
in sections III.F.4.b.ii. (Critical Access Hospitals), III.F.4.b.iii 
(Maryland Total Cost of Care Model) if other options to identify claims 
are not feasible, and III.F.4.b.vii. (Date of Service and Date of 
Order) of this final rule as those scenarios would fall outside the 
scope of the AUC program requirements.
    We received comments on the modifier discussion and proposals. The 
following is a summary of the comments we received and our responses.
    Comment: Two commenters requested clarification on where the 
modifiers are to be placed on the claim. They noted that the proposed 
rule states that the modifier should be placed on the same line as the 
G-code denoting which qualified CDSM was consulted, however prior 
guidance in MLN Matters article 11268 states that the modifier should 
be placed on the same line as the CPT code for the imaging service.
    Response: Thank you for bringing this to our attention and we 
apologize for the confusion. The description in the proposed rule was 
incorrect and has been revised in this final rule to be consistent with 
the previously communicated instructions in MLN Matters article 11268.
    Comment: One commenter agreed with the proposed modifier 
clarifications. Three commenters supported the proposal to end the use 
of modifier QQ when the payment penalty phase of the program begins.
    Response: We appreciate the comments.
    Comment: Several commenters requested more clarification around the 
use of modifier MA. One commenter asked if MA can only be used in the 
emergency department and another commenter asked if MA applies to 
EMTALA patients generally or only to patients with certain conditions. 
One commenter requested more specific information including guidelines 
for accurate and appropriate use of modifier MA to avoid overuse. 
Another commenter requested that CMS confirm modifier MA includes 
suspected or confirmed emergency medical conditions and recommended 
adding ``suspected or confirmed'' to the regulatory text. One commenter 
requested that CMS ensure this exception accounts for the time-
sensitive evaluation needs of emergency patients.
    Response: We have addressed and provided clarification on the 
emergency services exception, denoted with modifier MA, in notice and 
comment rulemaking in prior years. The statute and regulations do not 
limit the use of this exception, and thus modifier MA, to emergency 
department settings. The exception, as specified in both statute and 
regulation, is for applicable imaging services for individuals with an 
emergency medical condition, which the statute defines with a cross 
reference to section 1867(e)(1) of the Act. The exception may be used 
consistent with the regulations and additional clarification as 
discussed in prior rulemaking. Most recently, in the CY 2019 PFS final 
rule (83 FR 59699), which reiterated clarifications from the CY 2017 
PFS final rule, we reminded readers that we agree that exceptions 
granted for an individual with an emergency medical condition include 
instances where an emergency medical condition is suspected, but not 
yet confirmed. We further stated that this may include, for example, 
instances of severe pain or severe allergic reactions. In these 
instances, the exception is applicable even if it is determined later 
that the patient did not in fact have an emergency medical condition. 
Given the clarifications previously communicated through rulemaking and 
the existing description for modifier MA, we disagree that the 
regulatory text for the emergency services exception requires 
modification or further clarification.
    Comment: One commenter asked what modifier is to be used for 
patients in the emergency department who do not qualify for the 
emergency services exception, but whose insurance is unknown when 
treated (as hospitals do not collect insurance information prior to 
emergency department medical screening), and therefore, a CDSM is not 
triggered. Another commenter requested that all emergency department 
visits be excluded since hospitals approach every patient as if they 
have an emergency medical condition thus requiring AUC consultations 
for emergency room patients without an emergency medical condition 
causes confusion and inconsistent practices within the emergency 
department.
    Response: Because the statute explicitly includes the emergency 
department as an applicable setting under the AUC program, we are 
unable to categorically exclude all advanced diagnostic imaging 
services furnished in the emergency department, including those 
furnished to patients whose insurance is unknown at the time of 
treatment.
    Comment: One commenter asked whether, and if so, how to report low 
acuity scores from CDSM consultations and whether low acuity scores 
will be reimbursed. Another commenter requested CMS clarify if claims 
with modifier MF or MG will be denied during the penalty phase.
    Response: We believe the commenter asking about low acuity scores 
is referring to consultations where the order for the imaging service 
would not adhere to the AUC consulted (modifier MF) and are responding 
under this assumption. The statute specifies that, in order for a claim 
to be paid, information about the appropriateness of the ordered 
service is to be included on the claim. This reflects the certification 
or documentation qualified CDSMs are required to generate at the time 
of order under Sec.  414.94(g)(1)(vi) when an ordering professional 
consults AUC and includes whether the service would adhere to the AUC 
consulted, whether the service would not adhere to the AUC consulted 
and whether the AUC consulted was not applicable to the service. As 
such, both modifier MF or MG may be appended to the claim to meet this 
requirement and the inclusion of these modifiers would not cause the 
claim for the service to be denied during the payment penalty phase.
    Comment: We received many comments on our proposals for modifier 
MH. Two commenters supported the proposals to repurpose modifier MH for

[[Page 65237]]

use in situations in which the ordering professional is not required to 
consult AUC and the claim is not required to report AUC consultation 
information when other modifiers do not apply and claims system edits 
cannot automatically exclude the claims. Two commenters recommended 
repurposing modifier QQ instead of MH and four commenters requested 
modifier MH be maintained and CMS instead create a separate modifier 
for these scenarios. Commenters cited a variety of reasons for their 
disagreement with this proposal. Other commenters requested CMS 
maintain modifier MH unchanged because it will continue to be needed to 
identify situations when the ordering professional does not consult or 
provide AUC information to the furnishing professional. Some commenters 
noted that modifier MH is needed to identify outliers for the prior 
authorization component and two commenters stated that modifier MH was 
specifically created to indicate which ordering professionals were 
outliers so the Secretary can impose requirements to ensure the AUC 
program is followed. Still, other commenters stated that maintaining 
modifier MH is important to avoid imposing burden, like regulatory 
enforcement or follow-up with ordering professionals to track down AUC 
information, on furnishing professionals and facilities. Some 
commenters supported maintaining modifier MH to avoid delays or 
impediments to care. One commenter requested modifier MH be maintained 
at the start of the payment penalty phase as a failsafe to avoid delays 
in care if the ordering professional has not provided AUC consultation 
information. One commenter stated that requiring furnishing providers 
not to provide imaging services for non-compliant clinicians could 
create a dangerous situation where patients are unable to obtain 
medically necessary care. One commenter disagreed with repurposing MH 
because their systems have already been programmed for the current use 
of MH and significant resources would be needed to reprogram and train 
if MH is repurposed. Other commenters recommended creating a new 
modifier instead of repurposing modifier MH to avoid confusion and 
continued reporting of MH for its current use.
    Response: To avoid confusion, CMS agrees with commenters that 
modifier MH should not be repurposed for use on claims as proposed. 
However, we do not agree with commenters requesting that modifier MH be 
maintained for current usage once the payment penalty phase begins 
because such a provision was not specified in statute. The statute 
requires consultations to occur and for specific consultation 
information to be reported on the claim for the subsequently furnished 
imaging service in order for the claim to be paid. Unless an exception 
applies, Congress did not include a caveat excluding claims for 
services ordered by ordering professionals who either did not consult 
AUC or failed to provide consultation information to the furnishing 
professional from the statutory reporting requirements. As such, CMS 
does not have the authority to exclude these scenarios from the AUC 
program requirements. We also note that modifier MH was not created 
specifically to inform the outlier identification and prior 
authorization component of the program, as some commenters believe. 
Instead the other modifiers created to report the appropriateness of 
the consultation will be integral for identifying outlier ordering 
professionals as directed by the statute. Section 1834(q)(5)(B)(i) of 
the Act describes that the determination of an outlier ordering 
professional is to be based on low adherence to applicable AUC without 
mention of ordering professionals who fail to comply with the program 
requirements altogether. The statute does not provide a means for 
excusing or otherwise acknowledging these ordering professionals and we 
do not believe continued use of modifier MH during the payment penalty 
phase is within the parameters of the statute. Therefore, we intend to 
fully retire modifier MH when the payment penalty phase of the program 
begins.
    Comment: One commenter asked if an ordering professional would be 
expected to do something on a pro forma basis to see if the order did 
adhere to applicable AUC guidelines and urged CMS to provide some 
grounding of good faith expectation for the furnishing provider to 
address missing AUC data to correct a claim when the AUC information 
was not originally provided. One commenter recommended that CMS create 
a document for furnishing professionals to use that would assist them 
in explaining to ordering professionals why they are required to 
consult AUC and provide that information with the order because there 
will be situations where the ordering professionals continue to fail to 
provide consultation information which causes the furnishing 
professionals to either provide the service for free or refuse to 
provide the service until the ordering professional provides necessary 
information.
    Response: The AUC program requirements do not include provisions 
for further or additional AUC consultations by ordering professionals. 
We recognize and have discussed the challenging nature of this program 
where the furnishing professional is subject to immediate penalty based 
on the actions (or lack thereof) of the ordering professional, whose 
behavior the furnishing professional is unable to control. Regardless, 
CMS is obligated to implement these statutory provisions and does not 
have the authority to modify or mitigate the requirements. We will 
continue to work on education and outreach and explore opportunities to 
update and expand our written outreach materials which may help to 
inform or remind ordering professionals of their responsibilities under 
the AUC program. Below, we summarize and respond to comments on 
education and outreach, as well as the general nature, utility and 
appropriateness of the AUC program.
    Comment: One commenter stated that, similar to issues with patient 
relationship codes, automatic crossover to non-Medicare secondary 
payers results in denials from secondary insurance when AUC modifiers 
are sent. The claims are denied for invalid modifiers and CMS should 
find a way to strip out the modifiers before submission to secondary 
non-Medicare payers to reduce denials. Two commenters suggested CMS 
consider requesting a new value code to be used for facility reporting 
on a UB-04 when the entity is exempt. One commenter stated that CMS has 
not specified what G-codes or modifiers would be required for reporting 
and this approach has been rejected by the National Uniform Claim 
Committee (NUCC) and National Uniform Billing Committee (NUBC) which 
stated that G-codes and modifiers would be administratively burdensome. 
One commenter requested that CMS ensure there is a simplified tracking 
and reporting system.
    Response: The modifiers the AUC program are valid HCPCS modifiers. 
Health Insurance Portability and Accountability Act of 1996 (HIPAA) 
transaction and code set regulations require all payers to accept all 
valid HCPCS modifiers. We will continue to consider all claims 
processing options. However, through extensive research and engagement 
with stakeholders including the NUCC and NUBC, we have not identified a 
more streamlined and less burdensome approach to capturing all 
statutorily required information on the Medicare claim in real time.
    After consideration of public comments, we are finalizing our 
proposals and ending the use of modifier QQ when the payment penalty

[[Page 65238]]

phase begins. We will establish a new modifier to identify claims for 
services where the ordering professional is not required to consult AUC 
and the already established modifiers do not apply. This new modifier 
will apply when claims system edits cannot automatically exclude the 
claims to include the scenarios discussed in this final rule. 
Therefore, we are not finalizing our proposal to repurpose modifier MH 
for this use and instead, we intend to end the use of modifier MH when 
the payment penalty phase begins.
ix. Additional Claims Processing Information
    Section 1834(q)(1)(D) of the Act specifies the applicable settings 
for the AUC program as a physician's office, a HOPD (including an 
emergency department), and ASC and any other provider-led outpatient 
setting determined appropriate by the Secretary. As discussed in the CY 
2019 PFS final rule (83 FR 59690 and 59691), we added IDTFs to the 
definition of applicable setting at Sec.  414.94(b) to the three 
applicable settings specified in statute because it is a provider-led 
outpatient setting in which advanced diagnostic imaging services are 
furnished by licensed, certified nonphysician personnel under 
appropriate physician supervision. To identify these settings through 
the Medicare claims system we evaluated type of bill and place of 
service codes to identify those aligned with applicable settings under 
the AUC program. For institutional claims, we proposed to limit AUC 
program claims processing edits to apply only to type of bill 13x 
(hospital outpatient). This claim type code encompasses the HOPD and 
the emergency department which represent all applicable settings under 
the program that will bill Medicare using institutional claims. For 
practitioner claims, we proposed to limit the edits to claims with 
place of service codes 11 (office), 15 (mobile unit), 19 (off campus 
outpatient hospital), 22 (on campus outpatient hospital), 23 (emergency 
room) and 24 (ASC). These place of service codes should encompass all 
applicable settings under the AUC program as defined at Sec.  
414.94(b). Because these type of bill and place of service codes 
reflect the applicable settings within which advanced diagnostic 
imaging services must be furnished to be subject to the AUC program 
requirements, we believe setting these parameters will allow us to more 
accurately pay claims while avoiding the need for other types of 
professionals and facilities to append modifiers to their claims.
    We received public comments on limiting AUC program claims 
processing edits to apply only to institutional claims with type of 
bill 13x (hospital outpatient) and limiting the edits to professional 
claims with place of service codes 11 (office), 15 (mobile unit), 19 
(off campus outpatient hospital), 22 (on campus outpatient hospital), 
23 (emergency room) and 24 (ASC). The following is a summary of the 
comments we received and our responses.
    Comment: One commenter noted that the proposals do not include 
claim types or place of service codes for IDTFs and requested that CMS 
clarify how claims processing edits would apply to IDTFs. Two 
commenters agreed with the place of service code proposals.
    Response: We believe the institutional type of bill and 
professional claim place of service codes proposed above include all 
the applicable settings, including IDTFs, within which advanced 
diagnostic imaging services must be furnished to be subject to the AUC 
program requirements. We appreciate the comments.
    After consideration of public comments, we are finalizing as 
proposed.
x. Claims Processing Summary
    We have presented above some of the scenarios that CMS and 
stakeholders have identified as being potentially challenging or 
impracticable for application of the AUC program claims processing 
edits for purposes of the payment penalty phase. We requested feedback 
on whether additional scenarios require consideration and whether the 
proposed claims processing solutions will adequately address the issues 
raised. We also requested feedback on areas that stakeholders believe 
need more education to inform our ongoing outreach and education 
efforts. While much of the discussion is about identifying claims that 
are not subject to the AUC program, we note that physicians and other 
practitioners, or providers submitting claims for advanced imaging 
services that are not subject to the AUC program can voluntarily report 
AUC consultation information. We intend to allow those claims to 
process through the system. We requested commenters to provide 
additional information to assist us in developing edits that ensure 
only appropriate claims are subject to AUC claims processing edits.
c. Timing of Payment Penalties
    We had previously announced in August 2020, via the CMS AUC 
website, that the education and operations testing period of the AUC 
program would be extended through 2021 and the payment penalty phase 
will begin in January 2022. However, given the many complexities around 
the scope and application of AUC program claims processing edits, we 
believe that notice and comment rulemaking is the most appropriate 
means for us to discuss the implementation and claims processing 
issues, the start date of the payment penalty phase, and to obtain 
stakeholder feedback before subsequently finalizing a course of action 
in the final rule. This process will help ensure that we will 
appropriately identify claims for denial when the payment penalty phase 
of the program begins. In addition, we acknowledge the circumstances of 
physicians and other practitioners, and providers, due to the PHE for 
COVID-19 and that additional time may be needed to prepare for the 
payment penalty phase given the challenges and practice disruptions 
they have experienced while responding to the PHE.
    The earliest that our claims processing system can begin screening 
claims using the AUC program claims processing edits for the payment 
penalty phase is October 2022. This is because it would not be possible 
for us to finalize implementation and claims processing plans in this 
final rule (typically published on or before November 1) and make those 
decisions effective any earlier than the 3rd calendar quarter of 2022. 
Implementing the types of claims processing edits necessary for this 
program generally requires a long lead time. However, we note that an 
effective date for the claims processing edits in October 2022 may be 
misaligned with typical annual updates to the systems used by the 
health care providers that are subject to the AUC program such as EHR, 
CDSM or claims submission systems. Therefore, we believe the earliest 
practicable effective date for the AUC program claims processing edits 
and payment penalty phase is January 1, 2023.
    While the above date takes into account technical system and 
programming concerns, it does not expressly take into the account the 
impact that the PHE for COVID-19 has had, and may yet have, on 
practitioners, providers and beneficiaries. Therefore, we proposed a 
flexible effective date for AUC program claims processing edits and 
payment penalty phase to begin the later of January 1, 2023, or the 
January 1 that follows the declared end of the PHE for COVID-19.
    We acknowledge that the AUC program has been significantly delayed. 
We solicited public comment on this

[[Page 65239]]

proposal for the payment penalty phase to begin, and whether we have 
appropriately taken into account the PHE for COVID-19 and other 
factors. We recognize that some practitioners and institutions have 
already invested in qualified CDSMs, while others have had to redirect 
their resources during the PHE. We solicited information from the 
public on the state of readiness of practitioners, facilities, and EHR 
and CDSM vendors.
    We received public comments on these proposals for the start of the 
payment penalty phase of the AUC program. The following is a summary of 
the comments we received and our responses.
    Comment: One commenter requested no further delay to starting the 
program, and 94 commenters supported the proposal to begin the payment 
penalty of the program on the later of January 1, 2023 or the January 1 
of the year after the year in which the PHE for COVID-19 ends. One 
commenter supported delaying the start of the payment penalty phase in 
2022, but encouraged full implementation in 2023, another commenter 
requested CMS ensure full implementation in 2023. One commenter 
requested the payment penalty phase be delayed until 2024, while other 
commenters requested the payment penalty phase not begin until January 
1, 2024 or January 1 of the year after the year in which the PHE ends, 
whichever is later. One of these commenters recommended this timeframe 
to ensure a testing year with all coding and billing requirements in 
place to allow time for HIT developers to make software changes to 
accommodate claims processing requirements. One commenter stated that 
physicians must be given at least 12 months to prepare for the penalty 
phase of the program once CMS makes public that all claims processing 
edits have been made and tested successfully. One commenter stressed 
the importance of ensuring physicians have the opportunity to adjust to 
the AUC program in a thoughtful and deliberate manner that would allow 
interoperability and the opportunity to develop solutions for data 
exchange between the ordering and furnishing professionals to leverage 
IT to reduce burden and suggested gradual implementation where claims 
are paid regardless of whether information is included on the claim. 
One commenter recommended using 2023 as an educational year where 
claims with errors are returned for correction without any financial 
penalty or denial due to AUC and implement the payment penalty phase no 
earlier than 2024. Another commenter suggested that CMS continue 
voluntary participation where AUC consultation using a CDSM is not 
required and reimbursement is not contingent on documentation of 
consultation on the furnishing professional's claim.
    Two commenters stated that they do not support the AUC program, one 
commenter requested that the AUC program should be abandoned and 
another commenter requested that the policy be revoked because it 
impacts timely access to care. Two commenters, citing implementation 
challenges and costs, stated that it is inconsistent with the best 
interests of Medicare and practices to divert resources from patient 
care to fully implement the AUC program. Another commenter asserted 
that imposing AUC requirements on ordering professionals for 
radiologists to be paid will be an ``administrative nightmare.'' One 
commenter noted that hospitals are working on the implementation of AUC 
within their systems and the process has not been easy. Several 
commenters addressed the burden of the AUC program requesting that CMS 
ensure a least burdensome approach for implementation and work to 
alleviate burden and improve relevance of the program to physicians and 
Medicare. One commenter noted that, as designed, the AUC program does 
not foster the type of education about AUC that is necessary for AUC to 
have its intended effect.
    Other commenters offered suggestions on further delays. Some 
commenters suggested the program not progress to the payment penalty 
phase until the vast majority of claims would meet the requirements to 
be paid. One commenter encouraged CMS to continue to analyze claims to 
ensure significantly higher percentage of claims report compliant AUC 
information and consider additional delays in the future. Another 
commenter also requested that CMS continue to monitor claims and 
consider deferring the payment penalty phase until at least 75 percent 
of claims for advanced diagnostic imaging services for the particular 
clinical specialty include adequate information for payment. Two 
commenters recommended CMS delay the program and solicit feedback on 
whether it requires updating before full implementation. Two commenters 
suggested additional delays and one commenter suggested indefinite 
delay. One commenter supported further delay in the absence of full 
program repeal with consideration for the overlap and duplicative 
burden with Medicare quality programs.
    Commenters offered additional opinions on the AUC program in light 
of Medicare quality programs. Seven commenters asserted that the AUC 
program is unnecessary for APM participants because they are 
accountable for quality and cost of care, including incentives to 
reduce unnecessary imaging. These commenters noted that the AUC program 
does not consider quality, patient outcomes or other important factors 
more appropriately addressed in APMs. Two commenters requested CMS 
consider if a stand-alone AUC program is necessary or if requirements 
are redundant for QPP participants and one commenter requested CMS 
consider combining the AUC program with existing quality programs. One 
commenter suggested CMS consider aligning the goals and requirements of 
the AUC program with APMs and quality reporting programs to minimize 
burden and duplication. Other commenters requested CMS reduce burden of 
the AUC program since it has been superseded by the QPP. One commenter 
expressed disappointment at the absence of dialogue about how existing 
quality programs can be leveraged to encourage AUC consultation.
    Some commenters suggested alternate options for enforcing 
compliance with AUC consultation requirements. Two commenters 
recommended allowing the use of qualified clinical data registries and 
another commenter recommended collecting requisite data directly from 
CDSMs. One commenter requested an annual attestation and CDSM audit 
approach and another suggested replacing claim-by-claim adjudication 
with provider attestation. Two commenters recommended CMS consider 
limiting AUC reporting to priority areas. Two commenters suggested 
revising the program so that payment penalties are paid by the 
referring physician and not the rendering provider. One commenter 
recommended CMS re-evaluate the foundational design of the program and 
the value it brings relative to potential burden and disruptions to 
clinical workflow. One commenter suggested a better solution than the 
AUC program would be to have rheumatology societies, orthopedic 
societies and primary care societies write best practice white papers, 
incorporate those guidelines into training and into a quality measure 
for those specialties.
    Some commenters recommended that CMS engage with Congress to 
address the future of the AUC program. Two commenters requested the 
program be further delayed so CMS can work with

[[Page 65240]]

Congress to re-evaluate the feasibility and utility of the program and 
how appropriate use of imaging can be addressed through the QPP or 
other value-based initiatives and one commenter recommended CMS work 
with Congress to evaluate the validity of the AUC program given the 
significant time lapse between program inception and implementation. 
Some commenters also referenced the provision accompanying H.R. 4502 
directing CMS to prepare a report to Congress on program 
implementation. Specifically, H. Rept. 117-96 ``requests a report 
within 180 days of enactment of this Act on implementation of this 
program, including challenges and successes. In this report, CMS shall 
consider existing quality improvement programs and relevant models 
authorized under section 1115A of the Act and their influence on 
encouraging appropriate use of advanced diagnostic imaging. The 
Committee directs CMS to consult with stakeholders, including medical 
professional societies and developers of AUC and clinical guidelines, 
when formulating its report.'' \91\ One commenter requested that CMS 
work expeditiously and in consultation with medical societies to 
fulfill the Congressional request once the appropriations bill is 
finalized and that the report include a comprehensive examination of 
existing and emerging quality improvement programs and relevant models 
being pursued by CMS Innovation Center and how they can influence 
appropriate use of advanced diagnostic imaging.
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    Many commenters requested that CMS use the additional time 
resulting from the proposed delay of the payment penalty phase to 
increase education and outreach efforts. One commenter shared that 
radiology practices are finding that ordering professionals are non-
compliant and hospitals are non-responsive, thinking that they are not 
required to comply with the AUC program requirements so more education 
and webinars are needed. Commenters encouraged stakeholder engagement 
and identification of additional guidance and new flexibilities, 
significant education and technical assistance efforts, ongoing 
dialogue with providers and CDSM vendors to resolve remaining 
implementation issues and feedback on best practices. One commenter 
requested CMS provide regular program updates quarterly beginning at 
the end of the first quarter of 2022 on the status of implementation 
and the anticipated payment penalty start date. One commenter stated 
that CMS initiate an education and outreach campaign akin to efforts 
for operationalizing the new Medicare Beneficiary Identifier. Several 
commenters requested CMS release claims information more frequently. 
One commenter requested quarterly claims data updates about AUC 
reporting uptake and common errors. One commenter requested that CMS 
release more detailed information on claims that were compliant with 
AUC, particularly what percentage included modifier MH. This commenter 
stated that a high percentage of claims with modifier MH would indicate 
that citing a 9-10 percent compliance rate in the proposed rule is 
disingenuous since modifier MH likely indicates that the ordering 
professional and furnishing professional have not established a 
communication process and those claims would have been denied in the 
payment penalty phase.
    Response: We appreciate the extensive and thoughtful comments and 
recommendations on the AUC program and the proposal to begin the 
payment penalty phase of the program on the later of January 1, 2023, 
or the January 1 that follows the declared end of the PHE for COVID-19. 
We also appreciate that stakeholders would like CMS to do more to 
address the extensive concerns stakeholders have about the 
appropriateness of the AUC program. However, we note that this program 
is required by statute, and must implement the program within the 
bounds of our statutory authority. We will continue to explore 
opportunities for reducing burden of the AUC program by leveraging 
other quality programs within the provisions set forth in statute. We 
further appreciate the requests and suggestions for expanded education 
and outreach efforts. We will continue to make information available on 
the AUC website and explore more opportunities for increasing these 
efforts and the scope of information available, including reporting 
compliance during the remainder of the educational and operations 
testing period, to assist all stakeholders in better understanding and 
complying with the AUC program requirements.
    After consideration of public comments, we are finalizing our 
proposal to begin the payment penalty phase of the AUC program on the 
later of January 1, 2023 or the January 1 that follows the declared end 
of the PHE for COVID-19.
5. Summary
    In summary, we provided clarifications and proposals around the 
scope of the AUC program specifically pertaining to updates or 
modifications to orders for advanced diagnostic imaging services and 
the extreme and uncontrollable circumstances significant hardship 
exception. We also proposed several claims processing solutions to 
ensure accurate identification of claims that are and are not subject 
to the AUC program requirements. These proposals addressed special 
circumstances related to: services furnished by a CAH, services paid 
under the Maryland Total Cost of Care Model, inpatients converted to 
outpatients, situations when Medicare is the secondary payer, and 
imaging services ordered prior to the payment penalty phase but 
furnished on or after the start of the payment penalty phase. We also 
discussed identifying the ordering professional on practitioner claims 
for the imaging service and request feedback on whether it is more 
appropriate to deny or return claims that fail AUC claims processing 
edits. We also proposed to begin the AUC claims processing systems 
edits and payment penalty phase of the program on the later of January 
1, 2023, or the January 1 of the year after the year in which the PHE 
for COVID-19 ends. We invited the public to submit comments on these 
clarifications and proposals.
    We are finalizing all proposals except our proposal to repurpose 
modifier MH. Specifically, we are finalizing the following:
    Provisions specific to orders for advanced diagnostic imaging 
services that are modified in accordance with chapter 15, sections 
80.6.1-4 of the Medicare BPM. When the ordering professional cannot be 
reached to submit a new order, the AUC consultation information that 
accompanied the original order is to be included on the claim for the 
imaging service(s) ultimately furnished.
    Claims submitted by physicians or practitioners for the PC of an 
advanced diagnostic imaging service when the TC was not furnished in an 
applicable setting are not subject to the AUC program since the setting 
where the TC of the imaging service is furnished is not subject to the 
AUC program consultation and reporting requirements. A new HCPCS 
modifier will be established to identify claims for services where the 
ordering professional is not required to consult AUC and when 
previously established modifiers described above (MA-MG) do not apply. 
These are claims for which system edits cannot automatically exclude 
the claim. This new modifier will be used to identify practitioner 
claims for the PC of advanced diagnostic imaging services

[[Page 65241]]

that are not subject to the AUC program because the TC was not 
furnished in an applicable setting and when CMS has not identified an 
automated mechanism to identify the claim.
    We will allow institutional claims with condition code 44 to bypass 
AUC claims processing edits.
    We will allow claims that identify Medicare as the secondary payer 
(using block 1 or the electronic equivalent of the practitioner claims 
and using FL 50/51 or the electronic equivalent of institutional 
claims) to bypass the AUC program claims processing edits.
    For imaging services ordered prior to, but furnished on or after 
the effective date of the AUC program claims processing edits, the 
furnishing professional is to apply the new HCPCS modifier that will be 
created as discussed above for use on claims for advanced diagnostic 
imaging services that are not subject to the AUC program that are not 
otherwise identified by modifiers MA--MG or edits within the claims 
processing system.
    End the use of modifier QQ when the payment penalty phase begins 
and use a specific modifier to identify scenarios where the ordering 
professional is not required to consult AUC and the claim is not 
required to report AUC consultation information when other modifiers do 
not apply and claims system edits cannot automatically exclude the 
claims. We will not finalize as proposed, to repurpose modifier MH for 
this purpose. Instead, we will establish a new HCPCS modifier and 
intend to end the use of modifier MH when the payment penalty phase 
begins.
    Limit AUC program claims processing edits to apply only to 
institutional claim type of bill 13x (hospital outpatient) and, for 
professional claims, limit the edits to claims with place of service 
codes 11 (office), 15 (mobile unit), 19 (off campus outpatient 
hospital), 22 (on campus outpatient hospital), 23 (emergency room) and 
24 (ASC).
    Begin the payment penalty phase to begin the later of January 1, 
2023, or the January 1 that follows the declared end of the PHE for 
COVID-19.
    We will continue to post information on our website for this 
program, accessible at www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/index.html.

G. Removal of Selected National Coverage Determinations

    CMS periodically identifies and removes National Coverage 
Determinations (NCDs) that no longer contain clinically pertinent and 
current information, in other words those items and services that no 
longer reflect current medical practice, or that involve items or 
services that are used infrequently by beneficiaries. Clinical science 
and technology evolve, and items and services that were once considered 
state-of-the-art or cutting edge and experimental may be established as 
reasonable and necessary for Medicare beneficiaries or replaced by more 
beneficial technologies or clinical paradigms.
    In the CY 2021 PFS final rule (85 FR 84472), we established 
rulemaking as an appropriate vehicle for receiving public comment on 
removing outdated NCDs, replacing the prior subregulatory 
administrative process used on two occasions in 2013 and 2015. Using 
rulemaking under section 1871(a)(2) of the Act allows us to consider 
removal of several NCDs at once as compared to the public comment 
process established in section 1862(l) of the Act, to be used in making 
and reconsidering individual NCDs.
    Eliminating an NCD that provides national coverage for items and 
services means that the item or service will no longer be automatically 
covered by Medicare (42 CFR 405.1060). Instead, the initial coverage 
determinations for those items and services will be made by local 
Medicare Administrative Contractors (MACs). On the other hand, removing 
an NCD that bars coverage for an item or service under title XVIII of 
the Act (that is, national noncoverage NCD), allows MACs to cover the 
item or service if the MAC determines that such action is appropriate 
under the statute. Removing a national non-coverage NCD may permit more 
immediate access to technologies that may now be beneficial for some 
uses. As the scientific community continues to conduct research, which 
produces new evidence, the evidence base we previously reviewed may 
have evolved to support other policy conclusions.
    In the CY 2021 PFS final rule, we did not establish an exclusive 
list of criteria that we would use for identifying and evaluating NCDs 
for removal. Instead, based on recommendations in public comments, and 
to be more flexible and nimble, we added considerations to the six 
factors established in 2013 to guide our decision making process. In 
addition to the six factors listed below, we also consider the general 
age of an NCD, changes in medical practice/standard of care, the pace 
of medical technology development since the last determination, and 
availability and quality of clinical evidence and information to 
support removal of an NCD. We would consider proposing the removal of 
an NCD if any of the following factors are present:
     We believe that allowing local contractor discretion to 
make a coverage decision better serves the needs of the Medicare 
program and its beneficiaries.
     The technology is generally acknowledged to be obsolete 
and is no longer marketed.
     In the case of a noncoverage NCD based on the experimental 
status of an item or service, the item or service in the NCD is no 
longer considered experimental.
     The NCD has been superseded by subsequent Medicare policy.
     The national policy does not meet the definition of an 
``NCD'' as defined in sections 1862(l) or 1869(f) of the Act.
     The benefit category determination is no longer consistent 
with a category in the statute.
    When we evaluate particular NCDs for removal, we take into account 
information gathered from stakeholders, the claims data for those items 
and services, and factors such as whether there may be documentation 
requirements within the NCD that are outdated and create a barrier to 
coverage. The rulemaking process provides an opportunity to consider 
public input before the NCD would be removed. We could decide to retain 
those NCDs after considering public comments.
    In Table 33, we list the NCDs that we proposed to remove. In 
addition to conducting an internal review to identify appropriate NCDs 
for removal, we receive removal requests from a variety of external 
stakeholders, such as medical specialty societies, device 
manufacturers, beneficiaries, physicians and providers, and other 
interested individuals. Additionally, sometimes topics are brought to 
our attention by the MAC medical directors. Also, we received comments 
to the NCD Removal proposal in response to the CY 2021 PFS proposed 
rule suggesting another seven NCDs for CMS to consider removing. After 
reviewing those comments and considering other available evidence and 
information, we proposed to remove one of those seven NCDs in this 
rulemaking cycle. We have opened a national coverage analysis (NCA) 
using the NCD process for one and stated in the CY 2021 PFS proposed 
rule that we believed the other five NCDs should be retained.
    We solicited comment on the two NCDs discussed in Table 33, as well 
as comments recommending other NCDs for CMS to consider for removal in 
a future rulemaking or through the NCD process.

[[Page 65242]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.055

    The following outlines each NCD and provides a summary of the 
rationale for removal. Each of the current NCDs below is available in 
the Medicare National Coverage Determinations Manual located at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.
1. NCD 180.2 Enteral and Parenteral Nutritional Therapy (July 11, 1984)
     Circumstances/Factor: We believe that allowing local 
contractor discretion to make a coverage decision better serves the 
needs of the Medicare program and its beneficiaries.
     Rationale: External stakeholders suggested that portions 
of this NCD are outdated. Enteral nutrition is the delivery of food to 
a patient with a functioning gastrointestinal tract who, due to 
pathology to, or non-function of the structures that normally permit 
food to reach the digestive tract, cannot maintain weight and strength. 
Enteral nutrition is provided through a nasogastric, jejunostomy, or 
gastrostomy tube. Parenteral nutrition is provided intravenously to the 
patient with pathology of the alimentary tract severe enough, that it 
does not allow for absorption of sufficient nutrients. This NCD does 
not provide as a matter of course, for pharmacy prepared parental 
solutions, which would increase patient safety. It also unnecessarily 
adds to patient and provider burden as it requires repeated reviews of 
medical necessity for those individuals who need enteral or parenteral 
nutrition services as a result of chronic diseases that affect the 
ability to eat or to digest/absorb nutrition. Local contractors have 
proposed LCDs that, if finalized, would provide parenteral and enteral 
nutrition coverage for certain Medicare beneficiaries. Therefore, we 
believe that removing this NCD would better serve the needs of the 
Medicare program and its beneficiaries.
2. NCD 220.6 Positron Emission Tomography (PET) Scans (September 3, 
2013)
     Circumstances/Factor: We believe that allowing local 
contractor discretion to make a coverage decision better serves the 
needs of the Medicare program and its beneficiaries.
     Rationale: External stakeholders suggested this NCD may be 
outdated. NCD 220.6 established broad national non-coverage for non-
oncologic indications of PET and was established in 2000. Thus, we 
required that every non-oncologic indication for PET must have its own 
NCD in order to receive coverage. In 2013, we reconsidered the NCD to 
allow coverage for diagnostic PET imaging for oncologic uses not 
already determined by an NCD, to be made at the discretion of local 
MACs, due to ``various improvements in the technical, regulatory and 
professional aspects of PET imaging for diagnosis.'' Since the 2013 
reconsideration, new non-oncologic PET agents have been approved by the 
FDA and multiple professional medical societies have published 
guidelines relevant to appropriate use of these agents. We believe that 
local contractor discretion provides an immediate avenue to potential 
coverage in appropriate candidates for non-oncologic indications. 
Therefore, we proposed to eliminate subsection 220.6 to remove the 
broad national bar to coverage of PET scans for non-oncologic 
indications, thus allowing local Medicare contractors to make a 
coverage determination under section 1862(a)(1)(A) of the Act for 
beneficiaries. We believe this framework better serves the needs of the 
Medicare program and its beneficiaries. For clarity, we did not propose 
to change any other subsections of 220.6. Thus, the NCDs listed at 
220.6.1 through 220.6.20 will not be changed by removing this NCD.
    In summary, we solicited comment on the proposal to remove the two 
NCDs, as well as comments recommending other NCDs for CMS to consider 
for future removal. We requested commenters include a rationale to 
support their comments. We use the public comments to help inform our 
decision to take one of three actions on the three NCDs proposed for 
removal:
     Remove the NCD, as proposed, allowing for coverage to be 
determined by the MACs.
     Retain the current policy as an NCD.
     Reconsider the NCD by opening a National Coverage 
Analysis. Comments suggesting that the NCD should be revised, rather 
than eliminated, should include new evidence that was not previously 
available at the time of the original NCD or at the time the NCD was 
last reconsidered, in order to support a change in national coverage.
    We received public comments on the Removal of Selected National 
Coverage Determinations (NCDs). The following is a summary of the 
comments we received and our responses.
    Comment: Many commenters supported removing NCD 220.6 Positron 
Emission Tomography (PET) Scans. No commenters opposed removing this 
NCD. Several commenters additionally offered suggestions for 
replacement language to be placed in Pub. 100-3 the Medicare National 
Coverage Determinations (NCD) Manual to specify that non-oncologic uses 
of PET will be at MAC discretion.
    Response: We thank commenters for their support and for suggested 
revisions to the NCD Manual. We will finalize removal as proposed. When 
we remove an NCD, as part of the implementation process we update the 
applicable section of the Manual. We generally replace the prior NCD 
Manual section with language indicating that the NCD has been removed 
and that in the absence of an NCD, coverage determinations will be made 
by the MACs under section 1862(a)(1)(A) of the Act.
    Comment: One commenter, while supporting removal of NCD 220.6, 
expressed concern that we might also remove NCDs 220.6.1 PET for 
Perfusion of the Heart and 220.6.8 FDG PET for Myocardial Viability.
    Response: We did not propose to remove NCDs 220.6.1 or 220.6.8. The 
NCDs listed at 220.6.1 through 220.6.20 are not repealed or changed.
    Comment: Several commenters supported the removal of NCD 180.2 
Enteral and Parenteral Nutritional Therapy. One commenter stated that 
local coverage will create opportunities for new guidance through new 
coverage articles and coding guidance and will increase the opportunity 
to for the commenter to provide the best care possible to Medicare 
beneficiaries. Several commenters agreed that the 1984 NCD is outdated 
and does not reflect current clinical practice. Several commenters 
agreed with CMS' goal of

[[Page 65243]]

improving patient access, as well as efficacy and safety and several 
agreed that removing this NCD would better serve the needs of the 
Medicare program and its beneficiaries.
    Response: We thank commenters for their support.
    Comment: Several commenters requested that instead of removing NCD 
180.2 that CMS reconsider the NCD. A few of these commenters also cited 
general concerns about allowing MACs to make local coverage 
determinations (LCDs) including perceived discrepancies in the 
availability of coverage across regions of the country.
    Response: We appreciate the commenters' suggestion, but because the 
current NCD is outdated we believe it should be removed, rather than 
revised through the NCD process. As we have noted, the NCD does not 
provide as a matter of course, for coverage of pharmacy prepared 
parenteral solutions. Removing the NCD is the fastest way to enable 
coverage for pharmacy developed formulas and to advance patient safety. 
The NCD also unnecessarily adds to patient and provider burden as it 
requires repeated reviews of medical necessity for those individuals 
who need enteral or parenteral nutrition services as a result of 
chronic diseases that affect the ability to eat or to digest/absorb 
nutrition. Therefore, we believe that removing this NCD would better 
serve the needs of the Medicare program and its beneficiaries, instead 
of reconsidering and revising the NCD.
    Comment: Some commenters requested that CMS reconsider NCD 180.2 
and create a new benefit category for enteral and parenteral nutrition 
to encompass more than the current statutory definition of prosthetic 
devices. We also received several comments requesting that CMS either 
reconsider NCD 180.2 or open a new NCA to add coverage for amino acid 
supplements and medical foods for Inborn Errors of Metabolism (IEM), 
such as Phenylketonuria, Maple Syrup Urine Disease, and Homocystinuria.
    Response: The scope of benefits available to eligible Medicare 
beneficiaries under Parts A and B is prescribed by law in title XVIII 
of the Act. See sections 1812, 1833, and 1861(s) (definition of medical 
and other health services) of the Act. Congress has not empowered the 
Secretary to establish and add new benefit categories. We have covered 
parenteral and enteral nutrition based on the prosthetic devices 
benefit in section 1861(s)(8) of the Act for certain patients. Enteral 
nutrition is the delivery of food to a patient with a functioning 
gastrointestinal tract who, due to pathology to, or non-function of the 
structures that normally permit food to reach the digestive tract, 
cannot maintain weight and strength. Enteral nutrition is provided 
through a nasogastric, jejunostomy, or gastrostomy tube. Parenteral 
nutrition is provided intravenously to the patient with pathology of 
the alimentary tract severe enough, that it does not allow for 
absorption of sufficient nutrients. We do not have the authority to 
establish new Medicare benefit categories or to establish coverage 
through NCDs for items or services that fall outside the scope of the 
Medicare Part A or Part B benefits prescribed in the Act. We do not 
have authority under the current statute to cover oral nutritional 
material for patients whose medical condition would not require a 
prosthetic device.
    Comment: Some commenters stated that nutritional supplements for 
IEM should be considered and covered as medications.
    Response: Although Medicare does cover certain drugs and 
biologicals under Part B, the nutritional materials do not meet the 
statutory definition of drugs under the statutory definition in 
section1861(t)(1) of the Act because they do not have a monograph in 
USP-NF (the United States Pharmacopeia (USP) and the National Formulary 
(NF)).
    Comment: Some commenters discussing coverage for IEM expressed 
fears that the proposal to remove NCD 180.2 will take away their 
current coverage for these nutritional formulas for their children or 
family members under other health insurance programs.
    Response: A Medicare NCD establishes whether or not an item or 
service is covered nationally under Title XVIII of the Act. Although 
the NCD is a controlling authority for Medicare contractors and 
Administrative Law Judges as specified in Sec.  405.1060, it does not 
have the force of law and is not controlling for other programs.
    Comment: One commenter requested that CMS require the MACs to act 
quickly to update local coverage decisions and applicable coverage 
articles.
    Response: We understand that the MACs have completed updates to two 
LCDs, one each for enteral nutrition and parenteral nutrition, and 
associated coverage articles which became effective for services 
performed on or after September 5, 2021, and apply to each of the DME 
MACs.
    Comment: Several commenters were also concerned that the new LCDs 
that recently became effective in September 2021, as well as other CMS 
manuals and local coverage articles still follow and reference NCD 
180.2.
    Response: Once our NCD is removed from the National Coverage 
Determinations Manual, we will coordinate any necessary technical 
changes to remove cross-references to the removed NCD 180.2 from any, 
LCDs, CMS manuals, guidance documents, or articles.
    Comment: A few commenters requested that CMS address in NCD 180.2 
the role of registered dietician nutritionists (RDNs) as part of the 
health care team in supporting both the ordering physician and the 
Medicare beneficiary in developing, implementing, and monitoring the 
enteral or parental nutrition plan of care. The commenters also 
requested CMS provide coverage for medical nutrition therapy (MNT) 
provided by RDNs for enteral and parenteral nutrition therapy.
    Response: The Enteral and Parenteral Nutritional Therapy NCD (NCD 
180.2) does not include a discussion of coverage for related 
practitioner services or Medical Nutrition Therapy that is addressed in 
a separate regulation. We are not accepting the commenters' suggestion 
to retain and revise the NCD to address those issues. We are, however, 
addressing other issues related to Medical Nutrition Therapy separately 
in this final rule.
    Comment: Some commenters recommended additional NCDs for future 
removal including: NCD 20.7 Percutaneous Transluminal Angioplasty 
(PTA); NCD 140.1 Abortion; NCD 160.22 Ambulatory EEG Monitoring; NCD 
220.6.19 Positron Emission Tomography (NaF-18) to Identify Bone 
Metastasis of Cancer; NCD 220.6.20 Beta Amyloid Positron Tomography in 
Dementia and Neurodegenerative Disease; NCD 220.13 Percutaneous Image-
Guided Breast Biopsy; NCD 230.2 Uroflowmetric Evaluations; NCD 230.11 
Diagnostic Pap Smears; and NCD 230.16 Bladder Stimulators (Pacemakers).
    Response: We thank commenters for their recommendations and will 
take the suggestions under advisement for future review.
    Comment: One commenter, while agreeing with using the rulemaking 
process to remove NCDs, stated that 10 years may be too long to keep 
pace with current science and clinical developments. The commenter 
suggested that a ``hybrid of annual review as an opportunity to remove 
obviously outdated NCDs with 10 years as a marker for an additional 
level of scrutiny may be effective to maintain NCD relevance''. The 
commenter stated that this would require an additional

[[Page 65244]]

level of effort and commitment that may prove challenging for CMS and 
stakeholders to manage.
    Response: We appreciate the commenter's recommendation and agree 
that this would prove challenging for CMS to manage. We will consider 
whether the hybrid approach could be included as part of our internal 
process. We acknowledge the rapid pace of medical technology 
development and changes in standard of care and/or clinical evidence 
may occur more rapidly than every 10 years, and we will consider those 
factors, as well as we evaluate whether existing NCDs should be 
removed.
    After consideration of public comments, we are finalizing as 
proposed removal of both NCD 180.2 Enteral and Parenteral Nutrition 
Therapy and NCD 220.6 Positron Emission Tomography (PET) Scans because 
removing these two NCDs better serves the needs of the Medicare program 
and its beneficiaries.

H. Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive 
Cardiac Rehabilitation

    Conditions of coverage for pulmonary rehabilitation (PR), cardiac 
rehabilitation (CR) and intensive cardiac rehabilitation (ICR) are 
codified at 42 CFR 410.47 and 410.49. We proposed revisions to the PR 
and CR/ICR regulations to emphasize that though one program treats a 
respiratory disease and one treats cardiac conditions, both types of 
programs aim to improve quality of life for their participants using 
similar methods. Because many components are shared between PR and CR/
ICR, we strive to ensure consistency in the regulatory language used 
for these therapeutic programs. Additionally, we proposed to more 
closely conform the PR and CR regulations by removing a PR requirement, 
and to add COVID-19 as a covered condition for PR for certain 
beneficiaries. As discussed by Fleg and colleagues (2020),\92\ CR and 
PR continue to be severely underutilized despite clear benefits on 
clinical and patient-centered outcomes. In fact, Million Hearts[supreg] 
2022, a national initiative co-led by the Centers for Disease Control 
and Prevention (CDC) and CMS to prevent 1 million heart attacks and 
strokes within 5 years, has incorporated a goal for increasing CR 
utilization. Million Hearts[supreg] worked with CR professionals to set 
a goal of 70 percent CR participation for eligible patients.\93\ With 
these proposals to improve accuracy and consistency of the regulatory 
language specifying Medicare conditions of coverage for PR and CR/ICR, 
we hope to assist programs to better understand the PR and CR/ICR 
conditions of coverage.
---------------------------------------------------------------------------

    \92\ 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.
    \93\ https://millionhearts.hhs.gov/tools-protocols/action-guides/cardiac-change-package/index.html.
---------------------------------------------------------------------------

    We received 29 public comments on these proposals. Commenters 
overwhelmingly supported adding COVID-19 as a covered condition for PR 
for certain beneficiaries. Commenters also largely agreed with the 
proposed revisions to the PR and CR/ICR regulatory text to improve 
consistency and accuracy across PR and CR/ICR conditions of coverage.
    In the following sections, we provide detailed summaries and 
responses to the comments submitted on these proposals.
1. Statutory Authority
    Section 144(a) of the Medicare Improvements for Patients and 
Providers Act of 2008 (Pub. L. 110-275, July 15, 2008) (MIPPA) amended 
Title XVIII to add new section 1861(eee) of the Act to provide coverage 
of CR and ICR under Medicare part B, as well as new section 1861(fff) 
of the Act to provide coverage of PR under Medicare part B. The statute 
specified certain conditions for coverage of these services and an 
effective date of January 1, 2010. Conditions of coverage for PR, CR 
and ICR consistent with the statutory provisions of section 144(a) of 
the MIPPA were codified in Sec. Sec.  410.47 and 410.49 respectively 
through the CY 2010 PFS final rule with comment period (74 FR 61872 
through 61886 and 62002 through 62003 (PR) 62004 through 62005 (CR/
ICR)).
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 expanded coverage of PR 
further using the NCD process.
    The conditions of coverage for CR and ICR set forth in MIPPA were 
codified in Sec.  410.49 through the CY 2010 PFS final rule with 
comment period. In 2014, we expanded 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 Bipartisan Budget Act (Pub. L. 115-123, 
February 9, 2018) (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).
    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.
    As set forth in statute, PR, CR and ICR are programs furnishing 
physician-supervised items and services that may be furnished in a 
physician's office or hospital outpatient setting or in other settings 
determined appropriate by the Secretary.\94\ When items and services 
are furnished under these programs, a physician must be immediately 
available and accessible for medical consultation and medical 
emergencies. PR, CR and ICR programs must include: Physician-prescribed 
exercise, psychosocial assessment, outcomes assessment, cardiac risk 
factor modification (for CR/ICR) and education or training (for PR), 
and individualized treatment plans (ITPs) established, reviewed and 
signed by a physician every 30 days. The statute also includes 
physician requirements for PR and CR/ICR programs. Namely, section

[[Page 65245]]

1861(eee)(5) of the Act requires that the Secretary establish standards 
to ensure that a physician with expertise in the management of 
individuals with cardiac pathophysiology is responsible for the CR/ICR 
program and that such physician, in consultation with appropriate 
staff, is involved substantially in directing the progress of 
individual in the program. Section 1861(fff)(3) of the Act similarly 
requires the Secretary establish standards that ensure that a physician 
with expertise in the management of individuals with respiratory 
pathophysiology is responsible for the PR program and, in consultation 
with appropriate staff, is involved substantially in directing the 
progress of individual in the program. We established physician 
standards for PR at Sec.  410.47 and for CR/ICR at Sec.  410.49.
---------------------------------------------------------------------------

    \94\ Section 51008 of the BBA of 2018 makes changes to the 
statute that will permit other specific practitioners to supervise 
the items and services effective on January 1, 2024.
---------------------------------------------------------------------------

    Under the statute, PR and CR/ICR programs include individualized 
treatment that is furnished under a written plan established, reviewed, 
and signed by a physician every 30 days. We codified this requirement 
in Sec. Sec.  410.47 and 410.49 by defining and describing the ITP 
which must be established, reviewed, and signed by a physician every 30 
days. Because the statute requires a plan to be established, reviewed, 
and signed by a physician every 30 days, we cannot alter this 
requirement.
    Stakeholders have indicated to us that it is very challenging for a 
program to fulfill these tasks on each patient's first day of PR or CR/
ICR. Stakeholders have also expressed concerns that there is not 
separate and additional payment for medical directors or other 
physicians to develop and sign the ITPs. In response to these concerns, 
we note that the medical director and any staff physician(s) working in 
the PR or CR/ICR program who is involved in the patient's care and has 
knowledge related to the patient's condition, or the patient's treating 
and/or referring physician, may establish, review and sign ITPs. When 
appropriate and when all billing requirements are met, a separately 
billable E/M service may be furnished by the medical director or other 
PR or CR/ICR staff physician(s) working in the program in connection 
with establishing and signing the ITP on or before the first day of PR 
or CR/ICR. Additionally, physicians treating patients for their 
cardiovascular or respiratory conditions, but who are not staff of the 
PR or CR/ICR programs, are not precluded from developing and signing 
ITPs for their patients before they begin PR or CR/ICR programs. While 
the CY 2010 PFS final rule for PR (74 FR at 61883) stated that the PR 
physician must review and sign the ITP prior to initiation of PR even 
if the plan was developed by a different physician, we recognize that 
this imposes greater burden and may potentially delay treatment. ITPs 
developed and signed on or before the first day of PR by a physician 
who is treating the patient's respiratory condition outside of the PR 
program will not require an additional signature from the PR medical 
director (or any other physician working in the program) on or before 
the first day of PR. Similarly, ITPs developed and signed on or before 
the first day of CR/ICR by a physician outside of the CR/ICR program 
treating the patient's cardiovascular condition, do not require an 
additional signature from the CR/ICR medical director (or other 
physician working in the program) on or before the first day of CR/ICR. 
The PR and CR/ICR medical director and other appropriate staff would 
review these ITPs on or before the first day services are furnished. 
The medical director or other physician working in the program, in 
consultation with staff, may revise the ITP as needed to ensure the 
plan is appropriately individualized, regardless of which physician 
establishes and signs the plan.
3. Revisions
    As described above, PR and CR/ICR programs are subject to many of 
the same statutory requirements. Despite the consistency in 
requirements set forth in statute, we recognize that some of the 
conditions of coverage codified in regulation are not identical across 
both programs. We proposed conforming changes to the regulatory text 
for both PR and CR/ICR to establish consistency in terminology, 
definitions and requirements where appropriate which will result in 
clearer and more streamlined regulatory text. We also proposed to 
adjust the regulatory structure of Sec.  410.47 to align with Sec.  
410.49. The revisions will also enable stakeholders with interest in 
both PR and CR/ICR programs to more easily compare requirements and 
implement programs.
a. Definitions
    We proposed revisions to six PR definitions at Sec.  410.47(a), 
including individualized treatment plan, medical director, outcomes 
assessment, physician-prescribed exercise, psychosocial assessment and 
supervising physician; and revisions to three CR/ICR definitions at 
Sec.  410.49(a), including medical director, outcomes assessment, and 
physician-prescribed exercise. Specifically, the proposed revisions to 
the PR definitions of ITP, psychosocial assessment and supervising 
physician align with the definitions of the same terms for CR/ICR. The 
proposed revisions to the PR definition of physician-prescribed 
exercise align with the definition of physician-prescribed exercise for 
CR/ICR and also include revisions to provide examples of physical 
activities appropriate to the patient population (which were relocated 
from the PR components section (previously Sec.  410.47(c)). Similar 
revisions were proposed for the CR/ICR definition of physician-
prescribed exercise. We proposed to modify language in the PR 
definition of medical director to align with the CR/ICR definition of 
medical director to more specifically describe the role of the PR 
medical director. We proposed conforming changes to the CR/ICR 
definition of medical director. Proposed revisions to the PR and CR/ICR 
definitions of outcomes assessment removed and revised redundant and 
unnecessary language. Also, we proposed to clearly state that outcome 
assessments may be performed by either the physician or the PR or CR/
ICR program staff and that all results of these evaluations performed 
by program staff must be considered by the physician in the development 
and/or review of ITPs. These proposals are consistent with descriptions 
provided in the CY 2010 PFS proposed rule (74 FR at 33608, 33613) which 
state that PR and CR/ICR staff must provide outcomes assessments to the 
physician and serve to clearly communicate the important supportive 
role program staff may play to the physicians of these rehabilitation 
programs. The conforming changes are designed to more accurately define 
the existing terms and ensure consistency in definitions used for the 
same terms across PR and CR/ICR programs. We chose to largely maintain 
the CR/ICR regulatory text and align the PR regulatory text with CR/ICR 
based on stakeholder feedback and questions regarding the PR 
requirements. Aligning PR with CR/ICR, as opposed to aligning CR/ICR 
with PR requirements, better addresses stakeholder feedback and 
improves consistency in terminology, definitions and descriptions of 
conditions of coverage. With the proposed revisions and increased 
consistency, we also aimed to improve program efficiency in 
implementing the conditions of coverage.
    We received 11 public comments generally addressing the conforming 
changes throughout our proposals. We received two public comments 
specific to the proposed definition changes. The

[[Page 65246]]

following is a summary of the comments we received and our responses.
    Comment: We received one comment requesting the use of waiver 
authority (sections 1115A, 1899 and 1135 of the Act) to allow NPs to 
order, establish plans of care and supervise PR and CR/ICR.
    Response: The scope of the proposed rule did not include proposals 
to use waiver authority to waive any requirements specified under the 
conditions of coverage at Sec. Sec.  410.47 and 410.49, and, as such we 
will not address waivers in this final rule. As referenced above in 
section III.H.2. of this final rule (background), section 51008 of the 
BBA of 2018 makes changes to the statute that will permit other 
specific practitioners, including NPs, to supervise the items and 
services effective on January 1, 2024.
    Comment: One commenter requested clarification on the role of 
resident level training and fellow level training and their billing 
status.
    Response: The conditions of coverage for PR and CR/ICR do not 
modify or impact existing rules for residents and fellows. Provisions 
specific to residents, interns and fellows are included in the Medicare 
Benefit Policy Manual (Pub. 100-02), Chapter 15, section 30.3, and the 
Medicare Claims Processing Manual (Pub. 100-04), Chapter 12, section 
100. Information is also included in the Medicare Learning Network 
(MLN) Booklet entitled Guidelines for Teaching Physicians, Interns, and 
Residents.\95\ The existing requirements under Medicare for residents 
and fellows would apply as appropriate. We note that there are not 
separate provisions for residents, fellows and interns specific to PR 
and CR/ICR services.
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    \95\ https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/teaching-physicians-fact-sheet-icn006437.pdf.
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    Comment: Some commenters generally supported the proposed revisions 
for consistency and accuracy throughout the PR and CR/ICR regulatory 
text. One commenter specifically expressed agreement with the proposed 
definition changes. Another commenter supported the proposed changes to 
the outcomes assessment definition incorporating language recognizing 
the important role program staff serve with respect to developing and/
or reviewing ITPs.
    Response: We appreciate the commenters that submitted these 
supportive comments.
    After consideration of public comments, we are finalizing the 
definition revisions as proposed.
b. Covered Conditions
    The definition for PR at Sec.  410.47(a) specifies that PR is a 
physician-supervised program for COPD and certain other chronic 
respiratory diseases. The CDC uses the term post-COVID conditions to 
describe health issues that persist more than 4 weeks after first being 
infected with the causative virus \96\ indicating that this timeframe 
provides a rough approximation of effects that occur beyond the acute 
period. Similarly, the National Institute for Health and Care 
Excellence (NICE), the Scottish Intercollegiate Guidelines Network 
(SIGN) and the Royal College of General Practitioners (RCGP) have 
jointly used 4 weeks to differentiate the acute symptoms of COVID from 
`long COVID,' the signs and symptoms that continue or develop after 
acute COVID-19.\97\ Based on the information from the CDC, NICE, SIGN 
and RCGP, we consider COVID-19 to be chronic when symptoms persist for 
more than 4 weeks. Symptoms include dyspnea, depression and anxiety 
which can impair physical function and cause 
incapacitation.98 99 We proposed to cover PR for Medicare 
beneficiaries who have been diagnosed with severe manifestations of 
COVID-19, defined as requiring hospitalization in the ICU or otherwise, 
and who experience continuing symptomatology, including respiratory 
dysfunction, for at least 4 weeks post discharge.
---------------------------------------------------------------------------

    \96\ Centers for Disease Control and Prevention. Post-COVID 
Conditions: Information for Healthcare Providers. Updated July 9, 
2021. Accessed 9/16/2021 at https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/post-covid-conditions.html.
    \97\ NICE guideline [NG188]. COVID-19 rapid guideline: Managing 
the long-term effects of COVID-19. December 18, 2020. Accessed 4/30/
2021 at https://www.nice.org.uk/guidance/ng188.
    \98\ Post-COVID Conditions updated 7/12/2021 accessed 9/16/2021 
at https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects.html.
    \99\ NIH launches new initiative to study ``Long COVID'' updated 
2/23/21 accessed at https://www.nih.gov/about-nih/who-we-are/nih-director/statements/nih-launches-new-initiative-study-long-covid.
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    Management of COVID-19 post-acute syndrome is an evolving issue in 
the health of our beneficiaries. We recognize that there is limited 
evidence available assessing the benefits that PR may provide for 
patients who were diagnosed with COVID-19. However, early research and 
consensus statements emphasize the restorative role that PR will likely 
play in the patient recovering from COVID-19.100 101 We 
solicited comments regarding the appropriateness of the coverage 
criteria for PR for beneficiaries diagnosed with COVID-19, including 
both the characteristics of the patients for whom PR is covered and the 
timing of their symptoms as presented above.
---------------------------------------------------------------------------

    \100\ Liu K, Zhang W, Yang Y, Zhang J, Li Y, Chen Y. Respiratory 
rehabilitation in elderly patients with COVID-19: A randomized 
controlled study. Complement Ther Clin Pract. 2020 May;39:101166. 
doi: 10.1016/j.ctcp.2020.101166. Epub 2020 Apr 1. PMID: 32379637.
    \101\ Barker-Davies RM, O'Sullivan O, Senaratne KPP, et al. The 
Stanford Hall consensus statement for post-COVID-19 rehabilitation. 
Br J Sports Med. 2020;54(16):949-959. doi:10.1136/bjsports-2020-
102596. PMID: 33743391.
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    We received public comments on this proposal to cover PR for 
Medicare beneficiaries who have been diagnosed with severe 
manifestations of COVID-19, defined as requiring hospitalization in the 
ICU or otherwise, and who experience continuing symptomatology, 
including respiratory dysfunction, for at least 4 weeks post discharge, 
as well as the appropriateness of the proposed coverage criteria. The 
following is a summary of the comments we received and our responses.
    Comment: All commenters supported expanding coverage of PR to 
include beneficiaries who had COVID-19; however, commenters had varying 
opinions regarding the specific coverage parameters appropriate for 
this patient population. Some commenters expressed agreement with the 
coverage parameters as proposed. Other commenters recommended expanding 
coverage to include all beneficiaries who have been diagnosed with 
severe COVID-19 and are experiencing post-COVID syndrome and further 
noted that the PR conditions of coverage should evolve and change as 
the definition and understanding of post-COVID syndrome improve. Some 
commenters requested that the requirements for patients to be 
hospitalized and also wait 4 weeks after hospitalization to participate 
in PR be removed. Other commenters recommended removing the 
hospitalization requirement. One commenter requested that CMS confirm 
that the proposal would mean any hospitalized patient would be eligible 
for PR if they have symptoms beyond 4 weeks. This commenter requested 
that CMS clarify the phrasing of the policy. Commenters requesting 
further expansion of the proposed coverage criteria to include patients 
who were not hospitalized cited data and publications that continue to 
be released as more information becomes available to inform treatment 
options for COVID-19 patients. These commenters noted that early 
experience indicates that, in addition to hospitalized patients, 
patients who are not hospitalized may still experience severe and 
persistent symptoms from COVID-19 and PR has helped to improve such 
patients'

[[Page 65247]]

conditions. One commenter requested that coverage not be limited to 
only patients with ``severe manifestations'' of COVID-19 because mild 
cases can also result in ongoing pulmonary complications. Another 
commenter supported the proposed language covering PR for patients with 
``severe manifestations of COVID-19'' and stated it is not diagnosis 
driven and these patients should be treated similarly to patients with 
emphysema and COPD.
    Response: We agree that coverage of PR for beneficiaries who 
experienced COVID-19 is important in treating ongoing symptoms and 
complications of the disease. We recognize that patients recovering 
from COVID-19 who were able to be treated at home, also exhibit long-
term symptoms of this disease, though usually of a lesser severity than 
those who were hospitalized for their treatment (Boutou, et al., 
2021).\102\ In a series of 150 outpatients treated for COVID-19 studied 
by Lougue, et al., 2021,\103\ persistent symptoms were reported by one-
third of outpatients at a median 169 days (SD 37.1) after illness 
onset. Though the most frequent symptoms were those of fatigue and loss 
of smell, persistent breathing difficulties were reported by 
approximately 5-10 percent of these individuals.
---------------------------------------------------------------------------

    \102\ Boutou AK, Asimakos A, Kortianou E, Vogiatzis I, 
Tzouvelekis A. Long COVID-19 Pulmonary Sequelae and Management 
Considerations. Journal of Personalized Medicine. 2021; 11(9):838. 
https://doi.org/10.3390/jpm11090838.
    \103\ Logue JK, Franko NM, McCulloch DJ, et al. Sequelae in 
Adults at 6 Months After COVID-19 Infection. JAMA Netw Open. 
2021;4(2):e210830. doi:10.1001/jamanetworkopen.2021.0830.
---------------------------------------------------------------------------

    Therefore, after consideration of public comments and the rapidly 
evolving evidence base, we believe it prudent to further expand 
coverage of PR for COVID-19 beyond our proposal. As such, we are 
finalizing that PR is covered for beneficiaries who have had confirmed 
or suspected COVID-19 and experience persistent symptoms that include 
respiratory dysfunction for at least 4 weeks. To be clear, this 
includes beneficiaries regardless of whether they were hospitalized as 
this expanded coverage is agnostic to the setting in which they were 
treated for COVID-19. A positive COVID-19 test is not required, however 
eligible beneficiaries must have had confirmed or suspected COVID-19, 
and they must experience persistent symptoms of COVID-19 that include 
respiratory dysfunction for at least 4 weeks. The 4-week time frame may 
begin with symptom onset. We believe this expansion of coverage will 
equip healthcare providers with another tool to assist patients in 
overcoming long-lasting, residual symptoms of COVID-19 that, for many, 
significantly impact activities of daily living. Furthermore, we are 
aware that data suggests individuals belonging to racial and ethnic 
minority groups are at an increased risk of acquiring COVID-19 compared 
to other individuals and also that they may experience worse clinical 
outcomes from the disease.104 105 Expanding coverage of PR 
will afford physicians the ability to refer more individuals who 
require restorative therapies to rehabilitation services that may allow 
for as full a recovery as possible. This expansion of PR coverage to 
beneficiaries that had COVID-19, whether hospitalized or not, offers an 
important treatment option, especially for those in racial and ethnic 
minority groups that have been disproportionately affected by COVID-19.
---------------------------------------------------------------------------

    \104\ Centers for Disease Control and Prevention. Health Equity 
Considerations and Racial and Ethnic Minority Groups. Updated 4/19/
2021. Accessed 10/4/20 21 at https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html.
    \105\ Mishra V, Seyedzenouzi G, Almohtadi A, et al. Health 
Inequalities During COVID-19 and Their Effects on Morbidity and 
Mortality. J Healthc Leadersh. 2021;13:19-26. Published 2021 Jan 19. 
doi:10.2147/JHL.S270175.
---------------------------------------------------------------------------

    We will continue to monitor the evidence base for PR and COVID-19 
and revisit this policy when and if appropriate based on clinical 
evidence.
    Comment: Two commenters requested further expansion of covered 
conditions for PR and CR/ICR. One commenter requested coverage of PR 
for conditions like adult respiratory distress syndrome. One commenter 
requested that under the CR/ICR regulation, chronic heart failure 
patients should not have to wait 6 weeks after hospital discharge to 
participate in CR if they are able to tolerate rehabilitation sooner, 
as determined by their physician.
    Response: In our proposed rule, we only sought to expand coverage 
of PR for beneficiaries who experienced COVID-19. We believe it is 
important to make changes to coverage provisions, including covered 
conditions, with the public's input using processes like notice and 
comment rulemaking or the NCD process. Because we did not propose to 
cover other conditions (nor receive public comments on proposals to 
cover other conditions), we will not expand coverage to other 
conditions in this final rule. As discussed in section III.H.2. 
(background) of this final rule, we may use the NCD process to cover 
additional conditions for PR, CR and ICR. Information on how to request 
an NCD is available at https://www.cms.gov/Medicare/Coverage/DeterminationProcess/howtorequestanNCD.
    After consideration of public comments and the evolving evidence 
base, we are finalizing that PR is covered for beneficiaries who have 
had confirmed or suspected COVID-19 and experience persistent symptoms 
that include respiratory dysfunction for at least 4 weeks.
c. Components
    We proposed revisions to the description of each of the five PR 
components under Sec.  410.47(b)(2) (previously Sec.  410.47(c)). 
Revisions to the descriptions of physician prescribed exercise, 
psychosocial assessment and outcomes assessment include removing 
language already used in the definition of each term or references to 
the definitions in Sec.  410.47(a). The inclusion of already 
established definition language is redundant, and therefore, 
unnecessary. Revisions to the education or training component more 
concisely explain, but do not change, the existing requirements for 
meeting this component. Revisions to the description of the ITP align 
with the description used for the CR/ICR ITP. As noted in the section 
above, we largely aligned the PR regulatory text with CR/ICR to better 
address stakeholder feedback and improve consistency in terminology, 
definitions and descriptions of conditions of coverage to assist in 
improving program efficiency in implementing the conditions of 
coverage.
    We received 11 public comments generally addressing the conforming 
changes throughout our proposals. We also received several comments 
related to requirements we did not propose to change. The following is 
a summary of the comments we received and our responses.
    Comment: Commenters expressed general support of the revisions for 
consistency and accuracy throughout the PR and CR/ICR regulatory text.
    Response: We appreciate these comments.
    Comment: One commenter requested clarification that NPPs may 
provide prescribed exercises for beneficiaries in a PR program.
    Response: We are not adopting the commenter's suggestion because 
our regulations do not specify staff requirements or responsibilities. 
The medical director is responsible for the program, and thus, the 
staff roles and responsibilities.
    Comment: Several commenters offered feedback on the requirement for 
the ITP to be signed by a physician by the first day PR or CR/ICR 
services are

[[Page 65248]]

furnished. Specifically, one commenter requested that the regulations 
allow more time to acquire the appropriate signatures on the treatment 
plan because sometimes providers are unavailable to immediately sign 
off on the first day, with another commenter echoing this concern by 
explaining that it is challenging to obtain a physician signature on 
the ITP no later than the same date of the first PR or CR/ICR session.
    Response: As we discussed above in section III.H.2. of this final 
rule (background) that, under the statute, PR and CR/ICR programs 
include individualized treatment that is furnished under a written plan 
established, reviewed, and signed by a physician every 30 days. Because 
this timeframe is specified in statute, we do not have the authority to 
allow for the ITP to be signed by a physician after the first day 
services are furnished. In section III.H.2. of this final rule, we also 
address potential opportunities for the ITPs to be established and 
signed by a physician during separate E/M visits prior to a 
beneficiary's first session of PR or CR/ICR.
    Comment: One commenter indicated that the clarification was helpful 
in section III.H.2. of this final rule (background) that a separately 
billable E/M visit may be furnished by the program medical director or 
other program staff physicians in connection with establishing and 
signing the ITP on or before the first PR or CR/ICR session. This 
commenter stated that this will not be billable by outside physicians, 
but did not further expand on this statement.
    Response: Our regulations do not preclude outside physicians (who 
are independent from the PR or CR/ICR program) from developing and 
signing ITPs during E/M visits for the treatment of the respiratory or 
cardiac condition.
    After consideration of public comments, we are finalizing the 
revisions to the component descriptions as proposed.
d. Settings
    We proposed minor edits to align the PR setting text in Sec.  
410.47(b)(3)(i) (previously Sec.  410.47(d)(1)) with the CR/ICR setting 
text and reorganize this section to move and update, consistent with 
the corresponding CR/ICR section, the requirement that all settings 
must have a physician immediately available and accessible for medical 
consultations and emergencies.
    We received 11 public comments generally addressing the conforming 
changes throughout our proposals. We also received several comments 
requesting coverage of PR in additional settings and comments 
requesting revisions to the requirement that a physician be immediately 
available and accessible. The following is a summary of the comments we 
received and our responses.
    Comment: One commenter requested physical therapy and occupational 
therapy private practices and rehabilitation agency settings be added 
to covered settings. One commenter requested coverage for in home 
virtual CR (without reference to the separate telehealth provisions 
discussed in other sections of the proposed rule).
    Response: The scope of the proposed revisions to the setting 
requirements for PR were limited to reorganizing and updating the 
language for consistency and accuracy with corresponding CR/ICR 
regulatory text. We did not consider or propose to add settings. We 
believe it is important to make changes to coverage provisions, 
including covered settings, with the public's input using notice and 
comment rulemaking. Because we did not propose and receive public 
comments on covering other settings, we will not expand coverage to 
other settings in this final rule. If supported by clinical evidence 
and within the parameters set forth in statute, we may consider other 
settings in future notice and comment rulemaking. In response to the 
PHE for COVID-19, we established numerous temporary waivers and 
flexibilities. For example, effective through the end of the year in 
which the PHE for COVID-19 ends, direct supervision of PR and CR/ICR 
can include a virtual presence of the physician through two-way, audio-
video communications technology. Additionally, the HCPCS codes for PR, 
CR and ICR, were added to the Medicare telehealth services list on a 
temporary basis for the duration of the PHE which means providers can 
furnish these services in accordance with the telehealth flexibilities 
available during the PHE using audio and video equipment permitting 
two-way, real-time interactive communication. Furthermore, through the 
Hospitals without Walls initiative, PR, CR and ICR services can be 
furnished in a patient's home that is serving as part of the hospital 
during the PHE for COVID-19, provided the patient is registered as a 
hospital outpatient when the services are furnished and other 
conditions are met. Additional information about PHE related waivers 
and flexibilities is available on the CMS website at https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page. Additional information about 
telehealth rules and requirements are available both in this final rule 
and on the CMS website at https://www.cms.gov/medicare/medicare-general-information/telehealth.
    Comment: One commenter requested that the PR and CR/ICR regulations 
be updated to allow PR and CR/ICR patients to be treated in the same 
setting at the same time. This commenter stated that currently the 
services cannot be provided in the same location at the same time.
    Response: We believe this commenter is referencing situations where 
a distinct patient or group of patients are participating in PR while a 
separate distinct patient or group of patients are participating in CR/
ICR in the same location. We do not interpret this comment as 
referencing a single patient receiving PR and CR/ICR at the same time 
during the same session. The conditions of coverage for PR and CR/ICR 
do not prohibit PR services from being furnished to PR patients in the 
same setting and at the same time that CR/ICR services are furnished to 
CR/ICR patients. However, all coverage requirements for each distinct 
program must be met to comply with the conditions of coverage specified 
in the regulations. Both PR and CR/ICR services may not be furnished to 
a single patient at the same time. In other words, programs may not 
furnish and bill for PR and CR/ICR services furnished to the same 
patient during a single session. If a patient is participating in both 
PR and CR/ICR, the patient would need to separately complete sessions 
for each program and cannot receive PR program services during the same 
session in which they are receiving CR/ICR program services.
    Comment: Several commenters stated that requiring a physician to be 
immediately available and accessible is an insurmountable obstacle in 
rural areas. These commenters requested the CR NCD be revised to allow 
CR programs to operate under general supervision of a physician when an 
automated external defibrillator (AED) is immediately available and the 
patient is attended by nursing staff currently trained in Basic Life 
Support and AED use.
    Response: The requirement for a physician to be immediately 
available and accessible is specified in statute at section 
1861(eee)(2)(B) of the Act and we are not waiving this requirement for 
rural areas.
    Comment: Several commenters suggested that CMS permit the CR 
supervising physician to be immediately available and accessible 
through a

[[Page 65249]]

virtual presence, particularly in rural areas.
    Response: In response to the PHE for COVID-19, we established 
numerous temporary waivers and flexibilities. For example, effective 
through the end of the year in which the PHE for COVID-19 ends, direct 
supervision of PR and CR/ICR can include a virtual presence of the 
physician through two-way, audio-video communications technology. 
Additionally, the HCPCS codes for PR, CR and ICR, were added to the 
Medicare telehealth services list on a temporary basis for the duration 
of the PHE which means providers can furnish these services in 
accordance with the telehealth flexibilities available during the PHE 
using audio and video equipment permitting two-way, real-time 
interactive communication.
    Comment: Some commenters expressed general support of the revisions 
for consistency and accuracy throughout the PR and CR/ICR regulatory 
text.
    Response: We appreciate the support.
    After consideration of public comments, we are finalizing the 
setting revisions as proposed.
e. Physician Standards
    We proposed revisions to align regulatory text regarding the 
standards for the PR medical director and the supervising physician 
found at Sec.  410.47(c) and (d) (previously Sec.  410.47(e)) with the 
corresponding CR/ICR medical director and supervising physician text 
and minor conforming changes to CR/ICR language Sec.  410.49(d) and 
(e). These revisions will not only align similar requirements for PR 
and CR/ICR programs, but also more accurately describe the roles and 
responsibilities of physicians in PR programs, and thereby address 
stakeholder feedback requesting more specificity around the roles and 
standards for the physicians involved in PR programs. Specifically, we 
proposed to replace the existing PR ``physician standards'' section 
with two separate sections. The first, entitled ``medical director 
standards'' delineates requirements for the PR medical director, and 
the second, ``supervising physician standards'' delineates requirements 
for physicians fulfilling the supervising physician role when PR items 
and services are furnished. These revisions also include removing 
language that is redundant to the definition for medical director 
already set forth in Sec.  410.47(a) and the requirement that a 
physician have ``direct patient contact related to the periodic review 
of his or her treatment plan.'' We proposed to remove the direct 
patient contact language because this requirement is overly burdensome 
and unnecessary since a physician is already required to, in 
consultation with staff, review patient ITPs every 30 days. Direct 
physician-patient contact can be written into an ITP for patients who 
require such attention; however, it is not necessary for every patient 
and the need for it should instead be specified by the clinician. 
Furthermore, while we believe direct physician-patient contact within 
the PR program every 30 days is not necessary for every PR patient, we 
note that patients are seen by PR staff and their progress is tracked 
at each session where staff are able to identify the need for direct 
physician-patient contact as appropriate. Additionally, patients 
participating in PR generally continue to have ongoing interactions 
with their treating physicians outside of PR. Because the need for 
direct physician-patient contact is individualized and patients 
continue to engage with their treating physicians outside of PR, we 
proposed to remove the requirement for direct physician-patient contact 
within the PR program every 30 days. We requested public comment on 
whether removing the regulatory requirement for direct physician-
patient contact every 30 days would be potentially detrimental to PR 
patients by eliminating a critical physician interaction, or if 
necessary interactions are already occurring outside of the PR program 
at appropriate intervals as determined by a physician treating the 
patient for his or her respiratory condition.
    These revisions and clearer delineations of the roles and standards 
for the PR medical director and, separately, the supervising physician, 
are important to address stakeholder feedback and reduce burden on PR 
programs, physicians and patients while ensuring treatment is truly 
individualized as directed by statute. As these revisions, more 
accurately describe and delineate the roles and standards for the 
medical director and the supervising physician, please note that the PR 
or CR/ICR medical director may serve as a supervising physician if he 
or she also meets the requirements for a supervising physician. Two 
different physicians are not necessarily required, as long as the 
definitions and descriptions in Sec. Sec.  410.47 and 410.49 are met.
    The following is a summary of the comments we received and our 
responses.
    Comment: Some commenters expressed general support of the revisions 
for consistency and accuracy throughout the PR and CR/ICR regulatory 
text. One commenter specifically supported the proposed alignment of 
standards between CR/ICR and PR for the medical director and 
supervising physician standards.
    Response: We appreciate the support.
    Comment: One commenter requested that the requirement for the 
medical director to possess a license from the State in which the 
program is offered be removed and instead allow a license from any 
State.
    Response: Under sections 1861(eee)(5) and (fff)(3) of the Act, the 
physician responsible for both PR and CR/ICR programs (the medical 
director as defined in regulation) is required to be licensed to 
practice medicine in the State in which the PR or CR/ICR program is 
offered. Because this requirement is specified in statute, we do not 
have the authority to modify it.
    Comment: Some commenters supported removing the PR requirement that 
a physician have ``direct patient contact related to the periodic 
review of his or her treatment plan.'' All commenters agreed with this 
proposal and no commenters indicated that removing the requirement 
would be potentially detrimental to PR patients.
    Response: We appreciate the support.
    After consideration of public comments, we are finalizing the 
physician standards revisions as proposed, including removal of the 
direct physician-patient contact requirement. We reiterate that for 
patients that may require greater interaction with a physician, such 
direct physician-patient contact may be included in the patient's ITP. 
However, as discussed above, we believe this requirement is overly 
burdensome and unnecessary for all patients and, as such, we are 
finalizing our proposal to remove the requirement.
f. Limitations
    We proposed conforming changes to Sec. Sec.  410.47(e) (previously 
Sec.  410.47(f)) and 410.49(f) to improve clarity of these sections and 
more closely align the descriptions for session duration, number of 
sessions covered and time-period over which sessions must be provided.
    Comment: Some commenters expressed general support the revisions 
for consistency and accuracy throughout the PR and CR/ICR regulatory 
text.
    Response: We appreciate the support.
    After consideration of public comments, we are finalizing the 
revisions in this section as proposed.
4. Summary
    To improve consistency and accuracy across PR and CR/ICR conditions 
of

[[Page 65250]]

coverage, we proposed largely conforming changes throughout Sec. Sec.  
410.47 and 410.49. We also proposed to add coverage of PR for 
beneficiaries who were hospitalized with a COVID-19 diagnosis and 
experience persistent symptoms, including respiratory dysfunction, for 
least 4 weeks after hospital discharge and to remove a PR program 
requirement that is overly burdensome and unnecessary for all PR 
patients which was also not expressly required in statute. After 
considering public comments and additional clinical evidence, we are 
finalizing the revisions to improve consistency and accuracy across PR 
and CR/ICR conditions of coverage as proposed. We are also finalizing 
the removal of the PR requirement for direct physician-patient contact. 
We are expanding upon our proposal to cover PR for beneficiaries who 
were hospitalized with a COVID-19 diagnosis and experience persistent 
symptoms, including respiratory dysfunction, for at least 4 weeks after 
hospital discharge. We are removing the proposed hospitalization 
requirement and finalizing 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.
    We believe these revisions will result in clearer and more 
streamlined regulatory text and better assist stakeholders in 
understanding and implementing PR, CR and ICR programs. Furthermore, we 
believe coverage of PR for beneficiaries who experienced COVID-19 is an 
important treatment option for patients as they recover.

I. Medical Nutrition Therapy

    Medical nutrition therapy became a distinct Medicare benefit under 
section 1861(s)(2) of the Act under section 105 of the Medicare, 
Medicaid, and SCHIP Benefits Improvement Protection Act of 2000 (BIPA). 
Medicare beneficiaries with diabetes or renal disease can receive 
individualized medical nutrition therapy (MNT) provided by a registered 
dietitian or nutrition professional, pursuant to a referral by a 
physician (as defined in section 1861(r)(1) of the Act), with no cost 
to the beneficiary. Currently, 42 CFR 410.132(c), further requires that 
the referral must be made by the treating physician. The treating 
physician was defined as the primary care physician or specialist, 
coordinating care for the beneficiary with diabetes or renal disease. 
The regulation also specifically defines renal disease as including 
chronic renal insufficiency based on glomerular filtration rate (GFR) 
eligibility criteria.
    The National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK), National Kidney Foundation and Academy of Nutrition 
and Dietetics support MNT for adults with chronic kidney disease (CKD). 
The National Kidney Foundation and the Academy of Nutrition and 
Dietetics' Clinical Practice Guideline on Nutrition in Chronic Kidney 
Disease \106\ acknowledges that the goals of MNT are to optimize 
nutritional status, and to minimize risks imposed by comorbid 
conditions and alterations in metabolism on the progression of kidney 
disease and on adverse clinical outcomes. The authors recognize that 
patients with CKD have changing needs according to their disease stage 
and they recommended MNT for each stage of CKD.
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    \106\ https://www.kidney.org/sites/default/files/Nutrition_GL%2BSubmission_101719_Public_Review_Copy.pdf.
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    In addition, evidence supports the use of MNT as a component of 
quality diabetes care, including its integration into the medical 
management of diabetes. Nutrition therapy that includes the development 
of an eating plan designed to improve blood glucose, blood pressure, 
and lipid profiles is important in the management of diabetes and can 
lower the risk of cardiovascular disease, coronary heart disease, and 
stroke. Despite these findings and endorsement by leading clinical 
societies, including the American Diabetes Association, American 
College of Cardiology and the National Kidney Foundation, less than 2 
percent of the estimated 14 million eligible Medicare beneficiaries 
have accessed MNT.
    Over the years, we have heard from several stakeholder groups 
requesting that we update the MNT regulations to improve beneficiary 
access. In the proposed rule, we provided background on the MNT 
services, discussed the MNT regulation revisions, and included 
proposals to implement these modifications. We proposed to make changes 
to the treating physician requirements and update the chronic renal 
insufficiency GFR criteria in order to improve access and utilization 
of the MNT benefit. The statute expressly requires the order of a 
physician; therefore, we are unable to extend referral privileges to 
NPPs.
1. Background: MNT
    MNT is defined in sections 1861(s)(2)(V) and 1861(vv)(1) of the Act 
and codified in Sec. Sec.  410.130 (definitions), 410.132 (MNT), and 
410.134 (provider qualifications).
a. Definitions (Sec.  410.130)
    In 42 CFR subpart G, we define the following definitions that apply 
to MNT at Sec.  410.130:
     Chronic renal insufficiency.
     Diabetes.
     Episode of care.
     Medical nutrition therapy services.
     Physician.
     Renal disease.
     Treating physician.
b. Medical Nutrition Therapy (Sec.  410.132).
    In Sec.  410.132(a), we outline the conditions for coverage of MNT 
services. That is, Medicare Part B pays for MNT services provided by a 
registered dietitian or nutrition professional as defined in Sec.  
410.134 when the beneficiary is referred for the service by the 
treating physician. Services covered consist of face-to-face 
nutritional assessments and interventions in accordance with 
nationally-accepted dietary or nutritional protocols. The regulation 
contains an exception that permits MNT services to be provided as 
telehealth services under Sec.  410.78.
    In Sec.  410.132(b), we outline the limitations on coverage of MNT 
services. First, the MNT services based on a diagnosis of renal disease 
as described in 42 CFR subpart G are not covered for beneficiaries 
receiving maintenance dialysis for which payment is made under section 
1881 of the Act. Also, a beneficiary may only receive the maximum 
number of hours covered under the DSMT benefit for both DSMT and MNT 
during the initial DSMT training period unless additional hours are 
determined to be medically necessary under the national coverage 
determination (NCD) process. In years when the beneficiary is eligible 
for MNT and follow-up DSMT, Medicare will cover the maximum number of 
hours covered under MNT unless additional hours are determined to be 
medically necessary under the NCD process. Under the current MNT NCD 
(NCD 180.1), Medicare covers 3 hours of MNT the initial year of 
referral and up to 2 hours of MNT for subsequent years. In addition, if 
a beneficiary has both diabetes and renal disease, Medicare will cover 
the maximum number of hours covered under the renal MNT benefit in one 
episode of care unless he or she is receiving initial DSMT services, in 
which case the beneficiary would receive whichever is greater. Finally, 
an exception to the maximum number of hours described here may be made 
when the treating physician determines that there is a change of

[[Page 65251]]

diagnosis, medical condition, or treatment regimen related to diabetes 
or renal disease that requires a change in MNT during an episode of 
care.
    At Sec.  410.132(c), we discuss that a referral may only be made by 
the treating physician when the beneficiary has been diagnosed with 
diabetes or renal disease as defined in 42 CFR subpart G with 
documentation maintained by the referring physician in the 
beneficiary's medical record. We also note that referrals must be made 
for each episode of care and any additional assessments or 
interventions required by a change of diagnosis, medical condition, or 
treatment regimen during an episode of care.
c. Provider Qualifications (Sec.  410.134)
    For Medicare Part B coverage of MNT, only a registered dietitian or 
nutrition professional may provide the services. At Sec.  410.134, we 
define registered dietitian or nutrition professional as an individual 
who, on or after December 22, 2000: (1) Holds a bachelor's or higher 
degree granted by a regionally accredited college or university in the 
United States (or an equivalent foreign degree) with completion of the 
academic requirements of a program in nutrition or dietetics accredited 
by an appropriate national accreditation organization recognized for 
this purpose; (2) has completed at least 900 hours of supervised 
dietetics practice under the supervision of a registered dietitian or 
nutrition professional; and (3) is licensed or certified as a dietitian 
or nutrition professional by the State in which the services are 
performed. In a State that does not provide for licensure or 
certification, the individual will be deemed to have met this 
requirement if he or she is recognized as a registered dietitian by the 
Commission on Dietetic Registration or its successor organization. 
However, a dietitian or nutritionist licensed or certified in a State 
as of December 21, 2000 is not required to hold a bachelor's or higher 
degree granted by a regionally accredited college or university in the 
United States (or an equivalent foreign degree) with completion of the 
academic requirements of a program in nutrition or dietetics accredited 
by an appropriate national accreditation organization recognized for 
this purpose; (2) and need not complete at least 900 hours of 
supervised dietetics practice under the supervision of a registered 
dietitian or nutrition professional. In addition, a registered 
dietitian in good standing, as recognized by the Commission of Dietetic 
Registration or its successor organization, is deemed to have met these 
requirements.
2. Proposal for MNT Revisions
a. Removal of the Treating Physician Restriction
    For CY 2022, we proposed to revise the regulations at Sec. Sec.  
410.130 and 410.132. Sections 1861(s)(2)(V) and 1861(vv)(1) of the Act 
define MNT services as nutritional diagnostic, therapy, and counseling 
services for the purpose of disease management which are furnished by a 
registered dietitian or nutrition professional pursuant to a referral 
by a physician (either an M.D. or D.O.) (as defined in section 
1861(r)(1) of the Act). The current regulation further provides that 
Medicare pays for MNT services when the beneficiary is referred for the 
service by the treating physician, which is defined as the primary care 
physician or specialist coordinating care for the beneficiary with 
diabetes or renal disease. As discussed above in section III.I.2. of 
this final rule and codified at Sec.  410.132(c), we required referrals 
only by the treating physician when the beneficiary has been diagnosed 
with diabetes or a renal disease, with documentation maintained by the 
referring physician in the beneficiary's medical record. In the CY 2002 
PFS final rule (66 FR 55246, November 1, 2001), we believed the 
treating physician requirement was necessary to ensure coordination of 
care by the primary care physician or specialist for beneficiaries with 
chronic diseases in order to assure quality (66 FR 55277). This 
relatively narrow definition, however, is now believed to have 
contributed to the low uptake of referrals to MNT services, although we 
note that few studies have examined MNT use.
    We proposed to eliminate the requirement that the referral be made 
by the treating physician and, consistent with the language of the 
statute, require MNT services to be pursuant to a referral by a 
physician (as defined in section 1861(r)(1) of the Act) at Sec. Sec.  
410.130 and 410.132. It would be reasonable for any physician to refer 
a beneficiary to MNT. The treating physician restriction is no longer 
necessary to expect care to be coordinated. Care coordination between 
the hospital or post-acute care provider and the primary care provider 
is the goal and a standard of care in today's medical environment. We 
have worked to improve, through various efforts, the exchange of 
patient information between healthcare settings, and that a patient's 
healthcare information follows them after discharge from a hospital or 
post-acute care provider. Such improved transitions of care and 
exchange of information helps to assure that Medicare beneficiaries 
will continue to receive quality services. We proposed to delete the 
term treating and the definition of treating physician, as there is a 
separate definition for physician within this provision. Therefore, we 
did not propose any change to Medicare's definition of treating 
physician and the deletion of treating physician only applies to this 
provision.
b. Update the GFR Eligibility Criteria for Patients With CKD
    We proposed to revise the regulations at Sec.  410.130. Section 
1861(s)(2)(V) of the Act states that MNT services are available to 
beneficiaries with diabetes or a renal disease. In 2001, we established 
the definition of chronic renal insufficiency for the purpose of the 
MNT benefit using definitions from the Institute of Medicine report, 
``The Role of Nutrition in Maintaining Health in the Nation's 
Elderly.'' \107\ The definitions and staging of CKD have evolved since 
the release of the report and stakeholders have noted that our 
definition does not reflect current medical practice. Therefore, we 
proposed to update the GFR eligibility criteria so that it aligns with 
up to date accepted standards for CKD stage 3 through stage 4, 
specifically GFR 15--59 mL/min/1.73m2. The accepted CKD staging system 
separates stage 3 into two parts: Stage 3-a; and Stage 3-b. Stage 3-a 
is GFR 45--59 mL/min/1.73m2. The existing regulatory upper limit of 50 
mL/min/1.73m2 is mid stage 3-a and does not meet the widely accepted 
standard of when a person is diagnosed with moderate kidney disease. 
The NIDDK and National Kidney Foundation's staging of CKD align with 
the proposed change in GFR criteria.108 109
---------------------------------------------------------------------------

    \107\ IOM (2000). The Role of Nutrition in Maintaining Health in 
the Nation's Elderly: Evaluating Coverage of Nutrition Services for 
the Medicare. Retrieved from http://www.nap.edu/catalog/9741.html.
    \108\ NIH (National Institute of Diabetes and Digestive and 
Kidney Diseases) (2021). Kidney Disease Statistics for the United 
States. Retrieved from https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease.
    \109\ National Kidney Foundation (2021). eGFR. Retrieved from 
https://www.kidney.org/atoz/content/gfr.
---------------------------------------------------------------------------

    We note that health care providers use estimated glomerular 
filtration rate, or eGFR, calculations to classify the severity of a 
person's disease, from mild loss of kidney function to end-stage

[[Page 65252]]

kidney disease.\110\ The eGFR helps determine prognosis and treatment, 
such as when hemodialysis or a transplant may be needed. Since 1999, 
race has been a variable used in estimating GFR. Current eGFR 
calculations also use a person's age, sex, and serum creatinine levels. 
Serum creatinine, which the kidneys filter out, is a waste product from 
the normal metabolism of muscle cells in one's body. Studies have shown 
that Black Americans, on average, can have higher levels of serum 
creatinine in their blood, independent of kidney function. To account 
for this difference, eGFR calculations include a person's self-reported 
race to give more valid results. The use of self-reported race has been 
controversial. Misdiagnosis could lead to a person receiving incorrect 
drug dosing or delays in receiving dialysis or a kidney transplant. 
Current eGFR calculations could be exacerbating racial inequities in a 
disease that disproportionately affects Black people. Health care 
providers should be aware of ongoing research and evolving 
recommendations on GFR estimation in order to reduce and eliminate 
racial and ethnic disparities.
---------------------------------------------------------------------------

    \110\ National Institutes of Health (2021). NIH-supported study 
suggests alternative to race-based kidney function calculations. 
Retrieved from https://www.nih.gov/news-events/news-releases/nih-supported-study-suggests-alternative-race-based-kidney-function-calculations.
---------------------------------------------------------------------------

3. Summary of Regulatory Text Changes
    We proposed to make changes to the treating physician requirements 
and GFR eligibility criteria outlined in Sec. Sec.  410.130 and 
410.132, consistent with statutory limitations. We proposed to revise 
Sec. Sec.  410.130 (definitions) and 410.132 (MNT) by: (1) Revising the 
chronic renal insufficiency definition; (2) striking the treating 
physician definition; and (3) revising conditions for coverage of MNT 
services, limitations on coverage of MNT services, and referrals.
(1) Definition of Chronic Renal Insufficiency
    We proposed to revise Sec.  410.130 by revising the chronic renal 
insufficiency definition by removing the GFR eligibility criteria of 
13--50 ml/min/1.73m2 and replacing with 15--59 ml/min/1.73m2.
(2) Definition of Treating Physician
    We proposed to revise Sec.  410.130 by removing the definition of 
treating physician.
(3) Proposed Changes to Conditions for Coverage of MNT Services, 
Limitations on Coverage of MNT Services, and Referrals
    At Sec.  410.132, we proposed to revise conditions for coverage of 
MNT services, limitations on coverage of MNT services, and referrals by 
removing the terms ``the'' and ``treating,'' and replacing them with 
``a,'' at paragraphs (a), (b)(5), and (c). In paragraph (c), we also 
proposed to strike the term, ``maintained,'' and replace it with the 
term, ``noted.''
4. Summary of Public Comments and Responses
    We received public comments on the proposed revisions to the MNT 
benefit. The following is a summary of the comments we received and our 
responses.
    Comment: The majority of commenters supported the proposals to 
remove the treating physician requirement and update the chronic renal 
insufficiency GFR criteria at Sec. Sec.  410.130 and 410.132. The 
commenters stated that they believe that by removing the requirement 
that the MNT referral be made by the treating physician, CMS will 
expand the reach of this important benefit. Commenters also supported 
aligning the chronic renal insufficiency criteria to reflect current 
medical practice regarding the standards for CKD stages 3 through 4, 
which is GFR 15--59 mL/min/1.73m2.
    Response: We appreciate the commenters for their support of CMS' 
efforts to improve access and utilization of the MNT benefit.
    Comment: Numerous commenters requested that CMS expand coverage of 
MNT services to individuals with other diseases and conditions, 
including malnutrition, prediabetes, obesity, eating disorders, cancer, 
HIV/AIDS, hypertension, dyslipidemia, gastrointestinal diseases, 
cardiovascular disease, and other conditions causing unintended weight 
loss.
    Response: We do not have the authority to extend coverage beyond 
beneficiaries with diabetes or a renal disease as the benefit is 
defined in statute in section 1861(s)(2)(V) of the Act.
    Comment: Several commenters requested that the definition of 
diabetes in Sec.  410.130 include Hemoglobin A1C greater than 6.5 
percent, as they noted is recommended in national standards of medical 
care for diabetes. They believe that the MNT regulation definition of 
diabetes is outdated. They noted that both the USPSTF and the American 
Diabetes Association Standards of Care recommend use of any of the 
following three testing methods to screen for abnormal blood glucose: 
Fasting plasma glucose; Hemoglobin A1C; and 2-hour plasma glucose.
    Response: We appreciate the submission of this additional 
information from the commenters. We believe it is important to make 
changes to coverage provisions, including definitions, with the 
public's input using processes like notice and comment rulemaking. 
Because we did not propose and receive public comments on the 
definition of diabetes, we will not amend the definition in this final 
rule. We will consider revisions to the Sec.  410.130 definition of 
diabetes with future rulemaking, with the opportunity for further 
public feedback.
    Comment: Commenters advocated further expansion of the definition 
of renal disease in Sec.  410.130 to include CKD stage 1 and stage 2. 
They noted that section 1861(s)(2)(V)(ii) of the Act allows for MNT for 
a beneficiary with diabetes or a renal disease who is not receiving 
maintenance dialysis.
    Response: We appreciate the comment but we are not adopting the 
suggested changes in the definition of renal disease to refer to stages 
1 and 2. We believe chronic renal insufficiency or CKD stages 3-4 
(cross-referenced in the definition of renal disease, both defined in 
Sec.  410.130) is the stage that interventions are often initiated in 
attempts to prevent progression of kidney disease to kidney failure and 
does not align with CKD stage 1 or stage 2. Furthermore, our definition 
of renal disease provides coverage of MNT for beneficiaries with 
chronic renal insufficiency (CKD stages 3-4) or end-stage renal disease 
(CKD stage 5 or kidney failure) when dialysis is not received, or post-
transplantation kidney patients for 36 months; however, this does not 
include MNT services for beneficiaries with CKD stage 1 or stage 2.
    Comment: Several commenters requested that CMS allow NPPs to make 
referrals to MNT, including NPs, PAs, and CNSs. One commenter described 
a few ways that they believe CMS could authorize NPs to refer for MNT, 
including: Utilizing the waiver authorities under sections 1115A (CMS 
Innovation Center Model) and 1899 (Medicare Shared Savings Program) of 
the Act; and clarifying that NPs are authorized to refer for MNT 
services as a component of the initial preventive physical examination 
(IPPE) and the annual wellness visit (AWV). They stated that the IPPE 
and AWV are Medicare covered services when

[[Page 65253]]

furnished by NPs, which include MNT referrals.
    Response: As noted previously in this section of the final rule, 
section 1861(vv)(1) of the Act expressly requires the order of a 
physician for MNT to be covered under Part B; therefore, we are unable 
to extend MNT referral privileges to NPPs even if the NPP attempted to 
provide a referral for the service as a participant in the Medicare 
Shared Savings Program (section 1899 of the Act) or as part of the IPPE 
or AWV. The comments addressing CMS 1115A waiver authorities are 
appreciated and we will take these comments into consideration; 
although, the process for the Center for Medicare and Medicaid 
Innovation to develop and select a test model is out of scope of this 
proposed rule, and therefore, we are not addressing in this final rule.
    Comment: A few commenters expressed concern that the quality of 
care may be compromised if the treating physician requirement is 
removed. One commenter requested a reporting requirement to the 
treating physician by the registered dietician or nutrition 
professional at the onset of the MNT services, and periodic updates to 
the treating physician during the course of treatment. The commenter 
stated that the primary care physician or specialist is primarily 
responsible for coordinating all the patient's care and must be kept up 
to date on all critical services and resulting outcomes.
    Response: We believe a reporting requirement would place undue 
burden on the registered dietitian or nutrition professional providing 
the MNT service. As noted previously in this section of the final rule, 
we believe the treating physician restriction is no longer necessary to 
expect care coordination between the referring provider and the primary 
care provider, and therefore, does not require a regulatory mandate for 
reporting. We have worked to advance the appropriate access and sharing 
of a beneficiary's medical information between health care settings. 
Such efforts help to improve the quality, safety, and efficiency of 
health care delivery.
    After consideration of public comments, we are finalizing the 
changes as proposed to the treating physician requirement and to update 
the GFR criteria in the regulations at Sec. Sec.  410.130 and 410.132. 
Therefore, we are also finalizing the regulatory language as proposed.
5. Summary
    The MNT services may help reduce illnesses and improve quality of 
life for people with diabetes or renal disease. We believe the changes 
to the treating physician requirements and GFR eligibility criteria are 
in the best interest of the Medicare program and its beneficiaries. The 
physician requirement change will increase the capacity and 
availability of physicians who can refer beneficiaries to MNT, which 
would alleviate some of the demand on primary care physicians as the 
usual source to perform this particular function. We note that 
stakeholders have contacted us and suggested such flexibility in the 
past. We recognize that MNT is not a highly utilized service and we 
believe these revisions will allow for Medicare patients to gain 
greater access to MNT services.

J. Medicare Shared Savings Program

    On March 23, 2010, the Patient Protection and Affordable Care Act 
(Pub. L. 111-148) was enacted, followed by enactment of the Health Care 
and Education Reconciliation Act of 2010 (Pub. L. 111-152) on March 30, 
2010, which amended certain provisions of the Patient Protection and 
Affordable Care Act (hereinafter collectively referred to as ``the 
Affordable Care Act''). Section 3022 of the Affordable Care Act amended 
Title XVIII of the Act (42 U.S.C. 1395 et seq.) by adding section 1899 
to 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.) Eligible groups of 
providers and suppliers, including physicians, hospitals, and other 
healthcare providers, may participate in the Shared Savings Program by 
forming or participating in an Accountable Care Organization (ACO). 
Under the Shared Savings Program, providers of services and suppliers 
that participate in an ACO continue to receive traditional Medicare FFS 
payments under Parts A and B, but the ACO may be eligible to receive a 
shared savings payment if it meets specified quality and savings 
requirements.
    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-

[[Page 65254]]

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 which 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 
current agreement periods expire on December 31, 2020, the option to 
extend their existing agreement period by 1-year, and allow ACOs in the 
BASIC track's glide path the option to elect to maintain their current 
level of participation for performance year 2021; (2) adjust program 
calculations to remove payment amounts for episodes of care for 
treatment of COVID-19; and (3) expand the definition of primary care 
services for purposes of determining beneficiary assignment to include 
telehealth codes for virtual check-ins, e-visits, and telephonic 
communication. We also clarified the applicability of the program's 
extreme and uncontrollable circumstances policy to mitigate shared 
losses for the period of the PHE for COVID-19 starting in January 2020.
    We have also made use of the annual CY PFS rules to address quality 
reporting for the Shared Savings Program and certain other issues. 
Refer to the CY 2020 PFS proposed rule for a summary of policies 
finalized in prior PFS rules (84 FR 40705). In the CY 2020 PFS final 
rule (84 FR 62903 through 62914), we finalized refinements to the 
Shared Savings Program quality measure set and a technical change to 
the SNF 3-day rule waiver provision of the Shared Savings Program 
regulations. In the CY 2021 PFS final rule, we finalized new Shared 
Savings Program quality reporting requirements that align with the 
Alternative Payment Model (APM) Performance Pathway (APP) under the 
Quality Payment Program and revised the quality performance standard 
for performance years beginning on or after January 1, 2021, to reduce 
reporting burden and focus on patient outcomes. We also finalized a 
policy that waived the requirement that ACOs administer the Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) for ACOs survey 
for performance year 2020. In addition, we finalized updates to the 
definition of primary care services used for beneficiary assignment, 
and policies to reduce burden associated with repayment mechanisms. In 
the CY 2021 PFS final rule, we also finalized the Shared Savings 
Program provisions included in the March 31, 2020 COVID-19 IFC and the 
May 8, 2020 COVID-19 IFC, with several modifications in response to 
public comments received.
    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 Merit-Based Incentive Payment System (MIPS) and Advanced APMs and 
related policies applicable to eligible clinicians who participate in 
APMs, including the Shared Savings Program.
    In sections III.J.1 through III.J.5. of this final rule, we 
summarize and respond to comments we received on the proposed 
modifications to the Shared Savings Program's policies discussed in 
section III.J of the CY 2022 PFS proposed rule (86 FR 39261 through 
39291). Some commenters' suggestions for modifications to Shared 
Savings Program policies went beyond the scope of the policies 
addressed in section III.J. of the CY 2022 PFS proposed rule, and will 
not be addressed in this section of this final rule. As a general 
summary, in sections III.J.1 through III.J.5 of this final rule, we are 
finalizing the following changes to Shared Savings Program policies to:
     Amend the reporting requirements under the APM Performance 
Pathway (APP) for performance year 2022 and subsequent performance 
years.
    ++ Update the APM Performance Pathway (APP) measure set to remove 
the Risk-Standardized, All-Cause Unplanned Admissions for Multiple 
Chronic Conditions (MCC) for ACOs and replace it with the Risk 
Standardized, All-Cause Unplanned Admissions for Multiple Chronic 
Conditions for MIPS.
     Amend the quality performance standard for performance 
year 2023 by freezing the quality performance standard at the 30th 
percentile MIPS Quality performance category score and publicly 
displaying prior year performance scores that equate to the

[[Page 65255]]

30th or 40th percentile MIPS Quality performance category scores.
     Revise the extreme and uncontrollable circumstances policy 
to align with the decision to freeze the quality performance standard 
at the 30th percentile MIPS Quality performance category score for 
performance year 2023.
     Update the definition of primary care services used in 
beneficiary assignment at Sec.  425.400(c).
     Revise the repayment mechanism arrangement policy in the 
following manner:
    ++ To reduce the percentages used in the existing methodology for 
determining the repayment mechanism amount and to specify the number of 
assigned beneficiaries used as a multiplier in the calculations, such 
that the ACO's repayment mechanism amount would be calculated as the 
lesser of the following: (1) One-half percent of the total per capita 
Medicare Parts A and B FFS expenditures for the ACO's assigned 
beneficiaries, based on expenditures and the number of assigned 
beneficiaries for the most recent calendar year for which 12 months of 
data are available; or (2) 1 percent of the total Medicare Parts A and 
B FFS revenue of its ACO participants, based on revenue for the most 
recent calendar year for which 12 months of data are available, and 
based on the ACO's number of assigned beneficiaries for the most recent 
calendar year for which 12 months of data are available.
    ++ To specify how we identify the number of assigned beneficiaries 
used in the repayment mechanism amount calculation and the annual 
repayment mechanism amount recalculation.
    ++ To allow a one-time opportunity for certain ACOs that 
established a repayment mechanism to support their participation in a 
two-sided model beginning on July 1, 2019, January 1, 2020, or January 
1, 2021, to elect to decrease the amount of their existing repayment 
mechanisms.
    ++ To revise the threshold for determining whether an increase in 
the repayment mechanism amount is required.
     Streamline the application process by revising 
requirements concerning the disclosure of prior participation in the 
Shared Savings Program by the ACO, ACO participants, and ACO providers/
suppliers, in light of other requirements that consider an ACO's prior 
participation.
     Reduce the frequency and circumstances under which ACOs 
submit sample ACO participant agreements and executed ACO participant 
agreements to CMS.
     Amend the beneficiary notification requirement as it 
applies to ACOs under prospective assignment and ACOs under preliminary 
prospective assignment with retrospective reconciliation.
    We also describe several comment solicitations that were included 
in section III.J of the CY 2022 PFS proposed rule in the following 
sections of this final rule: III.J.1.c.(1) (Addressing Health 
Disparities and Promoting Health Equity), III.J.1.c.(2) (Feasibility of 
TIN Level Reporting and Sampling for eCQMs/MIPS CQMs), III.J.1.c.(3) 
(Reporting Options for Specialist Providers within an ACO), and section 
III.J.6 (Considerations Related to the Use of Regional FFS Expenditures 
and the Risk Adjustment Methodology in Establishing, Adjusting, 
Updating, and Resetting the ACO's Historical Benchmark).
1. Quality 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. 
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, with a focus on outcomes. In the November 2011 final rule, we 
adopted 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 subsequently updated 
the measures comprising the quality performance measure set for the 
Shared Savings Program through rulemaking in the CY 2015, 2016, 2017, 
and 2019 PFS final rules (79 FR 67907 through 67920, 80 FR 71263 
through 71268, 81 FR 80484 through 80489, and 83 FR 59707 through 59715 
respectively).
    Between performance years 2017 (the first performance year under 
MIPS) and 2020, eligible clinicians who were participating in an ACO 
and who were subject to MIPS (MIPS eligible clinicians) were scored 
under the APM scoring standard under MIPS (81 FR 77260). These 
clinicians include any MIPS eligible clinicians who were participating 
in an ACO in a track, or payment model within a track (Track 1 and 
Levels A through D of the BASIC track) of the Shared Savings Program 
that is not an Advanced APM, as well as those MIPS eligible clinicians 
participating in an ACO in a track, or payment model within a track 
(Track 2, Level E of the BASIC track, and the ENHANCED track, or the 
Medicare ACO Track 1+ Model (Track 1+ Model)) that is an Advanced APM, 
but who do not become Qualifying APM Participants (QPs) as specified in 
Sec.  414.1425, and are not otherwise excluded from MIPS.
    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 through 84736). For performance year 
2021 and subsequent years, ACOs are required to report quality data via 
the APP. In addition, CMS finalized a phase-in approach to the new 
Shared Savings Program quality performance standard that ACOs must 
achieve in order to be eligible to share in savings or avoid maximum 
losses. This phase-in allows for a gradual increase of the quality 
performance standard from a quality performance score that is 
equivalent to or higher than the 30th percentile across all MIPS 
Quality performance category scores in performance years 2021 and 2022 
to a quality performance score that is equivalent to or higher than the 
40th percentile across all MIPS Quality performance category scores in 
performance year 2023 and subsequent years.
b. Clarification of the Application of CAHPS for MIPS Sampling Policies 
to Shared Savings Program ACOs
    In the CY 2021 PFS final rule (85 FR 84722), we finalized that 
beginning in performance year 2021, Shared Savings Program Accountable 
Care Organizations (ACOs) are required to report quality data via the 
Alternative Payment Model (APM) Performance Pathway (APP). As part of 
the APP, ACOs are required to administer the CAHPS for MIPS survey (85 
FR 84730 through 84732).
    In the CY 2021 PFS final rule, we noted, in response to public 
comments, that the CAHPS for MIPS survey uses the same survey 
instrument to assess the same patient experience domains (or Summary 
Survey Measures (SSMs)) as the CAHPS for ACO survey. We noted that both 
the CAHPS for MIPS and the CAHPS for ACOs survey use the same 
shortened, streamlined version of the

[[Page 65256]]

survey that we implemented for both CAHPS for ACOs and CAHPS for MIPS 
in 2018, reflecting efforts by CMS to reduce the number of questions. 
Moreover, in 2019, the two programs used identical survey instruments.
    As discussed in the CY 2021 PFS final rule, we conducted analyses 
to assess the impact of aligning CAHPS scoring and benchmarking using 
2019 CAHPS for ACOs and CAHPS for MIPS data. The results of these 
analyses indicate that scoring ACOs using the MIPS methodology resulted 
in ACOs having a similar distribution of quality points as MIPS groups. 
This distribution was wider than the distribution of quality points 
using the ACO scoring methodology largely due to differences across the 
two programs in the approach to benchmarking (85 FR 84731).
    In addition, we clarified that beneficiaries assigned to an ACO or 
MIPS group, who are eligible for the CAHPS for MIPS or CAHPS for ACOs 
survey, are randomly selected for inclusion in the sample. Samples are 
drawn at the ACO level for CAHPS for ACOs and at the TIN level for MIPS 
groups. Therefore, each ACO or MIPS group sample is representative of 
the ACO or group population.
    We stated that due to the alignment of CAHPS for ACOs with CAHPS 
for MIPS, we will use the benchmarking and scoring methodology for 
CAHPS for MIPS to assess ACOs' performance on the CAHPS survey 
measures. We explained that a single set of benchmarks will be 
calculated using data from all applicable CAHPS for MIPS reporters. We 
score the CAHPS for MIPS survey as one quality measure, which is a 
different scoring approach from the Shared Savings Program quality 
scoring methodology, which scored the 10 CAHPS for ACOs SSMs in one 
patient/caregiver experience quality domain. As described in the CY 
2017 Quality Payment Program final rule (81 FR 77284), each scored SSM 
has an individual benchmark and is scored individually and compared 
against the benchmark to establish the number of points earned. The 
CAHPS score is the average number of points across scored SSMs.
    As stated in the CY 2021 PFS final rule (85 FR 84731), eligible 
beneficiaries assigned to an ACO or MIPS group are randomly selected to 
be included in the sample for the CAHPS for ACOs or CAHPS for MIPS 
survey. In the CY 2021 PFS final rule, we explained that the target 
sample size for CAHPS samples for all participating ACOs, groups, and 
virtual groups is 860; for ACOs, groups, and virtual groups with 860 or 
more survey-eligible patients, a random sample of 860 patients is 
drawn. We also noted that groups and virtual groups with fewer than 860 
survey-eligible patients are eligible to participate in the CAHPS for 
MIPS if they meet the minimum sampling thresholds for CAHPS for MIPS:
     Large groups or virtual groups with 100 or more eligible 
clinicians: 416 eligible patients.
     Medium groups or virtual groups with 25-99 eligible 
clinicians: 255 eligible patients.
     Small groups or virtual groups with 2-24 eligible 
clinicians: 125 eligible patients.
    These minimum sampling thresholds are necessary to ensure that 
groups have an adequate sample size to ensure that the survey responses 
will be representative of the care furnished by the clinicians in the 
group. Groups that do not have an adequate sample size would be at risk 
for not receiving enough survey responses to be representative of the 
care provided.
    In the CY 2021 PFS final rule, we stated that we will continue to 
draw the CAHPS survey samples for Shared Savings Program ACOs 
administering the CAHPS for MIPS survey at the Shared Savings Program 
ACO level, with a target sample size of 860 going forward. Although we 
did not specifically state in the CY 2021 PFS final rule that the MIPS 
minimum sampling thresholds would also apply to ACOs participating in 
the Shared Savings Program, in the CY 2022 PFS proposed rule (86 FR 
39264), we clarified that the sampling thresholds apply for performance 
year 2021 and subsequent years. As we explained in the CY 2022 PFS 
proposed rule, by adopting the APP as the reporting mechanism for 
Shared Savings Program ACOs, we replaced the CAHPS for ACOs that was 
previously used in the Shared Savings Program with the CAHPS for MIPS. 
In the CY 2022 PFS proposed rule, we stated that our intent in 
including the CAHPS for MIPS in the APP was to align reporting 
requirements under the Shared Savings Program with MIPS. Thus, as we 
noted in the CY 2022 PFS proposed rule, we believe that the discussion 
in the CY 2021 PFS final rule regarding the CAHPS for MIPS minimum 
sampling thresholds for groups and virtual groups can be reasonably 
understood to indicate that the CAHPS for MIPS minimum sampling 
thresholds would also apply to Shared Savings Program ACOs. We also 
noted that we had received stakeholder feedback after the publication 
of the CY 2021 PFS final rule asking whether the CAHPS for MIPS minimum 
sampling thresholds would also apply to Shared Savings Program ACOs. As 
stated in the CY 2022 PFS proposed rule, based on the feedback we had 
received, we determined that it was necessary to clarify that the 
minimum sampling threshold will apply.
    As discussed in the CY 2022 PFS proposed rule, minimum sampling 
thresholds are necessary to ensure that ACOs have an adequate sample 
size to ensure that the survey responses will be representative of the 
care furnished by the ACO clinicians. As we stated in the proposed 
rule, we do not want ACOs to be required to contract with a vendor to 
administer the survey if there is a high risk that the ACO will not 
have a sufficient sample size to generate a response rate for the 
survey that will be sufficient to reliably calculate a score for the 
CAHPS for MIPS survey. We noted that aligning the minimum sampling 
thresholds for ACOs with the CAHPS for MIPS minimum sampling thresholds 
allows for consistency across all entities reporting the CAHPS for 
MIPS. Furthermore, we noted our belief that applying the CAHPS for MIPS 
minimum sampling thresholds does not negatively impact Shared Savings 
Program ACOs because only a few ACOs would potentially be impacted by 
these minimum sampling thresholds.
    In the proposed rule, we noted that based on the analysis of proxy 
data from 2020, nearly all ACOs will fall into the large size 
classification; that is, they will have 100 or more eligible clinicians 
that have assigned their billing to TINs participating in the ACO. To 
quantify the actual number of eligible clinicians associated with each 
ACO, we used the latest available reassignment and claims data from an 
internal file that is regularly created twice each performance year to 
identify the number of individual providers (NPIs) associated with each 
ACO's participant TINs. We conducted an analysis with proxy ACO 
sampling frames from 2020 and 44 ACOs fell into the medium size 
category of 25-99 eligible clinicians, and no ACOs were determined to 
have fewer than 24 eligible clinicians. Based on this analysis, we 
estimated that few ACOs would not be able to administer the CAHPS for 
MIPS due to sample size. All ACOs classified as medium-sized had more 
than 860 beneficiaries eligible for sampling. However, based on our 
analysis, we noted that one large-sized ACO would not have been able to 
administer the CAHPS survey for performance year 2020, if we had 
required ACOs to administer a CAHPS for MIPS survey in performance year 
2020 and these sampling rules had applied at that time because the 
sample

[[Page 65257]]

size requirements would not have been met. Two additional large-sized 
ACOs were close to the minimum sampling threshold and would have been 
at risk for not being able to administer the CAHPS for MIPS survey for 
performance year 2020. We noted that in both cases, these ACOs would 
have been eligible for CAHPS sampling based on their counts of 
assigned, quality-eligible \111\ beneficiaries with two visits during 
the performance year; however, a large proportion (over 50 percent) of 
the beneficiaries assigned to these ACOs were residing in nursing homes 
and institutionalized beneficiaries are excluded from CAHPS for MIPS 
sampling.
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    \111\ Quality-eligible refers to assigned beneficiaries that 
were alive, enrolled in Medicare Part A and Part B for the whole 
performance period, were not in hospice, and did not reside outside 
of the United States.
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    Given that the minimum sampling sizes are set to ensure that groups 
or ACOs receive enough responses to be representative of the care their 
clinicians provide, we stated in the proposed rule that we believe it 
is important that we should not burden ACOs that fall below the 
thresholds with the cost of hiring a vendor and fielding a CAHPS for 
MIPS survey that may not produce enough responses to calculate the 
CAHPS for MIPS score. Accordingly, we stated that we will inform any 
ACO that is at risk of falling below the minimum sampling threshold 
that it may not have enough beneficiaries to field a CAHPS for MIPS 
survey prior to the deadline for contracting with a CAHPS for MIPS 
survey vendor. An ACO that does not meet the minimum sampling threshold 
to administer the survey will not receive a score for the CAHPS for 
MIPS survey under the APP. When an ACO fails to meet the sampling 
threshold and is unable to administer the survey, the ACO's measure set 
will be scored accordingly, and the number of measures included in the 
calculation of the ACO's quality performance score will be reduced from 
10 to 9 measures or from 6 to 5 measures in the APP for performance 
year 2021. This means that the denominator used to calculate the 
quality score will be lower, such that an ACO that falls below the 
minimum threshold will not be penalized for its inability to administer 
a CAHPS for MIPS survey.
    We solicited comment on this clarification. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter supported CMS' decision not to penalize ACOs 
that are unable to administer the CAHPS for MIPS survey because they 
fall below the minimum sampling threshold.
    Response: We thank the commenter for their support.
    Comment: One commenter expressed concern that the 860-beneficiary 
sample size is the same for all ACOs regardless of their size and may 
not adequately represent an ACO's full population.
    Response: Although the overall number of assigned beneficiaries may 
differ between small, medium, and large ACOs, we believe that a sample 
size of 860 beneficiaries is reasonable and will produce scores on the 
CAHPS for MIPS measure meeting the adequate reliability threshold 
regardless of the size of an ACO's assigned beneficiary population. As 
we explained in the CY 2021 PFS final rule (85 FR 84731), eligible 
beneficiaries who are assigned to an ACO or MIPS group are randomly 
selected to be included in the sample for the CAHPS for MIPS survey. 
The use of a randomly selected survey sample ensures that the sample 
will be representative of the overall population served by the ACO or 
MIPS group. The target sample size of 860 beneficiaries was established 
using the results of analyses that sought to establish measures that 
allowed for meaningful comparisons to be made across ACOs and MIPS 
groups.
    Accordingly, consistent with the clarification discussed in the CY 
2022 PFS proposed rule, the CAHPS for MIPS minimum sampling thresholds 
will apply to Shared Savings Program ACOs for performance year 2021 and 
subsequent performance years.
    In the CY 2022 PFS proposed rule (86 FR 39265), we also noted that 
the term ``performance period'' is used to describe the time-period 
over which quality performance is assessed under MIPS, which is a full 
calendar year (January 1 through December 31) (except as otherwise 
specified for administrative claims-based measures in the MIPS final 
list of quality measures). In contrast, the Shared Savings Program uses 
the term ``performance year'' to describe each period for which ACOs' 
quality performance is assessed. For performance year 2021 and 
subsequent performance years, the relevant period is also the full 
calendar year. Therefore, in the proposed rule, we further clarified 
that while the terminology used in the Shared Savings Program and MIPS 
differs, the period of time for which quality performance is assessed 
under the APP is the same for both programs.
c. Amending the Reporting Requirements Under the APM Performance 
Pathway for Performance Years 2022 and 2023
    In the CY 2021 PFS final rule, we finalized a change to the quality 
reporting requirements for purposes of the Shared Savings Program (85 
FR 84720 through 84734). Effective for performance year 2021 and 
subsequent performance years, Shared Savings Program ACOs are required 
to report quality data via the APP. The quality reporting requirements 
under the Shared Savings Program align with the requirements that apply 
under the APP under the Quality Payment Program. Under this new 
approach, ACOs only need to report one set of quality metrics via the 
APP to satisfy the quality reporting requirements under both the Shared 
Savings Program and the MIPS. The quality measures reported via the APP 
for purposes of the MIPS Quality performance category will also be used 
to determine the quality performance of the ACO for purposes of 
determining eligibility for shared savings and calculating shared 
losses, where applicable. We refer readers to the CY 2022 PFS proposed 
rule (86 FR 39265 and 39266) for an overview of the requirements for 
ACOs reporting under the APP that were adopted in the CY 2021 PFS final 
rule.
    In the CY 2022 PFS proposed rule (86 FR 39266), we explained that, 
since the CY 2021 PFS final rule was issued, stakeholders have 
continued to express concerns about requiring ACOs to report 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. We noted that for performance 
years beginning on or after January 1, 2019, ACOs are required to 
certify that they meet the CEHRT use requirements as specified at Sec.  
425.506(f). Specifically, an ACO in a track that:
     Does not meet the financial risk standard to be an 
Advanced APM 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 50 percent; or
     Meets the financial risk standard to be an Advanced APM 
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

[[Page 65258]]

the threshold established under Sec.  414.1415(a)(1)(i).
    We noted that we define CEHRT for purposes of the Shared Savings 
Program at Sec.  425.20 and the term has the same meaning as provided 
under Sec.  414.1305 for purposes of the Quality Payment Program. For 
2019 and subsequent years, CEHRT is defined to mean EHR technology that 
meets the 2015 Edition Base EHR definition and that has been certified 
to the 2015 Edition health IT certification criteria necessary to 
report on applicable objectives and measures specified for the MIPS 
Promoting Interoperability performance category and includes clinical 
quality measure certification criteria that support the calculation and 
reporting of clinical quality measures that can be electronically 
accepted by CMS. Health IT certified to clinical quality measure 
certification criteria can help to support ACOs' efforts to meet 
quality measure reporting requirements.
    We stated that, according to a National Association of Accountable 
Care Organizations (NAACOS) survey \112\ regarding the readiness of 
ACOs to report eCQM/MIPS CQM data, 77 percent of respondents had 
indicated they do not have the infrastructure in place to aggregate 
data on behalf of their ACO participant TINs on quality performance 
across all payers starting in 2022. On average, an ACO has 36 ACO 
participant TINs and the largest Shared Savings Program ACO has 436 ACO 
participant TINs. The NAACOS survey also noted that almost 40 percent 
of ACOs have more than 15 EHR systems. Additionally, we noted that 
stakeholders had raised privacy and other concerns about reporting 
eCQMs/MIPS CQMs on all-payer populations, rather than a sample of 
assigned Medicare beneficiaries, as required for the CMS web interface 
measures. These concerns focused on perceived HIPAA Privacy Rule 
limitations on sharing protected health information (PHI) for non-
Medicare beneficiaries with an ACO.
---------------------------------------------------------------------------

    \112\ https://www.naacos.com/assets/docs/pdf/2021/NAACOS-QualityhandoutCCSQmeeting03222021.pdf.
---------------------------------------------------------------------------

    We also stated in the proposed rule (85 FR 39266) that we had heard 
concerns from ACOs that are acting, for the purpose of HIPAA 
compliance, as business associates of their health care provider ACO 
participants regarding their ability to update their business associate 
agreements (BAAs) to include the PHI of patients who are not covered by 
Medicare. Stakeholders indicated that their current agreements may only 
address sharing the PHI of Medicare beneficiaries. Therefore, they 
raised concerns that reporting all payer eCQMs would violate their 
BAAs, as well as the HIPAA Privacy Rule business associate requirements 
at 45 CFR 164.502(a) and 164.504(e).
    As we noted in the proposed rule, to report eCQMs successfully, 
health care providers must adhere to the requirements identified by the 
CMS quality program in which they intend to participate (86 FR 39266). 
For purposes of reporting eCQMs/MIPS CQMs under MIPS, clinicians are 
expressly required under Sec.  414.1340(a) to submit data on the 
applicable percentage of patients that meet the measure's denominator 
criteria, regardless of payer. Under Sec.  
414.1380(b)(1)(i)(B)(1)(iii), failure to meet this requirement may 
result in the clinician receiving zero points for the measure, which 
may adversely impact their MIPS final score and payment adjustment. As 
such, in the proposed rule, we stated our belief that the disclosure of 
all-payer data to CMS as required by Sec.  414.1340(a) would be 
permitted by the HIPAA Privacy Rule under the provision that permits 
disclosures of PHI as ``required by law.'' \113\ Under this provision, 
a HIPAA covered entity, or its business associate when authorized by 
its BAA, may use or disclose PHI to the extent that such use or 
disclosure is required by law and the use or disclosure complies with 
and is limited to the relevant requirements of such law. We also noted 
that the HIPAA Privacy Rule minimum necessary standard does not apply 
to uses or disclosures that are required by law.\114\
---------------------------------------------------------------------------

    \113\ See 45 CFR 164.512(a).
    \114\ See 45 CFR 164.502(b)(2)(v).
---------------------------------------------------------------------------

    Furthermore, we stated that the HIPAA Privacy Rule generally 
permits a covered entity to disclose PHI to a business associate and to 
allow a business associate to create, receive, maintain, or transmit 
PHI on its behalf, provided that the parties have a BAA that meets the 
requirements of 45 CFR 164.504(e) and permits the business associate to 
use or disclose PHI only as permitted or required by its BAA or as 
required by law. The BAA must, among other things, establish the 
permitted and required uses and disclosures of PHI by the business 
associate. Accordingly, we explained that ACO providers and suppliers 
that are MIPS eligible clinicians will need to review and update any 
relevant BAAs as necessary to include the disclosure of all-payer data, 
in addition to data for Medicare beneficiaries to the ACO. We stated 
that we believe ACO providers/suppliers should be able to update those 
agreements, in consultation with their legal counsel as necessary, to 
reflect the need to share data for patients covered by all payers with 
the ACO, in order to permit the ACO to completely and accurately report 
data on eCQMs/MIPS CQMs consistent with the MIPS reporting 
requirements.
    In addition, we corrected a statement from the CY 2021 PFS final 
rule (85 FR 84730). In that final rule, we provided an example of how 
an ACO could aggregate eCQM measure data. In this example, we stated 
that an ACO could, on behalf of its ACO participants, combine the 
results from all the ACO participant TIN QRDA 3 files, by adding 
numerators, denominators, etc. and create an aggregate QRDA 3 file (or 
other compliant file format) and submit as an ACO to CMS. However, as 
explained in the CY 2022 PFS proposed rule (86 FR 39267), this example 
did not take into account the potential for duplicate patients for a 
given measure across the ACO participant TINs within an ACO. It also 
did not take into account that two of the three eCQMs require that the 
most recent blood pressure or HgbA1c be captured to assess performance 
for those measures. Accordingly, we clarified that an ACO that submits 
eCQM quality data to CMS must de-duplicate the patient level measures 
data across its ACO providers/suppliers to ensure that the aggregated 
QRDA 3 file that is submitted to CMS incorporates only quality data 
that meets the intent of the measure.
    As discussed in section IV.A.3.d.(1)(d) of the CY 2022 PFS proposed 
rule, we proposed to extend the CMS Web Interface as a collection type 
for the Quality Payment Program for PY 2022 for MIPS Groups, Virtual 
groups, and Shared Savings Program ACOs reporting under the APP. For PY 
2023, we proposed that the CMS Web Interface would be a collection type 
under the APP only for Shared Savings Program ACOs. Accordingly, we 
proposed to modify the quality measure set that must be reported by 
Shared Savings Program ACOs under the APP, as discussed in section III 
J.1.c. and section IV.A.3.c.(2)(a) of the CY 2022 PFS proposed rule.
    To further address stakeholder feedback about ACOs' readiness to 
report all-payer measures, and in particular the concerns regarding 
aggregation of eCQM/MIPS CQM data across multiple ACO participant TINs 
using multiple different EHR technology, while also providing 
incentives for ACOs to take the steps necessary to report all-payer 
measures, we proposed that:

[[Page 65259]]

     For performance year 2022: An ACO would be required to 
report on either:
    ++ The ten CMS Web Interface measures and administer a CAHPS for 
MIPS survey and CMS would calculate the two claims-based measures 
included under the APP, or
    ++ The three eCQM/MIPS CQMs and administer a CAHPS for MIPS survey 
and CMS would calculate the two claims-based measures included under 
the APP. If an ACO selects this option, meets the data completeness 
requirement at Sec.  414.1340 and the case minimum requirement at Sec.  
414.1380 for all three eCQMs/MIPS CQMs, and achieves a quality 
performance score equivalent to or higher than the 30th percentile of 
the performance benchmark on at least one measure in the APP measure 
set, the ACO would meet the quality performance standard used to 
determine eligibility for shared savings and to avoid maximum shared 
losses, if applicable, for that performance year. In the CY 2022 PFS 
proposed rule (86 FR 39267), we stated that we believed that allowing 
ACOs that report eCQMs/MIPS CQMs to meet the quality performance 
standard if they achieve a score that is equivalent to or higher than 
the 30th percentile benchmark on one measure in the APP measure set 
would 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 required beginning in 
performance year 2024. We proposed that if an ACO chooses this option, 
its performance on all three eCQMs/MIPS CQMs would be used for purposes 
of MIPS scoring under the APP. We also noted that if an ACO decides to 
report both the ten CMS Web Interface measures and the three eCQMs/MIPS 
CQMs, it will receive the higher of the two quality scores for purposes 
of the MIPS Quality performance category.
    If an ACO does not report any of the ten CMS Web Interface measures 
or any of the three eCQMs/MIPS CQMs and does not administer a CAHPS for 
MIPS survey under the APP, the ACO would not meet the quality 
performance standard. We proposed that:
     For performance year 2023: The ACO would be required to 
report on either:
    ++ The ten CMS Web Interface measures, at least one eCQM/MIPS CQM, 
and administer a CAHPS for MIPS survey and CMS would calculate the two 
claims-based measures included under the APP; or
    ++ The three eCQMs/MIPS CQMs and administer a CAHPS for MIPS survey 
and CMS would calculate the two claims-based measures included under 
the APP. If an ACO selects this option, meets the data completeness 
requirement at Sec.  414.1340 and the case minimum requirement at Sec.  
414.1380 for all three eCQMs/MIPS CQMs, and achieves a quality 
performance score equivalent to or higher than the 30th percentile of 
the performance benchmark on at least one measure in the APP measure 
set, the ACO would meet the quality performance standard used to 
determine eligibility for shared savings and to avoid maximum shared 
losses, if applicable, for that performance year. If an ACO chooses 
this option, its performance on all three eCQMs/MIPS CQMs would be used 
for purposes of MIPS scoring under the APP. We also noted that if an 
ACO decides to report both the ten CMS Web Interface measures and the 
three eCQMs/MIPS CQMs, it will receive the higher of the two quality 
scores for purposes of the MIPS Quality performance category.
    We also proposed that if an ACO does not report at least one eCQM/
MIPS CQM in the APP measure set, the ACO would not meet the quality 
performance standard.
     For performance year 2024 and subsequent performance 
years: The ACO would be required to report the three eCQMs/MIPS CQMs 
and administer a CAHPS for MIPS survey and CMS would calculate the two 
claims-based measures included under the APP. If an ACO does not report 
any of the three eCQMs/MIPS CQMs and does not administer a CAHPS for 
MIPS survey under the APP, the ACO would not meet the quality 
performance standard.
    Finally, for the first performance year of an ACO's first agreement 
period under the Shared Savings Program, if the ACO meets MIPS data 
completeness and case minimum requirements, we proposed that the ACO 
would meet the quality performance standard, if:
     For performance year 2022. The ACO reports the ten CMS Web 
Interface measures or the three eCQMs/MIPS CQMs and administers a CAHPS 
for MIPS survey under the APP.
     For performance year 2023. The ACO reports the ten CMS Web 
Interface measures and at least one eCQM/MIPS CQM measure or reports 
the three eCQMs/MIPS CQMs, and administers a CAHPS for MIPS survey 
under the APP.
     For performance year 2024 and subsequent performance 
years. The ACO reports on the three eCQMs/MIPS CQMs and administers a 
CAHPS for MIPS survey under the APP.
    We proposed changes to the regulation at Sec.  425.512(a) to 
reflect these changes to the quality reporting requirements for 
performance years 2022 and 2023.
    We solicited comment on these proposed updates to the reporting 
requirements under the APP for performance year 2022 and subsequent 
years. In addition, we solicited comment on whether we should extend 
the CMS Web Interface collection type for more than the 2 years 
proposed. We explained our belief that the proposed 2-year extension 
would provide sufficient time to allow ACOs and their ACO participants 
to take the necessary steps to address the concerns raised by 
stakeholders, but noted that we were interested in hearing if 
stakeholders believe additional time would be needed to enable ACOs and 
their ACO participants to prepare for eCQM/MIPS CQM reporting.
    We received several public comments on the proposed updates to the 
reporting requirements under the APP for Shared Savings Program ACOs 
for performance year 2022 and subsequent years. We also received 
several public comments in response to our comment solicitation on the 
extension of the CMS Web Interface as a collection type. The following 
is a summary of the comments we received and our responses.
    Comment: We received several comments in support of the proposed 
updates to the reporting requirements under the APP for Shared Savings 
Program ACOs. Several commenters supported CMS' acknowledgement of the 
complexity of the transition to all-payer eCQMs/MIPS CQMs. Another 
commenter appreciated the ability to test the reporting of eCQMs 
without the risk of being penalized. One commenter supported CMS' plans 
to improve data collection and reduce burden through digital quality 
measurement and applauded CMS for being responsive to ACO and other 
stakeholder concerns regarding the timeline. Several commenters 
appreciated CMS' proposal to provide more time to implement new systems 
to allow for aggregating all-payer data across multiple EHR systems and 
multiple health care practices. One commenter supported the transition 
to the reporting and submission of all-payer data for the three eCQMs/
MIPS CQMs and stated their organization's readiness to support ACOs to 
be able to report on these measures. Another commenter encouraged CMS 
to improve education and guidance to support the transition.
    Response: We have provided many resources and will continue to 
provide such resources to support ACOs as they

[[Page 65260]]

transition to reporting the 3 eCQMs/MIPS CQMs. Commenters should refer 
to the ``PY2021 APM Performance Pathway Toolkit'' that is available on 
the Quality Payment Program Resource Library website at https://qpp.cms.gov/resources/resource-library. This toolkit contains multiple 
documents on how to report under the APP for performance year 2021 and 
how to aggregate data to the ACO level, a scoring guide, and a document 
describing the specific APP policies that apply to Shared Savings 
Program ACOs. These documents will be updated for each upcoming 
performance year.
    Comment: Several commenters expressed concerns about the proposed 
updates to the quality reporting requirements and the timeline for ACOs 
to transition to reporting eCQMs/MIPS CQMs given that it could be 
difficult for an ACO to test eCQM reporting. Further, these commenters 
expressed concerns regarding industry's readiness to implement, test, 
and prepare all systems to report eCQMs/MIPS CQMs in 2 years. Several 
commenters appreciated the gradual transition to reporting eCQMs/MIPS 
CQMs, but stated that the proposal to require reporting on just one 
eCQM/MIPS CQM would require the same technological and administrative 
lift as reporting on all three eCQMs/MIPS CQMs and recommended that CMS 
remove its proposal to require reporting on at least one eCQM/MIPS CQM 
in 2023.
    Several commenters recommended that CMS delay the eCQM/MIPS CQM 
reporting requirements. Some commenters suggested a delay of 2-5 years, 
and a few commenters suggested delaying until there have been 
sufficient EHR and IT improvements to make reporting eCQMs 
``feasible,'' including more standard data fields and interoperability 
to resolve issues with aggregating eCQM data at the ACO level. Some 
commenters stated that the need for IT improvements disproportionately 
impacts independent physician practices, and those serving rural and 
underserved populations.
    Response: We interpret the commenters' note about the infeasibility 
of reporting eCQMs as a reference to the inability of ACOs to update 
their infrastructure and establish the workflows needed to aggregate 
data and report on the 3 eCQMs/MIPS CQMs. As such, we believe allowing 
an additional year beyond the 2-year extension of the CMS Web Interface 
collection type proposed in the CY 2022 PFS proposed rule will provide 
ACOs with the time necessary to prepare to implement and report on the 
eCQM/MIPS CQMs. This further extension will allow ACOs additional time 
to ensure that they have the necessary infrastructure in place to 
successfully meet the new quality reporting requirements. We further 
believe that this additional time will help to ensure appropriate 
development and testing of the systems necessary to collect and 
aggregate data across ACO participants. The additional time will also 
ensure that ACOs can begin to create the workflows in their systems and 
make the necessary updates to report on the eCQM/MIPS CQMs. We believe 
this extended transition will also address commenters' concerns about 
the impact of the new reporting requirements on independent physician 
practices serving rural and underserved populations.
    We understand the concern that the components of implementing an 
interoperable system are the same regardless of the number of eCQM/MIPS 
CQMs required to be reported. As a result, we also understand 
commenters' concern that our proposed requirement that ACOs report on 
at least one eCQM/MIPS CQM for performance year 2023 would likely 
impose the same burden as reporting all three eCQM/MIPS CQMs, given the 
necessary updates to their EHR systems, data aggregation, and workflow 
mappings that would be required to report one eCQM/MIPS CQM. In light 
of these concerns, we are not finalizing our proposal to require ACOs 
to report on at least one eCQM/MIPS CQM for performance year 2023 as 
discussed in section III.J.1.c of this final rule.
    Comment: Many commenters generally supported the use of eCQMs, but 
had concerns about whether accurate, complete, and comparable eCQM 
reporting can be accomplished in the proposed 2-year extension period 
and supported further extending the timeframe until these challenges 
have been addressed. One commenter had concerns about including data 
from patients who receive care from non-ACO physicians or specialists 
in the same practice locations as physicians who are ACO providers/
suppliers. Another commenter had concerns with the inclusion of 
emergency physicians, who may be participating in a Shared Savings 
Program ACO, but may not have an active role in the ACO. Another 
commenter recommended that CMS allow ACOs to exclude ACO participant 
TINs that use EMRs with insufficient quality data reporting 
capabilities. Another commenter questioned how data completeness 
standards could be met, given the issues of de-duplication and patients 
adding or moving insurance coverage. Many commenters called for CMS to 
provide more education and guidance to support ACOs in successfully 
transitioning to eCQM reporting given the complexities. A few 
commenters pointed out the added difficulty of making the changes 
necessary to transition to eCQM reporting during a global pandemic. One 
commenter expressed concern that eCQMs include data from an ACO's 
entire patient population, stating that this could penalize ACOs that 
include safety net clinics whose patients face social determinants of 
health (SDOH) barriers that drive down quality results. One commenter 
shared their concern regarding the shift from comparing the quality of 
care provided between ACOs to broadening this comparison to include all 
MIPS eligible clinicians. This commenter noted that the quality data 
reported by ACOs reflects coordination of care across the care 
continuum while MIPS reporting reflects care provided by individual 
clinicians and groups.
    Response: We understand the concerns raised by the commenters 
regarding reporting on care from non-ACO practitioners. The 
determination of whether a service provided by a non-ACO practitioner 
would be attributed to the ACO TIN depends on the type of care being 
provided, the timing of the service, and confirmation by the ACO TIN 
that the patient received the service. If a physician or other 
practitioner does not bill under the TIN of an ACO participant, and 
thus, is not considered to be participating in the ACO, then a visit 
with this health care provider would not need to be included in the 
denominator for a measure's performance data. However, actions taken by 
a practitioner outside the ACO could be included in the measure's 
numerator of the ACO if the action of the practitioner occurs within 
the same reporting period and meets the criteria for the measure's 
numerator and the practitioner is coordinating with health care 
providers in the ACO.
    We appreciate the commenters' concerns and recommendations 
regarding the shift from comparing quality performance between ACOs to 
comparing all MIPS eligible clinicians. We believe by assessing ACO 
quality performance in relation to all Medicare FFS reporters, MIPS 
eligible clinicians, APM entities and other ACOs eliminates differences 
in the way ACOs are scored compared to their MIPS eligible clinicians.
    In reference to the commenter's concern regarding how data 
completeness could be met given issues of de-duplication, we note that 
the ACO would utilize the QRDA I format, which specifies patient level 
collection of data

[[Page 65261]]

from each of the ACO's participant TINs. The ACO would then aggregate 
these data across the ACO and submit them to CMS in the QRDA III 
format. Collecting and aggregating these data in the QRDA I format 
allows for de-duplication given the granularity of the data. In 
reference to patients who change or add different insurance, we note 
that patients regularly change coverage but that does not remove the 
patients' data from the EHR. We believe requiring ACOs to transition to 
reporting eCQMs/MIPS CQMs should help further align quality measurement 
and improvement efforts, improving quality of care provided.
    Comment: Several commenters expressed concerns regarding technical 
aspects of the data aggregation that is needed to report eCQMs/MIPS 
CQMs. One commenter cited that QRDA III files provide de-identified 
aggregate data, making it difficult to aggregate data or report eCQMs 
at the ACO level. Another commenter expressed concern that aggregated 
summary-level data submitted with QRDA III files for eCQMs, including 
data reported by specialists, would not be representative of the 
primary care received by the patient. A few commenters were concerned 
that aggregation of data would raise HIPAA concerns and require patient 
consent, to share non-Medicare patient information with the ACO and 
with CMS for a population that is not assigned to the ACO. They noted 
that obtaining this consent would be an additional burden.
    Response: As noted previously, use of the QRDA I format does not 
have the same limitations with respect to de-identified aggregate data 
that make the QRDA III ill-suited for compiling the information needed 
to report eCQMs/MIPS CQMs at the ACO level.
    We will continue to add documents to the ``PY2021 APM Performance 
Pathway Toolkit'' that is available on the Quality Payment Program 
Resource Library website at https://qpp.cms.gov/resources/resource-library to provide guidance on how the data should be reported to CMS.
    We also recommend that ACOs refer to the measure specifications for 
each of the eCQMs. Specifications for all eCQMs can be found in the QPP 
resource library in the zip file titled ``2021 Electronic Clinical 
Quality Measures (eCQMs) Specifications''. These documents can be found 
in the QPP resource library at https://qpp.cms.gov/resources/resource-library.
    With respect to the HIPAA concerns raised by commenters, for the 
reasons discussed in the CY 2022 PFS proposed rule (86 FR 39266 and 
39267), we believe the disclosure of all-payer protected health 
information to CMS as required by Sec.  414.1340(a) is permitted by the 
HIPAA Privacy rule under the provision that permits disclosures as 
``required by law'' of an individual's PHI ``without the written 
authorization of the individual . . . or the opportunity for the 
individual to agree or to object.'' \115\ As we noted in the proposed 
rule, the HIPAA Privacy Rule minimum necessary standard does not apply 
to uses or disclosures that are required by law.\116\
---------------------------------------------------------------------------

    \115\ 45 CFR 164.512(a).
    \116\ See 45 CFR 164.502(b)(2)(v).
---------------------------------------------------------------------------

    Regarding disclosures of PHI between an ACO participant TIN and the 
ACO, we encourage ACOs and their ACO participants to consult with their 
legal counsels as necessary to ensure that their Business Associate 
Agreements (BAAs) address the need to share data for patients covered 
by all payers with the ACO to permit the ACO to comply with its legal 
obligation to completely and accurately report data to CMS on eCQMs/
MIPS CQMs. We noted in the proposed rule that the HIPAA Privacy rule 
generally permits a covered entity to disclose PHI to a business 
associate and to allow a business associate to create, receive, 
maintain, or transmit PHI on its behalf, provided that the parties have 
a BAA that meets the requirements of 45 CFR 164.504(e) and permits the 
business associate to use or disclose PHI only as permitted or required 
by its BAA or as required by law. We also note that we are considering 
whether it would be appropriate to revise the regulations at Sec. Sec.  
425.702(c)(5) and 425.704(b) to allow data sharing with an ACO that has 
structured its relationship with its ACO participants as an organized 
health care arrangement (OHCA), as that term is defined in the HIPAA 
regulations at 45 CFR 160.103. Any changes to the current requirements 
governing data sharing with ACOs would be addressed in notice-and-
comment rulemaking for future performance years.
    In light of the concerns raised by the commenters about the 
proposed timeline for implementing the eCQM/MIPS CQM reporting 
requirements under the APP for Shared Savings Program ACOs, we are 
finalizing our proposed changes to the quality reporting requirements 
with the following modifications. As discussed in section 
IV.A.3.d.(1)(d) of this final rule, we are extending the use of the CMS 
Web Interface as a collection type for the Quality Payment Program for 
performance years 2022, 2023, and 2024 for Shared Savings Program ACOs 
reporting under the APP. The CMS Web Interface will be unavailable 
starting with CY 2025. Accordingly, we are modifying the quality 
measure set for the APP for Shared Savings Program ACOs to retain the 
CMS Web Interface as an additional reporting option for performance 
year 2024, as discussed in sections IV.A.3.c.(2)(a) and IV.A.3.d.(1)(d) 
of this final rule. In addition, we are not finalizing the proposed 
requirement that an ACO must report at least one eCQM/MIPS CQM in 
performance year 2023 in order to meet the quality performance 
standard.
    Accordingly, for performance year 2022 and subsequent performance 
years, ACOs must meet the requirements described below and summarized 
in Table 34 in order to meet the quality reporting requirements under 
the Shared Savings Program. Please see Table 35 of this final rule for 
the final APP measure set that must be reported by Shared Savings 
Program ACOs for performance year 2022 and subsequent performance 
years.
     For performance years 2022, 2023, and 2024: An ACO must 
report on either:
    ++ The 10 CMS Web Interface measures and administer a CAHPS for 
MIPS survey and CMS will calculate the two claims-based measures 
included under the APP, or
    ++ The three eCQM/MIPS CQMs and administer a CAHPS for MIPS survey 
and CMS will calculate the two claims-based measures included under the 
APP.
    If an ACO (1) does not report any of the 10 CMS Web Interface 
measures or any of the three eCQMs/MIPS CQMs and (2) does not 
administer a CAHPS for MIPS survey under the APP, the ACO will not meet 
the quality performance standard.
    To provide an incentive for ACOs to begin the transition to eCQM/
MIPS CQM reporting before performance year 2025, we are finalizing in 
section III.J.A.1.d. of this final rule that, for performance years 
2022 and 2023, if an ACO reports the three eCQMs/MIPS CQMs, meets the 
data completeness requirement at Sec.  414.1340 and the case minimum 
requirement at Sec.  414.1380 for all three eCQMs/MIPS CQMs, and 
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 a quality performance 
score equivalent to or higher than the 30th percentile of the 
performance benchmark on at least one of the remaining five measures in 
the APP measure set, the ACO will meet the

[[Page 65262]]

quality performance standard used to determine eligibility for shared 
savings and to avoid maximum shared losses, if applicable, for that 
performance year.
    We believe that the quality performance standard policies we are 
finalizing for performance years 2022 and 2023 will 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.
    We note that if an ACO chooses to report the three eCQMs/MIPS CQMs, 
its performance on all three eCQMs/MIPS CQMs will be used for purposes 
of MIPS scoring under the APP. If an ACO decides to report both the 10 
CMS Web Interface measures and the three eCQMs/MIPS CQMs, it will 
receive the higher of the two quality scores for purposes of the MIPS 
Quality performance category.
    Please note that, as indicated in Tables 34 and 51 of this final 
rule, three of the CMS Web Interface measures (Statin Therapy for the 
Prevention and Treatment of Cardiovascular Disease (Quality ID# 438); 
Depression Remission at Twelve Months (Quality ID# 370), and Preventive 
Care and Screening: Tobacco Cessation: Screening and Cessation 
Intervention (Quality ID# 226)) do not have benchmarks for performance 
year 2022, and therefore, will not be scored. However, these measures 
are required to be reported in order to complete the CMS Web Interface 
dataset. Based on the ACO's chosen reporting option, either 6 (three 
eCQMs/MIPS CQMs + two claims-based measures + CAHPS for MIPs Survey 
measure) or 10 measures (seven CMS Web Interface measures + two claims-
based measures + CAHPS for MIPS Survey measure) will be included in the 
calculation of the ACO's quality performance score.
     For performance year 2025 and subsequent performance 
years: The ACO must report the three eCQMs/MIPS CQMs and administer a 
CAHPS for MIPS survey and CMS will calculate the two claims-based 
measures included under the APP. If an ACO does not report any of the 
three eCQMs/MIPS CQMs and does not administer a CAHPS for MIPS survey 
under the APP, the ACO will not meet the quality performance standard.
    We believe providing ACOs a total of 4 years (from performance year 
2021 to performance year 2024) to transition to eCQM/MIPS CQM reporting 
is responsive to the commenters' concerns that it could take ACOs 3 to 
5 years to transition to all-payer reporting. We believe this timeline 
will allow ACOs sufficient time to put IT infrastructure in place to 
capture, aggregate, and report all-payer quality measure data to CMS. 
Additionally, the removal of the proposed requirement that ACOs 
reporting the 10 CMS Web Interface measures in performance year 2023 
must also report at least one of the three eCQMs/MIPS CQMs under the 
APP will prevent duplicate reporting of quality data given that the 
three eCQMs/MIPS CQMs are also CMS Web Interface measures. The removal 
of this proposed requirement also reduces burden for ACOs that elect to 
report through the CMS Web Interface in performance year 2023, by 
eliminating the requirement that these ACOs also take the steps 
necessary to report one eCQM/MIPS CQM.
    We note that in addition to the comments discussed above regarding 
ACOs' readiness to report eCQMs/MIPS CQMs, in a recent ACO Learning 
System webinar entitled ``Harnessing Data to Improve Quality'', 
participants were asked, ``where is your ACO in your journey to 
implement eCQMs?''. In response, many ACOs indicated that they are 
reviewing measure specifications for the transition to reporting eCQMs/
MIPS CQMs. Of the 46 respondents, half were reviewing measure 
specifications (50 percent), nearly half were engaging with ACO 
leadership on issues related to eCQM implementation (48 percent), and a 
number were beginning to educate providers on eCQMs (24 percent). Only 
15 percent of respondents reported they had not yet started eCQM 
implementation. Since hearing concerns from stakeholders earlier this 
year regarding the burdens imposed by the requirement to report on 
eCQM/MIPS CQMs, we have been working with the CMS Office of Burden 
Reduction and Health Informatics (OBRHI) and ONC to identify barriers 
to implementation and plan to provide technical assistance to ACOs and 
IT vendors. OBRHI is developing case studies to assist ACOs in making 
the transition to eCQMs/MIPS CQMs, and we are in discussions with ONC 
regarding providing technical assistance to address the unique 
challenges facing ACOs with respect to reporting eCQMs/MIPS CQMs.
    As noted previously in this section of the final rule, we also 
suggest that ACOs refer to the ``PY2021 APM Performance Pathway 
Toolkit'' that is available on the Quality Payment Program Resource 
Library website at https://qpp.cms.gov/resources/resource-library. This 
toolkit contains multiple documents related to how to report under the 
APP for performance year 2021, including a scoring guide and a document 
that specifically addresses the APP policies applicable to Shared 
Savings Program ACOs. These documents will be updated for each upcoming 
performance year. Furthermore, as stated in one of our previous 
responses, we have specifications for all eCQMs (including the three 
eCQMs/MIPS eCQMs that ACOs will report on under the APP) that can be 
found in the QPP resource library in the zip file titled ``2021 
Electronic Clinical Quality Measures (eCQMs) Specifications''.
    We did not receive any comments on the proposed quality performance 
standard for ACOs in the first performance year of their first 
agreement period under the Shared Savings Program. However, we are 
finalizing our proposal with modifications in order to align with the 
quality reporting requirements we are finalizing for performance year 
2022 and subsequent years, as described below.
    Accordingly, for the first performance year of an ACO's first 
agreement period under the Shared Savings Program, if the ACO meets 
MIPS data completeness and case minimum requirements, the ACO will meet 
the quality performance standard under the Shared Savings Program, if:
     For performance years 2022, 2023 and 2024. The ACO reports 
the ten CMS Web Interface measures or the three eCQMs/MIPS CQMs and 
administers a CAHPS for MIPS survey under the APP.
     For performance year 2025 and subsequent performance 
years. The ACO reports on the three eCQMs/MIPS CQMs and administers a 
CAHPS for MIPS survey under the APP.
    We are also finalizing changes to the regulation at Sec.  
425.512(a) to reflect the final quality reporting requirements under 
the Shared Savings Program for performance years 2022 and subsequent 
performance years that we are adopting in this final rule. We note that 
it is now our preference to omit the word ``measures'' when describing 
the eCQMs/MIPS CQMs in order to avoid redundancy. Therefore, we are 
revising all references to ``eCQM/MIPS CQM measures'' in Sec.  
425.512(a) to read ``eCQMs/MIPS CQMs''.

[[Page 65263]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.056

(1) Solicitation of Comments on Addressing Health Disparities and 
Promoting Health Equity
    In the CY 2022 PFS proposed rule (86 FR 39269 and 39270), we 
solicited comments and recommendations on how ACOs can utilize their 
resources to ensure that patients, regardless of racial/ethnic group, 
geographic location and/or income status, have access to equal care and 
how ACOs can improve the quality of care provided to certain 
communities, while addressing the disparities that currently exist in 
healthcare. We also solicited comments and recommendations on how we 
can encourage health care providers serving vulnerable populations to 
participate in ACOs and other value-based care initiatives, including 
whether any adjustments should be made to quality

[[Page 65264]]

measure benchmarks to take into account ACOs serving vulnerable 
populations. We appreciate the feedback we received in response to this 
comment solicitation. We may consider this information to inform future 
rulemaking.
(2) Solicitation of Comments on Feasibility of TIN Level Reporting and 
Sampling for eCQMs/MIPS CQMs
    We also solicited comment on allowing ACO providers/suppliers to 
submit eCQMs/MIPS CQMs to CMS at the ACO participant TIN level and 
potential approaches CMS could use to calculate/aggregate the TIN level 
quality data to create an ACO level score. We solicited comment on how 
stakeholders would envision CMS determining an appropriate beneficiary 
population. We also solicited comment on whether CMS should create a 
specific sampling methodology for ACOs, alternate sampling 
methodologies that could be used, as well as phase-in and tiered 
implementation strategies. We appreciate the feedback we received in 
response to this comment solicitation. We may consider this information 
to inform future rulemaking.
(3) Comment Solicitation for Reporting Options for Specialist Providers 
Within an ACO
    In order to address measure applicability for specialist providers, 
we solicited comment on allowing ACO participant TINs to report either 
the eCQMs/MIPS CQMs in the APP measure set at the TIN level or the 
applicable MIPS Value Pathways, including how APP and MIPS Value 
Pathway data reported at the ACO participant TIN level could be 
aggregated in order to assess ACO quality performance. In addition, we 
solicited input on the role specialists play in ACOs and what specialty 
measures in the current eCQM or MIPS CQM set should be considered for 
inclusion in the Shared Savings Program quality measure set in future 
performance years. We appreciate the feedback we received in response 
to this comment solicitation. We may consider this information to 
inform future rulemaking.
(4) Updates to the APM Performance Pathway (APP) Measure Set
    In the CY 2022 PFS proposed rule, we proposed to replace the Risk-
Standardized, All-Cause Unplanned Admissions for Multiple Chronic 
Conditions for ACOs (MCC for ACOs measure) with the Risk Standardized, 
All-Cause Unplanned Admissions for Multiple Chronic Conditions for MIPS 
(MCC for MIPS measure) for performance year 2022 (86 FR 39270 and 
39271). We also proposed to remove the MCC for ACOs measure from the 
APP measure set in order to reduce the potential for confusion around 
performance scores and feedback for MIPS eligible clinicians who might 
otherwise have been scored on both measures with differing results. We 
noted that this proposed change would continue the transition towards 
alignment of the quality measures reported by MIPS eligible clinicians 
who are not participants in APMs, such as the Shared Savings Program, 
and those who are, as discussed in the CY 2021 PFS final rule (85 FR 
84720).
    We explained that by removing the MCC for ACOs measure and aligning 
the quality measure set for the Shared Savings Program with MIPS, we 
would have the opportunity to align quality measurement between CMS 
programs. In addition, given that the Hospital-Wide, 30-day, All-Cause 
Unplanned Readmission (HWR) Rate for MIPS Eligible Clinician Groups 
measure included in the APP looks at an ACO's all Medicare population 
rather than just the ACO's assigned beneficiary population, we stated 
that we believed the proposal to move to the MCC for MIPS measure would 
be consistent with the approach under the APP of assessing, measuring 
and improving quality of care across a broader population of patients.
    Table 25 of the CY 2022 PFS proposed rule (86 FR 39271) set forth 
the proposed measure set under the APP that we proposed would be 
reported by Shared Savings Program ACOs for performance year 2022 and 
subsequent performance years.
    We received many public comments on our proposal to replace the MCC 
for ACOs measure with the MCC for MIPS measure and on the proposed APP 
measure set for performance year 2022 and subsequent performance years. 
The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters supported our proposal to replace the 
MCC for ACOs measure in the APP measure set with the MCC for MIPS 
measure for performance year 2022 and subsequent performance years. 
Some commenters stated that this change would reduce confusion for MIPS 
eligible clinicians who might otherwise have been scored on both 
measures with differing results and that it supports the agency's 
effort to align quality measures between MIPS and APMs. Other 
commenters explained that they support consolidation of measures across 
programs to reduce complexity. One commenter stated that adding the MCC 
for MIPS measure to the APP will create an opportunity for clinicians 
to become more familiar with the measure before transitioning to 
reporting under the APP.
    Response: We agree that replacing the MCC for ACOs measure with the 
MCC for MIPS measure would permit the use of a single measure across 
both the Shared Savings Program and MIPS. We note that this policy is 
also consistent with our goal to align the measures and quality 
reporting requirements under the Shared Savings Program with MIPS as 
stated in the CY 2021 PFS final rule (85 FR 84720 through 84722). 
Further, this policy also improves the ability to compare performance 
across ACO participants and MIPS eligible clinicians.
    Comment: A few commenters were opposed to the proposal and 
requested that CMS retain the current MCC for ACOs measure. Some 
commenters expressed concern that ACOs may not have the ability to 
meaningfully influence treatment of beneficiaries not assigned to the 
ACO. These commenters stated that the rationale for changing to the MCC 
for MIPS measure is likely flawed and that further testing is needed to 
assess the impact of the proposed change. The commenters explained that 
the broader denominator that will be produced when applying the MCC for 
MIPS measure to ACOs will be reflective of MIPS eligible clinicians' 
performance who may not participate in the Shared Savings Program, 
rather than the performance of ACOs, because many ACOs contract with a 
broad set of provider types that may or may not have an agreement with 
the ACO. The commenters recommended that CMS conduct analyses of the 
two MCC measures, such as comparisons of the measure denominators and 
resulting performance scores for ACOs and the associated eligible 
clinicians, to determine whether the assumption that scores will likely 
be similar is correct prior to finalizing this change. Another 
commenter cited the infeasibility of taking on responsibility for the 
full Medicare population in its ACO practices as a result of their 
patient population's preference to access care at the local Emergency 
Room (ER). Therefore, they are concerned that they do not have 
knowledge of these patients to assist with chronic disease management 
and care coordination needs.
    Response: We acknowledge the concerns raised by the commenters 
regarding our proposal to include the MCC for MIPS measure in the APP 
measure set. In proposing to shift to the MCC for MIPS measure for ACOs

[[Page 65265]]

beginning in performance year 2022, we were guided by our goal of 
harmonizing measures across CMS programs. In addition, we cannot 
evaluate clinician group performance across CMS programs without 
eliminating the use of multiple benchmarks for the same measure. The 
shift to a single MCC measure allows us to compare the performance of 
ACOs to that of TINs in the traditional MIPS as part of a combined 
calculation that includes both MIPS providers and ACOs and generates a 
single distribution of scores for benchmarking.
    The MCC for MIPS measure uses an office visit-based attribution 
algorithm to identify the clinician most responsible for the patient's 
care for purposes of determining the population to include in the 
measure denominator. The visit codes used for the attribution algorithm 
are the same as the visit codes used for the ACO beneficiary 
assignment. Based on the attribution algorithm, the patient is assigned 
to a primary care provider or to a relevant specialist based on the 
number and pattern of their visits. The patient then ``follows'' their 
clinician to the TIN designated by the clinician (that is, they are 
assigned to their clinician's TIN). ACO-level scores are determined 
after the TINs of ACO participants are mapped to their respective ACOs.
    In our preliminary analysis comparing the MCC for MIPS measure with 
the MCC for ACOs measure, we note that there is a high correlation of 
0.89 between ACO-level scores obtained using the old ACO MCC measure 
and the MIPS MCC measure. However, we acknowledge that ACOs' scores on 
the MCC measure may change as a result of including the MCC for MIPS 
measure in the APP measure set. We intend to conduct additional 
analyses to further model the impact of the shift to the MCC for MIPS 
measure on ACOs' scores for the MCC measure. The MCC for MIPS measure 
attribution considers only certain types of providers (primary care 
providers or specialists including cardiologists, pulmonologists, 
nephrologists, neurologists, and endocrinologists) who care for 
patients with MCCs, and excludes patients who would be attributed to 
hematologists/oncologists. In reference to commenters' concerns about 
taking on responsibilities of the full Medicare population, we continue 
to believe that moving to the MCC for MIPS measure will reduce the 
potential for confusion around performance scores and feedback for MIPS 
eligible clinicians who might otherwise have been scored on both 
measures with differing results. We also note that there is a strong 
overlap between the assigned beneficiary population for the MCC for 
ACOs measure and the attributed beneficiary population for the MCC for 
MIPS measure. Accordingly, we are finalizing our proposal to replace 
the MCC for ACOs measure with the MCC for MIPS measure in the APP 
measure set for performance year 2022 and subsequent performance years. 
Further details on the specifications for the MCC for MIPS measure can 
be found in Table A-5 in Appendix A of this final rule.
    Comment: Several commenters generally supported the overall 
proposed APP measure set. One commenter applauded the inclusion of the 
evidence-based eCQMs combined with CAHPS and administrative measures of 
utilization. Another commenter appreciated the reduced number of 
measures because it will ease provider burden.
    Response: We thank commenters for their positive feedback on the 
proposed APP quality measure set. The reduced measure set is intended 
to reduce reporting burden on ACOs and focus on quality measures that 
address patient outcomes.
    Comment: Several commenters noted that the measure set selected for 
the APP is narrowly focused and could result in a greater emphasis 
being placed on patient satisfaction as there will only be three 
clinical measures. Some commenters stated that the measure set selected 
for the APP would result in an ACO's entire performance hinging on only 
two or three measures, with a commenter noting that a very small 
measure set may overemphasize certain metrics or underlying beneficiary 
conditions, or create clinical disruption. Several commenters stated it 
was inappropriate for an ACO's performance to be based on only a couple 
of measures in a program where ACOs are financially accountable for 
total cost of care losses for a large population.
    One commenter expressed concern that the proposed measure set does 
not encourage or promote patient care. Another commenter stated that 
CMS had not yet struck the right balance between quality of care and 
minimizing burden. One commenter applauded CMS for moving toward more 
outcomes-based, primary care measures, but explained that this measure 
set did not yet achieve this goal. Several commenters mentioned that 
evaluating the totality of an ACO's quality performance on such a small 
measure set was inappropriate and unfair. Another commenter requested 
that CMS consult with the ACO community and patient representatives as 
it works to determine the measure set.
    Response: As we stated in the CY 2021 PFS final rule (85 FR 84728), 
the transition to the APP measure set was intended to reduce reporting 
burden and eliminate differences in the way ACOs are scored under the 
Shared Savings Program compared to the way their MIPS eligible 
clinicians are scored under MIPS, while also moving toward a more 
outcome-based, primary care focused measure set. Additionally, we 
selected the measures to be included in the measure set because they 
are broadly applicable for the primary care population and population 
health goals that are associated with the Shared Savings Program. These 
measures align with the Meaningful Measures framework while also being 
appropriate for assessing ACO quality performance as they focus on 
prevalent and high priority chronic health conditions. These measures 
are also relevant in assessing the quality of care furnished by the 
broad range of clinicians in a variety of specialties that participate 
in ACOs. For example, hypertension and diabetes are chronic conditions 
that are applicable to both primary care practitioners and specialists. 
Also, as noted in the CY 2021 PFS final rule (85 FR 84728), the APP 
measure set is intended to assess a sample of the areas where ACOs 
should be focused on improving the quality of care.
    After consideration of the comments received, we are finalizing the 
APP measure set as proposed. Table 35 lists the measures included in 
the final APP measure set that will be reported by Shared Savings 
Program ACOs for performance year 2022 and subsequent performance 
years. As discussed in section III.J.1.c. of this final rule, we are 
finalizing the following quality reporting requirements for Shared 
Savings Program ACOs for performance year 2022 and subsequent 
performance years:
     For performance years 2022, 2023 and 2024: An ACO will be 
required to report either:
    ++ The 10 CMS Web Interface measures and administer a CAHPS for 
MIPS survey and CMS will calculate the two claims-based measures 
included under the APP, or
    ++ The three eCQM/MIPS CQMs and administer a CAHPS for MIPS survey 
and CMS will calculate the two claims-based measures included under the 
APP.
     For performance year 2025 and subsequent performance 
years: An ACO will be required to report the three eCQMs/MIPS CQMs and 
administer a CAHPS for MIPS survey and CMS will

[[Page 65266]]

calculate the two claims-based measures included under the APP.
[GRAPHIC] [TIFF OMITTED] TR19NO21.057

d. Shared Savings Program Quality Performance Standard
(1) Freezing the Quality Performance Standard at the 30th percentile of 
All MIPS Quality Performance Category Scores for Performance Year 2023
    The quality performance standard is the minimum performance level 
ACOs must achieve in order to be eligible to share in any savings 
earned, avoid maximum shared losses under certain payment tracks, and 
avoid quality-related compliance actions. As noted above, in the CY 
2021 PFS final rule we finalized a gradual phase in of the revised 
quality performance standard.
    Specifically, an ACO would meet the quality performance standard 
if:
     For performance years 2021 and 2022, the ACO achieves a 
quality performance score that is equivalent to or higher than the 30th 
percentile across all MIPS Quality performance category scores, 
excluding entities/providers eligible for facility-based scoring; and
     For performance year 2023 and subsequent performance 
years, the ACO achieves a quality performance score that is equivalent 
to or higher than the 40th percentile across all MIPS Quality 
performance category scores, excluding

[[Page 65267]]

entities/providers eligible for facility-based scoring (85 FR 84735).
    We finalized this phase-in approach to address the concerns raised 
by commenters about the limited time for ACOs to gain familiarity with 
the new quality reporting requirements under the APP and potential 
challenges in meeting the new quality performance standard, as well as 
concerns regarding the shift from a domain-based scoring approach to 
the original proposal to require an ACO to achieve an overall quality 
score equivalent to the 40th percentile across all MIPS quality 
performance category scores starting in performance year 2021. In 
conjunction with the decision to phase-in the quality performance 
standard, we also adopted a phase-in of the reporting requirements 
under the APP for Shared Savings Program ACOs, as described previously.
    In the CY 2021 PFS final rule, we also discussed the potential 
impact of the final policies on ACO quality performance. We projected 
that, absent an improvement in quality performance by ACOs, roughly 1-
in-5 ACOs, or approximately 20 percent of ACOs, could fall below the 
40th percentile MIPS Quality performance category score by performance 
year 2023, and would not be eligible to share in savings or would owe 
maximum shared losses, if applicable (85 FR 85007 through 85008). For 
the CY 2021 rulemaking, we conducted an analysis in order to understand 
better how well ACOs might perform once the CMS Web Interface is no 
longer an available collection type. The analysis simulated ACO 
performance on eCQMs/MIPS CQMs using 2018 and 2019 quality data 
submitted via the CMS Web Interface. Based on the analysis of the 2018 
and 2019 data, there were two differing estimates of the number of ACOs 
that would not meet the quality performance standard. The estimated 
percent of Shared Savings Program ACOs falling below the 40th 
percentile MIPS Quality performance category score was 6.5 percent 
based on a simulation using 2018 data and 22.9 percent based on a 
simulation using 2019 data.
    In the CY 2022 PFS proposed rule (86 FR 39272), we acknowledged 
that even with the steps that ACOs are taking to develop their capacity 
for reporting of the eCQMs/MIPS CQMs and our proposals to phase-in 
reporting of these measures, transitioning to eCQM/MIPS CQM quality 
data reporting and aggregation may come with unforeseen data collection 
and/or system operational issues. Therefore, we explained that we had 
concluded that it would be appropriate to freeze the quality 
performance at the 30th percentile MIPS Quality performance category 
score for an additional year before raising the quality performance 
standard to the 40th percentile starting in performance year 2024. We 
explained that we believed this proposal, in conjunction with our 
proposal to extend the CMS Web Interface to allow for a gradual phase 
in of reporting the three eCQMs/MIPS CQMs, would be responsive to 
stakeholder concerns related to the transition to eCQMs/MIPS CQMs and 
the need for data aggregation and would provide time for both ACOs and 
EHR vendors to put in place processes and systems, such that ACOs will 
be well positioned to report eCQM/MIPS CQMs by performance year 2024.
    As discussed earlier in this final rule, as part of the gradual 
phase-in to full reporting of eCQMs/MIPS CQMs, in the CY 2022 PFS 
proposed rule (86 FR 39272) we proposed to include incentives to 
encourage the early adoption of full eCQM/MIPS CQM reporting prior to 
performance year 2024. As part of the phase-in, and in order to 
transition ACOs to reporting all-payer eCQMs/MIPS CQMs, for performance 
year 2023 we proposed to require an ACO to report at least one eCQM/
MIPS CQM (that meets data completeness and case minimum requirements) 
in addition to the CMS Web Interface measures in order to meet the 
quality performance standard. In addition, we also proposed for both 
performance year 2022 and performance year 2023 that ACOs that elect to 
report all three eCQMs/MIPS CQMs and meet the data completeness 
requirement and case minimum requirement for all three measures would 
meet the quality performance standard if they achieve a quality 
performance score equivalent to or higher than the 30th percentile of 
the performance benchmark on at least one measure in the APP measure 
set.
    In the proposed rule, we noted that we believed our proposal to 
freeze the quality performance standard at the 30th percentile for an 
additional year was consistent with the requirement in the statute that 
CMS increase the quality performance standard over time. We explained 
that two ways to increase the quality performance standard are: (1) By 
increasing the threshold for the quality performance standard, and (2) 
by moving to a requirement that ACOs report for on all-payer measure 
populations for purposes of assessing Shared Savings Program quality 
performance. We proposed to do both by requiring that ACOs begin the 
transition to reporting all-payer measures before increasing the 
quality performance standard starting in performance year 2024.
    Therefore, we proposed to freeze the quality performance standard 
at the 30th percentile across all MIPS Quality performance category 
scores for performance year 2023, and to establish incentives to 
encourage ACOs to begin the transition to eCQM/MIPS CQM reporting in 
performance year 2022 and performance year 2023. Under this proposal, 
CMS would designate the quality performance standard for Shared Savings 
Program ACOs as the ACO reporting via the APP established under Sec.  
414.1367 and for:
     Performance year 2022, if an ACO reports:
    ++ The 10 CMS Web Interface measures and achieves a quality 
performance score that is equivalent to or higher than the 30th 
percentile across all MIPS Quality performance category scores, 
excluding entities/providers eligible for facility-based scoring, or
    ++ The three eCQMs/MIPS CQMs, meeting the data completeness 
requirement at Sec.  414.1340 and the case minimum requirement at Sec.  
414.1380 for all three measures, and achieves a quality performance 
score equivalent to or higher than the 30th percentile of the 
performance benchmark on at least one measure in the APP measure set.
    If the ACO does not report any of the 10 CMS Web Interface measures 
or any of the three eCQMs/MIPS CQMs and does not administer a CAHPS for 
MIPS survey, the ACO would not meet the quality performance standard.
     Performance year 2023, if an ACO reports:
    ++ The 10 CMS Web Interface measures and at least one eCQM/MIPS CQM 
measure, and achieves a quality performance score that is equivalent to 
or higher than the 30th percentile across all MIPS Quality performance 
category scores, excluding entities/providers eligible for facility-
based scoring, or
    ++ The three eCQMs/MIPS CQMs, meeting the data completeness 
requirement at Sec.  414.1340 and the case minimum requirement at Sec.  
414.1380 for all three measures, and achieves a quality performance 
score equivalent to or higher than the 30th percentile of the 
performance benchmark on at least one measure in the APP measure set.
    If the ACO does not report at least one eCQM/MIPS CQM, the ACO 
would not meet the quality performance standard.
    We also proposed that for performance year 2024 and all subsequent 
performance years, we would designate the quality performance standard 
for all Shared Savings Program ACOs, with the exception of ACOs in the 
first performance year of their first agreement period under the Shared

[[Page 65268]]

Savings Program, as the ACO reporting quality data via the APP 
established under Sec.  414.1367 according to the method of submission 
established by CMS and achieving a 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. We also proposed to revise the 
regulation at Sec.  425.512 to reflect the extended phase-in of the ACO 
quality performance standard.
    In the proposed rule, we recognized the change from the CMS Web 
Interface collection type to the eCQM/MIPS CQM collection type would 
add complexity for ACOs as they may need to utilize new approaches to 
combining data across EHR systems to allow for a new data submission 
type, as well as aggregating ACO participant data for submission to 
CMS. However, we indicated that we believed the proposal to delay the 
increase in the quality performance standard, coupled with the proposal 
to extend the CMS Web Interface, with incentives for early adoption of 
eCQM/MIPS CQM reporting, would give ACOs ample time to prepare for the 
transition to full eCQM/MIPS CQM reporting in performance year 2024 and 
the incremental increase in the quality performance standard to the 
40th percentile MIPS Quality performance category score. We also stated 
our belief that the proposed timeline for phasing in the new quality 
performance requirements under the Shared Savings Program would signal 
to ACOs, EHR vendors, and other stakeholders that eCQM/MIPS CQM 
reporting is the path forward for the Shared Savings Program and 
clearly establish the standard that ACOs would need to achieve in order 
to be eligible to share in maximum savings and avoid owing the maximum 
shared losses, if applicable.
    Additionally, as noted in the proposed rule, we also considered the 
possibility of extending the freeze of the Shared Savings Program 
quality performance standard at the 30th percentile MIPS Quality 
performance category score for performance year 2024. We explained that 
this alternative would delay the incremental increase in the quality 
performance standard until all ACOs have at least one year of 
experience in reporting data for all three eCQM/MIPS CQM measures. This 
delay would allow ACOs additional time to gain experience reporting on 
the eCQMs/MIPS CQMs and also provide CMS with more information on ACO 
performance on all-payer measures and the ability of ACOs to aggregate 
data across multiple EHR systems and multiple practices, in order to 
inform the quality performance standard in outlying years.
    We solicited comment on our proposal to freeze the Shared Savings 
Program quality performance standard at the 30th percentile across all 
MIPS Quality performance category scores, excluding entities/providers 
eligible for facility-based scoring for performance year 2023 and to 
increase the quality performance standard to the 40th percentile across 
all MIPS Quality performance category scores, excluding entities/
providers eligible for facility-based scoring starting in performance 
year 2024. In addition, we solicited comment on the alternative of 
freezing the Shared Savings Program quality performance standard at the 
30th percentile across all MIPS Quality performance category scores, 
excluding entities/providers eligible for facility-based scoring for 
PYs 2023 and 2024.
    We received many public comments on our proposal and the 
alternative discussed in the proposed rule. The following is a summary 
of the comments we received and our responses.
    Comment: Several commenters expressed concerns with the proposed 
approach of setting the quality performance standard at the 30th 
percentile across all MIPS Quality performance category scores starting 
in performance year 2023. Commenters also had concerns about the 
quality scoring methodology, citing concerns with the comparison to the 
MIPS final quality scores. Specifically, the commenters found the 
current methodology to be unfair to ACOs, as ACOs must report on a set 
list of measures, while MIPS reporters may select from a broader 
measure set, making these groups incomparable. Commenters expressed 
concern that the current methodology would result in many ACOs not 
being able to meet the 40th percentile threshold for performance year 
2024. One commenter indicated that the proposed increase could result 
in physician practices leaving the Shared Savings Program and suggested 
CMS allow more time for further questions about the transition to the 
APP to be clarified. Some commenters suggested reverting to the 
previous methodology for determining if an ACO met the quality 
performance standard, while other commenters suggested providing 
quality benchmarks ahead of the performance year and comparing ACOs 
only to other similarly situated ACOs. In addition, the commenters that 
supported establishing prospective quality benchmarks indicated that 
including 2020 data would be unfair on account of the challenges 
presented by the PHE for COVID-19. Another commenter indicated that 
freezing the quality performance standard would not resolve 
transparency issues surrounding the calculation of the quality 
performance score. Other commenters recommended CMS provide more 
information about how the threshold is calculated, indicating that 
without proper transparency, an increase to the 40th percentile would 
be too significant for many ACOs to achieve, especially those new to 
the program.
    Response: We appreciate the commenters' concerns regarding the 
proposal to increase the quality performance standard to the 40th 
percentile across all MIPS Quality performance category scores starting 
in performance year 2023. The Shared Savings Program quality reporting 
requirements and quality performance standard that we are finalizing 
for performance year 2022 and subsequent performance years are 
described in sections III.J.1.c. and III.J.1.d. of this final rule, 
respectively. We stated in the CY 2021 PFS final rule (85 FR 84735) 
that each ACO's quality performance score will be calculated using the 
ACO's performance on the measures reported under the APP, any 
applicable MIPS bonus points, and quality improvement points. The 
methodology used to calculate MIPS Quality performance category scores 
is described in the ``2021 APM Performance Pathway Scoring Guide'' and 
the ``2021 APM Performance Pathway for Shared Savings Program 
Accountable Care Organizations (ACOs) User Guide'' found within the 
``PY2021 APM Performance Pathway Toolkit'' that is available on the 
Quality Payment Program Resource Library website at https://qpp.cms.gov/resources/resource-library. These documents will be updated 
for each upcoming performance year. We believe that assessing an ACO's 
quality performance score against the quality performance scores for 
all individuals, groups, and APM entities is consistent with our goal 
to align the quality reporting requirements under the Shared Savings 
Program with the requirements that will apply under the APP for 
purposes of the Quality Payment Program.
    It is important to note that ACOs can earn up to 10 additional 
percentage points based on their improvement in the quality performance 
category from the previous year which should help to increase the ACOs' 
scores and alleviate concerns about other MIPS eligible clinicians 
being able to pick the measures they report. We believe the

[[Page 65269]]

ability to earn points for quality improvement will assist ACOs in 
achieving quality performance scores equivalent to or higher than the 
30th or 40th percentile across all MIPS Quality performance category 
scores. As noted in the CY 2022 PFS proposed rule (86 FR 39274) and in 
section III.J.1.d.(2). of this final rule, for performance year 2018, 
the MIPS Quality performance category score at the 30th percentile was 
equivalent to 83.9 and the MIPS Quality performance category score at 
the 40th percentile was equivalent to 93.3. For performance year 2019, 
the MIPS Quality performance category score at 30th percentile was 
equivalent to 87.9 and the MIPS Quality performance category score at 
the 40th percentile was equivalent to 95.7.
    As discussed in section IV.A.3.e.(1)(c)(ii) of this final rule, we 
are not finalizing the proposal to use performance period benchmarks or 
data from the CY 2019 performance period/2021 MIPS payment year to 
calculate quality measure benchmarks for the CY 2022 performance 
period/2024 MIPS payment year. Analysis of the CY 2020 performance 
period/2022 MIPS payment year data supports its use for benchmarking 
purposes. Those quality measure benchmarks will be made available to 
clinicians before the start of the CY 2022 performance period.
    Since the publication of the CY 2022 PFS proposed rule, we have 
identified standards in our regulations that prevent us from finalizing 
without modification our proposal to allow ACOs that elect to fully 
report all three eCQMs/MIPS CQMs to meet the quality performance 
standard if they achieve a quality performance score equivalent to or 
higher than the 30th percentile on at least one measure in the APP 
measure set. Adopting this policy would result in the ENHANCED track 
and the BASIC track level E of the Shared Savings Program no longer 
qualifying as Advanced APMs. This, in turn, would prevent eligible 
clinicians in the ACOs that participate in these tracks from becoming 
Qualifying APM Participants (QPs) based on their participation in the 
Shared Savings Program during performance years 2022 and 2023. They 
would instead be subject to the MIPS reporting requirements and payment 
adjustment. Therefore, we are finalizing a modified policy that avoids 
this result while still providing an incentive for ACOs to fully report 
all three eCQMs/MIPS CQMs.
    Section 414.1410(a) provides that an APM is an Advanced APM for a 
payment year if CMS determines that it meets the criteria in Sec.  
414.1415 during the QP Performance Period. Section 414.1415(b)(1) 
requires that, to be an Advanced APM, an APM must include quality 
measure performance as a factor when determining payment to 
participants for covered professional services under the terms of the 
APM. Section 414.1415(b)(2) requires, in relevant part, that at least 
one of the quality measures used in the payment arrangement be a MIPS-
comparable measure. Section 414.1415(b)(3) provides that in addition to 
the quality measure described under paragraph (b)(2), the quality 
measures upon which an Advanced APM bases payment must include at least 
one additional measure that is an outcome measure unless CMS determines 
that there are no available or applicable outcome measures included in 
the MIPS final quality measures list for the Advanced APM's first QP 
Performance Period.
    Our proposal to permit an ACO that reports the three eCQMs/MIPS 
CQMs and scores above the 30th percentile on at least one measure in 
the APP measure set is inconsistent with the requirements of Sec.  
414.1415(b)(1) through (3) for two reasons. First, under the proposed 
policy, the Shared Savings Program would base the quality performance 
scores for certain ACOs, and therefore, these ACOs' payments, on a 
single measure when Sec.  414.1415(b)(1) and (3) require that payment 
be based on at least two measures. Second, our proposal did not require 
that one of the measures that is used to determine the quality 
performance score be an outcome measure, which is also required by 
Sec.  414.1415(b)(1) and (3). As CMS must determine whether an APM is 
an Advanced APM based in part on the APM's compliance with the 
standards of Sec.  414.1415(b), finalizing our proposal would require 
CMS to determine that the ENHANCED track and the BASIC track level E of 
the Shared Savings Program are not Advanced APMs.
    While the policy options we can adopt in this final rule are 
limited by the aforementioned regulations and the scope of our 
proposal, based on the comments received raising concerns related to 
the current quality performance standard, we are already considering a 
broader set of policy options for performance year 2023 and future 
years that would provide an incentive for ACOs to transition to full 
eCQM/MIPS CQM reporting. Among other things, we are considering 
reinstating the sliding scale quality performance standard methodology 
for determining shared savings and shared losses in next year's 
rulemaking for ACOs that report on the three eCQMs/MIPS CQMs Under the 
sliding scale methodology, we would multiply the ACO's quality score, 
based on the ACO's performance on the three eCQMs/MIPS CQMs as reported 
by the ACO, the two claims-based measures calculated by CMS, and the 
CAHPS for MIPS survey, by the sharing rate for the track (or payment 
model within a track) to determine the ACO's shared savings. We believe 
this approach would avoid the all or nothing approach under the current 
regulations, under which ACOs that fail to achieve the required minimum 
quality performance score are ineligible to share in any of the savings 
they achieve. Given the high level of performance in the MIPS Quality 
performance category and the challenge of transitioning to full eCQM/
MIPS CQM reporting, we believe it is appropriate to offer some reward 
to ACOs that elect to report the eCQM/MIPS CQMs, but may not be able to 
achieve a quality performance score equivalent to the 30th or 40th 
percentile across all MIPS Quality performance category scores. As a 
result, we believe a sliding scale methodology for calculating shared 
savings could provide an incentive for continuous improvement and also 
encourage ACOs, particularly ACOs that serve large vulnerable 
populations or have large numbers of specialists who may not perform as 
well on the eCQMs/MIPS CQMs, to take the steps necessary to transition 
to eCQM/MIPS CQM reporting.
    We are finalizing, with modifications, our proposal to freeze the 
quality performance standard at the 30th percentile across all MIPS 
Quality performance category scores for performance year 2023, and to 
establish incentives to encourage ACOs to begin the transition to eCQM/
MIPS CQM reporting in performance year 2022 and performance year 2023. 
Our final policies address the commenters' concerns by lowering the 
quality performance standard ACOs must meet in order to share in 
savings or avoid maximum shared losses, if applicable, during the 
transition to new reporting mechanisms. These final policies with 
respect to the quality performance standard are also aligned with the 
final quality reporting requirements discussed in section III.J.1.c. of 
this final rule. Accordingly, we are designating the quality 
performance standard for all Shared Savings Program ACOs, with the 
exception of ACOs in the first performance year of their first 
agreement period, as the ACO reporting quality data via the APP 
established under Sec.  414.1367 according to the

[[Page 65270]]

method of submission established by CMS and for:
     Performance years 2022 and 2023:
    ++ Achieving a quality performance score that is equivalent to or 
higher than the 30th percentile across all MIPS Quality performance 
category scores, excluding entities/providers eligible for facility-
based scoring, or
    ++ If the ACO reports the three eCQMs/MIPS CQMs, meeting the data 
completeness requirement at Sec.  414.1340 and the case minimum 
requirement at Sec.  414.1380 for all three measures, and 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 a quality performance score 
equivalent to or higher than the 30th percentile of the performance 
benchmark on at least one of the remaining five measures in the APP 
measure set. Consequently, the ACO would be required to meet the 
performance benchmark on either 2 outcome measures (one measure at the 
10th percentile and the other at the 30th percentile), or 1 outcome 
measure at the 10th percentile and any other measure in the APP measure 
set at the 30th percentile. The outcome measures in the APP measure set 
are listed in Table 36.
    If the ACO (1) does not report any of the 10 CMS Web Interface 
measures or any of the three eCQMs/MIPS CQMs and (2) does not 
administer a CAHPS for MIPS survey, the ACO would not meet the quality 
performance standard.
     Performance year 2024 and subsequent performance years: 
Achieving a 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.
    If the ACO (1) does not report any of the 10 CMS Web Interface 
measures or any of the three eCQMs/MIPS CQMs and (2) does not 
administer a CAHPS for MIPS survey, the ACO would not meet the quality 
performance standard.
    We are also finalizing conforming revisions to the regulation at 
Sec.  425.512(a) to reflect the extended phase-in of the ACO quality 
performance standard adopted in this final rule.
    We will continue to monitor the ACOs' performance under the APP and 
determine whether they meet the quality performance standard and may 
revisit these policies in future rulemaking if necessary to promote an 
attainable quality performance standard and degree of improvement.
[GRAPHIC] [TIFF OMITTED] TR19NO21.058

    Comment: Several commenters supported the alternative of freezing 
the Shared Savings Program quality performance standard at the 30th 
percentile across all MIPS Quality performance category scores, 
excluding entities/providers eligible for facility-based scoring for 
performance years 2023 and 2024, with commenters citing their 
appreciation for the additional flexibility allowed by freezing the 
quality performance standard for an additional year. Commenters also 
noted that this alternative would give health care providers and ACOs 
sufficient time to adjust to the new reporting requirements and to 
recover from any financial and operational losses sustained as a result 
of the PHE for COVID-19. A commenter suggested that CMS freeze the 
standard through 2025, explaining that the additional time would 
provide ACOs with more time to adjust to the revised quality 
performance standard methodology.
    Response: We appreciate the commenters' input on this alternative. 
However, we believe that the additional year of keeping the quality 
performance category score at the 30th percentile is sufficient, 
especially given the fact that we are extending the CMS Web Interface 
as a collection type until 2024 and ACOs typically perform well on the 
CMS Web Interface measures. We believe that the extension of the CMS 
Web Interface and the incentive to report eCQMs/MIPS CQMs will in fact 
help improve the ACOs' performance. However, we will continue to 
monitor the ACOs' performance under the APP and may consider this 
feedback in

[[Page 65271]]

developing policies for future rulemaking.
(2) Comment Solicitation on Publicly Displaying Prior Year Performance 
Scores That Equate to the 30th or 40th Percentile Across MIPS Quality 
Performance Category Scores
    In the CY 2022 PFS proposed rule (86 FR 39274), we explained that 
stakeholders 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 stakeholders 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. For a given performance year, the 
30th or 40th percentile MIPS Quality performance category score is 
calculated based on the distribution across all MIPS Quality 
performance category scores, excluding entities/providers eligible for 
scoring for facility-based scoring, only once MIPS final scoring is 
complete.
    Therefore, we stated there is no information that can be provided 
prior to or during the performance year. However, we noted that for 
performance year 2018 the MIPS Quality performance category score at 
the 30th percentile was equivalent to 83.9 and the MIPS Quality 
performance category score at the 40th percentile was equivalent to 
93.3. For performance year 2019 the MIPS Quality performance category 
score at 30th percentile was equivalent to 87.9 and the MIPS Quality 
performance category score at the 40th percentile was equivalent to 
95.7.
    We 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. We also 
solicited comment on other ways we could address these concerns.
    The following is a summary of the public comments we received on 
this comment solicitation and our response.
    Comment: Several commenters supported publicly displaying prior 
year performance scores that equate to the 30th or 40th percentile 
across all MIPS Quality category performance scores. Commenters 
explained that publicly displaying the information will promote 
transparency, enable ACOs to be better informed about the quality 
standards they must meet, and ensure ACOs' ability to appropriately 
track performance and increase the likelihood of achieving high-quality 
performance scores. One commenter expressed concern that publicly 
displaying prior year performance scores is not the optimal way to 
address stakeholder concerns 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. A few 
commenters suggested that CMS provide more information on the 
methodology used to calculate this standard.
    Response: We thank commenters for their suggestions. As noted above 
and in the CY 2022 PFS proposed rule (86 FR 39274), the performance 
year 2018 MIPS Quality performance category score at the 30th 
percentile was equivalent to 83.9 and the MIPS Quality performance 
category score at the 40th percentile was equivalent to 93.3. For 
performance year 2019 the MIPS Quality performance category score at 
30th percentile was equivalent to 87.9 and the MIPS Quality performance 
category score at the 40th percentile was equivalent to 95.7.
    We will work toward providing additional historical information on 
performance scores as it becomes available. However, as noted in the CY 
2022 PFS proposed rule (86 FR 39274), for a given performance year, the 
30th or 40th percentile across all MIPS Quality performance category 
scores is calculated after MIPS final scoring is complete based on the 
distribution across all MIPS Quality performance category scores, 
excluding entities/providers eligible for scoring for facility-based 
scoring. Therefore, we are not able to provide this information prior 
to or during the performance year. Nevertheless, 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 will release this 
historical information on the Shared Savings Program website as soon as 
it becomes available.
    Comment: One commenter requested that CMS provide additional 
information regarding how ``entities eligible for facility-based 
scoring'' will be removed from the calculations used to determine the 
30th and 40th percentile across all MIPS Quality category performance 
scores, and whether, when reporting eCQMs/MIPS CQMs under the APP, ACOs 
will be accountable for reporting quality data for facilities such as 
FQHCs, and/or other entities eligible for facility-based scoring.
    Response: Under the policies finalized in the CY 2021 PFS final 
rule (85 FR 84735), we exclude entities/providers eligible for 
facility-based scoring from the determination of the overall MIPS 
Quality performance category score because facility-based scoring is 
determined using the Hospital Value Based Purchasing (HVBP) Total 
Performance Score (TPS), which includes quality and cost. Facility-
based provider scores are not considered as part of ACO quality scores, 
and APM participants (including ACO participants) have not typically 
been eligible for facility-based scoring in previous years. As a 
result, ACO quality scores will not be impacted by this exemption.
e. Revisions to the Extreme and Uncontrollable Circumstances Policy
    In the CY 2021 PFS final rule (85 FR 84744 through 84747), we 
updated the extreme and uncontrollable circumstances policy for 
performance year 2021 and subsequent performance years to align with 
the gradual phase in of the revised quality performance standard. 
Specifically, we finalized that for:
     Performance year 2021 and performance year 2022, the 
minimum quality performance score for an ACO affected by an extreme and 
uncontrollable circumstance during the performance year, including the 
applicable quality data reporting period for the performance year, will 
be set equal to the 30th percentile MIPS Quality performance category 
score. If the ACO is able to report quality data and meets the MIPS 
data completeness and case minimum requirements, we will use the higher 
of the ACO's quality performance score or the 30th percentile MIPS 
Quality performance category score. If an ACO is unable to report 
quality data and meet the MIPS Quality data completeness and case 
minimum requirements due to an extreme and uncontrollable circumstance, 
we will apply the 30th percentile MIPS Quality performance category 
score.

[[Page 65272]]

     Performance year 2023, the minimum quality performance 
score for an ACO affected by an extreme and uncontrollable circumstance 
during the performance year, including the applicable quality data 
reporting period for the performance year, will be set equal to the 
40th percentile MIPS Quality performance category score. If the ACO is 
able to report quality data and meets the MIPS data completeness and 
case minimum requirements, we will use the higher of the ACO's quality 
performance score or the 40th percentile MIPS Quality performance 
category score. If an ACO is unable to report quality data and meet the 
MIPS Quality data completeness and case minimum requirements due to an 
extreme and uncontrollable circumstance, we will apply the 40th 
percentile MIPS Quality performance category score (85 FR 84746).
    In the CY 2022 PFS proposed rule (86 FR 39274), we also proposed to 
update the extreme and uncontrollable circumstances policy under the 
Shared Savings Program consistent with our proposal to freeze the 
quality performance standard for Shared Savings Program ACOS at the 
30th percentile for performance year 2023. Specifically, we proposed to 
set the minimum quality performance score for an ACO affected by an 
extreme and uncontrollable circumstance during performance year 2023, 
including the applicable quality data reporting period for the 
performance year, to equal 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.
    If the ACO is able to report quality data via the APP, including at 
least one eCQM/MIPS CQM, and meets data completeness and case minimum 
requirements, we proposed to use the higher of the ACO's quality 
performance score or the equivalent of the 30th percentile MIPS Quality 
performance category score. If the ACO is unable to report quality data 
and meet the MIPS Quality data completeness and case minimum 
requirements due to an extreme and uncontrollable circumstance, we 
proposed to apply the 30th percentile MIPS Quality performance category 
score.
    Similarly, we proposed that for performance year 2024 and 
subsequent years, the minimum quality performance score for an ACO 
affected by an extreme and uncontrollable circumstance during the 
performance year, including the applicable quality data reporting 
period for the performance year, would be set equal to 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 stated in the proposed rule that if the ACO is able to report 
quality data via the APP and meets the MIPS data completeness and case 
minimum requirements, we would use the higher of the ACO's MIPS Quality 
performance category score or the 40th percentile MIPS Quality 
performance category score. If the ACO is unable to report quality data 
and meet the MIPS Quality data completeness and case minimum 
requirements due to an extreme and uncontrollable circumstance, we 
proposed to apply the 40th percentile MIPS Quality performance category 
score. We noted our belief that these proposed updates were appropriate 
to align with the proposed changes to the quality performance standard 
in the CY 2022 PFS proposed rule, and would also allow impacted ACOs to 
be eligible to share in savings at their maximum sharing rate or to 
avoid maximum shared losses, if applicable (86 FR 39274 and 3975). We 
also proposed to make conforming changes to the Shared Savings Program 
regulations at Sec.  425.512(b) to reflect these proposed revisions to 
the extreme and uncontrollable circumstances policy.
    We solicited comment on the proposed revisions to the extreme and 
uncontrollable circumstances policy and received few public comments. 
The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the proposed updates to the 
extreme and uncontrollable circumstances policy under the Shared 
Savings Program to align with the proposed changes to the quality 
performance standard.
    Response: We appreciate the commenters' support.
    As discussed in section III.J.1.d. of this final rule, we are 
finalizing the proposed updates to the quality performance standard 
with modifications. Therefore, we are finalizing the proposed changes 
to the extreme and uncontrollable circumstances policy under the Shared 
Savings Program with modifications to conform to the final policies we 
are adopting in this final rule regarding the quality performance 
standard.
    For performance year 2023, if the ACO is able to report quality 
data via the APP and meets the MIPS data completeness and case minimum 
requirements, we will use the higher of the ACO's MIPS Quality 
performance category score or the 30th percentile across all MIPS 
Quality performance category scores, excluding entities/providers 
eligible for facility-based scoring, for the relevant performance year. 
If the ACO is unable to report quality data and meet the MIPS Quality 
data completeness and case minimum requirements due to an extreme and 
uncontrollable circumstance, we will apply the 30th percentile across 
all MIPS Quality performance category score.
    For performance year 2024 and subsequent performance years, the 
minimum quality performance score for an ACO affected by an extreme and 
uncontrollable circumstance during the performance year, including the 
applicable quality data reporting period for the performance year, will 
be set equal to the 40th percentile across all MIPS Quality performance 
category scores, excluding entities/providers eligible for facility-
based scoring, for the relevant performance year. If the ACO is able to 
report quality data via the APP and meets the MIPS data completeness 
and case minimum requirements, we will use the higher of the ACO's MIPS 
Quality performance category score or the 40th percentile across all 
MIPS Quality performance category scores, excluding entities/providers 
eligible for facility-based scoring, for the relevant performance year. 
If the ACO is unable to report quality data and meet the MIPS Quality 
data completeness and case minimum requirements due to an extreme and 
uncontrollable circumstance, we will apply the 40th percentile MIPS 
Quality performance category score.
    We are also finalizing changes to the Shared Savings Program 
regulations at Sec.  425.512(b)(2) and (b)(3) to reflect these 
revisions to the extreme and uncontrollable circumstances policy. We 
note that the changes to Sec.  425.512(b)(3)(i) and (ii) we are 
adopting in this final rule differ slightly from the proposed rule 
because we are eliminating the references to the ACO reporting quality 
data via the APP and meeting the data completeness and case minimum 
requirements as duplicative of the existing introductory language in 
Sec.  425.512(b)(3).
2. Revisions to the Definition of Primary Care Services Used in Shared 
Savings Program Beneficiary Assignment
a. 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

[[Page 65273]]

or after January 1, 2019, the Secretary shall assign beneficiaries to 
an ACO based on their utilization of primary care services provided by 
a physician who is an ACO professional and all services furnished by 
RHCs and FQHCs. However, the statute does not specify a list of 
services considered to be primary care services for purposes of 
beneficiary assignment.
    In the November 2011 final rule (76 FR 67853), we established the 
initial list of services, identified by Current Procedural Terminology 
(CPT) and Healthcare Common Procedure Coding System (HCPCS) codes, that 
we considered to be primary care services. In that final rule, we 
indicated that we intended to monitor CPT and HCPCS codes and would 
consider making changes to the definition of primary care services to 
add or delete codes used to identify primary care services, if there 
were sufficient evidence that revisions were warranted. We have updated 
the list of primary care service codes in subsequent rulemaking to 
reflect additions or modifications to the codes that have been 
recognized for payment under the Medicare PFS and to incorporate other 
changes to the definition of primary care services for purposes of the 
Shared Savings Program.
    In the June 2015 final rule (80 FR 32746 through 32748), we 
expanded the definition of primary care services to include two 
transitional care management (TCM) codes (CPT codes 99495 and 99496), 
and one chronic care management (CCM) code (CPT code 99490). As 
discussed in the final rule, the TCM codes were established to pay a 
patient's physician or practitioner to coordinate the patient's care in 
the 30 days following a hospital or SNF stay. Including these codes in 
the definition of primary care services reflects our belief that the 
work of community physicians and practitioners in managing a patient's 
care following discharge from a hospital or nursing facility (NF) to 
ensure better continuity of care for these patients and help reduce 
avoidable readmissions is a key aspect of primary care.
    In the CY 2016 PFS final rule (80 FR 71270 through 71273), we 
revised the definition of primary care services to exclude services 
billed under CPT codes 99304 through 99318, containing the place of 
service 31 modifier specifying that the service was furnished in a SNF. 
We also revised the definition of primary care services to include 
claims submitted by Electing Teaching Amendment (ETA) hospitals.
    In the CY 2018 PFS final rule (82 FR 53212 and 53213), we revised 
the definition of primary care services to include three additional CCM 
service codes, 99487, 99489, and G0506, and four behavioral health 
integration (BHI) service codes, G0502, G0503, G0504 and G0507.
    We further revised the definition of primary care services in the 
November 2018 final rule (also referred to as the CY 2019 PFS final 
rule) (83 FR 59964 through 59968), by adding new codes to the 
definition of primary care services (CPT codes 99497, 99498, 96160, 
96161, 99354, and 99355, and HCPCS codes G0444, G0442, and G0443), and 
by revising how we determine whether services identified by CPT codes 
99304 through 99318 were furnished in a SNF.
    In the May 8, 2020 COVID-19 IFC (85 FR 27582 through 27586), we 
revised the definition of primary care services for purposes of 
beneficiary assignment for the performance year starting on January 1, 
2020, and for any subsequent performance year that starts during the 
COVID-19 PHE defined in Sec.  [thinsp]400.200, to include the following 
additions specified in Sec.  [thinsp]425.400(c)(2): (1) HCPCS code 
G2010 (remote evaluation of patient video/images) and HCPCS code G2012 
(virtual check-in); (2) CPT codes 99421, 99422 and 99423 (online 
digital evaluation and management service (e-visit)); and (3) CPT codes 
99441, 99442, and 99443 (telephone evaluation and management services).
    In the CY 2021 PFS final rule (85 FR 84786 through 84793), we 
finalized the additional primary care service codes adopted in the May 
8, 2020 COVID-19 IFC with modifications to allow these codes to be used 
in determining beneficiary assignment when the assignment window (as 
defined at Sec.  425.20) for a benchmark or performance year includes 
any months during the PHE for COVID-19 defined in Sec.  400.200, and to 
apply these additional primary care service codes to all months of the 
assignment window, when the assignment window includes any month(s) 
during the PHE for COVID-19.
    In the CY 2021 PFS final rule (85 FR 84748 through 84755), we 
expanded the definition of primary care services for purposes of 
determining beneficiary assignment to include: Online digital E/M CPT 
codes 99421, 99422, and 99423; assessment of and care planning for 
patients with cognitive impairment CPT code 99483; chronic care 
management code CPT code 99491; exclusion of advance care planning CPT 
code 99497 and the add-on code 99498 when billed in an inpatient care 
setting; remote evaluation of patient video/images HCPCS codes G2010; 
virtual check-in HCPCS code G2012; non-complex chronic care management 
HCPCS code G2058 and its replacement CPT code 99439; principal care 
management HCPCS codes G2064 and G2065; and psychiatric collaborative 
care model HCPCS code G2214. In this same final rule (85 FR 84755 
through 84756), we finalized revisions to the existing exclusion for 
professional services billed under CPT codes 99304 through 99318 that 
are furnished in a SNF to include services reported on an FQHC or RHC 
claim that includes CPT codes 99304 through 99318, when those services 
are furnished in a SNF.
    For performance years beginning on January 1, 2021, and subsequent 
performance years, we defined primary care services in Sec.  
[thinsp]425.400(c)(1)(v) for purposes of assigning beneficiaries to 
ACOs under Sec.  [thinsp]425.402 as the set of services identified by 
the following HCPCS/CPT codes:
CPT Codes
    (1) 96160 and 96161 (codes for administration of health risk 
assessment).
    (2) 99201 through 99215 (codes for office or other outpatient visit 
for the evaluation and management of a patient).
    (3) 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).
    (4) 99319 through 99340 (codes for patient domiciliary, rest home, 
or custodial care visit).
    (5) 99341 through 99350 (codes for evaluation and management 
services furnished in a patient's home for claims identified by place 
of service modifier 12).
    (6) 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 Sec.  425.400(c)(1)(v)).
    (7) 99421, 99422, and 99423 (codes for online digital evaluation 
and management).
    (8) 99439 (code for non-complex chronic care management).
    (9) 99483 (code for assessment of and care planning for patients 
with cognitive impairment).
    (10) 99484, 99492, 99493 and 99494 (codes for behavioral health 
integration services).
    (11) 99487, 99489, 99490 and 99491 (codes for chronic care 
management).
    (12) 99495 and 99496 (codes for transitional care management 
services).

[[Page 65274]]

    (13) 99497 and 99498 (codes for advance care planning; services 
identified by these codes furnished in an inpatient setting are 
excluded).
HCPCS Codes
    (1) G0402 (code for the Welcome to Medicare visit).
    (2) G0438 and G0439 (codes for the annual wellness visits).
    (3) G0442 (code for alcohol misuse screening service).
    (4) G0443 (code for alcohol misuse counseling service).
    (5) G0444 (code for annual depression screening service).
    (6) G0463 (code for services furnished in Electing Teaching 
Amendment hospitals).
    (7) G0506 (code for chronic care management).
    (8) G2010 (code for the remote evaluation of patient video/images).
    (9) G2012 (code for virtual check-in).
    (10) G2058 (code for non-complex chronic care management).
    (11) G2064 and G2065 (codes for principal care management 
services).
    (12) G2214 (code for psychiatric collaborative care model).
b. Revisions
(1) HCPCS and CPT Codes Used in Assignment
    In the CY 2022 PFS proposed rule (86 FR 39276), we explained that 
based on feedback from ACOs and our further review of the HCPCS and CPT 
codes currently recognized for payment under the PFS, we believed 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, 2022, and 
subsequent performance years.
    We proposed to revise the definition of primary care services in 
the Shared Savings Program regulations to include the following 
additions: (1) Chronic Care Management (CCM) CPT code 99X21, if 
finalized through the CY 2022 PFS rulemaking; (2) Principal Care 
Management (PCM) CPT codes 99X22, 99X23, 99X24, and 99X25, if finalized 
through the CY 2022 PFS rulemaking; (3) Prolonged office or other 
outpatient evaluation and management (E/M) service HCPCS code G2212; 
and (4) Communication Technology-Based Service (CTBS) HCPCS code G2252, 
if payment for this code is made permanent through the CY 2022 PFS 
rulemaking. The following provides additional information about the CPT 
codes and HCPCS codes that we proposed to add to the definition of 
primary care services used in assignment:
     Chronic Care Management (CCM) CPT code 99X21. For CY 2022, 
the American Medical Association (AMA) CPT Editorial Panel created a 
new CPT code that describes CCM services furnished by clinical staff 
under the supervision of a physician or NPP who can bill E/M services, 
and CCM services personally furnished by a physician or NPP. In the 
proposed rule, we proposed valuation of CPT code 99X21 (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 30 
minutes by a physician or other qualified health care professional, per 
calendar month). CPT code 99X21 is being finalized as CPT code 99437, 
as discussed elsewhere in this final rule.
    In earlier rulemaking, we finalized the inclusion of CCM CPT codes 
99487, 99489, 99490, and 99491 (codes for chronic care management) in 
the definition of primary care services for the Shared Savings Program. 
Refer to the June 2015 final rule (80 FR 32746 through 32748), CY 2018 
PFS final rule (82 FR 53212 through 53213), and CY 2021 PFS final rule 
(85 FR 84749 through 84750 and 84754). ``Non-complex'' CCM services 
(CPT codes 99490 and 99491), and ``complex'' CCM services (CPT codes 
99487 and 99489) share a common set of service elements, including the 
following: (1) Initiating visit, (2) structured recording of patient 
information using certified electronic health record technology (EHR), 
(3) 24/7 access to physicians or other qualified health care 
professionals or clinical staff and continuity of care, (4) 
comprehensive care management including systematic assessment of the 
patient's medical, functional, and psychosocial needs, (5) 
comprehensive care plan including a comprehensive care plan for all 
health issues with particular focus on the chronic conditions being 
managed, and (6) management of care transitions. They differ in the 
amount of clinical staff service time provided, the involvement and 
work of the billing practitioner, and the extent of care planning 
performed.
    In the proposed rule, we explained that the CCM services that will 
be furnished under the new CPT code 99X21 are similar to the CCM 
services that are billed under the existing CCM codes that are included 
in the Shared Savings Program's current definition of primary care 
services, which includes CCM CPT codes 99487, 99489, 99490, 99491 and 
HCPCS code G0506. Because the Shared Savings Program's definition of 
primary care services includes other CCM CPT codes and HCPCS codes, we 
proposed to include CPT code 99X21, if finalized, in the definition of 
primary care services under Sec.  425.400(c) for the performance year 
starting on January 1, 2022, and subsequent performance years.
     Principal Care Management (PCM) services CPT Codes 99X22, 
99X23, 99X24, and 99X25. The AMA CPT Editorial Panel has created the 
following new CPT codes that describe PCM services furnished by 
clinical staff under the supervision of a physician or NPP who can bill 
E/M services, and PCM services personally furnished by a physician or 
NPP:
    ++ 99X22 (Principal care management services, for a single high-
risk disease, with the following required elements: One complex chronic 
condition expected to last at least 3 months, and which places the 
patient at significant risk of hospitalization, acute exacerbation/
decompensation, functional decline, or death, the condition requires 
development, monitoring, or revision of disease-specific care plan, the 
condition requires frequent adjustments in the medication regimen, and/
or the management of the condition is unusually complex due to 
comorbidities; ongoing communication and care coordination between 
relevant practitioners furnishing care; first 30 minutes provided 
personally by a physician or other qualified health care professional, 
per calendar month).
    ++ 99X23 (Principal care management services, for a single high-
risk disease, with the following required elements: One complex chronic 
condition expected to last at least 3 months, and which places the 
patient at significant risk of hospitalization, acute exacerbation/
decompensation, functional decline, or death; the condition requires 
development, monitoring, or revision of disease-specific care plan, the 
condition requires frequent adjustments in the medication regimen, and/
or the management of the condition is unusually complex due to 
comorbidities; ongoing communication and care coordination between 
relevant

[[Page 65275]]

practitioners furnishing care; additional 30 minutes provided 
personally by a physician or other qualified health care professional, 
per calendar month).
    ++ 99X24 (Principal care management services, for a single high-
risk disease, with the following required elements: One complex chronic 
condition expected to last at least 3 months, and which places the 
patient at significant risk of hospitalization, acute exacerbation/
decompensation, functional decline, or death; the condition requires 
development, monitoring, or revision of disease-specific care plan; the 
condition requires frequent adjustments in the medication regimen, and/
or the management of the condition is unusually complex due to 
comorbidities; ongoing communication and care coordination between 
relevant practitioners furnishing care; first 30 minutes of clinical 
staff time directed by physician or other qualified health care 
professional, per calendar month).
    ++ 99X25 (Principal care management services, for a single high-
risk disease, with the following required elements: One complex chronic 
condition expected to last at least 3 months, and which places the 
patient at significant risk of hospitalization, acute exacerbation/
decompensation, functional decline, or death; the condition requires 
development, monitoring, or revision of disease-specific care plan; the 
condition requires frequent adjustments in the medication regimen, and/
or the management of the condition is unusually complex due to 
comorbidities; ongoing communication and care coordination between 
relevant practitioners furnishing care; each additional 30 minutes of 
clinical staff time directed by a physician or other qualified health 
care professional, per calendar month). As discussed elsewhere in this 
final rule, CPT code 99X22 is being finalized as CPT code 99424, CPT 
code 99X23 is being finalized as CPT code 99425, CPT code 99X24 is 
being finalized as CPT code 99426, and CPT code 99X25 is being 
finalized as CPT code 99427.
    In the CY 2022 PFS proposed rule (86 FR 39277), we explained our 
belief that because the Shared Savings Program's definition of primary 
care services already includes the temporary HCPCS codes G2064 and 
G2065 that will be replaced by the permanent CPT codes 99X22 and 99X24, 
and CPT codes 99X23 and 99X25 represent the same services furnished for 
a greater length of time, it would be appropriate to include CPT code 
99X22, 99X23, 99X24, and 99X25, as finalized through the CY 2022 PFS 
rulemaking, in the definition of primary care services under Sec.  
425.400(c) for the performance year starting on January 1, 2022, and 
subsequent performance years. Although the temporary HCPCS codes G2064 
and G2065 will be replaced by the permanent CPT codes, we stated that 
the Shared Savings Program would retain the temporary HCPCS codes in 
the definition of primary care services used for assignment, to be used 
in conducting beneficiary assignment for benchmark years.
     Prolonged office or other outpatient evaluation and 
management (E/M) service HCPCS code G2212: In the CY 2021 PFS final 
rule (85 FR 84573 through 84574), CMS finalized a new HCPCS code G2212 
(Prolonged office or other outpatient evaluation and management 
service(s) beyond the maximum required time of the primary procedure 
which has been selected using total time on the date of the primary 
service; each additional 15 minutes by the physician or qualified 
healthcare professional, with or without direct patient contact (List 
separately in addition to CPT codes 99205, 99215 for office or other 
outpatient evaluation and management services) (Do not report G2212 on 
the same date of service as 99354, 99355, 99358, 99359, 99415, 99416). 
(Do not report G2212 for any time unit less than 15 minutes)) to be 
used when billing Medicare for prolonged office/outpatient E/M visits 
instead of CPT code 99417, starting in 2021. We stated our belief that 
the creation of HCPCS code G2212 will serve to resolve the potential 
differences between Medicare and other interpretations of CPT rules, 
and better address questions about the required times and what time may 
be counted toward the required time to report prolonged office/
outpatient E/M visits (see the CY 2020 PFS final rule for a more 
detailed discussion of this issue, (84 FR 62849 through 62850)).
    The current definition of primary care services used in the Shared 
Savings Program assignment methodology includes CPT codes 99201 and 
99215 (codes for office or other outpatient visit for the E/M of a 
patient). Because HCPCS code G2212 is defined as an add-on code for 
those office/outpatient E/M services, representing the same underlying 
services being furnished for a longer period of time, we proposed to 
include HCPCS code G2212 in the definition of primary care services 
under Sec.  425.400(c) for the performance year starting on January 1, 
2022, and subsequent performance years.
     Communication Technology-Based Service (CTBS) HCPCS code 
G2252: In the CY 2021 PFS final rule (85 FR 84536), CMS established 
additional coding and payment for services delivered via synchronous 
communication technology, which can include audio-only communication on 
an interim basis for CY 2021. We stated our belief that establishing 
payment for a longer service (11-20 minutes) on an interim basis would 
support access to care for beneficiaries who may be reluctant to return 
to in-person visits unless absolutely necessary, and allow us to 
consider whether this policy should be adopted on a permanent basis. 
Therefore, for CY 2021, on an interim basis, we established HCPCS code 
G2252 (Brief communication technology-based service, e.g., virtual 
check-in, by a physician or other qualified health care professional 
who can report evaluation and management services, provided to an 
established patient, not originating from a related E/M service 
provided within the previous 7 days nor leading to an E/M service or 
procedure within the next 24 hours or soonest available appointment; 
11-20 minutes of medical discussion). As discussed elsewhere in this 
final rule, we are finalizing our proposal to permanently establish 
separate coding and payment for the longer virtual check-in service 
described by HCPCS code G2252.
    HCPCS code G2252 is similar to G2012 (Brief communication 
technology-based service, e.g. virtual check-in, by a physician or 
other qualified health care professional who can report evaluation and 
management services, provided to an established patient, not 
originating from a related E/M service provided within the previous 7 
days nor leading to an E/M service or procedure within the next 24 
hours or soonest available appointment; 5-10 minutes of medical 
discussion), but allows for an extended period of medical discussion. 
Because G2012 is already included the definition of primary care 
services at Sec.  425.400(c), in the CY 2022 PFS proposed rule (86 FR 
39277), we explained our belief that including G2252 in the Shared 
Savings Program definition of primary care services used for 
assignment, beginning with performance year 2022, would result in more 
accurate assignment of beneficiaries based on where they receive the 
plurality of their primary care services. Accordingly, we proposed to 
include HCPCS code G2252 in the definition of primary care services 
under Sec.  425.400(c) for the performance year starting on January 1, 
2022, and subsequent performance years.
    We proposed to specify a revised definition of primary care 
services in a

[[Page 65276]]

new provision of the Shared Savings Program regulations at Sec.  
[thinsp]425.400(c)(1)(vi) to include the list of HCPCS and CPT codes 
specified in Sec.  [thinsp]425.400(c)(1)(v) with the additional CPT 
codes 99X21, 99X22, 99X23, 99X24, and 99X25, and HCPCS codes G2212 and 
G2252, if finalized through the CY 2022 PFS rulemaking. As noted 
previously, elsewhere in this final rule, we are finalizing CPT code 
99X21 as 99437, CPT code 99X22 as 99424, CPT code 99X23 as 99425, CPT 
code 99X24 as 99426, and CPT code 99X25 as 99427. We proposed that the 
new provision at Sec.  [thinsp]425.400(c)(1)(vi) would be applicable 
for use in determining beneficiary assignment for the performance year 
starting on January 1, 2022, and subsequent performance years. Further, 
we proposed technical modifications to the introductory text in Sec.  
[thinsp]425.400(c)(1)(v) to specify the applicability of this provision 
for determining beneficiary assignment for the performance year 
starting on January 1, 2021.
(2) Extending the Applicability of the Expanded Definition of Primary 
Care Services in Response to the PHE for COVID-19
    As previously described in this section III.J.2.a. of this final 
rule, in the May 8, 2020 COVID-19 IFC (85 FR 27582 through 27586), we 
adopted an expanded definition of primary care services for purposes of 
beneficiary assignment to reflect services furnished during the PHE for 
COVID-19. This expanded definition was finalized with modifications in 
the CY 2021 PFS final rule (85 FR 84785 through 84793). According to 
Sec.  425.400(c)(2), when the assignment window (as defined in Sec.  
425.20) for a benchmark or performance year includes any month(s) 
during the PHE for COVID-19 defined in Sec.  400.200, in determining 
beneficiary assignment, we use the primary care service codes 
identified in Sec.  425.400(c)(1), and additional primary care service 
codes as follows:
    CPT codes:
    (1) 99421, 99422, and 99423 (codes for online digital evaluation 
and management services).
    (2) 99441, 99442, and 99443 (codes for telephone evaluation and 
management services).
    HCPCS codes:
    (1) G2010 (code for the remote evaluation of patient video/images).
    (2) G2012 (code for virtual check-in).
    These additional primary care services are applicable to all months 
of the assignment window, when the assignment window includes any 
month(s) during the COVID-19 PHE defined in Sec.  400.200.
    In the CY 2021 PFS final rule (85 FR 84748 through 84755), we 
updated the definition of primary care services under Sec.  
[thinsp]425.400(c) permanently for purposes of determining beneficiary 
assignment under Sec.  [thinsp]425.402 for the performance year 
starting on January 1, 2021, and subsequent performance years, so that 
the following codes would not be linked to the duration of the PHE for 
COVID-19: (1) HCPCS code G2010 (remote evaluation of patient video/
images) and HCPCS code G2012 (virtual check-in); (2) CPT codes 99421, 
99422 and 99423 (online digital evaluation and management service (e-
visit)).
    In the CY 2021 PFS final rule, we noted that we did not consider 
including CPT codes 99441, 99442, and 99443 in the definition of 
primary care services at Sec.  [thinsp]425.400(c) on a permanent basis 
(85 FR 84751). Telephone E/M services CPT codes 99441 (Telephone 
evaluation and management service by a physician or other qualified 
health care professional who may report evaluation and management 
services provided to an established patient, parent, or guardian not 
originating from a related E/M service provided within the previous 7 
days nor leading to an E/M service or procedure within the next 24 
hours or soonest available appointment; 5-10 minutes of medical 
discussion); 99442 (Telephone evaluation and management service by a 
physician or other qualified health care professional who may report 
evaluation and management services provided to an established patient, 
parent, or guardian not originating from a related E/M service provided 
within the previous 7 days nor leading to an E/M service or procedure 
within the next 24 hours or soonest available appointment; 11-20 
minutes of medical discussion); and 99443 (Telephone evaluation and 
management service by a physician or other qualified health care 
professional who may report evaluation and management services provided 
to an established patient, parent, or guardian not originating from a 
related E/M service provided within the previous 7 days nor leading to 
an E/M service or procedure within the next 24 hours or soonest 
available appointment; 21-30 minutes of medical discussion) are non-
covered services when not provided during the PHE for COVID-19, as 
defined in Sec.  400.200, and so could not be included in the 
definition of primary care services for purposes of assignment outside 
the context of the PHE.
    In the CY 2022 PFS proposed rule, we proposed to revise the 
timeframe for services added on a temporary basis to the Medicare 
telehealth services list to allow additional time for stakeholders to 
perform an adequate analysis of those services for consideration in 
determining whether to include them on the Medicare telehealth services 
list on a permanent basis. As discussed in section II.D of this final 
rule, we are finalizing this revised timeframe, as proposed, and will 
retain all services added to the Medicare telehealth services list on a 
temporary, Category 3 basis until the end of CY 2023.
    In order to remain consistent with Medicare FFS payment policies, 
in the CY 2022 PFS proposed rule (86 FR 39278), we proposed to revise 
our existing definition of primary care services for purposes of 
beneficiary assignment in order to include CPT codes 99441, 99442, and 
99443 until they are no longer payable under the Medicare FFS payment 
policies as specified under section 1834(m) of the Act and Sec. Sec.  
410.78 and 414.65. We proposed to specify this modification by revising 
Sec.  425.400(c)(2)(i)(A)(2) to include an exception to the 
applicability of the expanded definition of primary care services, to 
extend the timeframe for use of CPT codes 99441, 99442, and 99443, and 
by making conforming revisions to paragraphs (c)(2)(i) and (c)(2)(ii).
(3) Incorporation of Replacement Codes Into the Definition of Primary 
Care Services to Reflect Current Coding
    In the June 2015 final rule (80 FR 32746 through 32748), we 
established a policy under which we make any revisions to the 
definition of primary care services for purposes of beneficiary 
assignment through the annual PFS rulemaking process. We established 
this policy in order to promote flexibility for the Shared Savings 
Program and to allow the definition of primary care services used for 
assignment in the Shared Savings Program to respond quickly to HCPCS/
CPT coding changes made in the annual PFS rulemaking process. 
Accordingly, as part of the PFS rulemaking process, we periodically 
update the definition of primary care services used for assignment to 
include additional codes that we designate as primary care services for 
purposes of the Shared Savings Program, including new HCPCS/CPT codes 
or revenue codes and any subsequently modified or replacement codes.
    On a routine basis, the CPT Editorial Panel may delete existing CPT 
codes and replace them with new CPT codes. In addition, one use of 
HCPCS G-codes is to identify professional healthcare procedures and 
services that may not

[[Page 65277]]

have assigned CPT codes. Thus, the CPT Editorial Panel may also create 
new CPT codes to replace these temporary HCPCS codes.
    Currently, there may be a period of time between the issuance of a 
replacement code and the effective date of the final rule that 
incorporates the replacement code into the definition of primary care 
services, when the replacement code is not captured in the Shared 
Savings Program assignment methodology. Therefore, in the CY 2022 PFS 
proposed rule (86 FR 39279), we proposed to incorporate into the 
definition of primary care services a permanent CPT code when it 
directly replaces another CPT code or a temporary HCPCS code (for 
example, a G-code) that is already included in the definition of 
primary care services for purposes of determining beneficiary 
assignment under the Shared Savings Program. In general, we would 
expect to determine that a code is a direct replacement for another 
code based either on it having a substantially similar code description 
or the relevant discussion in CMS rulemaking establishing payment for 
the replacement code. We explained that this approach would help to 
ensure the appropriate identification of primary care services used in 
the Shared Savings Program's assignment methodology by allowing for the 
immediate inclusion of replacement CPT codes in the determination of 
beneficiary assignment and lead to continuity in the assignment of 
beneficiaries receiving those services based on current coding. This 
continuity would improve predictability for ACOs, while also increasing 
the consistency of care coordination for their assigned beneficiaries.
    We further proposed that such replacement codes would be 
incorporated into the definition of the primary care services for 
purposes of determining beneficiary assignment for the performance year 
starting on January 1, 2022, and subsequent performance years, when the 
assignment window for a benchmark or performance year (as defined in 
Sec.  425.20) includes any day on or after the effective date of the 
replacement code for payment purposes under FFS Medicare. For ACOs 
under preliminary prospective assignment with retrospective 
reconciliation, CMS assigns beneficiaries in a preliminary manner at 
the beginning of a performance year and quarterly based on the most 
recent 12 months of data available. For final assignment for a 12-month 
benchmark year or performance year, the assignment window is the 12-
month calendar year that corresponds to the performance year or 
benchmark year. We stated that under this proposal, a replacement CPT 
code that becomes effective during a 12-month initial, quarterly, or 
final assignment window would be included in the definition of primary 
care services used to determine beneficiary assignment for the 
applicable performance year or benchmark year. For ACOs under 
prospective assignment, claims-based beneficiary assignment is 
determined prospectively at the beginning of each benchmark and 
performance year based on the beneficiary's use of primary care 
services in the most recent 12 months for which data are available, 
based on an offset assignment window before the start of the benchmark 
or performance year. We explained that under this proposal, a 
replacement CPT code that becomes effective during the offset 
assignment window would be included in the definition of primary care 
services used to determine beneficiary assignment for the applicable 
performance year or benchmark year.
    In the CY 2022 PFS proposed rule, we noted that we anticipated that 
we would continue to undergo periodic notice and comment rulemaking, 
through the annual PFS rulemaking, to amend the list of CPT codes and 
HCPCS codes that make up the definition of primary care services used 
for assignment in the Shared Savings Program to codify the applicable 
replacement CPT codes.
    We proposed to incorporate the revised definition of primary care 
services used for assignment in a new provision of the Shared Savings 
Program regulations at Sec.  [thinsp]425.400(c)(1)(vi), applicable for 
use in determining beneficiary assignment for the performance year 
starting on January 1, 2022, and subsequent performance years. As part 
of this revised definition, we proposed to incorporate a provision in 
paragraph (c)(1)(vi)(C), specifying that the primary care service codes 
for purposes of assigning beneficiaries include a CPT code identified 
by CMS that directly replaces a CPT code specified in Sec.  
425.400(c)(1)(vi)(A) or a HCPCS code specified in Sec.  
425.400(c)(1)(vi)(B), 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.
    We solicited comment on these 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, 2022, and 
subsequent performance years. We also welcomed comments on any other 
existing HCPCS or CPT codes, and new HCPCS or CPT codes proposed 
elsewhere in the proposed rule, that we should consider adding to the 
definition of primary care services for purposes of assignment in 
future rulemaking.
    We received public comments on these proposed changes to the 
definition of primary care services used for assigning beneficiaries to 
Shared Savings Program ACOs for the performance year starting on 
January 1, 2022, and subsequent performance years. Additionally, we 
received one comment suggesting further changes to the HCPCS and CPT 
codes that are considered for purposes of beneficiary assignment. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters supported our proposals regarding the 
expansion of the definition of primary care services for purposes of 
assignment in the Shared Savings Program regulations. Many commenters 
agreed that the proposed updates to the definition of primary care 
services will help to improve the accuracy of beneficiary assignment to 
ACOs participating in the Shared Savings Program by keeping assignment 
closely aligned with primary care relationships. Several commenters 
agreed that the proposed additions are similar to services already 
included on the list of primary care services considered for purposes 
of assignment. One commenter indicated that including chronic care 
management and principal care management codes ensures that patients 
are correctly linked through the assignment process to the providers 
who provide their holistic spectrum of care. Another commenter 
appreciated the inclusion of care management services and stated that 
successful care coordination is a foundational element of ACOs' work 
and these codes are frequently used by ACO participants. An additional 
commenter supported the proposed changes and stated that the updates 
would increase opportunities for advanced practice registered nurses 
(APRNs) to participate in ACOs and would allow their patients to be 
assigned to ACOs participating in the Shared Savings Program through 
claims-based assignment. Another commenter, although supportive of the 
proposed changes, stated that CMS needs to continue to refine the 
existing assignment methodology by continuing the transition toward 
primary care as a base, but did not provide specific suggestions for 
additional modifications.
    Response: We appreciate the commenters' support for our proposal to 
revise the definition of primary care

[[Page 65278]]

services used for assignment under the Shared Savings Program 
regulations to include the following additions: (1) Chronic Care 
Management (CCM) CPT code 99X21, which is being finalized as 99437 as 
discussed elsewhere in this final rule; (2) Principal Care Management 
(PCM) CPT codes 99X22, 99X23, 99X24, and 99X25, which are being 
finalized as CPT codes 99424, 99425, 99426, and 99427, respectively, as 
discussed elsewhere in this final rule; (3) Prolonged office or other 
outpatient evaluation and management (E/M) service HCPCS code G2212; 
and (4) Communication Technology-Based Service (CTBS) HCPCS code G2252. 
We agree that expanding the definition of primary care services used 
for beneficiary assignment as proposed will allow for more accurate 
assignment and that maintaining an updated list of codes that includes 
chronic care management (CCM), principal care management (PCM), and 
other E/M services is important in determining where patients receive 
most of their primary care while also ensuring that the definition of 
primary care services used for purposes of assignment remains in 
alignment with HCPCS/CPT coding changes made under the PFS.
    After consideration of public comments, we are finalizing our 
proposal to incorporate the aforementioned codes into the definition of 
primary care services that will be used in determining beneficiary 
assignment for the performance year starting on January 1, 2022, and 
subsequent performance years. We are also finalizing our proposal to 
specify the updated definition of primary care services used in 
assignment for these performance years in a new provision of the 
regulations at Sec.  [thinsp]425.400(c)(1)(vi). We note that we have 
updated the organization of Sec.  425.400(c)(1)(vi) for purposes of 
this final rule to ensure that the new CPT codes, as finalized 
elsewhere in this final rule, are listed in numerical order for 
simplicity and ease of identification.
    Comment: Several commenters supported our proposal to revise the 
existing definition of primary care services for purposes of 
beneficiary assignment in order to include CPT codes 99441, 99442, and 
99443 until they are no longer payable under the Medicare FFS payment 
policies as specified under section 1834(m) of the Act and Sec. Sec.  
410.78 and 414.65. Many commenters stated that they believe this 
proposal would align with payment policies under the PFS and help to 
ensure that beneficiaries are appropriately aligned with an ACO based 
on their receipt of primary care services, which will strengthen the 
Shared Savings Program assignment methodology. A few commenters noted 
that they supported our proposal to continue using CPT codes 99441, 
99442, and 99443 in Shared Savings Program assignment until these codes 
are no longer payable under Medicare FFS policies, because telehealth 
has been an important lifeline during the pandemic for patients, who 
are able to receive necessary care while avoiding risks of in-person 
visits. These commenters described how they have relied on telehealth 
to maintain patient relationships during the PHE for COVID-19, 
including the audio-only telephone E/M services that were temporarily 
added to the list of services eligible to be delivered via telehealth 
during the PHE for COVID-19. One commenter stated that the extension of 
the use of telephone E&M CPT codes 99441 through 99443 would help to 
facilitate ACO participants' adaptation to changing clinical 
environments in response to the PHE. Another commenter appreciated CMS' 
proposal to extend these codes to allow time to conduct further 
analysis to determine if they should be permanently added to the 
Medicare telehealth service list. Another commenter fully supported the 
extension of these services' inclusion on the Medicare telehealth 
services list but requested that CMS closely monitor the impact 
telehealth has on populations assigned to ACOs. In particular, the 
commenter suggested that if ACOs are losing assigned beneficiaries as a 
result of telehealth visits with telehealth vendors that are not ACO 
participants, CMS should consider establishing a requirement that the 
telehealth vendor be an ACO participant or preferred provider in order 
for the services to be considered in beneficiary assignment.
    Response: We agree that including CPT codes 99441, 99442, and 99443 
in the definition of primary care services used for beneficiary 
assignment until they are no longer payable under the PFS FFS payment 
policies will allow for more accurate assignment and promote continuity 
of care. With regard to the impact of telehealth utilization on 
beneficiary assignment, we conduct ongoing monitoring of the impact of 
telehealth utilization on assignment and thus far the impact has been 
minimal and has not warranted policy changes.
    After consideration of public comments, we are finalizing our 
proposal to revise the existing definition of primary care services for 
purposes of beneficiary assignment in order to include CPT codes 99441, 
99442, and 99443 until they are no longer payable under Medicare FFS 
payment policies as specified under section 1834(m) of the Act and 
Sec. Sec.  410.78 and 414.65.
    Comment: Several commenters supported our proposal to incorporate 
into the definition of primary care services used for assignment a 
permanent CPT code when it directly replaces another CPT code or a 
temporary HCPCS code (for example, a G-code) that is already included 
in the definition of primary care services for purposes of determining 
beneficiary assignment under the Shared Savings Program. One commenter 
supported the finalization of this policy because it would streamline 
use of these services across the healthcare industry, presumably by 
accounting for the transition between the temporary and permanent codes 
and encouraging the adoption and use of new, permanent codes. Another 
commenter was supportive of the proposal because it would shorten the 
gap between when codes are updated and when they are available for use 
in assignment, which will align the claims-based assignment methodology 
with the PFS and help to ensure beneficiaries are appropriately aligned 
with the ACO that is responsible for their overall care.
    Response: We agree that finalizing this proposal will ensure 
alignment between the Shared Savings Program assignment methodology and 
payment and coding guidelines under the PFS.
    After consideration of the public comments, we are finalizing our 
proposal to incorporate into the definition of primary care services 
used for assignment a permanent CPT code when it directly replaces 
another CPT code or a temporary HCPCS code (for example, G-code) that 
is already included in the definition of primary care services for 
purposes of determining beneficiary assignment under the Shared Savings 
Program.
    Comment: Regarding our solicitation for comment on any other 
existing HCPCS or CPT codes, and new HCPCS or CPT codes that we should 
consider adding to the definition of primary care services for purposes 
of assignment, one commenter stated that we should consider deleting 
HCPCS code G0506 (Comprehensive assessment of and care planning by the 
physician or other qualified health care professional for patients 
requiring chronic care management services) from the current definition 
of primary care services for the Medicare Shared Savings Program 
patient assignment methodology. The commenter stated that HCPCS code 
G0506 was identified as potentially misvalued in October 2020 and 
potentially duplicates the physician work valued under CPT code 99491,

[[Page 65279]]

and therefore, CMS should consider deleting G0506.
    Response: We appreciate this feedback and will consider it for 
future rulemaking.
3. Repayment Mechanisms
a. Background
    An ACO that will participate in a two-sided model must demonstrate 
that it has established an adequate repayment mechanism to provide CMS 
assurance of its ability to repay shared losses for which the ACO may 
be liable upon reconciliation for each performance year. The 
requirements for an ACO to establish and maintain an adequate repayment 
mechanism are described in Sec.  425.204(f), and we have provided 
additional program guidance on repayment mechanism arrangements.\117\ 
We established the repayment mechanism requirements through earlier 
rulemaking,\118\ and recently modified the repayment mechanism 
requirements in the December 2018 final rule (83 FR 67928 through 
67938) and the CY 2021 PFS final rule (85 FR 84756 through 84763).
---------------------------------------------------------------------------

    \117\ Medicare Shared Savings Program, Repayment Mechanism 
Arrangements, Guidance Document, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/Repayment-Mechanism-Guidance.pdf (hereinafter Repayment 
Mechanism Arrangements Guidance).
    \118\ Refer to the November 2011 final rule, 76 FR 67802, 67937 
through 67940 (establishing the requirement for Track 2 ACOs). Refer 
to the June 2015 final rule, 80 FR 32692, 32781 through 32785 
(adopting the same general requirements for Track 3 ACOs with 
respect to the repayment mechanism and discussing modifications to 
reduce burden of the repayment requirements on ACOs).
---------------------------------------------------------------------------

    According to Sec.  425.204(f)(4)(ii), for a BASIC track or ENHANCED 
track ACO, the repayment mechanism amount must be equal to the lesser 
of the following: (1) 1 percent of the total per capita Medicare Parts 
A and B FFS expenditures for the ACO's assigned beneficiaries, based on 
expenditures for the most recent calendar year for which 12 months of 
data are available; or (2) 2 percent of the total Medicare Parts A and 
B FFS revenue of its ACO participants, based on revenue for the most 
recent calendar year for which 12 months of data are available. As 
discussed in the December 2018 final rule (83 FR 67866), this approach 
allows CMS to use the same sources of revenue and expenditure data 
during the program's annual application cycle to estimate the ACO's 
repayment mechanism amount and to determine the ACO's participation 
options according to whether the ACO is categorized as a low revenue 
ACO or high revenue ACO.
    As specified under Sec.  425.204(f)(4)(iii), for agreement periods 
beginning on or after July 1, 2019, CMS recalculates the ACO's 
repayment mechanism amount before the second and each subsequent 
performance year in the agreement period based on the certified ACO 
participant list for the relevant performance year. We require an 
increase in the repayment mechanism amount if the recalculated 
repayment mechanism amount exceeds the existing repayment mechanism 
amount by at least 50 percent or $1,000,000, whichever is the lesser 
value. Under Sec.  425.204(f)(4)(iii), an ACO cannot decrease the 
amount of its repayment mechanism during its agreement period as a 
result of changes in its composition.
    As discussed in prior rulemaking, program stakeholders have 
continued to identify the repayment mechanism requirement as a 
potential barrier for some ACOs to enter into performance-based risk 
tracks, particularly small, physician-only and rural ACOs that may lack 
access to the capital that is needed to establish a repayment mechanism 
with a large dollar amount (see for example, 83 FR 67929).
    The design of the current repayment mechanism amount calculation, 
which is based on a percentage of expenditures for the ACO's assigned 
beneficiaries or a percentage of ACO participant revenue, seeks to 
approximate a percentage of the ACO's maximum possible shared losses, 
according to the loss recoupment limits (also referred to as the loss 
sharing limits) applicable to ACOs under two-sided models. As described 
in the CY 2022 PFS proposed rule (86 FR 39280), comparing the 
calculations for determining repayment mechanism amounts to the 
calculations for determining the loss sharing limits indicates that 
repayment mechanisms cover approximately 25 percent of estimated 
maximum possible losses for ACOs in the BASIC track (determined by 
dividing 1 percent, the percentage used in the repayment mechanism 
amount calculation under Sec.  425.204(f)(4)(ii)(A), by 4 percent, the 
percentage of the benchmark-based loss sharing limit under Level E of 
the BASIC track under Sec.  425.605(d)(1)(v)(D)(2)), and 7 percent of 
estimated maximum possible losses for ACOs in the ENHANCED track 
(determined by dividing 1 percent, the percentage used in the repayment 
mechanism amount calculation under Sec.  425.204(f)(4)(ii)(A), by 15 
percent, the percentage of the benchmark-based loss sharing limit under 
the ENHANCED track under Sec.  425.610(g)). Based on operational 
experience, we have found that the repayment mechanism amounts for most 
ACOs are much larger than needed to cover actual losses, as repayment 
mechanism amount calculations have been based on a percentage of an 
amount that approximates the ACO's loss sharing limit (which is as high 
as 15 percent of updated benchmark expenditures in the ENHANCED 
track),\119\ and actual historical shared losses have been much lower 
than the loss sharing limit, averaging 0.96 percent of the ACO's 
benchmark. Some ACOs have been required to establish repayment 
mechanisms with amounts that are 9 times greater than their actual 
shared losses. Additionally, of the 35 times ACOs have owed shared 
losses, as determined based on reconciliation for the Shared Savings 
Program's first performance year concluding on December 31, 2013, 
through performance years (or a performance period) in 2019, only one 
ACO has neglected to repay CMS timely, and most ACOs chose to repay 
shared losses without the use of their repayment mechanism 
arrangements. For the one ACO that did not repay CMS, we were able to 
recoup more than half of the shared losses owed using the ACO's 
repayment mechanism, and the remaining debt was referred to the 
Department of Treasury for collection.
---------------------------------------------------------------------------

    \119\ The repayment mechanism amount calculations have varied 
over time, and the loss sharing limits are variable based on track/
level. For reference: For BASIC track or ENHANCED track ACOs, refer 
to the repayment mechanism amount calculation methodology specified 
in Sec.  425.204(f)(4)(ii), as described in this section of this 
final rule.
    Repayment mechanism amounts for ACOs participating in Track 2 
and Track 3 (subsequently renamed the ENHANCED track), in agreement 
periods beginning on or before January 1, 2019, are calculated as 1 
percent of total per capita Medicare Parts A and B FFS expenditures 
for the ACO's assigned beneficiaries for a reference year (refer to 
76 FR 67978 and 67979, 80 FR 32838, and Sec.  425.204(f)(4)(i)).
    Refer to the loss recoupment limits for Levels C, D and E of the 
BASIC track, Track 2 and the ENHANCED track as specified in subpart 
G of the Shared Savings Program regulations.
    Refer to the Medicare ACO Track 1+ Model Participation Agreement 
(available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/track-1plus-model-par-agreement.pdf), specifying a bifurcated approach used to determine 
the estimated amount of an ACO's repayment mechanism for consistency 
with the bifurcated approach to determining the loss sharing limit 
under the Track 1+ Model.
---------------------------------------------------------------------------

    As we explained in the CY 2022 PFS proposed rule (86 FR 39280), 
considering this experience, which suggests there may be low risk to 
the Shared Savings Program by allowing lower repayment mechanism 
amounts, and the potential reduction in burden on ACOs by lower 
repayment

[[Page 65280]]

mechanism amounts, we believe it is appropriate to modify the approach 
to calculating repayment mechanism amounts. Further, we noted that we 
believe reducing the required amounts of repayment mechanisms may allow 
ACOs to use these funds to improve patient care and coordination and 
reduce a potential barrier to entry into performance-based risk models.
    In the CY 2022 PFS proposed rule (86 FR 39279 through 39288), we 
discussed four proposed policy changes regarding required repayment 
mechanism amounts. Under the first policy, we would modify the 
methodology for calculating repayment mechanism amounts to reduce the 
required amounts. Second, we would specify how we identify the number 
of assigned beneficiaries used in the repayment mechanism amount 
calculation and the annual repayment mechanism amount recalculation. 
Third, we would permit eligible ACOs that established a repayment 
mechanism to support their participation in a two-sided model beginning 
on July 1, 2019, January 1, 2020, or January 1, 2021, to elect to 
reduce the amount of their existing repayment mechanisms if their 
recalculated repayment mechanism amount for performance year 2022 is 
lower than their existing repayment mechanism amount. Fourth, we would 
modify the threshold for determining whether an ACO is required to 
increase its repayment mechanism amount during its ACO's agreement 
period.
    Within this section of this final rule we respond to more general 
comments received on the proposed modifications to the Shared Savings 
Program's repayment mechanism requirements, and summarize comments that 
go beyond the scope of these proposals. In section III.J.3.b of this 
final rule, we summarize and respond to public comments we received on 
the proposed changes more specifically.
    Comment: Several commenters explained that securing a repayment 
mechanism is a time consuming, costly regulatory burden for ACOs. Some 
commenters explained that the administrative burden and financial cost 
of securing a repayment mechanism pose barriers for ACOs to move to 
two-sided models, can act as a deterrent to ACO participation, or cause 
ACOs to divert resources away from care improvement initiatives. Some 
commenters stated more generally their appreciation for and support of 
CMS proposing ways to minimize the burdens associated with the 
repayment mechanisms. Several commenters pointed to CMS' determination, 
as described in the CY 2022 PFS proposed rule, that the repayment 
mechanism amounts for most ACOs are larger than needed to cover actual 
losses, and reduced repayment mechanism amounts would better reflect 
the amounts needed to cover potential shared losses under the Shared 
Savings Program.
    Commenters addressing the proposed revisions to required repayment 
mechanism amounts expressed support for a combination of policies that 
would decrease the amount of repayment mechanisms, including all or 
several of the following: Modifying the methodology for calculating 
repayment mechanism amounts, permitting eligible ACOs in two-sided 
models a one-time opportunity to reduce their repayment mechanism 
amount, and modifying the threshold for when an ACO needs to increase 
its repayment mechanism amount during an ongoing agreement period. Some 
commenters explained that such changes would decrease the 
administrative burden and financial burden of participation in the 
Shared Savings Program. Several commenters indicated that these changes 
could free financial resources for investing in other aspects of ACO 
operations, including patient care and coordination, and initiatives to 
improve quality, access, and patient experience. A commenter described 
the proposed modifications to repayment mechanism obligations as ``ACO-
friendly'' and welcomed the additional flexibility in the Shared 
Savings Program.
    Response: We appreciate commenters' support for the modifications 
to the repayment mechanism calculation methodology that we proposed in 
the CY 2022 PFS proposed rule that would result in lower required 
repayment mechanism amounts for ACOs. We appreciate commenters' support 
for our assessment that lower repayment mechanism amounts under the 
proposed calculation methodology would better reflect the amounts 
needed to cover actual shared losses under the Shared Savings Program. 
These comments also reaffirm our belief that lower repayment mechanism 
amounts under the proposed approach would reduce administrative burden 
and financial costs on ACOs, potentially allowing ACOs to use these 
funds to improve patient care and coordination and reduce a potential 
barrier to entry into performance-based risk models. Further, we 
continue to believe that the lower repayment mechanism amounts under 
the proposals would provide CMS with reasonable assurance of an ACO's 
ability to repay shared losses and would help protect the Medicare 
trust funds in the event CMS uses an ACO's repayment mechanism funds to 
support recoupment of shared losses.
    As described in greater detail in section III.J.3.b of this final 
rule, we are finalizing our proposed modifications to the Shared 
Savings Programs' repayment mechanism requirements. Although not 
addressed specifically in the CY 2022 PFS proposed rule, we believe 
this collection of repayment mechanism policy changes may have a number 
of beneficial health equity impacts on Shared Savings Program ACOs and 
the populations of Medicare FFS beneficiaries they serve. Lower 
repayment mechanism requirements would require ACOs to set aside 
relatively smaller dollar amounts, such as for ACOs establishing and 
maintaining an escrow account as their repayment mechanism, or could 
result in lower fees charged by financial institutions for letters of 
credit and by insurance companies for surety bonds. As a result, low 
revenue ACOs and smaller, rural and physician-only ACOs may be better 
able to afford repayment mechanisms, and therefore, may more readily 
transition to performance-based risk. We have indicated in earlier 
rulemaking that ACOs under performance-based risk models, and 
specifically those participating under higher levels of risk and 
potential reward, have greater potential to control their assigned 
beneficiaries' Medicare Parts A and B FFS expenditures by coordinating 
care across care settings, and thus may achieve significant change in 
spending. Additionally, we anticipate that relatively lower repayment 
mechanism amounts and less frequent repayment mechanism amount 
increases during the ACO's agreement period would give ACOs an 
opportunity to repurpose these funds for other uses, such as to improve 
patient care and coordination, or support quality improvement 
activities. That, in turn, may lead to care improvements for the ACO's 
Medicare FFS beneficiaries generally, including care for medically 
complex and high-risk populations. Further, repayment mechanism amount 
requirements based on either a percentage of expenditures for an ACO's 
assigned beneficiaries or percentage of its ACO participant revenue, 
reflect the higher cost of care that may be associated with serving 
medically complex Medicare FFS beneficiaries. We believe that reducing 
the percentages used in these repayment mechanism amount calculations 
will result in relatively lower burden on ACOs serving medically 
complex populations, and such ACOs may see a larger absolute dollar 
value reduction in

[[Page 65281]]

their repayment mechanism amounts compared to other ACOs.
    Comment: Some commenters suggested changes to repayment mechanism 
policies that were outside the scope of this rulemaking, including the 
following:
     Suggestions that CMS share its lessons learned about the 
amount of repayment mechanisms for Shared Savings Program ACOs with the 
Innovation Center, and that CMS consider lowering the financial 
collateral requirements for the Global and Professional Direct 
Contracting (GPDC) model and Comprehensive Kidney Care Contracting 
(CKCC) under the Kidney Care Choices model.
     Requests for additional modifications to Shared Savings 
Program requirements, including that CMS eliminate the requirement for 
ACOs to maintain their repayment mechanism for the 12-month ``tail 
period'' beyond the expiration of their agreement period which was 
described as creating unnecessary, additional burden which is costly 
for ACOs.
     Suggestions that CMS provide greater flexibility for ACOs 
needing to adjust their repayment mechanisms over time, such as by 
permitting the release funds for a limited window, such as 60 days, for 
ACOs changing repayment mechanisms.
     Suggestions that CMS expand the permissible repayment 
mechanism types under the Shared Savings Program, to include 
reinsurance and withholding Medicare payments.
    Response: Comments of this nature are beyond the scope of the 
policies and are not being addressed in this final rule.
b. Revisions
(1) Repayment Mechanism Amount Calculations
    In the CY 2022 PFS proposed rule (86 FR 39280 through 39283), we 
considered two options for modifying the calculation of repayment 
mechanism amounts to result in lower amounts: (1) Reducing the 
percentages used in the existing repayment mechanism amount 
calculations specified in Sec.  425.204(f)(4)(ii); or (2) revising the 
methodology to use a per beneficiary dollar amount estimation 
methodology. In evaluating these options, we considered the potential 
impact on low revenue ACOs and high revenue ACOs, as defined according 
to Sec.  425.20. We also considered a balance of factors, including 
whether to retain an approach similar to the existing methodology or to 
use an alternative approach that could simplify the repayment mechanism 
amount calculation to make it more predictable. Additionally, we 
considered the magnitude of potential decreases in the repayment 
mechanism amounts under each option. We proposed the first option, to 
reduce the percentages used in the existing repayment mechanism amount 
calculations, but we solicited comment on the second, alternative 
option we considered. We proposed to lower the repayment mechanism 
amounts by reducing the percentages used in our current methodology, 
under which we calculate the repayment mechanism amount as the lesser 
of the following: (1) 1 percent of the total per capita Medicare Parts 
A and B FFS expenditures for the ACO's assigned beneficiaries, based on 
expenditures for the most recent calendar year for which 12 months of 
data are available; or (2) 2 percent of the total Medicare Parts A and 
B FFS revenue of its ACO participants, based on revenue for the most 
recent calendar year for which 12 months of data are available. 
Specifically, we proposed to calculate the amount as the lesser of the 
following: (1) One-half (0.5) percent of the total per capita Medicare 
Parts A and B FFS expenditures for the ACO's assigned beneficiaries, 
based on expenditures for the most recent calendar year for which 12 
months of data are available; or (2) 1 percent of the total Medicare 
Parts A and B FFS revenue of its ACO participants, based on revenue for 
the most recent calendar year for which 12 months of data are 
available.
    As discussed in the CY 2022 PFS proposed rule, under this proposal, 
ACOs would receive a 50 percent decrease in their repayment mechanism 
amounts compared to the current methodology. These amounts would offer 
lower repayment mechanism amounts for ACOs, while still reserving what 
we believe to be a reasonable amount in the event CMS uses an ACO's 
repayment mechanism funds to support recoupment of shared losses. Our 
review of data for ACOs under a two-sided model revealed that if this 
repayment mechanism amount calculation method were in place for 
performance year 2021, the amount by which repayment mechanism amounts 
would be reduced (the ``repayment mechanism savings'') would average 
$297,665 for low revenue ACOs and $2.31 million for high revenue ACOs; 
the minimum repayment mechanism savings would be $27,030 for low 
revenue ACOs and $78,106 for high revenue ACOs; and the maximum 
repayment mechanism savings would be $1.97 million for low revenue ACOs 
and $11.70 million for high revenue ACOs.
    A second, alternative option we considered would be to estimate the 
repayment mechanism amount using a per beneficiary dollar amount that 
would be based on a percentage of actual historical median per capita 
shared losses for Shared Savings Program ACOs, multiplied by an 
estimate of the size of the ACO's assigned population as identified 
during the annual application or annual change request cycle. In 
considering this option, we analyzed data from the 35 instances when 
Shared Savings Program ACOs in two-sided models have ever incurred 
shared losses, defined as performance year expenditures above the ACO's 
benchmark by an amount equal to or greater than the ACO's minimum loss 
rate. Using data from actual historical shared losses, we determined 
median per beneficiary shared losses were $100.90 and calculated per 
beneficiary dollar amounts projected to cover 5 to 25 percent of shared 
losses for ACOs, as illustrated in Table 37.

[[Page 65282]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.059

    Under this second, alternative option, we considered using separate 
per beneficiary dollar amounts for low revenue ACOs and high revenue 
ACOs. We stated our belief that using two separate percentages is 
supported for a number of reasons. Compared to high revenue ACOs, low 
revenue ACOs are likely to have a lower loss sharing limit in the BASIC 
track (determined as a percentage of ACO participant revenue not to 
exceed a percentage of the ACO's updated benchmark), under which 
eligible low revenue ACOs may participate for up to two agreement 
periods. Historically, low revenue ACOs have owed shared losses less 
often and have had lower amounts of per beneficiary shared losses 
compared to high revenue ACOs. Additionally, we stated that high 
revenue ACOs, which tend to include institutional providers and are 
typically larger and better capitalized, are likely better financially 
prepared to secure a higher amount in their repayment mechanism than 
low revenue ACOs, which tend to be smaller and have less capital. For 
low revenue ACOs, to cover 10 percent of median actual historical 
shared losses, rounding to the nearest $1 increment, we considered 
requiring a repayment mechanism amount equal to $10 per beneficiary. 
For high revenue ACOs, to cover 20 percent of median actual historical 
shared losses we considered requiring $20 per beneficiary (refer to 
Table 37). These amounts would offer a lower repayment mechanism amount 
for 99 percent of low and high revenue ACOs with existing repayment 
mechanisms, while still reserving what we believe to be a reasonable 
amount in the event CMS uses an ACO's repayment mechanism funds to 
support recoupment of shared losses. Our review of data for ACOs in a 
two-sided model revealed that if this repayment mechanism amount 
calculation method were in place for performance year 2021, the 
repayment mechanism savings would average $410,682 for low revenue ACOs 
and $3.84 million for high revenue ACOs; the minimum repayment 
mechanism savings would be $6,513 for low revenue ACOs and $120,491 for 
high revenue ACOs; and the maximum repayment mechanism savings would be 
$3.45 million for low revenue ACOs and $19.73 million for high revenue 
ACOs.
    In the CY 2022 PFS proposed rule, we explained that there are a 
number of advantages to the option under which we would calculate 
repayment mechanism amounts using per beneficiary dollar amounts for 
low revenue ACOs and high revenue ACOs. For one, low revenue ACOs would 
receive additional relief through lower repayment mechanism amounts, 
relative to high revenue ACOs, under this approach. We explained our 
belief that this is appropriate considering the lower potential loss 
liability for low revenue ACOs and the fact that low revenue ACOs tend 
to be less well capitalized and may face potential barriers to 
establishing repayment mechanisms. Second, this approach aligns with 
the existing repayment mechanism amount calculation methodology, which 
tends to require proportionally higher amounts for high revenue ACOs 
because those ACOs tend to have higher average total expenditures for 
ACO assigned beneficiaries and higher total ACO participant revenue, 
compared to low revenue ACOs. Third, an approach that uses a per 
beneficiary dollar amount would simplify the method to calculate the 
repayment mechanism amount, compared to the existing methodology, and 
may help ACOs better project repayment mechanism amounts prior to 
entering two-sided models, either at the point of application to a new 
agreement period or during the ACO's agreement period within the BASIC 
track's glide path as ACOs transition from a one-sided model to a two-
sided model. Lastly, this approach would lower the mean repayment 
mechanism amount for ACOs more than the reduction that would occur 
under our proposal to lower the percentages used in the existing amount 
calculation methodology.
    However, we noted significant concerns with an approach that uses a 
per beneficiary dollar amount that is applied based on whether an ACO 
is determined to be a low revenue ACO or a high revenue ACO, which if 
unresolved outweigh the potential benefits of the approach. For one, 
there would be a significant repayment mechanism amount difference for 
ACOs near the 35 percent threshold that differentiates low revenue ACOs 
and high revenue ACOs, and this difference in repayment mechanism 
amount may not correlate to covering a significant additional increase 
in risk.
    Second, the determination of whether an ACO is a low revenue ACO or 
high revenue ACO can change during the application cycle and between 
performance years within an agreement period. Although changes in ACO 
composition have the potential to affect repayment mechanism amounts 
determined under the existing calculation methodology, ACO composition 
changes could result in a greater magnitude of change in the repayment 
mechanism amount under an approach that applies a $10 per beneficiary 
amount for low revenue ACOs and a $20 per beneficiary amount for high 
revenue ACOs.
    For ACOs establishing a repayment mechanism under the per 
beneficiary dollar amount approach, a change in revenue determination 
in later stages of the application cycle or change request cycle would 
delay calculation of an ACO's final repayment mechanism amount. In 
turn, this could delay when

[[Page 65283]]

the ACO could submit finalized repayment mechanism documentation to 
demonstrate it meets the repayment mechanism requirement for entering a 
two-sided model. We are also concerned that ACOs whose revenue 
determinations change from low revenue to high revenue would face a 
substantial increase in the required repayment mechanism amount which 
they could find challenging to finance. However, based on our 
operational experience there have been relatively few cases where an 
ACO's revenue determination changes during the later stages of the 
application review period or change request cycle.
    During an ACO's agreement period, a change in the ACO's revenue 
determination may cause significant fluctuation in an ACO's repayment 
mechanism amount under an approach that calculates the repayment 
mechanism amount using a per beneficiary dollar amount based on whether 
an ACO is determined to be a low revenue ACO or a high revenue ACO. 
Based on our operational experience, however, few ACOs entering 
agreement periods beginning on July 1, 2019, and in subsequent years, 
have experienced a change in revenue determination during their 
agreement period. Section 425.600(e) specifies an approach to 
addressing the circumstance where an ACO that entered an agreement 
period under Level E of the BASIC track because it was low revenue and 
experienced with performance-based risk Medicare ACO initiatives, 
becomes high revenue during its agreement period. This approach 
requires the ACO to take corrective action to meet the definition of 
low revenue ACO, or CMS takes compliance action as specified in 
Sec. Sec.  425.216 and 425.218, which may include termination of the 
participation agreement. Further, in the absence of a policy to permit 
decreases in the repayment mechanism amount during the ACO's agreement 
period, ACOs that establish a repayment mechanism based on a high 
revenue ACO determination and are subsequently determined to be a low 
revenue ACO would need to maintain a relatively higher repayment 
mechanism amount for the duration of their 5-year agreement period.
    To resolve these concerns, we considered using a single per 
beneficiary dollar amount for all ACOs, based on the values described 
in Table 37. However, we were unable to identify a single per 
beneficiary dollar amount that would account for historically higher 
per beneficiary shared losses owed by high revenue ACOs, while 
resulting in lower repayment mechanism amounts compared to the existing 
repayment mechanism calculation approach for most low revenue ACOs. 
Specifically, the dollar amount that would allow for relatively lower 
repayment mechanism amounts for all ACOs would be $8 per beneficiary, 
to cover 7.5 percent of median actual historical shared losses, 
rounding to the nearest $1 increment, which we believe is too low for 
high revenue ACOs. A higher per beneficiary dollar amount, such as $15, 
to cover 15 percent of median actual historical shared losses, rounding 
to the nearest $1 increment, would be relatively disadvantageous to 
approximately 20 percent of low revenue ACOs.
    As we noted in the CY 2022 PFS proposed rule, both our proposal and 
the second, alternative option would lower repayment mechanism amounts, 
and therefore, would reduce the amount available to CMS to support 
repayment of shared losses. However, we explained our belief that the 
risk of not collecting shared losses is mitigated for a number of 
reasons. As noted in the CY 2022 PFS proposed rule, in our analysis of 
repayment mechanism amounts compared to actual historical shared 
losses, we believe the lower amounts would continue to provide CMS with 
reasonable assurance of an ACO's ability to repay shared losses. 
Further, as discussed in earlier rulemaking (85 FR 50249), the Shared 
Savings Program's existing policies require ACOs to pay shared losses, 
in full, within 90 days of written notification from CMS of the amount 
owed (according to Sec. Sec.  425.605(e)(3), 425.606(h)(3), and 
425.610(h)(3)). ACOs have an interest in fully paying the amount of 
shared losses owed within the 90-day payment window to remain in 
compliance with the Shared Savings Program's requirements and avoid 
compliance actions including involuntary termination from the program. 
CMS may terminate an ACO's participation agreement for reasons 
including, but not limited to, non-compliance with requirements in 
Sec.  425.218(b)(1), such as failure to repay shared losses owed 
according to the program's regulations and may take pre-termination 
actions as described in Sec.  425.216(a). Under Sec.  
425.221(b)(2)(ii)(B), an ACO under a two-sided model whose 
participation agreement is terminated by CMS under Sec.  425.218 is 
liable for a pro-rated share of any shared losses determined for the 
performance year during which the termination becomes effective. ACOs 
must also timely repay shared losses owed to avoid accruing interest on 
any unpaid amounts and to avoid referral of an unpaid debt to the 
Department of Treasury for collection. Based on our operational 
experience, nearly all ACOs fully repay shared losses without use of 
their repayment mechanism arrangement. Under our proposal, ACOs would 
continue to have the option to secure a repayment mechanism at an 
amount greater than the CMS required amount, if they believe that is 
appropriate to prepare their ACO to repay all shared losses.
    Furthermore, we explained our belief that reduced repayment 
mechanism amounts could reduce costs for ACOs in fees charged by 
financial institutions for letters of credit and by insurance companies 
for surety bonds, although we would not anticipate a significant 
reduction in fees charged by banks or credit unions for establishing 
and maintaining escrow accounts. For example, reducing the required 
repayment mechanism amount of a given ACO by $1 million, could reduce 
the cost of obtaining a letter of credit or surety bond by roughly 1 or 
2 percent, in this example resulting in $10,000 or $20,000 in reduced 
fees for the ACO. We estimated that such relief, in total for all 
participating ACOs, could be worth $2 to $4 million annually under the 
proposed approach (assuming a reduction of approximately $196 million 
in repayment mechanism amounts, in aggregate) and $3 to $6 million 
annually under the second, alternative option (assuming a reduction of 
approximately $322 million in repayment mechanism amounts, in 
aggregate).
    In light of these considerations, we proposed to revise the 
regulations at Sec.  425.204(f)(4)(ii) to reduce by one-half the 
percentages used in the methodology for calculating repayment mechanism 
amounts for ACOs in a two-sided model of the BASIC track or the 
ENHANCED track. We proposed to revise the percentage specified in Sec.  
425.204(f)(4)(ii)(A), for calculating an amount based on expenditures 
for the ACO's assigned beneficiaries, from 1 percent to one-half 
percent. We proposed to revise the percentage specified in Sec.  
425.204(f)(4)(ii)(B), for calculating an amount based on ACO 
participant revenue, from 2 percent to 1 percent. Under this approach 
for calculating repayment mechanism amounts for ACOs in a two-sided 
model of the BASIC track or the ENHANCED track, the repayment mechanism 
amount would be equal to the lesser of the following: (1) One-half 
percent of the total per capita Medicare Parts A and B FFS expenditures 
for the ACO's assigned beneficiaries, based on expenditures for the 
most recent

[[Page 65284]]

calendar year for which 12 months of data are available; or (2) 1 
percent of the total Medicare Parts A and B FFS revenue of its ACO 
participants, based on revenue for the most recent calendar year for 
which 12 months of data are available.
    We solicited comments on this proposal and the second, alternative 
option for calculating repayment mechanism amounts using a per 
beneficiary dollar amount, based on a percentage of actual historical 
median per capita shared losses for Shared Savings Program ACOs, 
multiplied by an estimate of the size of the ACO's assigned population 
as identified during the annual application or annual change request 
cycle. We also solicited comments on applying different per beneficiary 
dollar amounts for low revenue ACOs and high revenue ACOs under this 
alternative approach. We welcomed comments to address the dollar 
amounts projected to cover the percentage of median actual historical 
shared losses that would be an appropriate basis for low revenue ACOs 
(such as $10) and high revenue ACOs (such as $20) under this 
methodology. Additionally, we solicited comments on approaches for 
addressing our concerns about changes in revenue determinations 
significantly affecting an ACO's repayment mechanism amount, such as 
applying a single per beneficiary dollar amount to all ACOs. We also 
noted that if we were to adopt such an approach, we would need to 
address with greater specificity factors including: (1) How we would 
identify the population of assigned beneficiaries that would be used in 
the calculation as a multiplier for the per beneficiary dollar amount; 
and (2) the frequency with which we would consider modifications to the 
per beneficiary dollar amount. We welcomed comments on these 
considerations.
    We proposed that these modifications would be effective and 
applicable on January 1, 2022. We noted that the Shared Savings 
Program's application cycle (for new, renewing and re-entering ACOs) 
and change request cycle (for ACOs within an agreement period) for the 
performance year beginning on January 1, 2022 occurs between spring and 
fall 2021. During this timeframe, ACOs preparing to enter two-sided 
models for performance year 2022 are awaiting the final repayment 
mechanism amount for establishing a repayment mechanism, and ACOs 
within two-sided models are awaiting the determination of whether their 
repayment mechanism amount must be increased in accordance with Sec.  
425.204(f)(4)(iii) (as discussed in section III.J.3.b.(4) of this final 
rule). We explained that if the proposed modifications to the repayment 
mechanism amount calculation methodology are finalized and become 
effective and applicable on January 1, 2022, we would communicate to 
ACOs their final repayment mechanism amounts after the issuance of the 
final rule. We committed to ensuring that ACOs do not overfund their 
repayment mechanism arrangements according to the existing methodology 
if we finalized the proposed revisions to reduce repayment mechanism 
amounts.
    We received public comments on the proposed modifications to the 
Shared Savings Program repayment mechanism amount calculations, and the 
alternative approach on which we solicited comments. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported the proposal to modify the 
methodology for calculating repayment mechanism amounts to reduce the 
required amounts by one-half such that the required repayment mechanism 
amount would be the lesser of the following: (1) One-half percent of 
the total per capita Medicare Parts A and B FFS expenditures for the 
ACO's assigned beneficiaries, based on expenditures for the most recent 
calendar year for which 12-months of data are available; or (2) 1 
percent of the total Medicare Parts A and B FFS revenue of its ACO 
participants, based on revenue for the most recent calendar year for 
which 12-months of data are available.
    More specifically, several commenters suggested that this reduction 
in the required repayment mechanism amounts would minimize 
administrative costs of, or reduce administrative barriers for, ACOs 
participating in the Shared Savings Program. A commenter supporting 
this proposal stated that the modification would allow ACOs to use 
these funds to improve patient care and coordination. Several 
commenters explained their support for this proposed change as it would 
encourage more providers to enter or stay in the Shared Savings 
Program, particularly small and rural providers that have not yet had 
to take on performance-based risk.
    Some commenters stated that reducing the required repayment 
mechanism amounts better reflects an appropriate portion of potential 
shared losses under the program's financial models.
    Response: We agree with commenters and appreciate their support for 
the proposal.
    Comment: Commenters also supported our findings, described in the 
CY 2022 PFS proposed rule, and restated in section III.J.3.a of this 
final rule, that the repayment mechanism amounts for most ACOs are much 
larger than needed to cover actual losses, as determined based on the 
existing amount calculation methodology and in light of CMS' 
operational experience at the time of the CY 2022 PFS proposed rule.
    Response: We agree with commenters and appreciate their support for 
the findings underlying our proposed modifications to the repayment 
mechanism calculation methodology, as described in the CY 2022 PFS 
proposed rule.
    Comment: Several commenters explained that the relatively lower 
repayment mechanism amounts that would result from the proposed 
approach are sufficient to prompt third-party due diligence and 
establish credit worthiness for ACOs seeking to obtain a repayment 
mechanism arrangement.
    Response: We believe that a financial institution issuing a 
repayment mechanism conducts some form of due diligence on the 
financial strength, solvency and credit worthiness of the ACO, and this 
external review serves as further validation of the ACO's financial 
readiness to participate in a two-sided model. We agree this is an 
important function of the repayment mechanism requirements.
    Comment: Several commenters addressed the alternative approach CMS 
described for calculating the required repayment amount values using a 
per beneficiary dollar amount, based on a percentage of actual 
historical median per capita shared losses for ACOs and multiplied by 
an estimate of the size of the ACO's assigned population. Several 
commenters preferred the alternative approach to utilize a per 
beneficiary dollar amount to calculate required repayment mechanism 
values, explaining this approach would improve transparency and allow 
ACOs to better predict their repayment mechanism amount prior to moving 
to two-sided risk. However, these commenters were not supportive of 
setting different per beneficiary dollar amounts for high revenue ACOs 
and low revenue ACOs, explaining that the high-low revenue distinction 
in the Shared Savings Program is arbitrary and creates an uneven 
playing field for ACO participants. These commenters suggested that CMS 
should generally stop distinguishing ACOs based on ACO revenue status 
in the Shared Savings Program, explaining that it has the unintended 
consequence of

[[Page 65285]]

discouraging partnerships between certain types of providers, such as 
hospitals and specialists, and penalizes ACOs that work to include a 
variety of provider types in their ACO participant list. A commenter 
expressed support for the proposal to reduce the percentages used in 
the repayment mechanism amount calculation, explaining that setting a 
per Medicare beneficiary amount would not reflect the difference in the 
per capita costs of Medicare beneficiaries that can vary from $8,500 
all the way up to $17,000 even in similarly composed low revenue ACOs.
    Response: We appreciate the comments received on the alternative 
option we considered for calculating repayment mechanism amounts using 
a per beneficiary dollar amount. We also appreciate comments that 
inform our consideration of using separate per beneficiary dollar 
amounts for low revenue ACOs and high revenue ACOs. However, the 
comments suggesting that CMS should generally stop distinguishing ACOs 
based on ACO revenue status are beyond the scope of the alternative 
approach to calculating repayment mechanism amounts, and therefore, 
will not be addressed in this final rule.
    Although several commenters supported the alternative approach that 
would use per beneficiary dollar amounts to calculate repayment 
mechanism amounts, we decline to adopt this alternative approach with 
this final rule. We believe there are a number of aspects of such an 
approach that would require additional time to develop and evaluate, 
and we believe that the proposed approach to lowering the percentages 
in the existing repayment mechanism amount calculations would be a more 
appropriate method for reducing repayment mechanism burden on ACOs in 
the near term. In particular, we appreciate the commenter pointing to 
the variability in per capita costs of Medicare beneficiaries among 
ACOs, and providing the example of the range in per capita costs for 
similarly composed low revenue ACOs. We believe this suggests that 
using a single per beneficiary dollar amount for determining repayment 
mechanism amounts for each revenue status, or a single per beneficiary 
dollar amount for all ACOs, could potentially oversimplify the 
repayment mechanism calculation by removing an ACO-specific measure of 
costs (such as ACO participant revenue or ACO assigned beneficiary 
expenditures). This points to the need for additional considerations 
for identifying an appropriate per beneficiary dollar amount value 
under the alternative approach. Further, as we described in the CY 2022 
PFS proposed rule, and restated elsewhere in this section of this final 
rule, we would need to decide how to identify the population of 
assigned beneficiaries that would be used in the calculation as a 
multiplier for the per beneficiary dollar amount, and the frequency 
with which we would consider modifications to the per beneficiary 
dollar amount. We did not receive comments on these other factors. 
Although we are not adopting an approach that uses per beneficiary 
dollar amounts to calculate repayment mechanism amounts with this final 
rule, we continue to believe such an approach could help ACOs better 
project repayment mechanism amounts prior to entering two-sided models, 
and therefore, be more transparent. We may revisit considerations for 
calculating repayment mechanism amounts using an alternative approach, 
such as per beneficiary dollar amounts, in future notice and comment 
rulemaking for the Shared Savings Program.
    After consideration of public comments, we are finalizing as 
proposed to revise the percentage specified in Sec.  
425.204(f)(4)(ii)(A), for calculating an amount based on expenditures 
for the ACO's assigned beneficiaries, from 1 percent to one-half 
percent, and to revise the percentage specified in Sec.  
425.204(f)(4)(ii)(B), for calculating an amount based on ACO 
participant revenue, from 2 percent to 1 percent. Under this approach 
for calculating repayment mechanism amounts for ACOs in a two-sided 
model of the BASIC track or the ENHANCED track, the repayment mechanism 
amount will be equal to the lesser of the following: (1) One-half 
percent of the total per capita Medicare Parts A and B FFS expenditures 
for the ACO's assigned beneficiaries, based on expenditures for the 
most recent calendar year for which 12 months of data are available; or 
(2) 1 percent of the total Medicare Parts A and B FFS revenue of its 
ACO participants, based on revenue for the most recent calendar year 
for which 12 months of data are available.
(2) Population of Assigned Beneficiaries Used in Calculating and 
Recalculating Repayment Mechanism Amounts
    In the CY 2022 PFS proposed rule (86 FR 39283 through 39286), we 
proposed to amend the regulations at Sec. Sec.  425.204(f)(4)(ii) and 
425.204(f)(4)(iii) to specify how we identify the number of assigned 
beneficiaries used in calculating and recalculating the repayment 
mechanism amount (respectively). For context, our current approach for 
calculating repayment mechanism amounts is described at Sec.  
425.204(f)(4)(ii) (for ACOs establishing a repayment mechanism to 
support their participation under a two-sided model) and under Sec.  
425.204(f)(4)(iii) (the annual recalculation to determine if an ACO is 
required to increase the amount of its repayment mechanism).
    In accordance with Sec.  425.204(f)(4)(ii), for ACOs in a two-sided 
model of the BASIC track, or the ENHANCED track, the repayment 
mechanism amount must be equal to the lesser of the following: (1) 1 
percent of the total per capita Medicare Parts A and B FFS expenditures 
for the ACO's assigned beneficiaries, based on expenditures for the 
most recent calendar year for which 12 months of data are available 
(hereinafter referred to as an expenditure-based amount); or (2) 2 
percent of the total Medicare Parts A and B FFS revenue of its ACO 
participants, based on revenue for the most recent calendar year for 
which 12 months of data are available (hereinafter referred to as a 
revenue-based amount).
    In the CY 2022 PFS proposed rule, we explained that we use the 
following steps to calculate the expenditure-based amount specified in 
Sec.  425.204(f)(4)(ii)(A), which is a percentage of the total per 
capita Medicare Parts A and B FFS expenditures for the ACO's assigned 
beneficiaries, based on expenditures for the most recent calendar year 
for which 12 months of data are available (referred to below as the 
``relevant historical calendar year''):
     Step 1: Identify the beneficiaries that would have been 
assigned to the ACO for the relevant historical calendar year 
(determined based on the ACO participant list for the upcoming 
performance year submitted by the ACO for CMS' review during the 
application cycle or change request cycle, referred to below as the 
``ACO participant list for the upcoming performance year'') and 
multiply the number of such beneficiaries by an assignment growth 
factor to account for expected growth in assignment.
     Step 2: Determine estimated per capita FFS expenditures by 
calculating the total per capita Medicare Parts A and B FFS 
expenditures incurred during the relevant historical calendar year by 
the beneficiaries identified in step 1, and dividing that amount by the 
total number of beneficiaries identified in step 1 before the 
assignment growth factor is applied; and multiplying the resulting per 
capita FFS expenditure amount by a dollar trend factor to account for 
expected growth in Medicare FFS expenditures.

[[Page 65286]]

     Step 3: Calculate the product of the number of assigned 
beneficiaries determined according to step 1, and the estimated per 
capita FFS expenditures determined according to step 2.
     Step 4: Calculate the repayment mechanism amount by 
multiplying the amount determined in step 3 by the applicable 
percentage (1 percent under the existing regulations).
    We also explained in the proposed rule that we use the following 
steps in calculating the revenue-based amount specified in Sec.  
425.204(f)(4)(ii)(B), which is based on revenue for the most recent 
calendar year for which 12 months of data are available (referred to 
below as the ``relevant historical calendar year''):
     Step 1: Identify the beneficiaries that would have been 
assigned to the ACO for the relevant historical calendar year 
(determined based on the ACO participant list for the upcoming 
performance year) and multiply the number of such beneficiaries by an 
assignment growth factor.
     Step 2: Using the ACO participant list for the upcoming 
performance year, determine the estimated per capita FFS revenues of 
ACO participants by calculating ACO participants' total Medicare Parts 
A and B FFS revenue based on claims for services furnished to any 
beneficiary by ACO participants during the relevant historical calendar 
year, and dividing the dollar amount by the total number of assigned 
beneficiaries identified in step 1 before the assignment growth factor 
is applied; \120\ and multiplying the resulting number by a dollar 
trend factor to account for expected growth in Medicare FFS revenue.
---------------------------------------------------------------------------

    \120\ We divide the total Medicare Parts A and B FFS revenue by 
the number of assigned beneficiaries determined in step 1, as 
opposed to the number of beneficiaries that is the basis for 
determining FFS revenues in step 2, in order for the expenditure-
based and revenue-based per capita amounts to be calculated on the 
same basis.
---------------------------------------------------------------------------

     Step 3: Calculate the product of the number of assigned 
beneficiaries determined according to step 1, and the estimated per 
capita FFS revenues of ACO participants determined according to step 2.
     Step 4: Calculate the repayment mechanism amount by 
multiplying the amount determined in step 3 by the applicable 
percentage (2 percent under the existing regulations).
    Regardless of the ACO's selected assignment methodology, within 
step 1 of the expenditure-based and revenue-based repayment mechanism 
amount calculations, CMS uses an assigned beneficiary population 
identified based on preliminary prospective assignment with 
retrospective reconciliation as described in Sec.  425.400(a)(2). This 
ensures that the assignment window used to determine assigned 
beneficiaries aligns with the relevant historical calendar year used to 
calculate expenditures and revenue used in step 2 of the expenditure-
based amount and revenue-based amount calculation.
    In the proposed rule, we explained that there are several important 
reasons why we use historical data for determining the assigned 
beneficiary population, Medicare Parts A and B FFS expenditures for the 
ACO's assigned beneficiaries, and ACO participants' Medicare Parts A 
and B FFS revenue. For one, this approach ensures CMS' timely 
determination of final repayment amount estimates for ACOs required to 
establish a repayment mechanism arrangement prior to the start of a new 
agreement period under a two-sided model, or prior to start of the 
upcoming performance year under a two-sided model (for ACOs 
transitioning from a one-sided to a two-sided model along the BASIC 
track's glide path). Second, under this approach, the data used to 
determine repayment mechanism amounts is consistent with the data used 
in making other determinations during the application cycle and annual 
change request cycle, including determination of whether an ACO is 
categorized as a low revenue ACO or high revenue ACO.
    In accordance with Sec.  425.204(f)(4)(iii), for agreement periods 
beginning on or after July 1, 2019, CMS recalculates the ACO's 
repayment mechanism amount before the second and each subsequent 
performance year in the agreement period in accordance with Sec.  
425.204(f), based on the certified ACO participant list for the 
relevant performance year. We explained that in annually recalculating 
ACOs' repayment mechanism amounts we use the same methodology that 
applies when calculating the expenditure-based amount and revenue-based 
amount in accordance with Sec.  425.204(f)(4)(ii), which governs the 
initial repayment mechanism amount calculation that is performed for 
the first year of an agreement period in which an ACO is required to 
obtain a repayment mechanism. That is, in recalculating the repayment 
amount we determine the assigned beneficiary population, Medicare Parts 
A and B FFS expenditures for the ACO's assigned beneficiaries, and ACO 
participants' Medicare Parts A and B FFS revenue, for the most recent 
calendar year for which 12 months of data are available.
    In the CY 2022 PFS proposed rule, we proposed to modify the 
methodology for the annual repayment mechanism amount recalculation. 
Specifically, we proposed to determine the number of assigned 
beneficiaries that is used as a multiplier in step 3 of the 
expenditure-based amount and revenue-based amount calculations, based 
on more recently available assignment data, rather than using a 
population projected to be assigned to the ACO based on historical data 
(that is, for the most recent calendar year for which 12 months of data 
are available). In determining the number of beneficiaries used as a 
multiplier in the recalculation estimate, we proposed to determine the 
size of the ACO's assigned population based on the number of 
beneficiaries assigned to the ACO at the beginning of the performance 
year, as specified under Sec.  425.400(a)(2)(i) (for ACOs under 
preliminary prospective assignment with retrospective reconciliation) 
or paragraph (a)(3)(i) (for ACOs under prospective assignment). This 
population of assigned beneficiaries is specified in the ACO's initial 
assignment list report for the performance year. For all ACOs, this 
population is identified based on an assignment window that is offset 
from the calendar year (that is, from October 1 through September 30 
prior to the start of the performance year), and which is the basis for 
determining prospective assignment for the performance year. Under the 
proposed approach, which uses more recent assignment data in 
determining the recalculation estimate, we would not apply an 
assignment growth factor as a multiplier for the population size since 
we would no longer be using historical data to project the size of the 
ACO's assigned population. We explained our belief that this proposed 
approach would help ensure the recalculated repayment mechanism amounts 
account for an ACO's composition as reflected in the size of its 
assigned population for the performance year for which the recalculated 
amount relates, and thereby provide more accurate recalculated amounts.
    We explained in the CY 2022 PFS proposed rule that we anticipated 
performing the annual recalculation of the repayment mechanism amounts 
shortly before or shortly after the start of the new performance year. 
We stated that under the proposed approach, CMS would perform the 
recalculation of the repayment mechanism once the initial assignment 
list report is available, which is typically delivered to ACOs in the 
early winter (around mid-December), prior to the start of the relevant 
future performance year. We also noted that under the existing

[[Page 65287]]

approach and the proposed approach to determining the assigned 
population used as a multiplier in the annual recalculation of the 
repayment mechanism amounts, the effects on ACO's amounts are varied, 
resulting in relatively higher or lower amounts depending on the change 
in the size of the population.
    In annually recalculating the repayment mechanism amount under the 
proposed approach, we would follow the previously described steps for 
calculating the expenditure-based amount and revenue-based amount, 
except that the number of beneficiaries used as a multiplier in step 3 
of the calculations would be based on the population that will be 
assigned to the ACO for the next performance year, rather than the 
relevant historical calendar year. Since we are using a recently 
identified assigned population, we would not apply an assignment growth 
factor as a multiplier for the population size in step 1 (as previously 
described). In step 3 of the expenditure-based amount calculation, we 
would calculate the product of the total number of assigned 
beneficiaries specified in the ACO's initial assignment list report for 
the relevant future performance year, and the estimated per capita FFS 
expenditures determined for the relevant historical calendar year 
(determined according to step 2). In step 3 of the revenue-based amount 
calculation, we would calculate the product of the total number of 
assigned beneficiaries specified within the ACO's initial assignment 
list report for the relevant future performance year, and the estimated 
per capita FFS revenues of ACO participants determined for the relevant 
historical calendar year (determined according to step 2).
    In the CY 2022 PFS proposed rule (86 FR 39285 and 39286), we 
provided two examples to illustrate the calculation and recalculation 
of the repayment mechanism amounts after the proposals, if finalized, 
would become effective on January 1, 2022. The first example involved 
an ACO applying to enter a two-sided model for an agreement period 
beginning on January 1, 2022. For such an ACO, we stated that we would 
calculate the repayment mechanism amount during the application cycle 
which occurs during CY 2021. During this time, CY 2020 is the most 
recent calendar year for which 12 months of data are available and is 
the relevant historical calendar year for purposes of calculating the 
repayment mechanism amount. In this example, the proposed approach to 
identifying the assigned beneficiary population, Medicare Parts A and B 
FFS expenditures for the ACO's assigned beneficiaries, and ACO 
participants' Medicare Parts A and B FFS revenue used within these 
calculations would be consistent with our current operational approach. 
This first example provides greater specificity about the repayment 
mechanism amount calculations than is outlined in the existing 
regulations at Sec.  425.204(f)(4)(ii), including a description of how 
CMS identifies the number of beneficiaries used as a multiplier in 
these calculations.
    In step 1 of the expenditure-based amount and revenue-based amount 
calculations, we would identify the beneficiaries that would have been 
assigned to the ACO for CY 2020, determined based on the ACO 
participant list for performance year 2022 submitted with the ACO's 
application, and determined using preliminary prospective assignment 
with retrospective reconciliation. That is, we would determine 
assignment based on the 12-month assignment window from January 1, 
2020, through December 31, 2020.\121\ We would multiply the number of 
such beneficiaries by an assignment growth factor.
---------------------------------------------------------------------------

    \121\ Refer to the Medicare Shared Savings Program, Shared 
Savings and Losses and Assignment Methodology Specifications 
(version #9, February 2021), available at https://www.cms.gov/files/document/medicare-shared-savings-program-shared-savings-and-losses-and-assignment-methodology-specifications.pdf-0.
---------------------------------------------------------------------------

    In step 2 of the expenditure-based amount calculation, we would 
calculate total Medicare Parts A and B FFS expenditures incurred in CY 
2020 by the beneficiaries determined under step 1 to be assigned to the 
ACO for CY 2020. In step 2 of the revenue-based amount calculation, we 
would calculate ACO participants' total Medicare Parts A and B FFS 
revenue, based on claims for services furnished to any beneficiary by 
ACO participants during CY 2020. We would determine the estimated per 
capita FFS expenditures, and the estimated per capita FFS revenues of 
ACO participants, by dividing the CY 2020 dollar amounts by the number 
of assigned beneficiaries for CY 2020 (determined in accordance with 
step 1) before the assignment growth factor is applied. We would 
multiply the resulting numbers by a dollar trend factor.
    In step 3 of the expenditure-based amount calculation, the number 
of assigned beneficiaries for CY 2020 determined under step 1 would be 
multiplied by the estimated per capita FFS expenditures determined for 
CY 2020 in accordance with step 2. In step 3 of the revenue-based 
amount calculation, the number of assigned beneficiaries for CY 2020 
determined under step 1 would be multiplied by the estimated per capita 
Medicare FFS revenues of ACO participants determined for CY 2020 in 
accordance with step 2.
    In step 4, we would calculate the repayment mechanism amount by 
multiplying the amount determined in step 3 by the applicable 
percentage. Under the existing regulation, the applicable percentage is 
1 percent under the expenditure-based amount calculation, and 2 percent 
under the revenue-based amount calculation. As described in section 
III.J.3.b.(1) of this final rule, under the policies we are finalizing, 
the applicable percentages will be one-half percent under the 
expenditure-based amount calculation, and 1 percent under the revenue-
based amount calculation.
    Our second example illustrated how we would perform the annual 
recalculation of the repayment mechanism amount for performance year 
2022 under the proposed policy.
    In step 1 of both the expenditure-based amount and revenue-based 
amount calculations, we use a similar method for identifying the CY 
2020 assigned population as described in the first example. That is, we 
would identify the beneficiaries that would have been assigned to the 
ACO for CY 2020, determined based on the ACO's certified ACO 
participant list for performance year 2022, and determined using 
preliminary prospective assignment with retrospective reconciliation. 
Again, we would determine assignment based on the 12-month assignment 
window from January 1, 2020, through December 31, 2020. Unlike in our 
first example, we would not multiply the number of such beneficiaries 
by an assignment growth factor.
    In step 2 of the expenditure-based amount calculation, we would 
calculate total Medicare Parts A and B FFS expenditures incurred in CY 
2020 by the beneficiaries CMS determined under step 1 would have been 
assigned to the ACO for CY 2020. In step 2 of the revenue-based amount 
calculation, we would calculate ACO participants' total Medicare Parts 
A and B FFS revenue, based on claims for services furnished to any 
beneficiary by ACO participants during CY 2020, using the ACO's 
certified ACO participant list for performance year 2022. We would 
determine the estimated per capita FFS expenditures, and the estimated 
per capita FFS revenues of ACO participants, by dividing the CY 2020

[[Page 65288]]

dollar amounts by the number of assigned beneficiaries for CY 2020 
(determined in accordance with step 1, which does not apply an 
assignment growth factor). We would then multiply the resulting number 
by a dollar trend factor.
    In step 3, we would not use the number of assigned beneficiaries as 
determined under step 1. Rather, we would identify the total number of 
assigned beneficiaries specified in the ACO's initial assignment list 
report for performance year 2022. This population of assigned 
beneficiaries would be the population identified based on the 
assignment window from October 1, 2020 through September 30, 2021,\122\ 
and which would be the basis for determining prospective assignment for 
performance year 2022. Assignment would be determined based on the 
ACO's certified ACO participant list for performance year 2022. In step 
3 of the expenditure-based amount calculation, the number of assigned 
beneficiaries for performance year 2022 would be multiplied by the 
estimated per capita FFS expenditures determined for CY 2020 in 
accordance with step 2. In step 3 of the revenue-based amount 
calculation, the number of assigned beneficiaries for performance year 
2022 would be multiplied by the estimated per capita FFS revenues 
determined for CY 2020 in accordance with step 2.
---------------------------------------------------------------------------

    \122\ We note there was an inadvertent error in the prospective 
assignment window described in the CY 2022 PFS proposed rule (86 FR 
39286), which we are correcting within this final rule, for clarity.
---------------------------------------------------------------------------

    In step 4, we would recalculate the repayment mechanism amount by 
multiplying the amount determined in step 3 by the applicable 
percentage. Under the policies we are finalizing in this rule, the 
applicable percentages will be one-half percent under the expenditure-
based amount calculation, and 1 percent under the revenue-based amount 
calculation.
    We proposed to modify Sec.  425.204(f)(4)(ii) to more clearly 
specify the assigned population used as a multiplier in calculating the 
repayment mechanism amount. Under the existing regulation text at Sec.  
425.204(f)(4)(ii)(A), the potential repayment mechanism amount is a 
specified percentage of total per capita Medicare Parts A and B FFS 
expenditures ``for the ACO's assigned beneficiaries, based on 
expenditures for the most recent calendar year for which 12 months of 
data are available.'' We proposed to amend paragraph (f)(4)(ii)(A) to 
refer to a specified percentage of total per capita Medicare Parts A 
and B FFS expenditures ``for the ACO's assigned beneficiaries, based on 
expenditures and the number of assigned beneficiaries for the most 
recent calendar year for which 12 months of data are available'' 
(emphasis added to reflect revised text).
    Under the existing regulation text at Sec.  425.204(f)(4)(ii)(B), 
the potential repayment mechanism amount is a specified percentage of 
total Medicare Parts A and B FFS revenue ``of its ACO participants, 
based on revenue for the most recent calendar year for which 12 months 
of data are available.'' We proposed to amend paragraph (f)(4)(ii)(B) 
to refer to a specified percentage of total Medicare Parts A and B FFS 
revenue ``of its ACO participants, based on revenue for the most recent 
calendar year for which 12 months of data are available, and based on 
the ACO's number of assigned beneficiaries for the most recent calendar 
year for which 12 months of data are available'' (emphasis added to 
reflect revised text).
    We also proposed technical and conforming changes to the 
introductory text of Sec.  425.204(f)(4)(iii). We propose to remove as 
unnecessary and irrelevant the text specifying that the provision 
applies for agreement periods beginning on or after July 1, 2019. We 
proposed to revise the introductory text for clarity to specify that 
CMS will recalculate the ACO's repayment mechanism amount ``for'' the 
second and each subsequent performance year in the agreement period, 
rather than ``before'' the second and each subsequent performance year 
in the agreement period. We proposed to make a conforming change to the 
introductory text of Sec.  425.204(f)(4)(iii) to specify that CMS' 
recalculation of the ACO's repayment mechanism amount would be in 
accordance with Sec.  425.204(f)(4)(ii) based on the certified ACO 
participant list for the relevant performance year, ``except that the 
number of assigned beneficiaries used in the calculations would be the 
number of beneficiaries assigned to the ACO at the beginning of the 
relevant performance year under Sec.  425.400(a)(2)(i) (for ACOs under 
preliminary prospective assignment with retrospective reconciliation) 
or Sec.  425.400(a)(3)(i) (for ACOs under prospective assignment).''
    We proposed that these modifications would be effective and 
applicable on January 1, 2022. We explained that if finalized as 
proposed, these policies would be used in the following manner: (1) In 
determining required repayment mechanism amounts for ACOs establishing 
a repayment mechanism arrangement to support their participation in a 
two-sided model beginning with performance year 2022, and in subsequent 
performance years; (2) in making annual repayment mechanism amount 
recalculations for performance year 2022 and subsequent performance 
years; and (3) determining whether an eligible ACO has a one-time 
opportunity to decrease the amount of its repayment mechanism amount as 
described in section III.J.3.b.(3) of the CY 2022 PFS proposed rule 
(refer to section III.J.3.b.(3) of this final rule).
    We received public comments on the proposals on the population of 
assigned beneficiaries used in calculating and recalculating repayment 
mechanism amounts. The following is a summary of the comments we 
received and our responses.
    Comment: Commenters generally expressed support for CMS' proposals 
for how to identify the number of assigned beneficiaries used in the 
repayment mechanism amount calculation and in the annual repayment 
mechanism amount recalculation.
    Response: We appreciate the commenters' support for our proposals.
    After consideration of public comments, we are finalizing as 
proposed to amend the regulations at Sec. Sec.  425.204(f)(4)(ii) and 
(iii) to specify how we identify the number of assigned beneficiaries 
used in calculating and recalculating the repayment mechanism amount 
(respectively). Further, we received no public comments on our proposed 
technical and conforming changes to the introductory text of Sec.  
425.204(f)(4)(iii), and therefore, are finalizing these changes as 
proposed. We refer readers to the detailed descriptions of these 
proposals as restated in this section of this final rule.
(3) Optional One-Time Repayment Mechanism Decrease for Eligible ACOs
    As described in the CY 2022 PFS proposed rule (86 FR 39286 and 
39287), we proposed to allow certain ACOs a one-time opportunity to 
decrease the amount of their repayment mechanisms. This proposed 
optional one-time repayment mechanism decrease was in connection with 
the proposal for lowering the repayment mechanism amounts specified in 
the CY 2022 PFS proposed rule (86 FR 39280 through 39283) and in 
section III.J.3.b.(1) of this final rule. We explained that the purpose 
of this proposal is to let any ACO that established a repayment 
mechanism to support its participation in a two-sided model beginning 
on July 1, 2019, January 1, 2020, or January 1, 2021, to decrease its 
repayment mechanism amount before it seeks to renew its agreement under 
the new proposed policy, which if finalized, would otherwise be the 
first opportunity for the ACO to reduce its repayment

[[Page 65289]]

mechanism amount. Along these lines, the one-time decrease would also 
avoid unnecessary burden that could result if ACOs seek to terminate 
their participation agreements early and apply to re-enter the program 
in order to reduce their required repayment mechanism amounts.
    We explained that if the proposed repayment mechanism amount 
policies are finalized and become effective and applicable on January 
1, 2022, we would use the revised methodology for calculating repayment 
mechanism amounts (specified in the CY 2022 PFS proposed rule, 86 FR 
39280 through 39283, and in section III.J.3.b.(1) of this final rule) 
to determine repayment mechanism amounts for ACOs establishing a 
repayment mechanism to support their participation in a two-sided model 
beginning with performance year 2022. Therefore, ACOs entering a two-
sided model for an agreement period beginning on January 1, 2022, and 
ACOs with an earlier start date participating in the BASIC track's 
glide path and entering a two-sided model starting on January 1, 2022, 
would have repayment mechanism amounts determined according to the 
proposed amount calculation methodology, if finalized. Therefore, such 
ACOs would not need or be eligible for the proposed one-time 
opportunity to decrease the amount of their repayment mechanism.
    Under this proposal, an eligible ACO that established a repayment 
mechanism to support its participation in a two-sided model beginning 
on July 1, 2019, January 1, 2020, or January 1, 2021, may elect to 
decrease the amount of its repayment mechanism if the recalculated 
repayment mechanism amount for performance year 2022 is less than the 
existing repayment mechanism amount. To determine if an ACO is eligible 
to lower its repayment mechanism amount, we proposed to compare the 
ACO's existing repayment mechanism amount with the recalculated amount 
of the ACO's repayment mechanism based on its certified ACO participant 
list for performance year 2022, calculated in accordance with Sec.  
425.204(f)(4)(iii) (including any modifications finalized with CY 2022 
PFS rulemaking to the recalculation methodology which would be 
effective and applicable January 1, 2022). If the recalculated 
repayment mechanism amount for performance year 2022 is less than the 
existing repayment mechanism amount, the ACO would be eligible to 
decrease the amount of its repayment mechanism to the recalculated 
amount. Under this approach, we would permit a one-time decrease in the 
repayment mechanism amount even for relatively small differences in 
dollar amounts.
    We proposed that CMS would notify the ACO in writing that the ACO 
may elect to decrease the amount of its repayment mechanism. We 
explained that if the proposal became final, we anticipated that we 
would notify an ACO of its opportunity to reduce its repayment 
mechanism amount after the start of performance year 2022. We also 
proposed that an ACO must submit such election, and revised repayment 
mechanism documentation, in a form and manner and by a deadline 
specified by CMS. We expected that the deadline for submitting the 
election and revised repayment documentation would be 30 days from the 
date of the written notice from CMS, although we recognized that there 
may be circumstances that necessitate a longer timeframe. CMS would 
review the revised repayment mechanism documentation and may reject the 
election if the repayment mechanism documentation does not comply with 
the requirements of Sec.  425.204(f).
    We proposed to amend Sec.  425.204 to add paragraph (f)(4)(v) to 
establish the policy and relevant procedure that would allow eligible 
ACOs that established a repayment mechanism to support their 
participation in a two-sided model beginning on July 1, 2019, January 
1, 2020, or January 1, 2021, to elect to lower the amount of their 
repayment mechanism arrangements.
    We received public comments on the proposed optional one-time 
repayment mechanism decrease for eligible ACOs. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters expressed support for the proposed approach 
that provides a one-time opportunity for eligible ACOs that established 
a repayment mechanism to support their participation in a two-sided 
model beginning on July 1, 2019, January 1, 2020, or January 1, 2021, 
to elect to decrease the amount of their existing repayment mechanisms 
if their recalculated amount for performance year 2022 is less than 
their existing repayment mechanism amount. Some commenters explained 
their belief that it would be fair to permit such ACOs to decrease the 
amount of their repayment mechanisms.
    Response: We appreciate the commenters' support for the proposal. 
As described in section III.J.3.b.(1) of this final rule, we are 
finalizing our proposal to reduce by one-half the percentages used in 
the methodology for calculating repayment mechanism amounts for ACOs. 
We continue to believe the proposed one-time decrease opportunity could 
avoid unnecessary burden on ACOs from having to maintain their existing 
repayment mechanism at a potentially higher amount until they seek to 
renew their agreement, or in the event they would seek to terminate 
their participation agreements early and apply to re-enter the program 
in order to reduce their required repayment mechanism amounts.
    Comment: One commenter urged that CMS promptly allow reimbursement 
for any ACOs that have overpaid escrow once this proposal is made 
final.
    Response: As we interpret the comment, we believe the commenter is 
concerned about the procedure by which an ACO would obtain the excess 
funds held in its escrow account. If an ACO with an existing repayment 
mechanism in the form of escrow account is permitted to decrease the 
amount of its repayment mechanism, and if the ACO elects to so decrease 
the amount of funds in its escrow account, CMS will instruct the escrow 
agent to disburse to the ACO any funds above the new minimum required 
amount. These returned funds would include accrued interest.
    After consideration of public comments, we are finalizing as 
proposed to amend Sec.  425.204 to add paragraph (f)(4)(v)(A) to 
establish the policy that would allow eligible ACOs that established a 
repayment mechanism to support their participation in a two-sided model 
beginning on July 1, 2019, January 1, 2020, or January 1, 2021, to 
elect to lower the amount of their repayment mechanism arrangements. We 
received no public comments on the proposed procedures for eligible 
ACOs to make such election to decrease the amount of their repayment 
mechanism. Therefore, we are finalizing as proposed to amend Sec.  
425.204 to add paragraph (f)(4)(v)(B) specifying that CMS will notify 
the ACO in writing if the ACO may elect to decrease the amount of its 
repayment mechanism. We are also finalizing as proposed the policy that 
the ACO must submit such election, and revised repayment mechanism 
documentation, in a form and manner and by a deadline specified by CMS. 
We will review the revised repayment mechanism documentation and may 
reject the election if the repayment mechanism documentation does not 
comply with the requirements of Sec.  425.204(f).

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(4) Threshold for Increasing Repayment Mechanism Amounts
    In accordance with Sec.  425.204(f)(4)(iii), for agreement periods 
beginning on or after July 1, 2019, CMS recalculates the ACO's 
repayment mechanism amount before the second and each subsequent 
performance year in the agreement period based on the certified ACO 
participant list for the relevant performance year. If the recalculated 
repayment mechanism amount exceeds the existing repayment mechanism 
amount by at least 50 percent or $1,000,000, whichever is the lesser 
value, CMS notifies the ACO in writing that the amount of its repayment 
mechanism must be increased to the recalculated repayment mechanism 
amount. Within 90 days after receipt of such written notice from CMS, 
the ACO must submit for CMS approval documentation that the amount of 
its repayment mechanism has been increased to the amount specified by 
CMS.
    In establishing the annual repayment mechanism amount recalculation 
policy in earlier rulemaking (83 FR 67930), we explained the purpose of 
this approach was to address changes in the ACO's composition of ACO 
participant TINs and the individuals who bill through the participant 
TINs over the course of an agreement period and to ensure the adequacy 
of an ACO's repayment mechanism. In establishing the annual 
recalculation policy (83 FR 67932), we explained that a threshold of 50 
percent or $1,000,000 would likely require an increased repayment 
mechanism amount only for ACOs that had the largest changes in their 
estimated repayment mechanism value (the top 5 to 10 percent of ACOs). 
We believed this approach would minimize an ACO's administrative burden 
and financial institution fees while adjusting for meaningful changes 
in repayment mechanism amounts that would help protect the Medicare 
Trust Funds.
    As described in the CY 2022 PFS proposed rule (86 FR 39287), we 
continue to believe that the annual repayment mechanism amount 
recalculation serves an important function in identifying the need for 
repayment mechanism increases when an ACO's composition changes. Such 
changes could result in higher expenditures for the ACO's assigned 
beneficiaries, higher ACO participant revenue, or a larger assigned 
beneficiary population. Each of these changes could increase the amount 
of potential shared losses for an ACO under a two-sided model.
    We stated in the proposed rule that, based on our operational 
experience with the recalculation policy, we have found that ACOs whose 
recalculated repayment mechanism amount is at least 50 percent higher 
than their existing amount, but less than $1,000,000 more, tend to be 
low revenue ACOs with relatively smaller existing repayment mechanism 
amounts, typically less than $300,000. We recognized that it is 
burdensome for ACOs to modify repayment mechanism arrangements to 
revise the amount of the repayment mechanism. These modifications are 
time consuming to arrange, and can result in additional fees charged by 
financial institutions for ACOs to modify their arrangements, in 
addition to requiring ACOs to set aside additional funds (such as with 
escrow accounts). We explained our belief that the burden for these 
ACOs to increase their repayment mechanism amounts is disproportional 
to the benefit CMS receives by having access to additional repayment 
mechanism arrangement funds to support repayment of losses.
    In light of our proposal to reduce repayment mechanism amounts, we 
revisited the thresholds that would require an increase in an ACO's 
repayment mechanism amount upon annual recalculation in accordance with 
Sec.  425.204(f)(4)(iii). We were concerned that if we finalized our 
proposal to reduce repayment mechanism amounts, applying the existing 
50 percent threshold to a lower repayment mechanism amount would be 
more burdensome for ACOs because they would be required to amend their 
repayment mechanisms to reflect relatively smaller increases in their 
repayment mechanism amounts, which would be even more disproportional 
to the benefit received by CMS.
    In the CY 2022 PFS proposed rule (86 FR 39287), we explained our 
belief that requiring an increase in the repayment mechanism amount if 
the recalculated amount for the performance year is at least $1,000,000 
greater than the existing amount balances our interest in ensuring the 
repayment mechanism amount accounts for significant changes in an ACO's 
composition during its agreement period, while avoiding burdensome 
repayment mechanism modifications for relatively small dollar amounts. 
Therefore, we proposed to amend the regulations at Sec.  
425.204(f)(4)(iii)(A) to remove the 50 percent threshold from the 
annual repayment mechanism increase threshold, such that if the 
recalculated repayment mechanism amount exceeds the existing repayment 
mechanism amount by at least $1,000,000, we will notify the ACO in 
writing that the amount of its repayment mechanism must be increased to 
the recalculated repayment mechanism amount. We anticipated this 
approach would reduce the number of ACOs required to annually increase 
their repayment mechanism amounts and would further simplify the 
repayment mechanism amount calculations.
    As specified in the CY 2022 PFS proposed rule (86 FR 39288), we 
proposed that this modification would be effective and applicable on 
January 1, 2022. We explained that the revised threshold (if finalized) 
would be used in determining required repayment mechanism increases for 
performance year 2022, and subsequent performance years.
    We received public comments on the proposed revision to the 
threshold for determining whether an increase in the repayment 
mechanism amount is required during the ACO's agreement period. The 
following is a summary of the comments we received and our responses.
    Comment: Commenters generally expressed support for CMS' proposal 
to modify the threshold for increasing an ACO's repayment mechanism 
amount during its agreement period by removing the 50 percent 
threshold, and instead require ACOs to increase their repayment 
mechanism amount if the recalculated amount is at least $1,000,000 
greater than the existing amount.
    Some commenters indicated that this approach would minimize 
administrative burdens for ACOs, such as by reducing administrative 
complexity, and minimize the financial costs for ACOs of participating 
in the Shared Savings Program. Several commenters explained that this 
proposed approach would allow ACOs to focus their limited time and 
resources on care coordination interventions as opposed to unnecessary 
administrative requirements.
    Response: We agree with commenters that this approach could reduce 
administrative burden and financial costs on ACOs.
    After consideration of public comments, we are finalizing our 
proposal to amend the regulations at Sec.  425.204(f)(4)(iii)(A) to 
remove the 50 percent threshold from the annual repayment mechanism 
increase threshold, such that if the recalculated repayment mechanism 
amount exceeds the existing repayment mechanism amount by at least 
$1,000,000, we will notify the ACO in writing that the amount of its 
repayment mechanism

[[Page 65291]]

must be increased to the recalculated repayment mechanism amount.
4. Reducing Shared Savings Program Application Burden
a. Background
    To participate in the Shared Savings Program, a prospective ACO 
must submit an application and certify that it satisfies all the 
eligibility and other requirements of the Shared Savings Program, 
including regulatory requirements to disclose prior participation. 
Under Sec.  425.204(b), an ACO must disclose in its Shared Savings 
Program application whether the ACO, its ACO participants, or its ACO 
providers/suppliers have participated in the Shared Savings Program 
under the same or a different name or is related to or affiliated with 
another Shared Savings Program ACO, and if the related participation 
agreement was terminated voluntarily or involuntarily.
    The application evaluation criteria for renewing and re-entering 
ACOs are designed to prevent an ACO with a history of poor performance 
or noncompliance with the Shared Savings Program regulations from 
participating in the program. Under Sec.  425.224(b), we determine 
whether to approve an application based on an evaluation of several 
criteria, including the following: (1) Whether the ACO has a history of 
noncompliance with the program's requirements, including a failure to 
meet the quality performance standard; (2) the ACO's history of 
financial performance; (3) whether an ACO under a two-sided model 
failed to repay shared losses owed to the program; and (4) whether the 
ACO has demonstrated in its application that it has corrected the 
deficiencies that caused it to perform poorly or to be terminated in a 
prior application cycle.
    Additionally, under Sec.  425.204(c)(6), all applicants, including 
initial, renewing, and re-entering applicants, must submit as part of 
the application process and upon request by CMS, documents 
demonstrating that their ACO participants, ACO providers/suppliers, and 
other individuals or entities performing functions or services related 
to ACO activities are required to comply with the requirements of the 
Shared Savings Program. Currently, such documents must include a sample 
or form agreement and the first and signature pages of each executed 
ACO participant agreement. In some instances, we may request all pages 
of an executed ACO participant agreement to confirm that it conforms to 
the sample form agreement submitted by the ACO. The ACO is also 
required to certify that each of its ACO participant agreements meet 
all Shared Savings Program requirements in 42 CFR part 425. 
Additionally, under Sec.  425.116(c), we require an ACO to submit an 
executed ACO participant agreement for each ACO participant at the time 
of its initial application, participation agreement renewal process, 
and when making additions to its list of ACO participants in accordance 
with Sec.  425.118. The agreements may be submitted in the form and 
manner specified under Sec.  425.204(c)(6) or as otherwise specified by 
CMS.
    In conducting Shared Savings Program application reviews, we have 
found that the document submission requirements in Sec. Sec.  
425.204(b) and (c)(6), and 425.116(c) substantially increase applicant 
burden without lending significant value to our review of an 
organization's application to confirm that the ACO meets all the 
eligibility requirements for participation. As described in the CY 2022 
PFS proposed rule, we proposed specific policy refinements aimed at 
reducing administrative burden during the application process.
b. Revisions
    In the CY 2022 PFS proposed rule, we proposed to modify Sec.  
425.204(b) so that the prior participation disclosure requirement is 
prescribed only at the request of CMS during the application process--
rather than as a mandatory submission with the ACO's initial or renewal 
application. We stated that, in accordance with Sec.  425.224(b), we 
will continue to review an ACO's history of compliance with Shared 
Savings Program regulations, and quality and financial performance 
results and, when appropriate, request additional information from an 
ACO regarding prior participation.
    We also proposed to modify Sec.  425.204(c)(6) to remove provisions 
requiring an ACO to submit sample ACO participant agreements during the 
application process. Under this proposal, sample ACO participant 
agreements and the first and signature pages of each executed ACO 
participant agreement would need to be submitted during the application 
process only if requested by CMS, rather than as a mandatory submission 
with the ACO's initial or renewal application. The ACO must continue to 
certify that all ACO participant agreements comply with the regulatory 
requirements of the Shared Savings Program, and CMS retains the 
discretion to request ACO participant agreement documentation at any 
time during an agreement period.
    In addition, we proposed to modify Sec.  425.116(c) to remove 
provisions requiring an ACO to submit an executed ACO participant 
agreement for each ACO participant at the time of its initial 
application or participation agreement renewal process. We stated that 
we would retain the requirement that an ACO must submit an executed ACO 
participant agreement for new ACO participants that it requests to add 
to its list of ACO participants.
    We stated in the proposed rule that we believe these three 
proposals will collectively reduce the administrative and programmatic 
burden for ACOs significantly, and without sacrificing program 
integrity. We reinforced that ACOs are responsible for ensuring that 
their ACO participant agreements meet Shared Savings Program 
requirements.
    We received several comments on our proposals aimed at reducing 
burden during the Shared Savings Program application process. 
Commenters were generally supportive of CMS' efforts to reduce 
administrative burden for ACOs during the application process noting 
that the proposed changes would continue to ensure program integrity, 
greatly reduce administrative burden and control programmatic costs, 
and increase participation among ACOs. We describe the proposals and 
respond to comments below.
(1) Prior Participation Requirement (Sec.  425.204(b))
    In the CY 2022 PFS proposed rule, we proposed to modify Sec.  
425.204(b) so that the prior participation disclosure requirement is 
prescribed only at the request of CMS, rather than as a mandatory 
submission with the ACO's initial or renewal application. During the 
application cycle and for the purposes of evaluating program 
eligibility, we already determine prior participation for initial and 
re-entering ACO applicants by reviewing ACO and ACO participant-level 
information. We screen all ACO applicants, initial ACOs and re-entering 
ACOs, to determine if they have participated in the Shared Savings 
Program, including if their prior participation agreement was 
terminated early (voluntarily or involuntarily). We also identify 
initial ACOs as re-entering ACOs if greater than 50 percent of their 
ACO participants were included on the ACO participant list, under Sec.  
425.118, of the same ACO in any of the 5 most recent performance years 
prior to the agreement start date (Sec.  425.20), in order to hold 
these ACOs accountable for their ACO participants' experience with the 
program.
    Additionally, all ACO participants and ACO providers/suppliers 
undergo a

[[Page 65292]]

rigorous screening process during the application cycle (and throughout 
the agreement period, if approved to participate in the program) to 
ensure they meet certain program requirements. CMS' screening processes 
are protective of the program and provide CMS with eligibility 
information about individual ACO participants including: Medicare-
enrollment status (Sec.  425.20); program integrity history (Sec.  
425.305(a)); any participation in other Medicare shared savings 
initiatives (Sec.  425.114); and participation in other Shared Savings 
Program ACOs, including whether the ACO participant submitted claims 
used in beneficiary assignment (Sec.  425.306). These robust 
application screening processes for ACO participants and ACO providers/
suppliers provide necessary information about ACOs and individual ACO 
participants.
    We proposed to revise Sec.  425.204(b) to provide that, upon 
request by CMS during the application cycle, the ACO must submit 
information regarding prior participation in the Shared Savings Program 
by the ACO, its ACO participants, or its ACO providers/suppliers, 
including such information as may be necessary for CMS to determine 
whether to approve an ACO's application in accordance with Sec.  
425.224(b). As described in the CY 2022 PFS proposed rule (86 FR 
39289), to ensure future compliance we may request additional 
information from an ACO concerning its prior participation or the prior 
participation of their ACO participants or its ACO providers/suppliers. 
In that case, we would require the ACO to include in its response 
assurances describing how they will remain in compliance with program 
requirements--particularly as to the quality performance standard and 
financial performance--while completing the full term of the 
participation agreement. In conjunction with the robust evaluation 
criteria of Sec.  425.224(b) for renewing and re-entering ACOs, and the 
application screening processes for ACO participants and providers/
suppliers, we believe CMS can effectively evaluate an ACO's prior 
participation and determine its suitability to participate in the 
program without requiring ACOs to self-identify prior participation 
under Sec.  425.204(b), including the cause of termination (if any), 
and what safeguards have been put into place.
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters unanimously supported the proposed change to 
the Shared Savings Program application process to eliminate the 
requirement for an ACO to inform CMS about past participation, but to 
make this information available upon CMS request, and confirmed CMS' 
belief that this refinement would reduce program burden during the 
application cycle without sacrificing program integrity.
    Response: We appreciate the commenters for their support of this 
proposal.
    After consideration of the public comments, we are finalizing 
without modification the proposed change to Sec.  425.204(b) so that 
the prior participation disclosure requirement is prescribed only at 
the request of CMS, rather than as a mandatory submission with the 
ACO's initial or renewal application.
(2) Submission of Sample Agreements (Sec.  425.204(c)(6))
    In the CY 2022 PFS proposed rule, we proposed to revise Sec.  
425.204(c)(6) to require an ACO to submit sample or form ACO 
participant agreement documents during the application cycle only upon 
request by CMS. As stated in the proposed rule, we review sample 
agreements to ensure they contain the language required under Sec.  
425.116. However, it is ultimately the ACO's responsibility to ensure 
that all of its ACO participant agreements comply with the Shared 
Savings Program requirements. We also noted our concerns that CMS 
review of sample participant agreements gave the incorrect impression 
that CMS had determined that an agreement met all regulatory 
requirements.
    We explained our belief that removing the requirement at Sec.  
425.204(c)(6) to submit sample agreements reduces administrative burden 
on both ACOs and CMS in the submission and reviewing of sample 
agreements. Under our proposal, we retained the ability to request ACO 
sample participant agreements during the application cycle and at any 
point during an agreement period. We also noted that we do not expect 
to routinely make such requests during the application cycle, but that 
such requests could be particularly useful in cases where an ACO has a 
history of noncompliance with Sec.  425.116 or other program 
requirements.
    Under our proposal, we retained the requirement in Sec.  
425.204(c)(6) that the ACO must certify that each of its ACO 
participant agreements comply with the requirements of the Shared 
Savings Program. We explained that we believe this modification to 
Sec.  425.204(c)(6) more clearly prescribes that the ACO is ultimately 
responsible for compliance with all program requirements.
    The following is a summary of the comments we received and our 
responses.
    Comment: The majority of commenters supported CMS' proposal to 
reduce the frequency and circumstances under which ACOs must submit 
sample ACO participant agreements to CMS and noted that this policy 
refinement reduces administrative burden during the application 
process.
    Response: We appreciate the commenters' support.
    Comment: Several commenters suggested alternative proposals to 
those outlined in the proposed rule. One commenter noted that the 
proposed changes would place a tremendous burden on ACOs, and 
therefore, opposed the policy change, recommending that CMS continue 
with compliance checks through the application process and submission 
of signed participant agreements. One commenter suggested permitting 
ACOs to request a CMS review of their sample ACO participant agreements 
prior to the ACO participant list change request review cycle. This 
commenter noted that an ACO-requested review and subsequent CMS 
approval of the sample agreement would mitigate ACO concerns that an 
agreement could be deemed noncompliant after submission of any executed 
agreements. Another commenter requested CMS to provide tools to help 
ACOs create agreements that comply with Shared Savings Program 
requirements.
    Response: We thank the commenters and understand ACOs' concern for 
ensuring program compliance with respect to ACO participant agreements. 
However, we continue to believe that the proposed policy will uphold 
program integrity while easing administrative burden. We acknowledge 
that submission of documentation will impose some administrative burden 
for those ACOs that receive such a request. But because ACOs will no 
longer be required to submit the documentation routinely, the overall 
administrative burden to ACOs is reduced. Each year CMS will continue 
to oversee the application processes and when warranted, request 
appropriate documentation from an ACO to determine compliance with 
Shared Savings program requirements.
    When CMS chooses to request sample ACO participant agreements, we 
will review them for compliance with Sec.  425.116, but we reiterate 
that each ACO is responsible for ensuring that all of their ACO 
participant agreements are compliant with Sec.  425.116 and all other 
applicable laws and regulations. Any

[[Page 65293]]

CMS review of ACO participant agreements is limited only to determining 
compliance with one or more specific Shared Savings Program 
requirements and does not preclude CMS, HHS, or any other Federal or 
State agency from enforcing any applicable laws and regulations.
    CMS is not a party to ACO participant agreements, which may include 
other terms and conditions beyond those that are required in the 
regulation. Additionally, based on our 9 years of program experience, 
we have found it is no longer necessary to go through this extensive 
sample agreement review process. We have utilized our experience to 
develop guidance for ACOs intended to assist with crafting their ACO 
participant agreements in compliance with our regulations. 
Specifically, before, during, and after the Shared Savings Program 
application cycle and/or performance year, CMS makes guidance documents 
(at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/program-guidance-and-specifications) and technical 
assistance resources available to ACOs (through assigned ACO 
Coordinators and the Shared Savings Program Helpdesk for email 
inquiries) requesting help with any questions and/or concerns that 
allow ACOs to receive timely responses to their questions.
    After considering the public comments, we are finalizing without 
modification the proposed revision to Sec.  425.204(c)(6) to require an 
ACO to submit sample or form ACO participant agreement documents during 
the application cycle only upon request by CMS.
(3) Submission of Executed Participant Agreements (Sec.  425.116(c))
    We proposed to modify Sec.  425.116(c) to remove language requiring 
an ACO to submit an executed ACO participant agreement for each ACO 
participant at the time of its initial application and during the 
participation agreement renewal process. We explained that the 
submission of agreements at the time of initial application is governed 
by Sec.  425.204(c)(6) and does not need to be addressed in Sec.  
425.116(c). We further explained that, unless there have been 
amendments to an ACO participant agreement, we would not need to 
collect for a second time executed ACO participant agreements with ACO 
participants who are actively participating in an ACO at the time it is 
applying to renew its participation agreement with the program.
    We proposed to retain the remainder of Sec.  425.116(c), which 
requires an ACO to submit ACO participant agreements when requesting 
additions to their ACO participant list in accordance with Sec.  
425.118 and specifies that the agreements may be submitted in the form 
and manner specified under Sec.  425.204(c)(6). We noted that although 
ACOs may request additions to an ACO participant list at specified 
times during a performance year, all approved ACO participant list 
additions become effective on January 1 of the following performance 
year (Sec.  425.118(b)(1)(ii)). We stated that we continue to find 
value in reviewing executed ACO participant agreements in these 
circumstances. ACO participant additions may take the form of an 
initial applicant or renewing ACO submitting proposed ACO participants 
(that may or may not have participated with another ACO), or a 
currently participating ACO adding proposed participants (that may or 
may not be participating with another ACO) to their ACO participant 
list. Collecting executed agreements (which may include collecting only 
the first and signature page(s) under Sec.  425.204(c)(6)) for 
additions to an ACO's participant list provides CMS with evidence that 
the ACO and the participant are each aware of the agreement and are 
participating together in the Shared Savings Program. If CMS needs to 
review executed participant agreements other than when ACOs are adding 
to their list of ACO participants, CMS can request them at that time 
under Sec.  425.204(c)(6) or under its audit authority in accordance 
with Sec.  425.314.
    The following is a summary of the comments we received and our 
responses.
    Comment: All commenters supported CMS' proposal to reduce the 
frequency with which ACOs must submit executed ACO participant 
agreements to CMS. One commenter noted that this proposed modification 
was appreciated because the work involved is time consuming and 
duplicative. Another commenter contended that re-executing agreements 
for all existing ACO participants at the time of a renewal application 
is particularly difficult for large ACOs and appreciated the proposed 
policy change.
    Response: We appreciate the commenters' support for this proposal 
and wish to clarify that renewal or early renewal applicants entering 
into a new Shared Savings Program agreement period are not required to 
submit a newly executed ACO participant agreement for any ACO 
participant with which the ACO already has an ACO participant agreement 
if that ACO participant will continue to participate in the ACO during 
the new agreement period. When renewal or early renewal applicants 
indicate that an existing ACO participant will continue to participate 
in the ACO during the new agreement period, the ACO has the option to 
either submit a newly executed ACO participant agreement or to resubmit 
the existing ACO participant agreement executed by the ACO and the ACO 
participant. In either case, the agreement must meet the Shared Savings 
Program requirements under Sec.  425.116.
    Comment: A few commenters suggested other burden reduction changes 
to the ACO application process that were outside the scope of this 
rulemaking. These commenters suggested that CMS extend the deadline for 
ACOs to add participants and to provide ACOs direct access to PECOS so 
that they can manage participant agreements directly in the CMS 
database.
    Response: Comments of this nature are beyond the scope of the 
policies discussed in the CY 2022 PFS proposed rule and are not being 
addressed in this final rule.
    After considering the public comments, we are finalizing without 
change our proposal to amend Sec.  425.116(c) to remove language 
requiring an ACO to submit an executed ACO participant agreement for 
each ACO participant at the time of its initial application and during 
the participation agreement renewal process.
    In summary, we are finalizing without change our proposal to modify 
section Sec.  425.204(b) regarding the disclosure of prior 
participation information. Specifically, under this final rule, an ACO 
will be obligated to submit prior participation information only at the 
request of CMS during the application process. We are finalizing 
without change our proposal to modify Sec.  425.204(c)(6) regarding the 
submission of sample ACO participant agreements during the application 
process. Specifically, under this final rule, an ACO will obligated to 
submit such documents only upon the request of CMS. Lastly, we are 
finalizing without change our proposal to modify Sec.  425.116(c) by 
removing language requiring an ACO to submit an executed ACO 
participant agreement for each ACO participant at the time of its 
initial application or participation agreement renewal process. Under 
this final rule, an ACO is obligated to submit an executed ACO 
participant agreement only for those ACO participants that the ACO 
seeks to add to its list of ACO participants.

[[Page 65294]]

5. Beneficiary Information Notices for ACOs With Prospective Assignment
a. Background
    To ensure full transparency between Shared Savings Program ACOs and 
the beneficiaries they serve, Sec.  425.312(a)(1) provides that an ACO 
must ensure that Medicare FFS beneficiaries are notified about all of 
the following: (1) That its ACO providers/suppliers are participating 
in the Shared Savings Program; (2) the beneficiary's opportunity to 
decline claims data sharing; and (3) the beneficiary's ability to, and 
the process by which, he or she may identify or change identification 
of the individual he or she designated as their primary clinician for 
purposes of voluntary alignment. Under Sec.  425.312(a)(2)(i), we 
require this information to be furnished by an ACO participant posting 
signs in its facilities and, in settings in which beneficiaries receive 
primary care services, making standardized written notices available 
upon request.
    In the December 2018 final rule, we specified at Sec.  
425.312(a)(2)(ii) that, during the performance year beginning on July 
1, 2019 and each subsequent performance year, the information must also 
be furnished by an ACO or ACO participant providing each beneficiary 
with a standardized written notice prior to or at the first primary 
care visit of the performance year in the form and manner specified by 
CMS. While we continued to encourage ACO participants to distribute the 
notice to beneficiaries at the point of care to address any beneficiary 
questions or concerns, the flexibility was granted so that an ACO or 
its ACO participants could distribute beneficiary notifications through 
electronic transmission (such as email) or mail. We note that, 
regardless of the method of notification used, CMS may review evidence 
related to the dissemination of the beneficiary information notice at 
any time under its audit authority in accordance with Sec.  425.314.
    We believe the modifications made to the beneficiary notification 
requirements in the December 2018 final rule help empower beneficiary 
choice, support beneficiary engagement, improve transparency, and 
ensure that beneficiaries are informed about the program and how it may 
affect their care and the use of their data. In making the decision to 
provide a CMS-approved template, we aimed to make the notification a 
comprehensive resource that compiled information about the program and 
what participation in the program means for beneficiary care. In 
addition, we believed that the availability of CMS-approved beneficiary 
notification templates would mitigate the potential for administrative 
and operational burden on providers.
b. Revisions
    In considering the several different iterations of the beneficiary 
notice requirement over the history of the program,\123\ we have 
concluded that the current requirement to provide beneficiary 
notifications prior to or at the first primary care visit of the 
performance year is overly broad with respect to ACOs that have 
selected the prospective assignment methodology. Such ACOs are 
currently required to provide the beneficiary notice to beneficiaries 
who will never be assigned to the ACO for the performance year.
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    \123\ We have made several revisions to the beneficiary 
notification provisions over time. Refer to the November 2011 final 
rule, 76 FR 67802, 67945 through 67946 (establishing the requirement 
for beneficiary notifications). Refer to the June 2015 final rule, 
80 FR 32692, 32740 through 32743 (establishing requirements for ACO 
to use a CMS-approved template for beneficiary notifications, 
allowing ACOs to obtain claims data for beneficiaries, and 
establishing an avenue for beneficiaries to opt out of data-
sharing).
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    As noted in the CY 2022 PFS proposed rule, the purpose of the 
beneficiary notification is to empower beneficiaries, encourage 
beneficiary engagement, and improve transparency. For an ACO 
participating under the prospective assignment methodology, as 
described in Sec.  425.400(a)(3), all of the ACO's beneficiaries are 
assigned at the beginning of the performance year. Under Sec.  
425.704(d)(1)(ii), such ACOs may request beneficiary identifiable 
claims data only for FFS beneficiaries that appear on the ACOs' 
prospective assignment list at the beginning of the performance year 
and who have not opted out of data sharing. Beneficiaries who are not 
assigned at the beginning of the performance year to an ACO that has 
selected prospective assignment will never be assigned to the ACO 
during the relevant performance year and will not be subject to data 
sharing with the ACO. In short, such beneficiaries have no need to 
receive any information about the Shared Savings Program during the 
performance year. Therefore, as stated in the CY 2022 PFS proposed 
rule, we believe that it causes unnecessary confusion for beneficiaries 
to receive the notice if they are not prospectively assigned to an ACO 
because the notice describes details that will not apply to them (for 
example, information on data sharing and the SNF 3-day rule waiver).
    In contrast, for ACOs under preliminarily prospective assignment 
with retrospective reconciliation, the preliminary prospective 
assignment list provided to the ACO at the beginning of the performance 
year does not include all FFS beneficiaries who may ultimately be 
assigned to the ACO. As such, we continue to believe all FFS 
beneficiaries receiving primary care services from ACO providers and/or 
suppliers participating in ACOs that have selected preliminary 
prospective assignment with retrospective reconciliation should receive 
the notice. This ensures that all beneficiaries ultimately assigned to 
the ACO will be informed of their right to decline data sharing.
    In the CY 2022 PFS proposed rule, we proposed to amend Sec.  
425.312(a)(2) to set forth different beneficiary notification 
obligations depending on the assignment methodology selected by the 
ACO. Specifically, we proposed at Sec.  425.312(a)(2)(ii) to provide 
that, in the case of an ACO that has selected preliminary prospective 
assignment with retrospective reconciliation, the ACO or ACO 
participant must provide the standardized written beneficiary notice to 
each FFS beneficiary prior to or at the first primary care visit of the 
performance year. We proposed to add at Sec.  425.312(a)(2)(iii) that, 
in the case of an ACO that has selected prospective assignment, the ACO 
or ACO participant must provide the standardized written notice to each 
prospectively assigned beneficiary prior to or at the first primary 
care visit of the performance year.
    In the CY 2022 PFS proposed rule, we stated that we continue to 
believe that the requirement to provide the beneficiary information 
notice is important to empowering beneficiaries and providing important 
information about their care, but we also understand that the current 
requirement of disseminating the beneficiary information notice 
annually may have the potential to be overly burdensome to ACOs and/or 
their ACO participants. We solicited comment from stakeholders on 
whether we should modify the frequency with which the beneficiary 
information notice must be furnished, for example, by reducing the 
frequency of the existing requirement from annually to once per 
agreement period.
    We received public comments on our proposal to eliminate the 
requirement for ACOs that have selected the prospective assignment 
methodology to provide the beneficiary information notice to 
beneficiaries who are not prospectively assigned, and therefore, to 
whom it would not affect. The following is a summary of the comments we 
received and our responses.

[[Page 65295]]

    Comment: Many commenters supported the proposal to amend the 
beneficiary notification requirement such that ACOs that have selected 
prospective assignment do not have to send notification to 
beneficiaries who are not prospectively assigned to them.
    Response: We appreciate the commenters' support.
    Comment: Many commenters advocated that CMS remove the obligation 
for ACOs to furnish standardized written beneficiary information 
notices. These commenters stated that the requirement to provide 
written beneficiary notices is redundant and imposes an unnecessary 
burden on ACOs. The commenters stated that the same effect is achieved 
by providing notice via in-office posters, the Medicare & You handbook, 
and/or after-visit summaries. Some commenters shared that if CMS 
believes it is necessary to inform patients about ACO goals and 
objectives using methods other than the posted notices that are already 
a requirement of the Shared Savings Program, that CMS should provide 
such notifications. The commenters noted that if CMS furnished such 
notifications, beneficiaries would not receive notifications from 
multiple ACOs, which would reduce the cost and burden currently placed 
on ACOs.
    Response: While we appreciate commenters' feedback, we decline to 
eliminate the requirement that ACOs furnish the standardized written 
beneficiary notifications required under Sec.  425.312. For several 
reasons, we continue to believe that it is important for ACOs to 
furnish these notifications. First, such notices provide important 
information to beneficiaries about their care and serve to improve 
transparency. For example, the standardized written notice informs a 
beneficiary that CMS may share the beneficiary's claims data with the 
ACO and that the beneficiary can prevent such claims data sharing by 
following instructions provided in the notice. In the absence of such 
notification, a beneficiary may incorrectly assume that there is no 
difference between receiving care from an ACO participant and receiving 
care from a provider or supplier that is not participating in an ACO. 
Second, the standardized written notices provide an opportunity for 
direct engagement of the beneficiary with the ACO or an ACO 
participant, thereby serving to strengthen the beneficiary's 
relationship with the ACO and ACO participants from whom the 
beneficiary may receive care. Because the notice is furnished by the 
ACO or an ACO participant, it is qualitatively different from a notice 
furnished by CMS. For this reason, we decline to accept the commenters' 
suggestion that CMS furnish the required beneficiary notifications.
    We do not agree with the commenters' assertion that the requirement 
to provide written beneficiary notices is redundant and that the same 
effect is achieved by providing notice via in-office posters, the 
Medicare & You handbook, or ``after-visit summaries.'' We note that 
``after-visit summaries'' are not required by our regulations and are 
therefore not a reliable mechanism for ensuring that beneficiaries 
receive the required information. Although posters and the Medicare & 
You handbook may be a sufficient notification mechanism for some 
beneficiaries, not all beneficiaries will read the posters or the 
Medicare & You handbook. Moreover, the information contained in the 
Medicare & You handbook cannot be as complete as the information that 
must be included in the standardized written notices required under 
Sec.  425.312(a)(2). For example, the Medicare & You handbook would not 
identify the specific ACO with which CMS may share the beneficiary's 
claims data. Written notifications distributed directly to 
beneficiaries by ACOs and ACO participants offer an additional avenue 
for ensuring that more beneficiaries are aware of their healthcare 
provider's participation in an ACO, the claims data that CMS may share 
with the ACO, the opportunity to prevent such claims data sharing, and 
the opportunity to designate a particular practitioner for purposes of 
voluntary alignment to the ACO. Simply put, the standardized written 
beneficiary notices are not redundant; rather, they are one of multiple 
notice mechanisms that together ensure that beneficiaries are likely to 
receive and understand comprehensive information regarding the 
significance of receiving care from a provider or supplier 
participating in the Shared Savings Program.
    We appreciate the commenters' desire to reduce the burden on ACOs 
by eliminating the chance of a beneficiary receiving notices from 
multiple ACOs. We note that under this final rule, a beneficiary 
aligned to an ACO that has selected prospective assignment will not 
receive notifications from multiple ACOs.
    We received public comments on whether we should modify the 
frequency with which the beneficiary information notice must be 
furnished, for example, by reducing the frequency of the existing 
requirement from annually to once per agreement period. The following 
is a summary of the comments we received and our responses.
    Comment: A few commenters expressed support for reducing the 
frequency of the beneficiary information notice to once per agreement 
period. Commenters related that requiring ACOs to notify beneficiaries 
annually when there have been no programmatic changes can cause 
unnecessary confusion and burden on patients. Some commenters also 
suggested modifying the language within the notice to be plainer and 
more beneficiary-friendly. Additionally, commenters noted that removing 
the annual requirement would significantly reduce burden on ACOs, both 
administratively with paperwork, and financially, in terms of expenses 
and resources.
    Response: We appreciate the commenters for the feedback. We will 
consider this information in future rulemaking.
    After consideration of public comments, we are finalizing the 
proposed policy without modification. Accordingly, we are finalizing 
the amendment of Sec.  425.312(a)(2) to set forth different beneficiary 
notification obligations depending on the assignment methodology 
selected by the ACO. Specifically, we will finalize our proposal at 
Sec.  425.312(a)(2)(ii) to provide that, in the case of an ACO that has 
selected preliminary prospective assignment with retrospective 
reconciliation, the ACO or ACO participant must provide the 
standardized written beneficiary notice to each FFS beneficiary prior 
to or at the first primary care visit of the performance year. We will 
also finalize our proposal to add at Sec.  425.312(a)(2)(iii) that, in 
the case of an ACO that has selected prospective assignment, the ACO or 
ACO participant must provide the standardized written notice to each 
prospectively assigned beneficiary prior to or at the first primary 
care visit of the performance year.
6. Comments on Considerations Related to the Use of Regional FFS 
Expenditures and the Risk Adjustment Methodology in Establishing, 
Adjusting, Updating, and Resetting the ACO's Historical Benchmark
a. Background on the Shared Savings Program Benchmarking Methodology
    Section 1899(d)(1)(B)(ii) of the Act addresses how ACO benchmarks 
are to be established and updated under the Shared Savings Program. 
This provision specifies that the Secretary shall estimate a benchmark 
for each agreement period for each ACO using

[[Page 65296]]

the most recent available 3 years of per beneficiary expenditures for 
Parts A and B services for Medicare FFS beneficiaries assigned to the 
ACO. This benchmark shall be adjusted for beneficiary characteristics 
and such other factors as the Secretary determines appropriate and 
updated by the projected absolute amount of growth in national per 
capita expenditures for Parts A and B services under the original 
Medicare FFS program, as estimated by the Secretary. The benchmark 
shall be reset at the start of each agreement period. In addition to 
the statutory benchmarking methodology established in section 1899(d) 
of the Act, section 1899(i)(3) of the Act grants the Secretary the 
authority to use other payment models, including payment models that 
would 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 that the 
alternative methodology would result in program expenditures equal to 
or lower than those that would result under the statutory payment 
model.
    In the November 2011 final rule establishing the Shared Savings 
Program, we adopted policies for establishing, updating, and resetting 
the benchmark at Sec.  425.602. The Shared Savings Program's 
regulations have since evolved to include different benchmarking 
methodologies, including modifications to Sec.  425.602, and the 
addition of separate benchmarking policies for ACOs entering a second 
or subsequent agreement period at Sec.  425.603. Benchmarking policies 
applicable to all ACOs in agreement periods beginning on July 1, 2019, 
and in subsequent years, are specified in Sec.  425.601. We refer 
readers to discussions of the benchmark calculations in earlier 
rulemaking for details on the development of the current policies (see 
November 2011 final rule, 76 FR 67909 through 67927; June 2015 final 
rule, 80 FR 32785 through 32796; June 2016 final rule, 81 FR 37953 
through 37991; and December 2018 final rule, 83 FR 68005 through 
68030).
    For details on the benchmarking calculations, we refer readers to 
the regulations at 42 CFR part 425, subpart G, as well as the Medicare 
Shared Savings Program, Shared Savings and Losses and Assignment 
Methodology Specifications (version #9, February 2021), available at 
https://www.cms.gov/files/document/medicare-shared-savings-program-shared-savings-and-losses-and-assignment-methodology-specifications.pdf-0.
    In section III.J.6 of the CY 2022 PFS proposed rule (86 FR 39291 
through 39295), we summarized select aspects of the Shared Savings 
Program's benchmarking methodology and related concerns that have been 
expressed by ACOs and other stakeholders. We specified some 
considerations based on our initial analyses of these issues, and 
solicited comment on considerations that may inform future policy 
developments. However, we noted that we are still in the process of 
monitoring program calculations based on the initial performance years 
of experience under the new participation options and program 
modifications that were adopted as part of the Pathways to Success 
rulemaking and are applicable for ACOs in agreement periods beginning 
on July 1, 2019, and in subsequent years, including changes to the 
benchmarking methodology (finalized in the December 2018 final rule (83 
FR 67816)). In addition, we also specified that we are monitoring the 
impact of any anomalies in Medicare FFS expenditures and healthcare 
utilization by Medicare FFS beneficiaries resulting from the PHE for 
COVID-19, which we anticipate could further inform our considerations 
of future modifications to Shared Savings Program benchmarking policies 
(see for example, discussion in the CY 2021 PFS final rule, 85 FR 84770 
through 84785).
    We appreciate commenters' careful consideration of these issues, as 
reflected in the public comments we received about the current Shared 
Savings Program benchmarking methodology, and the potential alternative 
benchmarking approaches described in the proposed rule. In this section 
of this final rule, we review the comment solicitations, and summarize 
the comments received. We appreciate the ongoing dialogue between CMS, 
ACOs and other program stakeholders on considerations for improving the 
Shared Savings Program's benchmarking policies. Because we sought 
comments on these issues for purposes of informing future rulemaking 
and did not propose any changes to the Shared Savings Program's 
benchmarking methodology, we decline at this time to provide detailed 
responses to the commenters' suggestions and concerns. However, we will 
take these comments into consideration as we contemplate additional 
refinements to the Shared Savings Program's benchmarking methodologies. 
We will propose any specific policy changes in future notice and 
comment rulemaking.
b. Comments on Calculation of the Regional Adjustment and Blended 
National-Regional Growth Rates for Trending and Updating the Benchmark
    In the CY 2022 PFS proposed rule (86 FR 39291 through 39294), we 
discussed some of our considerations based on our initial analyses of 
stakeholders' concerns about the methodology for calculating regional 
FFS expenditures used in certain benchmark calculations, specifically 
the regional adjustment and the blended national-regional growth rates 
used in trending and updating the benchmark. We explained that we were 
investigating these concerns and performing additional simulations. We 
solicited comments on these considerations and other related issues, as 
well as suggested approaches to modifying the program's benchmarking 
methodology, which could inform future rulemaking.
    We received public comments on the alternative benchmarking 
methodologies discussed in the proposed rule. The following is a 
summary of the comment solicitations, the comments we received and our 
responses.
(1) Overview of Benchmarking Policies Using Regional FFS Expenditures
    As we described in the CY 2022 PFS proposed rule, in calculating 
the historical benchmark, we use historical expenditures for the ACO's 
assigned beneficiaries, as well as factors based on regional FFS 
expenditures, factors based on national FFS expenditures, and factors 
based on a blend of national and regional FFS expenditures. As we have 
described in earlier rulemaking, incorporating regional expenditures 
into benchmark calculations makes the ACO's cost target more 
independent of its historical expenditures and more reflective of FFS 
spending in its region (see for example, 81 FR 37950, 37951 and 37955). 
We have also acknowledged in earlier rulemaking that the incorporation 
of factors based on regional FFS expenditures into ACO benchmarks will 
have varying effects on ACOs depending on each organization's 
individual circumstances (see for example, 81 FR 37950, 37954 through 
37957, and 81 FR 37975 through 37977; and 83 FR 67816, 68017 and 
68026).
    In accordance with Sec.  425.601(a)(8), we adjust historical 
benchmark expenditures by Medicare enrollment type (ESRD, disabled, 
aged/dual eligible, aged/non-dual eligible) by a percentage of the 
difference between the average per capita expenditure amount for the 
ACO's regional service area and the ACO's historical benchmark amount

[[Page 65297]]

(referred to herein as the ``regional adjustment''). The percentage 
that is applied in calculating the regional adjustment is determined in 
accordance with Sec.  425.601(f) and 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 the applicable 
weights. CMS caps the per capita dollar amount of the regional 
adjustment for each Medicare enrollment type at a dollar amount equal 
to 5 percent of national per capita 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.
    In accordance with Sec.  425.601(a)(5), in establishing and 
resetting an ACO's benchmark, CMS trends forward expenditures for each 
benchmark year (BY1 and BY2) to BY3 dollars using a blend of national 
and regional growth rates, making separate calculations for each 
Medicare enrollment type. Similarly, in accordance with Sec.  
425.601(b), CMS updates the historical benchmark annually for each year 
of the agreement period using a blend of national and regional growth 
rates between BY3 and the performance year. 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 this 
policy under which we update the historical benchmark using a blend of 
national and regional growth rates, rather than the projected absolute 
amount of growth in national per capita expenditures for Parts A and B 
services under the original Medicare FFS program as required under 
section 1899(d)(1)(B)(ii) of the Act. CMS accounts for an ACO's 
penetration in its region when calculating the national-regional 
blended growth rates, by placing a higher weight on the national 
component of the blend and a lower weight on the regional component as 
the ACO's penetration in its region increases.
    In determining regional FFS expenditures, CMS uses average county 
FFS expenditures for assignable beneficiaries, including the ACO's 
assigned beneficiaries, in each county in the ACO's regional service 
area for the 12-month calendar year corresponding to the relevant 
benchmark or performance year.124, 125 CMS weights these 
county-level FFS expenditure amounts by the proportion of the ACO's 
assigned beneficiaries residing in each county, with all calculations 
performed separately by Medicare enrollment type. Refer to Sec.  
425.601(c) (calculating county expenditures) and (d) (calculating 
regional expenditures).
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    \124\ Assignable beneficiary, as defined in Sec.  425.20, 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).
    \125\ The ACO's regional service area, as defined in Sec.  
425.20, means all counties where one or more beneficiaries assigned 
to the ACO reside.
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    As described in the CY 2022 PFS proposed rule (86 FR 39292), ACOs 
and other program stakeholders have expressed concerns with the 
approach to determining regional FFS expenditures using a population of 
assignable beneficiaries that includes the ACO's assigned 
beneficiaries, including with respect to the impact on the calculation 
of the regional adjustment and the blended national-regional growth 
rate used to trend and update an ACO's historical benchmark, suggesting 
this policy results in relatively lower benchmarks for ACOs, 
particularly ACOs with high market penetration in their regional 
service area, which may tend to be ACOs located in rural areas.\126\ 
For example, the National Association of ACOs' (NAACOS') summary 
``Fixing the Rural Glitch'' explains its belief that by including the 
costs of all beneficiaries in the regional adjustment--both those 
assigned to the ACO and those who are not--CMS penalizes an ACO for 
reducing costs relative to its regional competitors. That is, as an ACO 
reduces the costs of its own assigned beneficiaries, it also reduces 
the average regional costs. According to NAACOS, this will ultimately 
reduce savings for efficient ACOs in all areas, but the effect may be 
most dramatic for rural ACOs because they will tend to care for a 
greater portion of their region's total beneficiary population than an 
urban ACO.\127\ As another example, a stakeholder suggests that 
incorporating factors based on regional FFS expenditures into the 
Shared Savings Program's benchmarking methodology systemically 
penalizes ACOs with a large market share when they reduce costs, 
leading to disparate payments to ACOs with identical performance.\128\ 
ACOs and other program stakeholders have suggested that CMS remove the 
effects of the ACO's own performance from factors based on regional FFS 
expenditures, such as by excluding an ACO's assigned beneficiaries from 
the population of assignable beneficiaries used to determine regional 
FFS expenditures.\129\ Other alternatives that have been suggested to 
address these concerns include capping an ACO's penetration in the 
region at 50 percent by Medicare enrollment type, or expanding the 
ACO's region.\130\ In recent years, legislative changes have been 
introduced, which if enacted would require the removal of the ACO's 
assigned beneficiaries from regional expenditure 
calculations.131 132 In the CY 2022 PFS proposed rule, we 
expressed our appreciation for ACOs and other program stakeholders 
bringing their concerns, and suggested alternatives, to our attention. 
We stated that we had begun to analyze these concerns about the use of 
factors based on regional FFS expenditures in

[[Page 65298]]

calculating ACO benchmarks, and to consider possible modifications to 
the Shared Savings Program's benchmarking methodology to ensure the 
sustainability of the program's financial models. We noted that any 
such modifications would need to be adopted through notice and comment 
rulemaking.
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    \126\ See for example the CY 2021 PFS final rule, summarizing 
commenters' concerns about the program's benchmarking methodology 
received in response to modifications to Shared Savings Program 
policies that were adopted in the May 8, 2020 COVID-19 IFC to 
address the impact of the PHE for COVID-19, although we noted these 
comments went beyond the modifications to the program's regulations 
established in that IFC (85 FR 84783 through 84785).
    \127\ See NAACOS, Fixing the Rural Glitch, available at https://www.naacos.com/assets/docs/pdf/2021/RuralGlitchExplainer.pdf.
    \128\ Aledade, ``Opportunities for 2022 Improvements to MSSP 
ACOs in the Physician Fee Schedule'' (June 2021), provided as a 
document during E.O. 12866 Meeting (CMS-1751), available at https://mobile.reginfo.gov/public/do/viewEO12866Meeting?viewRule=false&rin=0938-AU42&meetingId=49323&acronym=0938-HHS/CMS.
    \129\ See for example, 85 FR 84784; see also, NAACOS, Fixing the 
Rural Glitch, available at https://www.naacos.com/assets/docs/pdf/2021/RuralGlitchExplainer.pdf.
    \130\ See for example, Aledade, ``Opportunities for 2022 
Improvements to MSSP ACOs in the Physician Fee Schedule'' (June 
2021), provided as a document during E.O. 12866 Meeting (CMS-1751), 
available at https://mobile.reginfo.gov/public/do/viewEO12866Meeting?viewRule=false&rin=0938-AU42&meetingId=49323&acronym=0938-HHS/CMS.
    \131\ See S.2648--Rural ACO Improvement Act, 116th Congress 
(2019-2020), available at https://www.congress.gov/bill/116th-congress/senate-bill/2648/text (including a provision on Exclusion 
Of Assigned Beneficiaries In Certain Circumstances Including 
Determination Of Regional Adjustments), and H.R. 5212--Accountable 
Care in Rural America Act, 116th Congress (2019-2020), available at 
https://www.congress.gov/bill/116th-congress/house-bill/5212/text.
    \132\ See also, Letter from NAACOS et al., to Representatives 
Arrington, DelBene, Kelly, Bera, O'Halleran, Sewell, Dunn and Gooden 
(June 15, 2021), describing the introduction of H.R. 3746, the 
Accountable Care in Rural America Act. Available at https://www.naacos.com/naacos-and-12-others-write-congress-in-support-of-the-accountable-care-in-rural-america-act--h-r--3746-. H.R. 3746--
117th Congress (2021-2022), available at https://www.congress.gov/bill/117th-congress/house-bill/3746/text?r=58&s=1.
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    The following is a summary of the public comments we received and 
our response.
    Comment: Several commenters, including MedPAC, did not support 
amending the Shared Savings Program benchmarking methodology to remove 
an ACO's assigned beneficiaries from the assignable beneficiary 
population used in determining regional FFS expenditures. These 
commenters noted that the balance of current Shared Savings Program 
incentives already tends to favor ACOs that are efficient within their 
region (that is, historically low-spending ACOs) and this imbalance 
would be exacerbated by removing an ACO's assigned beneficiary 
expenditures from its benchmark. Among other factors, these commenters 
noted that such an approach could create a situation that would reward 
low-spending ACOs without improving their efficiency of care and would 
reduce incentives for participation among high spending ACOs (including 
ACOs serving high-spending beneficiaries in a region, or operating in 
high cost or high need areas) that the commenters stated were likely to 
have the greatest opportunity for efficiency improvements. One 
commenter indicated that an approach that removes the ACO's assigned 
beneficiaries from benchmark calculations may advantage experienced 
ACOs that are already successful in lowering spending for their 
assigned population, more so than new ACOs. This commenter also 
explained that in circumstances where an ACO's beneficiaries are 
removed and the remaining population for the benchmark calculation is 
healthier or utilizing fewer health care services, the ACO will be left 
to compete against an unattainable benchmark.
    Some comments pointed to the need for further clarity from CMS on 
the impact of removing the ACO's assigned beneficiaries from the 
assignable population used to determine regional FFS expenditures. A 
commenter stated that they were unsure how they would be impacted 
(positively or negatively) by an approach that would reduce the 
influence of an ACO's assigned beneficiaries on regional expenditure 
calculations, and recommended CMS propose and allow time for response 
to any such alternative policies. A few commenters suggested that ACOs 
that include physicians or facilities providing specialist care might 
be negatively impacted as these health care providers serve patients 
with high costs of care and requested that CMS provide more information 
about the potential impacts on these ACOs.
    Many commenters who responded to the comment solicitation favored 
CMS making regulatory changes to remove ACO-assigned beneficiaries from 
the regional reference population used in the current benchmarking 
methodology, raising concerns about the impact of the existing approach 
to calculating regional expenditures more broadly or specifically with 
respect to the regional adjustment or the blended national-regional 
factors used to trend and update the benchmark. Most commenters 
favoring this approach called for the changes to be made as soon as 
possible, with some commenters suggesting that CMS finalize a policy 
change in this final rule. A commenter requested that the changes be 
made retroactively, calling on CMS to re-calculate shared savings and 
losses from prior years and to pay additional shared savings to ACOs 
that were negatively affected by the current policy. While noting it 
was important to address calculation of regional FFS expenditures in 
the Shared Savings Program, several commenters recommended that CMS 
also review methodologies used in existing and developing Innovation 
Center models to ensure they appropriately account for an APM 
participant's regional presence.
    Some commenters described the current policy on calculating 
regional expenditures as penalizing ACOs when they reduce costs by also 
reducing the regional costs against which the ACO is compared. 
Commenters suggested that this can hinder an ACO's ability to generate 
savings and earn shared savings. A commenter suggested the policy would 
reduce the financial incentives for ACOs to fund critical care 
improvement initiatives that are fundamental to total cost of care 
reduction. The same commenter noted that ACOs could ultimately face 
shared losses even if they have the same performance as a prior year in 
which they achieved savings due to continually decreasing benchmarks. 
Some commenters stressed that removing the ACO's assigned beneficiaries 
from the regional reference population was important for creating more 
fair and accurate benchmarks and a level playing field for ACOs which, 
in turn, would help the Shared Savings Program to attract and retain 
participants. Some commenters noted that accurate and reliable 
benchmarking is critical for the long-term success of the Shared 
Savings Program and APMs more generally.
    Many commenters maintained that the current approach to determining 
regional FFS expenditures particularly disadvantages rural ACOs or ACOs 
with high market penetration in their regional service areas, which may 
tend to be ACOs operating in rural areas. Some commenters referred to 
the issue as the ``rural glitch''. Several commenters described this 
aspect of the Shared Savings Program's benchmarking methodology as 
creating a value-based care equity issue, because it systematically 
disadvantages ACOs in rural areas by making it harder for them to 
achieve savings even when they improve quality and reduce costs on par 
with their counterparts in urban areas. Several commenters underscored 
the importance of and urgency for CMS to remove ACO assigned 
beneficiary costs from the regional factors used in Shared Savings 
Program benchmarking to create sustainability for value-based care in 
rural communities. More specifically, a commenter suggested that CMS 
should take this approach to allow Medicare patients in rural areas to 
have the same or similar ability to access providers participating in 
innovative delivery system models as their urban counterparts.
    While acknowledging the potential impact on rural ACOs, some 
commenters noted that the current policy also adversely affects many 
suburban and urban ACOs. A few commenters described the current policy 
as penalizing ACOs that are successful or the most efficient providers 
in their market.
    Some commenters indicated their support for the Value in Health 
Care Act of 2021,\133\ particularly regarding the removal of ACO 
assigned beneficiaries from the methodology for calculating the 
regional expenditures used to establish, adjust and update the 
benchmark. A commenter suggested CMS support another piece of 
legislation, the Accountable Care in Rural America Act,\134\ to address 
exclusion of ACO assigned beneficiaries from the methodology for 
calculating regional expenditures. At least one commenter explained 
that while they have endorsed legislation aimed at fixing the ``rural 
glitch'', they believe

[[Page 65299]]

that it is fully within CMS' authority to fix this issue through 
rulemaking.
---------------------------------------------------------------------------

    \133\ Refer to H.R. 4587--117th Congress (2021-2022), available 
at https://www.congress.gov/bill/117th-congress/house-bill/4587/text.
    \134\ Refer to H.R. 3746--117th Congress (2021-2022), available 
at https://www.congress.gov/bill/117th-congress/house-bill/3746/text?r=58&s=1.
---------------------------------------------------------------------------

    Response: We will take these comments into consideration as we 
contemplate additional refinements to the Shared Savings Program's 
benchmarking methodologies and will propose any specific policy 
changes, if deemed appropriate, in future notice and comment 
rulemaking.
(2) Methodology for Removing ACO Assigned Beneficiaries From Regional 
FFS Expenditures
    As we explained in the CY 2022 PFS proposed rule (86 FR 39292 and 
39293), there may be several possible approaches that we could consider 
for removing an ACO's assigned beneficiaries from the assignable 
beneficiary population used in regional expenditure calculations, which 
would vary in the degree of additional program calculations and the 
level of complexity. As we described in the proposed rule, we simulated 
the impact of removing an ACO's assigned beneficiaries from the 
regional expenditure calculations using an approach that would pose 
relatively limited operational burden and would leverage data elements 
already computed under the current benchmarking methodology. This 
approach relies on the premise that per capita risk-adjusted regional 
FFS expenditures for all assignable beneficiaries in an ACO's regional 
service area (a) can be interpreted as a weighted average of per capita 
risk-adjusted FFS expenditures for the ACO's assigned beneficiaries (b) 
and per capita risk-adjusted FFS expenditures for assignable 
beneficiaries in the region who are not assigned to the ACO (c), where 
the weight on (b) is the ACO's regional market share \135\ and the 
weight on (c) is one minus the ACO's regional market share. Shown as an 
equation this is:
---------------------------------------------------------------------------

    \135\ What is referred to here as the ``ACO's regional market 
share'' is the share of assignable beneficiaries in the ACO's 
regional service area that are assigned to the ACO, which is the 
weight that it is applied to the national component of the national-
regional blend under Sec.  425.601(a)(5)(iv) and (v).

(a) = [(b) x (ACO's regional market share)] + [(c) x (1-ACO's regional 
---------------------------------------------------------------------------
market share)].

Thus, to remove the ACO's assigned beneficiaries from the regional 
expenditure calculation, we would insert the applicable values into the 
above equation and solve for (c) by rearranging the equation as 
follows:

(c) = {(a)-[(b) x (ACO's regional market share)]{time} /(1-ACO's 
regional market share).

    By using such ACO- and regional-level values, this approach, 
performed separately by Medicare enrollment type, would avoid the need 
to calculate individualized ACO county-level risk-adjusted 
expenditures. We solicited comment on the approach we outlined, or 
alternative approaches to calculating regional FFS expenditures without 
an ACO's assigned beneficiaries. In particular, we solicited comment on 
specific approaches that would strike the balance of achieving the 
desired outcome of removing the ACO's assigned beneficiaries from 
program calculations without introducing an inordinate amount of 
operational and administrative complexity such that the steps and data 
included in the calculations can be understood by ACOs and other 
program stakeholders, and the potential for calculation errors is 
minimized.
    As we explained in the CY 2022 PFS proposed rule (86 FR 39293), we 
performed initial simulations, for a subset of Shared Savings Program 
ACOs, using data for the 6-month performance year starting on July 1, 
2019 (sometimes referred to as performance year 2019A), for which 
expenditures were determined based on expenditures for CY 2019, to 
observe the effects of potential modifications to the benchmarking 
methodology. In performing these simulations, we used the 
aforementioned approach for removing expenditures for the ACO's 
assigned beneficiaries from the calculation of regional FFS 
expenditures, by removing the impact of an ACO's assigned beneficiaries 
from the assignable population as weighted by the ACO's regional market 
share. Specifically, we simulated the effects on the per capita updated 
benchmark of several alternate policies that would remove an ACO's 
assigned beneficiaries from regional expenditures used to trend and 
update the benchmark (either alone or as part of a national-regional 
blend) or from regional expenditures used to calculate the regional 
adjustment, or from both. When looking at average impacts by quintile 
of the ACO's penetration in its regional service area (that is, market 
share) and rural or non-rural status, the various alternatives resulted 
in estimated increases in the updated benchmark by amounts ranging from 
0.1 percent to 1.4 percent, with ACOs with higher market shares tending 
to see slightly higher average increases than ACOs with lower market 
shares and rural ACOs seeing slightly higher average increases than 
non-rural ACOs. We also observed that some ACOs experienced decreases 
in their benchmark amounts, ranging from -0.02 percent to -1.5 percent 
under these simulations of alternate benchmarking policies. We noted 
that additional analysis would be needed to consider the impact of such 
policies on a broader set of ACOs participating in the Shared Savings 
Program, including ACOs that did not participate in a 6-month 
performance year from July 1, 2019, through December 31, 2019. We 
solicited comment on this estimated range of impacts on ACO benchmark 
values, and on the potential mixed effects on ACOs that could result 
from modifications to the benchmarking methodology.
    In the CY 2022 PFS proposed rule (86 FR 39293), we explained our 
belief that in considering alternative benchmarking methodologies to 
address ACOs' penetration in their regional service areas it would be 
important to consider what would constitute heavy penetration by an ACO 
in its regional service area, and the extent to which market 
penetration should be considered in benchmark calculations. Based on 
preliminary analysis of data for CY 2019 using performance year 2021 
ACO Participant Lists for all ACOs participating in the program as of 
January 1, 2021, the median ACO regional market share was approximately 
16.2 percent, with a minimum of 0.9 percent and a maximum of 59.2 
percent. Further, 90 percent of ACOs had a regional market share of 
less than 37.8 percent, and 80 percent of ACOs had a regional market 
share of less than 29.3 percent. Accordingly, we solicited comment on 
what would constitute heavy penetration in the ACO's regional service 
area and how removing the ACO's assigned beneficiaries from regional 
calculations, dependent on the level of penetration, could either 
increase or decrease the ACO's benchmark. We also solicited comment on 
approaches that could strike a balance between adjusting program 
policies to address impacts on the potentially few ACOs that are 
heavily penetrated in their regional service area while maintaining 
stability for most ACOs that have relatively low penetration in their 
regional service area.
    The following is a summary of the public comments we received and 
our response.
    Comment: Some commenters addressed the question of how to remove an 
ACO's assigned beneficiaries from the reference population used in 
calculating factors based on regional FFS expenditures. A few 
commenters directly addressed the formula CMS

[[Page 65300]]

presented in the CY 2022 PFS proposed rule, appearing to support the 
potential approach for performing this exclusion. Some commenters 
indicated CMS' mathematical approach was ``directionally correct'', 
relatively simple, and works well in nearly every case while using data 
that CMS already produces. One commenter appreciated the transparency 
of the approach laid out by CMS but sought further clarification on 
whether the time period for measuring the ACO's market share would be 
the same period used to calculate expenditures.
    Several commenters addressed CMS' analyses simulating the effect of 
removing an ACOs' assigned beneficiaries from regional expenditure 
calculations on ACO benchmarks. A few commenters noted that CMS showed 
a range of results, both positive and negative, but did not state how 
many ACOs would benefit versus be harmed. By their own analysis, a 
commenter found that nearly 80 percent of ACOs would benefit and that 
there was no consistent pattern among ACOs that would benefit versus 
those that would be harmed. Another commenter expressed their belief 
that CMS' analysis made it clear that the current benchmarking 
methodology could be made more fair. A commenter remarked that CMS' 
simulations found that removing each ACO's assigned beneficiaries would 
slightly increase the average benchmark, even for ACOs with low market 
share or those in urban areas. This commenter surmised that the ACOs 
that saw negative effects were likely to be historically high-spending 
ACOs. Another commenter responding to CMS' simulation results 
recommended that CMS set a cap on the adjustment to the benchmark for 
ACOs that would be harmed.
    Some commenters addressed the issue of how to identify the 
population of Medicare FFS beneficiaries to remove from the assignable 
population used to determine regional FFS expenditures. Several 
commenters generally supported excluding ACO assigned beneficiaries 
from the regional reference population but did not clarify whether they 
preferred to see only an ACO's own beneficiaries removed or all ACO 
assigned beneficiaries. Suggestions from other commenters included 
removing all of a respective region's ACO-assigned beneficiaries, or 
beneficiaries attributed to all Medicare ACO initiatives, including the 
Global and Professional Direct Contracting Model. However, commenters 
acknowledged the possibility that the remaining beneficiary population 
could be too small, which, as a commenter indicated, could lead to 
significant variability in the regional component of the benchmark.
    Some commenters responded directly to CMS' request for comment on 
what would constitute heavy penetration by an ACO in its regional 
service area, and the extent to which market penetration should be 
considered in benchmark calculations. A commenter recommended that CMS 
set the high penetration mark at 30 percent, but did not provide 
specific suggestions for how this penetration level might be 
incorporated into the Shared Savings Program's benchmarking 
methodology. Some commenters discussed using 50 percent market share as 
a threshold in certain benchmark calculations. MedPAC noted that CMS 
found relatively few Shared Savings Program ACOs with high market 
share, which was consistent with its own analyses and believed that 
this relatively small number of ACOs with high market penetration is 
not enough to warrant a change in policy of this magnitude. MedPAC also 
noted that the current blended national-regional trend factor 
reasonably attempts to address high ACO market shares and recommended 
that, like the existing blend, any changes in policy should attempt to 
avoid imposing a market share threshold or ``cliff.''
    Response: We will take these comments into consideration as we 
contemplate additional refinements to the Shared Savings Program's 
benchmarking methodologies and will propose any specific policy 
changes, if deemed appropriate, in future notice and comment 
rulemaking.
(3) Unintended Consequences of Removing ACO Assigned Beneficiaries From 
Regional Calculations, and Identifying Other Needed Modifications
    In the CY 2022 PFS proposed rule (86 FR 39293 and 39294), we 
solicited comment on the following considerations, and other possible 
unintended consequences that could result from removing an individual 
ACO's assigned beneficiaries from regional calculations.
     Would this approach create incentives for ACOs to have 
assigned beneficiaries who are healthier than the remaining comparison 
population that is the basis for benchmark factors based on regional 
FFS expenditures (so as to yield a higher benchmark), which could lead 
ACOs to seek out healthier beneficiaries and avoid at-risk or higher-
cost beneficiaries?
    ++ Would this approach incent the formation of large ACOs within a 
particular market to obtain the most competitive benchmarks resulting 
in market consolidation, and discourage participation by relatively 
smaller ACOs, thus increasing costs for the Medicare Trust Funds if CMS 
pays larger amounts of shared savings to ACOs that have consolidated to 
take advantage of the ability to attract more low-cost beneficiaries in 
their region?
    ++ Would a change in the regional benchmarking methodology 
encourage ACOs to avoid at-risk or higher-cost beneficiaries and 
potentially exacerbate inequities in access to health care?
     We solicited comment on the potential for negative impacts 
on ACOs that serve larger proportions of medically complex 
beneficiaries, such as ACOs whose assigned beneficiary populations 
include larger proportions of beneficiaries who are medically complex 
and cared for in ambulatory or home-based settings or who reside in 
long term care facilities, resulting from an approach that removes the 
ACO's assigned beneficiaries from the assignable beneficiary population 
used to determine regional FFS expenditures. Would such an approach 
yield a benchmark so low that such ACOs have little incentive to 
participate in the Shared Savings Program?
     Would removing an individual ACO's assigned beneficiaries 
result in regional FFS expenditures based on very small populations, 
thus introducing significant variability into regional FFS expenditure 
trends used in benchmark calculations?
    Additionally, we solicited comment on whether removal of an ACO's 
assigned beneficiaries from regional FFS expenditure calculations would 
bring about a need to remove ACO assigned beneficiaries from other 
Shared Savings Program financial calculations based on a broader 
Medicare population, including factors based on national FFS 
expenditures, which are used in calculating blended national and 
regional expenditure trend and update factors, truncation points used 
in calculating benchmark and performance year expenditures, and the 5 
percent cap on the regional adjustment.
    The following is a summary of the public comments we received and 
our response.
    Comment: Commenters offered differing perspectives on the potential 
unintended consequences that could result from an approach that would 
remove ACO assigned beneficiaries from the regional FFS expenditure 
calculations including the following:
     Several commenters expressed the belief that removing ACO 
assigned beneficiaries from regional FFS expenditure calculations would

[[Page 65301]]

penalize ACOs serving medically complex, high cost patients in a 
region. A commenter noted that this approach could result in such ACOs 
leaving the Shared Savings Program or could be a deterrent to entry for 
future ACOs. Another commenter suggested that ACOs would be 
incentivized to avoid growth and expansion of services into high risk, 
high cost, high need areas, regardless of whether they are rural or 
urban, citing evidence for this phenomenon published in Health 
Affairs.\136\
---------------------------------------------------------------------------

    \136\ Citing Markovitz AA, et al. Risk Adjustment In Medicare 
ACO Program Deters Coding Increases But May Lead ACOs To Drop High-
Risk Beneficiaries. Health Affairs. February 2019. Available at 
https://www.healthaffairs.org/doi/10.1377/hlthaff.2018.05407.
---------------------------------------------------------------------------

     Several commenters expressed concern that the policy would 
create increased incentives for patient selection or ``cherry 
picking''. Another commenter disagreed, stating they did not believe 
that removing an ACO's assigned beneficiaries would create any of the 
unintended consequences CMS has contemplated, including cherry-picking 
healthier beneficiaries. Several other commenters also believed the 
likelihood of ACOs avoiding high-risk patients if ACO assigned 
beneficiaries are removed from the regional reference population is 
quite low and is outweighed by their concerns about the other effects 
of the existing policy. Commenters noted various safeguards or 
guardrails, such as provider choice among patients and risk adjustment, 
are already built into the framework of the Shared Savings Program to 
help to prevent ACOs from purposefully avoiding certain populations.
     One commenter expressed concerns about potential market 
consolidation effects, while a few other commenters explained that 
while there has been increased consolidation in recent years across the 
healthcare industry, there is not strong evidence showing ACOs are 
driving this change. A few other commenters also expressed the belief 
that a change in policy regarding the calculation of regional 
expenditures would not lead to provider consolidation, but would 
increase participation in ACOs in rural markets, expanding access to 
coordinated care and encouraging alternative payment model 
participation across the country.
     MedPAC expressed concern that the population used to 
determine regional FFS expenditures would become less comparable with 
the ACO's assigned population as the ACO's regional market share 
increases, even after risk adjustment, citing evidence from a 2009 
evaluation of the Physician Group Practice (PGP) demonstration \137\ (a 
predecessor to the Shared Savings Program). Several other commenters 
believed that concerns about small reference populations resulting from 
removing ACO-assigned beneficiaries is an issue for a minority of ACOs, 
such as those serving dual eligible Medicare and Medicaid 
beneficiaries, ESRD beneficiaries, and other high-risk beneficiary 
groups. The commenters suggested that, in these cases, CMS should 
consider expanding the regional service area to include assignable 
beneficiaries in adjoining counties or increasing the number of years 
included in the calculation of regional expenditures to improve the 
stability of the regional adjustment. Another commenter acknowledged 
that there are concerns about extreme differences between the ACO 
population and non-ACO population that risk adjustment does not handle 
well, but that these considerations affect only a small fraction of 
ACOs and can be addressed by expanding the definition of the region to 
include contiguous counties.
---------------------------------------------------------------------------

    \137\ Citing Secretary of Health and Human Services, Report to 
Congress, Physician Group Practice Demonstration Evaluation Report. 
2009. Available at https://innovation.cms.gov/files/reports/pgp-rtc-sept.pdf.
---------------------------------------------------------------------------

    Response: We will take these comments into consideration as we 
contemplate additional refinements to the Shared Savings Program's 
benchmarking methodologies and will propose any specific policy 
changes, if deemed appropriate, in future notice and comment 
rulemaking.
(4) Alternative Approaches to Determining Regional FFS Expenditures and 
Alternative Benchmarking Methodologies
    In the CY 2022 PFS proposed rule (86 FR 39294), we solicited 
comment on using other approaches to calculating benchmarks under the 
Shared Savings Program. In particular, we solicited comment on 
alternatives to determining regional FFS expenditures that would reduce 
the influence of an ACO's assigned beneficiaries on regional 
expenditure calculations, such as basing these expenditures on a larger 
geographic area, including using State-level data, Core-Based 
Statistical Area (CBSA)-level data, or a combination of data for these 
larger geographic areas and county-level data (such as blended county/
State regional expenditures). We also solicited comment on alternative 
benchmarking methodologies that may incorporate data sources other than 
Medicare FFS expenditure trends, such as by incorporating factors based 
on Medicare Advantage rates, or other published trends.
    We also solicited comment on considerations related to the 
potential use of our authority under section 1899(i)(3) of the Act to 
implement suggested modifications to the benchmarking methodology, in 
particular alternative approaches to updating the historical benchmark 
or other alternative benchmarking methodologies that diverge from the 
requirements of section 1899(d)(1)(B)(ii) of the Act, since to do so we 
must determine that the alternative payment methodology will improve 
the quality and efficiency of items and services furnished to Medicare 
beneficiaries, without resulting in additional program expenditures.
    The following is a summary of the public comments we received and 
our response.
    Comment: Commenters suggested a number of alternative approaches 
for addressing the impact of an ACO's own performance on its benchmark 
or countering the potentially adverse effects of removing the ACO's 
assigned beneficiaries from regional expenditure calculations 
including:
     Several commenters suggested that CMS should expand the 
definition of regional service area in cases where ACO market 
penetration is high, with some of those commenters suggesting this 
would mitigate concerns about the reference population being too small 
after removing the ACO's assigned beneficiaries. Some commenters 
specifically called for using a threshold of 50 percent market 
penetration in such an approach. For example, a commenter recommended 
expanding the ACO's regional service area to include all contiguous 
counties when an ACO's assigned beneficiary population in a county 
exceeds 50 percent, with allowances for alternate thresholds to be used 
in certain special cases, such as: When the ACO's regional service area 
includes very small counties to expand the ACO's regional service area 
to include the contiguous counties; when an ACO represents more than 50 
percent of a combined statistical area, to use national inflation in 
place of regional inflation; or when there are significant risk score 
differences between assigned and non-assigned beneficiaries, to 
consider using a lower threshold for expanding the ACO's regional 
service area to include contiguous counties, such as a threshold of at 
least 30 percent or higher, instead of 50 percent.
     One commenter, concerned about the potential for ``cherry-
picking'', suggested using geographic units smaller than counties to 
define an

[[Page 65302]]

ACO's regional service area as these geographic units may be more 
socio-economically homogenous; alternatively, the commenter suggested 
maintaining a county-level definition of region, but adjusting the 
benchmarking process to adequately account for beneficiary social, 
functional, and clinical risk factors and to provide an upward 
financial adjustment for ACOs serving these higher cost populations. 
Along a similar vein, several commenters encouraged CMS to explore 
further ways to stratify benchmarks based on patient risk factors, such 
as to set separate benchmarks for certain high-cost patients.
     MedPAC suggested modifications to both the national and 
regional components of the blended national-regional trend factors. 
MedPAC also suggested that CMS alter the calculation of regional 
spending in the trend factor by extending the ACO's regional service 
area to a larger market area (for example, CBSAs, health service areas, 
or hospital referral regions) in lieu of excluding ACO assigned 
beneficiaries from regional expenditure calculations. Based on its own 
analysis, MedPAC concluded that expanding an ACO's regional service 
area would help to reduce an ACO's influence on its regional benchmark 
calculation without explicitly favoring certain categories of ACOs (for 
example, historically low-spending ACOs). MedPAC also suggested that 
the national portion of the blended national-regional trend factor 
could be standardized for average wages or adjusted to reflect local 
wage and geographic practice indices.
     Some commenters suggesting removal of ACO assigned 
beneficiaries from the regional reference population also suggested 
that CMS use a regional-only trend rather than a national trend or a 
blended national-regional trend in establishing and updating the ACO's 
benchmark. These commenters explained that the use of a blended trend 
factor often over-emphasizes the national trend component for high 
market share ACOs and that this is especially problematic during the 
COVID-19 pandemic because the national trend does not reflect important 
local market dynamics that vary across the country. Specifically, these 
commenters noted that in 2020 regional spending decreased by 10 percent 
or more in some markets, while remaining relatively ``flat'' in other 
markets. These commenters concluded that ACOs in COVID-19 ``hot spots'' 
likely have higher costs than the overall nation, and therefore, using 
the national trend as part of the benchmarking methodology is 
detrimental and unfair to these ACOs as it does not reflect the 
pandemic's effect on costs in their regions. Another commenter 
generally suggested that CMS adjust blended national-regional growth 
rates to account for ACOs in COVID-19 ``hot spots'', but did not 
provide details describing such an approach.
     Several commenters suggested that CMS consider approaches 
being used in Innovation Center models. Several commenters suggested 
CMS use an approach under the Shared Savings Program similar to the 
approach used in the Direct Contracting Model to adjust benchmarks 
based on regional FFS expenditures. For example, MedPAC specifically 
suggested that ACOs selecting prospective assignment be offered a trend 
factor that is set prospectively prior to the start of the performance 
year and developed utilizing the local and national estimates in the 
rate book developed for the Direct Contracting model. In its comments, 
MedPAC underscored that any changes that CMS considers making to the 
benchmarking methodology should enhance incentives for care improvement 
and avoid penalizing ACOs with assigned beneficiary populations that 
are more complex and costly than the ACO's regional average. Several 
commenters suggested that CMS establish additional benchmark options 
based on patient population and clinical need, especially for complex 
patient populations, referring to the approaches used under the Primary 
Care First Seriously Ill Population model and Direct Contracting model 
High Needs track.
     One commenter suggested that CMS take the following 
approach to incentivize participation and retention among ACOs, 
regardless of their initial efficiency relative to their region: (1) 
Continue to have ACOs move to increased (50 percent to 100 percent) 
regional weighting over time; (2) For ACOs more efficient (lower 
spending) than their region, apply only positive regional adjustments; 
(3) For ACOs less efficient (higher spending) than their region, allow 
for purely historical benchmarks until the ACO moves below the regional 
average.
     Several commenters expressed concerns about use of 2020 
and 2021 data in establishing ACO historical benchmarks because of the 
impact of the COVID-19 PHE on expenditures. One commenter suggested 
that CMS waive the requirement in Sec.  425.601 that the benchmark is 
established or reset using data from the three most recent years prior 
to the start of the agreement period, and instead utilize data from 
2017, 2018 and 2019 to establish or reset benchmarks for agreement 
periods that begin on January 1, 2022. This commenter suggested that 
CMS could alternatively offer ACOs with agreement periods beginning 
January 1, 2022, the option to choose use of benchmark year data either 
from 2019, 2020 and 2021 or from 2017, 2018 and 2019. Another commenter 
suggested CMS adjust how performance years 2020 and 2021 will be 
weighted in the calculation of financial benchmarks for future 
agreement periods.
    Response: We will take these comments into consideration as we 
contemplate additional refinements to the Shared Savings Program's 
benchmarking methodologies and will propose any specific policy 
changes, if deemed appropriate, in future notice and comment 
rulemaking.
    For reference, as noted in the CY 2022 PFS proposed rule (86 FR 
39294), for each calendar year, CMS releases two public use files 
(PUFs): (1) County-level Aggregate Expenditure and Risk Score Data on 
Assignable Beneficiaries PUF, and (2) Number of ACO Assigned 
Beneficiaries by County PUF. These files are available online at 
https://www.cms.gov/Research-Statistics-Data-and-Systems/Downloadable-Public-Use-Files/SSPACO/SSP_Benchmark. Stakeholders may find this data 
helpful to inform their further consideration of these issues.
c. Comments on the Shared Savings Program's Risk Adjustment Methodology
    In the CY 2022 PFS proposed rule (86 FR 39294 and 39295), we 
discussed stakeholders' concerns about the methodology for risk 
adjusting the ACO's historical benchmark each performance year during 
its agreement period, and we sought comment on approaches to 
potentially address these concerns, and some related considerations. 
The following is a summary of the comment solicitations, the comments 
we received and our response.
    As described in the CY 2022 PFS proposed rule, we take into account 
changes in severity and case mix of the ACO's assigned beneficiary 
population when establishing the benchmark and also in adjusting the 
benchmark each performance year. In accordance with Sec.  
425.601(a)(3), in establishing the benchmark, we adjust expenditures 
for changes in severity and case mix using prospective HCC risk scores. 
Under Sec.  425.601(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

[[Page 65303]]

beneficiary population between BY3 and the performance year (refer to 
Sec.  425.601(a)(10); Sec.  425.605(a)(1), (a)(2); Sec.  425.610(a)(2), 
(a)(3)). In making 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). We use CMS-HCC prospective 
risk scores to adjust the historical benchmark for changes in severity 
and case mix for all assigned beneficiaries, subject to a cap of 
positive 3 percent for the agreement period. This cap is the maximum 
increase in risk scores allowed for each agreement period, such that 
any positive adjustments between BY3 and any performance year in the 
agreement period cannot be larger than 3 percent. That is, the risk 
ratios (ratio of performance year risk score to the BY3 risk score) 
applied to historical benchmark expenditures to capture changes in 
health status between BY3 and the performance year will never be higher 
than 1.030 for any performance year over the course of the agreement 
period. This cap is applied separately for the population of 
beneficiaries in each Medicare enrollment type.\138\
---------------------------------------------------------------------------

    \138\ Refer to the December 2018 final rule (83 FR 68007 through 
68013), section on ``Risk Adjustment Methodology for Adjusting 
Historical Benchmark Each Performance Year''. See also, the Medicare 
Shared Savings Program, Shared Savings and Losses and Assignment 
Methodology Specifications (version #9, February 2021), section 3.6, 
available at https://www.cms.gov/files/document/medicare-shared-savings-program-shared-savings-and-losses-and-assignment-methodology-specifications.pdf-0.
---------------------------------------------------------------------------

    ACOs and other stakeholders have expressed concerns that the 
program's methodology for capping any increase in the risk adjustment 
to the historical benchmark, such that any positive adjustment between 
benchmark year 3 and any performance year in the agreement period 
cannot be larger than 3 percent, does not account for risk score growth 
in the ACO's regional service area, and thereby penalizes 
ACOs.139 140 In earlier rulemaking, commenters indicated 
that the 3 percent cap on risk score increases is especially 
problematic for ACOs whose regional service area includes a population 
of beneficiaries whose risk scores rise more than the cap. A commenter 
encouraged CMS to adopt a policy of applying a cap on risk score growth 
after accounting for regional increase in risk scores (85 FR 84784).
---------------------------------------------------------------------------

    \139\ 85 FR 84783 through 84785.
    \140\ Aledade, ``Opportunities for 2022 Improvements to MSSP 
ACOs in the Physician Fee Schedule'' (June 2021), provided as a 
document during E.O. 12866 Meeting (CMS-1751), available at https://mobile.reginfo.gov/public/do/viewEO12866Meeting?viewRule=false&rin=0938-AU42&meetingId=49323&acronym=0938-HHS/CMS.
---------------------------------------------------------------------------

    In the CY 2022 PFS proposed rule, we solicited comment on the 
following issues related to the risk adjustment methodology--
     Approaches, generally, to improving the risk adjustment 
methodology for the Shared Savings Program, and specifically for ACOs 
with medically-complex, high-cost beneficiaries.
     Approaches to risk adjustment that would balance the need 
for accurate and complete coding, while protecting against 
incentivizing coding intensity initiatives by ACO participants and ACO 
providers/suppliers (which may be even more problematic for ACOs with 
high penetration in their region) that increase risk score growth above 
the existing 3 percent cap.
     Alternate approaches that would increase the cap on an 
ACO's risk score growth in relation to risk score growth in the ACO's 
regional service area, such as:
    ++ Allowing the ACO risk score growth cap to increase by a 
percentage of the difference between the current 3 percent cap and risk 
score growth in the ACO's regional service area. In this alternate 
approach, the percentage applied would be equal to 1 minus the ACO's 
regional market share. This approach would raise the existing cap while 
limiting the ability for ACOs with high penetration in their region to 
increase their cap by engaging in coding intensity initiatives that 
raise the regional risk score.
    ++ Setting the ACO risk score growth cap at some level between the 
existing 3 percent risk score cap and the regional risk score growth, 
which would account for a portion of the regional risk score growth 
that exceeds the current cap.
     The potential interactions between policies to remove 
assigned beneficiaries from the assignable beneficiary population used 
to calculate regional FFS expenditures and growth rates (as described 
elsewhere in this section of this final rule), and policies addressing 
regional risk score growth.
    Comment: Several commenters responding to the comment solicitation 
on the Shared Savings Program's risk adjustment methodology explained 
that risk adjustment is an important aspect of setting fair ACO 
benchmarks and evaluating expenditures during the performance year. The 
commenters noted that accurate risk adjustment should remove or 
minimize differences in health and other risk factors that impact 
performance but are outside the ACO's control.
    MedPAC indicated that the existing risk adjustment approach may be 
effective in balancing a number of considerations. MedPAC expects that 
changes in an ACO's population health status would be accounted for by 
the CMS-HCC model, and the current 3 percent potential increase to 
benchmarks--in addition to being susceptible to rewarding ACOs for 
coding--would likely cover anomalies when ACO populations have 
deteriorating health status. Another commenter expressed the belief 
that, while not perfect, the CMS-HCC model used in the Shared Savings 
Program is known to providers and does a decent job of capturing the 
risk of Medicare FFS beneficiaries.
    Many commenters remain concerned about the existing risk adjustment 
methodology under which there is a 3 percent cap on positive 
adjustments resulting from risk score increases over the ACO's 5-year 
agreement period, and many of these commenters also expressed concern 
about the absence of a cap (or floor) on negative adjustments to 
account for risk score decreases. Several commenters believe the 
current approach is unfair to ACOs and inadequate, indicating that risk 
adjustment caps may be somewhat reasonable in the early years of a 5-
year agreement period, but not in the later years of the agreement 
period. One commenter noted that freezing risk scores over 5 years 
could create a constant struggle against a population's outdated risk 
score (calculated several years earlier) for which ACOs are at 
financial risk. The commenter also explained that CMS has already 
recognized the necessity of shorter-term caps on risk and price 
adjustments, referring to the Bundled Payments for Care Improvement 
initiative (trend factor variation capped on a quarter-over-quarter 
basis) and the Next Generation ACO model (risk scores capped at 3 
percent over 2 years). Some commenters referred to an analysis by CMS 
described in earlier rulemaking which indicated that 32 percent of ACOs 
would have a risk ratio greater than 1.03 for the aged/dual eligible 
enrollment type over 5 years. According to some of these commenters, 
this analysis demonstrates that the current 3 percent cap is not 
appropriately set as it limits risk score growth for more than just 
outliers. With respect to a cap on risk score decreases, a few 
commenters noted that CMS had previously been hesitant to introduce 
such a cap out of concern about creating a gaming opportunity for ACOs. 
It appears that these commenters may have been

[[Page 65304]]

referring to the discussion in the December 2018 final rule (83 FR 
68010 and 68011), in which CMS explained that it shared the concerns 
raised by some commenters that capping risk score decreases would 
encourage favorable risk selection, such that ACOs might seek to 
attract low-cost beneficiaries or avoid high-cost beneficiaries in 
order to lower their performance year expenditures without any 
corresponding adjustment to their benchmark due to the cap on negative 
risk adjustments. These commenters believed that CMS has other tools 
for monitoring for potential gaming, such as continuing to monitor 
voluntary alignment, but they did not explain how such monitoring would 
address CMS' concerns about capping risk score decreases.
    Some commenters raised particular concerns about the current risk 
adjustment policy in light of the PHE for COVID-19. Several commenters 
raised concerns regarding the application of a 3 percent cap on risk 
score increases over the ACO's 5-year agreement period and the lack of 
a floor for risk score decreases given the widespread and unparalleled 
effects of the PHE for COVID-19. A few commenters indicated their 
expectation that most ACOs' risk scores for 2021 will be extremely low 
as providers were unable to capture many beneficiaries' HCCs due to 
reduced patient volume in 2020. They explained that if in-person 
patient volume resumes in 2021, 2022, and beyond, ACOs will likely have 
a significant increase in risk scores simply because patients are once 
again receiving care in physicians' offices. One commenter suggested 
that beneficiaries may also have worse health status due to delayed 
diagnosis and delay in seeking care, providing the example of hospitals 
noting significant increases in case mix index (CMI) for hospitalized 
patients related to these delays. Several commenters suggested that 
more ACOs will be subject to the existing 3 percent cap under these 
circumstances. One commenter noted that the current risk adjustment 
methodology could penalize ACOs for patients' need to stay in the 
safety of their homes during the pandemic. Another commenter indicated 
that ACOs could be forced to exit the Shared Savings Program as a 
result.
    Many commenters also remained concerned that the current policy 
places a cap on the ACO's risk score growth but does not restrict 
regional risk score growth. Commenters noted that this penalizes ACOs 
in markets where a region's risk score growth exceeds the cap. To 
illustrate this, some commenters gave the example of a case where both 
the ACO's risk score and the regional risk score grow by 6 percent. In 
this circumstance, the benchmark would be reduced by 3 percent, despite 
the fact that the ACO's risk score growth matched that of the region. 
Several commenters provided examples based on 2020 data, noting that 
the average risk ratio for counties above 1.03 was 1.042 in the aged/
non-dual eligible population and was 1.055 in the dual eligible 
population, indicating a larger negative impact for this more 
vulnerable population. One commenter suggested that higher risk score 
growth at the county level is due to underlying population changes and 
once a county diverges from the national average it will continue in 
that direction without reversion to the mean. As a result, the 
commenter suggested that the problem of these negative impacts would 
continue unless CMS modifies the risk adjustment methodology using the 
approach described in the CY 2022 PFS proposed rule, which would allow 
the ACO risk score growth cap to increase by a percentage of the 
difference between the current 3 percent cap and risk score growth in 
the ACO's regional service area. Another commenter suggested that by 
including a cap on the ACO's risk score, but not on risk score growth 
for the region, CMS is creating new incentives that run counter to the 
original purpose of CMS-HCC risk adjustment, which the commenter 
believed is to level the playing field and remove disincentives for 
treating high cost patients. Several commenters indicated that the 
increased variation in risk scores introduced by the COVID-19 pandemic 
has further demonstrated the impact of the 3 percent cap on risk score 
growth in reducing ACO benchmarks, when risk score growth in the ACO's 
region exceeds the ACO's risk score growth. MedPAC did not appear to 
support aligning ACO and regional risk score growth out of concern that 
this would effectively reward ACOs for greater coding intensity in 
their region, particularly for those with higher market share.
    Several commenters suggested that the existing policy is also 
driving inequity and may disadvantage ACOs that serve more vulnerable 
populations or beneficiaries with complex medical needs. Some 
commenters explained that beneficiaries who are in the disabled and the 
aged/dual eligible Medicare enrollment types are, in most combinations, 
more than twice as likely to have risk score growth above the cap as 
those who are in the aged/non-dual eligible category. Some commenters 
indicated that due to a variety of factors, such as sample size and 
volatility, the rates at which Medicare enrollment types are subject to 
the 3 percent cap on risk score growth are often significantly 
different. A commenter explained that there can also be significant 
risk score volatility when the high-risk patient population is small. 
As a result of these factors, some commenters explained that the 
current approach may disadvantage ACOs that serve more vulnerable 
populations (such as ACOs composed of community health centers), or 
ACOs that serve a disproportionate number of dual eligible patients 
needing complex services (such as ACOs based around an academic medical 
center). A commenter stated that there currently exists a disincentive 
for ACOs to take on certain vulnerable populations, such as 
beneficiaries with ESRD or who need SNF-level care. However, another 
commenter noted that the current model has some protections for ACOs 
that experience a disproportionate increase in the medical complexity 
of their population, highlighting that the current risk adjustment 
method makes separate adjustments for assigned beneficiaries in each 
enrollment type, which allows ACOs to increase the proportion of their 
ESRD, dual eligible, and disabled populations without being affected by 
the 3 percent cap.
    Commenters seemed to offer differing perspectives on CMS' concerns 
about creating incentives for coding initiatives including:
     MedPAC expressed support for CMS' considerable caution in 
this area, noting that population-based models can be highly 
susceptible to coding incentives and that the Shared Savings Program 
does not include a retrospective coding adjustment to offset these 
incentives. MedPAC recommended that CMS should address the underlying 
incentives for coding intensity and the accuracy of risk adjustment 
before considering any policy that would increase the risk score growth 
cap.
     One commenter that was supportive of the approach CMS 
described in the CY 2022 PFS proposed rule, under which an ACO's risk 
score growth cap would be allowed to increase by a percentage of the 
difference between the current 3 percent cap and risk score growth in 
the ACO's regional service area, believed this approach would continue 
to insulate CMS from coding intensity.
     One commenter stated that capping positive risk score 
growth at 3 percent over the 5-year agreement period, while intended to 
limit incentives for coding intensity, has the effect of harming

[[Page 65305]]

ACOs that provide care and services to beneficiaries with complex 
medical needs, and suggested that this approach does not adequately 
account for changes in beneficiaries' disease burden over time. Another 
commenter stated that CMS should abolish the policy of capping year-
over-year risk-score growth, as CMS does not want ACOs to ``cherry 
pick'' patients or avoid providing care to high-risk, high-cost 
beneficiaries. The commenter explained its belief that by encouraging 
ACOs to properly code the risk of their beneficiary population, CMS 
would help to ensure ACOs will have necessary resources to invest in 
infrastructure and serve higher-risk patients more effectively.
     A few commenters explained that the current methodology of 
normalizing risk adjustment in a region can penalize ACOs that have 
been coding accurately and whose beneficiaries maintain the same health 
status over the course of the ACO's agreement period. Under this 
scenario, an ACO could see a decrease in its risk score if others in 
its region increase their coding intensity. The commenters indicated 
that this issue is further exacerbated for ACOs that include a large 
number of specialists, since they have fewer opportunities to increase 
their risk score, but did not explain why they believed this to be the 
case.
    Commenters suggested a variety of alternative approaches to risk 
adjusting historical benchmarks each performance year during the ACO's 
agreement period, including the suggestions summarized below.
    Response: We will take these comments into consideration as we 
contemplate additional refinements to the Shared Savings Program's 
benchmarking methodologies and will propose any specific policy 
changes, if deemed appropriate, in future notice and comment 
rulemaking.
    Comment: Commenters also offered suggestions related to the 
following issues:
    Suggestions for capping positive/negative risk score adjustments 
included the following:
     Many commenters suggested that CMS increase the cap on 
risk score growth during an ACO's 5-year agreement period to no less 
than 5 percent and implement a floor of no greater than negative 5 
percent for risk score decreases. A commenter requested that CMS 
consider applying a cap on risk score growth of 10 percent over 5 
years.
     Several commenters suggested that CMS should consider 
temporarily removing or increasing the 3 percent cap following an 
anomalous year, such as 2020, during which risk scores were impacted by 
the COVID-19 pandemic.
     A commenter suggested that CMS implement a floor on the 
risk score, adjust for the effects of COVID-19, and apply a cap on risk 
score increases, if any, that is the same for all Medicare populations, 
including Medicare Advantage.
     Some commenters encouraged CMS to cap the aggregate risk 
ratio across Medicare enrollment types. They indicated that this would 
be more fair because the rates at which Medicare enrollment types are 
subject to the 3 percent cap on risk score growth are often 
significantly different, due to a variety of factors, such as sample 
size and volatility.
     A commenter recommended that, at a minimum, CMS should 
increase the cap on risk score growth for high-risk populations 
(specifically, ESRD, aged/dual eligible and disabled), to ensure 
vulnerable beneficiaries are better served by Shared Savings Program 
ACOs.
    Suggestions for addressing differences in risk score growth between 
the ACO and the ACO's regional service area included the following:
     A few commenters noted their support for modifying the 
risk adjustment methodology to enable the risk score growth cap to 
increase by a percentage of the difference between the current 3 
percent cap and risk score growth in the ACO's regional service area, 
with a commenter explicitly citing the approach described in the 
proposed rule in which the percentage applied to the difference would 
equal 1 minus the ACO's market share. The commenter, who believes this 
change should be applied retroactively to at least performance year 
2021, explained that removing an ACO's assigned beneficiaries from its 
regional trend would simplify the equation because an ACO could no 
longer impact its regional risk score.
     Some commenters 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. Some commenters also called for 
this approach to be applied retroactively beginning with performance 
year 2021. A number of the commenters who supported aligning ACO and 
regional risk score growth caps also called for increasing the cap on 
positive risk score adjustments and applying a cap on negative risk 
score adjustments.
    Other suggestions related to Shared Savings Program risk adjustment 
included the following:
     MedPAC recommended that CMS use 2 years of diagnostic data 
for risk adjustment as permitted under the 21st Century Cures Act, 
which they believe would improve the accuracy of coefficients estimated 
with FFS data and reduce year-to-year variation in beneficiary risk 
scores, along with reducing the administrative burden for ACO 
participants related to HCC documentation. MedPAC further suggested 
that CMS should only consider changes to the 3 percent cap after making 
this suggested change and after observing the effect of the phase-in 
from 2020 to 2022 of the Alternative Payment Condition Count (APCC) 
CMS-HCC risk adjustment model, which they noted was designed to improve 
the accuracy of risk adjustment for high-spending beneficiaries.
     Several commenters suggested that CMS adopt a single 
(standardized) approach for measuring the health status of a population 
across Medicare Advantage and Medicare ACO initiatives. Some commenters 
suggested, for example, that CMS recalibrate the risk adjustment 
methodology across all Medicare programs and models by updating the HCC 
Model to use ICD-10 codes to improve accuracy, refining HCC diagnoses, 
and incorporating social determinants of health. Several commenters 
suggested that, at a minimum, CMS should align the risk adjustment 
methodology used in the Shared Savings Program's ENHANCED track with 
Medicare Advantage. Another commenter suggested that CMS examine the 
risk adjustment methodology in general and analyze how fairly it is 
applied within both Medicare Advantage and traditional Medicare.
     Several commenters encouraged CMS to consider including 
social risk factors in the risk adjustment models used for ACO 
benchmarking. A commenter suggested this could be an incentive for ACOs 
to improve social risk and demographic data collection. Another 
commenter suggested that including factors related to a patient's 
background (for example, sociodemographic status, language, and post-
discharge support structure) in the risk-adjustment methodology could 
reduce barriers to more robust participation by safety net hospitals.
     A few commenters encouraged CMS to examine coding patterns 
on a local/regional level and to employ a more ``veracious'' approach 
to calculating coding intensity adjustment factors that considers the 
increasing prevalence of chronic disease in a region, noting that the 
current Shared Savings Program risk adjustment methodology attributes 
all

[[Page 65306]]

growth in risk scores beyond demographic risk entirely to coding 
intensity when populations may instead be increasingly chronically ill 
or have a different burden of illness between the baseline population 
and the attributed population.
     A commenter encouraged CMS to explore ways to implement 
the Innovation Center's concurrent HCC risk adjustment model in the 
Shared Savings Program, explaining that such models are better able to 
predict costs for populations with high disease burden or who are 
otherwise seriously ill, as they can better capture a rapid 
deterioration in health in the current year, such as through the 
occurrence of acute episodes that are difficult to predict or prevent 
(for example, heart attacks).
     Several commenters suggested that CMS avoid establishing a 
risk adjustment methodology that creates adverse incentives for 
practices to select or avoid certain beneficiaries based on their 
health risk status. A commenter detailed a combination of policies to 
achieve this, including some that related to ACO and regional risk 
score caps. Specifically, the commenter recommended: Establishing a 
risk adjustment cap that accounts for the size of the ACO's assigned 
beneficiary population (in recognition of the fact that a smaller 
assigned beneficiary population will be more volatile in terms of 
utilization and costs and may not be comparable risk-wise to other ACOs 
in the region); considering an ACO's assigned beneficiary population 
break-down across dual eligible and non-dual eligible beneficiaries 
when calculating the cap; capping the reference population risk score 
in the same way that the ACO population risk score is capped prior to 
normalizing; considering the proportion of vulnerable populations a 
given ACO serves; and looking to the Innovation Center's risk 
adjustment methodologies, and applying promising practices as 
appropriate in the Shared Savings Program.
     A commenter suggested that CMS consider applying a frailty 
adjustment in the Shared Savings Program risk adjustment methodology 
such as is used in the PACE program.
     A commenter suggested that CMS consider excluding 
unforeseeably expensive Part B drugs from Shared Savings Program 
benchmark and performance year expenditure calculations, or otherwise 
accommodating these costs. The commenter explained that pharmaceuticals 
represent an area of rapid technological improvement that has 
increasingly been accompanied by extremely high acquisition costs. As a 
result, the commenter believed that these products create cost 
imbalances between benchmark and performance periods that are not 
sufficiently addressed through risk adjustment.
    Response: We will take these comments into consideration as we 
contemplate additional refinements to the Shared Savings Program's 
benchmarking methodologies and will propose any specific policy 
changes, if deemed appropriate, in future notice and comment 
rulemaking.

K. Medicare Ground Ambulance Data Collection System

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 under section 1834(l) 
of the Act. 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 and three temporary add-on 
payments to the base rate and/or mileage rate. The two permanent add-on 
payments at Sec.  414.610(c)(5)(i) are: (1) A 50 percent increase in 
the standard mileage rate for ground ambulance transports that 
originate in rural areas where the travel distance is between 1 and 17 
miles; and (2) a 50 percent increase to both the base and mileage rate 
for rural air ambulance transports. The three temporary add-on payments 
at sections 1834(l)(12)(A) and (13)(A) of the Act and Sec.  414.610 
are: (1) A 3 percent increase to the base and mileage rate for ground 
ambulance transports that originate in rural areas; (2) a 2 percent 
increase to the base and mileage rate for ground ambulance transports 
that originate in urban areas; and (3) a 22.6 percent increase in the 
base rate for ground ambulance transports that originate in ``super 
rural'' areas. Section 50203(a)(1) and (2) of the Bipartisan Budget Act 
(BBA) of 2018 (Pub. L. 115-123, February 9, 2018) includes an extension 
of the temporary add-on payments through December 31, 2022.
    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. Statutory Requirements for the Ground Ambulance Providers and 
Suppliers To Submit Cost and Other Information
    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 to submit cost and other information. 
Specifically, section 1834(l)(17)(A) of the Act requires the Secretary 
to develop a data collection system (which may include use of a cost 
survey) to collect cost, revenue, utilization, and other information 
determined appropriate by the Secretary for providers and suppliers of 
ground ambulance services. Section 1834(l)(17)(B)(i) of the Act 
requires 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 requires 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. Section 1834(l)(17)(F) of the Act 
requires that no later than March 15, 2023 and as determined necessary 
by MedPAC, MedPAC must submit a report to Congress on the information 
submitted by the ground ambulance providers and suppliers through the 
data collection system on the adequacy of payments for ground ambulance 
services and geographic variations in the cost of furnishing such 
services.
    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

[[Page 65307]]

reporting by ground ambulance providers and suppliers (referred 
collectively as ``ground ambulance organizations'') at Sec. Sec.  
414.601, 414.605, 414.610(c)(9), and 414.626. In the CY 2020 PFS final 
rule (84 FR 62863 through 629897), we 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. This instrument includes the 
specific questions that will be asked of ground ambulance organizations 
about the total service volume, costs, and revenue associated with a 
provider or supplier's entire ground ambulance organization in such a 
way that MedPAC could use to calculate an average cost per ground 
ambulance transport. In the CY 2022 PFS proposed rule (86 FR 39295), we 
referred the reader to our CY 2020 PFS final rule (84 FR 62863 through 
62897) for more specifics on the establishment of the Medicare Ground 
Ambulance Data Collection System.
3. Revisions to the Medicare Ground Ambulance Data Collection 
Instrument
    As described in the CY 2020 PFS final rule (84 FR 62867), the 
Medicare Ground Ambulance Data Collection Instrument uses screening 
questions and skip patterns so that it is applicable to all ground 
ambulance organizations regardless of their size, scope of operations 
and services offered, and structure. We stated that we believe this 
approach is easier to navigate and less time consuming to complete than 
a cost report template or instrument and that it minimizes respondent 
burden by directing ground ambulance organizations to only view and 
respond to questions that apply to their specific type of organization, 
all while still collecting the information required in sections 
1834(l)(17)(A) of the Act.
    The CY 2020 PFS final rule provided a detailed overview of the 
elements of the data collection instrument, including questions to 
collect information on costs, revenues, utilization (which CMS defines 
for the purposes of the data collection instrument as service volume 
and service mix), as well as the characteristics of ground ambulance 
organizations. Table 38 includes a high-level summary of the 13 
sections of the Medicare Ground Ambulance Data Collection Instrument.
[GRAPHIC] [TIFF OMITTED] TR19NO21.060

    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 three primary channels. 
First, we receive email and other 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 to commonly asked questions. This 
document is available on the CMS website at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html. Through review of

[[Page 65308]]

questions and feedback, we have 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. Second, our contractor also asked a 
small number of ground ambulance organizations to complete and provide 
feedback on a paper version of the Medicare Ground Ambulance Data 
Collection Instrument. This feedback was helpful to identify some 
additional opportunities for clarification. Third, we continue to 
identify opportunities to clarify instructions and correct a small 
number of typos as we work to develop the web-based, programmed version 
of the Medicare Ground Ambulance Data Collection Instrument.
    Based on information that we received via the three sources 
described above, in the CY 2022 PFS proposed rule (86 FR 39296), we 
proposed the following changes and clarifications to the Medicare 
Ground Ambulance Data Collection Instrument. The changes and 
clarifications aim to reduce burden on respondents, improve data 
quality, or both.
    We received public comments on our overall changes and 
clarifications to the Medicare Ground Ambulance Data Collection System. 
The following is a summary of the comments we received and our 
responses.
    Comment: Some commenters noted their general support for our 
proposed modifications to the Medicare Ground Ambulance Data Collection 
System. A commenter stated that its member organizations are 
appreciative of CMS' previous solicitation of stakeholder feedback in 
the development of the survey tool. A commenter supported CMS efforts 
to provide and update the Frequently Asked Questions (FAQ) for the 
Medicare Ground Ambulance Data Collection document and ongoing efforts 
to create clarity around this system. However, this commenter stated 
that the process is still complex and cumbersome and may prevent 
compliance from ground ambulance organizations. A commenter supported 
the agency collecting information on ground ambulance cost, revenue, 
utilization and other information, however, the commenter reminded CMS 
that this data is for purposes of assessing the adequacy of Medicare 
payments for ground ambulance services and that any data collected that 
are not directly for this purpose would be improper and not add value 
to this purpose and intent.
    Response: We appreciate the overall support for the changes and 
clarifications to the Medicare Ground Ambulance Data Collection System. 
The data collected through the Medicare Ground Ambulance Data 
Collection System will provide us with the necessary information needed 
to determine the adequacy of Medicare payment rates for ground 
ambulance services and geographic variations in the costs of furnishing 
such services, as well as the data MedPAC needs to prepare its 
statutorily-required report to Congress. We have attempted to limit the 
complexity and administrative burden of the Medicare Ground Ambulance 
Data Collection System as much as possible while ensuring that the 
collected data satisfy these statutory requirements.
a. Change to the Shared Services Questions in Section 2 (Organizational 
Characteristics)
    One component of the data collection instrument is ground ambulance 
organization characteristics, which is information regarding the 
identity of the organization and respondent(s) service area, ownership, 
response time, and other characteristics (84 FR 62871 through 62875). 
One characteristic on which we sought information is organization type, 
including whether costs are shared with fire or police response or 
health care delivery operations (84 FR 62871). The instrument contains 
a number of questions that are relevant to the issue of shared costs.
    Section 2, Question 7 asks ``Which category best describes your 
ground ambulance operation?'' and allows respondents to select one of 
the following options:
    (a) Fire department-based; (b) Police or other public safety 
department-based (including all-hazards public safety organizations); 
(c) Government stand-alone emergency medical services (EMS) agency; (d) 
Hospital or other Medicare provider of services (such as skilled 
nursing facility); (e) Independent/proprietary organization primarily 
providing EMS services; (f) Independent/proprietary organization 
primarily providing non-emergency services; or (g) Other (please 
specify).
    Section 2, Question 8 subsequently requests respondents answering 
a, b, or d to Question 7 to ``confirm that your ground ambulance 
operation shares operational costs, such as building space or 
personnel, with these other operations.'' Section 2, Question 9 asks 
``Does your ground ambulance operation share any operational costs, 
such as building space or personnel, with one of the following,'' 
offering respondents the following options: (a) A fire department (not 
presented if the response to Section 2, Question 7 is ``a''); (b) A 
police or other public safety department (not presented if the response 
to Section 2, Question 7 is ``b''); (c) A hospital or other Medicare 
provider of services (such as a skilled nursing facility) (not 
presented if the response to Section 2, Question 7 is ``d''); (d) 
Another healthcare organization (excluding hospitals, skilled nursing 
facilities, or other Medicare provider of services); (e) Another 
healthcare organization (excluding hospitals, skilled nursing 
facilities, or other Medicare provider of services); (f) Other 
(specify).
    Collectively, the purpose of these three questions is to collect 
information on whether a portion of organizations' costs and revenues 
may be related to services or operations other than providing ground 
ambulance services. When this occurs, ground ambulance organizations 
are presented with additional instructions specifying how they should 
report costs and revenues associated with providing ground ambulance 
services rather than these other services or operations.
    Based on feedback from ground ambulance organizations, we believe 
the specific wording of Section 2, Question 9 may be confusing. The 
question asks respondents whether they share operational costs with 
``one of the following,'' implying respondents are limited to a single 
response, even though in some cases respondents may wish to select 
multiple responses. Furthermore, ground ambulance organizations may 
have difficulty interpreting the phrase ``share any operational 
costs.'' We received questions from some ground ambulance organizations 
asking whether renting space from a fire department qualified as a 
``shared operational cost.'' The intent of the question was to ask 
about shared ownership and accounting, not renting facility space, 
sharing a physical space with a separate organization, or similar 
business and logistical arrangements.
    In the CY PFS 2022 proposed rule (86 FR 39297), we proposed to 
revise Section 2, Question 9, to read, ``Does your organization provide 
any of the following services or operations (select all that apply)?'' 
retaining the current response options. This proposed change clarifies 
that the intent of Section 2, Question 9 is to collect information on 
services or operations provided by the sampled organization. We 
solicited comments on our proposal regarding reporting shared services.
    We did not receive public comments on this proposal. Therefore, we 
are finalizing our proposal to revise Section

[[Page 65309]]

2, Question 9 to read, ``Does your organization provide any of the 
following services or operations (select all that apply)?'' retaining 
the current response options.
b. Change to Average Trip Time Question
    We stated that the area served by ambulance organizations is an 
important characteristic and finalized a policy to collect information 
on the geographic area served by each ambulance organization in Section 
3 of the data collection instrument (84 FR 62875). We included 
questions related to average trip time in primary and secondary service 
areas (questions 3 and 6 of Section 3) that were important to 
understand how geographic distance between the ground ambulance 
organization's facilities and patients affects costs (84 FR 62873).
    Section 3 (Service Area), Questions 3 and 6 in the instrument ask 
ground ambulance organizations to report their ``average trip time'' 
using a set of categorical time ranges (for example, 30-60 minutes). 
These questions define average trip time as ``the time the ambulance 
leaves the station to when that ambulance is available to take another 
call.'' Based on feedback from ground ambulance organizations, we 
believe this definition may be confusing in cases where an ambulance 
responds to a call from a location other than the station (for example, 
while en route to another call, from a standby event, or from a 
hospital). Based on the literal wording of the question, it is not 
clear whether and if so, how ground ambulance organizations should 
report trip times for responses not originating at a station when 
responding to this question, leading to potentially missing or biased 
data.
    In the CY 2022 PFS proposed rule (86 FR 39297), we proposed that 
this question be revised to ask for ``average time on task'' defined as 
``from the time an ambulance begins its response to the time when the 
ambulance is available to respond to another call (that is, time on 
task)'' to better capture interfacility transfers and situations when 
an ambulance is already out and responds from a site other than the 
central station. We believe this change in the wording of the question 
will be clearer to respondents and will result in higher-quality 
reported data. We solicited comments on our proposal to change the 
definition of the average trip time.
    We received public comments on our proposal to revise the average 
trip time question. The following is a summary of the comments we 
received and our responses.
    Comment: A commenter indicated that time on task could be difficult 
to calculate for many organizations. The commenter provided an example 
where an ambulance transports a patient to the hospital and while 
returning to the station, the ambulance crew is assigned to another 
call. In this example, the crew may not have completed the patient care 
report for the first call, so accurately documenting time on task will 
prove to be difficult.
    Response: We recognize that not all ground ambulance organization 
may track time on task as proposed. However, we heard from some ground 
ambulance organizations that the initial question wording requesting 
for ``average trip time'' would be problematic for other reasons. 
Specifically, our initial definition of ``average trip time'' only 
applied to situations where the ambulance left from a station. We 
believe that this change will provide ground ambulance organizations 
with greater flexibility to report information regarding the active 
time for their ambulance crews.
    After consideration of public comments, we are finalizing our 
proposed revision to the average trip time question to request for 
``average time on task'' defined as ``from the time an ambulance begins 
its response to the time when the ambulance is available to respond to 
another call (that is, time on task)'' to better capture interfacility 
transfers and situations when an ambulance is already out and responds 
from a site other than the central station.
c. Change to Secondary Service Area Instructions
    In Section 3, Question 4 instructions define the secondary service 
area for an organization as ``outside [its] primary service area, but 
one where [it] regularly provide[s] services through mutual or auto-aid 
arrangements. The instruction directs organizations to ``not include 
areas where [they] provide services only under exceptional 
circumstances.'' We were notified that some ground ambulance 
organizations are unsure how to report areas where they (a) did have 
mutual or auto-aid arrangements in place, which aligns with the 
definition of secondary service area in the instructions, but where (b) 
they responded to calls only very rarely, for example once a year, 
which could be considered an ``exceptional circumstance'' and ignored 
for reporting per the instruction.
    Although the instructions leave the determination of whether an 
organization has a secondary service area at the discretion of the 
sampled ground ambulance organization, we believe that some 
organizations may benefit from a rule of thumb or example to help 
assess whether they should or should not report a ZIP code as being 
part of their secondary service area. In the CY 2022 PFS proposed rule 
(86 FR 39297), we proposed to add the following text to the Section 3, 
Question 4 instructions: ``Some, but not all, ground ambulance 
organizations regularly provide service outside of their primary 
service area, for example through mutual or auto-aid agreements with 
nearby municipalities. If this applies to your organization, please 
report areas that are outside your primary service area but where you 
regularly provide services as part of your secondary service area. You 
do not need to report areas where you provide services very rarely or 
only under exceptional circumstances (for example, when participating 
in coordinated national or State responses to disasters or mass 
casualty events). Use your judgment as to whether your organization 
regularly serves a secondary service area. For example, you may choose 
to consider ZIP codes outside your primary service area but where you 
had 5 or more responses during the data collection period as part of 
your secondary service area if you believe these transports have a 
significant impact on your organization's costs.'' Even with this added 
text, ground ambulance organizations could still determine whether they 
do or do not have a secondary service area for the purposes of 
reporting in the Medicare Ground Ambulance Data Collection System. We 
solicited comments on our proposal to revise the secondary service area 
instructions.
    We received a public comment on our proposal to revise the 
secondary service area instructions. The following is a summary of the 
comment we received and our response.
    Comment: A commenter supported our proposed change to the 
instructions in this section of the Medicare Ground Ambulance Data 
Collection Instrument. This commenter stated that many of their primary 
service areas do not follow strict county boundary lines or ZIP code 
designations so the commenter requested that CMS provide additional 
language to clarify how ambulance organizations designate primary 
service areas when the service area is based on the needs of the 
population.
    Response: We appreciate the commenter's support for the proposed 
change. In the instrument, we define primary service area as the set of 
ZIP codes in which the ground ambulance organization is exclusively or 
primarily

[[Page 65310]]

responsible for providing service at one or more levels (that is, Basic 
Life Support (BLS) or Advanced Life Support (ALS)) and in which it is 
highly likely that the majority of the organization's transport pickups 
occur. We appreciate the commenter's point that ground ambulance 
organizations' approaches to determining their primary service area may 
differ. While not all primary service areas will align cleanly with ZIP 
code boundaries, we chose to select a single, uniform, ZIP code-based 
approach for ground ambulance organizations to report service areas in 
order to minimize burden and ensure the collected information is useful 
for analysis as noted in the CY 2020 PFS final rule (84 FR 62874). We 
will continue to provide education and give opportunities to 
organizations to ask questions regarding the Medicare Ground Ambulance 
Data Collection Instrument, including the instructions for reporting 
service areas.
    After consideration of public comments, we are finalizing our 
change to the secondary service area instructions as proposed.
d. Change to the 90th Percentile Emergency Response Time
    Section 4 (Emergency Response Time), Question 3 asks ground 
ambulance organizations to report the 90th percentile emergency 
response time, which the question defines as the time separating the 
quickest 90 percent of responses from the longest 10 percent of 
responses. The intent of the question was to collect information to 
help CMS understand the difference between average response times and 
atypical ``outlier'' response time. In the CY 2020 PFS proposed rule 
(84 FR 40688), we proposed to include a question on average response 
time. As we noted in the CY 2020 PFS final rule (84 FR 62873), several 
commenters to the CY 2020 PFS proposed rule recommended requesting 
ground ambulance organizations to provide 90th percentile response time 
rather than or in addition to the average response time. The commenters 
believed 90th percentile response time is a more accurate indicator of 
ambulance services capabilities and quality. The commenters stated that 
the average time has too wide a range for error, since roughly half of 
responses are quicker/slower than average. The commenters further 
stated that using average response time also tends to flatten the data, 
which means the fastest and slowest organizations did not stand out as 
much. In response to these comments (84 FR 62874), we finalized an 
additional question to the instrument requesting ground ambulance 
organizations responding to emergency calls for service to report their 
90th percentile response time.
    Based on feedback from ground ambulance organizations that we have 
received on this question since we finalized the instrument, we believe 
most ground ambulance organizations will find it challenging to 
interpret this question and report the requested information. Several 
ground ambulance organizations have indicated that they would 
misinterpret this question, describing a shorter 90th percentile 
emergency response time compared to average response time, which, while 
mathematically possible, is not the intent as we were interested in 
characterizing outlier emergency responses with unusually long response 
times.
    Thus, in the CY PFS 2022 proposed rule (86 FR 39298), we proposed 
to revise the question to state: ``what is your best estimate of the 
share of responses (enter percentage) that take more than twice as long 
as the average response time as reported in the prior question?'' We 
believe this will be an easier question for ground ambulance 
organizations to understand. The goal of this question is to help CMS 
understand whether the organization has some response times that are 
much longer than its typical response time. Although the question 
language will be different, the reported information will still help 
CMS understand the extent to which a small number of emergency 
responses may be substantially longer than the average response for 
each organization. We solicited comments on our proposal to revise the 
question to ask respondents to report the share of responses with more 
than twice the average response time instead of their 90th percentile 
emergency response time.
    We did not receive public comments on this proposal, and therefore, 
we are finalizing our proposal to revise the question to state: ``what 
is your best estimate of the share of responses (enter percentage) that 
take more than twice as long as the average response time as reported 
in the prior question?''.
e. Change To Reporting Paid Ambulance Transports
    In the CY 2020 PFS final rule (84 FR 62876 through 62877), we 
established a series of questions in the data collection instrument to 
collect data on the volume and the mix of services, including paid 
ground ambulance transports, that is, ground ambulance transports where 
the ambulance provider or supplier was paid for a billed amount in part 
or in full. The general instructions for Section 5 (Ground Ambulance 
Service Volume) note: ``A paid ground ambulance transport refers to a 
ground ambulance transport for which your organization has been paid in 
full or in part by a payer and/or patient only. Depending on how your 
organization collects data, you may report (a) the number of transports 
furnished during the data collection period that were also paid during 
the data collection period, or (b) the number of transports paid during 
the data collection period even if some transports occurred prior to 
the data collection period.'' Furthermore, Section 5, Question 7 asks 
respondents, ``what was the total number of paid ground ambulance 
transports in calendar year 202X [or fill fiscal year as appropriate], 
across all payer types and regardless of the level of service or 
geography? (Enter number).''
    Based on questions and feedback from ground ambulance organizations 
that we have received since we finalized the instrument, we believe 
respondents may have different interpretations of this question, which 
could lead to inconsistent reported data, including the reported total 
ground ambulance transports during the data collection period (Section 
5, Question 6). The intent of this question was to capture the reported 
number of ground ambulance transports during the data collection 
period, provided such transports were paid by the time the information 
was prepared for reporting to CMS. We did not intend for organizations 
to report the total number of ground ambulance transports for which 
they received the payment itself during the data collection period.
    We recognize that there is a temporal disconnect between when 
services are provided and when initial and final payment may be 
received. In order to standardize the information that is reported by 
all ground ambulance organizations, and to align the reported 
information on the number of responses and transports during the data 
collection period with information reported on the number of paid 
transports, we proposed in the CY 2022 PFS proposed rule (86 FR 39298) 
to clarify Section 5, Question 7 to ask ``Of the ground ambulance 
transports your organization provided in calendar year 202X [or fill 
fiscal year as appropriate], how many were paid (either in part or in 
full) across all payer types and regardless of the level of service or 
geography by the time you are reporting data to CMS?''
    We recognize that the ``runout period,'' that is, the time from 
when services are provided to the time when data is being analyzed, 
will be short and

[[Page 65311]]

variable across organizations, particularly for transports towards the 
end of organizations' data collection periods. Despite this limitation, 
we believe this approach is preferable to alternatives where (a) 
respondents have variable interpretations of Section 5, Question 7 and 
(b) where respondents are asked to report the number of transports for 
which payment was received during the data collection period, even if 
the transports for which payment was received happened prior to the 
data collection period. In the latter case, the number of paid ground 
ambulance transports could not be directly compared to the number of 
total ground ambulance transports reported in Section 5, Question 6.
    We also proposed to revise the general instructions in Section 5 to 
delete the following text as it will no longer be relevant: ``Depending 
on how your organization collects data, you may report (a) the number 
of transports furnished during the data collection period that were 
also paid during the data collection period, or (b) the number of 
transports paid during the data collection period even if some 
transports occurred prior to the data collection period''
    We solicited comments on our proposal to revise reporting paid 
ground ambulance transports.
    We received a public comment on our proposal to revise reporting 
paid ground ambulance transports. The following is a summary of the 
comment we received and our response.
    Comment: A commenter supported our proposed change in the 
instructions for reporting paid ambulance transports but requested 
clarification on whether the ``transports provided'' during the period 
refers to the date of service or another period.
    Response: Our proposal specifies that the transports in question 
must have been furnished (that is, with dates of service) during the 
data collection period and paid at least through the end of the data 
collection period and potentially through the date on which the ground 
ambulance organization reports the required information via the 
Medicare Ground Ambulance Data Collection System.
    After consideration of public comments, we are finalizing our 
revised instructions in Section 5 of the instrument as proposed.
f. Change to Questions Related to Labor Hours
    Section 7 (Labor Costs) of the data collection instrument asks 
respondents to report compensation and hours worked for ground 
ambulance staff. The instrument currently requests respondents to 
report, separately for each staff category: Total compensation, total 
hours worked inclusive of all responsibilities, and total hours worked 
unrelated to either ground ambulance or public safety responsibilities. 
The rationale for requesting total compensation and hours, even if 
these include compensation and hours for activities other than those 
related to ground ambulance services, was to preserve the ability to 
compare compensation between organizations and to external benchmarks 
such as Bureau of Labor Statistics data. The last item, total hours 
worked unrelated to either ground ambulance or public safety 
responsibilities, can be subtracted from overall total hours worked 
related to ground ambulance and public safety responsibilities 
combined, and further allocation could separate ground ambulance time 
and compensation from public safety time and compensation for fire and 
other public safety-based ground ambulance organizations.
    Based on questions received by ground ambulance organizations since 
we finalized the instrument and feedback through testing on Section 7 
questions, we learned that some ground ambulance organizations may 
misinterpret the Section 7 questions. Specifically, we believe some 
organizations may assume the question is requesting for hours 
``related'' rather than ``unrelated'' to ground ambulance or public 
safety responsibilities given the focus of the data collection effort, 
despite instructions to the contrary. Relatedly, we were notified that 
some organizations were confused that the Section 7 questions did not 
provide an opportunity to report total hours worked related to ground 
ambulance responsibilities, which they assumed was an unintentional 
omission from the instrument.
    In the CY 2022 PFS proposed rule (86 FR 39299), we proposed to 
change the instructions in Section 7 to request respondents to report 
hours worked on different activities in such a way that the sum of 
hours worked across different activities equals total hours worked 
annually. We believe this approach will be easier for respondents to 
understand and estimate, resulting in less burden for respondents and 
higher quality reported information.
    For stand-alone ground ambulance organizations, we proposed to 
request respondents to report each of the following per staff category: 
(a.) Total annual compensation; (b.) Total hours worked annually; (c.) 
Total hours worked annually related to ground ambulance operations; and 
(d.) Total hours worked annually related to all other responsibilities. 
With this change, the instructions in Section 7 will note that ``total 
hours worked annually related to ground ambulance operations'' plus 
``total hours worked annually related to all other responsibilities'' 
should equal ``total hours worked annually.''
    For fire department or other public safety-based ground ambulance 
organizations, we proposed to request respondents to report each of the 
following per staff category: (a.) Total annual compensation; (b.) 
Total hours worked annually; (c.) Total hours worked annually related 
to ground ambulance operations; (d.) Total hours worked annually 
related to fire, police, or other public safety operations; and (e.) 
Total hours worked annually related to all other responsibilities The 
Section 7 instructions will note that the sum of total hours worked 
related to ground ambulance operations; fire, police, or other public 
safety operations; and all other responsibilities should equal total 
hours worked annually. We solicited comments on our proposal to revise 
the labor hours.
    We did not receive public comments on this proposal, and therefore, 
we are finalizing the revised questions and instructions in Section 7 
of the Medicare Ground Ambulance Data Collection Instrument as 
proposed.
g. Change to Instructions Related to Facility, Vehicle, and Equipment 
Certain Expenses
    In the CY 2020 PFS final rule (84 FR 62882 through 62886), we 
finalized policies to collect cost information related to facilities, 
vehicles, and other equipment, consumables and supplies. The purpose of 
Sections 8 (Facilities Costs), 9 (Vehicles Costs), and 10 (Equipment, 
Consumable, and Supply Costs) in the instrument is to collect total 
expenses during the data collection period related to facilities, 
vehicles, and equipment and supplies, respectively. Based on feedback 
from ground ambulance organizations that we have received since we 
finalized the instrument, we are concerned that some respondents, 
particularly those that do not currently depreciate facilities, 
vehicles, and/or equipment for accounting purposes, may not be sure 
where to report some components of total expenses in these categories. 
Although we believe most ground ambulance organizations depreciate 
facilities, vehicles, and capital medical equipment, we were notified 
that some ground ambulance organizations do not depreciate these items 
in their regular accounting practices. Upon a review of

[[Page 65312]]

the instrument, we found that the instructions and opportunities to 
report costs for organizations using a cash basis for accounting were 
inconsistent across Sections 8, 9, and 10 of the instrument. In some 
instances, ground ambulance organizations are requested to report 
annual depreciation expenses only, without a clear question related to 
expenses should the organization not regularly depreciate a certain 
category of asset. In other cases, there are questions requesting 
respondents to report annual expenses other than annual depreciation 
expenses, but the instructions provide incomplete guidance on what 
expenses are in scope.
    We considered several factors when developing our proposals to 
address these inconsistencies. Overall, the purpose of the questions in 
Sections 8, 9, and 10 is to collect comprehensive information on total 
expenses related to facilities, vehicles, and equipment and supplies 
during the organizations' data collection periods. We believe the 
primary purpose of changes and clarifications to questions in this 
section should be to ensure all expenses are reported from both 
organizations that do and do not depreciate facilities, vehicles, and 
equipment for accounting purposes. We understand that allowing 
organizations flexibility to report cost information using their 
current accounting approach will reduce burden. The instructions to the 
instrument currently state: ``In general, you will be able to report 
information collected under your organization's current accounting 
practices. We understand that some ground ambulance organizations use 
accrual-basis accounting while others use cash-basis accounting.'' We 
continue to believe this is the correct approach, and that alternatives 
will impose considerable additional burden on ground ambulance 
organizations.
    We considered several broad alternatives on how to report facility, 
vehicle, and equipment expenses in Sections 8, 9, and 10. One option is 
to require all organizations to calculate and report depreciation for 
facilities, vehicles, and equipment using a standardized approach. 
Although this will increase burden for respondents, potentially 
significantly for organizations that do not currently calculate 
depreciation, it will result in the most standardized information being 
submitted to CMS and the fewest changes to the layout of the 
instrument. Another option will be to retain the current structure of 
the instrument but provide more detailed instructions on how 
organizations that do and do not depreciate facilities, vehicles, and 
equipment should report information. A third option is to add new 
screening questions to the instrument asking individually whether the 
organization depreciates facilities, vehicles, and equipment. The 
responses to these screening questions could be used to tailor the 
instructions, table headings, and question text later in the instrument 
to avoid confusion.
    After considering these options, in the CY PFS 2022 proposed rule 
(86 FR 39300), we proposed to add screening questions to the instrument 
asking individually whether the organization depreciates facilities, 
vehicles, and equipment. We believe this will not substantively affect 
response burden for organizations and may in some cases reduce burden 
by clarifying what and how information on expenses must be reported in 
Sections 8, 9, and 10.
    There are two specific places in Sections 8 and 9 in the instrument 
where we believe the instructions on how to report annual expenses may 
not be clear. First, Section 8.2, Question 1 asks respondents to report 
annual expenses for each facility that they report as being related to 
their ground ambulance operation in Section 8.1, Question 3. Section 
8.2, Question 1 is a table with columns for ``annual lease or rental 
costs,'' ``annual depreciation expenses,'' and ``annual mortgage, bond 
interest, and other costs of ownership.'' Although the instructions 
note ``do not report depreciation if your organization does not 
capitalize facilities for accounting purposes,'' it is not immediately 
clear where organizations that do not capitalize facilities should 
report expenses if the facility is owned outright (for example, in 
cases where a facility is acquired during the data collection period).
    Second, Section 9.1, Question 5 and Section 9.2, Question 5 are 
tables where respondents report costs associated with individual 
vehicles. Both tables currently ask, ``What was the annual depreciation 
expense for this vehicle?'' Although the instructions note ``for owned 
vehicles, do not report depreciation if your organization accounts for 
vehicles on a cash basis,'' the instructions do not indicate where 
expenses for vehicles purchased during the data collection period 
should be reported by organizations that do not capitalize vehicles for 
accounting purposes.
    We considered several options to clarify the instructions in 
Sections 8 and 9 specifically. One option is to preserve current table 
structures and item numbers in both sections while providing additional 
written instructions. We believe that although this will minimize 
disruption to the layout of the instrument, it will also do the least 
to address potential confusion around these questions. Another option 
is to add new columns in Sections 8 and 9 for facilities and vehicles 
purchased outright during the data collection period for organizations 
that do not depreciate these expenses. We proposed to add an additional 
column for clarity, but noted that if the screening questions are added 
as described above not all columns will appear for all respondents, 
particularly given our proposal to add screening questions related to 
reporting expenses in Sections 8 and 9.
    We also believe there are specific instructions in Section 10 that 
may not be clear. Section 10.1, Question 1 and Section 10.2, Question 1 
request respondents to report ``annual depreciation expenses'' for 
medical and non-medical capital equipment, respectively. The Section 10 
instructions note ``do not report depreciation if your organization 
uses a cash basis for accounting'' and that ``for capital expenditures, 
medical and non-medical equipment, most organizations will amortize 
costs over the life of the good'' but do not specify that organizations 
that do not depreciate medical or non-medical equipment should skip 
these questions and report expenses for equipment acquired during the 
data collection period in Section 10.1, Question 3, and Section 10.2, 
Question 3 instead.
    We considered several options to clarify the instructions in 
Section 10 specifically. One option is to clarify in the instructions 
that organizations that do not depreciate medical or non-medical 
equipment should skip Section 10.1, Question 1 and Section 10.2, 
Question 1 and report expenses for equipment acquired during the data 
collection period in Section 10.1, Question 3, and Section 10.2, 
Question 3 instead. Although this will involve the least change to the 
instrument, we will lose the ability to distinguish between expenses 
for the kinds of equipment that most ground ambulance organizations 
depreciate for organizations reporting in this way. Another option is 
to change the instructions for Section 10.1, Question 1 and Section 
10.2, Question 1 to refer to broad types of equipment that are 
typically considered capital medical and non-medical equipment, and 
then request respondents to report relevant annual expenses for 
qualifying equipment in these questions, regardless of whether the 
expenses are annual depreciation expenses or purchase costs (for 
organizations not calculating depreciation). We proposed to request

[[Page 65313]]

organizations that do not depreciate equipment to report expenses 
associated with purchasing equipment in Section 10.1, Question 1 and 
Section 10.2, Question 1. This option will preserve our and MedPAC's 
ability to separately analyze these expenses. We solicited comment on 
these alternatives to address instructions related to facility, 
vehicle, and equipment expenses.
    We did not receive public comments on our proposed changes to the 
instructions related to facility, vehicle, and equipment certain 
expenses in Sections 8, 9, and 10 of the instrument, and therefore, we 
are finalizing these changes as proposed.
h. Changes to Questions Related to National Provider Identifier's 
(NPIs) Under Broader Parent Organizations
    Some ground ambulance NPIs are part of broader parent organization 
companies that own and/or operate multiple ground ambulance NPIs. 
Section 2, Question 2 asks, ``Did your organization use more than one 
NPI to bill Medicare for ground ambulance services during the data 
collection period?'' Based on feedback from ground ambulance 
organizations that we have received since we finalized the instrument, 
we were notified that the use of ``organization'' in this question is 
potentially confusing because it is not clear whether the term applies 
to the organization sampled to report information to the Medicare 
Ground Ambulance Data Collection System (which, by definition, is an 
individual NPI) or to a broader ``parent organization.'' In the CY 2022 
PFS proposed rule (86 FR 39300), we proposed clarifying the question to 
ask ``Is this NPI part of a larger `parent organization' that owns or 
operates multiple NPIs billing for ground ambulance services?'' We also 
proposed to clarify the wording of the follow-up instruction for 
organizations that answer ``yes'' to this question. The follow-up 
instruction currently reads, ``You are being asked to complete this 
instrument and enter data only for the following NPI: [pre-populate 
number].'' Because very large parent organizations may have several 
NPIs sampled and a single or small number of staff collecting and 
reporting data for multiple NPIs, we proposed to revise the text to 
read, ``You are being asked to complete this instrument and enter data 
separately for each sampled NPI. The following questions refer only to 
the following NPI: [pre-populate number].''
    The instrument requests these organizations to report an allocated 
share of parent organization expenses at the end of most sections of 
the instrument. For example, Question 3 in Section 7.2 on paid 
administration, facilities, and medical director staff costs asks, 
``Please report the allocated portion of administrative labor costs 
incurred at the level of the parent organization/central office of this 
NPI based on your organization's approach for allocating costs to 
specific NPIs. (Enter dollar amount.)''
    There are four sections in the instrument that lack similar 
questions: Section 7.1 (Paid EMT/Response Staff Compensation and Hours 
Worked), Section 7.3 (Volunteer Labor), Section 9.1 (Ground Ambulance 
Vehicle Costs), and Section 10.1 (Medical Equipment/Supplies). Without 
these questions, total reported costs may be biased downward for NPIs 
that are part of broader parent organizations. We proposed to add 
questions like the one reproduced above to the end of these four 
sections for completeness. The text will be the same as the above 
except for replacing ``EMT/response staff labor costs,'' ``costs 
associated with volunteer labor,'' ``ground ambulance vehicle costs,'' 
and ``medical equipment and supply costs'' for ``administrative labor 
costs'' in the respective sections.
    Relatedly, for completeness, we proposed to clarify in the 
instructions for Section 12 (Total Cost), Question 1, that 
organizations part of broader parent organizations should include an 
allocated portion of parent organization (or ``central office'') costs 
when reporting their total costs in this question. We solicited 
comments on our proposal to address questions related to NPIs under 
broader parent organizations.
    We did not receive public comments on our proposed changes to 
questions related to NPIs under broader parent organizations, and 
therefore, we are finalizing these changes as proposed.
i. Other Clarifications to the Medicare Ground Ambulance Data 
Collection Instrument
    In the CY 2022 PFS proposed rule, (86 FR 39301), we proposed the 
following 11 additional clarifications and updates to the instrument.
    i. Replacing all first-person language (for example, ``we'') with 
third-person language (for example, ``CMS'') throughout the instrument 
for editorial consistency.
    ii. Section 2, Question 17: There is a typo where this question 
referred to itself rather than, as is implied by the ordering and 
framing of the question, the prior item. The question currently asks, 
``other than what was reported in item 17 . . . ,'' when it should 
read, ``other than what was reported in item 16 . . .''.
    iii. Section 3, Question 2: This question currently asks, ``are you 
the primary emergency ambulance provider . . . ,'' using ``provider'' 
more colloquially than elsewhere in the instrument where the same word 
is sometimes used to differentiate between Medicare providers of 
service and Medicare suppliers. We proposed to reword this question to 
read, ``are you the primary emergency ambulance organization . . .''
    iv. Section 4, Questions 1 and 2 Clarification: The question 
currently defines response time as ``the time from when the call comes 
in to when the ambulance or another EMS response vehicle arrives on the 
scene.'' We proposed clarifying this definition to say ``the time from 
when the call comes in to dispatch to when the ambulance or another EMS 
response vehicle arrives on the scene.'' Relatedly, for Section 4, 
Question 2, we proposed adding a second answer option for this question 
that reads, ``From the time our organization receives a call from 
dispatch to the time the ambulance or other EMS vehicle is at the 
scene.'' Respondents would still have the option to write-in their own 
response in Section 4, Question 2, if neither of the pre-programmed 
options apply to their organization.
    v. Section 5, Question 3a. Clarification: This question requests 
respondents to report the percentage of ground ambulance responses that 
involve a non-transporting agency and the percentage of ground 
ambulance transports in which the non-transporting agency continues to 
provide medical care in the ambulance during a transport. Based on 
feedback from ground ambulance organizations that we have received 
since we finalized the instrument, we believe many organizations do not 
currently track this data and will not easily be able to begin tracking 
it. We proposed clarifying this question to note that estimated 
percentages are acceptable, as they are in response to certain other 
questions in the instrument (where noted). We specifically proposed to 
edit Section 5 question 3a. to read: ``What is your best estimate of 
the percentage of total ground ambulance responses that involved a non-
transporting agency? (Enter percentage)''
    vi. Section 7.1 Instruction Clarification: We proposed clarifying 
``You will report on these staff in a different section'' to ``You will 
report on these staff in a later section'' to make it clear that the 
opportunity to report on

[[Page 65314]]

these staff follows the current instruction.
    vii. Sections 7.1 and 7.2 Instruction Clarification: We proposed to 
add ``employer payroll taxes'' as an additional example of a component 
contributing to total compensation, without altering any of the 
definitions or other instructions in these sections.
    viii. Section 7.2, Question 3 Clarification: We proposed adding a 
clarification warning for respondents not to consider labor that was 
reported elsewhere when responding to this question.
    ix. Section 7.3, Question 4 Clarification: We proposed adding a 
clarification that medical director volunteer hours do not contribute 
to this response and a reminder that they are reported separately below 
(Section 7.3, Question 5).
    x. Section 10 Instructions: We proposed to correct a typo in the 
instructions where the instrument describes ``operation expenses'' 
rather than ``operating expenses'' as intended.
    xi. Section 13, Question 3 Clarification: Based on the instructions 
for this question, organizations may report revenue from specific 
payers that include patient cost-sharing amounts. To ensure patient 
cost-sharing is not reported twice, we recommended clarifying the item 
in the chart that currently reads, ``Patient self-pay (amount patients 
pay for deductibles, coinsurance, etc.) to read, ``Patient self-pay 
(cash payment and the amount patients paid for deductibles, 
coinsurance, and other cost-sharing only if not reported in a row 
above.)'' We solicited comments on these clarifications and updates to 
the instrument.
    We received public comments on these clarifications and updates to 
the instrument. The following is a summary of the comments we received 
and our responses.
    Comment: Some commenters supported our proposed clarification to 
Section 5, Question 3a regarding reporting the percentage of ground 
ambulance responses that involve a non-transporting agency. A commenter 
expressed their appreciation for a policy that can promote simplicity 
and efficiency of data collection and reporting. A commenter supported 
the clarification and noted that information on joint responses is 
difficult to track and collect.
    Response: We appreciate the commenters' support.
    Comment: A commenter supported our proposed clarification for 
Section 5, Question 3a, but recommended that CMS maintain strict 
expectations for respondents to provide accurate estimates in this 
response, noting a common scenario in which a ground ambulance provider 
or supplier utilizes an ALS provider or supplier from a non-transport 
agency to continue caring for the patient during transportation. 
According to the commenter, this common scenario forces the non-
transport agency to assume the labor and equipment costs associated 
with the ALS provider or supplier while an ALS level 1 reimbursement is 
paid to the ground ambulance provider or supplier that provided the 
medically necessary ground ambulance transport. The commenter stated 
that this information is crucial in demonstrating the need for CMS to 
provide reimbursement to all agencies involved in caring for Medicare 
beneficiaries. The commenter suggested that CMS make these responses 
publicly accessible in addition to all other data reported in a timely 
fashion.
    Response: While we appreciate the importance of joint responses in 
determining expenses for all contributing ground ambulance 
organizations and other services, the Medicare Ground Ambulance Data 
Collection Instrument currently does not collect detailed information 
on the number of services with joint responses of different types. 
Instead, our approach is to question broadly whether the ground 
ambulance organization collecting and reporting data participates in 
joint responses and, if so, which general types of labor and other 
inputs are involved.
    Comment: A commenter supported our proposed clarifications to 
Section 13, Question 3 on reporting revenue, stating that this is a 
helpful clarification for reporting organizations to distinguish 
between patient self-pay types.
    Response: We appreciate the commenter's support.
    After consideration of public comments, we are finalizing all the 
clarifications as proposed.
4. Collection and Reporting of Information Under the Data Collection 
System
    In the CY 2020 PFS final rule (84 FR 62893), we finalized our 
sampling proposals to implement a 25 percent stratified sample in each 
of the first 4 years of data collection and codified the representative 
sample approach at Sec.  414.626(c). CMS' sampling approach is designed 
to result in representative samples of ground ambulance organizations 
in terms of key characteristics including provider versus supplier 
status, service area population density, volume of transports, and 
ownership category. The selected ground ambulance organizations for 
year 1 and year 2 have already been listed on the CMS website at 
https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html.
    In the CY 2020 PFS final rule (84 FR 62894), we finalized the data 
collection period as a continuous 12-month period of time, which is 
either the calendar year aligning with the data collection year, or the 
organization's annual accounting period that begins during the data 
collection year when an organization has an annual accounting period 
(such as a fiscal year) that differs from the calendar year and the 
organization elects to collect and report data over this period rather 
than the calendar year. We also finalized our proposal to require 
organizations to report data during a 5-month data reporting period 
starting immediately following the end of the data collection period. 
The data collection and reporting requirements for selected ground 
ambulance organizations were codified at Sec.  414.626(b).
    As part of the Medicare Ground Ambulance Data Collection System, 
sampled ground ambulance organizations will report information to CMS 
using a web-based version of a data collection instrument that is 
posted on the CMS website at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html. We are currently developing the 
Medicare Ground Ambulance Data Collection System and stated in the CY 
2020 PFS final rule (84 FR 62867) that the web-based survey would be 
available before the start of the first data reporting period to allow 
time for users to register, receive their secure login information, and 
receive training from CMS on how to use the system.
    Due to the COVID-19 public health emergency (PHE), we issued two 
blanket waivers (May 5, 2020 and November 25, 2020) to delay the data 
collection and data reporting periods under the Medicare Ground 
Ambulance Data Collection System. The first waiver delayed the data 
collection period and data reporting period for selected year 1 ground 
ambulance organizations and the second waiver delayed the data 
collection periods and data reporting periods for selected year 1 and 
year 2 ground ambulance organizations.
    This revised modification has been issued on page 32 in the 
following document: https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf. Specifically, we modified the 
data collection period and data reporting

[[Page 65315]]

period, as defined at Sec.  414.626(a), for ground ambulance 
organizations (as defined at Sec.  414.605) that were selected by CMS 
under Sec.  414.626(c) to collect data beginning between January 1, 
2020 and December 31, 2020 (year 1) and for ground ambulance 
organizations that were selected to collect data beginning between 
January 1, 2021 and December 31, 2021 (year 2) for purposes of 
complying with the data reporting requirements described at Sec.  
414.626.
    Under this modification, these ground ambulance organizations will 
select a new continuous 12-month data collection period (organizations 
may choose a collection period aligning with the calendar year or the 
organization's fiscal year) that begins between January 1, 2022 and 
December 31, 2022, to collect data necessary to complete the Medicare 
Ground Ambulance Data Collection Instrument during their selected data 
collection period, and submit a completed Medicare Ground Ambulance 
Data Collection Instrument during the data reporting period that 
corresponds to their selected data collection period. We modified this 
data collection and reporting period to increase flexibilities for 
ground ambulance organizations that would otherwise be required to 
collect data in 2020-2021 so that they can focus on their operations 
and patient care during the COVID-19 PHE. We stated, when the blanket 
waiver was granted, in the COVID-19 Frequently Asked Questions (FAQs) 
on Medicare Fee-for-Service (FFS) Billing document (page 63 of this 
document: https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf) that CMS will not allow an option to continue with their 
current data collection period because the data collected in 2020 and 
2021 during the PHE may not be reflective of typical costs and revenues 
associated with providing ground ambulance services.
    As a result of the COVID-19 delay, ground ambulance organizations 
selected in year 1, 2, and 3 will have the same data collection periods 
beginning between January 1, 2022 and December 31, 2022 and will have 
the same data reporting periods beginning between January 1, 2023 and 
December 31, 2023. In the CY 2020 PFS final rule (84 FR 62893), we 
finalized our sampling proposals to implement a 25 percent stratified 
sample in each of the 4 years of data collection. Prior to the delay, 
we anticipated approximately equal shares of ground ambulance 
organizations will collect and report data in 4 consecutive periods. 
However, as a result of the delays, there will now be approximately 75 
percent of the ground ambulance organizations that will have data 
collection periods that start in the same year and subsequently will 
have data reporting periods starting in the same year. Later, a final 
25 percent sample of ground ambulance organizations in year 4 will 
collect and report data.
    When finalizing our policies in regard to ground ambulance 
collection and reporting of data, we did not intend to have 
approximately 75 percent of ground ambulance organizations collect and 
report data at the same time. To provide MedPAC with the data needed 
for analysis, acknowledging that due to the COVID-19 delay there will 
be a delay in CMS providing that data, we believe that we should revise 
the data collection period and data reporting period for selected 
ground ambulance organizations in year 3.
    Accordingly, in the CY 2022 PFS proposed rule (86 FR 39302), we 
proposed to revise the data collection period beginning between January 
1, 2022 and December 31, 2022 and data reporting period beginning 
between January 1, 2023 and December 31, 2023 for selected ground 
ambulance organizations in year 3. Under this proposal, there will be a 
new data collection period beginning between January 1, 2023 and 
December 31, 2023 and a new reporting period beginning between January 
1, 2024 and December 31, 2024 for selected ground ambulance 
organizations in year 3. With this proposal, we plan to do the sample 
in 2022 for selected ground ambulance organizations in year 3 rather 
than the current plan in 2021. The main advantage of delaying the year 
3 sample is that the selected organizations would be more 
representative of the organizations actually collecting beginning in 
2023 and reporting beginning in 2024. The longer the delay between 
sampling and the data collection and data reporting, the more changes 
in the industry (for example, NPIs ceasing ground ambulance or all 
operations). This timeline will align with the data collection period 
and data reporting period requirements for selected ground ambulance 
organizations in year 4. As a result, there will be approximately 50 
percent of ground ambulance organizations selected in year 1 and 2 with 
data reporting periods beginning between January 1, 2023 and December 
31, 2023 and approximately 50 percent of ground ambulance organizations 
selected in year 3 and 4 with data reporting periods beginning between 
January 1, 2024 and December 31, 2024.
    Due to the delay caused by the PHE for COVID-19, we examined the 
possibility of extending the data reporting to encompass 4 years as 
planned instead of 2 years. We concluded that it will not be feasible 
to extend the data reporting period over 4 years. Extending the data 
reporting to encompass 4 years will further delay MedPAC receiving the 
data required to analyze for its report to Congress, which is required 
to be submitted by March 15, 2023. The sampling for year 1 and year 2 
selected ground ambulance organizations has already been completed and 
the lists for the selected ground ambulance organizations in year 1 and 
year 2 are posted on the CMS website.
    With this proposal, more data will be collected in 2023 as there 
will hopefully be more distance from the peak of the COVID-19 pandemic. 
Thus, it is our hope that 2023 will be even more reflective of a 
typical year of costs for ground ambulance organizations than 2022. As 
the course of the pandemic continues to evolve, we believe that our 
proposal provides a potential for more even distribution of data over 2 
years for comparison by MedPAC. We solicited comments on our proposal 
to revise the data collection period and data reporting period for 
ground ambulance organizations selected in year 3.
    We received public comments on our proposal to revise the data 
collection period and data reporting period for ground ambulance 
organizations selected in year 3. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters supported our proposed changes to the 
data collection period and data reporting periods for selected ground 
ambulance organizations in year 3. A commenter stated that the proposal 
to align the timeline for selected ground ambulance organizations in 
Years 1 and 2, and Years 3 and 4 is an appropriate response to the 
disruption that the pandemic caused with respect to the ground 
ambulance data collection and recognizes CMS' efforts to prevent 
further delays. This commenter stated that the proposed adjusted 
timeframe will provide their organization enough time to build up the 
appropriate collection tools and processes, and will allow for a smooth 
transition for submitting the required data.
    A commenter supported the data collection timeline as proposed and 
stated that it is important that assessments of the adequacy of ground 
ambulance payments not be based on data that reflects anomalous, 
temporary trends in utilization and costs caused by a global pandemic. 
The commenter stated that to the extent that these anomalous trends 
might still be occurring in 2022, the commenter

[[Page 65316]]

concurs with CMS' caution about using 2022 data because it could bias 
analyses of the geographic variation in costs and the adequacy of 
Medicare's ground ambulance payments.
    A commenter supported the proposal and stated that while their 
organization appreciated the need to delay the data collection process 
due to the PHE for COVID-19, the commenter is concerned that further 
delays will prevent MedPAC from having the data needed to produce their 
report to Congress.
    A commenter supported the delays to the ground ambulance data 
collection because their members were on the frontlines of responding 
to the pandemic, however, the commenter does not support collapsing the 
Congressionally mandated 4 years of data collection into 2 years. The 
commenter stated that the proposed timeline is problematic given that 
CMS did not beta test the Medicare Ground Ambulance Data Collection 
System and according to the commenter, the first year of the data 
collection is likely to be fraught with confusion and errors, despite 
CMS and its contractor's best efforts to address as many questions as 
possible before the data collection is fielded. This commenter 
recommended a 4-year timeline: Data collection period in 2022 and data 
reporting period in 2023 for selected ground ambulance organizations 
already selected in year 1; data collection period in 2023 and data 
reporting period in 2024 for selected ground ambulance organizations 
already selected in year 2, data collection period in 2024 and data 
reporting period in 2025 for selected ground ambulance organizations in 
year 3 and data collection period in 2025 and data reporting period in 
2026 for selected ground ambulance organizations in year 4. The 
commenter suggested a 12-month data reporting period rather than a 5-
month data reporting period that begins the day after the last day of 
the ground ambulance organization's data collection period. This 
commenter noted that MedPAC may not have time to complete their 
analysis and report on either the proposed timeline or the commenter's 
recommended timeline. However, the commenter stated that its approach 
would allow for timing that mirrors what the authorizing statute 
requires and it also would meet CMS stated goal that the data collected 
be ``more reflective of a typical year of costs for ground ambulance 
organizations'' than data collected during the turbulent of the 
pandemic, which continues to rage during this fourth surge with the 
Delta variant.
    Response: We appreciate the feedback on our proposed changes to the 
data collection period and data reporting period for selected ground 
ambulance organizations in year 3. As several commenters noted, we are 
keenly aware of the tension between the need to begin collecting data 
and the challenges and threats to generalizability of collecting data 
through the ongoing pandemic and PHE. Our proposal attempts to strike a 
balance between these two considerations. Under our proposal, 
information will be collected from fewer organizations during data 
collection periods starting in 2022, and from more organizations during 
data collection periods starting in 2023. Delaying data collection and 
reporting for more ground ambulance organizations, or stretching the 
data collection period and data reporting period over a 4-year period, 
will result in a longer delay before information is collected from all 
ground ambulance organizations. We are therefore not accepting the 
commenter's recommended 4-year timeline. We plan to conduct beta 
testing on the Medicare Ground Ambulance Data Collection System prior 
to data reporting in the system.
    After consideration of public comments, we are finalizing our 
proposal for 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. With this proposal, we plan to do 
the sample in 2022 for selected ground ambulance organizations in year 
3 rather than the current plan in 2021.
5. Change to the Notification Process for Selected Ground Ambulance 
Organizations Required to Report
    In the CY 2020 PFS final rule, we codified our notification process 
at Sec.  414.626(c)(3) and (b)(1). We stated at Sec.  414.626(c)(3) 
that CMS will notify an eligible ground ambulance organization that it 
has been selected to report data for a year at least 30 days prior to 
the beginning of the calendar year in which the ground ambulance 
organization must begin to collect data by posting a list of selected 
organizations on the CMS web page and providing written notification to 
each selected ground ambulance organization via email or U.S. mail.
    The Medicare Administrative Contractor (MAC) is responsible for 
providing written notifications to the selected ground ambulance 
organizations in their service area. We codified their role at Sec.  
414.626(b)(1) which states that within 30 days of the date we notify a 
ground ambulance organization that it has been selected to report data 
under this section, the ground ambulance must select a data collection 
period that corresponds with its annual accounting period and provide 
the start date of that data collection period to the ground ambulance 
organization's Medicare Administrative Contractor.
    In the CY 2022 PFS proposed rule (86 FR 39303), we proposed to make 
a technical revision to Sec.  414.626(b)(1) to state that the selected 
ground ambulance organization provide the start date of the data 
collection period to CMS or its contractor instead of the Medicare 
Administrator Contractor. This change will provide CMS with flexibility 
to have the MACs or other contracted entities provide written 
notifications and collect information from the selected ground 
ambulance organizations. If we find the response rate is low, having 
the flexibility to contract with other entities that could employ 
additional outreach resources may be useful. This revision will not 
preclude CMS from including the MACs in the notification process. We 
also proposed to correct a typographical error at Sec.  414.626(b)(1), 
which currently states ``a ground ambulance must select a data 
collection period'' to read ``a ground ambulance organization must 
select a data collection period.'' We solicited comments on our 
technical revisions to the citation at Sec.  414.626(b)(1).
    We did not receive public comments on this proposal, and therefore, 
we are finalizing it as proposed.
6. Payment Reduction for Failure to Report
    Section 1834(l)(17)(D)(i) of the Act requires that beginning 
January 1, 2022, subject to clause (ii), the Secretary reduce the 
payments made to a ground ambulance organizations under section 
1834(l)(17) of the Act for the applicable period by 10 percent if the 
ground ambulance organization is required to submit data under the data 
collection system with respect to a data collection period under the 
data collection period and does not sufficiently submit such data.
    We stated in the CY 2020 PFS final rule (84 FR 62895) that we would 
make a determination that the ground ambulance organization is subject 
to the 10 percent payment reduction no later than the date that is 3 
months following the date that the ground ambulance organization's data 
reporting period ends. In this final rule, we provided examples of when 
the determination will be made based on calendar year and fiscal year 
data collection period

[[Page 65317]]

beginning in 2020. Due to the delay caused by the PHE for COVID-19, we 
did not receive data collected in 2020. We will begin to follow this 
timeline to make a determination that the ground ambulance organization 
is subject to the 10 percent payment reduction when data collected in 
2022 is required to be reported in 2023 for selected ground ambulance 
organizations in year 1 and year 2.
    For example, if a selected ground ambulance organization's data 
collection period is based on a calendar year, that is, January 1, 2022 
through December 31, 2022, we will allow a ground ambulance 
organization 5 months to report the data collected during the data 
collection period. For this example, the data reporting period for this 
organization is January 1, 2023 to May 31, 2023. We will make a 
determination that the ground ambulance organization is subject to the 
10 percent payment reduction no later than August 31, 2023. With this 
timeframe, we will apply the 10 percent reduction in payments, if 
applicable (no hardship exemption or informal review is granted), for 
ambulance services provided between January 1, 2024 and December 31, 
2024.
    As another example, if a selected ground ambulance organization's 
data collection period is based on a fiscal year, that is, October 1, 
2022 through September 30, 2023, we will allow a ground ambulance 
organization 5 months to report the data collected during the data 
collection period. For this example, the data reporting period for this 
organization is October 1, 2023 to February 28, 2024, we will make a 
determination that the ground ambulance organization is subject to the 
10 percent payment reduction no later than June 1, 2024. With this 
timeframe, we will apply the 10 percent reduction in payments, if 
applicable (no hardship exemption or informal review is granted), for 
ambulance services provided between January 1, 2025 and December 31, 
2025.
    Comment: A commenter supported aligning the timelines for the 
application of penalties for not reporting data with our new timelines 
for data collection and reporting.
    Response: We appreciate the commenter's support.
7. Public Availability of Data
    We stated in the CY 2020 PFS final rule (84 FR 62897), the data 
will be made available to the public through posting on our website at 
least every 2 years and we will post the summary results by the last 
quarter of 2022. We codified the public availability at Sec.  
414.626(f), which states: (f) Public availability of data. Beginning in 
2022, and at least once every 2 years thereafter, we will post on its 
website data that it collected under this section, including but not 
limited to summary statistics and ground ambulance organization 
characteristics.
    Due to the COVID-19 delay, in the CY 2022 PFS proposed rule (86 FR 
39303), we proposed to revise Sec.  414.626(f) to state that we will 
make the data collected under Sec.  414.626 publicly available 
beginning in 2024. We solicited comments on our proposal to revise the 
timeline when the public availability of data will begin.
    We received a public comment on our proposal to revise the timeline 
when the public availability of data will begin. The following is a 
summary of the comment we received and our response.
    Comment: A commenter stated that it would provide greater 
transparency if CMS were to release data annually rather than waiting 
until 2024 for the first release. The commenter stated that this would 
be similar to cost reporting data or other data files released for 
other healthcare entities that are also released annually and that it 
would be important for the public to have access to the data that will 
be used by MedPAC for their analysis.
    Response: In the CY 2020 PFS final rule (84 FR 62897), we finalized 
our proposals for public availability of the data including to post on 
our website a report that includes summary statistics, respondent 
characteristics, and other relevant results in the aggregate so that 
individual ground ambulance organizations are not identifiable. The 
data above will be made available to the public through posting on our 
website at least every 2 years. We do not plan on releasing information 
collected via the Medicare Ground Ambulance Data Collection Instrument 
in precisely the same way that cost reporting data is released but 
intend to post as much data as possible, including summary statistics 
describing the data reported by subgroups of respondents, while 
protecting the confidentiality of the respondents.
    After consideration of public comments, we are finalizing the 
proposal as proposed.

L. Medicare Diabetes Prevention Program (MDPP)

    The Medicare Diabetes Prevention Program (MDPP) expanded model is a 
structured intervention that aims to prevent or delay onset of type 2 
diabetes among eligible Medicare beneficiaries diagnosed with pre-
diabetes. The MDPP expanded model is an expansion of duration and scope 
of the Diabetes Prevention Program (DPP) model test, which was 
initially tested through a Round One Health Care Innovation Award. MDPP 
services are furnished in community and health care settings by 
organizations that enroll in Medicare as MDPP suppliers, a new supplier 
type, even if they have an existing Medicare enrollment as another 
supplier type. MDPP services furnished under the MDPP expanded model 
are covered as an additional preventive service with no cost-sharing 
under Medicare. Eligible organizations seeking to furnish MDPP services 
began enrolling in Medicare as MDPP suppliers on January 1, 2018, and 
began furnishing MDPP services on April 1, 2018.
    We proposed to amend our regulation at Sec.  410.79 to preclude the 
provision of ongoing maintenance sessions unless the MDPP beneficiary 
has started his or her first core session on or before December 31, 
2021. In addition, we proposed to amend Sec.  414.84(b) and (c) to 
update the amount of the performance payments for the core sessions and 
core maintenance sessions and ongoing maintenance sessions (where 
applicable) to be consistent with our proposal. We proposed that this 
change apply to all MDPP beneficiaries starting the MDPP set of 
services on or after January 1, 2022. Additionally, we proposed to 
amend Sec.  424.205(b) to add a provision to waive the provider 
enrollment Medicare application fee for all organizations enrolling in 
Medicare as MDPP suppliers that submit an application on or after 
January 1, 2022. Finally, we proposed to make a conforming amendment to 
Sec.  424.502 to remove a reference to the CMS-20134 from the 
definition of ``institutional provider.'' (In accordance with Sec.  
424.514, institutional providers generally must pay the enrollment 
application fee.)
    We do not anticipate that the changes will impact our ability to 
complete an evaluation of the MDPP expanded model, but the evaluation 
will consider the changes we finalize. The evaluation will continue to 
use beneficiary-level Diabetes Prevention Recognition Program (DPRP) 
encounter data and program data furnished by the Centers for Disease 
Control and Prevention (CDC) in combination with Medicare claims data 
to analyze the long-term utilization of services by beneficiaries who 
have received the MDPP set of services. We will use these data as 
planned to assess whether the MDPP expanded model is expected to 
improve the quality of care without increasing spending, reduce 
spending without

[[Page 65318]]

reducing the quality of care, or improve the quality of care and reduce 
spending.
    While we acknowledge that additional changes will likely be needed 
in the future to improve access to MDPP, we anticipate that the 
programmatic adjustments finalized in this rule are likely to result in 
more MDPP suppliers, increased beneficiary access to MDPP services, and 
an ongoing reduction of the incidence of diabetes in eligible Medicare 
beneficiaries, in both urban and rural communities. We believe that the 
three changes that we are finalizing in this rule will make MDPP more 
attractive to potential suppliers by addressing consistent stakeholder 
comments about MDPP underpayment and the length of the MDPP service 
period, as well as more manageable for MDPP beneficiaries by reducing 
their commitment to MDPP to 1 year. We anticipate that removing the 
Medicare enrollment fee for suppliers, providing larger payments up 
front to suppliers, and paying more for attendance-only achievements 
will result in more organizations enrolling as MDPP suppliers and MDPP 
suppliers will be able to more consistently implement sustainable 
programs which will increase the availability of the MDPP set of 
services to more beneficiaries. Stakeholders have suggested that a 
payment structure that provides higher payments later in the set of 
services and places too much emphasis on weight-loss requirements 
disincentivizes MDPP suppliers from providing services to underserved 
populations who may be less successful at achieving the weight-loss 
goals. We believe that by providing larger payments up front and paying 
more for attendance-only achievements we will remove the potential 
disincentives and improve accessibility to underserved populations who 
may face barriers to weight-loss. We anticipate that these changes will 
increase beneficiary access to MDPP services in rural areas and it may 
have a positive impact on more equitable access to the service.
1. Changes to Sec.  410.79(b), (c), and (e)
    We proposed to amend certain MDPP expanded model policies 
previously finalized in the CY 2017 PFS final rule (81 FR 80459 through 
80475 and 80552 through 80558), the CY 2018 PFS final rule (82 FR 34157 
through 34158), and the CY 2021 PFS final rule 85 FR 50074). Previous 
rules established policies related to the set of MDPP services, 
beneficiary eligibility criteria, reimbursement structure, and supplier 
enrollment requirements and compliance standards.
    MDPP has experienced challenges recruiting suppliers to participate 
in the expanded model, which has limited beneficiary access to the 
preventive services offered under the expanded model. Existing and 
prospective suppliers have reported that the length of the set of MDPP 
services and the payment timing and amounts have made implementation 
and operation of MDPP burdensome and has hindered participation. 
Currently, MDPP suppliers are required to offer up to 2 years of MDPP 
services to eligible MDPP beneficiaries. The MDPP set of services, as 
defined in Sec.  410.79(b), consists of at least 16 sessions offered 
during the core sessions phase (Months 1-6), monthly maintenance 
sessions offered during the core maintenance sessions phase (Months 7-
12) (collectively the ``core sessions phase''), and additional monthly 
sessions offered during the ongoing maintenance sessions phase (Months 
13-24) for eligible beneficiaries. To be eligible for the ongoing 
maintenance sessions phase, a beneficiary must meet the minimum weight-
loss requirement (5 percent weight loss from baseline), as defined in 
Sec.  410.79(b), and maintain the minimum weight-loss requirement on a 
quarterly basis to continue to receive MDPP services in subsequent 
quarters. The ongoing maintenance sessions delivered in year 2 are a 
unique feature of MDPP. Both the CMS-funded Health Care Innovation 
Award (HCIA) to the Young Men's Christians Association (YMCA) of the 
USA (Y-USA), referred to as the DPP model test hereafter, and the CDC's 
National Diabetes Prevention Program (National DPP) was/are 12 months 
in length.
    We included the ongoing maintenance sessions phase in the MDPP set 
of services to support participants in solidifying the behavioral 
changes that resulted in weight loss during the first 12 months. In the 
CY 2017 PFS proposed rule, we proposed adding the ongoing maintenance 
sessions phase to follow the completion of the 12-month core sessions 
phase if the beneficiary achieved and maintained the required minimum 
weight loss of 5 percent from the baseline weight. That proposed rule 
did not place a limit on the number of ongoing maintenance session 
phases an eligible beneficiary could attend. In response to stakeholder 
comments, we modified the proposed policy to limit access to up to 2 
years of ongoing maintenance sessions after the 12-month core sessions 
phase. In the CY 2018 PFS, we again modified the policy to limit access 
to ongoing maintenance sessions to 1 year after the 12-month core 
sessions phase as long as MDPP beneficiaries maintained the 5 percent 
weight loss.
    Despite limiting the ongoing maintenance sessions phase to 1 year, 
we have heard that the MDPP suppliers find the implementation, 
operation, and costs of the ongoing maintenance sessions phase 
burdensome. We anticipate that the changes we proposed will improve the 
uptake of organizations enrolling in Medicare to become MDPP suppliers, 
thus enabling more beneficiaries to access the MDPP set of services. 
Collectively, this will improve CMS ability to evaluate the MDPP 
expanded model as more suppliers and beneficiaries participate in the 
expanded model test. Currently, more than 1,000 organizations 
nationally are eligible to become MDPP suppliers based on their 
preliminary or full CDC DPRP status. However, only 27 percent of 
eligible organizations are participating in MDPP. Based on an analysis 
of National Health and Nutrition Examination Survey (NHANES) data, an 
estimated 16.4 million people are eligible for MDPP;\141\ to date, over 
3,600 beneficiaries are participating in the MDPP set of services. We 
anticipate that the removal of the second year of the MDPP set of 
services on a prospective basis will make MDPP attractive to more MDPP 
eligible organizations and beneficiaries.
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    \141\ Lee AK, Warren B, Liu C, Foti K Selvin E (2019) Number and 
Characteristics of US Adults Meeting Prediabetes Criteria for 
Diabetes Prevention Programs: NHANES 2007-2016, J Gen Intern Med 
34(8):1400-2. https://link.springer.com/content/pdf/10.1007/s11606-019-04915-w.pdf.
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    The requirement to offer a second year of the MDPP set of services 
has also caused confusion among MDPP suppliers because it is 
inconsistent with the CDC National DPP requirements and curriculum. 
Because there is no defined curriculum for the ongoing maintenance 
sessions phase, MDPP suppliers repeat parts of the curriculum they 
previously used during the core sessions phase per CDC guidance and 
their updated 2021 DPRP Standards\142\. We have heard anecdotally, 
through written inquiries and questions asked by MDPP suppliers during 
MDPP educational events, that MDPP suppliers struggle with discerning 
the appropriate timing of determining whether a beneficiary has met 
and/or maintained the 5 percent minimum weight-loss requirement 
necessary for continued eligibility for and during the ongoing 
maintenance sessions phase. To be eligible to

[[Page 65319]]

continue to the ongoing maintenance phase of MDPP, beneficiaries must 
lose and/or maintain a 5 percent weight loss from baseline. MDPP 
suppliers are responsible for determining if a MDPP beneficiary has met 
and/or maintained the 5 percent weight loss from baseline during the 
applicable session and phase. A supplier must submit a claim to the 
Medicare Administrative Contractor (MAC) for the 5 percent weight loss 
achievement for each beneficiary, otherwise, all subsequent ongoing 
maintenance session claims may be rejected by the MAC. Suppliers have 
12 months from the date of service to submit claims, if they delay the 
claim submission for the 5 percent weight loss performance goal, this 
may impact a supplier's ability to get paid for the ongoing maintenance 
sessions. For example, if a beneficiary achieves the 5 percent weight 
loss goal during the first 6 months of MDPP, or during the core 
services period, and they do not submit the claim for the 5 percent 
weight loss goal until after the ongoing maintenance interval has 
started, the supplier risks having their claim for the ongoing 
maintenance interval rejected. Furthermore, in this scenario, the 
supplier will need to submit a claim for the second core maintenance 
session interval with a 5 percent weight loss for the beneficiary to 
continue with ongoing maintenance sessions. MDPP monitoring data 
suggest that 82 percent of MDPP beneficiaries for whom we have claims 
for the 5 percent weight loss goal achievement reach that goal in the 
first 6 months of the expanded model. However, our monitoring data show 
claims for MDPP ongoing maintenance sessions for only 10 percent of 
MDPP beneficiaries and that beneficiary attendance sharply drops after 
the first quarter of the initial core session. Collectively, these data 
suggest that suppliers may not be incentivized to retain MDPP 
beneficiaries after they attend the 9th core session in the set of MDPP 
services, which MDPP beneficiaries likely reach during the first 
quarter of the expanded model, or after the MDPP beneficiary has 
achieved the 5 percent weight loss milestone.
---------------------------------------------------------------------------

    \142\ CDC DPRP Standards (March 1, 2021) https://nationaldppcsc.cdc.gov/s/article/DPRP-Standards-and-Operating-Procedures.
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    Existing MDPP suppliers report frustration with the requirements 
associated with the ongoing maintenance phase and we believe that the 
additional burden and cost of providing the ongoing maintenance 
sessions is a deterrent to prospective MDPP suppliers. Organizations 
have communicated to CMS their difficulties in keeping MDPP 
beneficiaries engaged in the expanded model. For an example, suppliers 
are reimbursed after they successfully submit claims for beneficiary 
attendance, after the 1st, 4th, and 9th core sessions during the first 
6 months of the MDPP set of services, and then if beneficiaries attend 
2 monthly sessions per quarter thereafter. MDPP eligible organizations 
have cited beneficiary acquisition and retention as a leading barrier 
to their MDPP supplier enrollment. Stakeholders and suppliers have 
commented that the payment levels for a second year are inadequate to 
cover supplier costs given the low volume of beneficiaries who 
participate in the ongoing maintenance phase and drive up the per-
beneficiary costs for the supplier. Stakeholders comment that sessions 
have the same fixed costs, yet there are a diminishing number of MDPP 
beneficiaries eligible to participate. As previously noted, our FFS 
claims-based monitoring data show that only approximately 10 percent of 
MDPP beneficiaries continue with the ongoing maintenance sessions phase 
and the majority of MDPP beneficiaries achieve the 5 percent weight 
loss milestone within the first 6 months of the MDPP set of services. 
Given our data, stakeholder comments, the lack of the ongoing 
maintenance year alignment with the CDC's National DPP and the DPP 
model test, the ongoing maintenance phase is not sufficiently 
beneficial to continue requiring and may be causing harm to the 
expanded model's overall goals.
    As such, we proposed to amend our regulations to preclude coverage 
of ongoing maintenance sessions unless the MDPP beneficiary has started 
his or her first core session on or before December 31, 2021. 
Specifically, we proposed to amend Sec.  410.79(c)(1)(ii) to provide 
that an MDPP beneficiary is eligible for the first ongoing maintenance 
session interval only if the beneficiary started his or her first core 
session on or before December 31, 2021. As finalized, this change will 
effectively make the MDPP timeframe consistent with the National DPP 
for MDPP service periods that begin on or after January 1, 2022. In 
addition, as finalized, we believe that this policy will reduce the 
administrative burden and costs associated with the ongoing maintenance 
sessions phase to MDPP suppliers with minimal impact to beneficiaries 
given their historically low participation rate in the second year of 
MDPP. This proposed change is consistent with the authority in section 
1115A(c) of the Act, and we anticipate this change will improve our 
ability to evaluate the expanded model test due to an anticipated 
increase in supplier enrollment, which will increase beneficiary access 
to the expanded model.
    In conjunction with the proposed change to remove the ongoing 
maintenance sessions phase from the MDPP services period, we proposed 
to redistribute a portion of the ongoing maintenance sessions phase 
performance payments to certain core and core maintenance session 
performance payments to address stakeholder concerns that the current 
MDPP payment structure does not cover reasonable costs of MDPP 
suppliers to deliver the MDPP set of services. For example, the 
proposed attendance-based performance payments are based on a 
standardized per-session rate, paid after the 1st, 4th, and 9th 
sessions attended during the core sessions intervals, and after 
attending the two (2) sessions during each of the core maintenance 
intervals. Based on the comments we received, we are modifying this 
proposal to redistribute all the ongoing maintenance sessions phase 
performance payments to certain core and core maintenance session 
performance payments in the final rule consistent with Table 39. We 
proposed to increase performance payments for MDPP beneficiary 
achievement of the 5 percent weight loss goal, as well as continued 
attendance during each core maintenance interval. Based on comments we 
received, we will maintain the current 2021 performance payment amount 
for achievement of the 5 percent weight loss goal, increase the payment 
amounts to the attendance only goals to incentivize attendance, and 
increase the total maximum payment to $705.
    Our Office of the Actuary estimated that the average payment for an 
MDPP supplier will increase by $100 with the elimination of the second 
year of MDPP. While the maximum payment available to an MDPP supplier 
will decrease when compared to the maximum payment under the original 
2-year payment structure, the second year of the MDPP set of services 
have historically been far less utilized than first year set of 
services. Therefore, it is anticipated that eliminating the second year 
of payments will have minimal negative impact on the expanded model's 
costs. Table 39 shows the current 2021 non-cumulative performance 
payments, the proposed performance payments, and the finalized 
performance payment amounts for those MDPP beneficiaries who will start 
their first core service on or after January 1, 2022. We did not 
propose to change the payment rates for ongoing maintenance sessions in 
cases where a beneficiary remains eligible for them

[[Page 65320]]

(that is, because they started receiving the MDPP set of services on or 
before December 31, 2021 and achieved the minimum required weight 
loss); rather, we proposed to maintain those payment rates until such 
time as ongoing maintenance sessions are phased out.
[GRAPHIC] [TIFF OMITTED] TR19NO21.061

    Our data from the DPP model test showed beneficiaries who finished 
at least nine (9) sessions of the model were considered ``completers'' 
and had better weight loss and lower Medicare spending than non-
completers (those who attended fewer than 9 sessions). The DPP model 
test showed that beneficiaries who attend nine or more sessions will, 
on average, experience a 6.24 percentage point increase in weight loss 
compared to beneficiaries attending fewer than nine sessions. 
Currently, our payment structure does not pay for per session 
attendance, and stakeholders have commented that the expanded model, in 
its current state, is creating inequities in access to MDPP among 
eligible beneficiaries because suppliers cannot invest in the costs to 
retain beneficiaries who may have access barriers related to 
transportation or distance of the MDPP location from their home. We 
anticipate the changes to the payment structure, which will pay a total 
of $81 more per beneficiary who attends at least 9 sessions and $55 
more per core maintenance interval than what is currently paid, will 
encourage existing suppliers to retain MDPP beneficiaries given the 
one-year commitment versus two for the MDPP set of services. Continuous 
beneficiary attendance is critical to reaching key outcomes such as 5 
percent weight loss and reduced Medicare spending. Additionally, we 
expect more eligible organizations will enroll as MDPP suppliers due to 
our eliminating the ongoing maintenance period, thereby increasing the 
number of locations beneficiaries may access the MDPP set of services. 
We expect the changes to the MDPP payment structure will not affect 
MDPP's qualification for expansion. We will use the CDC DPRP and MDPP 
claims data as planned to assess whether the MDPP expanded model is 
expected to improve the quality of care without increasing spending, 
reduce spending without reducing the quality of care, or improve the 
quality of care and reduce spending. We anticipate that these 
programmatic adjustments are likely to result in more MDPP suppliers, 
increased beneficiary access to MDPP services and an ongoing reduction 
of the incidence of diabetes in eligible Medicare beneficiaries, in 
both urban and rural communities.
    In our regulatory impact analysis, the CMS Office of the Actuary 
updated its estimates that these changes will reduce Medicare spending 
over 10 years, with potential savings starting in 2027. There is no 
evidence that eliminating the second-year maintenance sessions, 
shortening the MDPP services period to 1 year, will have any negative 
effects on performance of the MDPP expanded model.
    Increasing the first-year payment amounts to suppliers and waiving 
the Medicare enrollment fee (as discussed below) should increase access 
to MDPP, resulting in more utilization of the MDPP set of services.
    We proposed a change to our emergency policy at Sec.  
410.79(e)(3)(v)(C) to account for the elimination of ongoing 
maintenance sessions for MDPP beneficiaries who start the set of MDPP 
services on or after January 1, 2022. Under this proposal, only 
beneficiaries who start the MDPP set of services between January 1, 
2021, and December 31, 2021 and who are in the second year of the set 
of MDPP services as of the start of an applicable 1135 waiver event may 
either resume or restart the ongoing maintenance session interval in 
which they were participating at the start of the applicable 1135 
waiver event if they elect not to continue with MDPP services virtually 
during the applicable 1135 waiver event. MDPP beneficiaries who are 
eligible to participate in MDPP ongoing maintenance phase sessions 
between January 1, 2021 and December 31, 2021 and who elected not to 
participate virtually during the COVID-19 PHE, will have the option to 
resume or restart the ongoing maintenance

[[Page 65321]]

session interval in accordance with Sec.  410.79(c)(3).
    As noted above, we proposed to remove the ongoing maintenance 
sessions phase for all MDPP beneficiaries who start MDPP set of 
services on or after January 1, 2022. MDPP beneficiaries who start the 
MDPP set of services on or before December 31, 2021 will be able to 
continue with the ongoing maintenance phase if they meet the 
eligibility requirements described in Sec.  410.79(c)(3). Table 40 
summarizes our proposal for the MDPP services period based on 
beneficiary start date.
[GRAPHIC] [TIFF OMITTED] TR19NO21.062

    Additionally, we proposed to remove the second duplicate paragraph 
(c)(3)(ii) given that the electronic CFR contains two paragraphs 
(c)(3)(ii), both containing the exact same language.
    We proposed to amend our regulation at Sec.  410.79(b), (c), and 
(e). We solicited comments on these proposals and ways to simplify the 
policies.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Overall, commenters were very supportive of the proposed 
changes, including the removal of the second year. Most commenters 
agreed that this change aligns with the CDC 2021 Standards and 
Operating Procedures for the National DPP and increases the ability of 
eligible organizations to offer the MDPP set of services to and retain 
participants. Commenters generally supported the removal of the second 
year as it allows eligible organizations to phase out Ongoing 
Maintenance sessions and align with the current CDC Recognition Program 
Standards and Operating Procedures. Other commenters indicated that 
participants are more likely to complete the MDPP set of services if it 
is only 1 year vs 2 years.
    We received several comments requesting that we keep the option of 
a second year given that some Medicaid and commercial plans offer a 
second year and may not require a 5 percent weight loss.
    Response: We appreciate the interest in keeping the second year as 
optional; however, we believe that it would be overly burdensome and 
confusing to suppliers, beneficiaries, and the Medicare Administrative 
Contractors (MACs) to have some beneficiaries enrolled in MDPP on or 
after January 1, 2022 continue with a second year. Permitting 
beneficiaries to participate in a second year would create additional 
confusion regarding beneficiary eligibility and the claims process. 
Although Medicaid and some commercial plans might offer a second year, 
the current utilization rate of the second year of MDPP set of services 
reveals that it is no longer necessary to the efficacy of the expanded 
model. We are finalizing this policy as proposed.
    Comment: Commenters stated that their understanding of this 
proposed change is that participants who are eligible to participate in 
MDPP ongoing maintenance (Months 13-24) between January 1, 2021 and 
December 31, 2021, but who elect not to participate virtually during 
the PHE, will have the option to resume or restart the ongoing 
maintenance session interval, even with the removal of this phase for 
beneficiaries beginning on or after January 1, 2022. The commenters 
requested clarifying language be added to the final rule if this 
understanding is correct, including whether there is a timeframe for 
these beneficiaries to re-start MDPP following the PHE.
    Response: We appreciated comments and support of the proposed rule 
provisions. Yes, beneficiaries who are eligible to participate in MDPP 
ongoing maintenance phase sessions between January 1, 2021 and December 
31, 2021 but who elect not to participate virtually during the PHE, 
will have the option to resume or restart the ongoing maintenance 
session interval in accordance with Sec.  410.79(e)(3)(v)(C). We added 
clarifying language to this final rule. We are not imposing a 
requirement for MDPP beneficiaries to restart the MDPP set of services 
following the end of the current PHE, nor are we establishing a 
deadline for when such beneficiaries must restart at this time because 
we do not believe that it is necessary due to the uncertainty of the 
PHE end date.
    Comment: Commenters encouraged CMS to go further and allow all 
current MDPP suppliers to stop offering ongoing maintenance sessions on 
January 1, 2022. For a period, MDPP suppliers may be delivering three 
interventions simultaneously: MDPP based on the 2022 changes, MDPP 
based on the prior iteration of the expanded model, and the National 
DPP, which would impose a substantial operational burden to program 
teams. As further rationale for this request, several MDPP suppliers

[[Page 65322]]

have shared that participants indicate they do not believe they need 
the second year.
    Response: We recognize that offering ongoing maintenance sessions 
to certain MDPP beneficiaries after January 1, 2022 may be temporarily 
burdensome. However, we believe that it is important to permit all 
eligible beneficiaries who have attended their first core session prior 
to January 1, 2022 the opportunity to participate in the full MDPP set 
of services as they existed at the time in which the beneficiary 
initiated the service. Otherwise, the scope of the set of services 
would change, perhaps abruptly, while the MDPP beneficiary is already 
receiving the set of services. Keep in mind that while MDPP suppliers 
are required to offer ongoing maintenance sessions after January 1, 
2022 to eligible MDPP beneficiaries who elect to continue with those 
services in accordance with the provisions of this final rule, MDPP 
beneficiaries are not required to participate in ongoing maintenance 
sessions. We are finalizing this policy as proposed.
    Comment: Many commenters requested that flexibilities to provide a 
virtual option continue after the current PHE. Commenters noted that 
permitting a virtual option outside the PHE may address harder to reach 
populations, thereby increasing access to the expanded model 
(especially for rural and lower income beneficiaries with 
transportation needs) and ensuring a more equitable approach to 
accessing the expanded model. One commenter suggested that CMS change 
the payment structure to adopt new technologies for one-on-one virtual 
fitness coaching.
    Several commenters suggested CMS make additional adjustments to 
align with CDC's DPRP standards. In particular, commenters recommended 
that CMS update the MDPP beneficiary eligibility requirements related 
to gestational diabetes and A1c levels. Commenters noted that the 
narrower eligibility criteria for MDPP may limit participation in the 
expanded model and cause confusion. In addition, we received many 
comments recommending that CMS consider removing or modifying the once 
per lifetime limitation. The commenters requested that CMS waive the 
once per lifetime requirement to allow for multiple attempts at weight 
loss. Also, several commenters expressed concern over the high-risk 
designation requirements for organizations enrolling in Medicare as 
MDPP suppliers. Commenters suggested that the designation is overly 
burdensome on businesses that do not have the capacity, profit, or 
bandwidth to address the extra requirements. One commenter requested 
that certified health providers such as Registered Dieticians and 
Registered Nutrition and Dietetics Technicians be the sole providers or 
provide the service with lay coaches to ensure correct nutrition 
information is relayed to beneficiaries. One commenter requested that 
CMS streamline the requirements for information collection for MDPP 
coaches. Several commenters expressed concern regarding the burden to 
become a supplier, particularly for those entities that serve 
historically underserved populations such as American Indians/Alaskan 
Natives (AI/AN). Commenters noted that the time it takes to become a 
CDC-recognized supplier can take 3 years, and then it can take another 
year to become an MDPP supplier after that. Finally, one commenter 
requested that CMS waive the requirement for tribes to become 
recognized by CDC before they can become MDPP suppliers.
    Response: We appreciate the commenters' support and interest in 
MDPP. These suggested changes are outside the scope of this final rule. 
The provisions we are finalizing in this rule are only to waive the 
Medicare enrollment fee for MDPP suppliers as of January 1, 2021, 
prospectively remove the ongoing maintenance phase of the MDPP set of 
services, and update the MDPP payment amounts.
    After consideration of public comments, we are finalizing Sec.  
410.79 (c) and (e) as proposed.
2. Changes to Sec.  414.84(b) and (c)
    We proposed to amend Sec.  414.84(b) and (c) to update the amount 
of the performance payments for the core sessions, core maintenance 
sessions and ongoing maintenance sessions (where applicable) to be 
consistent with our proposal. We proposed that this change apply to all 
MDPP beneficiaries starting the MDPP set of services on or after 
January 1, 2022.
    For those MDPP beneficiaries who started the first core session on 
or before December 31, 2021, we proposed that MDPP suppliers continue 
to submit claims for the ongoing maintenance sessions attended using 
the existing ongoing maintenance HCPCS G-codes, G9891, G9892, G9893, 
G9894, and G9895 when submitting claims for those MDPP beneficiaries 
who attended ongoing maintenance sessions.
    We proposed to amend our regulation at Sec.  414.84(b) and (c). We 
solicited comments on these proposals.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Overall, commenters were supportive of our proposal to 
redistribute some of the ongoing maintenance performance payment to the 
core and core maintenance session performance payments. However, many 
commenters recommended CMS to make further changes to the proposed 
payment structure and amounts. Many commenters recommended that CMS 
redistribute all, not just a portion, of the ongoing maintenance 
sessions phase performance payments to certain core and core 
maintenance session performance payments. The commenters noted that 
redistributing all the ongoing maintenance sessions phase performance 
payments would address ongoing concerns of MDPP suppliers of 
underpayment due to the current payment structure and help support long 
term sustainability of MDPP services. Several commenters stated that 
the proposed payment structure remains insufficient to cover the costs 
of MDPP and there is a large gap between costs and payment, especially 
when serving beneficiaries from diverse and low-income populations. 
These commenters suggested CMS to consider increasing the proposed 
payment rates to fully cover costs, including for serving diverse and 
low-income participants. One commenter expressed concern that the 
proposed total maximum payment amount in the restructured 1-year set of 
services is less than that available under the 2-year set of services. 
This commenter suggested that CMS ensure the finalized maximum payment 
is equal to the current 2021 payment amounts.
    Response: We agree with the commenters that redistributing all the 
ongoing maintenance session phase performance payments to certain core 
and core maintenance sessions will address some concerns of MDPP 
supplier underpayment and help support long term sustainability of MDPP 
services. After reviewing all of the comments received regarding the 
redistribution of the ongoing maintenance session phase performance 
payment amounts and the concerns about the inadequacy of the proposed 
payment amounts, we have determined that distributing the current total 
maximum payment amount will make MDPP more attractive to suppliers and 
increase beneficiary participation. We acknowledge that the final 
payment structure may remain insufficient to cover the costs of MDPP 
for some suppliers, but hope that increasing the maximum per 
beneficiary attendance-based payments by $253 may help address some of 
costs associated with

[[Page 65323]]

serving diverse and low-income participants. Stakeholders have told CMS 
that diverse and low-income beneficiaries have more barriers to weight 
loss, are less likely to achieve the 5 percent weight loss achieved 
performance goal, and require more effort from the MDPP suppliers. As 
such, by establishing payments with a heavy reliance on weight loss 
achieved, CMS is disincentivizing MDPP suppliers who serve diverse and 
low-income populations because the MDPP suppliers are receiving lower 
overall average per-beneficiary payments. We believe that shifting some 
of the payment amounts to the attendance only performance goals will 
increase the overall average per-beneficiary payment, thereby 
addressing some of the costs associated with serving diverse and low-
income populations.
    We are modifying the proposed Sec.  414.84(b) and (c) to 
redistribute all the ongoing maintenance sessions phase performance 
payments to certain core and core maintenance session performance 
payments in the final rule. Based on this modification, the total 
maximum payment will increase from the proposed $661 to $705. The $705 
payment amount is $1 more than the current maximum payment of $704 
under the original 2-year payment structure. Table 39 illustrates the 
updates to the payment amount redistribution and total maximum payment. 
We believe that this modification, along with the removal of Year 2 
from the MDPP set of services and the removal of the Medicare 
enrollment fee we are finalizing will help address some of the payment 
inadequacy comments we have received since MDPP was originally 
implemented.
    Comment: In addition to recommending that CMS redistribute all the 
ongoing maintenance performance payments, many commenters suggested 
that CMS make further changes to the proposed payment structure. 
Specifically, commenters recommended that we increase the amount of the 
performance payments available at the beginning of the MDPP set of 
services. Commenters stressed that staff time and programming expenses 
are highest during recruitment and enrollment (before core session 1) 
and during the first few weeks of the services (between core sessions 1 
and 4). One commenter, commented that the reimbursement structure needs 
to recognize the upfront costs to delivering the MDPP set of services. 
The commenter stated that payment levels should adequately cover the 
costs of core and maintenance sessions. The commenter stated that most 
organizations still see average cost of MDPP delivery in the $450--$600 
range per participant. The commenter calculated that, while the 
commenter received $462.78 per beneficiary during the Y-USA model test, 
MDPP suppliers receive currently receive an average of $262.40 per MDPP 
participant based on 2020 fee schedule and would receive $342.56 per 
participant based on proposed 2022 fee schedule. Several commenters 
requested that CMS align the total payment amount with the original 
model.
    The commenter encouraged CMS to further adjust the performance 
payment structure to pay more in the first 6 months of service delivery 
to ensure suppliers' up-front costs of serving a Medicare population 
(especially for organizations unused to health care administration 
costs) are covered sufficiently. This commenter stated that the current 
fee schedule does not account for any opportunity loss from recruitment 
efforts that do not convert to participation. Lastly, the commenter 
noted that the model's success relied on the power of community-based 
organizations delivering a low-cost program effectively, but these 
organizations are not in a position with capital on hand to wait for 
their first outcomes-based payments. Other commenters suggested that 
the payment structure should also reflect the services required by MDPP 
suppliers and their coaches to engage and build relationships with MDPP 
participants. Commenters stated that CMS should redistribute a portion 
of the payments, at least $100.00, to core session 1 to compensate 
organizations for successful recruitment and enrollment efforts and 
redistribute a portion of the payments, at least $100.00 each, to core 
sessions 4 and 9 to compensate organizations for successful retention 
efforts.
    Response: We agree that the current MDPP payment structure may not 
match the upfront costs to MDPP suppliers to deliver the MDPP set of 
services. In response to these comments, we are modifying proposed 
Sec.  414.84(b) and (c) to adjust the MDPP payment structure to 
increase the performance payments available at the beginning of the 
MDPP set of services. These changes to the payment structure will pay a 
total of $81 more per MDPP beneficiary who attends at least 9 sessions 
during the core sessions phase than proposed ($315 as finalized versus 
$234 as proposed) and $142 more per beneficiary who attends at least 9 
sessions during the core sessions phase than the current 2021 payment 
rates ($315 as finalized versus $173 current 2021 payment rates).
    As finalized, MDPP suppliers will receive a subtotal maximum 
payment for attendance only of $455. The proposed subtotal maximum 
payment for attendance only was $338 as proposed and $203 currently, 
the final payment structure will result in an increase of the subtotal 
maximum payment for attendance only of $117 and $252 respectively. As 
finalized, MDPP suppliers will receive a total maximum payment of $705. 
The proposed total maximum payment was $661 as proposed and $704 
currently, the final payment structure will result in an increase of 
the total maximum payment of $41 and $1 respectively. We believe these 
adjustments will increase the average payment to MDPP suppliers within 
the estimated average cost of MDPP delivery in the $450--$600 range per 
beneficiary provided by a commenter and will align the average per 
beneficiary payment with the estimated per beneficiary payment amount 
associated with the original model.
    As finalized, both core sessions 4 and 9 are over $100 ($105 and 
$175 respectively). While we increased the payment amount for the first 
core session from $26 to $35, we do not agree that CMS should increase 
the payment amount for the first core session further. First, 
continuous beneficiary attendance is critical to reaching key outcomes 
such as 5 percent weight loss and reduced Medicare spending. Our data 
from the DPP model test showed beneficiaries who finished at least nine 
(9) sessions of the model were considered ``completers'' and had better 
weight loss and lower Medicare spending than non-completers (those who 
attended fewer than 9 sessions). The DPP model test showed that 
beneficiaries who attend nine or more sessions will, on average, 
experience a 6.24 percentage point increase in weight loss compared to 
beneficiaries attending fewer than nine sessions. Second, increasing 
the payment amount for the first core session substantially may place 
the agency at a higher risk of fraud and abuse. A higher first core 
session payment may entice bad actors to enroll beneficiaries for the 
sole purpose of collecting the payment for the first core session with 
no intention of providing the remaining MDPP set of services. Not only 
does this create a risk to the agency, but it may create a risk for 
beneficiaries who may not be able to access the full MDPP set of 
services once they have attended the first session and no other 
services are offered. As such, we are finalizing the rule with the 
payment amounts listed in Table 39.

[[Page 65324]]

    Comment: Commenters encouraged CMS to reduce the emphasis on 
performance payments for weight-loss achievement and increase the 
performance payments for attendance-only achievements so that the 
payment methodology provides a stronger financial incentive for 
attendance. One commenter recommended that CMS refrain from increasing 
the payment for the 5 percent weight loss achievement to $179.00; 
rather, CMS should maintain the current (2021) payment for the 
achievement of 5 percent weight loss ($169.00) and increase the 
payments for attendance of the core maintenance sessions from $52.00 to 
$62.00. Several commenters stated that the proposed increase of the 
payment to $179.00 for 5 percent weight loss could have the unintended 
consequence of encouraging organizations to pursue ongoing 
participation by those who have already achieved 5 percent weight loss 
over those that have not yet achieved the 5 percent weight loss during 
the 9 core maintenance sessions. Commenters stressed that there should 
be an adequate financial incentive for suppliers to promote attendance 
amongst individuals who do not achieve 5 percent weight loss in the 
first 6 months. One commenter opined that session attendance payments 
at a level that covers operating costs only when a participant achieves 
5 percent weight loss, even for early sessions, establishes incentives 
for unrealistic, quick, weight loss that is not aligned with the design 
of DPP, or evidence-based diabetes prevention. The commenter suggested 
that reimbursement for session attendance should be increased, and set 
to encourage organizations to achieve consistent session attendance 
from participants.
    Response: We agree with the commenters recommendations that we 
should reduce the emphasis on performance payments for weight-loss 
achievement and increase the performance payments for attendance-only 
achievements so that the payment methodology provides a stronger 
financial incentive for attendance. As several commenters pointed out, 
placing too much emphasis on the weight-loss achieved goal could 
incentivize MDPP suppliers to seek out beneficiaries who are more 
likely to lose weight instead of focusing on the attendance of all 
eligible participants. While MDPP is a performance-based expanded 
model, we want to emphasize the importance of attending MDPP sessions 
along with the 5 percent weight loss goal. We are modifying the 
proposed Sec.  414.84(b) and (c) to adjust the MDPP payment structure 
to place more emphasis on beneficiary attendance consistent with Table 
39. We agree that we should not increase the payment for the 5 percent 
weight loss achievement from $169 to $179.00. As we stated before, MDPP 
is a performance-based expanded model. The goal of the expanded model 
is for beneficiaries to lose 5 percent of their weight from baseline 
during their participation. As such, achievement of this goal will 
still result in a higher reimbursement amount. However, we want to also 
emphasize the importance of attending MDPP sessions, therefore, we are 
shifting a larger portion of the Year 2 reimbursement amount to the 
attendance-goals to place additional emphasis on the importance of 
session attendance during the MDPP set of services. As finalized, we 
will maintain the current 2021 payment for the achievement of 5 percent 
weight loss of $169.00 and increase the payments for attendance of the 
core maintenance sessions to from $52.00 to $75.00. As finalized, MDPP 
suppliers will receive a subtotal maximum payment for attendance Only 
of $455. The proposed subtotal maximum payment for attendance only was 
$338 as proposed and $203 currently, the final payment structure will 
result in an increase of the subtotal maximum payment for attendance 
only of $117 and $252 respectively. We believe that these changes will 
provide more financial incentive for suppliers to promote consistent 
attendance from participants regardless of weight loss achievement. We 
are finalizing the rule with the payment amounts listed in Table 39.
    Comment: Other commenters suggested that CMS remove performance-
based payments entirely and simply pay MDPP suppliers for delivering 
MDPP services. One commenter stated that continuing payments to MDPP 
suppliers contingent on the beneficiary achieving a weight loss goal, 
attending a specific number of sessions, or any other performance goal 
is not consistent with the DPP model test or other preventive health 
programs, such as smoking cessation and obesity interventions, which do 
not base payments on the beneficiary achieving an outcome. One 
commenter opined that they would like to see MDPP suppliers receive 
payments for their efforts put into the long journey to preventing 
diabetes, not just for the attainment of the goal. One commenter 
encouraged CMS to provide organizations with an adequate revenue stream 
for MDPP delivery when beneficiaries attend sessions, even if 
beneficiaries do not achieve 5 percent weight loss during the first 
nine sessions. This commenter noted that the complex payment 
methodology runs counter to CMS' goal of Burden Reduction, Patients 
Over Paperwork, and increases the operating costs of both Medicare 
suppliers and the MACs.
    Response: While we agree with commenters that the MDPP payment 
structure does not align with preventive service benefits that are paid 
on a fee-for-for service basis, we disagree with the recommendations to 
align MDPP payments with that of other FFS prevention programs such as 
smoking cessation and obesity counseling. During the DPP model test, 
the Y-USA included attendance and weight loss as performance-based 
milestones. For an example, they tracked the number of participants who 
attended the 1st, 4th, and 9th core sessions and the number of 
participants who achieved the 5 percent and 9 percent weight loss 
goals. When OACT certified the DPP Model test in 2016, they based their 
payment structure assumptions on that of the DPP model test, and 
included performance-based payments for beneficiary achievement of 
attendance and weight loss milestones. MDPP is an expanded model, and 
it is different from the DPP model test in that it established a 
performance-based payment structure that is designed to incentivize 
MDPP suppliers to deliver a service that will result in weight loss and 
ultimately savings to CMS.
    In addition, while we do not agree that the payment structure runs 
counter to the CMS goals of Burden Reduction and Patients Over 
Paperwork, or that it increases the operating costs of both Medicare 
suppliers and the MACs, we recognize that the current level of 
complexity may cause barriers in enrollment and payments. We believe 
that the changes we are finalizing in this rule will simplify the 
payment structure and increase the overall payments received by MDPP 
suppliers. We are finalizing the rule with the payment amounts listed 
in Table 39.
    Comment: One commenter noted that the total proposed performance 
payment per beneficiary without the 5 percent weight loss is $338 
compared to $661 for those that achieve and maintain weight loss. This 
commenter stated that the reduced reimbursement for beneficiaries who 
do not meet the 5 percent weight loss is unacceptable and is not cost 
beneficial for Tribal Health Programs to participate. This commenter 
stated that American Indians/Alaskan Natives (AI/AN) have the highest 
risk of Type II diabetes and face challenges on lack of quality medical 
care, lack of access to healthy

[[Page 65325]]

food, and lack of access to safe or adequate places for physical 
activity. They included data by the University of Kansas Medical Center 
on the success rate of AI/AN in diabetes weight loss programs that 
found that only 36 percent of AI/AN lost weight and among those who 
lost weight, 76 percent lost an average of 2.98 percent body weight and 
only 6 participants, out of 72, lost 7 percent or more of their body 
weight. If this sample study reflects AI/AN communities, the success 
rate for a Tribal member to achieve and maintain 5 percent weight loss 
is less than 10 percent. The commenter recommended that CMS use other 
health outcome measures such as reductions in blood sugar levels and 
hypertension risk, lower BMI levels, increased intake of healthy foods, 
increased rate of physical activity, or risk reduction factors for 
performance payments instead of weight loss.
    Response: We acknowledge the evidence presented by the commenter 
that certain populations show improvements in health outcomes with 
participation in weight loss programs even though they do not achieve 
the 5 percent weight loss milestone. However, we did not propose to use 
other health outcome measures such as reductions in blood sugar levels, 
hypertension risk, or lower BMI levels instead of the 5 percent weight 
loss performance-based milestone, and we decline to adopt such changes 
at this time. As finalized, MDPP suppliers will receive a subtotal 
maximum payment for attendance only of $455, compared to the subtotal 
maximum payment for attendance only of $338 as proposed and $203 
currently. The final payment structure will result in an increase of 
the subtotal maximum payment for attendance only of $117 and $252 
respectively. We believe that these changes will provide more financial 
incentive for suppliers to promote consistent attendance from 
participants regardless of weight loss achievement.
    The changes we proposed to the rule and the modifications we are 
finalizing in this rule are in direct response to those concerns. By 
reducing the emphasis on the weight-loss achievement goals and 
increasing the attendance-payment amounts, we believe that we will 
adequately incentivize MDPP suppliers to deliver MDPP services even 
when weight-loss has not occurred.
    Comment: One commenter suggested that MDPP's lack of flexibility, 
such as risk-adjusted payments to serve patient populations that may 
face transportation and other barriers to attendance and/or who the 
evidence has shown may be less likely to achieve the 5 percent weight 
loss threshold contributes to increased health inequities and lack of 
opportunities for Medicare beneficiaries to participate.
    Response: We agree that many eligible beneficiaries face challenges 
that impact their ability to lose weight and achieve the 5 percent 
weight-loss goal. However, we believe that risk-adjusted payments would 
be too complicated to add to the expanded model at this time. In 
addition, we do not currently have a sufficiently large cohort nor 
enough data to accurately risk adjust the payments.
    Finally, we believe that reducing the MDPP set of services to 1 
year, shifting all of the Year 2 reimbursement amounts, and placing 
more emphasis on the attendance only goal payments will provide more 
financial incentive for suppliers to promote consistent attendance from 
participants regardless of weight loss achievement and increase access 
to beneficiaries who are less likely to achieve the 5 percent weight 
loss threshold and with the potential to increase health equity for 
Medicare beneficiaries.
    We will consider this recommendation for future rulemaking.
    Comment: One commenter recommended that CMS increase payment for 
session attendance regardless of weight loss outcomes with a bonus when 
an attendee attends 4 sessions within 6 weeks and 9 sessions within 12 
weeks.
    Response: We are modifying the proposed regulation text at Sec.  
414.84(b) and (c) to adjust the MDPP payment structure to place more 
emphasis on beneficiary attendance consistent with Table 39. We are not 
considering adding any bonus payments at this time because we believe 
that these changes will provide more financial incentive for suppliers 
to promote consistent attendance from participants regardless of weight 
loss achievement. We are finalizing the rule with the payment amounts 
listed in Table 39.
    Comment: One commenter recommended that CMS establish incremental 
weight loss outcome payments, paying for achievement of 4 percent 
weight loss and 5 percent weight loss. The commenter noted that adding 
the 4 percent weight loss outcome payment would align MDPP with the 
current National DPP standards which include a 4 percent outcome, based 
on evidence of diabetes prevention.
    Response: We appreciate the commenters' support and interest in 
MDPP. We did not propose to adjust the 5 percent weight loss 
achievement goal and we decline to do so now because incremental weight 
loss measurements would overly complicate the payment structure and 
make it more difficult to evaluate for the MDPP expanded model. We will 
continue to evaluate MDPP's alignment with the CDC's DPRP and make 
updates as necessary and feasible.
    Comment: One commenter recommended that CMS eliminate the 9 percent 
weight loss outcome payment.
    Response: We appreciate the commenters' interest in MDPP. We did 
not propose to eliminate the 9 percent weight loss achievement goal and 
we decline to do so now. The 9 percent weight loss goal was an outcome 
measure in the original DPP model test, and we believe it is important 
to retain the 9 percent weight loss goal as an outcome of the MDPP 
expanded model test.
    Comment: One commenter recommended that CMS establish an additional 
performance payment for each beneficiary who achieved the 5 percent 
weight-loss goal and then maintained the 5 percent weight-loss at the 
twelfth month of attendance.
    Response: We did not propose to add any new performance payments to 
the performance structure and we decline to do so now because adding 
additional payments would create more confusion for MDPP suppliers 
regarding claims submission. In addition, we believe that the finalized 
payment amounts already provides a higher payment amount for MDPP 
beneficiaries who maintain weight loss throughout the end of the 
twelfth month. The payment amount for the final performance goal 
``Attend 2 Core Maintenance Sessions'' during months 10-12 provides a 
higher payment amount $70 versus $93 for beneficiaries who have 
maintained the 5 percent weight-loss.
    Comment: One commenter recommended that CMS consider prospective 
bundled payments for a certain number of initial core sessions.
    Response: We will consider this recommendation for future 
rulemaking.
    After consideration of the comments received, we are finalizing our 
proposals with the following modifications:
     Redistribute all the ongoing maintenance sessions phase 
performance payments to certain core and core maintenance session 
performance payments consistent with Table 39, and
     Maintain the current 2021 performance payment amount for 
achievement of the 5 percent weight loss goal, increase the payment 
amounts to the attendance only goals to incentivize attendance, and 
increase the total maximum payment to $705.

[[Page 65326]]

3. Changes to Sec.  424.205(b)
    Medicare requires all organizations that deliver MDPP services to 
enroll separately in Medicare as a MDPP supplier and pay an enrollment 
application fee. This places a unique burden on MDPP suppliers. 
Approximately 39 percent of these entities are non-traditional 
suppliers that serve their local communities to increase diversity, 
equity, and inclusion of their services, including but not limited to 
YMCAs, county health departments, community health centers, and non-
profit organizations that focus on health education that otherwise 
would neither enroll nor be able to enroll as a Medicare supplier. 
Indeed, they are often very different from most other Medicare 
providers and suppliers in terms of business model and financial 
wherewithal, and they frequently furnish non-health care services to 
the community. In this vein, they cannot be considered in the same 
light as, for example, hospitals, SNFs, ambulance suppliers, or other 
organizations specifically and exclusively designed for the provision 
of health care services.
    The provider/supplier enrollment fee for CY 2021 is $599. Although 
MDPP suppliers may submit a written request to CMS for a hardship 
exception to the application fee in accordance with Sec.  424.514, many 
will not qualify. We have heard from stakeholders that the enrollment 
application fee factors into an organization's decision to participate 
in MDPP. Organizations must submit the provider enrollment fee during 
the initial start-up phase of their expanded model implementation. This 
is when costs are likely the highest for organizations and the timing 
of the first CMS reimbursement is farthest away. MDPP suppliers would 
need to provide a first core session to at least 24 beneficiaries to 
simply recoup the Medicare provider enrollment fee. For many potential 
MDPP suppliers, the provider enrollment application fee, when combined 
with the additional MDPP requirements, such as the claims processing 
requirements, result in an organization declining to invest in 
enrolling as an MDPP supplier.
    On April 9, 2020, CMS, through the COVID-19 Emergency Declaration 
Blanket Waivers for Health Care Providers, waived all provider 
enrollment application fees. We saw an immediate increase in MDPP 
supplier enrollment in Q2 2020, the quarter the blanket waivers were 
announced, but MDPP supplier enrollment slowed thereafter, likely due 
to the impact of the pandemic and many CDC National DPP organizations 
pausing their delivery of DPP. We believe that granting a waiver of the 
fee for MDPP suppliers to extend beyond the COVID-19 Emergency 
Declaration Blanket Waiver may increase MDPP supplier enrollment, which 
will ultimately improve beneficiary access to the expanded model and 
our ability to evaluate the outcome of the MDPP because increasing the 
number of MDPP suppliers may provide for a more robust evaluation of 
the expanded model. Given our prior discussion of the unique character 
of MDPP suppliers in comparison to more traditional provider and 
supplier types, we believe this policy change is warranted.
    In an effort to minimize the impact of this potential barrier and 
allow for a more robust expanded model evaluation, we proposed to 
utilize CMS' waiver authority under section 1115A(d)(1) of the Act to 
waive the provider enrollment Medicare application fee (described in 
sections 1866(j)(2)(C)(i) and (ii) of the Act) for all organizations 
that submit an application to enroll in Medicare as an MDPP supplier on 
or after January 1, 2022. We proposed to amend our regulation at Sec.  
424.205 (b) to reflect this waiver.
    We solicited comments on these proposals.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters were unanimous in their support of CMS' 
proposal to waive the Medicare enrollment fee for MDPP suppliers as of 
January 1, 2021 indicating the fee is cost prohibitive for many 
potential suppliers. Several commenters suggested that this change will 
advance CMS' health equity agenda and increase access to MDPP services 
for beneficiaries. Several commenters pointed to the idea that this 
change may be helpful to local community-based suppliers and will 
encourage more organizations to apply as MDPP suppliers. Other 
commenters highlighted that this change will increase access to tribal 
health programs, improve the program's ability to reach diverse and 
underserved communities, and entice community-based organizations 
(CBOs) and FQHCs to enroll as MDPP suppliers. One commenter indicated 
that removing the fee, along with the proposal to also modify the 
performance payment structure CMS, could demonstrate significant 
strides to making the delivery of the MDPP set of services financially 
viable for organizations.
    One commenter expressed concern that there are other hurdles a MDPP 
supplier faces when enrolling to be a supplier but did not provide 
details on these concerns. Another commenter indicated that additional 
changes to supplier enrollment, qualifying criteria, performance 
outcomes, and payment structure are necessary to incentivize more 
eligible organizations to enroll.
    Response: We appreciate the comments and support of the proposed 
rule provisions. We agree that this change has the potential to improve 
access to MDPP and increase MDPP supplier enrollment. We acknowledged 
that there are additional hurdles faced by organizations enrolling as 
MDPP suppliers. Within this final rule, we have addressed changes to 
other areas of concern. In addition to waiving the provider enrollment 
Medicare application fee, we modified the proposed policy to preclude 
the provision of ongoing maintenance sessions unless the MDPP 
beneficiary has started his or her first core session on or before 
December 31, 2021. We will continue to explore ways to reduce other 
hurdles in the future.
    Comment: One commenter expressed concern related to requirements 
and timeline for MDPP suppliers to submit data in order to obtain 
recognition by the CDC. The commenter indicated the collection of data 
is not applicable to their communities when there is no support for 
funding for their already under-served health care community.
    Response: The CDC DPRP recognition requirements are outside of the 
scope of this rule. The provisions we are finalizing in this rule are 
only to waive the Medicare enrollment fee for MDPP suppliers as of 
January 1, 2021 and update the MDPP payment structure and payment 
amounts.
    After consideration of public comments, we are finalizing as 
proposed.
4. Changes to Sec.  424.502
    We proposed to make a conforming amendment to Sec.  424.502 to 
remove the reference to the CMS-20134 from the definition of 
``institutional provider.'' The CY 2018 PFS final rule, which 
established the application fee for MDPP suppliers, amended the 
definition of ``institutional provider'' in section Sec.  424.502 to 
state that MDPP suppliers that complete the CMS-20134 enrollment 
application are ``institutional provider[s]''. Thus, the application 
fee described in section Sec.  424.514 applies to organizations 
enrolling in Medicare as MDPP suppliers. We proposed to reverse this 
policy by amending Sec.  424.502 to remove the reference to the CMS-
20134 thereby removing MDPP suppliers from the list

[[Page 65327]]

of institutional providers required to pay the Medicare enrollment fee 
under Sec.  424.514. As proposed, Sec.  424.514 will no longer be 
applicable to organizations enrolling in Medicare as an MDPP supplier.
    We solicited comments on this proposal.
    We did not receive public comments on this provision, and we are 
finalizing as proposed.

M. Clinical Laboratory Fee Schedule: Laboratory Specimen Collection Fee 
and Travel Allowance for Clinical Diagnostic Laboratory Tests and Use 
of Electronic Travel Logs

1. Background on Laboratory Specimen Collection Fees for COVID-19
    In the CY 2022 PFS proposed rule (86 FR 39309), we stated that we 
continue to believe that the laboratory specimen collection fees for 
COVID-19 CDLTs established in the context of and for the duration of 
the PHE for the COVID-19 pandemic should conclude at the termination of 
the PHE, as originally announced in the March 2020 COVID-19 IFC (85 FR 
19258). Specifically, we stated that we believe that these increased 
payments for specimen collection specifically for COVID-19 tests would 
no longer be warranted beyond the end of the PHE. The two new level II 
HCPCS codes established to identify specimen collection for COVID-19 
testing specifically are: Code G2023 (specimen collection for severe 
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus 
disease [COVID-19]), any specimen source); and code G2024 (specimen 
collection for severe acute respiratory syndrome coronavirus 2 (SARS-
Cov-2) (Coronavirus disease [COVID19]), from an individual in a SNF or 
by a laboratory on behalf of a HHA, any specimen source), for 
independent laboratories to use when billing Medicare for the nominal 
specimen collection fee for COVID-19 testing for the duration of the 
PHE for COVID-19.
    As discussed in the CY 2022 PFS proposed rule, the increased fees 
were intended to address additional resources needed specifically 
during the PHE for the COVID-19 pandemic, particularly for the 
collecting of specimens using nasopharyngeal and oropharyngeal swabs or 
collection of sputum, which required a trained laboratory professional 
and additional precautions to minimize exposure risks in handling 
specimens that are suspected or confirmed for COVID-19. We stated that 
we expect that the termination of the PHE will occur when there is a 
reduced risk of COVID-19, which will mean the increase of supplies, 
personal protective equipment (PPE), and heightened sterilization and 
safety protocols for laboratory specimen collection and handling will 
be at a more manageable level. Likewise, we stated that we expect the 
potential ongoing spread of COVID-19 likely will diminish after the PHE 
ends, which will mean that advanced safety precautions, extensive PPE, 
and specialized training for laboratory specimen collection likely will 
no longer be required to the same extent as during the PHE. Because we 
anticipated that the PHE will end when there is a reduced risk of 
COVID-19 and not before such circumstances exist, we maintained that 
the laboratory specimen collection fees for COVID-19 CDLTs established 
in the context of and for the duration of the PHE for the COVID-19 
pandemic should conclude at the termination of the PHE (86 FR 39310).

2. Specimen Collection Fee and Travel Allowance for Clinical Diagnostic 
Laboratory Tests

    In the CY 2022 PFS proposed rule (86 FR 39310), we requested broad 
comments on our policies for specimen collection fees and the travel 
allowance for consideration for possible updates to policies in the 
future through notice and comment rulemaking. We requested comments 
regarding the nominal specimen collection fees for trained personnel to 
collect specimens from homebound patients and inpatients (not in a 
hospital), how specimen collection practices may have changed as a 
result of, or from insight gained during, the PHE for COVID-19, what 
additional resources might be needed for specimen collection for COVID-
19 CDLTs and other tests after the PHE ends, as well as comments 
related to the calculation of costs for transportation and personnel 
expenses for trained personnel to collect specimens from such patients.
    The following is a summary of the public comments we received 
related to the specimen collection fee and changes in practice 
associated with the PHE for COVID-19 and our responses.
    Comment: Several commenters expressed appreciation that CMS 
recognized the need for additional resources required for specimen 
collection during the PHE and also for the expansion of access to 
laboratory testing in the home for Medicare beneficiaries. One 
commenter expressed support for CMS' decision to end the increased 
payment amounts for specimen collection at the termination of the PHE, 
stating that many laboratories realized financial profits during the 
PHE and suggested that those profits will continue to provide incentive 
to perform COVID-19 testing even after the termination of the PHE.
    Conversely, several commenters stated that instead of ending 
increased payments for specimen collection, CMS should instead expand 
and permanently authorize the specimen collection payment under HCPCS 
codes G2023 and G2024 and allow the usage of these codes for all CDLTs 
in order to compensate for the supplies, equipment, and sterilization 
protocols required for safe and uncontaminated specimen collection and 
handling in the suspected presence of SARS-CoV-2. Commenters stated 
that an increased payment for the specimen collection of all CDLTs is 
necessary to compensate for the supplies, equipment, and sterilization 
protocols required for safe specimen collection and handling, not just 
in cases with suspected presence of SARS-CoV-2. Several commenters 
requested that CMS permanently allow the usage of G2023 to report 
specimen collection for all sites of service where specimens are 
collected by clinical laboratories and not exclusively for homebound 
patients, suggesting that extending the payment of specimen to 
additional settings would improve patient access to laboratory testing. 
One commenter suggested that any site where clinical laboratory 
personnel collect specimens should be permitted to bill Medicare for 
G2023, including on-site collection at clinical laboratories, 
pharmacies billing as clinical laboratories, drive through testing 
locations, and urgent care clinics.
    Several commenters stated that the COVID-19 pandemic has 
permanently altered the public health paradigm, which the commenters 
stated necessitates permanent and resource-intensive infection control 
measures that merit higher specimen collection fees to account for such 
costs as heightened safety precautions, the need for PPE, and special 
training for specimen collection beyond the immediate PHE. The 
commenters stated that the novel coronavirus is transmitted through the 
air, widely circulating variants (for example, beta, delta) will 
continue to spread, more variants are likely to continue to emerge, and 
the duration of the vaccine protective immunity is unknown. For these 
reasons, the commenters stated that additional PPE and safety 
procedures and training necessary for safe specimen collection will be 
necessary indefinitely. Several commenters also stated that herd 
immunity has not yet been achieved and may still be years away; 
therefore, ongoing special training and protective measures, including 
PPE,

[[Page 65328]]

which require additional costs and supplies, will remain necessary. One 
commenter also stated that even if the overall testing volume for the 
novel coronavirus decreases, additional resources on a per test basis 
will remain the same. One commenter stated that laboratory tests that 
provide self-collection kits still require professionals for processing 
of the specimens, who in turn need appropriate infection control 
resources for that activity.
    Several commenters described the types of costs incurred and 
supplies needed for specimen collection, specifically:
     PPE including N-95 or higher respiratory or masks; face 
shields; goggles; gloves; isolation gowns;
     Specimen collection supplies including swabs; collection 
kits;
     Disinfecting and sterilization equipment including 
cleaning supplies; sanitizers; sterile gauze and bandages; biohazardous 
material disposal receptacles and bags;
     Laboratory training and expertise for staff, including 
employee time used for existing and new clinical laboratory technicians 
or health care professionals to train on proper specimen collection and 
handling techniques; and
     Additional staffing costs, including employee time for 
existing and additional new clinical laboratory technicians or health 
care professionals required to follow safe and accurate specimen 
collection procedures, enforce safe distancing requirements and fulfill 
administrative requirements such as logging information into infection 
control tracking databases at the institutional, local, State and/or 
Federal level.
    Several commenters stated that other Federal agencies have both 
recommended and mandated enhanced protective measures, including the 
Centers for Disease Control and Prevention (CDC) and Occupational 
Safety and Health Administration (OSHA), respectively, in suspected 
COVID-19 cases. Commenters also suggested that the laboratory specimen 
collection fee should be updated annually to reflect inflation and the 
growth in costs.
    Response: We appreciate the comments regarding the nominal specimen 
collection fees for the collection of specimens for COVID-19 clinical 
diagnostic laboratory testing. We acknowledge that the types of 
resources utilized and supplies needed for specimen collection have 
been influenced by the PHE for COVID-19. We plan to take this feedback 
into consideration for possible future rulemaking or guidance.
    The following is a summary of the public comments we received 
related to the methodology for calculating the travel allowance for 
laboratory specimen collection and our responses.
    Comment: Several commenters described their concerns with the 
current travel allowance policy, stating that the current system 
requires the individual tracking of miles and paperwork documenting 
those miles, and the calculation of billable charges. Commenters stated 
that this system creates inconsistencies across facilities providing 
specimen collection services and creates confusion and burden for 
health care providers and Medicare Administrative Contractors (MACs).
    Several commenters requested that CMS simplify the travel allowance 
by creating a single per-encounter flat-rate payment for travel to be 
updated annually by the Consumer Price Index for All Urban Consumers 
(CPI-U), which the commenters stated would eliminate the need for the 
current system which they describe as cumbersome and inefficient since 
it requires tracking individual miles traveled in paper or electronic 
logs. Commenters suggested that the single per-encounter flat-rate 
payment rate be calculated using total aggregate payments made for the 
travel allowance in 2018, divided by the number of patient encounters, 
and then reduced by a percentage in support of a separate rural add-on 
payment and updated annually to reflect inflation and the growth in 
costs.
    Commenters also stated that a single per-encounter flat-rate 
payment to reimburse the travel allowance would simplify personnel and 
transportation expenses, eliminating the individual tracking of miles 
and paper documenting those miles, as well as the calculation of 
billable charges. The commenters stated that the flat-rate approach 
would also provide greater consistency across facilities served and 
reduce the burden on health care providers and MACs, and therefore, 
further support continued patient access to these laboratory services. 
Several commenters also stated that the travel allowance is prone to 
billing inconsistencies, so simplifying the calculation of the travel 
allowance would increase the overall understanding of the policy among 
stakeholders, decrease the instances of health care providers 
inadvertently overbilling for mileage, and reduce program integrity 
concerns, creating clarity for all parties involved.
    Several commenters also requested that CMS create a rural add-on 
payment to supplement the single per-encounter flat-rate payment for 
travel, which the commenters stated would account for additional 
resources required to provide specimen collection in distant and remote 
areas and ensure that beneficiaries residing in rural areas can 
continue receiving specimen collection services.
    Several commenters also suggested that if CMS does not adopt a flat 
rate approach, CMS should consider modifying the existing travel 
allowance payment structure. Commenters recommended that salary and 
travel costs used to determine the travel allowance be updated to 
account for increased labor and fuel costs and adequately cover the 
costs associated with transportation and personnel expenses for trained 
personnel to travel to the location to collect the sample. Commenters 
also suggested that mileage calculations begin at an eligible 
laboratory or patient locations and end when the trained personnel no 
longer have the specimen in their possession. Several commenters also 
recommended that business requirements outlined in the annual Medicare 
travel allowance change request be updated to require the contractor to 
search their files to adjust claims already paid at the prior year 
travel allowance rather than require action by health care providers, 
instructing contractors to review claims and reprocess at the updated 
rates.
    Response: We appreciate the comments regarding the travel allowance 
for CDLTs. We plan to take this feedback into consideration for 
possible future rulemaking or guidance.
3. Medicare Clinical Laboratory Fee Schedule: Electronic Travel Logs
    In the CY 2022 PFS proposed rule (86 FR 39310 through 39311), we 
stated that we are making permanent the option for laboratories to 
maintain electronic logs of miles traveled for the purposes of covering 
the transportation and personnel expenses for trained personnel to 
travel to the location of an individual to collect a specimen sample. 
This option for laboratories to maintain electronic logs is not limited 
to COVID-19 specimen collection and applies to specimen collection for 
any CDLT. We will provide guidance in future instructions via 
forthcoming Change Requests and other materials such as MLN 
Matters[supreg] Articles. Laboratories will need to be able to produce 
electronic logs in a form and manner that can be shared with MACs, and 
should continue to consult with their local MACs regarding the format 
and process for ongoing submission of this information.

[[Page 65329]]

N. Medicare Provider and Supplier Enrollment

1. Enrollment Process
a. General Discussion
    Section 1866(j)(1)(A) of the Act requires the Secretary to 
establish a process for the enrollment of providers and suppliers in 
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 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 being able to enter and 
inappropriately bill Medicare. Since 2006, we have taken steps via 
rulemaking to outline our enrollment procedures. These regulations are 
generally incorporated in 42 CFR part 424, subpart P (currently 
Sec. Sec.  424.500 through 424.570 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. 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 the Medicare provider enrollment 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 discussed further in this section 
III.N. of this final rule, we proposed several changes to our existing 
provider enrollment regulations.
b. Legal Authorities
    There are two principal categories of legal authorities for our 
provider enrollment provisions. First, section 1866(j) of the Act 
furnishes specific authority regarding the enrollment process for 
providers and suppliers. Second, sections 1102 and 1871 of the Act 
provide general authority for the Secretary to prescribe regulations 
for the efficient administration of the Medicare program.
2. Provisions
a. Expansion of Authority To Deny or Revoke Based on Office of 
Inspector General (OIG) Exclusion
    Under Sec. Sec.  424.530(a)(2) and 424.535(a)(2), respectively, CMS 
denies or revokes a provider's or supplier's enrollment if the provider 
or supplier, or any owner, managing employee, authorized or delegated 
official, medical director, supervising physician, or other health care 
personnel of the provider or supplier is excluded by the OIG. We 
proposed several changes related to these authorities.
    First, we proposed to expand the categories of parties within the 
purview of these denial and revocation provisions to include excluded 
administrative or management services personnel who furnish services 
payable by a Federal health care program, such as a billing specialist, 
accountant, or human resources specialist. This change would align with 
existing OIG guidance stating that providers and suppliers may not 
employ excluded persons to provide management or administrative 
services that are payable by a Federal health care program.\143\
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    \143\ https://oig.hhs.gov/exclusions/files/sab-05092013.pdf.
---------------------------------------------------------------------------

    Second, existing Sec.  424.530(a)(2) references ``other health care 
personnel furnishing Medicare reimbursable services who is required to 
be reported on the enrollment application.'' To conform to our change 
described in the previous paragraph, we proposed to replace this 
language with ``other health care or administrative or management 
services personnel furnishing services payable by a Federal health care 
program.'' We also proposed to include this language within Sec.  
424.535(a)(2) so that the latter aligns with Sec.  424.530(a)(2).
    Third, Sec.  424.535(e) states that if the revocation was due to 
adverse activity (sanction, exclusion, or felony) against an owner, 
managing employee, authorized or delegated official, medical director, 
supervising physician, or other personnel of the provider or supplier 
furnishing Medicare reimbursable services, the revocation may be 
reversed if the provider or supplier terminates (and submits proof that 
it has terminated) its business relationship with that individual 
within 30 days of the revocation notification. For the reasons already 
outlined, we proposed to replace the language in Sec.  424.535(e) 
concerning other personnel furnishing Medicare reimbursable services 
with ``other health care or administrative or management services 
personnel furnishing services payable by a Federal health care 
program.''
    We received several public comments on these proposals. The 
following is a summary of them and our responses.
    Comment: Several commenters expressed concern that providers and 
suppliers (in their efforts to follow OIG compliance guidelines) may 
miss instances where a person they are reviewing against the OIG 
exclusion list has a name that does not exactly match that indicated on 
the OIG list as an excluded party, yet the two parties are in fact the 
same; this could mean that such person might avoid detection. The 
commenters suggested an exception to the application of expanded 
Sec. Sec.  424.530(a)(2) and 424.535(a)(2) if the provider or supplier 
demonstrated a good-faith effort to identify potentially excluded 
parties among their employees or other personnel.
    Response: We respectfully disagree with the commenters' recommended 
good-faith exception. It is ultimately the provider's or supplier's 
responsibility to ensure that the parties addressed in Sec. Sec.  
424.530(a)(2) and 424.535(a)(2) are not excluded by the OIG. While we 
recognize that this task may take more time with respect to a 
particular party if, for instance, the name-match issue to which the 
commenter refers arises, this does not and should not negate the 
provider's or supplier's responsibilities in this regard. The central 
principle associated with Sec. Sec.  424.530(a)(2) and 424.535(a)(2) 
involves the provider's or supplier's need to avoid relationships with 
OIG-excluded parties, not the level of effort the provider or supplier 
undertook to confirm that no such relationships exist.

[[Page 65330]]

    Comment: One commenter maintained that our proposal could increase 
provider burden, particularly for smaller practices. The commenter 
stated that some providers and suppliers hire third-party organizations 
to submit claims and perform other functions on their behalf; as part 
of these contracts, the third-party performs OIG exclusion searches on 
the persons who will be undertaking these activities. The commenter 
stated that our proposal would require providers and suppliers to 
update such contracts to ensure that the provider or supplier is held 
harmless should the third-party fail to adequately conduct these 
searches. The commenter recommended that CMS mitigate the 
administrative burden and other impacts of this proposal.
    Response: Consistent with our response to the previous commenters, 
we believe that the provider or supplier bears primary responsibility 
for ensuring adherence to Federal regulations irrespective of whether 
it delegates any compliance verification activities to a third-party. 
As for impact reduction, we emphasize that the only parties to which 
our expansion of Sec. Sec.  424.530(a)(2) and 424.535(a)(2) would apply 
are those engaged in administrative or managerial services that are 
payable by a Federal health care program; if the service does not fall 
within this latter category concerning Federal reimbursement, the 
expansion is inapplicable. Moreover, we believe that: (i) Many 
providers and suppliers already review such parties against the OIG 
exclusion list; and (ii) many of these parties also fall within one of 
the other categories addressed in Sec. Sec.  424.530(a)(2) and 
424.535(a)(2) (for example, managing employees), meaning that they are 
already covered under these two regulatory provisions. Given the 
foregoing, we do not foresee an increase in the overall administrative 
effect of Sec. Sec.  424.530(a)(2) and 424.535(a)(2) on the provider 
community.
    After consideration of these public comments, we are finalizing our 
revisions to Sec. Sec.  424.530(a)(2) and 424.535(a)(2) as proposed.
b. Deny or Revoke Enrollment for Surrender of Drug Enforcement 
Administration (DEA) Certificate of Registration in Response to Show 
Cause Order
    We have existing authority under Sec.  424.530(a)(11)(i) to deny a 
physician's or other eligible professional's enrollment if his or her 
DEA certificate of registration to dispense a controlled substance is 
currently suspended or revoked; a concomitant authority to revoke 
enrollment in this circumstance is outlined in Sec.  424.535(a)(13)(i). 
We proposed to expand these authorities to include situations where the 
physician or other eligible professional surrenders his or her DEA 
certificate in response to an order to show cause.
    We have encountered situations where a physician or other eligible 
professional who has engaged in improper prescribing or other DEA-
monitored activities relinquishes his or her DEA certificate pending a 
DEA show cause order so as to avoid a likely suspension or revocation 
of his or her DEA certificate or other similar circumstance. We believe 
these scenarios are no less serious from the standpoints of program 
integrity and beneficiary safety than a DEA certificate suspension or 
revocation. Hence, we believe this change is warranted.
    We received several public comments on these proposals. The 
following is a summary of them and our responses.
    Comment: Several commenters supported our proposal to expand 
Sec. Sec.  424.530(a)(11)(i) and 424.535(a)(13)(i). However, they urged 
that: (1) CMS carefully consider the facts of each situation before 
taking action; and (2) appeals processes be available for individuals 
denied or revoked under these provisions. One commenter stated that 
there could be reasons a physician surrendered his or her DEA 
certificate prior to a show cause order that may not merit denial or 
revocation. The commenter wanted CMS to ensure that innocent physicians 
are not revoked, since this could affect patient care.
    Response: We appreciate the commenters' support. We would closely 
examine the facts of cases involving expanded Sec. Sec.  
424.530(a)(11)(i) and 424.535(a)(13)(i) to determine whether a denial 
or revocation is warranted; should either of these latter actions 
ensue, the provider or supplier could appeal the matter under 42 CFR 
part 498.
    After consideration of these public comments, we are finalizing our 
revisions to Sec. Sec.  424.530(a)(11)(i) and 424.535(a)(13)(i) as 
proposed.
c. Creation of Specific Rebuttal Rights for Deactivations
    As outlined in Sec.  424.540, deactivation means that the 
provider's or supplier's billing privileges are stopped (but not 
revoked or terminated). Deactivation is intended to protect the 
provider or supplier from the misuse of its billing number and to 
safeguard the Trust Funds from unnecessary overpayments. Under existing 
regulations, a provider's or supplier's billing privileges may be 
deactivated if the provider or supplier: (1) Does not submit any 
Medicare claims for 12 consecutive calendar months; (2) fails to report 
certain changes in its enrollment information within required 
timeframes; or (3) fails to fully and accurately comply with a CMS 
revalidation request within 90 days.\144\
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    \144\ We proposed additional grounds for deactivation in the CMS 
proposed rule titled, ``Medicare and Medicaid Programs; CY 2022 Home 
Health Prospective Payment System Rate Update; Home Health Value-
Based Purchasing Model Requirements and Model Expansion; Home Health 
Quality Reporting Requirements; Home Infusion Therapy Services 
Requirements; Survey and Enforcement Requirements for Hospice 
Programs; Medicare Provider Enrollment Requirements; Inpatient 
Rehabilitation Facility Quality Reporting Program Requirements; and 
Long-term Care Hospital Quality Reporting Program Requirements'' 
(CMS-1747-P).
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    Since a deactivated provider's or supplier's billing privileges are 
stopped, Sec.  424.545(b) permits the affected provider or supplier to 
file a rebuttal in accordance with 42 CFR 405.374 (which allows 
rebuttals for Medicare payment suspensions). While we have outlined 
deactivation rebuttal procedures in subregulatory guidance, these 
procedures are not reflected in regulation. Consequently, we proposed 
to revise 42 CFR part 424, subpart P to describe the deactivation 
rebuttal process in detail, a process that would generally mirror our 
existing subregulatory procedures on the topic.
    The specific changes we proposed were as follows:
     At Sec.  424.545(b), we proposed to change the language 
that reads ``in accordance with Sec.  405.374 of this chapter'' to ``in 
accordance with Sec.  424.546.'' Instead of continuing to reference 
Sec.  405.374, we proposed to create a new Sec.  424.546 to address the 
deactivation rebuttal process.
     At new Sec.  424.546(a)(1), we proposed that if a provider 
or supplier receives written notice from CMS or its contractor that the 
provider's or supplier's billing privileges are to be or have been 
deactivated under Sec.  424.540, the provider or supplier has 15 
calendar days from the date of the written notice to submit a rebuttal 
to CMS.
     At new Sec.  424.546(a)(2), we proposed that CMS may, at 
its discretion, extend the 15-day time-period referenced in Sec.  
424.546(a)(1).
     At new Sec.  424.546(b)(1) through (4), we proposed that 
any rebuttal must: (1) Be in writing; (2) specify the facts or issues 
about which the provider or supplier disagrees with the deactivation's 
imposition and/or effective date, as well as the reasons for 
disagreement; (3) submit all

[[Page 65331]]

documentation the provider or supplier wants CMS to consider in its 
review of the deactivation; and (4) be submitted in the form of a 
letter that is signed and dated by the individual supplier (if the 
latter is enrolled as an individual physician or NPP), the authorized 
official or delegated official (as those terms are defined in Sec.  
424.502), or a legal representative (as defined in 42 CFR 498.10). 
Concerning paragraph (b)(4), 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 will be 
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.
     At new Sec.  424.546(c), we proposed that the provider's 
or supplier's failure to submit a rebuttal that is both timely under 
paragraph (a) and fully compliant with all of the requirements of 
paragraph (b) constitutes a waiver of all rebuttal rights under this 
section and Sec.  424.545(b).
     At new Sec.  424.546(d), we proposed that upon receipt of 
a timely and compliant deactivation rebuttal, CMS reviews the latter to 
determine whether the imposition of the deactivation and/or the 
designated effective date are correct.
     At new Sec.  424.546(e), we proposed that nothing in Sec.  
424.546 or Sec.  424.545(b) will require CMS to delay the imposition of 
a deactivation pending the completion of the CMS review described in 
paragraph (d).
     At new Sec.  424.546(f), and consistent with both current 
subregulatory policy concerning deactivation rebuttals, as well as 
payment suspension rebuttal regulations at Sec.  405.375(c), a 
determination made under Sec.  424.546 will not be an initial 
determination under Sec.  498.3(b) and, therefore, will not be 
appealable.
    We received several public comments on these proposals. The 
following is a summary of them and our responses.
    Comment: Although supporting our proposal to address deactivation 
rebuttal rights in regulation, several commenters suggested 
modifications. First, some commenters recommended that a deactivated 
provider or supplier have 30 days from its receipt of the deactivation 
notice to submit its rebuttal. One commenter stated that this would 
account for situations where mail is delayed or the deactivation notice 
was sent to the wrong location. Second, a good cause exception should 
exist for untimely or less-than-fully compliant rebuttals; an example 
would be when the provider or supplier could not access all the 
documentation it needed to support its rebuttal. Third, CMS should have 
to make its determination regarding the rebuttal submission within 15 
days of receiving it. Disagreeing that CMS' decision is not an initial 
determination (as proposed Sec.  424.546(f) states), the commenter 
believed that a 15-day response time for CMS was warranted or, in lieu 
of this, CMS should afford formal appeal rights; otherwise, CMS would 
have no incentive to quickly review a rebuttal submission.
    Response: We respectfully disagree with these recommendations and 
assertions for several reasons. First, we believe our proposed 15-day 
timeframe is sufficient for the provider or supplier to prepare and 
submit a detailed rebuttal. Indeed, this has been our experience with 
payment suspensions under Sec.  405.372, for which the affected 
provider or supplier has 15 days from the date of the payment 
suspension notice to submit a rebuttal under Sec.  405.374. Second, it 
is the deactivated provider's or supplier's responsibility to ensure 
that its rebuttal is timely and complete. Requiring CMS to grant good 
cause exceptions (above and beyond the discretionary timeliness 
extension that CMS may provide under proposed Sec.  424.546(a)(2)) 
could lead providers and suppliers to conclude that a fully compliant 
rebuttal is unnecessary because an exemption will typically be 
furnished. Third, we believe that deactivated providers and suppliers 
would want CMS to give the most thorough and detailed consideration of 
their rebuttal submission; this is our desire as well. To afford us 
this ability, therefore, we do not believe our timeframe for review 
should be so restricted. Fourth, we maintain our long-held position 
that a deactivation should neither constitute an initial determination 
nor entail appeal rights under 42 CFR part 498. This is because, unlike 
with a revocation, a deactivated provider or supplier remains enrolled 
in Medicare and does not lose their billing privileges. Therefore, we 
believe that a rebuttal (as opposed to 42 CFR part 489 appeal rights) 
is a proper and proportionate mechanism for the deactivated provider or 
supplier to contest the action.
    Comment: A commenter suggested that CMS give a deactivated provider 
or supplier 20 days (rather than 15) from the date it received the 
deactivation notice to submit its rebuttal. In a similar context, 
another commenter suggested that the timeframe be 15 days from the date 
of receipt of the deactivation notice instead of 15 days from the date 
of the notice itself; this presumes a 5-day timeframe for the notice to 
reach the provider or supplier via mail.
    Response: For reasons already stated, we believe that 15 days from 
the date of the notice is an adequate rebuttal timeframe.
    Comment: A commenter encouraged CMS to implement a system for 
correspondence (such as deactivation notices) to be sent and received 
electronically. The commenter stated that they believe this would lead 
to cost savings and more efficient communication.
    Response: We appreciate and will consider this suggestion with 
respect to provider enrollment correspondence, for we constantly seek 
to improve the enrollment process and alleviate burden for all 
stakeholders.
    After consideration of these public comments, we are finalizing our 
aforementioned deactivation rebuttal provisions as proposed.
d. Modernizing Enrollment Policies for Emerging Technologies in 
Independent Diagnostic Testing Facilities
    Section 410.33(a) states that CMS pays for diagnostic procedures 
under the PFS only when performed by the suppliers listed in that 
section. Among these supplier types are independent diagnostic testing 
facilities (IDTFs). An IDTF may be a fixed location, a mobile entity, 
or an individual NPP. It is independent of a physician's office or 
hospital, although the IDTF regulations outlined in Sec.  410.33(a) 
also apply when an IDTF furnishes diagnostic procedures in a 
physician's office.
    Section 410.33 as a whole contains provisions with which IDTFs must 
comply in order to enroll in (and maintain enrollment in) Medicare, 
such as requirements for nonphysician personnel (Sec.  410.33(c)). In 
addition, Sec.  410.33(g) contains various compliance standards that 
IDTFs must meet. We established these standards to help ensure the 
quality and safety of IDTF diagnostic testing and to strengthen our 
ability to verify the IDTF's adherence to enrollment requirements.
    IDTFs generally perform diagnostic tests on beneficiaries in, for 
instance, a health care facility, physician's office, or mobile 
setting. The IDTF standards at Sec.  410.33(g) (as well as other 
provisions at Sec.  410.33) were, in fact, designed for traditional 
IDTF suppliers that engage in direct or in-person beneficiary 
interaction, treatment, and/or testing.

[[Page 65332]]

Yet some health care entities have developed or utilize diagnostic 
tests that do not require such interaction. That is, certain IDTFs 
perform diagnostic services via computer modeling and analytics, or 
other forms of testing not involving direct beneficiary interaction. 
The service is often conducted by a technician who undertakes a 
computer analysis offsite or at another location at which the patient 
is not present. The physician then reviews the image to determine the 
appropriate course of action. In short, these entities generally, 
though not exclusively, have two overriding characteristics. First, the 
tests they perform do not involve direct patient interaction, meaning 
that the test is conducted away from the patient's physical presence 
and is non-invasive. Second, the test involves off-site computer 
modeling and analytics.
    Despite the comparatively new and innovative forms of testing these 
entities undertake, they can still qualify as IDTFs (notwithstanding 
the offsite and indirect nature of the test) so long as they meet the 
applicable requirements of Sec.  410.33. The dilemma is that these 
entities often cannot meet certain IDTF requirements, and thus cannot 
enroll in Medicare, strictly because of the test's indirect nature. In 
other words, the types of tests at issue do not fall within the 
category of those to which several of our standards in Sec.  410.33 
were intended to apply (specifically, to in-person procedures). To 
account for such technological advances in diagnostic testing, we 
believe that revisions to Sec.  410.33 are necessary. To this end, we 
proposed that IDTFs that have no beneficiary interaction, treatment, or 
testing whatsoever at their practice location will be either partially 
or wholly exempt from the following requirements in Sec.  410.33 
(hereafter occasionally referenced as ``exempted'' IDTFs).
    Section 410.33(c) requires all nonphysician personnel the IDTF uses 
to perform diagnostic tests to demonstrate the basic qualifications to 
perform these tests as evidenced by State licensure or State 
certification; the IDTF must maintain documentation available for 
review that these requirements are met. In the absence of a State 
licensing board, the technician must be certified by an appropriate 
national credentialing body. However, the aforementioned indirect tests 
and the performing personnel frequently do not require State licensure 
or State/national credentialing, meaning that Sec.  410.33(c) becomes a 
difficult requirement for such IDTFs to meet. Indeed, Sec.  410.33(c) 
has typically been applied to the qualifications needed to perform in-
person tests in traditional IDTF settings; that is, the staff at 
exempted IDTFs often will instead be primarily trained in the test's 
particular software and computer analytics (or other non-beneficiary-
based services)). Extending Sec.  410.33(c)'s purview to indirect tests 
reduces the number of personnel who can perform them, thus hindering 
beneficiary access to such services and potentially preventing the 
enrollment of otherwise qualified IDTFs.
    Accordingly, we proposed to divide current Sec.  410.33(c) into two 
paragraphs. New paragraph (c)(1) would contain the existing 
requirements of Sec.  410.33(c), with an exception for exempted IDTF 
personnel in new paragraph (c)(2). We proposed in the latter paragraph 
that, for services that do not require direct or in-person beneficiary 
interaction, treatment, or testing, any nonphysician personnel 
performing the test must meet all applicable State licensure 
requirements for doing so; if such State licensure requirements exist, 
the IDTF must maintain documentation available for review that these 
requirements have been met.
    While we believed that personnel performing the tests described in 
paragraph (c)(2) should meet whatever State requirements exist for 
those services, paragraph (c)(2) did not include any reference to 
national credentialing bodies. Further, we recognized that, in some 
instances, States may have no requirements for technicians involved in 
the particular type of computer analytics involved in the Medicare-
covered service.
    We also proposed that the following IDTF certification standards in 
Sec.  410.33(g) would not apply to exempted IDTFs:
     The IDTF must have a comprehensive liability insurance 
policy of at least $300,000 per location that covers both the place of 
business and all customers and employees of the IDTF (Sec.  
410.33(g)(6)).
     The IDTF must answer, document, and maintain documentation 
of a beneficiary's written clinical complaint at the physical site of 
the IDTF (Sec.  410.33(g)(8)).
     The IDTF must openly post the standards outlined in Sec.  
410.33(g) for review by patients and the public (Sec.  410.33(g)(9)).
    Concerning Sec.  410.33(g)(8), exempted IDTFs would not be 
furnishing direct services to beneficiaries that could result in a 
beneficiary's written clinical complaint. Thus, we believe this 
standard should be inapplicable to exempted IDTFs, and we proposed to 
revise paragraph (g)(8) in this vein. We proposed a similar approach 
with Sec.  410.33(g)(9); neither beneficiaries whose tests are sent to 
the exempted IDTF nor the public in general would visit its physical 
location, therefore negating the need for a posting of standards. As 
for Sec.  410.33(g)(6), the liability policy addressed therein was 
designed for IDTFs that provide services to beneficiaries in a facility 
or mobile unit and, thus, could have issues concerning medical 
negligence and/or malpractice. We recognized, however, that the 
performance of a particular test by an exempted IDTF could raise 
questions of possible liability. Therefore, we solicited public comment 
on the types of situations where this could arise, as well as on the 
following issues: (1) Whether exempted IDTFs should indeed be required 
to maintain a $300,000 liability policy; (2) whether a liability amount 
of less than $300,000 is warranted for these IDTFs and, if so, what 
that amount should be (for example, $50,000 or $100,000 or $200,000); 
and (3) whether no liability policy should be required for exempted 
IDTFs. (We also solicited comment on whether we should still apply the 
IDTF standards in Sec.  410.33(g)(6) and (8) to exempted IDTFs.)
    We received several public comments on these proposals. The 
following is a summary of them and our responses thereto:
    Comment: Several commenters supported our proposed IDTF supplier 
standard exemptions.
    Response: We appreciate the commenters' support.
    Comment: Several commenters asked CMS to clarify that the proposed 
exemptions apply when there is no direct or in-person beneficiary 
interaction, treatment, or testing at the place of the delivery of the 
service--that is, at the IDTF. One commenter explained that when an 
IDTF performs or administers an entire diagnostic test at, for example, 
the beneficiary's location, the beneficiary's location is the place of 
service; however, when one or more aspects of the test are performed at 
the IDTF, the IDTF is the place of service. To avoid any confusion as 
to the exemptions' applicability, the commenter suggested regulatory 
text stating that our exemptions would apply to IDTFs that only perform 
services that do not require direct or in-person beneficiary 
interaction, treatment, or testing at the place of service as defined 
in Sec.  410.33(e)(2).
    Response: We do not believe the recommended change is necessary. 
The current standards in Sec.  410.33(g) have always applied to the 
IDTF itself irrespective of the place of service under

[[Page 65333]]

Sec.  410.33(e)(2). Indeed, Sec.  410.33(e)(2) deals mostly with claim 
submission requirements and is largely immaterial to the question of 
whether the IDTF meets the Sec.  410.33(g) standards. We believe that 
the regulatory wording of our exemptions is clear as to the scope of 
the latter's applicability and that no need exists for a reference 
therein to Sec.  410.33(e)(2).
    Comment: Several commenters suggested that CMS retain the liability 
insurance requirement for exempted IDTFs. One commenter stated that 
malpractice liability could occur with these IDTFs as it does with 
IDTFs that perform in-person testing; if the exempted IDTF's 
malpractice risk is low, the insurance should not be expensive.
    Response: We maintain our position that liability insurance would 
be largely inapplicable to IDTFs performing indirect, non-in-person 
testing. Nevertheless, we intend to closely monitor the implementation 
of our Sec.  410.33 exemptions, including that pertaining to Sec.  
410.33(g)(6). Should we determine that modifications to our exemptions 
are necessary based on, for instance, program integrity or quality 
assurance concerns, future rulemaking will be considered.
    Comment: Several commenters recommended that CMS not finalize its 
proposed IDTF nonphysician personnel exemption regarding national 
credentialing and instead outline credentialing requirements (State 
and/or Federal) for these individuals. The commenters stated that they 
do not believe that, in the absence of applicable State licensure 
requirements, such personnel should be permitted to operate without 
meeting any qualifications; they maintained that staff performing any 
test (with or without direct beneficiary interaction) should be 
qualified to do so. The commenters also stated that they believe these 
persons should have national certification from a national accrediting 
body if no State licensure requirements exist. Some commenters 
suggested that if CMS does not establish formal national credentialing 
requirements for such personnel, the exempted IDTFs could at least be 
required to submit evidence that their nonphysician staff have some 
type of national certification.
    Response: We believe that our proposed exemption language in Sec.  
410.33(c)(2) is appropriate. Our understanding is that there are very 
few, if any, national health care certifications applicable to the 
technicians who will be performing indirect tests with no beneficiary 
interaction; many of these individuals are instead trained in non-
health care related computer analytical fields. To require them to be 
nationally credentialed by a national health care accrediting body 
would, in many cases, prohibit them from performing IDTF tests. This 
result would be inconsistent with the general aim of our exemptions, 
which is to prevent unnecessary and insurmountable barriers to the 
enrollment of these types of IDTFs. As with the aforementioned 
liability insurance exemption, however, we will maintain oversight of 
the enforcement of Sec.  410.33(g)(2) and, if necessary, consider 
modifications in future rulemaking.
    Comment: Though supportive of our IDTF proposals, a commenter urged 
CMS to continually examine how Medicare enrollment and other applicable 
regulations can be modified to allow for greater use of innovative 
technologies.
    Response: We agree with this comment and will consistently review 
our enrollment regulations and policies to, as warranted, account for 
emerging health care innovations.
    Comment: Several commenters recommended that CMS not finalize its 
exemption regarding the posting of IDTF standards at the IDTF's place 
of business; at a minimum, exempted IDTFs should have to post the 
standards online for review by IDTF personnel and beneficiaries. One 
commenter explained that even if patients are not on-site at the IDTF, 
they should have access to, and understand, the standards required of 
exempted IDTFs and their technicians.
    Response: We respectfully disagree that the above-referenced 
exemption should not be finalized. As previously indicated, the IDTF 
standards in Sec.  410.33(g) were originally intended for traditional 
IDTFs engaging in direct or in-person beneficiary interaction, 
treatment, and/or testing at the IDTF site. This was especially true 
concerning Sec.  410.33(g)(9), the core aim of which is to ensure that 
beneficiaries visiting the facility can actually view the standards 
while on site. Given that exempted IDTFs neither test nor treat 
patients at its location, such entities simply do not fall within the 
scope of facilities to which Sec.  410.33(g)(9) was always meant to 
apply. However, should we later determine that modifications to this 
exemption are warranted, we will consider future rulemaking.
    Comment: Several commenters stated that CMS should, for several 
reasons, create an additional exemption concerning Sec.  
410.33(g)(15)(i), which prohibits a fixed-based IDTF (excluding 
hospital-based IDTFs) from sharing its practice location with another 
Medicare provider or supplier. First, the commenters stated that the 
space-sharing prohibition (like other IDTF standards) is primarily 
directed towards IDTFs that treat patients on-site and is largely 
immaterial to indirect testing situations. Commenters also maintained 
that the prohibition is designed to prevent improper referral 
arrangements and kickbacks but that IDTFs with no on-site beneficiary 
interaction often simply seek to share administrative resources, which 
does not fall within the scope of the aforementioned inappropriate 
activities; the risk these IDTFs therefore pose in a space-sharing 
situation is comparatively small. In addition, the space-sharing 
prohibition currently does not apply to IDTFs that are mobile, a 
scenario the commenters believed is somewhat akin to off-site, indirect 
testing. Finally, the commenters stated that enforcing the space-
sharing prohibition against exempted IDTFs could limit beneficiary 
access to care.
    If a complete exception from this standard is unfeasible, the 
commenters requested that CMS at least elucidate the scope of the 
standard's application to exempted IDTFs that seek to share 
administrative and non-clinical operations with another remote provider 
or supplier, where neither entity provides on-site patient services.
    Response: We believe the space-sharing prohibition should still 
apply to exempted IDTFs. The overall concept behind this prohibition is 
that each IDTF must independently meet all IDTF requirements on its own 
merits, rather than in unison with another IDTF or Medicare provider or 
supplier. Even with the beneficiary off-site, having two exempted IDTFs 
at the same location could lead to confusion as to which IDTF performed 
the test, which personnel were used, etc. Given the program integrity 
concerns (which remain) that led to the establishment of our IDTF 
standards many years ago, we believe that the potential intermingling 
of IDTF resources via space-sharing should be avoided, regardless of 
whether beneficiaries are actually seen at the IDTF site. Moreover, and 
at least for purposes of the space-sharing exemption, mobile IDTFs are 
not analogous to exempted IDTFs. This is because it is, by and large, 
physically impossible for two mobile IDTF units to share the same 
space.
    Any clarification regarding the scope of the space-sharing 
exemption's applicability to the sharing of exempted IDTF resources 
would, as needed, be addressed in future rulemaking or guidance.
    Comment: Several commenters recommended that CMS limit and modify 
its proposed exemption from

[[Page 65334]]

Sec.  410.33(g)(8). First, they maintained that complaints could be 
maintained at a single location (which need not be on-site), though 
they must be made available to CMS upon request. In addition, the 
exempted IDTF should be able to require beneficiaries to submit 
clinical complaints in writing via a specified submission form or 
process (such as a comment ``box''), provided the IDTF informs 
beneficiaries of this requirement. The commenters stated that these two 
revisions would reduce the administrative burden on exempted IDTFs 
while ensuring that they can still properly address beneficiary 
complaints.
    Response: For reasons similar to those stated previously in this 
section not to finalize our proposed exemption to Sec.  410.33(g)(9), 
we do not believe modifications to our proposed Sec.  410.33(g)(8) 
exemption are needed. The original and continued purpose of Sec.  
410.33(g)(8) is to make certain that beneficiaries receiving direct, 
in-person tests can register clinical complaints. It was never intended 
to apply to situations where testing is distant and indirect, and we 
believe our Sec.  410.33(g)(8) exemption falls within the original 
intent of Sec.  410.33(g)(8). However, should we determine in the 
future that revisions to this exemption might be required, rulemaking 
will be contemplated.
    Comment: One commenter requested that CMS clarify the use of the 
language ``licensure or certification by the appropriate State health 
or education department'' currently in Sec.  410.33(c), a paragraph we 
proposed to redesignate as Sec.  410.33(c)(1) though without any change 
in its content or meaning. Specifically, the commenter stated this 
provision should clarify that a technician who receives certification 
(related to services furnished in the IDTF) from an educational program 
at a school overseen by the State's education department satisfies the 
requirements of existing Sec.  410.33(c), irrespective of any national 
certifications. The commenter maintained that such an interpretation is 
consistent with CMS' general policy concerning IDTF technician 
requirements and would better explain the types of State requirements 
that must be met. The commenter also urged CMS to confirm that an IDTF 
can use the aforementioned State certification in lieu of national 
credentialing to demonstrate Sec.  410.33(c) compliance.
    Response: We believe that the commenter is seeking clarification of 
the policies in existing Sec.  410.33(c) rather than our proposed 
exemption in Sec.  410.33(c)(2). Since, aside from the aforementioned 
redesignation, we did not propose any change to current Sec.  410.33(c) 
or the policy therein, we believe this comment is outside the scope of 
this final rule.
    Comment: A commenter stated that proposed Sec.  410.33(c)(2) does 
not include the language in current Sec.  410.33(c) concerning 
certifications from an educational program at a school overseen by the 
State's education department. The commenter asked CMS to explain this 
omission and/or more thoroughly identify the types of State 
qualifications (for example, certifications) by which exempted IDTF 
nonphysician personnel can demonstrate compliance with Federal and 
State requirements.
    Response: Existing Sec.  410.33(c)'s reference to State education 
program certifications was not included in proposed Sec.  410.33(c)(2) 
because we do not believe such certifications, which frequently focus 
on direct patient testing, would generally apply to the off-site, 
computer analytics-oriented testing that exempted IDTFs perform. As 
stated in proposed Sec.  410.33(c)(2), IDTF personnel must meet State 
licensure requirements for the tests being performed, assuming such 
requirements exist; nothing in proposed Sec.  410.33(c)(2) permits 
education to be used in lieu of licensure.
    Comment: One commenter requested that CMS clarify the applicable 
State licensure laws for nonphysician personnel at exempted IDTFs; 
specifically, the commenter asked whether the laws of the State in 
which the beneficiary is located or the State of the IDTF's practice 
location are governing.
    Response: The applicable State law in the commenter's scenario is 
the State in which the IDTF's practice location (as reported on the 
Form CMS-855) is located.
    After consideration of these public comments, we are finalizing our 
aforementioned IDTF provisions as proposed.
e. Revisions at Sec.  424.535(a)(8)
    Under Sec.  424.535(a)(8)(ii), CMS may revoke a provider's or 
supplier's enrollment if CMS determines that the provider or supplier 
has a pattern or practice of submitting claims that fail to meet 
Medicare requirements. In determining whether a revocation is 
appropriate under Sec.  424.535(a)(8)(ii), CMS considers, as 
appropriate and applicable, the factors outlined in Sec.  
424.535(a)(8)(ii)(A) through (F); respectively, these are:
    (A) The percentage of submitted claims that were denied.
    (B) The reason(s) for the claim denials.
    (C) Whether the provider or supplier has any history of final 
adverse actions and the nature of any such actions.
    (D) The length of time over which the pattern has continued.
    (E) How long the provider or supplier has been enrolled in 
Medicare.
    (F) Any other information regarding the provider or supplier's 
specific circumstances that CMS deems relevant to its determination.
    We have recently encountered situations where providers and 
suppliers have engaged in periods of non-compliant billing that, though 
comparatively brief, have or could have harmed the Medicare program. 
While we have attempted revocation action per Sec.  424.535(a)(8)(ii) 
against such providers and suppliers, the current wording of some of 
the factors in paragraphs (a)(8)(ii)(A) through (F) have hampered our 
ability to do so. To increase our flexibility to address periods of 
abusive billing irrespective of their duration, we proposed to revise 
Sec.  424.535(a)(8)(ii)(A) through (F) as follows:
     In paragraph (a)(8)(ii)(A), we proposed revisions to focus 
on the percentage of denials within subsets of the provider's or 
supplier's claim submissions rather than across the entire universe of 
their claim submissions. Specifically, we would consider the percentage 
of submitted claims that were denied during the timeframe under 
consideration. We believe existing paragraph (a)(8)(ii)(A) inhibits our 
capacity to target brief periods involving a significant percentage of 
denied claims; this is because this factor has been interpreted to 
require said percentage to be weighed against claim denials over the 
entire period of the provider's or supplier's enrollment. Proposed 
revised paragraph (a)(8)(ii)(A) would better enable CMS to address 
these non-compliant periods by restricting the scope of denial 
percentages to a shorter duration.
     For reasons similar to our revision of Sec.  
424.535(a)(8)(ii)(A), we proposed to remove Sec.  424.535(a)(8)(ii)(D) 
altogether. As already indicated, short but very intense periods of 
improper billing can endanger the Medicare program no less than a 
longer pattern of non-compliant yet merely moderate-volume billing. Yet 
the ``length of time'' standard in paragraph (a)(8)(ii)(D) often deters 
us from taking action under paragraph (a)(8)(ii) to address these 
shorter timeframes. Given this, we believed that eliminating paragraph 
(a)(8)(ii)(D) would strengthen our program integrity efforts.

[[Page 65335]]

     We also proposed to remove Sec.  424.535(a)(8)(ii)(E), 
which addresses the length of the provider's or supplier's enrollment. 
We believed the enrollment length should have no bearing on whether 
paragraph (a)(8)(ii) can be applied, for the main issue is the behavior 
itself and not the period of enrollment.
     We proposed to remove Sec.  424.535(a)(8)(ii)(B) as well. 
Notwithstanding our original inclusion of this factor in paragraph 
(a)(8)(ii), the overall purpose of paragraph (a)(8)(ii) has always been 
to deter non-compliant billing, regardless of the reason for it. Even 
if a period of erroneous claim submissions reflected no nefarious 
intent by the provider, the latter still failed to comply with Medicare 
billing requirements and thus presented a risk to the Medicare program. 
For this reason, we do not view the claim denial reason as particularly 
germane to the question of whether paragraph (a)(8)(ii) should apply in 
a particular case.
     In addition, we proposed to add new paragraph 
(a)(8)(ii)(C) by which we would consider the type of billing non-
compliance and the precise facts surrounding said non-compliance (to 
the extent this can be determined). We believed this paragraph would 
provide slightly more specificity than the broader, catch-all factor at 
Sec.  424.535(a)(8)(ii)(F) (which we will nonetheless retain). It would 
also allow us to more narrowly tailor our review to the unique facts of 
the case, thus also strengthening our ability to consider any 
aggravating or mitigating circumstances.
    In summary, we proposed that paragraph (a)(8)(ii) would include the 
following factors, respectively designated as paragraphs (A) through 
(D):
     The percentage of submitted claims that were denied during 
the period under consideration.
     Whether the provider or supplier has any history of final 
adverse actions and the nature of any such actions.
     The type of billing non-compliance and the specific facts 
surrounding said non-compliance (to the extent this can be determined).
     Any other information regarding the provider or supplier's 
specific circumstances that CMS deems relevant to its determination.
    We received several public comments on this proposal. The following 
is a summary of them and our responses thereto:
    Comment: Several commenters expressed concern about our proposal. 
They stated that the proposed revision and/or removal of factors in 
Sec.  424.535(a)(8)(ii) gives CMS unfettered discretion to target any 
short period of non-compliant billing without having to consider the 
provider's/supplier's behavior during its period of enrollment. The 
commenters stressed that brief periods of erroneous claims can occur 
for many reasons (for example, technological, system, or inadvertent 
mistakes, or changes in CMS or MAC procedures) without any ill intent 
by the provider or supplier; in some cases, the provider or supplier 
may be unaware that such errors even occurred. Revocation in such 
situations, the commenters stated, is far too severe a penalty, and our 
proposal in general could impose significant burdens on providers and 
suppliers.
    Response: While we appreciate the commenters' concerns, we must 
emphasize several things. First, our revocation authority under Sec.  
424.535(a)(8)(ii) is strictly discretionary and not mandatory. In every 
potential Sec.  424.535(a)(8)(ii) revocation case, we carefully weigh 
the facts and circumstances of the situation, conscientiously consider 
the regulatory factors (as appropriate and applicable), and only take 
revocation action when it is genuinely warranted. We have never applied 
Sec.  424.535(a)(8)(ii) as a matter of course, and this will not change 
under our revisions thereto. Second, and on the other hand, providers 
and suppliers have a responsibility to always submit correct claims. 
Simply because a period of repeated non-compliant billing was 
comparatively short does not remove this responsibility; even such 
brief periods involve the provider or supplier having failed to comply 
with Medicare billing requirements. Third, we have an obligation to 
protect the Medicare program and the Trust Funds. As we explained in 
section III.N of the proposed rule, we have encountered instances where 
short timeframes of non-compliant billing have led to significant Trust 
Fund dollars being improperly paid. We must have the authority to 
address such situations, and we believe our proposal helps facilitate 
this.
    Comment: One commenter stated that in potential Sec.  
424.535(a)(8)(ii) revocation cases, CMS should consider the provider's 
or supplier's overall history of billing compliance during its entire 
period of enrollment, rather than its billing compliance over a very 
short period.
    Response: We respectfully disagree. Requiring an analysis of the 
provider's or supplier's complete Medicare billing history (which could 
extend for many years) could hamper our attempts to address shorter but 
significant periods of non-compliant billing within that larger period. 
In several potential Sec.  424.535(a)(8)(ii) situations, we could not 
undertake action because, in effect, the provider's or supplier's 
length of enrollment (a criterion not altogether different from the 
entire period of billing during enrollment) overrode any shorter 
billing aberrations. We believe this problem must be remedied via 
revised Sec.  424.535(a)(8)(ii).
    Comment: One commenter supported our new factor under which CMS 
would consider the type of billing non-compliance and the specific 
facts of non-compliance. However, the commenter stated that this factor 
appears inconsistent with our proposed removal of Sec.  
424.535(a)(8)(ii)(B), which addresses the reason(s) for the claim 
denials. The commenter recommended that both the current version of 
Sec.  424.535(a)(8)(ii)(B) and the aforementioned new factor be 
included in Sec.  424.535(a)(8)(ii), stating that the claim denial 
reason is extremely relevant to whether any abusive conduct was 
involved. Several other commenters also urged the retention of Sec.  
424.535(a)(8)(ii)(B) for this same reason.
    Response: We do not believe this new factor contradicts our removal 
of Sec.  424.535(a)(8)(ii)(B). The former is merely intended to give 
CMS additional ability to consider all of the surrounding circumstances 
of the case, which may, but only at CMS' discretion, include the bases 
for the claim denials. By the same token, the core consideration is the 
incorrect claim submission itself rather than the reason it occurred. 
Even if a series of non-compliant claims did not involve any deceit by 
the provider or supplier, the fact remains that the latter did not 
adhere to Medicare claim submission requirements. To require us to 
consider the reason(s) for the claim denial would, in our view, at 
least partially alleviate the provider or supplier of its 
responsibility to always remain compliant with our billing policies. We 
believe such a result is inconsistent with the need to protect the 
Trust Funds.
    Comment: One commenter noted that the billing pattern's length 
should remain a factor in Sec.  424.535(a)(8)(ii) determinations.
    Response: We respectfully disagree. Similar to our aforementioned 
position concerning the provider's or supplier's overall billing 
history, we believe that retaining Sec.  424.535(a)(8)(ii)(D) would 
continue to hinder us from effectively dealing with the very periods of 
brief but significant billing non-compliance to which our proposal was 
aimed. Again, even brief timeframes of aberrant billing can result in 
sizable improper

[[Page 65336]]

payments. We note further that our removal of some of Sec.  
424.535(a)(8)(ii)'s more specific factors (such as claim denial reasons 
and the period of enrollment) is designed to give us greater 
flexibility to address the wide variety of factual scenarios that can 
arise (and have arisen) in Sec.  424.535(a)(8)(ii) cases. We have found 
in some instances that the greater the specificity of a particular 
factor, the more can it constrain our ability to act. It was with this 
in mind that we proposed the more wide-ranging factor in revised Sec.  
424.535(a)(8)(ii)(C).
    Comment: Consistent with other comments concerning this proposal, 
several commenters urged CMS not to finalize our changes to Sec.  
424.535(a)(8)(ii). At a minimum, some commenters recommended that 
before revoking a provider or supplier under revised Sec.  
424.535(a)(8)(ii), CMS should: (1) Give the provider or supplier an 
opportunity to correct such errors; or (2) otherwise provide advanced 
notice of CMS' concerns. Failure to do so, they stated, could 
negatively affect patient care if a revocation is prematurely issued.
    Response: We appreciate all of the concerns the commenters have 
expressed regarding our proposed revisions to Sec.  424.535(a)(8)(ii). 
Nonetheless, and for the reasons already identified, we intend to 
finalize them as proposed and without the commenters' suggested 
corrective or waiting period. If the provider or supplier is submitting 
non-compliant claims, it is the provider's or supplier's responsibility 
to remedy the matter on its own initiative; respectfully, it is not 
CMS' obligation to delay a crucial program integrity measure, such as a 
revocation, to enable the provider or supplier to execute steps that 
should have been taken previously.
    Should the provider or supplier disagree with its Sec.  
424.535(a)(8)(ii) revocation, it may exercise its appeal rights under 
42 CFR part 498.
    After consideration of these public comments, we are finalizing our 
revisions to Sec.  424.535(a)(8)(ii) as proposed.
f. Miscellaneous Comments
    We also received the following comments that did not directly 
pertain to our proposed regulatory revisions.
    Comment: We received several comments regarding the Medicare 
Diabetes Prevention Program (MDPP) enrollment process. Some commenters 
recommended that MDPP suppliers be subject to limited-risk level 
screening under Sec.  424.518 instead of the high-risk level screening 
currently applicable to MDPP suppliers. Another commenter urged CMS to 
make the provider enrollment application process less lengthy and 
arduous for MDPP suppliers. One commenter recommended that CMS either 
eliminate or modify the requirement that MDPP suppliers report the 
social security numbers of their board members in section 6 of the Form 
CMS-20134 enrollment application. Still another commenter suggested 
that CMS streamline the collection of MDPP enrollment information so 
that it need only be reported once. These commenters noted that the 
foregoing initiatives could reduce MDPP supplier cost and burden while 
spurring MDPP enrollment.
    Response: We appreciate these suggestions but believe they are 
outside the scope of this rule.
    Comment: One commenter stated that they supported the policy in 
Sec.  424.535(e) that permits reversal of a provider's or supplier's 
revocation if the provider or supplier terminates within 30 days its 
business relationship with the party that engaged in the adverse 
activity that led to the revocation. However, the commenter asked CMS 
to clarify how this impacts the provider's or supplier's claims during 
the 30-day period.
    Response: We appreciate this comment but stress that we did not 
propose to alter Sec.  424.535(e) other than to expand the parties to 
which it could apply (that is, to the additional parties addressed in 
proposed Sec. Sec.  424.530(a)(2) and 424.535(a)(2)). That is, the 
general ``30-day revocation reversal'' policy, which has existed for 
many years, is not changing with this rule. Accordingly, we believe 
that the stakeholder's comment concerning the claim aspects of said 
policy is outside the scope of this rule.
    Comment: A commenter stated that opioid treatment programs (OTPs) 
should not have to undergo high-risk level screening under Sec.  
424.518(a). The commenter maintained that such intense screening (1) is 
unwarranted given that OTPs are already subject to strict Federal and 
State oversight requirements and (2) has proven overly burdensome for 
OTPs.
    Response: We appreciate this comment but believe it is outside the 
scope of this rule.
    Comment: Concerning the reference to the PECOS system of records 
notice (SORN) in section III.N of the proposed rule, a commenter stated 
that this SORN includes identifiers/systems that CMS no longer uses 
(such as the Unique Provider Identification Number). The commenter 
stated that CMS should accordingly update the PECOS SORN.
    Response: This comment is outside the scope of this rule.
    Comment: A commenter stated that the OMB Control Number reference 
for the Form CMS-855 in section III.N of the proposed rule 
(specifically, OMB No. 0938-0635) should have included every control 
number associated with the form.
    Response: The reference to the Form CMS-855 in the proposed rule 
was a brief and generic one. We elected to simply include the OMB 
Control Number associated with most of the Form CMS-855 variations 
rather than exhaustively list them all.
2. Provider/Supplier Medical Review Requirements
a. Background
    CMS identifies improper payments in the Medicare FFS program 
through a variety of program integrity-related activities, and we use a 
network of contractors to carry out program integrity initiatives, 
including Recovery Audit contractors (RACs), the Supplemental Medical 
Review Contractor (SMRC), Unified Program Integrity Contractors 
(UPICs), Medicare Administrative Contractors (MACs), and the 
Comprehensive Error Rate Testing (CERT) contractor. We are purposely 
excluding Quality Improvement Organizations (QIOs) from this discussion 
and the following proposals since QIOs are governed by separate and 
distinct statutory and regulatory requirements. For information about 
the QIOs, see sections 1151-1163 of the Act and 42 CFR parts 475-480.
    Both UPICs and MACs perform prepayment medical review, while the 
RACs, SMRC, UPICs, MACs, and CERT all perform post-payment medical 
reviews. Both prepayment medical reviews and post-payment medical 
reviews are used by our contractors to determine, among other things, 
whether items or services are reasonable and necessary under section 
1862(a)(1) of the Act. In carrying out these reviews, each contractor 
requests additional documentation from providers and suppliers, which 
the contractors then assess to either support the payment of claims or 
conversely, deny (in full or in part) claims thereby protecting the 
Medicare Trust Funds against improper payments. Our contractors may 
also carry out follow-up prepayment or post-payment reviews on the same 
providers or suppliers to ensure improper payments are not continuing.
    Our contractors are authorized to request additional documentation 
through multiple statutory authorities, including sections 1815(a), 
1833(e) and

[[Page 65337]]

1862(a)(1)(A) of the Act. Sections 1815(a) and 1833(e) of the Act 
provide that no payments shall be made to any provider or supplier 
unless it has furnished such information as the Secretary may request 
in order to determine the amounts due such provider for the period with 
respect to which the amounts are being paid or any prior period. Under 
section 1862(a)(1)(A) of the Act, payment must generally be limited to 
those items and services that are reasonable and necessary.
b. Regulations Governing Prepayment and Post-Payment Medical Review
    Despite the statutory authority authorizing our contractors' 
activities, we do not have regulatory provisions governing certain 
medical review activities, specifically prepayment and post-payment 
medical reviews. In this final rule, we are codifying key terms and 
definitions associated with these two review types; finalizing 
contractors' authority to request additional documentation within 
established timeframes; and finalizing provisions detailing a 
provider's or supplier's responsibility to comply with requests for 
additional documentation, including the impact should a provider or 
supplier fail to comply with a request. These provisions are based on 
existing operational practices used by our contractors. Adding these 
provisions in regulation will enhance provider and supplier 
understanding of our review processes, as well as, improve consistency 
among our contractors.
c. Key Terms and Definitions
    To ensure consistency across prepayment and post-payment reviews 
and establish clear requirements, we proposed the following key terms 
and their definitions to Sec.  405.902: ``Additional documentation'' 
means any information requested by a contractor when conducting a 
prepayment review or post-payment review; ``Additional Documentation 
Request (ADR)'' means a contractor's initial documentation request in 
reviewing claims selected for prepayment review or post-payment review; 
``Post-payment medical review (or post-payment review)'' means a review 
that occurs after payment is made on the selected claim to determine 
whether the initial determination for payment was appropriate; and 
``Prepayment medical review (or prepayment review)'' means a review 
that occurs before an initial determination for payment is made on the 
selected claim to determine whether payment should be made. These 
definitions are consistent with longstanding manual language and common 
use of these terms by our contractors.
    We did not receive any public comments on this specific section and 
have decided to finalize as proposed.
d. Prepayment and Post-Payment Medical Review
    We proposed to add new Sec.  405.903 that outlines the prepayment 
medical review provisions.
     At paragraph (a), we proposed to codify our contractors' 
authority to conduct prepayment medical review on selected claims in 
order to determine whether and how much payment should be made.
     At paragraph (b), we proposed language detailing our 
contractors' authority to request additional documentation while 
conducting a prepayment review.
     At paragraph (b)(1), we proposed language stating that a 
provider or supplier will be provided 45 calendar days to submit 
additional documentation in response to a contractor's request except 
as stated in paragraphs (b)(2) and (c).
     At paragraph (b)(2), we proposed language stating that a 
contractor may accept documentation received after 45 calendar days for 
good cause. Good cause means situations such as natural disasters, 
interruptions in business practices, or other extenuating circumstances 
that the contractor deems good cause in accepting the documentation.
     At paragraph (c), we proposed language detailing a UPIC's 
authority to provide 30 calendar days to a provider or supplier 
submitting additional documentation and that a UPIC may accept 
documentation received after 30 calendar days for good cause. Good 
cause means situations such as natural disasters, interruptions in 
business practices, or other extenuating circumstances that the UPIC 
deems good cause in accepting the documentation.
    These provisions reflect longstanding requirements MACs and UPICs 
have used in conducting prepayment reviews. The different time-periods 
within which additional documentation must be received is based on 
unique processing requirements for each contractor. Although both 
conduct prepayment reviews, the UPICs work directly with law 
enforcement and focus on potentially fraudulent providers or suppliers. 
Thus, the different timeframes for receiving additional documentation 
is necessary to account for the distinction and enables each type of 
contractor to appropriately balance their need for documentation in 
completing reviews with the potential burden on providers and suppliers 
should reviews take longer than is warranted. Efforts to limit the 
burden placed on providers and suppliers as much as possible is also 
warranted so that patient care is not unnecessarily impacted.
    Additionally, both MACs and UPICs historically have had the 
authority to accept documentation received after the initial timeframe 
has expired based on good cause, such as natural disasters, 
interruptions in business practices, or other extenuating 
circumstances. These circumstances are best determined on a case-by-
case basis by the MAC or UPIC, and the language at paragraphs (b)(2) 
and (c), respectively, convey the MAC and UPIC authority to determine 
that good cause exists to warrant accepting documentation received 
after the initial timeframe given.
     At paragraph (d), we proposed that a contractor's 
prepayment review will result in an initial determination under Sec.  
405.920. Again, this has been the longstanding approach to the results 
of prepayment reviews.
    We also proposed similar provisions at new Sec.  405.929 regarding 
post-payment medical reviews.
     At paragraph (a), we proposed language outlining our 
contractors' authority to select claims and conduct post-payment 
medical reviews.
     At paragraph (b), we proposed language that specifies our 
contractors' authority to request additional documentation.
     At paragraph (b)(1), we proposed that a contractor will 
give a provider or supplier 45 calendar days to submit additional 
documentation in response to a request, except as stated in paragraphs 
(b)(2) and (c).
     At paragraphs (b)(2) and (c), we proposed that a 
contractor may accept documentation received after 30 days for good 
cause. Good cause means situations such as natural disasters, 
interruptions in business practices, or other extenuating circumstances 
that the contractor deems good cause in accepting the documentation.
     At paragraph (c), we proposed language that specifies the 
UPIC's authority to provide 30 calendar days when requesting additional 
documentation and that a UPIC may accept documentation received after 
30 calendar days for good cause. Good cause means situations such as 
natural disasters, interruptions in business practices, or other 
extenuating circumstances that the UPIC deems good cause in accepting 
the documentation.

[[Page 65338]]

     At paragraph (d), we proposed that when conducting a post-
payment review, a contractor's review will result in either no change 
or a revised determination under Sec.  405.984.
    As with prepayment reviews, these provisions reflect longstanding 
requirements UPICs and MACs, RACs, the CERT contractor, and SMRC have 
used in conducting post-payment reviews. While the MACs, RACs, CERT 
contractor, and SMRC have relatively comparable medical review 
processes, the UPICs are somewhat different given their close working 
relationship with law enforcement and focus on potentially fraudulent 
providers or suppliers. Thus, the different timeframes for receiving 
additional documentation is necessary to account for the distinction 
and enables each contractor to appropriately balance their need for 
documentation in completing reviews with the potential burden on 
providers and suppliers should reviews take longer than may be 
expected. Efforts to limit the burden placed on providers and suppliers 
as much as possible is also warranted so that patient care is not 
unnecessarily impacted.
    Given that for post-payment reviews the claims have already been 
paid, all the contractors have historically had the authority to accept 
documentation received after the initial timeframe has expired based on 
good cause. As with prepayment reviews, this may include situations 
such as natural disasters, interruptions in business practices, or 
other extenuating circumstances that the specific contractor deems good 
cause in accepting the document after 30 or 45 calendar days. These 
circumstances are best determined on a case-by-case basis, and the 
language at paragraphs (b)(2) and (c) convey the authority to determine 
that good cause exists to warrant accepting documentation received 
after 30 or 45 calendar days.
    We also proposed to add new Sec.  405.930 to clearly outline our 
contractors' authority to deny a claim should a provider or supplier 
fail to convey the additional documentation in response to a request. 
The language clarifies that the contractor must give the provider or 
supplier notice and time to respond to the additional documentation 
request. Contractors have authority to require additional documentation 
through multiple statutory provisions, including sections 1815(a), 
1833(e) and 1862(a)(1)(A) of the Act. While our contractors maintain 
discretion to provide additional time to a provider or supplier in 
responding to an additional documentation request, our contractors also 
have the authority to deny additional time and the associated claim(s) 
when the additional documentation is not received within the requested 
timeframe.
    We also proposed to revise the section heading of Sec.  405.986(a) 
to read, ``Establishing good cause for reopening.'' This revision 
clarifies the distinction made between the process for establishing 
good cause to reopen an initial determination made on a claim, and the 
good cause factors that may be applied in accepting documentation 
submitted after the applicable timeframes in Sec. Sec.  405.903 and 
405.929. In establishing criteria to determine whether to accept late 
documentation in response to an ADR, we adopted the criteria set forth 
in Sec. Sec.  405.903 and 405.929, and we did not utilize the good 
cause criteria for reopening an initial determination on a claim in 
Sec.  405.986. We believe this change will add further clarification to 
the substantive text to reflect that the section only applies to 
reopenings of initial determinations on a claim.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: All commenters supported our proposals, acknowledging our 
need to conduct oversight activities to protect the Medicare program.
    Response: We thank the commenters for their support.
    Comment: One commenter suggested that CMS provide additional 
flexibility to providers who cannot meet ADR deadlines due to the 
challenges of collecting the necessary information from other 
providers.
    Response: We appreciate the commenter's suggestion; however, the 
timeframes reflect longstanding practices, providing what we believe to 
be adequate time for providers and suppliers to respond. Further, we 
have provided exceptions where there is good cause to accept 
documentation after applicable timeframes.
    Comment: Several commenters suggested that CMS attempt to minimize 
the burden of these reviews, including contractors coordinating with 
referring and treating clinicians to gather orders, images, and other 
documentation.
    Response: We thank the commenters for their suggestion and seek to 
reduce burden on providers when we can. However, these comments are 
outside the scope of this rule and we may consider these suggestions in 
future rulemaking.
    After consideration of the public comments, we are finalizing our 
proposal without modification.

O. 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 for Patients and Communities (SUPPORT) 
Act established a new Medicare Part B benefit category 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 
established new codes for 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 84688), we adopted new add-on codes for take home 
supplies of nasal naloxone and injectable naloxone. We are continuing 
to monitor Medicare enrollment by OTPs and utilization of the new 
benefit to ensure that Medicare beneficiaries have appropriate access 
to care, as well as monitoring for fraud, waste, and abuse. For CY 
2022, we proposed several refinements to the regulations governing 
Medicare coverage and payment for OUD treatment services furnished by 
OTPs.
2. Annual Updates
    In the CY 2020 PFS final rule (84 FR 62667), we finalized a policy 
under which the payment for the drug component of episodes of care will 
be updated annually using the most recent data available from the 
applicable pricing mechanism at the time of ratesetting for the 
applicable calendar year. The payment for the non-drug component of the 
bundled payment for OUD treatment services will be updated annually 
based upon the Medicare Economic Index (MEI) (84 FR 62668 and 62669). 
The CY 2022 MEI update is 2.1 percent based on data through the 2nd 
quarter of 2021 and reflects published historical Bureau of Labor 
Statistics estimates of multifactor productivity (MFP) data through 
2020. The current

[[Page 65339]]

payment rates, as finalized in the CY 2021 PFS final rule, both with 
and without locality adjustments, can be found on the CMS OTP website 
under Billing and Payment at https://www.cms.gov/files/document/otp-billing-and-payment-fact-sheet.pdf. The list of the payment rates for 
OUD treatment services furnished by OTPs, with the annual update 
applied for CY 2022, will be made available at the time of publication 
of this final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Opioid-Treatment-Program. Additionally, please see the 
``Opioid Treatment Programs: CY 2022 Methadone Payment Exception'' 
interim final rule with comment period published elsewhere in this 
Federal Register related to the CY 2022 payment rate for methadone 
under the Medicare OTP benefit.
3. Refinements to Regulations Governing Medicare Payment to OTPs
    In the CY 2021 PFS final rule (85 FR 84684 through 84685), we 
extended the definition of OUD treatment services to include short 
acting opioid antagonist medications for the emergency treatment of 
known or suspected opioid overdose, such as naloxone, and overdose 
education furnished in conjunction with opioid antagonist medication. 
We also established an adjustment to the weekly bundled payments when 
the OTP furnishes take-home supplies of these medications at Sec.  
410.67(d)(4)(i)(E). This adjustment includes both a drug component and 
a non-drug component for overdose education. The payment for the drug 
component of the adjustment will be determined using the methodology in 
Sec.  410.67(d)(2)(i), and will be updated annually using the most 
recent data available at the time of ratesetting. The amount of the 
non-drug component of the adjustment, which includes overdose 
education, will be determined based on the CY 2020 Medicare payment 
rate for CPT code 96161; however, we did not explicitly address either 
geographic adjustments or annual updates to this payment rate.
    In the CY 2020 PFS final rule (84 FR 62666 through 62667), we 
finalized the application of a geographic adjustment to the non-drug 
component of the OTP bundled payments, as well as the add-on payment 
adjustments for non-drug services, using the Geographic Adjustment 
Factor (GAF). We explained that unlike the national pricing of drugs, 
the costs for the services included in the non-drug component of the 
OTP bundled payments for OUD treatment services are not constant across 
all geographic localities. For example, OTPs' costs for rent or 
employee wages could vary significantly across different localities and 
could potentially result in disparate costs for the services included 
in the non-drug component of OUD treatment services; therefore, we 
stated we believed it would be appropriate to apply a geographic 
locality adjustment to the non-drug component of the bundled payments. 
We also specifically stated our belief that the same logic regarding 
the differential costs for the non-drug services included in the 
bundled payments would apply and should be recognized for add-on 
payment adjustments for non-drug services. This geographic adjustment 
is codified in the regulations at Sec.  410.67(d)(4)(ii).
    Additionally, in the CY 2020 PFS final rule we finalized an annual 
update to the non-drug component of the bundled payment for an episode 
of care based upon the MEI (84 FR 62668 through 62669). We noted that 
we believed the same logic regarding the potential for changes in the 
costs of the services included in the non-drug component of the bundled 
payment rates also applied to the add-on payment adjustments for non-
drug services. This annual update is codified in the regulations at 
Sec.  410.67(d)(4)(iii).
    In the CY 2022 PFS proposed rule (86 FR 39317 through 39318), we 
explained that when we adopted the adjustment to the weekly bundled 
payments for take-home supplies of opioid antagonist medications in the 
CY 2021 PFS final rule, we did not specifically address either 
geographic adjustments or annual updates to the non-drug component of 
this adjustment and did not update the provisions governing the 
geographic adjustment and annual update in order to reference the new 
adjustment. Because the adjustment for take-home supplies of opioid 
antagonist medications includes a non-drug component, we stated that we 
believe the same considerations regarding varying costs based on 
geographic locality and the need for annual updates apply. Accordingly, 
we proposed to revise the regulation at Sec.  410.67(d)(4)(ii) to 
include the adjustment for take-home supplies of opioid antagonist 
medications in the list of items for which the non-drug component will 
be geographically adjusted using the GAF. We also proposed to revise 
the regulation at Sec.  410.67(d)(4)(iii) to include the adjustment for 
take-home supplies of opioid antagonist medications in the list of 
items that will be updated annually using the MEI.
    In addition, we stated that in the CY 2021 PFS final rule (85 FR 
84688) we had explained that, consistent with Sec.  410.67(d)(5), any 
payment to an OTP for naloxone would be duplicative if a claim for the 
same medication is separately paid under Medicare Part B or Part D for 
the same beneficiary on the same date of service, and that we would 
recoup any duplicative payment made to an OTP for naloxone. However, 
the regulation on duplicative payments at Sec.  410.67(d)(5) does not 
specifically reference payments for medications that are furnished as 
part of an adjustment to the bundled payment. Accordingly, we also 
proposed to revise Sec.  410.67(d)(5) to state explicitly that payments 
for medications that are delivered, administered or dispensed to a 
beneficiary as part of an adjustment to the bundled payment are 
considered a duplicative payment if a claim for delivery, 
administration or dispensing of the same medication(s) for the same 
beneficiary on the same date of service was also separately paid under 
Medicare Part B or Part D. We stated that consistent with the policies 
finalized in the CY 2020 PFS final rule (84 FR 62663 through 62664) 
regarding duplicative payments for medications dispensed as part of the 
weekly bundle, we believe that it is appropriate to also ensure that 
Medicare payments for drugs provided as an add-on to the bundled 
payment rate are not duplicative. We noted that this proposed revision 
would apply not only to duplicative payments for take-home supplies of 
naloxone, but also to duplicative payments for additional take-home 
supplies of other medications that are made under Sec.  
410.67(d)(4)(i)(D).
    We solicited public comments on these proposed changes.
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters supported making these proposed changes to the 
OTP regulations. A few commenters noted that applying the geographic 
adjustment to the non-drug component of the add-on payments for take-
home supplies of opioid antagonist medications will help OTPs to 
maintain financial viability, and therefore, ensure continued access to 
OUD treatment services for beneficiaries.
    Response: We appreciate commenters' support for these changes.
    After consideration of the public comments, we are finalizing our 
proposal to revise the regulation text at Sec.  410.67(d)(4)(ii) and 
(iii) as proposed to codify the application of the annual updates and 
locality adjustments to the non-drug component of the codes describing 
add-on payments for opioid antagonist medications (naloxone) that

[[Page 65340]]

were new for CY 2021. In addition, we are finalizing our proposal to 
revise the regulation text at Sec.  410.67(d)(5) as proposed to make 
clear that the prohibition on duplicative payments applies to drugs 
provided as part of an add-on payment, as well as the bundled payment.
4. OTP Coding and Payment for New Nasal Naloxone Product
    In the CY 2022 PFS proposed rule (86 FR 39318), we discussed that 
FDA had recently announced the approval of a new, higher dose naloxone 
hydrochloride nasal spray product used to treat opioid overdose and 
that the newly approved product delivers 8mg of naloxone.\145\ We 
stated that in the CY 2021 PFS final rule (85 FR 84683 through 84685), 
we finalized payment for HCPCS code G2215 (Take-home supply of nasal 
naloxone (provision of the services by a Medicare-enrolled Opioid 
Treatment Program); List separately in addition to code for primary 
procedure). HCPCS code G2215 was priced based on an assumption of a 
typical case in which the beneficiary would be provided with a box of 
two 4mg nasal spray products. We explained that at the time of drafting 
the proposed rule, we did not yet have any available pricing 
information for this newly approved product. However, in order to be 
able to make payment to OTPs under Medicare for this product, we 
proposed to create a new G-code describing a take-home supply of this 
higher dose naloxone hydrochloride nasal spray product.
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    We stated that under this proposal, we would price this new add-on 
code based on the established methodology under the OTP benefit for 
determining the adjustment for take-home supplies of opioid antagonist 
medications at Sec.  410.67(d)(4)(i)(E). This adjustment includes both 
a drug component and a non-drug component. The amount of the drug 
component of the adjustment would be determined using the methodology 
for pricing the drug component of an episode of care at Sec.  
410.67(d)(2)(i). Accordingly, consistent with the approach used to 
price the drug component of HCPCS code G2215, we would apply the 
payment methodology set forth in section 1847A of the Act to determine 
the payment for the new naloxone hydrochloride nasal spray product, 
except that payment amounts that are determined based on ASP or 
wholesale acquisition cost (WAC) would not include any add-on 
percentages (85 FR 84685). As stated in the CY 2021 PFS final rule (85 
FR 84685), we believe using ASP provides a transparent and public 
benchmark for manufacturers' actual pricing as it reflects the 
manufacturers' actual sales prices to all purchasers (with limited 
exceptions as noted in section 1847A(c)(2) of the Act) and is the only 
pricing methodology that includes off-invoice rebates and discounts as 
described in section 1847A(c)(3) of the Act. Therefore, we believe ASP 
to be the most market-based approach to set drug prices. Additionally, 
we proposed to price the drug component of the code based on an 
assumption of a typical dosage for a take-home supply of this new 
product to be a box of two 8mg nasal sprays. Consistent with the 
methodology established in Sec.  410.67(d)(4)(i)(E), the amount of the 
non-drug component of the code would be determined based on the CY 2020 
Medicare payment rate for CPT code 96161. In addition, payment for the 
add-on code would be limited to once every 30 days except when a 
further take-home supply of the medication is medically reasonable and 
necessary.
    We solicited public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported our proposal to create a new 
G-code describing a take-home supply of the new higher dose naloxone 
hydrochloride nasal spray product and recommended we finalize this 
proposal. One commenter noted that while they believe there is a 
potential for up-coding or overutilization of the higher strength 
naloxone, they believe that the benefits of adopting the proposed new 
add-on code for this new product outweigh the risks since the 
widespread availability of naloxone and other medications that can 
rapidly reverse an opioid overdose, along with education on its proper 
use, will save lives. Some commenters noted that drug overdose death 
rates reached an all-time high in 2020. These commenters stated that 
because many patients are experiencing overdoses from illicitly 
manufactured fentanyl, it is important that patients with OUD have 
access to the new, more potent overdose reversal drug. A few commenters 
expressed concern about the proposal to price the higher dose naloxone 
product using the ASP without the 6 percent add-on, noting that the 
payment for Part B drugs outside of the OTP benefit includes a 6 
percent add-on to account for overhead costs, administrative expenses, 
or additional mark-ups accrued in traditional drug distribution 
channels and recommended CMS include a factor for overhead/
administrative costs in its drug pricing methodology for take-home 
supplies of naloxone furnished by OTPs.
    Response: After considering the comments received, we are 
finalizing our proposal to establish a new code for a higher dose of 
naloxone hydrochloride nasal spray. We acknowledge the commenter's 
concern about potential for upcoding, but we agree that the benefits of 
adopting the new add-on code outweigh the risks because naloxone is a 
life-saving drug. In light of the comments regarding the increase in 
overdoses from illicitly manufactured fentanyl, which can require a 
more potent overdose reversal drug, we believe it is especially 
important to ensure that this new, higher-dose naloxone nasal spray is 
available to beneficiaries receiving OUD treatment services from OTPs. 
The new code is G1028 (Take-home supply of nasal naloxone; 2-pack of 
8mg per 0.1 mL nasal spray (provision of the services by a Medicare-
enrolled Opioid Treatment Program)); List separately in addition to 
code for primary procedure.) Additionally, we are updating the code 
descriptor for existing HCPCS code G2215 to reflect the dosage included 
in that code in order to distinguish it from the higher dosage in this 
new nasal naloxone code. The new code descriptor for HCPCS code G2215 
will be Take-home supply of nasal naloxone; 2-pack of 4mg per 0.1 mL 
nasal spray (provision of the services by a Medicare-enrolled Opioid 
Treatment Program)); List separately in addition to code for primary 
procedure.)
    With regard to the commenters' concerns about the proposal to price 
the higher dose naloxone product using the ASP or WAC without any add-
on percentages, as we discussed in the CY 2021 PFS final rule (85 FR 
84685), we believe this approach is most consistent with the approach 
we adopted in the CY 2020 PFS final rule for pricing the drug component 
of an episode of care that includes implantable or injectable 
medications. In addition, for the reasons discussed in the CY 2020 PFS 
final rule (84 FR 62652 and 62653), we continue to believe that 
limiting the payment amount to 100 percent of the volume-weighted ASP 
for a HCPCS code, when ASP is available, instead of 106 percent of the 
volume-weighted ASP for a HCPCS code will incentivize the use of the 
most clinically appropriate drug for a given patient. Similarly, as 
discussed in in the CY 2021 PFS final rule (85 FR 84685), we continue 
to believe that 100 percent of WAC is a closer estimate of

[[Page 65341]]

the actual acquisition cost for OTPs compared to WAC with an add-on 
percentage because, as defined in section 1847A(c)(6)(B) of the Act, 
WAC does not include prompt pay discounts, rebates or reductions in 
price.
    Accordingly, we will price HCPCS code G1028 as proposed; the 
payment rate for the drug component of the code will be based on the 
methodology at Sec.  410.67(d)(2)(i) and the amount of the non-drug 
component of the code will be determined based on the CY 2020 Medicare 
payment rate for CPT code 96161 as provided in Sec.  
410.67(d)(4)(i)(E). We note that we have WAC pricing information 
available for this higher-dose naloxone nasal spray. For CY 2022, 
consistent with Sec.  410.67(d)(2)(i)(A), the drug component of the new 
code will be priced at $125 for a 2-pack of the 8mg spray, which is 100 
percent of the WAC.
    Comment: One commenter expressed support for our proposal to 
geographically adjust the payment for the non-drug component of the 
codes for take-home supplies of naloxone, but stated that this payment 
should be updated by the hospital market basket update, not the MEI.
    Response: We thank the commenter for this feedback. We believe we 
should be consistent in applying the same geographic adjustment to the 
codes describing take-home supplies of naloxone that is applied to 
adjust the non-drug component of other codes under the OTP benefit. 
Therefore, we are finalizing our proposal that the non-drug component 
of the new naloxone code will be updated annually based on the MEI.
5. Out of Scope Comments
    Comment: We received one comment that stated that as of July 28, 
2021, the Drug Enforcement Administration (DEA) had published a final 
rule allowing OTPs to add mobile methadone units to their existing 
registration. The commenter requested that CMS specify that Medicare 
coverage for opioid use disorder by OTPs extend to services that are 
provided through mobile units.
    Response: We thank the commenter for this comment and note that 
this comment is outside of the scope of this final rule, as we did not 
make any proposals involving mobile vans for CY 2022. We may consider 
addressing this issue in the future rulemaking.
    Comment: One commenter stated that CMS should create a 17 percent 
rural add-on payment to be applied to the non-drug component of the 
codes for OTP services when services are furnished in low-population 
density areas where it is difficult to find doctors, nurses, and 
counselors to treat patients with OUD. The commenter noted that CMS 
could encourage expansion of access to OUD treatment services by 
providing add-on payments in areas that do not currently have an OTP 
provider.
    Response: We note that this comment is outside of the scope of this 
final rule, as we did not make any proposals related to a rural add-on 
code. We may consider addressing this issue in future rulemaking.
4. Counseling and Therapy Furnished Via Audio-Only Telephone
    In the CY 2020 PFS final rule (84 FR 62645 and 62646), we finalized 
allowing the use of two-way interactive audio/video communication 
technology, as clinically appropriate, to furnish the counseling and 
therapy portions of the weekly bundle of services and additional 
counseling or therapy services furnished by OTPs. Due to the PHE for 
COVID-19, 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 appeared in 
the April 6, 2020 Federal Register (85 FR 19230) (hereinafter referred 
to as the ``March 31, 2020 COVID-19 IFC''), we revised Sec.  
410.67(b)(3) and (4) to allow the therapy and counseling portions of 
the weekly bundles, and any additional counseling or therapy, to be 
furnished using audio-only telephone calls rather than via two-way 
interactive audio/video communication technology for the duration of 
the PHE for COVID-19. Under the policy adopted in the March 31, 2020 
COVID-19 IFC, counseling and therapy can be furnished using audio-only 
telephone calls only where two-way audio/video communications 
technology is not available to the beneficiary, and provided all other 
applicable requirements are met. In the March 31, 2020 COVID-19 IFC, we 
stated that we believed this change was necessary to ensure that 
beneficiaries with opioid use disorders would be able to continue to 
receive these important services during the PHE during which the public 
has been instructed to practice self-isolation or social distancing, 
and because interactive audio/video communication technology may not be 
available to all beneficiaries.
    As we discussed in the CY 2022 PFS proposed rule (86 FR 39318 
through 39319), we have continued to evaluate whether this flexibility 
will be needed after the end of the PHE. According to MedPAC's March 
2021 Report to the Congress, allowing audio-only interaction for 
certain telehealth services can improve beneficiary choice and equity 
in access to care for beneficiaries who do not have access to the 
technology for a video telehealth visit.\146\ Additionally, OTPs and 
organizations representing OTPs have encouraged us to reconsider our 
position on coverage of audio-only services following the conclusion of 
the PHE for COVID-19 and have suggested that CMS consider permanently 
allowing OTPs to furnish certain OUD treatment services using audio-
only telephone calls. Stakeholders have commented that allowing OTPs to 
furnish services via audio-only interactions facilitates broader access 
to services, particularly for vulnerable populations, and ensures 
providers have flexibility to deliver care to beneficiaries as 
efficiently and seamlessly as possible. Given the sensitivity of OUD 
treatment services, they noted that this is an area in which more 
flexibility will promote not only access but also effective and 
sustained treatment for beneficiaries in need of care. Some 
stakeholders have noted that the use of communication technology has 
reduced stress and stigma for those who require OUD treatment services 
and the allowance of audio-only services has greatly expanded access 
for beneficiaries who may not be able to use interactive video. One 
stakeholder stated that allowing use of audio-only communication to 
continue after the PHE for COVID-19 would be essential in addressing 
disparities in healthcare, especially for dually eligible beneficiaries 
who do not have access to audio-visual communication technology.
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    In the CY 2022 PFS proposed rule (86 FR 39319) we stated that after 
further consideration of the public comments and other stakeholder 
feedback, we were persuaded that using audio-only telephone calls to 
furnish therapy and counseling in cases where two-way audio/video 
communication technology is not available to the beneficiary after the 
end of the PHE for the COVID-19 pandemic would facilitate broader 
access to services. Therefore, we proposed to allow OTPs to continue to 
furnish the therapy and counseling portions of the weekly bundles, as 
well as any additional counseling or therapy that is billed under the 
add-on code, using audio-only telephone calls rather than via two-way 
interactive audio/video communication technology following the end of 
the PHE for COVID-19 in cases where audio/video

[[Page 65342]]

communication technology is not available to the beneficiary, provided 
all other applicable requirements are met. Accordingly, we proposed to 
revise the regulations at Sec.  410.67(b)(3) and (4) to allow OTPs to 
furnish therapy and counseling using audio-only telephone calls rather 
than via two-way interactive audio/video communication technology after 
the conclusion of the PHE for COVID-19 in cases where audio/video 
communication is not available to the beneficiary, provided all other 
applicable requirements are met. We noted that 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.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: We received many public comments that expressed support 
for our proposal to allow OTPs to furnish therapy and counseling using 
audio-only telephone calls rather than via two-way interactive audio/
video communication technology after the conclusion of the PHE for 
COVID-19, noting that this change would ensure continued access to care 
for beneficiaries receiving treatment at OTPs. Some commenters stated 
that audio-only services have helped to advance health equity and have 
been a vital linkage to care for many patients during the PHE and that 
these services have been especially beneficial for patients in rural 
areas who may not have access to reliable internet service, which 
limits their ability to access two-way, audio-video communications 
technology. One commenter agreed that CMS should permanently extend the 
ability to provide counseling via audio-only telehealth, but only for 
patients who are compliant with their treatment plan.
    Response: After consideration of the public comments, we are 
finalizing our proposal to revise the regulations at Sec.  410.67(b)(3) 
and (4) 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 PHE for COVID-19 in cases where audio/video 
communication is not available to the beneficiary, provided all other 
applicable requirements are met. As we explained in the proposed rule, 
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.
    Regarding the suggestion that CMS should only permanently extend 
the ability to provide counseling via audio-only telehealth for 
patients who are compliant with their treatment plan, we defer to the 
judgment of treating clinicians to determine when audio-only or audio/
video counseling or therapy are appropriate and whether there are 
certain circumstances, such as when patients are considered to be high 
risk, when in-person services are needed.
    Additionally, in the CY 2022 PFS proposed rule (86 FR 39319), we 
proposed that after the conclusion of the PHE for COVID-19, when two-
way interactive audio/video communication technology is used to furnish 
additional counseling and therapy services billed under the add-on 
code, OTPs would be required to append modifier 95 (Synchronous 
Telemedicine Service Rendered via Real-Time Interactive Audio and Video 
Telecommunications System) to the claim. We did not propose to require 
the use of this modifier when counseling and therapy services included 
in the weekly bundle are furnished using two-way interactive audio/
video communication technology. We recognized that it may be difficult 
to determine which modifier to use in cases where multiple services 
within the bundle are furnished using different modalities; therefore, 
we limited our proposal regarding the use of modifier 95 to claim lines 
for the counseling and therapy add-on code (HCPCS code G2080).
    We also proposed that, following the conclusion of the PHE for 
COVID-19, when counseling or therapy services are furnished using 
audio-only telephone calls, either as part of a weekly bundle or billed 
using the counseling and therapy add-on code (HCPCS code G2080), OTPs 
would be required to document in the beneficiary's medical record that 
the counseling or therapy was furnished via audio-only telephone call 
and the rationale for doing so. In addition, we proposed the use of a 
new service-level modifier to be appended to claims submitted for the 
counseling and therapy add-on code (HCPCS code G2080) when services are 
furnished via an audio-only interaction, which would serve to certify 
that the practitioner had the capacity to furnish the services using 
two-way, audio/video communication technology, but instead, used audio-
only technology because audio/video communication technology was not 
available to the beneficiary. We explained that the use of this 
modifier would allow CMS to track utilization of this flexibility in 
the claims data and evaluate that data as we consider ongoing 
refinements to the OTP benefit in the future. To avoid placing 
additional burden on OTPs during the PHE for COVID-19, we proposed that 
these new requirements would take effect on January 1, 2022, but would 
apply only for services furnished after the conclusion of the PHE for 
COVID-19. Accordingly, if the PHE for COVID-19 extends into 2022, OTPs 
that furnish counseling and therapy services using either two-way 
audio/video technology or audio-only telephone calls would not be 
required to use the applicable modifier or to comply with the new 
documentation requirements until after the end of the PHE.
    Accordingly, we proposed to revise Sec.  410.67(d) to add a new 
paragraph (6) to state that when substance use counseling under 
paragraph (b)(3) of this section or therapy services under paragraph 
(b)(4) of this section are furnished using audio-only telephone calls 
after the end of the PHE, as defined in 42 CFR 400.200, the 
practitioner must document in the beneficiary's medical record that the 
services were furnished using audio-only technology and the rationale 
for doing so. For purposes of the add-on code for additional counseling 
and therapy services, the practitioner would also be required to 
certify, in a form and manner specified by CMS, that they had the 
capacity to furnish the services using two-way, audio/video 
communication technology, but used audio-only technology because the 
beneficiary did not have access to two-way audio/video communication 
technology. We explained that under these proposals we would defer to 
clinician judgment in determining whether in-person counseling or 
therapy, rather than the use of audio-only telephone calls, would be 
most appropriate in certain circumstances, such as for patients who are 
considered to be high risk. Additionally, we solicited comment on 
whether we should put any additional or alternative conditions in place 
to promote program integrity, minimize patient safety concerns, and 
ensure that beneficiaries

[[Page 65343]]

have access to the most appropriate form of care.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters recommended that the agency not require 
additional documentation in the medical record to support the use of 
audio-only services, especially if this is the only way the patient can 
receive care, stating that additional documentation is duplicative and 
unnecessary. A few commenters supported the use of an audio-only claims 
coding modifier that could be used to track utilization and conduct 
effectiveness research for audio-visual vs. audio-only services, noting 
that evaluation of audio-only services would also be beneficial to 
demonstrate quality and efficacy for SUD treatment programs.
    Response: After consideration of the public comments, we are 
finalizing our proposal that a new service-level modifier be appended 
to claims submitted for the counseling and therapy add-on code (HCPCS 
code G2080) when services are furnished via an audio-only interaction. 
Consistent with policies finalized for other audio-only services 
furnished by physicians and certain NPPs in section II.D of this final 
rule, the use of this modifier will serve to certify that the 
practitioner had the capacity to furnish the services using two-way, 
audio/video communication technology, but instead, used audio-only 
technology because audio/video communication technology was not 
available to the beneficiary. Additionally, we are finalizing our 
proposal that after the conclusion of the PHE for COVID-19, when two-
way interactive audio/video communication technology is used to furnish 
additional counseling and therapy services billed under the counseling 
and therapy add-on code (HCPCS code G2080), OTPs will be required to 
append modifier 95 (Synchronous Telemedicine Service Rendered via Real-
Time Interactive Audio and Video Telecommunications System) to the 
claim. The use of these modifiers will allow us to track utilization of 
these flexibilities in the claims data and to evaluate that data as we 
consider future refinements to the OTP benefit.
    However, we are persuaded by the comments stating that the proposed 
requirement that OTPs document the use of audio-only services in the 
beneficiary's medical record would be duplicative because the new 
service-level modifier for services furnished via an audio-only 
interaction will also identify when a service was furnished via audio-
only communication. Therefore, we are not finalizing the proposal to 
require additional documentation in the medical record to support the 
use of audio-only services.
    Accordingly, we are finalizing our proposal to revise Sec.  410.67 
to add a new paragraph (d)(6) with modifications. As revised, the new 
paragraph (d)(6) will require that for purposes of the adjustment to 
the bundled payment for additional counseling or therapy services under 
Sec.  410.67(d)(4)(i)(A), after the end of the PHE for COVID-19, as 
defined in Sec.  400.200, when services are furnished using audio-only 
technology the practitioner must certify, in a form and manner 
specified by CMS, that they had the capacity to furnish the services 
using two-way, audio/video communication technology but used audio-only 
technology because audio/video communication technology was not 
available to the beneficiary.

P. Physician Self-Referral Updates

1. The Physician Self-Referral Statute and Regulations
    Section 1877 of the Act, also known as the physician self-referral 
law: (1) Prohibits a physician from making referrals for certain 
designated health services payable by Medicare to an entity with which 
he or she (or an immediate family member) has a financial relationship, 
unless an exception applies; and (2) prohibits the entity from filing 
claims with Medicare (or billing another individual, entity, or third 
party payer) for those referred services. A financial relationship is 
an ownership or investment interest in the entity or a compensation 
arrangement with the entity. The statute establishes a number of 
specific exceptions and grants the Secretary of the Department of 
Health and Human Services (the Secretary) the authority to create 
regulatory exceptions for financial relationships that do not pose a 
risk of program or patient abuse. Section 1903(s) of the Act extends 
aspects of the physician self-referral prohibitions to Medicaid. For 
additional information about section 1903(s) of the Act; see 66 FR 857 
through 858.
    The following discussion provides a chronology of our more 
significant and comprehensive rulemakings; it is not an exhaustive list 
of all rulemakings related to the physician self-referral law. After 
the passage of section 1877 of the Act, we proposed rulemakings in 1992 
(related only to referrals for clinical laboratory services) (57 FR 
8588) (the 1992 proposed rule) and 1998 (addressing referrals for all 
designated health services) (63 FR 1659) (the 1998 proposed rule). We 
finalized the proposals from the 1992 proposed rule in 1995 (60 FR 
41914) (the 1995 final rule), and issued final rules following the 1998 
proposed rule in three stages. The first final rulemaking (Phase I) was 
a final rule with comment period published in the January 4, 2001 
Federal Register (66 FR 856). The second final rulemaking (Phase II) 
was an interim final rule with comment period (69 FR 16054) published 
in the March 26, 2004 Federal Register. Due to a printing error, a 
portion of the Phase II preamble was omitted from the March 26, 2004 
Federal Register publication. That portion of the preamble, which 
addressed reporting requirements and sanctions, was published in the 
April 6, 2004 Federal Register (69 FR 17933). The third final 
rulemaking (Phase III) was a final rule published in the September 5, 
2007 Federal Register (72 FR 51012).
    In addition to Phase I, Phase II, and Phase III, we issued final 
regulations on August 19, 2008 in the Fiscal Year (FY) 2009 Inpatient 
Prospective Payment System final rule with comment period (73 FR 48434) 
(the FY 2009 IPPS final rule). That rulemaking made various revisions 
to the physician self-referral regulations, including: (1) Revisions to 
the ``stand in the shoes'' provisions; (2) establishment of provisions 
regarding the period of disallowance and temporary noncompliance with 
signature requirements; (3) prohibitions on per unit of service (often 
referred to as ``per-click'') and percentage-based compensation 
formulas for determining the rental charges for office space and 
equipment lease arrangements; and (4) expansion of the definition of 
``entity.''
    After passage of the Patient Protection and Affordable Care Act of 
2010 (Pub. L. 111-148) (Affordable Care Act), we issued final 
regulations on November 29, 2010 in the CY 2011 PFS final rule with 
comment period that codified a disclosure requirement established by 
the Affordable Care Act for the in-office ancillary services exception 
(75 FR 73443). We also issued final regulations on November 24, 2010 in 
the CY 2011 OPPS final rule with comment period (75 FR 71800), on 
November 30, 2011 in the CY 2012 OPPS final rule with comment period 
(76 FR 74122), and on November 10, 2014 in the CY 2015 OPPS final rule 
with comment period (79 FR 66987) that established or revised certain 
regulatory provisions concerning physician-owned hospitals to codify 
and interpret the Affordable Care Act's revisions to section 1877 of 
the Act.

[[Page 65344]]

    On November 16, 2015, in the CY 2016 PFS final rule, we issued 
regulations to reduce burden and facilitate compliance (80 FR 71300 
through 71341). In that rulemaking, we established two new exceptions, 
clarified certain provisions of the physician self-referral 
regulations, updated regulations to reflect changes in terminology, and 
revised definitions related to physician-owned hospitals. The new 
exception at Sec.  411.357(y) for timeshare arrangements included a 
limitation on certain per unit of service and percentage-based 
compensation formulas. On November 15, 2016, in the CY 2017 PFS final 
rule, we again finalized requirements that the rental charges for the 
lease of office space or equipment are not determined using a formula 
based on per unit of service rental charges, to the extent that such 
charges reflect services provided to patients referred by the lessor to 
the lessee (81 FR 80534). The requirements are identical to those in 
effect since October 1, 2009, and are included in the exceptions for 
the rental of office space at Sec.  411.357(a)(5)(ii)(B), the rental of 
equipment at Sec.  411.357(b)(4)(ii)(B), fair market value compensation 
at Sec.  411.357(l)(3)(ii), and indirect compensation arrangements at 
Sec.  411.357(p)(1)(ii)(B). The terms ``rental'' and ``lease'' both 
refer to an arrangement under which dominion and control of the rented 
or leases property is transferred from the lessor to the lessee. In 
this final rule, we generally use the term ``lease'' for consistency.
    In the December 2, 2020 Federal Register, we published a final rule 
entitled ``Modernizing and Clarifying the Physician Self-Referral 
Regulations'' (the ``MCR final rule'') (85 FR 77492) that established 
three new exceptions to the physician self-referral law applicable to 
compensation arrangements that qualify as ``value-based arrangements,'' 
established exceptions for limited remuneration to a physician and the 
donation of cybersecurity technology and services, and revised or 
clarified several existing exceptions. The MCR final rule also provided 
guidance and updated or established regulations related to the 
fundamental terminology used in many provisions of the physician self-
referral law. Most notably, we defined the term ``commercially 
reasonable'' in regulation, established an objective test for 
evaluating whether compensation varies with the volume or value of 
referrals or other business generated between the parties, and revised 
the definitions of ``fair market value'' and ``general market value.'' 
The MCR final rule also revised the definition of ``indirect 
compensation arrangement.''
    2. Indirect Compensation Arrangements (Sec.  411.354(c)(2))
    a. Summary of Proposals
    We proposed to revise and renumber the regulation at Sec.  
411.354(c)(2) that sets forth the conditions for the existence of an 
indirect compensation arrangement. First, we proposed to revise and 
renumber Sec.  411.354(c)(2)(ii), which identifies when aggregate 
compensation to a physician results in an indirect compensation 
arrangement (if the other conditions of Sec.  411.354(c)(2) are met), 
to more precisely address the concerns and effectuate the policies that 
we articulated in the MCR final rule. Specifically, we proposed to 
revise the regulation to include as a potential indirect compensation 
arrangement any unbroken chain of financial relationships in which the 
compensation arrangement closest to the physician (or immediate family 
member of the physician) involves compensation for anything other than 
services that he or she personally performs. This would have included 
arrangements for the lease of office space or equipment that meet the 
other conditions of the regulation at Sec.  411.354(c)(2), which would 
be subject to, among other requirements, the prohibition on percentage-
based and unit-based (often referred to as ``per-click'') compensation 
formulas at Sec.  411.357(p)(1)(ii) in the exception for indirect 
compensation arrangements (or subject to the requirements of another 
applicable exception). Second, after receiving inquiries from 
stakeholders requesting clarification on the term ``unit'' in Sec.  
411.354(c)(2)(ii)(A) following the publication of the MCR final rule, 
we proposed to define the term ``unit'' for purposes of applying the 
regulation. We also proposed to define ``services that are personally 
performed'' for purposes of applying proposed Sec.  
411.354(c)(2)(ii)(A)(4).
b. Definition of ``Indirect Compensation Arrangement''
    Although section 1877(h)(1) of the Act defines the term 
``compensation arrangement'' as including both direct and indirect 
compensation, the statute does not define the term ``indirect 
compensation arrangement.'' In Phase I, relying on the Secretary's 
authority under section 1877(b)(4) of the Act, we set forth in 
regulation the conditions under which an indirect compensation 
arrangement exists and a corresponding exception for such arrangements 
(66 FR 684 through 687). In Phase II, we revised the regulation at 
Sec.  411.354(c)(2)(ii) to distinguish the language identifying when an 
indirect compensation arrangement exists from the language of the 
exception for indirect compensation arrangements at Sec.  411.357(p) 
(69 FR 16069). Most recently, in the MCR final rule, we further revised 
the regulation at Sec.  411.354(c)(2) that identifies when an indirect 
compensation arrangement exists (85 FR 77544 through 77546).
    Prior to the MCR final rule, an unbroken chain of financial 
relationships between a referring physician (or a member of his or her 
immediate family) and the entity furnishing designated health services 
established an ``indirect compensation arrangement'' if all the 
elements of Sec.  411.354(c)(2), as then in effect, existed. The 
indirect compensation arrangement must satisfy the requirements of an 
applicable exception in order to avoid the referral and billing 
prohibitions of the physician self-referral law. (In the alternative, 
the parties could use an exception at Sec.  411.355 to except the 
physician's referrals on a service-by-service basis.) This two-step 
process, which first identified the universe of unbroken chains of 
financial relationships that might be of concern and then excepted from 
the physician self-referral law's prohibitions those unbroken chains of 
financial relationships that did not pose a risk of program or patient 
abuse, was developed to closely correspond to the statutory treatment 
of compensation arrangements directly between an entity and a referring 
physician (or an immediate family member of the referring physician) 
(69 FR 16059). When analyzing compliance with the requirement that 
compensation does not take into account the volume or value of a 
physician's referrals or the other business generated by the physician 
for the entity, which is included in the exception for indirect 
compensation arrangements at Sec.  411.357(p) and certain exceptions 
for direct compensation arrangements, special rules on unit-based 
compensation at Sec.  411.354(d)(2) and (3) that deemed certain 
compensation not to take into account the volume or value of the 
physician's referrals or the other business generated by the physician 
could be applied.
    As noted above, in the MCR final rule, we established an objective 
test for evaluating whether compensation varies with the volume or 
value of referrals or other business generated between the parties and 
responded to commenters that questioned whether compensation to a 
physician would run afoul of the objective tests under specified 
circumstances (85 FR 77539 through 77547). Inquiring about proposed

[[Page 65345]]

modifications to Sec.  411.354(c)(2)(ii) that we did not ultimately 
finalize, one commenter presented the example of a physician who 
performs surgeries at a hospital and receives a fixed amount per 
personally-performed RVU that is consistent with the fair market value 
of the physician's services (85 FR 77544). In developing our response 
to the commenter (and other commenters), we revisited the regulatory 
construct for determining which unbroken chains of financial 
relationships between entities and physicians (or immediate family 
members of physicians) establish indirect compensation arrangements and 
how to determine if they pose a risk of program or patient abuse (85 FR 
77545).
    With the underlying goal of reducing unnecessary burden on 
providers and suppliers, we stated that we do not see a need to treat 
compensation arrangements that may qualify as ``indirect compensation 
arrangements'' in the exact same way that the statute treats direct 
compensation arrangements when that construct creates unnecessary 
burden on the regulated industry (85 FR 77545 through 77546). We stated 
that it is possible to simplify the analysis of whether an unbroken 
chain of financial relationships presents a risk of patient or program 
abuse or poses program integrity concerns (85 FR 77546), and finalized 
revisions to Sec.  411.354(c)(2) intended to achieve the same result as 
the two-step Phase I regulatory construct in protecting against program 
or patient abuse while reducing unnecessary burden on the regulated 
industry (85 FR 77546). The revised (now current) regulation at Sec.  
411.354(c)(2)(ii) effectively incorporates and applies the conditions 
of the special rules on unit-based compensation at Sec.  411.354(d)(2) 
and (3) at the definitional level when determining whether there exists 
an indirect compensation arrangement that implicates the physician 
self-referral law.
    Under the regulation finalized in the MCR final rule, an unbroken 
chain of financial relationships between an entity and a physician is 
considered an indirect compensation arrangement if the physician (or 
immediate family member of the physician) receives aggregate 
compensation from the person or entity in the chain with which the 
physician (or immediate family member) has a direct financial 
relationship that varies with the volume or value of referrals or other 
business generated by the physician for the entity furnishing the 
designated health services, and any of the following are true: (1) The 
individual unit of compensation received by the physician (or immediate 
family member) is not fair market value for items or services actually 
provided; (2) the individual unit of compensation received by the 
physician (or immediate family member) is calculated using a formula 
that includes the physician's referrals to the entity furnishing 
designated health services as a variable, resulting in an increase or 
decrease in the physician's (or immediate family member's) compensation 
that positively correlates with the number or value of the physician's 
referrals to the entity; or (3) the individual unit of compensation 
received by the physician (or immediate family member) is calculated 
using a formula that includes other business generated by the physician 
for the entity furnishing designated health services as a variable, 
resulting in an increase or decrease in the physician's (or immediate 
family member's) compensation that positively correlates with the 
physician's generation of other business for the entity. In addition, 
the entity must have actual knowledge of, or act in reckless disregard 
or deliberate ignorance of, the fact that the referring physician (or 
immediate family member) receives aggregate compensation that varies 
with the volume or value of referrals or other business generated by 
the referring physician for the entity. Under the regulation, unless 
all the elements of Sec.  411.354(c)(2)(i), (ii), and (iii) exist, an 
unbroken chain of financial relationships between an entity furnishing 
designated health services and a physician (or immediate family member 
of a physician) is not considered an indirect compensation arrangement.
    As explained previously, the changes to the regulations that 
identify indirect compensation arrangements of concern under the 
physician self-referral law occurred in response to comments and 
inquiries primarily in the context of compensation paid to physicians 
for their personally performed services (85 FR 77539 through 77547). 
The revisions to Sec.  411.354(c)(2)(i) through (iii) were intended to 
more precisely identify arrangements that pose a risk of 
overutilization, patient steering, and other abusive conduct at an 
earlier stage of the analysis (85 FR 77546). However, in streamlining 
the former two-step process for analyzing unbroken chains of financial 
relationships, we inadvertently omitted a longstanding and important 
program integrity requirement that previously always applied when 
determining satisfaction of the requirements of the exception at Sec.  
411.357(p) for indirect compensation arrangements. Specifically, we 
inadvertently excluded from the definition of ``indirect compensation 
arrangement'' a subset of unbroken chains including compensation 
arrangements that we have long identified as presenting significant 
program integrity concerns: Certain arrangements involving unit of 
service-based payment for the rental or lease of office space or 
equipment. (See 73 FR 48713 through 48721; 81 FR 80524 through 80534; 
and 85 FR 77605 through 77608).)
    We have repeatedly stated our view that unit of service-based 
compensation formulas in arrangements for the lease of space and 
equipment are inherently susceptible to abuse because the physician 
lessor has an incentive to profit from referring a higher volume of 
patients to the lessee. Beginning with the 1998 proposed rule, we 
stated that unit of service-based payments for patients who are 
referred for the service by the lessor physician were not consistent 
with the requirement that compensation not reflect the volume or value 
of a physician's referrals or other business generated (63 FR 1714). In 
Phase I, we revisited the issue, reviewed the legislative history, and 
concluded that, as long as the per-unit payment reflected fair market 
value in arms' length bargaining and did not vary over the course of 
the arrangement, unit of service-based payments could qualify for the 
protection of an exception, provided that the other requirements of the 
applicable exception are met. (66 FR 876). We noted that such 
arrangements might run afoul of the anti-kickback statute and stated 
our intent to continue to monitor such arrangements for potential abuse 
(66 FR 878).
    Subsequently, in the 2009 IPPS final rule, based on our 
observations of program integrity concerns and comments in support of 
prohibiting unit of service-based compensation formulas in office space 
and equipment leases, we finalized revisions to the exceptions for the 
rental of office space at Sec.  411.357(a), the rental of equipment at 
Sec.  411.357(b), fair market value compensation at Sec.  411.357(l), 
and indirect compensation arrangements at Sec.  411.357(p). The revised 
exceptions required that, to the extent that such arrangements related 
to the lease of office space or equipment, the rental charges may not 
be determined using a formula based on: (1) A percentage of the revenue 
raised, earned, billed, collected, or otherwise attributable to the 
service performed or business generated in the office space; or (2) 
unit of service-based rental charges, to the

[[Page 65346]]

extent that such charges reflect services provided to patients referred 
by the lessor to the lessee (73 FR 48713 through 48714). Commenters 
largely supported the change. A significant number of commenters 
reported their own experiences of situations in which unit of service-
based compensation arrangements resulted in patients being referred for 
medically unnecessary treatment. Some hospitals reported being 
effectively compelled to lease equipment from physician groups (73 FR 
48715). In the 2016 PFS final rule, we included similar restrictions on 
percentage-based and unit of service-based compensation formulas in the 
new exception at Sec.  411.357(y) for timeshare arrangements. In 
support of that limitation, we again cited concerns that unit of 
service-based compensation formulas in arrangements involving the use 
of premises or equipment could lead to overutilization and patient 
steering (80 FR 71331 through 71332).
    We most recently addressed the issue of unit of service-based 
compensation formulas in depth in the 2017 PFS proposed and final 
rules. In those rules, at the direction of the D.C. Circuit Court in 
Council for Urological Interests v. Burwell, 790 F.3d 212 (DC Cir. 
2015), we explained our rationale for the restrictions as they apply to 
arrangements for the lease of office space or equipment or for the use 
of premises or equipment, again identifying overutilization and patient 
steering as the primary program integrity concerns supporting our 
conclusion that such compensation provisions present a significant 
program risk (81 FR 46452 through 46453 and 80528 through 80534). We 
reiterated that unit of service-based compensation formulas, in 
particular in arrangements for the lease of equipment:
     Create an incentive for overutilization of imaging 
services (as described by MedPAC in its comments to our proposal in the 
CY 2008 PFS proposed rule), as well as other services, including 
therapeutic services;
     Create an incentive for physicians to narrow their choice 
of treatment options to those for which they will realize a profit, 
even where the best course of action may be no treatment;
     Influence physicians to refer to the lessee instead of 
referring to another entity that utilizes the same or different (and 
perhaps more efficacious) technology to treat the patient's condition;
     Result in physicians steering patients to equipment they 
own, even if it means having the patient travel to a non-convenient 
site for services using the leased equipment; and
     Increase costs to the Medicare program when referring 
physicians pressure hospitals to use their leasing company despite not 
being the low cost provider.
    We also identified two advisory opinions issued by OIG in which OIG 
voiced concerns about unit of service-based compensation arrangements 
and indicated that such arrangements are disfavored under the anti-
kickback statute (81 FR 80528). Commenters again were largely 
supportive of the proposal, which merely re-proposed the then-existing 
prohibitions on such compensation formulas in arrangements for the 
lease or use of office space or equipment (81 FR 80528 through 80529).
    As discussed in prior rulemakings, our policies regarding unit of 
service-based compensation formulas relate to both the lease of office 
space or equipment--where dominion and control over the office space 
(the subject of the statutory exception at section 1877(e)(1)(A) of the 
Act and the regulatory exception at Sec.  411.357(a)) or equipment is 
transferred from the lessor to the lessee--and to arrangements for the 
use of premises (which may or may not be office space) or equipment--
where the grantee is granted a right to use the premises or equipment 
but dominion and control over the premises or equipment is not 
transferred from the grantor to the grantee. Our position on the 
inherent risks presented by unit of service-based compensation formulas 
in the context of the lease of office space or equipment and the use of 
premises or equipment has not changed since the CY 2016 and 2017 PFS 
final rules. This fact is evident elsewhere in the MCR final rule. For 
example, the rule finalized changes to the exception for fair market 
value items and services at Sec.  411.357(l), making it applicable to 
the lease of office space (85 FR 77606). With this change, we also 
revised the exception to state that the previously-established 
restrictions at Sec.  411.357(l)(3)(i) and (ii) applicable to fair 
market value equipment leases also apply to leases of office space. We 
reiterated our longstanding concerns with unit of service-based 
compensation formulas for leases of office space and equipment, 
described the history of such concerns, and stated, in response to a 
comment supporting the inclusion of the restriction, that it was ``a 
necessary safeguard'' for the reasons articulated in our prior 
rulemakings (85 FR 77607). We included similar restrictions on 
compensation for the lease of office space or equipment and the use of 
premises or equipment in the newly-finalized exception for limited 
remuneration to a physician at Sec.  411.357(z), citing the same 
concerns (85 FR 77624).
    We continue to believe that arrangements involving unit of service-
based compensation for the lease of office space or equipment or for 
the use of premises or equipment, whether direct or indirect, may pose 
a significant risk of program abuse, and proposed revisions to Sec.  
411.354(c)(2)(ii) to ensure that prohibitions on certain unit of 
service-based compensation formulas for the lease of office space or 
equipment or for the use of premises or equipment applies to all 
compensation arrangements that include them. Under proposed Sec.  
411.354(c)(2)(ii), an unbroken chain of financial relationships in 
which the compensation arrangement closest to the physician (or 
immediate family member) is an arrangement for the lease of office 
space or equipment or an arrangement for the use of premises or 
equipment would be an indirect compensation arrangement if all other 
conditions of Sec.  411.354(c)(2)(i) through (iii) are met. If the 
parties to the compensation arrangement elect to use the exception at 
Sec.  411.357(p) instead of another applicable exception, if any, the 
compensation for the lease of office space or equipment may not be 
determined using a formula based on per-unit of service rental charges 
to the extent that such charges reflect services provided to patients 
referred by the lessee to the lessor. Moreover, Sec.  411.357(p)(1)(i) 
requires that compensation received by a physician (or immediate family 
member)--including compensation for the lease of office space or 
equipment or for the use of premises or equipment--is not determined in 
any manner that takes into account the volume or value of referrals or 
other business generated by the physician for the entity furnishing 
designated health services.
    As we stated in the proposed rule and continue to believe, 
arrangements involving compensation to a physician for items or the 
services of others where the physician's referral of designated health 
services to an entity or other business generated by the physician for 
an entity may contribute to the compensation received by the physician 
are distinguishable from arrangements that solely involve compensation 
for a physician's personally performed services. Program integrity 
concerns arise when payment for items or services provided as the 
result of a physician's referrals or the other business the physician 
generates, rather than the physician's own labor, is included in the 
calculation of

[[Page 65347]]

compensation. As discussed previously, the MCR final rule policy that 
identifies indirect compensation arrangements of concern under the 
physician self-referral law in a single-step process was focused on 
reducing unnecessary burden related to the analysis of unbroken chains 
of financial relationships that do not pose a risk of program or 
patient abuse, and was developed in the context of compensation paid to 
physicians for their personally performed services. However, the 
current regulations, as finalized in the MCR final rule, are not 
limited to indirect compensation arrangements under which a physician 
(or immediate family member) is paid solely for services that he or she 
personally performs, which, as a general matter, do not raise 
significant program integrity concerns, provided that the compensation 
is consistent with fair market value for the personally performed 
services.
    If finalized, proposed Sec.  411.354(c)(2)(ii) would have required 
a two-step analysis of any unbroken chain of financial relationships in 
which the compensation paid under the arrangement closest to the 
physician (or immediate family member) is for anything other than 
services personally performed by the physician (or immediate family 
member), including arrangements for the lease of office space or 
equipment or for the use of premises or equipment. Specifically, we 
proposed to revise the condition at Sec.  411.354(c)(2)(ii)(A) to 
consider an unbroken chain of financial relationships between a 
physician and an entity that meets the other conditions of Sec.  
411.354(c)(2)(i) through (iii) to be an indirect compensation 
arrangement for purposes of the physician self-referral law if the unit 
of compensation received by the physician (or immediate family member) 
is payment for anything other than services personally performed by the 
physician (or immediate family member). We stated that the application 
of the proposed revision to all unbroken chains of financial 
relationships in which the compensation paid under the arrangement 
closest to the physician (or immediate family member) is for anything 
other than services personally performed by the physician (or immediate 
family member) was intended to better align with our view regarding the 
reduced risk of program or patient abuse where compensation is for 
personally performed services.
    We also proposed slight revisions to the language of Sec.  
411.354(c)(2)(ii)(A)(2) and (3) to clarify that these conditions relate 
to the formula for calculating the amount of compensation per unit. The 
condition at proposed Sec.  411.354(c)(ii)(A) stated that the referring 
physician (or immediate family member) receives aggregate compensation 
from the person or entity in the chain with which the physician (or 
immediate family member) has a direct financial relationship that 
varies with the volume or value of referrals or other business 
generated by the referring physician for the entity furnishing the 
designated health services and the individual unit of compensation 
received by the physician (or immediate family member): (1) Is not fair 
market value for items or services actually provided; (2) Is calculated 
using a formula that includes the physician's referrals to the entity 
furnishing designated health services as a variable, resulting in an 
increase or decrease in the amount of compensation that positively 
correlates with the number or value of the physician's referrals to the 
entity; (3) Is calculated using a formula that includes other business 
generated by the physician for the entity furnishing designated health 
services as a variable, resulting in an increase or decrease in the 
amount of compensation per unit that positively correlates with the 
physician's generation of other business for the entity; or (4) Is 
payment for anything other than services personally performed by the 
physician (or immediate family member). For purposes of proposed Sec.  
411.354(c)(2)(ii)(A)(4), services that are performed by any person 
other than the physician (or immediate family member), including, but 
not limited to, the referring physician's (or immediate family 
member's) employees, independent contractors, group practice members, 
or persons supervised by the physician (or the immediate family member) 
would not be personally performed by the physician. We proposed to 
codify this policy at Sec.  411.354(c)(2)(ii)(B)(3). We are finalizing 
our proposal to ensure that the prohibition on certain unit of service-
based compensation formulas for the lease of office space or equipment 
or for the use of premises or equipment applies to all compensation 
arrangements that include them. We are not finalizing our proposal 
regarding payment for anything other than services personally performed 
by the physician (or immediate family member) or our proposal to codify 
our interpretation of services that are personally performed by a 
physician (or immediate family member).
c. Definition of ``unit'' for Purposes of Applying Sec.  
411.354(c)(ii)(A)
    As explained above, under current Sec.  411.354(c)(2)--which was 
finalized in the MCR final rule--the determination of whether an 
indirect compensation arrangement exists requires the evaluation of the 
individual unit of compensation that the physician (or immediate family 
member) receives. If the individual unit of compensation does not meet 
any of the conditions at current Sec.  411.354(c)(2)(ii)(A)(1) through 
(3), the unbroken chain of financial relationships does not constitute 
an indirect compensation arrangement. Following the publication of the 
MCR final rule, we received inquiries from stakeholders regarding how 
the provisions of Sec.  411.354(c)(2)(ii)(A) should be applied in 
situations where compensation does not appear to be unit-based or is 
calculated using two or more different units or types of units. We 
proposed revisions to Sec.  411.354(c)(2)(ii)(B) to clarify how to 
identify the unit to analyze against the conditions of current Sec.  
411.354(c)(2)(ii)(A)(1) through (3), as well as proposed Sec.  
411.354(c)(2)(ii)(A)(4).
    As a preliminary matter, it is our position that all compensation 
essentially is unit-based compensation. The underlying unit may be a 
discrete item, a unit of service, a unit of time, or a unit that 
results from combining different types of units into a single unit used 
to calculate the compensation. The identification of purely time-based 
or service-based units is straightforward. With respect to compensation 
that is entirely paid per hour, per day, per month, per year, or per 
similar period of time, the individual unit of compensation is the 
smallest unit of time for which the compensation is paid. For example, 
where a physician is paid $150 per hour for his or her medical director 
services, the unit is an hour. Similarly, where a physician is paid 
$350,000 per year for his or her full-time professional services, the 
unit is a year. With respect to compensation that is entirely paid per 
service, such as a work relative value unit (wRVU) or the provision of 
a training seminar, the unit is the individual service. For example, 
where a physician is paid $30 per wRVU that he or she personally 
performs, the unit is a wRVU. Similarly, where a physician is paid 
$1000 to provide a training session on infection control measures for 
an organization's employees, the unit is a training session. 
Compensation formulas that incorporate a percentage of a variable are 
also unit-based. For example, if a physician is

[[Page 65348]]

paid 50 percent of the amount collected for the professional services 
that he or she performs in a calendar year, the unit is a calendar 
year. If a physician is paid 95 percent of the Medicare PFS amount for 
a particular service that he or she personally performs, the unit is 
the service.
    We are aware that compensation arrangements may include different 
units of compensation paid to a physician. According to stakeholders 
inquiring about the application of Sec.  411.354(c)(2)(ii)(A), a 
physician employed by a physician organization may receive an annual 
salary for his or her full-time professional services furnished to 
patients of the physician organization plus a productivity bonus for 
each wRVU that he or she personally performs. The stakeholders inquired 
how to identify the unit that results from combining different types of 
units into a single unit used to calculate the physician's 
compensation. In such instances, we consider the unit of compensation 
to be time-based and reflect the aggregate compensation paid to the 
physician during the period of time applicable to the payment; that is, 
the period of time during which compensation is paid (for example, per 
month or per year) or over the entire term of the arrangement. It is 
our understanding that fair market valuations generally follow this 
construct, determining the fair market value of various types of 
compensation for a physician's personally performed services, such as 
fixed salary payments and productivity or bonus compensation, by 
assessing the physician's compensation in the aggregate over a period 
of time. Further, a service-based unit of compensation is easily 
converted to a time-based unit by incorporating the period of time 
applicable to the payment for the services (for example, $30 per wRVU 
per month), while the reverse is not true. It is for these reasons that 
we believe that ``hybrid'' compensation--that is, compensation that has 
both a time-based unit component and a service-based unit component--is 
appropriately analyzed by converting it to compensation for a unit of 
time for purposes of applying Sec.  411.354(c)(2)(ii).
    To illustrate, assume that an employment arrangement between a 
physician and a physician organization specifies compensation of 
$200,000 per calendar year for the physician's full-time professional 
services plus a productivity bonus of $10 for each wRVU that he or she 
personally performs, and that the physician is paid on a monthly basis. 
The unit of compensation is a month, and the formula for determining 
the compensation per month is ($200,000 / 12 months) + ($10 x the 
number of wRVUs personally performed during the month). (In the 
alternative, the parties could analyze the arrangement under Sec.  
411.354(c)(2)(ii)(A) using a calendar year as the unit of 
compensation.) However, if the employment arrangement specified 
productivity bonus compensation of $10 per wRVU only for those 
personally performed wRVUs above a predetermined target, the unit is 
the period of time for which the target is applicable. To illustrate, 
instead of $10 for each wRVU that the physician personally performs, 
assume that the physician receives $10 for the wRVUs that he or she 
personally performs in excess of 4,000 wRVUs per calendar year. The 
unit of compensation is a calendar year, and the formula for 
determining the compensation per year is $200,000 + $10 x (actual 
number of wRVUs personally performed during the calendar year--4,000).
    We note that a compensation arrangement may also involve multiple 
units of the same type. For example, a physician employed by a 
physician organization may receive a salary of $200,000 per year for 
his or her full-time professional services plus $150 per hour for his 
or her personally performed medical director services or $500 per month 
for each of the physician organization's NPPs that he or she 
supervises. Or, a physician may receive compensation for services based 
on a fee schedule; for example, $50 for service A, $75 for service B, 
and $100 for service C. In circumstances where more than one unit of 
the same type is used to calculate the physician's compensation, each 
unit must be analyzed under Sec.  411.354(c)(2)(ii)(A)(1) through (4) 
to determine whether the conditions for an indirect compensation 
arrangement exist.
    To facilitate compliance with the physician self-referral law as it 
applies to indirect compensation arrangements, we proposed a new 
regulation at Sec.  411.354(c)(2)(ii)(B)(2) that expressly identifies 
the unit to consider for purposes of applying the regulation at Sec.  
411.354(c)(2)(ii)(A) and determining the existence of an indirect 
compensation arrangement that must satisfy the requirements of an 
applicable exception. Under proposed Sec.  411.354(c)(2)(ii)(B)(2), for 
purposes of applying Sec.  411.354(c)(2)(ii)(A), the individual unit 
was specified as: (1) Time, where the compensation paid to the 
physician (or immediate family member) is based solely on the period of 
time during which the services are provided; (2) service, where the 
compensation paid to the physician (or immediate family member) is 
based solely on the service provided; and (3) time, where the 
compensation paid to the physician (or immediate family member) is not 
based solely on the period of time during which a service is provided 
or based solely on the service provided. We are finalizing our proposal 
to clarify the unit for purposes of determining the existence of an 
indirect compensation arrangement with the modifications as described 
in our response to comments below.
    We solicited comment on the proposals discussed above and whether 
additional guidance is needed with respect to the determination of 
whether an indirect compensation arrangement exists. We received public 
comments on these proposals. The following is a summary of the comments 
we received and our responses.
    Comment: Many commenters acknowledged the longstanding CMS policy 
that compensation for the lease of office space or equipment or for the 
use of premises or equipment may not be determined using a formula 
based on per-unit of service (or ``per-click'') rental charges or 
``use'' fees to the extent that such charges reflect services provided 
to patients referred by the lessor to the lessee or by the party 
granting permission to use the premises or equipment (often referred to 
as the ``licensor'') to the party to which the permission is granted 
(often referred to as the ``licensee''), respectively. These commenters 
supported finalizing our proposal to retain the policy with respect to 
indirect compensation arrangements, with several noting that our 
failure to revise the regulations at Sec.  411.354(c)(2) in the MCR 
final rule to include the prohibition on per-click payments for the 
lease of office space or equipment must surely have been an oversight 
given that the agency: (1) Made no express statement that it was 
abandoning its policy with respect to unbroken chains of financial 
relationships where the compensation arrangement closest to a physician 
(or immediate family member of a physician) is for the lease of office 
space or equipment; and (2) retained the policy with respect to 
arrangements for the lease of office space or equipment that are 
directly (or are deemed to be directly) between an entity and a 
physician (or immediate family member of a physician). Several 
commenters asserted that the policy is necessary to protect against the 
program integrity concerns that underly the policy, but others asserted 
that per-click payments for the lease of equipment do not pose a risk 
to the Medicare program or its

[[Page 65349]]

beneficiaries and, therefore, the policy is unnecessary. A few 
commenters expressed concern with the burden of learning how to apply 
new regulations, some of whom supported a prohibition on per-click 
payments for the lease of office space and equipment, and some of whom 
opposed such a prohibition.
    Response: As we stated in the proposed rule, in the MCR final rule, 
we inadvertently omitted the important program integrity requirement 
related to per-click payments for the lease of office space and 
equipment or for the use of premises or equipment when revising our 
regulations at Sec.  411.354(c)(2) in order to identify arrangements 
that pose a risk of overutilization, patient steering, and other 
abusive conduct at an earlier state of the analysis (86 FR 29322). As 
the commenters correctly noted, this was in no way an abandonment of 
our longstanding policy with respect to unbroken chains of financial 
relationships where the compensation arrangement closest to a physician 
(or immediate family member of a physician) is for the lease of office 
space or equipment, nor was it an express indication that unbroken 
chains of financial relationships where the compensation arrangement 
closest to a physician (or immediate family member of a physician) is 
for the use of premises or equipment pose no risk of program or patient 
abuse. We are finalizing our proposal to address the inadvertent 
omission of arrangements involving unit of service-based payment for 
the lease of office space or equipment or for the use of premises or 
equipment from those unbroken chains of financial relationships that 
constitute indirect compensation arrangements under Sec.  
411.354(c)(2). However, as explained in the responses to comments 
below, we are finalizing revisions to address this omission in a more 
precise and targeted manner.
    With respect to commenters' concerns about the potential burden of 
learning how to apply new regulations, we note that, for all unbroken 
chains of financial relationships where the compensation arrangement 
closest to a physician (or immediate family member of a physician) is 
for the lease of office space or equipment or for the use of premises 
or equipment, the analysis under the physician self-referral law will 
revert to the two-step analysis in place since our Phase I regulations 
were finalized in 2004. Once a determination is made that an indirect 
compensation arrangement exists, the requirements of an applicable 
exception must be satisfied. If the parties to the indirect 
compensation arrangement rely on the exception for indirect 
compensation arrangements at Sec.  411.357(p), the compensation for 
each unit of office space, equipment, or premises may not be determined 
in any manner that takes into account the volume or value of the 
physician's referrals to or other business generated for the entity. 
The special rules at Sec.  411.354(d)(5) and (6) regarding when 
compensation takes into account the volume or value of a physician's 
referrals to or other business generated for an entity were finalized 
in the MCR final rule (85 FR 77535 through 77547). A compensation 
formula under which a physician (or immediate family member) receives a 
lease payment or a ``use'' fee--either as the direct lessor or licensor 
or through an ownership interest in a lessor or licensor--each time the 
office space, equipment, or premises is used to provide a service to a 
patient referred by the physician to the lessee or licensee would not 
satisfy this requirement, because the formula used to determine the 
compensation would include the physician's referrals to and other 
business generated for the entity as a variable, resulting in an 
increase in the physician's (or immediate family member's) compensation 
that positively correlates with the number or value of the physician's 
referrals to and other business generated for the entity. In addition, 
the exception for indirect compensation arrangements expressly requires 
that the compensation for the lease of office space or equipment may 
not be determined using a formula based on: (1) A percentage of the 
revenue raised, earned, billed, collected, or otherwise attributable to 
the services performed or business generated in the office space or to 
the services performed on or business generated through the use of the 
equipment; or (2) per-unit of service rental charges, to the extent 
that such charges reflect services provided to patients referred by the 
lessor to the lessee. This requirement has been in place since October 
1, 2009, and therefore, it is not a ``new'' policy or analysis that 
will result in burden to parties designing or reviewing their indirect 
compensation arrangements for compliance with the physician self-
referral law.
    Comment: Although the vast majority of commenters that addressed 
our proposal to revise the conditions under which an indirect 
compensation arrangement exists supported a prohibition on per-click 
payments for the lease of office space or equipment and the use of 
premises or equipment, many of these commenters asserted that our 
proposed revisions to Sec.  411.354(c)(2), if finalized, would be 
overbroad in application. Specifically, commenters objected to proposed 
Sec.  411.354(c)(2)(ii)(A)(4), which would have treated any unbroken 
chain of financial relationships in which the physician (or immediate 
family member) receives aggregate compensation that varies with the 
volume or value of referrals or other business generated by the 
physician for the entity as an indirect compensation arrangement that 
must satisfy the requirements of an applicable exception if the 
individual unit of compensation is payment for anything other than 
services personally performed by the physician (or immediate family 
member). All of these commenters urged CMS to take a more targeted 
approach to its policy concerns in this final rule.
    Some commenters noted that, if finalized, the regulations would 
prohibit all arrangements for services furnished ``under arrangement'' 
to a hospital or other entity--which are typically purchased on a per-
service basis--where the entire service is not performed personally by 
the physician who receives the unit-based compensation, including 
service arrangements that historically did not constitute indirect 
compensation arrangements or, if they did, satisfied the requirements 
of the exception for indirect compensation arrangements at Sec.  
411.357(p). Commenters explained that, as generally structured, in an 
arrangement involving services furnished ``under arrangement'' to a 
hospital (or other entity), a physician (or immediate family member) 
receives per-unit compensation for a complete service when the 
physician generated the referral of designated health services or 
generated other business billed by the entity (and when he or she did 
not). One of the commenters further explained that, under the current 
regulations at Sec.  411.354(c)(2), such arrangements would not 
constitute indirect compensation arrangements, provided that the amount 
of compensation that the physician (or immediate family member) 
receives per individual unit of service is fair market value and does 
not positively correlate with the number or value of the physician's 
referrals to or other business generated for the entity. Further, 
according to this commenter, under the regulations as they existed 
prior to the MCR final rule, although such unbroken chains of financial 
relationships constituted indirect compensation arrangements, the 
special rules at Sec.  411.354(d)(2) and (3) could be applied, and 
properly structured per-service payments were not considered to take 
into account the volume or value of the physician's referrals or other

[[Page 65350]]

business generated by the physician in violation of Sec.  
411.357(p)(1)(i). The commenter asserted that, if CMS finalizes this 
proposal, because Sec.  411.354(d)(2) and (3) are no longer applicable 
to an analysis of whether compensation takes into account the volume or 
value of referrals or other business generated (the ``volume or value 
standards''), compensation under the typical ``under arrangements'' 
service arrangement would violate the volume or value standards at 
Sec.  411.357(p)(1)(i).
    Other commenters highlighted that the application of the proposal 
to certain lithotripsy services would conflict with longstanding CMS 
policy related to unit-based compensation for such services when 
furnished as a full package of services (as opposed to a lease of 
equipment and a technician). One commenter posited that, given that CMS 
focused on ensuring the continuation of the prohibition on per-click 
payments for the lease of office space or equipment and the use of 
premises or equipment as support for the proposal, the broad 
application of the regulations, if finalized, must be an inadvertent 
oversight or mistake.
    Response: Our proposal to revise Sec.  411.354(c)(2) was intended 
to support policies finalized in the MCR final rule that were made in 
the context of assessing the risk of program and patient abuse 
associated with services personally performed by a physician. However, 
we agree that the regulation at proposed Sec.  411.354(c)(2)(ii)(A)(4) 
would have resulted in unintended limitations on unbroken chains of 
financial relationships that historically constituted indirect 
compensation arrangements but satisfied all requirements of an 
applicable exception and, therefore, were not considered to pose a risk 
of program or patient abuse. The commenters are correct that, under the 
MCR final rule, certain unbroken chains of financial relationships no 
longer constitute indirect compensation arrangements and, thus, are 
outside the reach of the physician self-referral law. Our proposal to 
revise Sec.  411.354(c)(2) was not based on a new review of these 
unbroken chains and a determination that they now pose a risk of 
program or patient abuse that had not historically existed. As noted in 
this section III.P., our proposal was intended to reinstate the 
prohibition on certain per-click compensation formulas in arrangements 
for the lease of office space or equipment that was inadvertently 
omitted in the MCR final rule changes and to ensure the application of 
this policy to arrangements for the use of premises and equipment. 
Accordingly, we are persuaded that a narrow, more targeted approach is 
appropriate. Under final Sec.  411.354(c)(2)(ii)(A)(2)(iv), an indirect 
compensation arrangement exists if the amount of compensation that the 
physician (or immediate family member) receives per individual unit is 
payment for the lease of office space or equipment or for the use of 
premises or equipment, and all other conditions at Sec.  411.354(c)(2) 
exist. As explained in the CY 2016 PFS final rule, an arrangement is 
for the lease of office space or equipment where dominion and control 
over the office space or equipment is transferred from the lessor to 
the lessee (80 FR 71325). In addition, an arrangement that grants a 
party permission to use the grantor's premises and equipment is a 
``use'' or ``license'' arrangement. In contrast, an arrangement for the 
provision and purchase of a complete service (or a package of services) 
that includes all the personnel, supplies, office (or other) space, and 
equipment necessary to provide the service (or the package of services) 
but does not transfer dominion and control over the office space or 
equipment from the provider of the service--for example, a service 
provided ``under arrangements'' to a hospital that is performed 
entirely by a physician's practice or a joint venture in which the 
physician is a partner--is not an arrangement for the lease of office 
space or equipment, nor is it a ``use'' arrangement where the licensee 
uses the premises and equipment to perform services. This is true even 
though office space or equipment are necessary components of the 
complete service (or package of services) (see 81 FR 80534).
    Comment: Several commenters requested clarification regarding when 
a service is considered to be personally performed by a physician (or 
immediate family member) as described at proposed Sec.  
411.354(c)(2)(ii)(B)(3), which states that services that are personally 
performed by a physician (or immediate family member) do not include 
services that are performed by any person other than the physician (or 
immediate family member), including, but not limited to, the 
physician's (or immediate family member's) employees, independent 
contractors, group practice members, or persons supervised by the 
physician (or the immediate family member). One commenter expressed 
appreciation for the proposed codification of CMS' policy, noting that 
the guidance would be helpful in properly allocating productivity 
credit to physicians in certain settings. Some commenters, in virtually 
identical statements, suggested that we should consider services to be 
personally performed by a physician, regardless of who actually 
furnishes them, as long as they are billed using a billing number 
assigned to the physician, including services furnished by another 
individual but billed as services ``incident to'' the physician's 
service. Many of these commenters urged CMS not to confirm its 
interpretation of when services are personally performed by a physician 
(or immediate family member) for purposes of the physician self-
referral law, arguing that proposed Sec.  411.354(c)(2)(ii)(B)(3) is 
inconsistent with Medicare claim submission rules that allow a 
physician to bill for the services of employees or contractors that are 
furnished incident to the physician's professional services. Another 
commenter suggested that, if CMS finalizes a narrower approach to the 
analysis of unbroken chains of financial relationships involving the 
lease or use of office space, equipment, or premises, there would be no 
need to clarify what it means to personally perform a service for 
purposes of the physician self-referral law.
    Response: As discussed in the response to other comments, we are 
not finalizing the policy at Sec.  411.354(c)(2)(ii)(A)(4). Therefore, 
we need not and are not finalizing the regulation at proposed Sec.  
411.354(c)(2)(ii)(B)(3). However, it appears that commenters discussing 
incident to billing may be conflating Medicare billing conventions with 
physician self-referral policy, and we believe that clarification is 
warranted. For purposes of the physician self-referral law, as stated 
in the definition of ``referral'' at Sec.  411.351, a designated health 
service is not personally performed by the referring physician if it is 
performed or provided by any other person, including, but not limited 
to, the referring physician's employees, independent contractors, or 
group practice members. This includes designated health services 
furnished incident to the referring physician's professional services. 
(See 66 FR 871 through 872 and 69 FR 16063.) To be clear, it is our 
longstanding policy that, for purposes of the physician self-referral 
law, an item or service is not personally performed by a physician if 
it is performed or provided by any other person, including, but not 
limited to, the referring physician's employees, independent 
contractors, or group practice members.
    Comment: One commenter requested confirmation whether compensation 
under certain arrangements would impermissibly take into account the 
volume or value of referrals or other

[[Page 65351]]

business generated if the arrangements qualify as ``indirect 
compensation arrangements'' under our proposal to treat any unbroken 
chain of financial relationships in which the physician (or immediate 
family member) receives aggregate compensation that varies with the 
volume or value of referrals or other business generated by the 
physician for the entity as an indirect compensation arrangement that 
must satisfy the requirements of an applicable exception if the 
individual unit of compensation is payment for anything other than 
services personally performed by the physician (or immediate family 
member). The commenter presented three distinct, but similar, 
scenarios. In all three scenarios, a hospital has an arrangement with a 
physician organization for the provision of the personal services of 
the physicians in the physician organization. There are no employed or 
independent contractor physicians in the physician organization. The 
commenter stated that the compensation under the arrangement is a fair 
market value, fixed dollar amount per wRVU personally performed by the 
physicians or NPPs.
    In the first scenario presented by the commenter, the arrangement 
with the physician organization also covers the provision of the 
personal services of the NPPs in the physician organization. The 
hospital pays the physician organization directly for each wRVU 
performed by the NPPs (as well as the physicians) in the physician 
organization. The commenter stated that the NPPs only perform services 
that they order in the exercise of their independent clinical judgment. 
Patients are not referred to the NPPs by the physicians in the 
physician organization. The commenter asserted that the services of the 
NPPs in this scenario do not result from ``referrals'' by the 
physicians in the physician organization and are not ``other business 
generated'' by such physicians.
    In the second and third scenarios presented by the commenter, the 
hospital also enters into an arrangement directly with each of the NPPs 
for their personally performed services, some of which are provided to 
patients referred to the NPPs by the physicians in the physician 
organization. The commenter stated that the compensation under each of 
these arrangements is a fair market value, fixed dollar amount per wRVU 
personally performed by the NPP. The hospital accepts reassignment of 
each physician's and NPP's right to bill and receive payment from 
Medicare and other payors. In the first of these scenarios, the 
physicians in the physician organization refer to the NPPs all the 
services that the NPPs then personally perform. The physician 
organization enters into a payment-to-bank arrangement with each NPP 
under which the hospital's direct payment to the NPP is deposited into 
a bank account belonging to the NPP and then, under a revocable 
agreement between the NPP and the bank, is swept into a bank account 
belonging to the physician organization. In the second of these 
scenarios, the physicians in the physician organization refer to the 
NPPs all the services that the NPPs then personally perform. However, 
the hospital makes payment directly to the physician organization as 
``agent'' for the NPPs. According to the commenter, the physician 
organization receives payment from the hospital on behalf of the NPPs, 
but not in its own right, for the services personally performed by the 
NPPs.
    Response: In all the scenarios presented by the commenter, the 
physicians would stand in the shoes of the physician organization under 
the regulations at Sec.  411.354(c)(1)(ii); therefore, the physicians 
would be deemed to have the same compensation arrangements with the 
hospital (and on the same terms) as the physician organization. In the 
scenarios presented by the commenter, each physician would be deemed to 
directly receive payment from the hospital for services that the 
physician personally performs, as well as for services that are 
performed by someone other than that physician (either another 
physician in the physician organization or an NPP in the physician 
organization). Such compensation arrangements would implicate the 
physician self-referral law; however, there would not be an unbroken 
chain of two or more financial relationships between the hospital and 
each physician, and the condition set forth at Sec.  411.354(c)(2)(i) 
would not be met. As a result, there would not be an indirect 
compensation arrangement between the hospital and any of the physicians 
in the physician organization. Even if the physicians did not stand in 
the shoes of the physician organization, as described previously, we 
are not finalizing our proposal to treat all unbroken chains of 
financial relationships in which the physician (or immediate family 
member) receives aggregate compensation that varies with the volume or 
value of referrals or other business generated by the physician for the 
entity as an indirect compensation if the individual unit of 
compensation is payment for anything other than services personally 
performed by the physician (or immediate family member). We note that 
the commenter's inquiry relates to and is within the scope of our 
proposal to include as indirect compensation arrangements certain 
unbroken chains of financial relationships where the individual unit of 
compensation is payment for anything other than services personally 
performed by the physician (or immediate family member). However, 
because we are not finalizing that proposal, the commenter's inquiry, 
on its face, is moot. An analysis of the application of the regulations 
at Sec.  411.354(d)(5) to the scenarios presented by the commenter is 
outside the scope of this rulemaking.
    Comment: A few commenters stated that, following the MCR final 
rule, some stakeholders have been uncertain how to identify the 
individual unit of compensation to which the provisions of current 
Sec.  411.354(c)(2)(ii)(A)(1) through (3) apply. These and other 
commenters generally supported finalizing the regulation at proposed 
Sec.  411.354(c)(2)(ii)(B)(2), which specifies the individual units of 
compensation to which to apply the regulations that determine when an 
indirect compensation arrangement exists.
    Response: As we explained in the proposed rule, it is our position 
that all compensation essentially is unit-based compensation. The 
underlying unit may be a discrete item, a unit of service, a unit of 
time, or a unit that results from combining different types of units 
into a single unit used to calculate the compensation. At final Sec.  
411.354(c)(2)(ii)(B), we are finalizing with revisions our proposal to 
specify the individual units of compensation to which to apply the 
regulations that determine when an indirect compensation arrangement 
exists. The revisions are intended to further clarify and simplify the 
application of the regulations at Sec.  411.354(c)(2) that establish 
the conditions under which an indirect compensation arrangement exists. 
Specifically, under final Sec.  411.354(c)(2)(ii)(B), the individual 
unit of compensation is the item, where the physician (or immediate 
family member) is compensated solely per item provided; the service, 
where the physician (or immediate family member) is compensated solely 
per service provided, including arrangements where the ``service'' 
provided by the physician (or immediate family member) includes both 
items and services, such as ``under arrangement'' service arrangements 
where both items and services are included in the complete service (or 
package of services) provided to the purchaser; and time, in all other

[[Page 65352]]

circumstances, including arrangements where the physician (or immediate 
family member) receives compensation for each item provided or unit of 
service performed (or both) in addition to compensation for each unit 
of time worked. The final regulations effectuate our policy, as stated 
in the proposed rule, that ``hybrid'' compensation--that is 
compensation that is comprised of payments for both time-based units 
and service-based or item-based units (or both)--is appropriately 
analyzed by converting it to compensation for a unit of time. In other 
words, the compensation paid to the physician (or immediate family 
member) must be totaled over a period of time, which period would be 
considered the individual ``unit'' of compensation for purposes of 
applying Sec.  411.354(c)(2)(ii). (See 86 FR 39323 through 39324.)
    Comment: One commenter claimed that there is confusion in the 
industry regarding the interpretation and application of the provisions 
at Sec.  411.354(c)(2)(ii)(A)(2) and (3), as finalized in the MCR final 
rule and as proposed for modification in the CY 2022 PFS proposed rule. 
The commenter interpreted Sec.  411.354(c)(2)(ii)(A)(2) and (3) to be a 
test of whether the amount of compensation per individual unit 
increases or decreases in a manner that positively correlates with 
referrals or other business generated by a physician. To illustrate, 
the commenter offered the example of a tiered compensation structure 
for physician compensation. In the commenter's example, the physician 
is paid a rate of $15 for the first 100 units of service provided and 
$20 per unit of service thereafter. The commenter concluded that this 
compensation structure would meet the conditions for the existence of 
an indirect compensation arrangement under Sec.  
411.354(c)(2)(ii)(A)(2) and (3), because the amount of compensation per 
individual unit of service could increase from $15 to $20 as the number 
of referrals or amount of other business generated increases. The 
commenter asserted that, in contrast, many stakeholders incorrectly 
believe that the conditions at Sec.  411.354(c)(2)(ii)(A)(2) and (3) 
are met if the physician's (or immediate family member's) aggregate 
compensation increases or decreases in a manner that positively 
correlates with referrals or other business generated by the physician, 
even if the amount of compensation per individual unit remains 
constant. The commenter requested that CMS confirm that Sec.  
411.354(c)(2)(ii)(A)(2) and (3) address variations in the unit of 
compensation itself, not variation in the aggregate compensation 
received by the physician (or immediate family member).
    Response: The commenter is correct that the focus of Sec.  
411.354(c)(2)(ii)(A)(2) and (3), as finalized in the MCR final rule and 
proposed for modification in the CY 2022 PFS proposed rule, is 
variation in the amount of compensation per individual unit itself, not 
the aggregate compensation received by the physician (or immediate 
family member). To avoid possible stakeholder confusion, in this final 
rule we are revising and renumbering the provisions in Sec.  
411.354(c)(2)(ii)(A) to explicitly distinguish between the conditions 
that must be met for aggregate compensation, on the one hand, and the 
conditions that must be met for the individual unit of compensation, on 
the other, in order for an indirect compensation arrangement to exist. 
We are making corresponding clarifying changes to Sec.  
411.354(c)(2)(ii)(C).
    Under final Sec.  411.354(c)(2)(ii)(A)(1), for an indirect 
compensation arrangement to exist, the referring physician (or 
immediate family member) must receive aggregate compensation from the 
person or entity in the chain with which the physician (or immediate 
family member) has a direct financial relationship that varies with the 
volume or value of referrals or other business generated by the 
referring physician for the entity furnishing the designated health 
services. When a physician is paid on a per unit of service or time 
basis, the physician's aggregate compensation will increase as the 
physician performs more services or completes more units of time. And, 
where the services performed by the physician correlate to designated 
health services referred or other business generated by the physician 
for the entity, the aggregate compensation received by the physician 
varies with the volume or value of referrals or other business 
generated by the physician for the entity. Under these circumstances, 
the condition at final Sec.  411.354(c)(2)(ii)(A)(1) is met.
    In addition to the test for aggregate compensation, one of the 
conditions in Sec.  411.354(c)(2)(ii)(A)(2) for the individual unit of 
compensation received by the physician (or immediate family member) 
must also be met for an indirect compensation arrangement to exist. 
Final Sec.  411.354(c)(2)(ii)(A)(2)(ii) and (iii) pertain to 
variability in the amount of compensation per individual unit relating 
to the volume or value of a physician's referrals or other business 
generated, respectively. In response to the comment requesting 
clarification of the application of these provisions, we are revising 
and renumbering the conditions that relate to the individual unit of 
compensation in Sec.  411.354(c)(2)(ii)(A)(2) to clarify the 
application of these conditions generally and to illustrate how the 
regulations will apply in the case of tiered compensation as described 
by the commenter.
    To illustrate, assume that the conditions for an indirect 
compensation arrangement between a physician and a hospital at 
Sec. Sec.  411.354(c)(2)(i), 411.354(c)(2)(ii)(A)(1), and 
411.354(c)(2)(iii) are met. In order for an indirect compensation 
arrangement to exist, one of the conditions for the individual unit of 
compensation in Sec.  411.354(c)(2)(ii)(A)(2) must also be met. In the 
commenter's example of tiered compensation, the individual unit of 
compensation received by the physician could increase from $15 to $20 
per unit if the physician provides over 100 units of service to the 
entity. We assume for purposes of this example that the physician's 
services are typically correlated with designated health services or 
other business generated for the hospital, and further that both $15 
and $20 per unit of service are within the range of fair market value 
for the services actually provided. Because the amount of compensation 
per individual unit of service could increase from $15 to $20 as the 
number or value of the physician's referrals to the entity increase or 
the amount or value of the other business generated by the physician 
for the entity increases, the conditions for an indirect compensation 
arrangement at final Sec.  411.354(c)(2)(ii)(A)(2)(ii) and (iii) are 
met. Therefore, the unbroken chain of financial relationships between 
the physician and the hospital would constitute an indirect 
compensation arrangement under Sec.  411.354(c)(2). Importantly, at 
this step in the analysis, it does not matter if the physician is being 
paid for his or her personally performed services or if the tiered 
compensation formula does not include designated health services or 
other business generated as a variable. Although these are important 
factors in determining compliance with certain exceptions, including 
the exception for indirect compensation arrangements at Sec.  
411.357(p), the analysis under final Sec.  411.354(c)(2)(ii)(A)(2)(ii) 
and (iii) focuses solely on whether the individual unit of compensation 
could increase as referrals or other business generated increase (or 
could decrease as referrals or other business generated decrease). 
Lastly, even if the physician

[[Page 65353]]

never performed the required number of services to trigger the increase 
from $15 to $20 per service, because the amount of compensation per 
individual unit of service could increase under the tiered compensation 
formula, the conditions for an indirect compensation arrangement at 
final Sec.  411.354(c)(2)(ii)(A)(2)(ii) and (iii) are met in this 
illustration.
    In general, we believe that tiered compensation models warrant 
additional scrutiny under the physician self-referral law when 
structured in a way that the amount of compensation per individual unit 
could increase as the number or value of the physician's referrals or 
the amount or value of other business generated by the physician 
increases. We are equally concerned with tiered compensation models 
where the amount of compensation per individual unit could decrease as 
the number or value of the physician's referrals decreases or the 
amount or value of other business generated by the physician decreases 
(for example, an arrangement under which a physician is paid $35 per 
wRVU if the physician furnishes 500 wRVUs during the month, but only 
$30 per wRVU if the physician does not reach the targeted 500 wRVUs). 
We have modified the conditions for the existence of an indirect 
compensation arrangement at Sec.  411.354(c)(2) to ensure that an 
unbroken chain of financial relationships involving a tiered 
compensation structure under the compensation arrangement closest to 
the physician (or immediate family member) is considered an indirect 
compensation arrangement. When these conditions are met, the 
compensation arrangement or the individual referrals of designated 
health services must satisfy the requirements of an applicable 
exception to the physician self-referral law. If the compensation 
arrangement to which the physician is a direct (or deemed direct) party 
is not a value-based arrangement and the entity is not an MCO or IPO, 
the only available exception in Sec.  411.357 is the exception for 
indirect compensation arrangements at Sec.  411.357(p). Among other 
things, the exception at Sec.  411.357(p) requires that the arrangement 
is set out in writing, thus ensuring greater transparency, and that the 
aggregate compensation received by the physician (or immediate family 
member) is fair market value for items and services actually provided. 
In addition, the exception requires that the compensation received by 
the physician (or immediate family member) is not determined in any 
manner that takes into account the volume or value of referrals or 
other business generated by the physician. The special rules at Sec.  
411.354(d)(5) and (6) are applied for purposes of determining 
satisfaction of this requirement. In applying the special rules at 
Sec.  411.354(d)(5) and (6) to tiered compensation under an indirect 
compensation arrangement, the focus of the analysis is the formula used 
in determining the amount of compensation that the physician (or 
immediate family member) receives per individual unit--that is, per 
item, per service, or per unit of time. Provided that the formula used 
to calculate the amount of compensation to the physician (or immediate 
family member) per individual unit (that is, the amount of compensation 
per item, per service, or per unit of time) does not include as a 
variable the physician's referrals to or other business generated for 
the entity with which the physician (or immediate family member) has 
the indirect compensation arrangement, the compensation received by the 
physician (or immediately family member) would not be determined in a 
manner that takes into account the volume or value of referrals or 
other business generated by the physician for the entity. We note that 
the application of Sec.  411.354(d)(5) and (6) with respect tiered 
compensation arrangements is the same for both direct compensation 
arrangements and indirect compensation arrangements.
    Comment: A few commenters urged CMS to delay the effective date of 
any revisions to the regulations addressing when an indirect 
compensation arrangement exists. These commenters asserted that 
affected parties would need time to identify and revise existing 
arrangements that would again implicate the physician self-referral 
law, but would not satisfy the requirements of an applicable exception 
to the law. Other commenters urged CMS not to delay the effective date 
of any final regulations that correct the inadvertent omission of the 
prohibition on per-click payments for the lease of office space or 
equipment and the use of premises or equipment in indirect compensation 
arrangements due to the important program integrity concerns at issue. 
These commenters also urged CMS not to ``grandfather'' any arrangements 
that were entered into after the effective date of the MCR final rule, 
noting that parties that entered into arrangements involving per-click 
payments for the lease of office space or equipment (or for the use of 
premises or equipment) after the effective date of the MCR final rule 
did so with full knowledge of CMS' longstanding concerns regarding such 
arrangements.
    Response: We decline to delay the effective date of the regulations 
we are finalizing in this final rule, nor are we ``grandfathering'' 
arrangements involving per-click payments for the lease of office space 
or equipment or for the use of premises or equipment that were entered 
into after the effective date of the MCR final rule. We expect that the 
number of affected lease arrangements that will again implicate the 
physician self-referral law is limited, and parties to such 
arrangements have over a decade of experience in applying the 
requirement at Sec.  411.357(p)(1)(ii) that prohibits compensation for 
the lease of office space or equipment that is determined using a 
formula based on per-unit of service rental charges, to the extent such 
charges reflect services provided to patients referred by the lessor to 
the lessee. We remind stakeholders that this requirement applies to all 
services, whether or not they are designated health services, that are 
provided to patients referred by the lessor to the lessee. The term 
``referral'' has its general meaning and not the meaning set forth at 
Sec.  411.351. For a more detailed explanation of this requirement, we 
refer readers to the FY 2009 IPPS final rule (73 FR 48713 through 
48721) and the CY 2017 PFS final rule (81 FR 80524 through 80534). We 
also expect that the number of affected unbroken chains of financial 
relationships that involve arrangements for the use of premises or 
equipment that will again implicate the physician self-referral law is 
similarly limited.
3. Exception for Preventive Screening Tests, Immunizations, and 
Vaccines (Sec.  411.355(h))
    As a general matter, vaccines fall within the definition of 
``outpatient prescription drugs'' at Sec.  411.351, and therefore, are 
considered designated health services for purposes of the physician 
self-referral law. Because the Federal Government purchased the initial 
supply of COVID-19 vaccines, Medicare does not make payment for COVID-
19 vaccines at this time,\147\ and COVID-19 vaccines do not fall within 
the definition of ``designated health services'' at Sec.  411.351. 
However, should COVID-19 vaccines become payable by Medicare, unless 
the requirements of an applicable exception to the physician self-
referral law are satisfied, the physician self-referral law's 
prohibitions under section 1877(a)(1) of the Act and Sec.  411.353(a) 
and (b) will apply to the

[[Page 65354]]

referral and billing of COVID-19 vaccines.
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    \147\ See https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies.
---------------------------------------------------------------------------

    In Phase I, using the Secretary's authority at section 1877(b)(4) 
of the Act to create additional exceptions that do not pose a risk of 
program or patient abuse, we finalized an exception at Sec.  411.355(h) 
that excludes from the physician self-referral law's referral and 
billing prohibitions certain preventive screening tests, immunizations, 
and vaccines covered under Medicare (66 FR 939). As finalized in Phase 
I, in addition to requirements related to compliance with the Federal 
anti-kickback statute and Federal and State laws and regulations 
related to billing and claims submission, the exception at Sec.  
411.355(h) required that the preventive screening test, immunization, 
or vaccine is subject to CMS-mandated frequency limits, reimbursed by 
Medicare based on a fee schedule, and listed on the CMS website and in 
annual PFS Updates. In Phase II, in recognition that some of the 
vaccines eligible for the exception may be paid by Medicare using 
different reimbursement methods, we removed the requirement that the 
preventive screening test, immunization, or vaccine is reimbursed based 
on a fee schedule (69 FR 16116). In the MCR final rule, as part of a 
broader effort to decouple the physician self-referral law from the 
Federal anti-kickback statute and Federal and State laws or regulations 
governing billing or claims submission, we removed the requirement at 
former Sec.  411.355(h)(2) that the arrangement does not violate the 
Federal anti-kickback statute, as well as the requirement at former 
Sec.  411.355(h)(3) that the arrangement does not violate any Federal 
or State law or regulation governing billing or claims submission (85 
FR 77567).
    Services to which the exception at Sec.  411.355(h) is applicable 
remain designated health services for purposes of the physician self-
referral law; however, referrals may be made and claims submitted for 
such services if all requirements of the exception are satisfied (69 FR 
16100). In the CY 2021 PFS final rule, we added COVID-19 vaccines to 
the list of immunization and vaccine codes to which the exception at 
Sec.  411.355(h) is applicable (85 FR 84954 through 85955). We did so 
to ensure that the physician self-referral law will not impede the 
availability of COVID-19 vaccines for Medicare and other patients if 
they become payable by Medicare (85 FR 84955).
    Under current Sec.  411.355(h)(1), a preventive screening test, 
immunization, or vaccine must be subject to CMS-mandated frequency 
limits, among other requirements. Frequency limits determine the 
maximum number of times that Medicare will pay for a service for a 
particular beneficiary during an established period, often a calendar 
year or 12-month period. CMS-mandated frequency limits also serve to 
minimize the risk of program or patient abuse due to a physician's 
financial self-interest, because Medicare will not pay for additional 
services referred and furnished in excess of the frequency limitation. 
In Phase I, we stated our belief that, under the terms of the exception 
at Sec.  411.355(h) as finalized in Phase I--which included the 
requirement that the service is subject to CMS-mandated frequency 
limits--the risk of abuse is extremely low. We also stated that the 
exclusion of certain preventive screening tests, immunizations, and 
vaccines from the reach of the physician self-referral law is 
consistent with the statutory language and structure and the expressed 
Congressional intent to provide preventive care to Medicare 
beneficiaries (66 FR 939).
    The United States continues to respond to the outbreak of COVID-19 
caused by the severe acute respiratory syndrome coronavirus 2 (SARS-
CoV-2). At this time, we have not mandated frequency limits for the 
COVID-19 vaccines identified on the List of CPT/HCPCS Codes (Code List) 
to which the exception at Sec.  411.355(h) is applicable and we are 
uncertain whether or, if so, when CMS may mandate frequency limits for 
COVID-19 vaccines. Thus, although COVID-19 vaccines are identified on 
the Code List as codes to which the exception at Sec.  411.355(h) is 
applicable, they could not satisfy the requirement at current Sec.  
411.355(h)(1) that the preventive screening test, immunization, or 
vaccine is subject to CMS-mandated frequency limits. We are concerned 
that the current absence of CMS-mandated frequency limits on the 
available COVID-19 vaccines could impede the availability of critically 
important COVID-19 vaccines for Medicare and other patients, as 
physician referrals for COVID-19 vaccines would be prohibited unless 
another exception to the physician self-referral law is applicable and 
all its requirements are satisfied. Therefore, we proposed to permit 
the use of the exception at Sec.  411.355(h) for COVID-19 vaccines even 
when they are not subject to CMS-mandated frequency limits, provided 
that all other requirements of the exception are satisfied. 
Specifically, we proposed to revise and renumber the regulation at 
Sec.  411.355(h). We are finalizing the regulation as proposed. Revised 
Sec.  411.355(h)(1) includes the conditions that must be met to avoid 
the physician self-referral law's referral and billing prohibitions. 
The requirement at current Sec.  411.355(h)(4) that the preventive 
screening test or vaccine is listed on the Code List as a code to which 
the exception at Sec.  411.355(h) is available will be renumbered as 
Sec.  411.355(h)(1)(i); the requirement at current Sec.  411.355(h)(4) 
that the preventive screening test or vaccine is covered by Medicare 
will be renumbered as Sec.  411.355(h)(1)(ii); and the requirement at 
current Sec.  411.355(h)(1) that the preventive screening test or 
vaccine is subject to a CMS-mandated frequency limit will be renumbered 
as Sec.  411.355(h)(1)(iii). As finalized, Sec.  411.355(h)(2) states 
that the requirement at Sec.  411.355(h)(1)(iii) does not apply to a 
COVID-19 vaccine code during such period that the vaccine is not 
subject to a CMS-mandated frequency limit. In light of the impact of 
the COVID-19 pandemic on the United States and the vital need to 
protect beneficiaries (and others) from the SARS-CoV-2 virus, we do not 
believe that making the exception at Sec.  411.355(h) available for 
COVID-19 vaccines to which no CMS-mandated frequency limits apply poses 
a risk of program or patient abuse.
    We solicited comment on our approach to this exception and its 
applicability to COVID-19 vaccines, including whether we should limit 
relief from the requirement at Sec.  411.355(h)(1)(iii) to the period 
during which the current PHE is in effect, until such time as CMS-
mandated frequency limits apply for COVID-19 vaccines, or some other 
period of time. Based on the comments, we are finalizing our proposal 
to permit the use of the exception at Sec.  411.355(h) for COVID-19 
vaccines during such period as the vaccines are not subject to CMS-
mandated frequency limits, provided that all other requirements of the 
exception are satisfied. As finalized, the availability of Sec.  
411.355(h)(1)(iii) for COVID-19 vaccines is not limited to the period 
during which the current PHE is in effect.
    We note that, as explained in section II.J. of this final rule, 
monoclonal antibody products used to treat COVID-19 are currently 
covered and paid for under the COVID-19 vaccine benefit in section 
1861(s)(10) of the Act. Thus, under final Sec.  411.355(h)(2), the 
requirement pertaining to CMS-mandated frequency limits at final Sec.  
411.355(h)(1)(iii) does not apply to monoclonal antibody products used 
to treat COVID-19 during such period as

[[Page 65355]]

the products are paid for under the COVID-19 vaccine benefit in section 
1861(s)(10) of the Act and are not subject to a CMS-mandated frequency 
limit.
    We also alternatively proposed to remove the CMS-mandated frequency 
limit requirement for all vaccines. We solicited comment on whether it 
would then be necessary to include alternative program integrity 
requirements in the exception at Sec.  411.355(h) if we were to do so. 
We stated that we were interested in comments regarding whether 
physicians are likely to order vaccines more frequently than 
recommended by the Department and any other organization the Department 
identifies as an authority on this matter. Based on our review of the 
comments related to this alternative proposal, we are not finalizing 
the alternative proposal.
    Finally, for clarity and consistency, we proposed to revise the 
terminology used in the exception at Sec.  411.355(h). Specifically, we 
proposed to remove the terms ``immunization'' and ``immunizations'' 
throughout Sec.  411.355(h) and the headers used in the Code List. In 
the proposed rule, we noted that the Centers for Disease Control and 
Prevention (CDC) defines immunization as a process by which a person 
becomes protected against a disease through vaccination. The term 
``immunization'' is often used interchangeably with vaccination or 
inoculation. The CDC defines the term ``vaccine'' as a product that 
stimulates a person's immune system to produce immunity to a specific 
disease, protecting the person from that disease.\148\ All the codes 
currently on the Code List to which the exception at Sec.  411.355(h) 
is applicable have a descriptor containing ``vaccine'' or a derivative 
of ``vaccine.''
---------------------------------------------------------------------------

    \148\ https://www.cdc.gov/vaccines/vac-gen/imz-basics.htm.
---------------------------------------------------------------------------

    Vaccines fall within the definition of ``outpatient prescription 
drugs'' at Sec.  411.351, and therefore, are considered designated 
health services for purposes of the physician self-referral law. As 
defined by the CDC, an immunization is not an item or service that is a 
``designated health service'' (as defined at Sec.  411.351) to which 
the physician self-referral law applies. We believe that ``vaccine'' is 
the appropriate term to use in Sec.  411.355(h) and in the headers in 
the Code List. Although we are not aware that including both terms in 
Sec.  411.355(h) and the Code List has caused stakeholder confusion to 
date, we proposed to improve the accuracy of the terminology at this 
time to prevent any possible confusion in the future. We are finalizing 
our proposal to remove the terms ``immunization'' and ``immunizations'' 
throughout Sec.  411.355(h) and the headers used in the Code List. The 
revisions to the title and text of Sec.  411.355(h) that we are 
finalizing in this final rule do not affect whether a code is a 
designated health service for purposes of the physician self-referral 
law.
    We received the following public comments regarding our proposals, 
and our responses follow.
    Comment: Several commenters supported our proposal to permit the 
use of the exception at Sec.  411.355(h) for COVID-19 vaccines during 
such period as the vaccines are not subject to CMS-mandated frequency 
limits, provided that all other requirements of the exception are 
satisfied. No commenters opposed the proposal. Commenters noted that 
removing the CMS-mandated frequency requirement for COVID-19 vaccines 
would reduce barriers to vaccine delivery and ensure that the physician 
self-referral law will not impede vaccine availability for 
beneficiaries. According to one commenter, if finalized, the proposal 
would allow physicians to make referrals for vaccines without fear of 
violating the physician self-referral law and would likely increase 
access to vaccines. Another commenter highlighted the continuing impact 
of the COVID-19 PHE on practices, physicians, and patients. The 
commenter noted that ensuring life-saving vaccines are available to 
Medicare beneficiaries is critical, particularly as new virus variants 
emerge and booster vaccinations are potentially required for many 
patients. Several commenters opposed limiting the suspension of the 
requirement for a frequency mandate to the period of the PHE. 
Commenters generally agreed with CMS that the proposal, if finalized, 
would not pose a risk of program or patient abuse.
    Response: In light of the impact of the COVID-19 pandemic on the 
United States and the vital need to protect Medicare beneficiaries (and 
others) from the SARS-CoV-2 virus, we remain concerned that the current 
absence of CMS-mandated frequency limits on COVID-19 vaccines could 
inadvertently impede the availability of the vaccines due to the 
application of the physician self-referral law's referral and billing 
prohibitions. Therefore, we are finalizing our proposal to permit the 
use of the exception at Sec.  411.355(h) for COVID-19 vaccines during 
such period as the vaccines are not subject to CMS-mandated frequency 
limits, provided that all other requirements of the exception are 
satisfied. We agree with the commenters that finalizing this proposal 
does not pose a risk of program or patient abuse. We also agree that we 
should permit the use of the exception at Sec.  411.355(h) for COVID-19 
vaccines until such time as CMS-mandated frequency limits apply for 
COVID-19 vaccines, without regard to the PHE timeframe, to ensure that 
we do not impede the continuing availability of COVID-19 vaccines.
    Comment: Several commenters supported our alternative proposal to 
remove the CMS-mandated frequency limit requirement for all vaccines. 
One commenter maintained that this proposal, if finalized, would reduce 
barriers to vaccine delivery. Several commenters contended that 
finalizing this proposal would not necessitate including alternative 
program integrity requirements in the exception at Sec.  411.355(h). 
Several commenters asserted that physicians are unlikely to order 
vaccines more frequently than recommended by the CDC's Advisory 
Committee on Immunization Practices (ACIP), especially given Medicare's 
current payment rates for non-COVID-19 vaccines and their 
administration. Another commenter explained that, because vaccines are 
generally administered at discrete intervals, based on age or medical 
indications, vaccines do not present the same program integrity 
concerns as other outpatient drugs and can even reduce health care 
costs by preventing more serious diseases.
    Response: We are not persuaded to remove the CMS-mandated frequency 
limit requirement for all vaccines at this time. In particular, we are 
concerned about potential harm to patients from receiving unnecessary 
or duplicative vaccinations. There are only a limited number of 
requirements under the exception at Sec.  411.355(h), and we are 
concerned that, in the absence of alternative requirements, an open-
ended exception permitting the furnishing of all vaccines, even if the 
vaccines are not subject to CMS-mandated frequency limits, may pose a 
risk of program or patient abuse.
    Comment: Several commenters supported our proposal to remove the 
terms ``immunization'' and ``immunizations'' throughout Sec.  
411.355(h) and the headers used in the Code List. No commenters opposed 
the proposal.
    Response: After consideration of the comments, we continue to 
believe that ``vaccine'' is the appropriate term to use in Sec.  
411.355(h) and in the headers in the Code List. Therefore, we are 
finalizing our proposal to remove the terms

[[Page 65356]]

``immunization'' and ``immunizations'' throughout Sec.  411.355(h) and 
the headers used in the Code List. We reiterate that the final 
revisions to Sec.  411.355(h) do not affect whether a code is a 
designated health service for purposes of the physician self-referral 
law.
4. List of CPT/HCPCS Codes (Sec.  411.351)
    As described in section III.P.1. of this final rule, unless an 
exception applies and all its requirements are satisfied, the physician 
self-referral law prohibits a physician from making a referral for the 
furnishing of certain designated health services if the physician has a 
financial relationship with the entity to which the referral is made. 
Recognizing that providing precise definitions of which designated 
health services implicate the physician self-referral law would 
facilitate compliance with the law, in the Phase I final rule, we 
determined to define certain designated health services by publishing 
specific lists of CPT and HCPCS codes that physicians and providers 
most commonly associate with a given designated health service (66 FR 
922). This list of CPT and HCPCS codes defines the entire scope of the 
designated health services category for purposes of the physician self-
referral law and is controlling vis-[agrave]-vis the definition of the 
category at Sec.  411.351, which contains a general explanation of the 
principles used to select the codes.
    In Phase I, we stated that, because HCPCS Level I and II codes 
change and can quickly become out-of-date, we would not include the 
list of CPT and HCPCS codes that are designated health services in the 
text of our regulations (66 FR 923). We also stated that the 
definitions of specific services in our regulations would cross-refer 
to a comprehensive table that would appear initially in the Federal 
Register along with Phase I and thereafter in an addendum to the annual 
final rule concerning payment policies under the PFS rule. We defined 
at Sec.  411.351 the term ``List of CPT/HCPCS Codes Used to Describe 
Certain Designated Health Services Under the Physician Referral 
Provisions (Section 1877 of the Social Security Act)'' to mean the list 
of certain designated health services under section 1877 of the Act 
initially posted on the CMS website and updated annually thereafter in 
an addendum to the PFS final rule and on the CMS website. In the Phase 
II interim final rule, we revised the term to ``List of CPT/HCPCS 
Codes'' and its definition to ``the list of CPT and HCPCS codes that 
identifies those items and services that are designated health services 
under section 1877 of the Act or that may qualify for certain 
exceptions under section 1877 of the Act.'' The Phase II definition 
also stated that the list is updated annually, as published in the 
Federal Register, and is posted on the CMS website at http://www.cms.gov/medlearn/refphys.asp. Other than including an updated URL 
for the location of the list on the CMS website, the current definition 
of ``List of CPT/HCPCS Codes'' is identical to the Phase II definition. 
The CMS website currently identifies this list as the Code List for 
Certain Designated Health Services (the Code List).\149\
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    \149\ https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.
_____________________________________-

    As we discussed in the proposed rule, coding changes have become 
more frequent since we initially began publishing the Code List. In an 
effort to more closely align with the frequency of the coding changes, 
we proposed to update the Code List more frequently than annually. 
Specifically, we proposed to update the Code List each calendar 
quarter, and provide public notification in advance of Code List 
updates. We stated that, if finalized, advance notification would be 
posted on the CMS website on March 1, June 1, September 1, and December 
1 of each year, with corresponding Code List updates effective on April 
1, July 1, October 1, and January 1, respectively. We also proposed a 
30-day public comment period following the posting of each advance 
notification of the upcoming quarterly Code List update. We stated in 
the proposed rule that we would provide information on our website 
regarding the process for submitting public comments through 
www.regulations.gov and address all public comments on the Code List on 
the CMS website. We stated that we anticipate that most comments would 
be addressed within 90 calendar days of the effective date of the Code 
List update to which they pertain; however, we indicated that a longer 
timeframe might be necessary to address complex comments or those that 
require coordination with external parties. We also stated that this 
new process and schedule would begin with the update effective April 1, 
2022. Based on the comments, we are not finalizing our proposal to 
update the Code List more frequently. The Code List that is effective 
January 1, 2022 is included in this final rule and will continue to be 
updated on an annual basis as described below.
    In addition, we proposed to publish the Code List solely on the CMS 
website (commencing after the publication of the January 1, 2022 Code 
List in this final rule). In the proposed rule, we stated that we 
believe that publication via the CMS website would facilitate 
compliance with the physician self-referral law and allow ready access 
to the most up-to-date Code List. We proposed corresponding revisions 
to the definition of ``List of CPT/HCPCS Codes'' at Sec.  411.351 and 
to update the URL that indicates where the Code List is published on 
the CMS website. We are finalizing our proposal to publish the Code 
List solely on the CMS website (commencing after the publication of the 
January 1, 2022 Code List in this final rule). We are finalizing the 
definition of ``List of CPT/HCPCS Codes'' at Sec.  411.351 to mean the 
list of CPT and HCPCS codes that identifies those items and services 
that are designated health services under section 1877 of the Act or 
that may qualify for certain exceptions under section 1877 of the Act. 
It is updated annually and posted on the CMS website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.
    We received the following comments regarding our proposals and our 
responses follow:
    Comment: Some commenters, including a representative of a large 
number of stakeholders, expressed concern that more frequent Code List 
updates would impose a significant burden on the industry and increase 
its risk of noncompliance with the physician self-referral law. These 
commenters urged CMS to continue to update the Code List on an annual 
basis only. By way of example, one commenter stated that quarterly 
adjustments to the Code List would create confusion and add another 
level of administrative burden to physician self-referral law 
compliance efforts. This commenter was concerned that certain 
compensation arrangements with physicians could inadvertently fall out 
of compliance with the physician self-referral law with more frequent 
changes to the Code List. Another commenter stated that more frequent 
Code List updates would require more frequent review and modification 
of arrangements with physicians in order to ensure compliance with the 
physician self-referral law. The commenter further stated that 
publishing more frequent Code List updates would require more resources 
to review and comply with the physician self-referral law. In contrast, 
several commenters generally supported our proposal to update the Code 
List more frequently, but did not articulate the rationale for their 
support.
    Response: Our proposal to update the Code List quarterly was 
intended to

[[Page 65357]]

benefit stakeholders by providing updates to the Code List at intervals 
that align more closely with the current coding cycles. We are 
persuaded by the commenters that the increased administrative and 
compliance burden outweighs the benefit of more frequent updates and 
are not finalizing our proposal to update the Code List quarterly. We 
will continue to update the Code List on an annual basis.
    Comment: All the commenters that addressed our proposal to publish 
the Code List solely on the CMS website supported website-only 
publishing.
    Response: After consideration of the comments, we are finalizing 
our proposal to publish the Code List solely on the CMS website. We 
continue to believe that publishing the Code List on the CMS website 
will facilitate compliance with the physician self-referral law and 
provide easier access to the most up-to-date Code List. Commencing 
after the publication of the January 1, 2022 Code List in this final 
rule, the Code List will be updated annually and published on the CMS 
website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.
    Comment: Several commenters stated that a 30-day advance notice and 
comment period for Code List updates is sufficient.
    Response: We agree that 30 days advance notice is sufficient prior 
to the publication of the annual Code List updates. Beginning with the 
Code List that is effective January 1, 2023, no less than 30 
consecutive calendar days prior to the effective date of a Code List 
update, we will provide advance notice of the updated Code List on the 
CMS website. We will also provide for a 30-day public comment period 
for each update using www.regulations.gov, and publish instructions for 
submitting comments on the CMS website. We will address all public 
comments that we receive through this process on the CMS website. We 
anticipate that most comments will be addressed within 90 calendar days 
of the effective date of the Code List update to which they pertain; 
however, a longer timeframe may be necessary to address complex 
comments or those that require coordination with external parties.
5. Annual Update to the List of CPT/HCPCS Codes
a. General
    As described in section III.P.1. of this final rule, unless an 
exception applies and its requirements are satisfied, the physician 
self-referral law prohibits a physician from making a referral for the 
furnishing of certain designated health services if the physician has a 
financial relationship with the entity to which the referral is made. 
Section 1877(h)(6) of the Act and Sec.  411.351 of our regulations 
specify that the following items and services are designated health 
services:
     Clinical laboratory services.
     Physical therapy, occupational therapy, and outpatient 
speech-language pathology services.
     Radiology and certain other imaging services.
     Radiation therapy services and supplies.
     Durable medical equipment and supplies.
     Parenteral and enteral nutrients, equipment, and supplies.
     Prosthetics, orthotics, and prosthetic devices and 
supplies.
     Home health services.
     Outpatient prescription drugs.
     Inpatient and outpatient hospital services.
b. Annual Update to the Code List
i. Background
    In Sec.  411.351, we specify that the entire scope of four 
categories of designated health services is defined in a list of CPT/
HCPCS codes (the Code List), which is updated annually to account for 
changes in the most recent CPT and HCPCS Level II publications. The 
categories defined and updated in this manner are:
     Clinical laboratory services.
     Physical therapy, occupational therapy, and outpatient 
speech-language pathology services.
     Radiology and certain other imaging services.
     Radiation therapy services and supplies.
    The Code List also identifies those items and services that may 
qualify for either of the following two exceptions to the physician 
self-referral prohibitions:
     EPO and other dialysis-related drugs (Sec.  411.355(g)).
     Preventive screening tests, immunizations, and vaccines 
(Sec.  411.355(h)).
    The definition of ``designated health services'' at Sec.  411.351 
excludes services for which payment is made by Medicare as part of a 
composite rate (unless the services are specifically included in the 
statutory or regulatory lists of items and services that are designated 
health services and are themselves payable through a composite rate, 
such as home health and inpatient and outpatient hospital services). 
Effective January 1, 2011, EPO and dialysis-related drugs furnished in 
or by an ESRD facility (except drugs for which there are no injectable 
equivalents or other forms of administration), have been reimbursed 
under a composite rate known as the ESRD prospective payment system 
(ESRD PPS) (75 FR 49030). Accordingly, EPO and any dialysis-related 
drugs that are paid for under ESRD PPS are not designated health 
services and are not listed among the drugs that could qualify for the 
exception at Sec.  411.355(g) for EPO and other dialysis-related drugs 
furnished by an ESRD facility.
    ESRD-related oral-only drugs, which are drugs or biologicals with 
no injectable equivalents or other forms of administration other than 
an oral form, were scheduled to be paid under ESRD PPS beginning 
January 1, 2014 (75 FR 49044). However, there have been several delays 
of the implementation of payment of these drugs under ESRD PPS. On 
December 19, 2014, section 204 of the Stephen Beck, Jr., Achieving a 
Better Life Experience Act of 2014 (ABLE) (Pub. L. 113-295) was enacted 
and delayed the inclusion of these oral-only drugs under the ESRD PPS 
until 2025. Until that time, such drugs furnished in or by an ESRD 
facility are not paid as part of a composite rate and, thus, are 
designated health services.
    As previously stated, because the Federal Government purchased the 
initial supply of COVID-19 vaccines, Medicare does not make payment for 
COVID-19 vaccines at this time, and COVID-19 vaccines do not fall 
within the definition of ``designated health service'' at Sec.  
411.351. However, should COVID-19 vaccines become payable by Medicare, 
unless the requirements of an applicable exception to the physician 
self-referral law are satisfied, the physician self-referral law's 
prohibitions under section 1877(a)(1) of the Act and Sec.  411.353(a) 
and (b) will apply to the referral and billing of COVID-19 vaccines.
    In the CY 2021 PFS final rule, we added COVID-19 vaccines to the 
list of immunization and vaccine codes to which the exception at Sec.  
411.355(h) is applicable (85 FR 84954 through 85955). We did so to 
ensure that the physician self-referral law will not impede the 
availability of COVID-19 vaccines for Medicare and other patients if 
they become payable by Medicare (85 FR 84955). We also included 
language in the CY 2021 Code List to ensure that any COVID-19 vaccine 
to which a CPT or HCPCS code applied prior to the publication of the CY 
2022 Code List would qualify for the exception at Sec.  411.355(h). 
Specifically, we stated that the physician self-referral prohibitions 
do not apply to CPT code 90749 (unlisted vaccine/toxoid) when it is 
used to identify a COVID-19 vaccine or

[[Page 65358]]

to any future CPT or HCPCS code designated for a COVID-19 vaccine. We 
continue to include this language in the CY 2022 Code List. The 
inclusion of CPT code 90749 on the Code List is not intended and should 
not be considered to direct or approve the use of CPT code 90749 for 
the identification and billing of any COVID-19 vaccine.
    As stated in section II.J. of this final rule, monoclonal antibody 
products used to treat COVID-19 are currently covered and paid for 
under the COVID-19 vaccine benefit in section 1861(s)(10) of the Act. 
We make a separate payment for the products (when not given to the 
provider or supplier for free by the government) and for the service to 
administer them. As ``vaccines,'' the products are designated health 
services for purposes of the physician self-referral law. Monoclonal 
antibody products covered and paid under the COVID-19 vaccine benefit 
in section 1861(s)(10) of the Act are included in the January 1, 2021 
list of codes that are eligible for the exception at Sec.  411.355(h) 
as ``any future CPT or HCPCS code designated for a COVID-19 vaccine.'' 
Accordingly, the physician self-referral prohibitions do not apply to 
them, provided that all requirements of the exception at Sec.  
411.355(h) are satisfied. Effective January 1, 2022, we are including 
in the list of codes that are eligible for the exception at Sec.  
411.355(h) the existing specific HCPCS codes for monoclonal antibody 
products that are covered and paid under the COVID-19 vaccine benefit 
in section 1861(s)(10) of the Act. The general descriptor on the Code 
List will apply to any future CPT or HCPCS codes for monoclonal 
antibody products that are covered and paid for under the COVID-19 
vaccine benefit in section 1861(s)(10) of the Act. For more information 
regarding monoclonal antibodies, please refer to our website at https://www.cms.gov/medicare/covid-19/monoclonal-antibody-covid-19-infusion.
    Since the PHE for COVID-19 is still ongoing, we remind readers that 
tests for COVID-19 identified in the Code List fall within the 
``clinical laboratory services'' category of designated health 
services.
    The Code List was last updated in Tables 58 and 59 of the CY 2021 
PFS final rule (85 FR 84956 through 84957).
ii. Response to Comments
    We received no comments relating to the Code List that became 
effective January 1, 2021.
iii. Revisions Effective for CY 2022
    The updated, comprehensive Code List effective January 1, 2022, is 
available on our website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.
    Additions and deletions to the Code List conform it to the most 
recent publications of CPT and HCPCS Level II and to changes in 
Medicare coverage policy and payment status.
    Tables 41 and 42 identify the additions and deletions, 
respectively, to the comprehensive Code List that become effective 
January 1, 2022. Tables 41 and 42 also identify the additions and 
deletions to the list of codes used to identify the items and services 
that may qualify for the exception in Sec.  411.355(g) (regarding 
dialysis-related outpatient prescription drugs furnished in or by an 
ESRD facility) and in Sec.  411.355(h) (regarding preventive screening 
tests, immunizations, and vaccines).
BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C

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

1. SUPPORT Act Requirements
    Section 2003 of the SUPPORT Act generally mandates that the 
prescribing of a Schedule II, III, IV, or V controlled substance under 
Medicare Part D be done electronically in accordance with an electronic 
prescription drug program beginning January 1, 2021, subject to 
exceptions, which the Secretary may specify. Section 2003 of the 
SUPPORT Act requires that the Secretary use rulemaking to specify 
circumstances and processes by which the Secretary may waive the 
Electronic Prescribing for Controlled Substances (EPCS) requirement, 
and provides the Secretary with authority to enforce and specify 
appropriate penalties for non-compliance with EPCS. The SUPPORT Act 
specifies some circumstances under which the Secretary may waive the 
electronic prescribing requirement with respect to controlled 
substances that are covered Part D drugs and permits HHS to develop 
other appropriate exceptions. Since the statute states that the 
Secretary shall, through rulemaking, specify circumstances and 
processes by which the Secretary ``may waive'' the EPCS requirement, we 
consider the list of circumstances to be illustrative. The 
circumstances that are listed in the statute under which the Secretary 
may waive the EPCS requirement are at section 1860D-4(e)(7) of the Act, 
as added by section 2003 of the SUPPORT Act, and include:
     A prescription issued when the practitioner and dispensing 
pharmacy are the same entity;
     A prescription issued that cannot be transmitted 
electronically under the most recently implemented version of the 
National Council for Prescription Drug Programs (NCPDP) SCRIPT 
standard, which is the SCRIPT 2017071 standard;
     A prescription issued by a practitioner who received a 
waiver or a renewal thereof for a period of time as determined by the 
Secretary, not to exceed 1 year, from the requirement to use electronic 
prescribing due to demonstrated economic hardship, technological 
limitations that are not reasonably within the control of the 
practitioner, or other exceptional circumstance demonstrated by the 
practitioner;
     A prescription issued by a practitioner under 
circumstances in which, notwithstanding the practitioner's ability to 
submit a prescription electronically as required by this subsection, 
such practitioner reasonably determines that it would be impractical 
for the individual involved to obtain substances prescribed by 
electronic prescription in a timely manner, and such delay would 
adversely impact the individual's medical condition involved;
     A prescription issued by a practitioner prescribing a drug 
under a research protocol;
     A prescription issued by a practitioner for a drug for 
which the FDA requires a prescription to contain elements that are not 
able to be included in electronic prescribing, such as a drug with risk 
evaluation and mitigation strategies that include elements to assure 
safe use;
     A prescription issued by a practitioner--
    ++ For an individual who receives hospice care under title XVIII of 
the Act; and
    ++ That is not covered under the hospice benefit under title XVIII 
of the Act; and
     A prescription issued by a practitioner for an individual 
who is--
    ++ A resident of a nursing facility (as defined in section 1919(a) 
of the Act); and
    ++ Dually eligible for benefits under title XVIII and title XIX of 
the Act.
2. Previous Regulatory Action
    To begin the process of implementing section 2003 of the SUPPORT 
Act, in August 2020, we released a Request for Information entitled 
``Medicare Program: Electronic Prescribing of Controlled Substances; 
Request for Information (RFI)'' (85 FR 47151) (hereinafter referred to 
as the August 2020 RFI). In August 2020, we released the CY 2021 PFS 
proposed rule (85 FR

[[Page 65362]]

50074) (hereinafter referred to as the CY 2021 PFS proposed rule), 
which proposed that Part D prescribers be required to use the NCPDP 
SCRIPT 2017071 standard for EPCS prescription transmissions. We 
proposed that this mandate would not become effective until January 1, 
2022.
    We received a combined total of 155 timely comments in response to 
the August 2020 RFI and the CY 2021 PFS proposed rule. Most commenters 
supported implementing EPCS and use of the NCPDP SCRIPT 2017071 
standard. Comments were mixed as to when compliance actions for EPCS 
should begin. Some commenters requested that CMS adhere to the January 
1, 2021 date specified in the SUPPORT Act because of the many safety 
benefits associated with EPCS articulated in the proposed rule. Some 
prescriber groups supported the proposed January 1, 2022 date, while 
others requested even more time for implementation. To balance the 
needs of prescribers who wanted more time to implement EPCS and 
commenters who wanted adherence to the January 1, 2021 date, we 
finalized this provision with an effective date of January 1, 2021 and 
a compliance date of January 1, 2022 in the CY 2021 Physician Fee 
Schedule final rule (85 FR 84472) (hereinafter referred to as the CY 
2021 PFS final rule). Due to the consensus among commenters that the 
NCPDP SCRIPT 2017071 standard was the best choice for EPCS, we required 
in the CY 2021 PFS final rule that Part D prescribers use this 
standard.
3. Current EPCS Environment
    A variety of Part D medications are classified as controlled 
substances by the Drug Enforcement Administration (DEA). Among these 
are medications used for the treatment of acute and chronic pain, (for 
example, hydrocodone, fentanyl, codeine, methadone), and stimulant 
medications (for example, Adderall[supreg], Ritalin[supreg]). 
Buprenorphine (for example, Suboxone[supreg]) is one of only three 
drugs approved by the FDA to treat opioid use disorders (OUD) including 
in outpatient settings, and is a Schedule III drug. Benzodiazepines and 
sedative-hypnotics (including Xanax[supreg], Valium[supreg], 
Ativan[supreg], Restoril[supreg], Midazolim[supreg], and 
Halcion[supreg]) are used for sleep, agitation, and seizure disorders. 
Anabolic steroids (for example, Depo-testosterone[supreg]) are used to 
treat impotence, delayed puberty, hormonal imbalance, and inoperable 
breast cancers.
    As discussed in the CY 2021 PFS proposed and final rules, we noted 
that electronic prescribing of controlled substances provides multiple 
advantages over the traditional processing of paper prescriptions. 
These advantages include, but are not limited to, improved workflow 
efficiencies; deterring and detecting prescription fraud and 
irregularities by requiring an extra layer of identity proofing, two-
factor authentication and digital signature processes; enhanced patient 
safety through patient identity checks, safety alerts, medication 
menus, electronic history files, and medication recommendations that 
lower the risk of errors and potentially harmful interactions; and 
providing more timely and accurate data than paper prescriptions by 
avoiding data entry errors and pharmacy calls to a prescriber to 
clarify written instructions. By allowing for the direct transmission 
of prescriptions for controlled substances between prescribers and 
pharmacies or facilities, EPCS may also reduce the burden on 
prescribers who need to coordinate and manage paper prescriptions among 
staff, patients, facilities, other care sites, and pharmacies. EPCS can 
also assure prescribers' identity more easily and may permit a single 
workflow for prescribing both controlled and non-controlled drugs, 
improving the overall prescribing process.
    From the patient standpoint, EPCS may reduce the logistical burden 
on patients and caregivers who may otherwise be required to make 
multiple trips between prescribers and pharmacies to transport paper 
prescriptions when filling time-sensitive prescriptions, while in pain, 
or otherwise in need of medical treatment with controlled substances. 
EPCS can lessen the time needed to obtain prescriptions by minimizing 
trips to the prescriber to pick up paper prescriptions for refills and 
minimize transportation costs to and from the prescriber's office. 
EPCS's identity and security requirements assure prescribers, patients, 
and pharmacies that prescriptions are processed as intended. In 
addition to helping with the reduction in fraud previously described, 
EPCS minimizes the likelihood that prescriptions have been tampered 
with, since electronic prescriptions are securely transmitted directly 
to the pharmacy from health information technology, which minimizes the 
likelihood of exposure to patients or other third parties. During the 
PHE for COVID-19, EPCS also helps parties maintain social distancing.
    It is due to these advantages, coupled with the SUPPORT Act's EPCS 
mandate, that we encourage all prescribers to conduct EPCS as soon as 
is feasible for them. We believe that although EPCS is ultimately more 
efficient, implementing EPCS does take additional time and resources. 
Prescribers must follow DEA guidance for EPCS, which is summarized at 
https://deadiversion.usdoj.gov/ecomm/e_rx/. Prescribers must first 
ensure that their current e-prescribing software can support EPCS and 
meet DEA requirements pursuant to 21 CFR part 1311. Further, DEA also 
requires prescribers to have their identities verified prior to being 
issued the authentication credentials needed to sign and issue 
electronic controlled substance prescriptions. For individual 
prescribers, identity proofing (that is, verification that the 
prescriber is who he or she claims to be) is conducted by a credential 
service provider (CSP) or certification authority (CA). Institutional 
practitioners, as defined under 21 CFR 1300.01, have the option of 
conducting in-house identity proofing of the practitioners authorized 
to use the institution's e-prescribing software. Alternatively, 
institutional practitioners may require their practitioners to undergo 
identity proofing by a CSP or CA. Once their identities have been 
confirmed, prescribers may be issued their authentication credentials. 
The authentication credentials must be two-factor, meaning that 
prescribers must be required to supply two factors to confirm both 
their identity and their authorization to access the e-prescribing 
software. The factors may be something the prescriber knows (such as a 
password or PIN), something the prescriber has (such as a smartcard or 
token), or a biometric (such as a fingerprint). For institutional 
practitioners, the authentication credentials may be issued by an 
entity within the institution that is separate from the entity that 
conducted identity proofing, if identity proofing was conducted in-
house. Otherwise, authentication credentials are issued by a CSP or CA. 
Once a prescriber has received his or her two-factor authentication 
credentials, the prescriber must be granted access to sign and issue 
electronic controlled substance prescriptions using the e-prescribing 
software. This step is completed by certain individuals specifically 
designated to manage the e-prescribing software's logical access 
controls. Prior to granting a prescriber access, the individuals 
managing logical access controls must verify that the prescriber's 
State authorization to practice and, where applicable, State 
authorization to prescribe controlled substances, are valid. 
Additionally, for

[[Page 65363]]

individual prescribers (those prescribers not prescribing under an 
institutional practitioner's DEA registration), the individuals 
managing logical access controls must verify that the prescriber's DEA 
registration is valid. This step is required even if the prescriber is 
already prescribing controlled substances on paper. After being granted 
access, prescribers may sign and issue electronic prescriptions for 
controlled substances using their two-factor authentication 
credentials. The EPCS application must require two-factor 
authentication for each transaction. Software and workflow training are 
available for each step of the process. When writing prescriptions, the 
prescriber may wish to talk with the patients and/or caregivers about 
electronic prescribing, so there is awareness of the general mechanics 
of how the prescription(s) will be conveyed to the pharmacy.
    We recognize that section 2003(c) of the SUPPORT Act tasked the 
Department of Justice (DOJ) with updating the requirements for the 
biometric component of multifactor authentication. As shown on the 
Spring 2021 Unified Agenda,\150\ rulemaking to address this mandate is 
currently in progress. After reviewing comments on the August 2020 RFI 
and CY 2021 PFS proposed rule and talking with industry stakeholders, 
we recognize that commenters believe that an update to the DOJ 
requirements should allow prescribers to start conducting EPCS with 
greater ease.
---------------------------------------------------------------------------

    \150\ https://www.reginfo.gov/public/do/eAgendaMain.
---------------------------------------------------------------------------

    The comments also stated that prescribers have felt strained by the 
COVID-19 pandemic. Prescribers reported feeling financially strained, 
worried about their own health and the health of their employees, and 
concerned about having to make rapid changes during a time when they 
are continuing to cope with the effects of the COVID-19 pandemic on 
their practices and their patients. Despite the strain that has been 
experienced by prescribers, we have noted an increase in EPCS during 
this PHE. Based on data from the first quarter of CY 2021, EPCS 
increased to 70 percent of all prescription drug events (PDEs) for 
controlled substances as compared to 38 percent in CY 2019.\151\ We 
believe that social distancing is likely to be at least partly 
responsible for the increase in EPCS during this PHE for COVID-19. With 
the use of electronic prescribing, one potential prescriber-patient 
interaction in which COVID-19 could be transmitted is eliminated, and 
any necessary prescriptions can be electronically transmitted to the 
pharmacy without the prescriber and patient having to see each other 
in-person and risk transmitting COVID-19. Some insurers, including Part 
D plans, have been permitting medication refills, including for 
controlled substances, earlier than usual or for a more extended period 
of time than is allowed. Pharmacies that were not doing so before the 
pandemic have been delivering medications, or delivering them at no 
charge, and communities and individuals have worked together to design 
ways for beneficiaries to continue to receive access to prescribed 
medications in tandem with government and private sector flexibilities 
during the PHE. We believe that these additional flexibilities may have 
encouraged prescribers to more broadly use EPCS, since it prevented 
them from having their prescription transmissions automatically denied. 
The reason for this is that EPCS transaction sets can pull certain 
pieces of required information for use in their transactions, which 
prevent the transactions from hitting system edits that would have 
previously prevented these practices.
---------------------------------------------------------------------------

    \151\ Based on Prescription Drug Event data processed through 
April 6, 2021.
---------------------------------------------------------------------------

4. Timeframe for EPCS Adoption
    Section 2003 of the SUPPORT Act mandates that EPCS for Part D 
controlled substances begin on January 1, 2021. Due to this statutory 
mandate coupled with the aforementioned advantages provided by EPCS, we 
encourage all prescribers to adopt EPCS as soon as is feasible for 
them. However, as stated in our CY 2021 PFS final rule, we recognize 
that although EPCS is ultimately more efficient, implementing EPCS 
takes additional time and resources. It is for this reason that, in our 
CY 2021 PFS final rule, we finalized a policy stating that CMS would 
not take compliance actions before January 1, 2022.
    In developing this policy, we considered responses from commenters 
encouraging earlier adoption of EPCS, due to its benefits for social 
distancing, improved patient safety and workflow efficiencies, fraud 
deterrence, adherence management, and reduced burdens. We agreed with 
commenters that EPCS has many benefits, which is why we specified an 
effective date of January 1, 2021 in our regulations, and a compliance 
date of January 1, 2022.
    Since finalizing the CY 2021 PFS final rule, we have received 
additional prescriber feedback indicating concern with having to 
implement EPCS rapidly. We have also learned more about the degree to 
which prescribers have been adversely affected by the COVID-19 
pandemic, and that the PHE and the widespread effects of the pandemic 
may last longer than we had anticipated last year. We want to ensure 
that our actions do not have unintended consequences, such as the 
abrupt discontinuation of prescribers' ability to prescribe Part D 
controlled substances to vulnerable populations, including Part D 
beneficiaries who need pain treatment or who have substance use 
disorders (SUDs). In addition, once DOJ has had the opportunity to 
implement updates to EPCS requirements, such updates will allow 
prescribers to start conducting EPCS more rapidly and easily. It is for 
these reasons that in the CY 2022 PFS proposed rule (86 FR 39104) 
(hereinafter referred to as the CY 2022 PFS proposed rule), we proposed 
to revise Sec.  423.160(a)(5) to change the date of initial EPCS 
compliance actions from January 1, 2022 to January 1, 2023. We welcomed 
comments on this proposal, including whether commenters believe that we 
should maintain the January 1, 2022 date of initial EPCS compliance 
actions, given the benefits of EPCS, and the feasibility for 
prescribers to adopt EPCS for Part D prescriptions by January 1, 2023.
    The following is a summary of the comments we received and our 
responses.
    Comment: The majority of commenters supported our proposal to delay 
the start of compliance actions to no earlier than January 1, 2023, 
rather than January 1, 2022, which is the date that we had finalized in 
the CY 2021 PFS final rule. In supporting this recommendation, 
commenters cited the devastating impact that the PHE has had on their 
practices, stating that the influx of patients, departure of staff, and 
depletion of financial resources would make it difficult for providers 
to implement EPCS by January 1, 2022. A few commenters that process or 
receive electronic prescriptions opposed our proposal to delay the 
start of compliance actions until January 1, 2023, citing the 
aforementioned benefits that EPCS has on social distancing and the 
workflow efficiencies gained from EPCS.
    Response: We thank commenters for supporting our proposal to change 
the earliest date of compliance actions to January 1, 2023. In 
addition, we appreciate the commenters for confirming our understanding 
of the benefits of EPCS. We recognize the benefits of EPCS, and it is 
for this reason that we encourage prescribers to conduct EPCS as soon 
as possible. In our CY 2021 PFS final rule, we named

[[Page 65364]]

the standard for prescribers to use when conducting EPCS for Part D 
controlled substances in order to facilitate adoption of EPCS. However, 
for the reasons stated in the CY 2022 PFS proposed rule, we continue to 
believe that delaying the start of compliance actions until on or after 
January 1, 2023 is appropriate.
    After consideration of the comments received, we are finalizing our 
proposal to extend the date of compliance actions to no earlier than 
January 1, 2023.
    For Part D controlled substance prescriptions written for 
beneficiaries in long-term care (LTC) facilities, we proposed to extend 
the date on or after which we will pursue compliance actions from 
January 1, 2022 to January 1, 2025. The intent of this proposed 
extension was to strike a balance between being responsive to 
stakeholder concerns surrounding the increased implementation barriers 
faced by LTC facilities, due to the unique challenges faced by LTC 
facilities, while at the same time helping ensure that these facilities 
eventually implement EPCS, due to its aforementioned benefits.
    We acknowledged that, in addition to the current challenge of 
having to manage care for vulnerable residents during the current 
COVID-19 pandemic, prescribers who work in LTC facilities or who 
provide care to residents in LTC facilities face technological barriers 
that other prescribers do not face. One such barrier is that the NCPDP 
SCRIPT 2017071 standard lacks appropriate guidance for LTC facilities. 
We understand that this is because early versions of the NCPDP SCRIPT 
Standard, such as NCPDP SCRIPT Standard versions 5.0 and 8.1, did not 
support the workflows in the LTC setting that require prescribers to 
issue a prescription for a patient to a non-prescriber (such as a 
nursing facility) that in turn forwards the prescription to a dispenser 
(LTC pharmacy). We nevertheless adopted the NCPDP SCRIPT 2017071 
standard in the CY 2021 PFS final rule [85 FR 84807] because it is the 
most commonly used standard for Part D e-prescribing, and we sought to 
minimize disruption and provider burden when implementing this 
statutory mandate. However, we understand that NCPDP is in the process 
of creating a new version of the SCRIPT standard that would be better 
suited for use by prescribers serving LTC facilities, which will allow 
willing partners to enable three-way communication between the 
prescriber, LTC facility, and pharmacy to bridge any outstanding gaps 
that impede adoption of the NCPDP SCRIPT 2017071 standard in the LTC 
setting.
    We understand that some LTC settings/services in rural communities 
do not have sufficient capabilities to support the NCPDP SCRIPT 2017071 
standard. This concern is exacerbated by the fact that based on 
stakeholder feedback and information in several reports,\152\ we 
believe LTC settings often include practitioners and staff serving 
large numbers of residents across multiple nursing homes. This unique 
set of circumstances means that some practitioners who primarily 
practice in suburban or urban areas may have to travel to see residents 
in rural facilities where there is limited broadband, making EPCS 
transmission set-ups difficult across LTC facilities. However, we 
believe that as broadband access increases and the impact of the PHE 
decreases, prescribers serving beneficiaries in LTCs should be able to 
more easily conduct EPCS.
---------------------------------------------------------------------------

    \152\ Waters, Rob. The Big Idea Behind a New Model of Small 
Nursing Homes. Health Affairs. 2021 Mar; 378-383; Levy et al. 
Physician Practices in Nursing Homes: Final Report. Office of the 
Assistant Secretary for Planning and Evaluation (ASPE). 2006 Apr; 
10-22.
---------------------------------------------------------------------------

    As a result, we proposed to revise Sec.  423.160(a)(5) to clarify 
that the earliest date of compliance actions against prescribers 
writing prescriptions for Part D beneficiaries in an LTC facility will 
be January 1, 2025. We did not propose a specific LTC waiver or 
exception to the EPCS requirement, and we did not anticipate extending 
the earliest date of compliance actions beyond January 1, 2025. We 
solicited comments on the benefits, burdens, and challenges of this 
approach.
    We received public comments on the benefits, burdens, and 
challenges of this approach. The following is a summary of the comments 
we received and our responses.
    Comment: Several commenters suggested that we exempt prescribers 
writing Part D controlled substance prescriptions for beneficiaries in 
LTCs from having to conduct EPCS until after version 2022011 of the 
NCPDP SCRIPT standard has been named, since this standard will contain 
the necessary three-way communication to facilitate the needs of the 
LTC community, whereas the current standard lacks such guidance.
    Response: We thank commenters for their insights into upcoming 
versions of the NCPDP SCRIPT standard. However, we are finalizing as 
proposed that the earliest date of compliance actions against 
prescribers writing Part D controlled substance prescriptions for 
beneficiaries in LTCs to be no earlier than January 1, 2025 to allow 
adequate time for EPCS to be adopted across the industry. We note that 
this extension of the earliest date for compliance actions is only 
applicable to the prescriptions written by prescribers for 
beneficiaries in LTC facilities, since the additional challenges for 
LTC do not apply when these prescribers are prescribing for 
beneficiaries who are not in LTC. As we stated in the proposed rule and 
earlier in this final rule, the intent of extending the date of 
compliance actions for prescriptions written for beneficiaries in LTC 
is to strike a balance between being responsive to stakeholder concerns 
surrounding the increased implementation barriers faced by LTC 
facilities, while at the same time helping ensure that these facilities 
eventually implement EPCS, due to its aforementioned benefits. The 
increased implementation barriers only present themselves when 
prescribers are writing prescriptions for beneficiaries in LTC, which 
is why we had only intended for the LTC extension to apply when 
prescribers are writing prescriptions for beneficiaries in LTC. In this 
final rule, we have clarified and refined the language at Sec.  
423.160(a)(5) to reflect our intent.
    As previously stated, EPCS has numerous advantages over manual 
prescribing, including deterring and detecting prescription fraud and 
irregularities by requiring an extra layer of identity proofing, two-
factor authentication and digital signature processes; and enhanced 
patient safety through patient identity checks, safety alerts, 
medication menus, electronic history files, and medication 
recommendations that lower the risk of errors and potentially harmful 
interactions. Given the benefits of EPCS, we decline to further delay 
taking compliance actions to enforce the EPCS requirements for Part D 
controlled substance prescriptions written for beneficiaries in LTCs 
beyond the date by which we believe prescribers in this setting can 
meet the requirement. Furthermore, we are not persuaded that we should 
further delay commencing compliance actions to await publication of the 
NCPDP SCRIPT 2022011 standard. Although we acknowledge that three-way 
communication is not as seamless in the 2017071 version of the standard 
as it may be in upcoming versions, it is still possible with some 
modifications to EPCS, and therefore, we do not believe it would be 
appropriate to adopt a further delay on this basis. However, we have 
decided to finalize the extension of compliance actions for prescribers 
writing prescriptions for beneficiaries in LTC to allow those 
prescribers the additional

[[Page 65365]]

time necessary to make the additional changes necessary to conduct EPCS 
using the NCPDP SCRIPT 2017071 standard. We also note that CMS does not 
intend to begin compliance actions for these prescriptions until on or 
after January 1, 2025. This protracted timeline for commencing 
compliance actions allows CMS additional time to examine how the 
industry adopts the new standard for beneficiaries in LTC, and 
determine the type of compliance actions that would be most 
appropriate.
    Comment: One commenter sought clarification as to whether 
medication transactions covered under the Part A benefit would be 
subject to compliance actions starting January 1, 2023 or 2025.
    Response: As stated in the CY 2022 PFS proposed rule, this EPCS 
mandate is only for transactions covered under Part D of the benefit. 
This mandate implements section 2003 of the SUPPORT Act, which is 
limited to Part D transactions. It is for this reason that we have not 
extended this mandate to other parts of the Medicare benefit, such as 
the Part A benefit.
    After consideration of public comments, we are finalizing our 
proposal at Sec.  423.160(b)(5) to extend the date that we will begin 
compliance actions based on prescriptions written for a beneficiary in 
a long-term care facility until January 1, 2025. In order to implement 
this provision, we will be excluding long term care prescriptions from 
our counting of compliance actions to help ensure that prescribers 
writing prescriptions for beneficiaries in these facilities do not have 
these prescriptions counted against them for purposes of the compliance 
threshold and the number of prescriptions written per prescriber for 
purposes of determining who is classified as a small prescriber under 
Sec.  423.165(a)(5)(ii).
5. Compliance Threshold
    The EPCS requirement applies to all controlled substance 
prescriptions for Part D drugs under a Part D plan, unless an exception 
to the requirement applies. In order to implement this mandate 
effectively, we seek to implement it in a manner that balances the 
mandate with helping ensure that prescribers are not overly burdened, 
and are able to issue prescriptions for their patients during the rare 
occurrences when EPCS is not feasible, such as:
     When it would be impractical for the patient to obtain 
medication(s) prescribed by electronic prescription in a timely manner 
and such delay would adversely impact the patient's medical condition,
     When the NCPDP standard does not support transmitting the 
prescription,
     When the prescriber is unable to meet DEA requirements for 
identity proofing for reasons beyond their control;
     Where EPCS is not available due to temporary technological 
failure.
    Based on our review of PDE data, the NCPDP standard, and our 
conversations with Part D stakeholders, we believe that there are very 
few scenarios under which a prescription could not be transmitted using 
the NCPDP standard.
    We note that section 1860D-4(e)(7)(B)(vi) of the Act provides that 
the Secretary may grant an exception for a prescription issued for a 
drug for which the FDA requires a prescription to contain elements that 
cannot be included in electronic prescribing. However, after reviewing 
the NCPDP standard implementation guide, we do not believe that there 
are any such prescriptions under the current standard. The statute 
gives as an example a drug with risk evaluation and mitigation 
strategies that include elements to assure safe use (ETASU). Based on 
our review of the current NCPDP standard, all opioid analgesics 
intended for outpatient use have a risk evaluation and mitigation 
strategy with ETASU, and as a result, would fall into the exception if 
there were one, which would frustrate the purpose of this statute.\153\ 
As a result, we declined to propose to adopt this suggested exception. 
However, we solicited comment on this decision.
---------------------------------------------------------------------------

    \153\ National Council for Prescription Drug Programs, 
``Implementation Guide'' January 2020.
---------------------------------------------------------------------------

    We also stated that there were other reasons that could make EPCS 
not feasible for prescribers who currently conduct EPCS, such as the 
aforementioned cases of temporary technological failures or cases where 
it would be impractical for the patient to obtain medication(s) 
prescribed by electronic prescription in a timely manner and such delay 
would adversely impact the patient's medical condition. However, we did 
not propose a specific exception for these cases, since based on our 
stakeholder feedback and review of PDE data, we believe that EPCS is 
not feasible in no more than an estimated 30 percent of instances due 
to circumstances such as the ones described previously. We believe that 
Part D prescribers should be able to conduct EPCS on 70 percent of 
their Part D controlled-substance prescriptions without being overly 
burdened or burdening patients. Under section 1860D-4(e)(7)(D) of the 
Act, we have authority to specify appropriate penalties for non-
compliance with the EPCS requirement. It follows, then, that we 
similarly have the authority to specify a threshold for when we would 
penalize non-compliance. For this reason, we proposed that in order for 
prescribers to be considered compliant with the EPCS mandate, they must 
prescribe at least 70 percent of their Part D controlled substance 
prescriptions electronically.
    Specifically, we proposed to revise Sec.  423.160(a)(5) to specify 
that 70 percent of all prescribing under Part D for Schedule II, III, 
IV, and V controlled substances be done electronically per calendar 
year, excluding from that calculation any prescriptions issued while a 
prescriber falls within an exception or a waiver. We intend to conduct 
this calculation by examining PDE data at the end of the calendar year 
and dividing the number of Part D controlled substances that the 
prescriber e-prescribed by the total number of Part D controlled 
substance prescriptions that the prescriber prescribed. We solicited 
comment on this method and the proposal to make 70 percent the 
compliance threshold for adherence to the EPCS mandate, and what 
circumstances would make EPCS not feasible.
    We received public comments on this method and the proposal to make 
70 percent the compliance threshold for adherence to the EPCS mandate, 
and what circumstances will make EPCS not feasible. The following is a 
summary of the comments we received and our responses.
    Comment: Most commenters supported our proposal to make 70 percent 
the compliance threshold for adherence to the EPCS mandate stating that 
it strikes the appropriate balance between implementing the statute and 
helping ensure that such implementation does not overwhelm prescribers. 
Two commenters suggested that we lower our compliance threshold to 50 
percent for the first year to avoid overwhelming prescribers.
    Response: We agree with the commenters that a compliance threshold 
of 70 percent is a suitable balance to help ensure that this mandate is 
implemented while not overwhelming prescribers. Although we understand 
that a compliance threshold of 50 percent would place less of a burden 
on prescribers, we believe a compliance threshold in which only a 
simple majority of a prescriber's prescriptions must be transmitted 
electronically would not be sufficient to fulfill the statutory 
mandate.

[[Page 65366]]

    After reviewing the PDE data,\154\ we did not find a substantial 
number of prescribers that transmitted between 50 to 70 percent of 
their Part D controlled substance prescriptions electronically, which 
leads us to believe that lowering the compliance threshold would not 
alleviate much of a burden for prescribers. After consideration of 
public comments, we are finalizing this provision as proposed, which 
would require prescribers 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. 
We note that, as previously stated, prescriptions for beneficiaries in 
LTC would be excluded from the calculation of the compliance threshold 
until the January 1, 2025 compliance threshold calculation is made, 
which would be using data beginning in January 1, 2024. As we explained 
in the CY 2022 PFS proposed rule, we will determine compliance with the 
EPCS requirement by examining PDE data at the end of the calendar year 
(86 FR 39330), which is why we will begin considering data for Part D 
prescriptions written for beneficiaries in LTC on January 1, 2024 and 
continuing through December 31, 2024 for compliance actions that we 
take on or after January 1, 2025.
---------------------------------------------------------------------------

    \154\ Based on Prescription Drug Event data processed through 
September 27, 2021.
---------------------------------------------------------------------------

6. Classes of Exceptions
a. Prescriptions Issued When the Prescriber and Dispensing Pharmacy are 
Same Entity
    Section 2003 of the SUPPORT Act requires that we specify 
circumstances by which we may waive the EPCS requirement, and the 
statute lists several possible circumstances to consider. We listed and 
sought comment on these circumstances in the August 2020 RFI. The first 
of these circumstances, which is listed at section 1860D-4(e)(7)(B)(i) 
of the Act, is when the practitioner issuing the prescription and 
dispensing pharmacy are the same entity.
    All August 2020 RFI commenters who commented on this exception 
supported it, stating that such an exception would promote patient 
safety, workflow efficiency, and health IT performance. Several 
commenters noted that requiring EPCS in this circumstance may create an 
unwarranted artificial workflow structure. We believe that this may be 
because the EPCS transactions conducted within an organization are 
commonly handled by a single database that exists within the 
organization, and should we not grant this exemption, these entities 
would be required to reconfigure their own processes, rather than 
leverage their own integrated databases. Were we to implement a 
requirement to use the NCPDP SCRIPT 2017071 standard within this closed 
system, this requirement could increase costs and the rate of 
performance errors, such as data corruption and patient matching 
errors, which we understand often happens when an entity is forced to 
split a unified database into a transaction system that relays 
information to and from the same entity. We solicited comment on this 
assumption. However, we did not receive any comments on the assumption.
    Therefore, we proposed to adopt at Sec.  423.160(a)(5)(i) the EPCS 
exception listed in section 1860D-4(e)(7)(B)(i) of the Act, for 
prescriptions issued where the prescriber and dispensing pharmacy are 
the same entity. We solicited comment on this proposal.
    Comment: All commenters who commented on this proposal supported 
it.
    Response: We thank the commenters for their support. We are 
finalizing this proposal as proposed.
b. Cases Where Prescribers Issue Only a Small Number of Part D 
Prescriptions
    As we develop regulations to implement section 2003 of the SUPPORT 
Act, we seek to help ensure that Part D prescribers, including small 
prescribers, are not overly burdened by our regulation. Based on the 
comments received from the August 2020 RFI and the stakeholder feedback 
that we received about EPCS in general, we believe it is appropriate to 
specify an exception to the EPCS requirement in cases where a 
prescriber issues a very low volume of controlled substance 
prescriptions for Part D drugs. For prescribers of very few Part D 
controlled substance prescriptions, the cost of installing EPCS 
equipment and software may be unduly burdensome relative to its benefit 
in terms of improving the security of prescriptions for controlled 
substances. As noted above, we do not want to disincentivize 
prescribers from prescribing controlled substances to Part D 
beneficiaries altogether, especially those who have few beneficiaries 
who need them.
    After reviewing the current PDE data and the costs associated with 
implementing EPCS, we proposed to exempt prescribers who prescribe 100 
or fewer Part D controlled substance prescriptions per year. Based on 
our stakeholder feedback, we understand that EHR companies provide the 
initial electronic prescribing set-up free of charge, provided the 
prescribers transmit a minimum number of transactions per year. We 
estimate that this amount is, on average, 100 Part D controlled 
substance transactions. In order to do EPCS, prescribers will have to 
have the capability to e-prescribe more broadly. It is for this reason 
that we weighed the cost of e-prescribing set-up in general, even 
though we do not intend to include non-part D prescriptions of 
controlled or non-controlled substances in our calculation of whether 
or not prescribers meet the threshold of 100 Part D controlled 
substance prescriptions per year. Since, based on our conversations 
with stakeholders, the cost of EPCS transactions is less than the cost 
of transmitting certain transactions manually, we believe that the 
initial investment to install EPCS equipment and software is likely 
justified once prescribers transmit more than 100 Part D controlled 
substance prescriptions per year. We solicited comment on this 
assumption and the cost of third-party applications required to conduct 
EPCS. However, we did not receive any comments on these assumptions.
    In order to implement this exception using the data that we have 
available, we proposed that this exception be given to individual 
prescribers, regardless of the size of the group practice that they 
belong to. We also believe that this exception will protect these small 
prescribers, should they change their place of employment or if their 
place of employment does not offer support for implementing EPCS.
    Based on our examination of PDE data and conversations with 
stakeholders, we believe that prescribers working under most research 
protocols will fall under the proposed exception for small prescribers. 
However, we solicited comment on this assumption. We did not receive 
any comments on it.
    Although we did not propose to adopt the suggested exception listed 
in section 1860D-4(e)(7)(B)(v) of the Act, which describes an exception 
for prescribers working under a research protocol, we believe that in 
most cases prescribers who will fall within this category will be 
included in the exception for small prescribers or in the exception for 
cases where the prescriber and dispenser are the same entity. We did 
not propose to specifically create an exception for prescribers working 
under a research protocol in the regulations, since we believe that so 
few prescribers will fall outside of these other exceptions. We believe 
an exception for prescribers working under a research protocol who do 
not otherwise meet these exceptions is unnecessary because we believe 
that

[[Page 65367]]

EHR companies will set up the appropriate EHR equipment, provided 
around 100 Part D controlled substance prescriptions are transmitted 
per year.
    We proposed to implement this proposal by examining PDE claims as 
of December 31 of the prior year to determine which prescribers fall 
within this exception. Prescribers can ascertain whether they meet this 
exception by looking at how many prescriptions for Part D controlled 
substances they conducted the prior year or by contacting the CMS 
contractor responsible for administering the compliance portion of this 
mandate. CMS and its contractor will be using PDE data from the prior 
year to determine whether the prescriber qualifies for the exception 
based on the number of Part D controlled substance claims the 
prescriber had issued the previous year. CMS will use the previous 
year's data to determine whether or not the prescriber falls under this 
exception for the year-in-question. We do not see a compelling reason 
to exempt prescribers conducting a research protocol on that basis 
alone.
    Based on our conversations with Prescription Drug Plans (PDPs), MA-
PD plans, and other organizations with which prescribers are 
affiliated, we are aware that some are willing to donate the technology 
and services necessary for prescribers to adopt EPCS. Based on those 
conversations, we believe that they are more willing to donate these 
technology and services to prescribers who are working under a research 
protocol, than to prescribers not working under such a protocol. 
However, we solicited comment on such an assumption, but we did not 
receive any comments. We did receive one comment on our decision to not 
propose an exception for those working under a research protocol. The 
following is a summary of the comment we received and our response.
    Comment: A commenter urged CMS to consider an exception for those 
working under a research protocol to allow for cases where a research 
protocol may transmit more than 100 Part D controlled substance 
prescriptions per year.
    Response: We have considered granting an exception to those working 
under a research protocol. However, we were unable to find a compelling 
reason to grant such an exception. Further, we reviewed PDE data to 
determine how many transactions would fall outside of our class of 
exceptions for cases involving a research protocol, and were unable to 
find any.\155\ For the reasons stated above and in the proposed rule, 
we decline to adopt a specific exception for those engaging in a 
research protocol.
---------------------------------------------------------------------------

    \155\ Based on Prescription Drug Event data processed through 
September 27, 2021.
---------------------------------------------------------------------------

    We proposed to amend Sec.  423.160(a)(5) by adding Sec.  
423.160(a)(5)(ii), which creates an exception for prescribers who issue 
100 or fewer controlled substance prescriptions for Part D drugs per 
calendar year as determined using PDE claims data as of December 31st 
of the preceding year, so that these prescribers will not be required 
to meet the EPCS requirement. We solicited comment on this proposal, 
including regarding the maximum number of Part D controlled substance 
prescriptions a prescriber can issue to be still considered a small 
prescriber and, so, to fall within this exception.
    The following is a summary of the comments we received and our 
responses.
    Comment: All commenters who commented on our proposal to grant an 
exception for prescribers who issue 100 or fewer Part D controlled 
substance prescriptions supported the proposal.
    Response: We thank commenters for their support of this proposal. 
After consideration of public comments, we are finalizing this proposal 
as proposed.
c. Cases of Recognized Emergencies and Extraordinary Circumstances
    Section 1860D-4(e)(7)(B)(iii) of the Act, as added by section 2003 
of the SUPPORT Act, lists an exception for consideration by the 
Secretary for cases of exceptional circumstance demonstrated by the 
prescriber. As stated in our proposal regarding the EPCS compliance 
threshold, we seek to help ensure that prescribers are able to issue 
prescriptions for their patients during the rare occurrences when EPCS 
is not feasible. We believe that the exception listed in the statute, 
which includes economic hardship, technological limitations that are 
not reasonably within the control of the prescriber, and other 
exceptional circumstances, includes prescribers who are overwhelmed due 
to having to treat patients during a pandemic or a natural disaster 
such as a hurricane, flood, or earthquake. It is our goal not to 
penalize prescribers for such circumstances, and we do not want to 
unduly increase their burden during difficult situations that impact 
them, and their patients. We solicited comment on what other 
extraordinary circumstances may prevent prescribers from being able to 
conduct EPCS.
    In order to help ensure that these extraordinary circumstances are 
accounted for, we proposed two exceptions to the EPCS requirement. The 
first proposed exception, at Sec.  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. We want to help ensure that the EPCS mandate 
does not interfere with necessary care for patients, especially during 
natural disasters or pandemics. As a result, we proposed to exempt 
prescribers who are issuing prescriptions in areas that are affected by 
such circumstances. To qualify for this exception, this circumstance 
will have to arise from an emergency or disaster declared by a Federal, 
State, or local government entity. We proposed to determine whether a 
prescriber qualifies for this exception based on whether the 
prescriber's NCPDP database address is located in the geographic area 
of an emergency or disaster declared by a Federal, State or local 
government entity. Since, as stated in the CY 2022 PFS proposed rule, 
we had intended this exception to avoid unduly burdening prescribers 
during difficult situations, CMS would like to clarify that this 
exception would be applicable only if the dispensing date of the 
medication occurs during the time period that the declared disaster is 
occurring.
    The second proposed exception, at Sec.  423.160(a)(5)(iv), is for 
prescribers who request and receive from CMS a waiver, which we 
proposed to 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 would define ``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. An example of such a 
circumstance would be if a prescriber was in a service area that lacks 
broadband access or EPCS providers refuse to install systems for the 
prescriber. The prescriber would have to be able to submit evidence of 
such an extraordinary circumstance to CMS.
    For purposes of the exception at Sec.  423.160(a)(5)(iii), prior to 
imposing any compliance actions on a prescriber, we proposed to 
ascertain whether there is an emergency or disaster declared by a 
Federal, State, or local government

[[Page 65368]]

entity for the geographic area associated with the prescriber's address 
in the NCPDP database.
    For purposes of the exception at Sec.  423.160(a)(5)(iv), we 
proposed that prescribers would be excepted from the EPCS requirements 
if they request and receive a waiver from CMS. We intend that 
prescribers will be able to submit a request for a waiver to inform CMS 
of any extraordinary circumstances that they may be facing and that 
will prevent the prescriber from conducting EPCS. This waiver could be 
for any circumstance outside of the prescriber's control and would not 
require an official declaration by a Federal, State, or local 
government. To meet the standard for a waiver, prescribers must provide 
documentation showing the existence of a circumstance beyond their 
control and that such a circumstance prevents them from conducting 
EPCS. 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 as determined by the Secretary, not to exceed one year, 
which suggests a timeframe not to exceed one year, but to be determined 
by the Secretary.
    To implement our proposals for exceptions for exceptional 
circumstances or disasters, we proposed to amend Sec.  423.160(a)(5) by 
adding paragraphs (a)(5)(iii) and (iv). Section 423.160(a)(5)(iii) 
would specify an exception for prescribers in the geographic service 
area of an emergency or disaster declared by a Federal, State or local 
government entity. We proposed at section 423.160(a)(5)(iv) that 
prescribers would be exempt from the EPCS requirements if they have 
received a CMS-approved waiver certifying that the prescriber is unable 
to conduct EPCS due to circumstances beyond the prescriber's control. 
We proposed that in order to receive a CMS-approved waiver, the 
prescriber will have to submit an attestation using a form, which will 
be made available on a CMS-supported website, so that prescribers will 
be able to request a waiver via an online portal.
    The following minimum set of information will be required on the 
attestation:
     Prescriber's first and last name;
     Prescriber's National Provider Identification (NPI);
     Prescriber's taxpayer identification number (TIN) or TIN 
associated with his or medical practice, when applicable;
     Prescriber's contact information, email address, telephone 
number, and mailing address; and
     A description of the extraordinary circumstance 
necessitating a waiver and how it affects the prescriber.
    Following receipt of the attestation, we will: (1) Provide a 
written acknowledgement of receipt of the request using the contact 
information submitted via the portal; and (2) provide a decision 
formally granting or denying the waiver using the contact information 
submitted via the portal. Under the policy, the prescriber will submit 
their attestation about the circumstance and receive a waiver, if 
warranted, based on such an attestation. After consideration of public 
comments, we are finalizing the waiver process as proposed.
    The following is a summary of the comments we received on the 
waiver process and our responses.
    Comment: One commenter suggested that we allow a process for waiver 
requests to be submitted via fax or over the phone, in case a 
prescriber does not have access to a computer, due to the extraordinary 
circumstance necessitating such a waiver.
    Response: We agree that prescribers should have the ability to 
submit an attestation using a medium other than a computer. We will 
make available on the CMS-supported website information to permit 
prescribers to request a waiver via phone, in addition to via the 
portal.
    Comment: Several commenters mentioned circumstances, such as 
cybersecurity attacks and technological failures, which may prevent 
prescribers from conducting EPCS. They stated that these circumstances 
should be eligible for a CMS waiver.
    Response: We agree that these events could be considered 
circumstances that would prevent prescribers from being able to conduct 
EPCS. We believe that in most cases, these events should not preclude a 
prescriber from meeting the 70 percent compliance threshold required by 
the regulation, and in some cases, prescribers may fall under an 
exception. However, should prescribers experience these events, we urge 
prescribers to submit an attestation detailing such an event. As 
described in subsequent paragraphs, should prescribers be unable to 
prescribe electronically, prescribers are able to submit an attestation 
of such. Should a waiver be granted, it would be for a term of up to 
one year.
    Comment: One commenter suggested that we include a waiver for any 
time certain doctors prescribe buprenorphine, since there are certain 
pharmacies that do not have much buprenorphine available to them. The 
commenter noted that this makes conducting EPCS difficult, since 
physicians are then required to re-route their electronic prescriptions 
when the pharmacy runs out of the prescription, which creates an 
administrative burden for prescribers.
    Response: Although CMS understands that this could create an 
additional burden for prescribers, CMS is not aware of, nor does the 
commenter explain, why this would not be an issue in cases where 
prescriptions are not transmitted electronically. However, CMS did seek 
to more fully examine this concern and reviewed PDE data to determine 
how often buprenorphine is prescribed in Part D.\156\ After reviewing 
this information, we discovered that buprenorphine prescriptions make 
up less than 2 percent of all Part D Schedule II, III, IV, and V 
prescriptions. It is for this reason that prescribers who experience 
difficulties electronically prescribing buprenorphine should still be 
able to meet the compliance threshold that allows prescribers to be 
considered fully compliant with EPCS if they electronically prescribe 
70 percent or more of their Part D prescriptions. As a result, we do 
not believe that an exception for this purpose is necessary. However, 
should a prescriber find that buprenorphine unavailability prevents the 
prescriber from utilizing EPCS, we encourage the prescriber to submit 
an attestation form about such events to request a waiver due to 
circumstances beyond the prescriber's control, which we will consider. 
In addition, we will continue to monitor PDE data for trends, including 
whether certain prescriptions are more frequently prescribed using 
paper prescriptions. If CMS finds that this is the case, we can take 
action, such as granting exceptions, to help ensure that EPCS is not 
becoming overly burdensome for these prescriptions.
---------------------------------------------------------------------------

    \156\ Based on Prescription Drug Event data processed through 
September 27, 2021.
---------------------------------------------------------------------------

d. Individuals in Hospice and Nursing Facilities
    Section 2003 of the SUPPORT Act, in adding section 1860D-
4(e)(7)(B)(vii) to the Act, tasked the Secretary to consider whether 
prescriptions for individuals under the Part D benefit for an 
individual enrolled in the Medicare Part A hospice benefit should be 
exempt from the EPCS requirement. After considering this issue, we 
believe that an exception for a prescription made for an individual 
enrolled in hospice would be inappropriate for several reasons. First, 
when electing hospice, patients have chosen to move from a curative 
model of care to a holistic palliative model of care. Regulations at 42 
CFR 418.202(f) stipulate that the Medicare hospice benefit covers only 
drugs and

[[Page 65369]]

biologicals used primarily for the relief of pain and symptom control 
for the terminal illness and related conditions. Under section 1860D-
2(e)(2)(B) of the Act, a drug is excluded from Part D coverage if 
payment for such drug, as prescribed and dispensed for the beneficiary, 
is available under Medicare Part A or Part B. Thus, in cases where, 
with respect to a beneficiary, the hospice benefit covers a drug or 
biological used primarily for the relief of pain or symptom control for 
the terminal illness or related conditions, such drug is excluded from 
Part D coverage under section 1860D-2(e)(2)(B) of the Act. The HHS OIG 
worked with CMS and the National Hospice and Palliative Care 
Organization (NHPCO) to identify four common categories of prescription 
drugs that are typically used to treat symptoms often experienced 
during the end of life, regardless of an individual's terminal 
diagnosis.\157\ The OIG has found that these categories of drugs should 
generally be paid under the hospice benefit.\158\ Thus, there may be 
very few instances in which a controlled substance prescribed for a 
Part D enrollee who has elected hospice could be covered under Part D. 
We believe an exception that will apply only in these rare instances 
could be confusing and burdensome for prescribers who furnish care to 
some Part D beneficiaries who are enrolled in hospice and for some who 
are not because to qualify for the exception they will have to 
determine when a particular enrollee has elected hospice. Further, a 
beneficiary is free to elect the hospice benefit and cancel that 
election as they choose, which will make it difficult for a prescriber 
to be sure at any point in time whether a beneficiary is, or is not, 
currently enrolled in hospice, and therefore, whether a paper 
prescription is permitted. We note that we did not propose for the EPCS 
requirement to apply to any prescriptions for Part A or Part B 
controlled substances in any event.
---------------------------------------------------------------------------

    \157\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Downloads/2014-PartD-Hospice-Guidance-Revised-Memo.pdf.
    \158\ https://oig.hhs.gov/oei/reports/oei-02-16-00570.pdf.
---------------------------------------------------------------------------

    Further, were CMS to provide an exception for prescriptions for 
Part D-covered controlled substances for hospice enrollees, it would 
pose an operational challenge to accurately match prescription data 
records with hospice enrollment data where the patient's hospice status 
can be fluid. It would be operationally challenging to ensure that 
paper prescriptions were only issued for beneficiaries enrolled in 
hospice (which would be permitted), and not for patients not enrolled 
in hospice (where EPCS will be required). We believed the cost of this 
potentially confusing and laborious analysis for the small number of 
prescriptions dispensed for beneficiaries enrolled in hospice but 
covered under Part D exceeds the benefit creating the exception would 
provide to prescribers.
    Therefore, we did not propose an exemption for prescribers issuing 
prescriptions for individuals enrolled in hospice. However, we 
solicited comment on this decision. We did not receive public comments 
on this provision. As proposed, we are not creating an exemption for 
prescribers issuing prescriptions for individuals enrolled in hospice.
    Section 1860D-4(e)(7)(B)(viii) of the Act suggests an exemption for 
prescribers issuing prescriptions for individuals who are residents of 
a nursing facility and eligible for Medicare and Medicaid benefits. We 
sought stakeholder feedback on this exemption in our August 2020 RFI 
and discussed it with our Federal partners at the DEA, and have been 
informed that there are situations where nursing facilities experience 
or are at risk of drug diversion. This stakeholder feedback did not 
inform us of any compelling reasons to include an exemption for 
prescribers issuing prescriptions for individuals who are residents of 
a nursing facility and eligible for Medicare and Medicaid benefits. We 
have also seen the severe impact that the COVID-19 pandemic has had on 
nursing facility residents, who are at high risk for infection, serious 
illness, and death from COVID-19, as well as other infectious diseases 
including clostridium difficile and the seasonal flu. It is for these 
reasons that we did not propose an exemption for prescribers issuing 
prescriptions for individuals who are residents of a nursing facility 
and eligible for Medicare and Medicaid benefits. We solicited comment 
on this issue, but we did not receive public comments on this 
provision. As proposed, we are not creating an exemption for 
prescribers issuing prescriptions for individuals who are residents of 
a nursing facility and eligible for Medicare and Medicaid benefits.
7. Fraud and Abuse Laws
    We are aware that PDPs, MA-PD plans, or other organizations with 
which prescribers are affiliated may wish to assist prescribers with 
satisfying the mandate for electronic prescribing of controlled 
substances for a covered Part D drug by providing technology and 
services necessary to effectuate the electronic prescribing of such 
drugs. Such assistance may implicate the payment and fraud and abuse 
laws that govern the financial relationships in the health care 
industry. Specifically, the donation of free or below-fair market value 
electronic prescribing technology or services to a practitioner (or any 
other person) may implicate the physician self-referral law and the 
Federal anti-kickback statute. However, there is an exception to the 
physician self-referral law's prohibition and a corresponding safe 
harbor under the Federal anti-kickback statute that will permit certain 
donations in the form of items or services (not including cash or cash 
equivalents) necessary and used solely to receive and transmit 
electronic prescription information if all requirements of the 
applicable exception or safe harbor are satisfied. In addition, other 
exceptions to the physician self-referral law and safe harbors under 
the Federal anti-kickback statute may apply.
    Section III.P.1. of this final rule provides a general discussion 
of the application of, prohibitions of, and exceptions to the physician 
self-referral law. For information specific to the exception for 
donations of electronic prescribing items and services, we refer 
readers to our August 8, 2006 final rule entitled ``Physicians' 
Referrals to Health Care Entities With Which They Have Financial 
Relationships; Exceptions for Certain Electronic Prescribing and 
Electronic Health Records Arrangements'' (71 FR 45140) and found at 
https://www.govinfo.gov/content/pkg/FR-2006-08-08/pdf/06-6667.pdf, and 
the regulations interpreting the physician self-referral law, including 
additional exceptions to its prohibitions, which are found in 42 CFR 
part 411, subpart J. Information regarding the Federal anti-kickback 
statute and its applicable safe harbors can be found at 
www.oig.hhs.gov.
    We received several comments regarding the fraud and abuse laws, 
which we have summarized below.
    Comment: Some commenters asked CMS to examine the regulations that 
set forth exceptions to the physician self-referral law and safe 
harbors under the Federal anti-kickback statute to determine whether 
revisions are necessary to permit PDPs, MA-PD plans, and other 
organizations to donate technology and services necessary for 
prescribers to adopt EPCS.
    Response: We did not propose to revise the existing physician self-
referral law exception for electronic prescribing items and services at 
42 CFR 411.357(v)

[[Page 65370]]

or any other exceptions to the physician self-referral law that may 
apply to donations of technology and services that parties may believe 
are necessary for prescribers to adopt EPCS. Any revisions to our 
regulations would occur only through notice and comment rulemaking. 
Stakeholders requesting revision of regulations issued by the HHS 
Office of Inspector General (OIG) should contact OIG.
8. Penalties
    Section 1860D-4(e)(7)(D) of the Act gives the Secretary the 
authority to enforce and specify appropriate penalties for non-
compliance with the EPCS requirement. We sought stakeholder feedback on 
whether CMS should impose penalties and if so, what those penalties 
should be. We have also examined State EPCS requirements and their 
accompanying penalties. However, because these requirements have only 
been recently implemented and most States do not have penalties for 
failing to adopt EPCS, we have not been able to evaluate what type of 
penalties have been effective for State mandates.
    In implementing the EPCS requirement, we seek to help ensure that 
we do not place too much of a burden on prescribers, as we do not want 
this requirement to have an unintended consequence of incentivizing 
prescribers to stop prescribing controlled substances to Part D 
beneficiaries, as appropriate, should they not have EPCS set-up. We 
also need sufficient time to gather more stakeholder feedback on the 
most effective and most appropriate type of penalties.
    Therefore, we proposed that with respect to compliance from January 
1, 2023 through December 31, 2023, CMS compliance actions will consist 
of sending letters to prescribers that we believe are violating the 
EPCS requirement during that period of time. These letters will consist 
of a notification to prescribers that they are violating the EPCS 
requirement, 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 
will re-evaluate whether further compliance actions will be necessary 
and what those compliance actions will be in future rulemaking. We 
solicited comment on this proposal, including what type of compliance 
action may be appropriate after the initial period described above, 
including whether any penalties should be phased in over time.
    We received public comments on this proposal, which we have 
summarized below, along with our responses to them.
    Comment: Most commenters supported our proposal to limit compliance 
actions in the first year to sending letters to prescribers, rather 
than imposing a penalty on the prescribers. These commenters encouraged 
the use of these letters in order to avoid overly burdening prescribers 
during the PHE. However, some commenters suggested that we impose 
penalties on prescribers who do not conduct EPCS, since these 
commenters stated that it will hasten EPCS implementation.
    Response: We agree that sending letters to prescribers, rather than 
imposing penalties, may avoid overly burdening prescribers who cannot 
meet the EPCS mandate in 2023. We will consider adopting penalties in 
future rulemaking. As previously noted, our intent is to avoid overly 
burdening prescribers, especially during this critical time during the 
PHE. In addition, we would like to further examine other EPCS programs 
and the effects that these penalties have had on EPCS in their States 
before imposing penalties on prescribers.
    After consideration of public comments, we will finalize our 
proposal to limit the 2023 compliance actions to a compliance letter.

R. Open Payments

1. Background
a. Open Payments Policies
    The Open Payments program is a statutorily-mandated program that 
promotes transparency by providing information to the public about the 
financial relationships between the pharmaceutical and medical device 
industry, and certain types of health care providers. Section 1128G of 
the Act requires manufacturers of covered drugs, devices, biologicals, 
or medical supplies (referred to as ``applicable manufacturers''), as 
well as applicable group purchasing organizations (GPOs), to annually 
submit information for the preceding calendar year about certain 
payments or other transfers of value made to ``covered recipients,'' 
currently defined as physicians, teaching hospitals, PAs, NP, CNSs, 
certified registered nurse anesthetists (CRNAs), anesthesiologist 
assistants (AAs), and certified nurse-midwives (CNMs).
    Payments or other transfers of value that must be reported include, 
but are not limited to, such things as research-related payments, 
honoraria, gifts, travel expenses, meals, grants, and other 
compensation. The type of information required to be reported includes, 
but is not limited to, the date and amount of the payment or other 
transfer of value, identifying information about the covered recipient, 
and details about products associated with the transaction. When a 
payment or other transfer of value is related to marketing, education, 
or research specific to a covered drug, device, biological or medical 
supply, the name of that covered drug, device, biological or medical 
supply also must be reported. The estimated burden of these reporting 
requirements, as outlined under OMB control number 0938-1237, is 
approximately 1.9 million hours over the course of 1 year.
    Section 1128G of the Act establishes certain minimum dollar 
thresholds for required reporting of individual and aggregate payments 
or transfers of value. To determine if multiple small individual 
payments or other transfers of value made to a covered recipient exceed 
the de minimis reporting threshold, applicable manufacturers and 
applicable GPOs must aggregate all individual payments made across all 
payment categories within a given reporting year. The statutory 
threshold established in 2013 was $10 for individual payments and $100 
for aggregated payments, and this amount has increased with the 
consumer price index each year. For CY 2021, the annual reporting 
thresholds for individual payments or other transfers of value is 
$11.04 and the aggregate amount is $110.40.
    The Open Payments program yields information for the general public 
about providers, as well as information that researchers may use to 
look into potential correlations between financial relationships and 
provider behaviors. Between August 2013 and the June 2020 publication, 
more than 76 million records have been disclosed under the Open 
Payments program, enabling significant transparency into applicable 
exchanges of value. We have been committed to stakeholder engagement in 
an effort to limit the burden in the Open Payments program reporting 
processes and improve clarity for the public. Additional background 
about the program and guidance, including frequently asked questions, 
regarding how the program works and what type of information is 
required to be reported is available at www.cms.gov/OpenPayments.
    In the February 8, 2013 Federal Register (78 FR 9458), we published 
regulations implementing section 1128G of the Act and establishing the 
Open Payments program. Section 1128G of the

[[Page 65371]]

Act requires applicable manufacturers and applicable GPOs to submit 
information annually about certain payments or other transfers of value 
made to covered recipients during the course of the preceding calendar 
year. Additionally, section 1128G of the Act defines covered drugs, 
devices, biologicals, or medical supplies as those covered under 
Medicare, a State plan under Medicaid, or the Children's Health 
Insurance Program (CHIP) (or a waiver of either such State plan), and 
requires applicable manufacturers and applicable GPOs to disclose any 
ownership or investment interests in such entities held by physicians 
or physicians' immediate family members, as well as information on any 
payments or other transfers of value provided to such physician owners 
or investors. Under section 1128G(e)(10)(A) of the Act, the term 
``payment or other transfer of value'' refers to a transfer of anything 
of value, though some exclusions apply.
    In the CY 2015 PFS final rule with comment period (79 FR 67548), we 
amended the regulations by standardizing reporting in the Open Payments 
program. Specifically, we: (1) Deleted the definition of ``covered 
device''; (2) removed the special rules for payments or other transfers 
of value related to continuing education programs; (3) clarified the 
marketed name reporting requirements for devices and medical supplies; 
and (4) required stock, stock options, and any other ownership 
interests to be reported as distinct forms of payment.
    In the CY 2017 PFS proposed rule (81 FR 46395), we solicited 
information from the public on a wide variety of topics regarding the 
Open Payments program. Since the implementation of the program and 
changes made in the CY 2015 PFS final rule with comment period, various 
commenters have provided us feedback. Consequently, we identified areas 
in the rule that might benefit from revision and solicited public 
comments to inform future rulemaking. We sought comment on whether the 
payment categories listed at 42 CFR 403.904(e)(2) are adequately 
inclusive to facilitate reporting of all payments or transfers of 
value, as well as ways to streamline or make the reporting process more 
efficient while facilitating our role in oversight, compliance, and 
enforcement, along with posing other program-specific questions. A 
summary of the comments we received was published in the CY 2017 PFS 
final rule (81 FR 80428 through 80429).
    On October 24, 2018, the Substance Use-Disorder Prevention that 
Promotes Opioid Recovery and Treatment for Patients and Communities Act 
(SUPPORT Act) (Pub. L. 115-271) was signed into law. Section 6111 of 
the SUPPORT Act amended the definition of ``covered recipient'' under 
section 1128G(e)(6) of the Act with respect to information required to 
be submitted on or after January 1, 2022, to include PAs, NPs, CNSs, 
CRNAs, and CNMs, in addition to the previously listed covered 
recipients of physicians and teaching hospitals. In the CY 2020 PFS 
final rule, we codified the Open Payments provisions of the SUPPORT Act 
and addressed public comments received from the CY 2017 PFS proposed 
rule by simplifying the process for reporting data by adjusting the 
Nature of Payment categories, and standardized data on reported covered 
drugs, devices, biologicals, or medical supplies.
    In the CY 2022 PFS proposed rule, we proposed to clarify existing 
Open Payments requirements, as well as add provisions that program 
stakeholders have requested and that we agree would improve the quality 
of the data. We proposed the following revisions effective for data 
collection beginning in CY 2023 and reporting in CY 2024: (1) Adding a 
mandatory payment context field for records to teaching hospitals; (2) 
adding the option to recertify annually even when no records are being 
reported; (3) disallowing record deletions without a substantiated 
reason; (4) updating the definition of ownership and investment 
interest; (5) adding a definition for a physician-owned distributorship 
as a subset of applicable manufacturers and group purchasing 
organizations, for the purposes of Open Payments program reporting 
only, which definition would not apply for purposes of any other laws 
or regulations, including, but not limited to, section 1128B of the Act 
(the Federal anti-kickback statute), the regulations at 42 CFR 
1001.952, and materials interpreting the anti-kickback statute, such as 
Special Fraud Alerts; and section 1877 of the Act and the regulations 
at 42 CFR part 411, subpart J (collectively, the physician self-
referral law); (6) requiring reporting entities to update their contact 
information; (7) disallowing publications delays for general payment 
records; (8) clarifying the exception for short-term loans applies for 
90 total days in a calendar year, regardless of whether the 90 days 
were consecutive; and (9) removing the option to submit and attest to 
general payment records with an ``Ownership'' Nature of Payment 
category. We noted that we believed these changes would increase the 
usability of the data, address concerns we have heard from 
stakeholders, and we believe our proposed implementation timeline 
allows reporting entities adequate time to prepare for changes to their 
data collection and reporting procedures.
    We received public comments on our proposals that would be 
effective for data collection beginning in CY 2023 and reporting in CY 
2024. We received 11 comments on the Open Payments proposals. 
Commenters generally submitted neutral or supportive comments with a 
few suggestions, which are individually outlined in section c below. We 
thank the commenters and after consideration of public comments, we are 
finalizing as proposed.
b. Legal Authority
    Four legal authorities from the statute ground our provisions:
     Sections 1102 and 1871 of the Act, which provide general 
authority for the Secretary to prescribe regulations for the efficient 
administration of the Medicare program.
     Section 1861 of the Act, which defines providers and 
suppliers.
     Section 1128G of the Act, as amended by section 6111 of 
the SUPPORT Act, which requires applicable manufacturers of drugs, 
devices, biologicals, or medical supplies covered under Medicare or a 
State plan under Medicaid or CHIP to report annually to the Secretary 
certain payments or other transfers of value to physicians and teaching 
hospitals, and to PAs, NPs, CNSs, CRNAs, and CNMs for information 
required to be submitted under section 1128G of the Act on or after 
January 1, 2022.
c. Provisions of the Regulations
(1) Payment Context Field for Teaching Hospitals
    We have received feedback from teaching hospitals during informal 
interviews that Open Payments submissions do not contain sufficient 
information to identify reported payments or transfers of value in 
their own records. This means that teaching hospitals are unable to 
verify records during the review and dispute process and must dispute 
the record in order to obtain additional information, which causes 
additional and unnecessary work for both teaching hospitals and 
reporting entities.
    To reduce the burden created by disputes for both reporting 
entities and teaching hospitals, we proposed a mandatory context field 
for payments or transfers of value attributed to teaching hospitals, 
which would contain information to better identify the

[[Page 65372]]

payment as deemed appropriate by the applicable manufacturer or GPO. 
Examples of data that the reporting entity may choose to include are: 
the check number or electronic wire number for the payment; related 
department of the hospital; or other pieces of relevant information.
    We received public comments on our proposal for a teaching hospital 
context field. The following is a summary of the comments we received 
and our responses.
    Comment: We received several comments on this proposal, which were 
evenly split in support and opposition. Commenters who agreed expressed 
support for our belief that the proposal would enhance communication 
between reporting entities and teaching hospitals in a proactive way, 
thereby reducing the need for disputes. One commenter suggested that 
additional inputs may include whether education was involved and which 
services were provided, and that CMS should expand the list of 
suggestions to avoid limiting reporting entities' inputs. Commenters 
who disagreed with the proposal stated that the field would increase 
burden without decreasing disputes, and the lack of standardization 
would be problematic since reporting entities would not have direction 
on what to input and teaching hospitals might not understand the 
additional context.
    Response: We believe that the additional field will be a minimal 
burden on reporting entities, but that the new field will give needed 
context to the payments based on feedback from both reporting entities 
and teaching hospitals. The integrity of the data is our highest 
priority, and this additional information will help ensure accuracy. We 
also believe that the flexibility regarding the field's contents will 
be much easier for reporting entities than specifying a mandatory piece 
of information. We hope to continue to minimize dispute-related issues, 
and we consider this new field to be a positive step to address both 
reporting entities' and covered recipients' communication concerns. 
Therefore, we are finalizing this provision as proposed.
(2) Optional Annual Recertification
    Over the course of the program, several entities have provided 
feedback that they would like the ability to attest that they have no 
reportable records for a particular year. At this time, an entity that 
does not have reportable payments or transfers of value does not need 
to recertify in Open Payments, but it also does not have a way to 
communicate to CMS that it believes it is still compliant even though 
it has not reported.
    We proposed to make it optional for an entity that does not have 
reportable payments or transfers of value for the program year to 
recertify its registration in Open Payments and attest that it does not 
have any records to submit, which would give peace of mind to reporting 
entities that are appropriately not reporting records. We believe this 
optional recertification for entities without reportable transactions 
will be a low burden to reporting entities, but will be invaluable to 
ensuring the integrity of the data. We proposed adding the following 
language to an option for entities that are recertifying without 
submitting records:
    ``1. I attest that I am a Chief Executive Officer, Chief Financial 
Officer, Chief Compliance Officer, or other Officer equivalent 
authorized representative for the reporting applicable manufacturer or 
applicable group purchasing organization with the authority to attest 
to the information submitted in the Open Payments system.
    2. I attest that, to the best of my knowledge, belief, and ability, 
my organization does not have any reportable payments or transfers of 
value or ownership and investment interest to report for the current 
program year.
    3. If I become aware of any information that my entity is required 
to report, I will submit this information to CMS as required per 42 CFR 
403.908(h)(1), which states that ``if an applicable manufacturer or 
applicable group purchasing organization discovers an error or omission 
in its annual report, it must submit corrected information to CMS 
immediately upon confirmation of the error or omission.''
    We received public comments on optional recertification for 
entities without reporting requirements. The following is a summary of 
the comments we received and our responses.
    Comment: We received two comments on this proposal, both of which 
were generally supportive although one included questions on how the 
new attestation would function. The commenter expressed concerns that 
the attestation would lead to additional consequences if later 
reportable records were discovered, and inquired as to whether CMS 
would add a notification functionality so that when the Submitter 
enters that the entity did not have any reportable records, the 
Attester would be notified.
    Response: We clarify that this optional activity is for the purpose 
of communication to the Open Payments program for the benefit of 
reporting entities, and is not intended as a method of penalization. We 
will continue to carefully evaluate instances of potential non-
compliance, including weighing mitigating and aggravating factors, as 
our regulations currently require. Furthermore, this attestation will 
not prevent reporting entities from submitting later-discovered 
records. We will further consider the system's functionality specific 
to the various roles, such as Submitter and Attester, but do not 
believe the detail of this functionality is relevant to rulemaking. 
Therefore, we are finalizing as proposed.
(3) Defining a Physician-Owned Distributorship
    The preamble to the 2013 Open Payments final rule (78 FR 9458) 
discusses physician-owned distributorships (PODs), as a subset of group 
purchasing organizations (GPOs), but does not provide a specific 
definition for this type of entity. Reporting entities currently have 
the ability to self-identify as a POD when registering with Open 
Payments, but due to the lack of a definition of the term ``physician-
owned distributorship'' or ``POD,'' this designation is not required. 
We believe that the disclosure of an entity's status as a POD is 
essential to the transparency that is central to the program, and will 
also help clear up confusion about whether PODs are required to report. 
Accordingly, we proposed to include the definition of a POD as set out 
at Sec.  403.902 as a subset of either an applicable manufacturer or 
applicable GPO.
    We also proposed to include language at Sec.  403.908(c)(4) to 
require PODs to self-identify when registering or recertifying.
    Furthermore, to better align the Open Payments program with the 
updated definition of ownership and investment interest at Sec.  
411.354(b)(3) (see 85 FR 77587), we included the exceptions for titular 
ownership and employee stock ownership programs (ESOPs) that are 
qualified under IRS regulations for consistency in application.
    In addition, we emphasized that:
     The proposed definition of a physician-owned 
distributorship does not apply for purposes of any other laws or 
regulations, including, but not limited to, section 1877 of the Act, 
the regulations at 42 CFR part 411, subpart J, section 1128B of the 
Act, or the regulations at 42 CFR 1001.952.
     ``Ownership or investment interest'' is defined at Sec.  
403.902 of the Open Payments regulations and would not include publicly 
traded securities or mutual funds.
     To be considered a physician owner(s), the owner would 
have to hold

[[Page 65373]]

at least one active professional license to practice as a physician 
issued by a U.S. State or territory.
     If a company with common ownership reports in a 
consolidated report with the POD, the reporting company would only be 
required to register as a POD if it meets the 5 percent ownership 
requirement when ownership of all entities in the report is calculated.
     The POD would be required to report ownership and 
investment interest as required by existing Open Payments requirements. 
Ownership or investment interest is defined at Sec.  403.902 to 
include, but is not limited to: stocks, stock option(s) (other than 
those received as compensation, until they are exercised); partnership 
shares, both limited and non-limited; limited liability company 
memberships; loans, bonds, or other financial instruments that are 
secured with an entity's property or revenue or a portion of that 
property or revenue. This definition explicitly excepts titular 
ownership and ESOPs that are qualified under IRS regulations.
     The POD would be required to identify as a POD whether or 
not the physician has a controlling interest in the reporting entity 
(for example, a silent partner whose only role is to provide capital 
and is not involved in the company's operations would still meet 
requirements for reporting).
     Five percent interest would be calculated as 5 percent of 
the total dollar value in USD of all ownership in the POD as of 
December 31, or the latest date that the ownership was held, as of the 
calendar year proceeding the Program Year. For example, if reporting 
ownership in a POD for Program Year 2022, the ownership will be 
calculated as of December 31, 2022, or the latest date in the calendar 
year that the physician held the ownership or investment interest.
     Indirect ownership interest would also have to be reported 
as required by Sec.  403.902. Indirect ownership is often the result of 
the use of holding companies and parent/subsidiary relationships.
     Any entity meeting this definition would be required to 
identify itself as a POD when submitting and attesting to its records. 
For example, if an applicable manufacturer meets the definition of a 
POD, it may not choose to identify itself simply as an ``Applicable 
Manufacturer'' but will have to choose its business type as 
``Applicable Manufacturer--Physician Owned Distributorship.''
     We believed that this proposed definition should not 
increase industry burden because it is a subset of existing 
definitions, but should clarify confusion about PODs being outside of 
reporting requirements.
    We received public comments on the requirement that physician-owned 
distributorships (PODs) self-identify when registering or recertifying.
    The following is a summary of the comments we received and our 
responses.
    Comment: We received several comments on this proposal, all of 
which expressed general support for the creation of a POD definition, 
although some provided suggestions on additional details to include. 
Two commenters noted that they believed that the proposed definition 
was not narrow enough to address concerns around PODs. One commenter 
suggested that CMS update the language to clarify that a POD may sell 
to a single entity, such as a hospital.
    Response: Many commenters' suggestions fell outside CMS' bounds of 
rulemaking authority, as statutory language limits the changes we may 
make to the program definitions. We do not believe we need to specify 
that the definition may include PODs that have a single customer as 
long as the definition does not exclude these entities. We therefore 
finalize the definition as proposed.
(4) Disallowing Record Deletion Without Reason
    While we have not seen evidence of the following conduct, we 
believe that our existing regulations might allow entities to be 
compliant by reporting and attesting to records, then deleting those 
records so that they are never publicly available. We proposed to 
prevent reporting followed by deletion by adding language at Sec.  
403.904(a)(3) that will state that an entity that has reported payments 
or transfers of value under the scope of this rule may not remove, 
delete, or alter the records in the Open Payments system unless it 
discovers an error in the information furnished, or the record is 
otherwise believed to meet existing exceptions for reporting that were 
previously unknown.
    An example of a properly deleted record would be the deletion of 
ownership records that were reported for a publicly traded company, 
since publicly traded companies are not required to report ownership 
and investment interest. We will add a dialogue box in the system for 
reporting entities to provide a reason for record deletion. We noted 
that deletions will continue to undergo additional scrutiny to ensure 
the integrity of the data.
    We received public comments on the requirement that a reporting 
entity provide a reason when deleting a record. The following is a 
summary of the comments we received and our responses.
    Comment: Some commenters were supportive of our proposal, while 
others were skeptical. These commenters mostly submitted system 
suggestions that would reduce burden, including: creating pre-filled 
options for deletion reasons instead of a free form text box; creating 
a threshold at which the reason for deletion would be required; and 
having the reason automatically populate as ``dispute'' if the deletion 
was on a disputed record.
    Response: We clarify that while we have not seen evidence of 
reporting entities reporting and deleting records to avoid publication, 
we believe our proposed language is nonetheless important to ensure 
such conduct is proscribed. Furthermore, CMS and reporting entities 
both currently bear an administrative burden- created when CMS needs 
documentation to confirm that a deletion is legitimate since 
attestation had previously been made as to the record's timeliness, 
completeness, and accuracy--when records are deleted without context. 
With proper reporting methodologies in place, deletions should be 
relatively rare and burden should be minimal, especially with respect 
to undisputed records. We believe that the proposed requirement will 
afford a needed layer of integrity to the data and we finalize it as 
proposed. However, we appreciate the feedback on logistical options and 
will take them into consideration as much as possible as we implement 
this requirement so as to minimize burden.
(5) Disallow Publication Delays of General Payments
    Delayed publication is permitted for Open Payments records based on 
concerns that the information provided in the record details may reveal 
proprietary information about an entity's research activities. 
According to Sec.  403.910, only payments that are made in connection 
with the following are allowed to be delayed from publication: (1) 
Research or development of a new drug, device, biological, or medical 
supply, or a new application of an existing drug, device, biological, 
or medical supply; or (2) Clinical investigations regarding a new drug, 
device, biological, or medical supply. As of December 26, 2020, there 
were 20,930 general records with a value of $26.4M that were delayed 
from publication for at least one Program Year, and based on the 
information

[[Page 65374]]

provided in the current format required for the submission of general 
records, we are unable to verify these records' connection with 
research or clinical investigations. Therefore, we proposed to 
eliminate the ability to delay general payments from publication and 
only permit publication delay of research payments, whose formatting 
does require the appropriate information to be provided, the details of 
which are specified at Sec.  403.904(f).
    Reporting entities may hesitate to include records that are 
currently being delayed as general payments because they are associated 
with a research study, but are not directly outlined in that research 
agreement. For example, a company may pay for an airline ticket for a 
physician to conduct research that is associated with a research 
agreement, but that travel was not explicitly outlined in that 
agreement. However, we do not believe that the current requirements for 
a research payment would exclude these types of payments from being 
reported as research payments, as long as they are made in connection 
with, and subject to, a research agreement.
    We received public comments on the removal of the ability to delay 
general payments. The following is a summary of the comments we 
received and our responses.
    Comment: Commenters were supportive or neutral. One commenter asked 
CMS to clarify whether payments associated with research but not 
explicitly outlined in the written agreement should be reported as 
research payments instead of general payments.
    Response: We believe that our proposal is clear that as long as a 
payment is made in connection with a written research agreement, it may 
be reported as a research payment even if it was not explicit in that 
agreement. We finalize this proposal as it was proposed, and we will 
update our guidance, including FAQs, to be aligned with this final 
rule.
(6) Short-Term Loans
    The 2013 Open Payments final rule makes a reporting exception for 
short-term equipment loans. A short-term medical supply or device loan 
means the loan of a covered device or a device under development, or 
the provision of a limited quantity of medical supplies for a short-
term trial period, not to exceed a loan period of 90 days or a quantity 
of 90 days of average daily use, to permit evaluation of the device or 
medical supply by the covered recipient. The Open Payments regulations 
also clarify that for a single product, the total number of days for 
the loan should not exceed 90 days for the entire year, regardless of 
whether the 90 days are consecutive. We believe that this aligns with 
the intention to limit the loan period to 90 days and not allow a new 
loan to start at the end of the previous loan period, thus avoiding the 
reporting requirements. We proposed to clarify this by stating that 
short-term medical supply or device loan means the loan of a covered 
device or a device under development, or the provision of a limited 
quantity of medical supplies for a short-term trial period, not to 
exceed a loan period of 90 cumulative days per calendar year or a 
quantity of 90 cumulative days of average daily use per calendar year, 
to permit evaluation of the device or medical supply by the covered 
recipient.
    We received one public comment on the proposal to clarify the 
definition of a short-term loan. The following is a summary of the 
comment we received and our responses.
    Comment: One commenter requested that this proposal be withdrawn on 
the basis that this behavior is not occurring and could impact the 
product evaluation process.
    Response: This proposal is merely a clarification of the existing 
regulatory requirement, and we are finalizing it as proposed.
(7) Remove General Ownership Records
    We currently have two ways for an entity to report ownership: 
entities may submit an ownership record; or a general record with a 
Nature of Payment category of ``Ownership.'' We proposed to remove the 
``Ownership'' Nature of Payment category. The statute requires special 
rules for the reporting of ownership interest, including dollar amount 
invested and value of interest, which is not captured by the general 
payment with the Nature of Payment category of ``Ownership.'' 
Furthermore, this would create a cleaner and more consistent data set.
    We received one public comment on the proposal to remove the 
ability to submit general ownership records.
    Comment: One commenter supported this proposal.
    Response: We will finalize as proposed.
(8) Updated Contact Information
    When sending communications to entities, the Open Payments program 
often finds that their contact information is outdated, especially if 
the entity has not recertified recently. To ensure data integrity, 
including in instances where we might discern irregularities or 
potential noncompliance, it is important that the Open Payments program 
be able to contact reporting entities. We proposed to require that a 
company that has had reportable payments or transfers of value within 
the past 2 calendar years keep current its contact information within 
the Open Payments system. For example, if an applicable manufacturer or 
group purchasing organization had reported records in Program Years 
2018 and 2022, but did not have records for Program Years 2019, 2020, 
or 2021, it would be required to keep updated contact information in 
the system during Program Years 2019 and 2020. The applicable 
manufacturer or group purchasing organization would not have to update 
its contact information for Program Year 2021. In Program Year 2022, 
since it once again had reportable records, it would be required to 
recertify and update its contact information as usual. We proposed to 
include this requirement at Sec.  403.908(c)(3).
    We received public comments on the requirement for reporting 
entities to keep their contact information updated. The following is a 
summary of the comments we received and our responses.
    Comment: Two commenters supported the proposal. One commenter 
expressed concern that the contact field would not be able to be 
updated in the event that a company goes out of business.
    Response: We acknowledge that the requirement to keep contact 
information updated, along with any other requirements, will be 
impossible to enforce if, for example, a company goes out of business. 
We will finalize as proposed.

IV. Summary of the Quality Payment Program Proposed Provisions, 
Analysis of and Responses to Public Comments, and Provisions of the 
Final Rule

A. CY 2022 Updates to the Quality Payment Program

1. Executive Summary
a. Overview
    This section of the final rule sets forth changes to the Quality 
Payment Program starting January 1, 2022, except as otherwise noted for 
specific provisions. The CY 2022 performance period/2024 MIPS payment 
year of the Quality Payment Program continues to build on the first few 
years of implementation of the Quality Payment Program to focus more on 
our measurement efforts, refine how clinicians will be able to 
participate in a more meaningful way and encourage participation in

[[Page 65375]]

Advanced Alternative Payment Models (APMs).
    Authorized by the Medicare Access and CHIP Reauthorization Act of 
2015 (MACRA) (Pub. L. 114-10, April 16, 2015), the Quality Payment 
Program is an incentive program that includes two participation tracks, 
the Merit-based Incentive Payment System (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. The weights of 
those four performance categories are specified in statute. For CY 
2022, those 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. If an 
eligible clinician participates in an Advanced APM and achieves 
Qualifying APM Participant (QP) status, they are excluded from the MIPS 
reporting requirements and payment adjustment. Those that are 
qualifying APM participants (QPs) for the year receive a 5 percent lump 
sum incentive payment during the corresponding payment year through CY 
2024, or a differential payment update under the PFS for payment years 
beginning in 2026.
    Participation in the Quality Payment Program slightly rose in the 
fourth year with 99.9999 percent comparing with 99.8989 percent in the 
third year. We saw 99.9999 percent of MIPS eligible clinicians 
participate in MIPS in 2020: 933,549 MIPS eligible clinicians received 
a payment adjustment and 933,547 MIPS eligible clinicians participated 
by reporting at least one measure or activity. This was a slight 
increase from our 2019 participation rates where 954,670 MIPS eligible 
clinicians received a payment adjustment and 954,573 MIPS eligible 
clinicians participated by reporting at least one measure or activity. 
Therefore, participation in MIPS did not meaningfully change in 2020 as 
compared to 2019. We did see a slight decrease in the number of MIPS 
eligible clinicians receiving a payment adjustment with 933,549 MIPS 
eligible clinicians in 2020 compared to 954,670 in 2019. In addition, 
90.6 percent of MIPS eligible clinicians received a positive payment 
adjustment for 2022 based on CY 2020 performance period/2022 MIPS 
payment year results. Please note that results for the CY 2020 
performance period/2022 MIPS payment year are subject to change as a 
result of the targeted review process which began on August 2, 2021 and 
will conclude on November 29, 2021 at 8:00 p.m., eastern standard time. 
For more information on the targeted review process for 2020 please see 
our announcement from September 27th at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1631/2020%20Scoring%20Updates_EUC%20Reweighting%20Requests%20Extension_Listserv.pdf.
    Regarding performance in Advanced APMs, for the 2020 QP Performance 
Period, 237,315 eligible clinicians earned Qualifying APM Participant 
(QP) status while another 10,609 eligible clinicians earned partial QP 
status.\159\ We note that due to the Public Health Emergency (PHE) for 
COVID-19, 192,344 (or about 20.60 percent of 933,549) MIPS eligible 
clinicians received reweighting for CY 2020 performance period/2022 
MIPS payment year of one or more MIPS performance categories due to our 
MIPS extreme and uncontrollable circumstances policy.
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    \159\ QPP Participation in 2019: Results at-a-Glance released 
10/27/2020 at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1190/QPP%202019%20Participation%20Results%20Infographic.pdf.
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    We plan to continue developing Quality Payment Program policies 
that more effectively reward high-quality of care for patients and 
increase opportunities for Advanced APM participation. We are moving 
forward with MIPS Value Pathways (MVPs) as MVPs allow for a more 
cohesive participation experience by connecting activities and measures 
from the 4 MIPS performance categories that are relevant to a 
specialty, medical condition, or a particular population. The MVPs will 
include the Promoting Interoperability performance category as a 
foundational element and incorporate population health claims-based 
measures, as feasible, along with relevant measures and activities for 
the quality, cost, and improvement activities performance categories. 
To provide clinicians and third party intermediaries with sufficient 
time to prepare for a shift to this new participation framework, in 
this rule, we proposed to begin transitioning to MVPs in the CY 2023 
performance period/2025 MIPS payment year.
    As we make long-term improvements, evolve MIPS policies, and plan 
to implement MVPs in the future, we remain committed to our program 
goals. We are aligning with broader CMS initiatives, such as the CMS 
Quality Measure Action Plan (https://www.cms.gov/files/document/2021-cms-quality-conference-cms-quality-measurement-action-plan-march-2021.pdf), to unify strategic efforts to adopt measures most critical 
to providing high quality care and accelerate strategic improvements 
for quality programs and measures. The vision for the CMS Quality 
Measure Action Plan is to use impactful quality measures to improve 
health outcomes and deliver value by empowering patients to make 
informed care decisions while reducing burden to clinicians. This plan 
supports CMS' work to identify activities for transformation of quality 
measurement and value-based programs and recognizes the need to 
modernize the current quality ecosystem of measurement and programs. 
Additionally, it will encourage further reductions to the burden of 
quality measure reporting and address the current lack of alignment. 
These efforts will also support identifying activities that are driving 
better patient outcomes at lower costs. The planned implementation of 
MVPs aligns with many of the objectives and goals the CMS Quality 
Measure Action Plan will strive to achieve.
    Through the proposals we describe below, we intend to transform and 
simplify the MIPS program through MVPs, promote the use of connected 
measures and activities, reward clinicians for providing high value 
care, and help all clinicians improve care and engage patients. We also 
intend to gather information from stakeholders to help guide efforts to 
advance health equity throughout CMS quality programs.
b. Summary of Major Provisions
(1) Major MIPS Provisions
    The MIPS program aims to drive value through the collection, 
assessment, and public reporting of data that informs and rewards the 
delivery of high-value care. Within MIPS we intend to pay for health 
care services in a way that drives value by linking performance on 
cost, quality, and the patient's experience of care.
    We have heard from clinicians that MIPS requirements are confusing, 
burdensome, and that it is difficult to choose measures from the 
several hundred MIPS and QCDR quality measures that are meaningful to 
their practices and have a direct benefit to patients. We have also 
heard concerns from stakeholders that MIPS does not allow for 
sufficient differentiation of performance across practices due in part 
to clinician quality measure selection bias. These aspects detract from 
the

[[Page 65376]]

program's ability to effectively measure and compare performance, 
provide meaningful feedback, and incentivize quality. MVPs are intended 
to lead to a simplified MIPS clinician experience, improve value, 
reduce burden, and better inform patient choice in selecting 
clinicians. We noted that the MVP framework will connect measures and 
activities across the 4 MIPS performance categories, incorporate a set 
of administrative claims-based quality measures that focus on 
population health, provide data and feedback to clinicians, and enhance 
information provided to patients. We intend to focus the future of MIPS 
on MVP development and implementation.
    Additionally, we have heard from patients, clinicians, and other 
stakeholders that they would like more comprehensive and granular 
reporting from the MIPS program. To that end, we proposed to establish 
voluntary subgroup reporting to help provide patients and clinicians 
information that is clinically meaningful at a more granular level.
    We issued a request for information (RFI) to address the Advancing 
to Digital Quality Measurement and the Use of Fast Healthcare 
Interoperability Resources (FHIR) in Physician Quality Programs; please 
refer to section IV.A.1.c. of this rule for more information. We also 
issued an RFI to address Closing the Health Equity Gap in CMS Clinician 
Quality Programs as discussed in section IV.A.1.d. of this rule.
(a) Basis and Scope
    At Sec.  414.1300, we previously codified the basis and scope of 
the MIPS and APMs. In order to support the continued application of 
voluntary reporters, we proposed to revise the basis and scope at Sec.  
414.1300(a)(2) to remove reference to section 1848(a) of the Act--
Payment for Physicians' Services Based on Fee Schedule and instead 
redesignate the text at Sec.  414.1300(a)(3) to Sec.  414.1300(a)(2) to 
state section 1848(k) of the Act--Quality Reporting System. At Sec.  
414.1400(a)(3), we also proposed to add new language to state section 
1848(m) of the Act--Incentive Payments for Quality Reporting.
    We did not receive public comments on this proposal, and therefore, 
we are finalizing it as proposed.
(b) MIPS Value Pathways and APM Performance Pathway
    We recognize that the transition to MVPs will take time and we will 
continue to evaluate the readiness of clinicians in making this 
transition, while balancing our strong interest in improving 
measurement and making MIPS more focused on value.
    As discussed in section IV.A.3.b. of this final rule, for MIPS 
Value Pathways (MVPs) we are finalizing our proposals:
     To define who can report MVPs, through the term MVP 
Participant.
     A delay to the CY 2023 performance period/2025 MIPS 
payment year: MVP implementation and subgroup reporting timelines. 
After considering public comments, we are finalizing the proposal with 
a modification such that multispecialty groups will be required to form 
subgroups in order to report MVPs beginning in the CY 2026 performance 
period/2028 MIPS payment year, instead of the CY 2025 performance 
period/2027 MIPS payment year as proposed.
     An introductory set of 7 MVPs to be available beginning 
with the CY 2023 performance period/2025 MIPS payment year.
     MVP reporting requirements that account for the four MIPS 
performance categories.
     During the CY 2023, CY 2024 and CY 2025 performance 
periods/2025, 2026 and 2027 MIPS payment years, voluntary subgroup 
reporting within MIPS limited to reporting through MVPs or the APP. For 
the MIPS program, eligibility, special status determination, and QP 
determination will continue to be determined at the group level for 
subgroup participants. Subgroup performance will be assessed at the 
subgroup level for three performance categories (the quality, cost, and 
improvement activities performance categories) and will be assessed at 
the group level for one performance category (the Promoting 
Interoperability performance category). Additionally, subgroups will 
continue to be included in group level reporting but will receive 
scores separate from their affiliated group.
     MVP scoring policies closely align with those used in 
traditional MIPS, with few exceptions.
     MVP scoring policies including policies for scoring 
administrative claims measures, including population health measures, 
scoring only the cost measures specified in the MVP, assigning 20 
points for each medium-weighted and 40 points for each high-weighted 
improvement activity specified in the MVP, scoring subgroups on their 
affiliated group's data for the Promoting Interoperability performance 
category, reweighting performance categories for subgroups in certain 
circumstances, and requirements that the quality performance category 
be scored with few exceptions for reweighting. While we are finalizing 
these policies as proposed, we may consider additional incentives to 
report MVPs in future rulemaking.
     To provide comparative feedback within performance 
feedback, comparing the performance of like clinicians who report on 
the same MVP.
    We also discuss in section IV.A.3.b. of this final rule, future 
considerations and goals of the MIPS program:
     We requested comment on the timeline to sunset traditional 
MIPS in the future, and to eventually make MVP reporting mandatory. 
Note: we are referring to the established MIPS participation options 
collectively as traditional MIPS (85 FR 84844).
     Through the MVP development work, gradually implement MVPs 
for all specialties and subspecialties that participate in the program.
    As discussed in section IV.A.3.c. of this final rule, for the APM 
Performance Pathway, to create stability within the APP, we did not 
propose any major changes to the APP.
(c) Other MIPS and APM Policies
    We are finalizing our proposals for the following provisions for 
MIPS beginning with the CY 2022 performance period/2024 MIPS payment 
year:
     As discussed in section IV.A.3.d. of this final rule, for 
the MIPS Performance Measures and Activities, we are finalizing our 
proposals and finalizing with modification our proposals regarding the 
data completeness threshold for the CY 2023 performance period/2025 
MIPS payment year and the quality measure set for the CY 2023 
performance period/2025 MIPS payment year:
    ++ In section IV.A.3.d.(1) of this final rule, for the quality 
performance category, to maintain the data completeness criteria 
threshold at 70 percent for the CY 2021 and 2022 performance periods/
2023 and 2024 MIPS payment years; maintain the data completeness 
criteria threshold at 70 percent for the CY 2023 performance period/
2025 MIPS payment year; extend the availability of the CMS Web 
Interface as a collection and submission type for the CY 2022 
performance period/2024 MIPS payment year; establish a set of 200 MIPS 
quality measures; and solicited public comments through a request for 
information (RFI) regarding the draft COVID-19 Vaccination by 
Clinicians measure specifications.
    ++ In section IV.A.3.d.(2) of this final rule, for the cost 
performance category, to establish 5 new episode-based cost measures 
for implementation into MIPS, which adds to the 2 global or population-
based measures and 18

[[Page 65377]]

episode-based measures. Additionally, we are finalizing a process for 
stakeholders to develop cost measures, outside the current measure 
development process where all cost measures are developed by CMS' 
measure development contractor.
    In section IV.A.3.e.(2) of this final rule, in regard to 
calculating the final score, we are finalizing our proposal on formulas 
for the complex patient bonus with two separate components (one for 
medical complexity and one for social complexity) and an overall cap of 
10 bonus points. Lastly, we are finalizing our proposal on updating the 
formulas for the bonuses to base them on standardized scores and to 
reward those who fall in higher quintiles and not reward those who fall 
below a cut-off point.
     As discussed in section IV.A.3.f. of this final rule, 
beginning with year 6 of MIPS (2024 MIPS payment year), the performance 
threshold must be either the mean or median of the final scores for all 
MIPS eligible clinicians for a prior period. We are finalizing our 
proposal to establish the performance threshold using the mean and the 
CY 2017 performance period/2019 MIPS payment year data, which will 
result in a performance threshold of 75 points. In addition, for the CY 
2022 performance period/2024 MIPS payment year, the additional 
performance threshold must be set at either (1) the 25th percentile of 
the range of possible final scores above the performance threshold, or 
(2) the 25th percentile of the actual final scores for MIPS eligible 
clinicians with final scores at or above the performance threshold with 
respect to a prior period. We note that under section 1848(q)(6)(C) of 
the Act, the additional MIPS payment adjustment factors for exceptional 
performance are available through the CY 2022 performance period/2024 
MIPS payment year, making this the last year of the additional 
performance threshold and the associated additional MIPS payment 
adjustment factors for exceptional performance. We are also finalizing 
our proposal to establish an additional performance threshold of 89 
points. This is the 25th percentile of actual final scores from the CY 
2017 performance period/2019 MIPS payment year at or above 75 points.
     As discussed in section IV.A.3.h. of this final rule, for 
Third Party Intermediaries, we are finalizing our proposals to modify 
third party intermediary requirements, remedial actions and termination 
policies. Specifically, beginning with the CY 2023 performance period/
2025 MIPS payment year, QCDRs, qualified registries, and health IT 
vendors must support MVPs that are applicable to the MVP participants 
on whose behalf they submit MIPS data. QCDRs, qualified registries, 
and, health IT vendors may also support the APP. We also are finalizing 
our proposal to require QCDRs, qualified registries, health IT vendors, 
and CMS-approved survey vendors to support subgroup reporting beginning 
with the CY 2023 performance period/2025 MIPS payment year. Although we 
did not address any changes to the QCDR measure testing requirement at 
Sec.  414.1400(b)(3)(v)(C)(1) in the CY 2022 PFS proposed rule, based 
on public comments received on our proposals, we are considering 
proposing in next year's rulemaking to further delay this requirement 
for traditional MIPS until the CY 2024 performance period/2026 MIPS 
payment year, instead of the CY 2023 performance period/2025 MIPS 
payment year as previously finalized.
     As discussed in section IV.A.3.i. of this final rule, for 
Public Reporting on Compare Tools hosted by the U.S. Department of 
Health and Human Services (Compare Tools), we are finalizing our 
proposal to publicly report clinician affiliations to certain types of 
facilities (for example, LTCHs, IRFs, etc.). We also solicited comments 
through a RFI to inform the ways in which utilization data may be 
useful to patients and caregivers for their health care decisions. In 
order to give MIPS eligible clinicians time to familiarize themselves 
with MVPs and subgroup reporting, we are finalizing our proposal to 
delay public reporting of new improvement activities and Promoting 
Interoperability measures and attestations reported via MVPs by 1 year, 
and begin publicly reporting subgroup-level performance information in 
PY 2024, on the compare tool hosted by the U.S. Department of Health 
and Human Services. We also are finalizing our proposal to create a 
separate subgroup workflow that would allow subgroup performance 
information to be publicly reported in an online location that can be 
navigated to and from an individual clinician or group profile page. 
This also aligns with the historical approach to report performance 
information at the level that it is submitted.
     As discussed in sections IV.A.4.b. and IV.A.4.c. of this 
rule, we are finalizing our proposal on a change to the APM Incentive 
Payment payment hierarchy to include at each level payment to one or 
more TINs associated with the QP during the payment year.
c. Advancing to Digital Quality Measurement and the Use of Fast 
Healthcare Interoperability Resources (FHIR) in Physician Quality 
Programs--Request for Information
    We aim to move fully to digital quality measurement in CMS quality 
reporting and value-based purchasing programs by 2025. As also detailed 
in the FY 2022 Hospital Inpatient PPS proposed rule (86 FR 25549 
through 25554), as part of this modernization of our quality 
measurement enterprise, we are issuing this request for information 
(RFI). The purpose of this RFI is to gather broad public input solely 
for planning purposes for our transition to digital quality 
measurement. Any updates to specific program requirements related to 
providing data for quality measurement and reporting provisions would 
be addressed through future rulemaking, as necessary. This RFI contains 
five parts:
     Background. This part provides information on our quality 
measurement programs and our goal to move fully to digital quality 
measurement by 2025. This part also provides a summary of recent HHS 
policy developments that are advancing interoperability and could 
support our move towards full digital quality measurement.
     Definition of Digital Quality Measures (dQMs). This part 
provides a potential definition for dQMs. Specific requests for input 
are included in the section.
     Use of Fast Healthcare Interoperability Resources 
(FHIR[supreg]) for current electronic clinical quality measures 
(eCQMs). This part provides information on current activities underway 
to align CMS eCQMs with the FHIR standard and support quality 
measurement via application programming interfaces (APIs), and 
contrasts this approach to current eCQM standards and practice.
     Changes Under Consideration to Advance Digital Quality 
Measurement: Actions in Four Areas to Transition to Digital Quality 
Measures by 2025. This part introduces four possible steps that would 
enable transformation of CMS' quality measurement enterprise to be 
fully digital by 2025. Specific requests for input are included in the 
section.
     Solicitation of Comments. This part lists all requests for 
input included in the sections of this RFI.
(1) Background
    As required by law, we implement quality measurement and value-
based purchasing programs across a broad range of inpatient acute care, 
outpatient, and post-acute care (PAC) settings

[[Page 65378]]

consistent with our mission to improve the quality of health care for 
Americans through measurement, transparency, and increasingly, value-
based purchasing. These quality programs are foundational for 
incentivizing value-based care, contributing to improvements in health 
care, enhancing patient outcomes, and informing consumer choice. In 
October 2020, we launched the CMS Quality Measure Action Plan.\160\ One 
key goal of the plan is to improve the efficiency of quality measures 
by a transition to digital measures and use of advanced data analytics. 
Our objective is to use data and information as essential aspects of a 
healthy, robust healthcare infrastructure to allow for payment and 
management of accountable, value-based care and development of learning 
health organizations.\161\ Consistent with the CMS Quality Measure 
Action Plan, we aim to move fully to digital quality measurement by 
2025. We acknowledge providers within the various care and practice 
settings covered by our quality programs may be at different stages of 
readiness, and therefore, the timeline for achieving full digital 
quality measurement across our quality reporting programs may vary.
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    \160\ https://www.cms.gov/files/document/2021-cms-quality-conference-cms-quality-measurement-action-plan-march-2021.pdf.
    \161\ CMS Quality Measure Action Plan: https://www.cms.gov/files/document/2021-cms-quality-conference-cms-quality-measurement-action-plan-march-2021.pdf.
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    We also continue to evolve the Medicare Promoting Interoperability 
Program's focus on the use of certified electronic health record (EHR) 
technology, from an initial focus on electronic data capture to 
enhancing information exchange and expanding quality measurement (83 FR 
41634). However, reporting data for quality measurement via EHRs 
remains burdensome, and our current approach to quality measurement 
does not readily incorporate emerging data sources such as patient-
reported outcomes (PRO) and patient-generated health data (PGHD).\162\ 
There is a need to streamline our approach to data collection, 
calculation, and reporting to fully leverage clinical and patient-
centered information for measurement, improvement, and learning.
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    \162\ What are patient generated health data: https://www.healthit.gov/topic/otherhot-topics/what-are-patient-generated-health-data.
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    Additionally, advancements in technical standards and associated 
regulatory initiatives to improve interoperability of healthcare data 
are creating an opportunity to significantly improve our quality 
measurement systems. In May 2020, we finalized interoperability 
requirements in the CMS Interoperability and Patient Access final rule 
(85 FR 25510) to support beneficiary access to data held by certain 
payers. At the same time, the Office of the National Coordinator for 
Health Information Technology (ONC) finalized policies in the ONC 21st 
Century Cures Act final rule (85 FR 25642) to advance the 
interoperability of health information technology (IT) as defined in 
section 4003 of the Cures Act, including the ``complete access, 
exchange, and use of all electronically accessible health 
information.'' Closely working with ONC, we collaboratively identified 
Health Level 7 (HL7[supreg]) FHIR Release 4.0.1 as the standard to 
support Application Programming Interface (API) policies in both rules. 
ONC, on behalf of HHS, adopted the HL7 FHIR Release 4.0.1 for APIs and 
related implementation specifications at 45 CFR 170.215. We believe the 
FHIR standard has the potential to be a more efficient and modular 
standard to enable APIs. We also believe this standard enables 
collaboration and information sharing, which is essential for 
delivering high-quality care and better outcomes at a lower cost. By 
aligning technology requirements for payers, health care providers, and 
health IT developers HHS can advance an interoperable health IT 
infrastructure that ensures providers and patients have access to 
health data when and where it is needed.
    In the ONC 21st Century Cures Act final rule, ONC adopted a 
``Standardized API for Patient and Population Services'' certification 
criterion for health IT that requires the use of FHIR Release 4 and 
several implementation specifications. Health IT certified to this 
criterion will offer single patient and multiple patient services that 
can be accessed by third party applications (85 FR 25742).\163\ The ONC 
21st Century Cures Act final rule also requires health IT developers to 
update their certified health IT to support the United States Core Data 
for Interoperability (USCDI) standard.\164\ The scope of patient data 
identified in the USCDI and the data standards that support this data 
set are expected to evolve over time, starting with data specified in 
Version 1 of the USCDI. In November 2020, ONC issued an interim final 
rule with comment period extending the date when health IT developers 
must make technology meeting updated certification criteria available 
under the ONC Health IT Certification Program until December 31, 2022 
(85 FR 70064).\165\
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    \163\ Application Programming Interfaces (API) Resource Guide, 
Version 1.0. Available at https://www.healthit.gov/sites/default/files/page/2020-11/API-Resource-Guide_v1_0.pdf.
    \164\ https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
    \165\ Information Blocking and the ONC Health IT Certification 
Program: Extension of Compliance Dates and Timeframes in Response to 
the Covid-19 Public Health Emergency. Available at https://www.govinfo.gov/content/pkg/FR-2020-11-04/pdf/2020-24376.pdf.
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    The CMS Interoperability and Patient Access final rule (85 FR 
25510) and program policies build on the ONC 21st Century Cures Act 
final rule (85 FR 25642). The CMS Interoperability and Patient Access 
final rule and policies require certain payers (for example, Medicare 
Advantage organizations, Medicaid and CHIP FFS programs, Medicaid 
managed care plans, CHIP managed care entities, and issuers of certain 
Qualified Health Plan [QHP] on the Federally-facilitated Exchanges 
[FFEs]) to implement and maintain a standards-based Patient Access API 
using HL7 FHIR Release 4.0.1 to make available certain data to their 
enrollees and beneficiaries (called ``patients'' in the CMS 
interoperability rule). These certain data include data concerning 
claims and encounters, with the intent to ensure access to their own 
health care information through third-party software applications. The 
rule also established new Conditions of Participation for Medicare and 
Medicaid participating hospitals and critical access hospitals (CAHs), 
requiring them to send electronic notifications to another healthcare 
facility or community provider or practitioner when a patient is 
admitted, discharged, or transferred if the hospital or CAH utilizes an 
electronic medical records system or other electronic administrative 
system which is conformant with the content exchange standard at 45 CFR 
170.205(d)(2) (85 FR 25603). In the CY 2021 PFS final rule (85 FR 
84472), we finalized a policy to align the certified EHR technology 
required for use in the Promoting Interoperability Programs and the 
MIPS Promoting Interoperability performance category with the updates 
to health IT certification criteria finalized in the ONC 21st Century 
Cures Act final rule. Under this policy, MIPS eligible clinicians, and 
eligible hospitals and CAHs participating in the Promoting 
Interoperability Programs, must use technology meeting the updated 
certification criteria for performance and reporting periods beginning 
in 2023 (85 FR 84825).
    The use of APIs can also reduce longstanding barriers to quality 
measurement. Currently, health IT

[[Page 65379]]

developers are required to implement individual measure specifications 
within their health IT products. The health IT developer must also 
accommodate how that product connects with the unique variety of 
systems within a specific care setting.\166\ This may be further 
complicated by systems that integrate a wide range of data schemas. 
This process is burdensome and costly, and it is difficult to reliably 
obtain high quality data across systems. As health IT developers map 
their health IT data to the FHIR standard and related implementation 
specifications, APIs can enable these structured data to be easily 
accessible for quality measurement or other use cases, such as care 
coordination, clinical decision support, and supporting patient access.
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    \166\ The Office of the National Coordinator for Health 
Information Technology, Strategy on Reducing Regulatory and 
Administrative Burden Relating to the Use of Health IT and EHRs, 
Final Report (Feb. 2020). Available at https://www.healthit.gov/sites/default/files/page/2020-02/BurdenReport_0.pdf.
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    We believe the emerging data standardization and interoperability 
enabled by APIs will support the transition to full digital quality 
measurement by 2025, and are committed to exploring and seeking input 
on potential solutions for the transition to digital quality 
measurement as described in this RFI.
(2) Definition of Digital Quality Measures
    In this section we seek to refine the definition of digital quality 
measures (dQMs) to further operationalize our objective \167\ of fully 
transitioning to dQMs by 2025. We previously noted dQMs use ``sources 
of health information that are captured and can be transmitted 
electronically and via interoperable systems.'' (85 FR 84845) In this 
RFI, we solicited input on future elaboration that would define a dQM 
as a software that processes digital data to produce a measure score or 
measure scores. Data sources for dQMs may include administrative 
systems, electronically submitted clinical assessment data, case 
management systems, EHRs, instruments (for example, medical devices and 
wearable devices), patient portals or applications (for example, for 
collection of patient-generated health data), health information 
exchanges (HIEs) or registries, and other sources. We also note that 
dQMs are intended to improve the patient experience including quality 
of care, improve the health of populations, and/or reduce costs.
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    \167\ Centers for Medicare and Medicaid Services. 2021 CMS 
Quality Conference: CMS Quality Measurement Action Plan. 2021. 
https://www.cms.gov/files/document/2021-cms-quality-conference-cms-quality-measurement-action-plan-march-2021.pdf.
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    We discuss one potential approach to developing dQM software in 
section IV.A.1.c of this final rule. In this section, we solicited 
comments on the potential definition of dQMs in this RFI.
    We also solicited feedback on how leveraging advances in technology 
(for example, FHIR APIs) to access and electronically transmit 
interoperable data for dQMs could reinforce other activities to support 
quality measurement and improvement (for example, the aggregation of 
data across multiple data sources, rapid-cycle feedback, and alignment 
of programmatic requirements).
    The transition to dQMs relies on advances in data standardization 
and interoperability. As providers and payers work to implement the 
required advances in interoperability over the next several years, we 
will continue to support reporting of eCQMs through CMS quality 
reporting programs and through the Promoting Interoperability 
programs.\168\ These fully digital measures continue to be important 
drivers of interoperability advancement and learning. As discussed in 
the next section, CMS is currently re-specifying and testing these 
measures to use FHIR rather than the currently adopted Quality Data 
Model (QDM) in anticipation of the wider use of FHIR standards. CMS 
intends to apply significant components of the output of this work, 
such as the re-specified measure logic and the learning done through 
measure testing with FHIR APIs, to define and build future dQMs that 
take advantage of the expansion of standardized, interoperable data.
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    \168\ eCQI Resource Center, https://ecqi.healthit.gov/.
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(3) Use of FHIR for Current eCQMs
    Since we adopted eCQMs in our hospital and clinician quality 
programs, we have heard from stakeholders about the technological 
challenges, burden, and related costs of reporting eCQM data. The CMS 
eCQM Strategy Project engaged with stakeholders through site visits and 
listening sessions with health systems and provider organizations to 
learn about their experiences. This stakeholder feedback identified 
recommendations to improve processes related to alignment; development; 
implementation and reporting; certification; and communication, 
education, and outreach. Over the past 2 years, we have focused on 
opportunities to streamline and modernize quality data collection and 
reporting processes, such as exploring FHIR[supreg] (http://hl7.org/fhir) as a framework for measure structure and data submission for 
quality reporting programs, specifically for eCQMs. FHIR is a free and 
open source standards framework (in both commercial and government 
settings) created by Health Level Seven International (HL7[supreg]) 
that establishes a common language and process for all health 
information technology. FHIR allows systems to communicate and 
information to be shared seamlessly, with a lower burden for hospitals, 
providers, clinicians, vendors, and quality measurement stakeholders. 
Specifically, for quality reporting, FHIR enables representing the data 
in eCQMs, as well as provides a structure for eCQMs and reporting, 
using FHIR as the standard for all. Whereas today, multiple standards 
being used to report eCQMs is challenging and burdensome.
    We are working to convert current eCQMs to the FHIR standard. We 
are currently testing the exchange of data elements represented in FHIR 
to CMS through ongoing HL7 Connectathons and integrated system testing 
by using and refining implementation guides. Submitting data through 
FHIR APIs has the potential to improve data exchange by providing 
consistent security, performance, scalability, and structure to all 
users. In addition, development of FHIR APIs could decrease provider 
burden by automating more of the measure data collection process. We 
continue to explore and expand potential applications of the FHIR 
standard and testing with eCQM use cases, and we are considering a 
transition to FHIR-based quality reporting with the use of the FHIR 
standard for eCQMs in quality and value-based reporting programs. As we 
move to an all-dQM format for quality programs, we are depending on 
testing results and community readiness to improve interoperability, 
reduce burden, and facilitate better patient care. We will continue to 
consider how to leverage the interoperability advantages offered by the 
FHIR standards and API-based data submission, including digital quality 
measurement.
(4) Changes Under Consideration To Advance Digital Quality Measurement: 
Potential Actions in Four Areas To Transition to Digital Quality 
Measures by 2025
    Building on the advances in interoperability and learning from 
testing of FHIR-converted eCQMs, we aim to move fully to dQMs, 
originating from sources of health information that

[[Page 65380]]

are captured and can be transmitted electronically via interoperable 
systems, by 2025.
    To enable this transformation, we are considering further 
modernization of the quality measurement enterprise in four major ways: 
(1) Leverage and advance standards for digital data and obtain all EHR 
data required for quality measures via provider FHIR-based APIs; (2) 
redesign our quality measures to be self-contained tools; (3) better 
support data aggregation; and (4) work to align measure requirements 
across our reporting programs, other Federal programs and agencies, and 
the private sector where appropriate.
    These changes would enable us to collect and utilize more timely, 
actionable, and standardized data from diverse sources and care 
settings to improve the scope and quality of data used in quality 
reporting and payment programs, reduce quality reporting burden, and 
make results available to stakeholders in a rapid-cycle fashion. Data 
collection and reporting efforts would become more efficient, supported 
by advances in interoperability and data standardization. Aggregation 
of data from multiple sources would allow assessments of costs and 
outcomes to be measured across multiple care settings for an individual 
patient or clinical conditions. We believe that aggregating data for 
measurement can incorporate a more holistic assessment of an 
individual's health and health care and produce the rich set of data 
needed to enable patients and caregivers to make informed decisions by 
combining data from multiple sources (for example, patient reported 
data, EHR data, and claims data) for measurement.
    Perhaps most importantly, these steps would help us deliver on the 
full promise of quality measurement and drive us toward a learning 
health system that transforms healthcare quality, safety, and 
coordination and effectively measures and achieves value-based care. 
The shift from a static to a learning health system hinges on the 
interoperability of healthcare data, and the use of standardized data. 
dQMs would leverage this interoperability to deliver on the promise of 
a learning health system wherein standards-based data sharing and 
analysis, rapid-cycle feedback, and quality measurement and incentives 
are aligned for continuous improvement in patient-centered care. 
Similarly, standardized, interoperable data used for measurement can 
also be used for other use cases, such as clinical decision support, 
care coordination and care decision support, which impacts health care 
and care quality.
    We solicited comments on four potential future actions that would 
enable transformation to a fully digital quality measurement enterprise 
by 2025.
(a) Leveraging and Advancing Standards for Digital Data and Obtaining 
All EHR Data Required for Quality Measures via Provider FHIR-Based APIs
    We are considering targeting the data required for our quality 
measures that utilize EHR data to be data retrieved via FHIR-based APIs 
based on standardized, interoperable data. Utilizing standardized data 
for EHR-based measurement (based on FHIR and associated implementation 
guides) and aligning where possible with interoperability requirements 
can eliminate the data collection burden providers currently experience 
with required chart-abstracted quality measures and reduce the burden 
of reporting digital quality measure results. We can fully leverage 
this advance to adapt eCQMs and expand to other dQMs through the 
adoption of interoperable standards across other digital data sources. 
We are considering methods and approaches to leverage the 
interoperability data requirements for APIs in certified health IT set 
by the ONC 21st Century Cures Act final rule to support modernization 
of CMS quality measure reporting. As discussed previously, these 
requirements will be included in certified technology in future years 
(85 FR 84825) including availability of data included in the USCDI via 
standards-based APIs, and CMS will require clinicians and hospitals 
participating in MIPS and the Promoting Interoperability Programs, 
respectively, to transition to use of certified technology updated 
consistent with the 2015 Cures Edition Update (85 FR 84825).
    Digital data used for measurement could also expand beyond data 
captured in traditional clinical settings, administrative claims data, 
and EHRs. Many important data sources are not currently captured 
digitally, such as survey and PGHD. We intend to work to innovate and 
broaden the digital data used across the quality measurement enterprise 
beyond the clinical EHR and administrative claims. Agreed upon 
standards for these data, and associated implementation guides will be 
important for interoperability and quality measurement. We will 
consider developing clear guidelines and requirements for these digital 
data that align with interoperability requirements, for example, 
requirements for expressing data in standards, exposing data via 
standards-based APIs, and incentivizing technologies that innovate data 
capture and interoperability.
    High quality data are also essential for reliable and valid 
measurement. Hence, in implementing the shift to collect all clinical 
EHR data via FHIR-based APIs, we would support efforts to strengthen 
and test the quality of the data obtained through FHIR-based APIs for 
quality measurement. We currently conduct audits of electronic data 
submitted to the Hospital IQR Program with functions including checks 
for data completeness and data accuracy, confirmation of proper data 
formatting, alignment with standards, and appropriate data cleaning (82 
FR 38398 through 38402). These functions would continue and be applied 
to dQMs and further expanded to automate the manual validation of the 
data compared to the original data source (for example, the medical 
record) where possible. Analytic advancements such as natural language 
processing, big data analytics, and artificial intelligence, can 
support this evolution. These techniques can be applied to validating 
observed patterns in data and inferences or conclusions drawn from 
associations, as data are received, to ensure high quality data are 
used for measurement.
    We solicited feedback on the goal of aligning data needed for 
quality measurement with interoperability requirements and the 
strengths and limitations of this approach. We also solicited feedback 
on the importance of and approaches to supporting inclusion of PGHD and 
other currently non-standardized data. We also welcome comment on 
approaches for testing data quality and validity.
(b) Redesigning Quality Measures To Be Self-Contained Tools
    We are considering approaches for including quality measures that 
take advantage of standardized data and interoperability requirements 
that have expanded flexibility and functionality compared to CMS' 
current eCQMs. We are considering defining and developing dQM software 
as end-to-end measure calculation solutions that retrieve data from 
primarily FHIR-based resources maintained by providers, payers, CMS, 
and others; calculate measure score(s), and produce reports. In 
general, we believe to optimize the use of standardized and 
interoperable data, the software solution for dQMs should do the 
following:
     Have the flexibility to support calculation of single or 
multiple quality measure(s).
     Perform three functions--

[[Page 65381]]

    ++ Obtain data via automated queries from a broad set of digital 
data sources (initially from EHRs, and in the future from claims, PRO, 
and PGHD);
    ++ Calculate the measure score according to measure logic; and
    ++ Generate measure score report(s).
     Be compatible with any data source systems that implement 
standard interoperability requirements.
     Exist separately from digital data source(s) and respect 
the limitations of the functionality of those data sources.
     Be tested and updated independently of the data source 
systems.
     Operate in accordance with health information protection 
requirements under applicable laws and comply with governance functions 
for health information exchange.
     Have the flexibility to be deployed by individual health 
systems, health IT vendors, data aggregators, and health plans; and/or 
run by CMS depending on the program and measure needs and 
specifications.
     Be designed to enable easy installation for supplemental 
uses by medical professionals and other non-technical end-users, such 
as local calculation of quality measure scores or quality improvement.
     Have the flexibility to employ current and evolving 
advanced analytic approaches such as natural language processing.
     Be designed to support pro-competitive practices for 
development, maintenance, and implementation, as well as diffusion of 
quality measurement and related quality improvement and clinical tools 
through, for example, the use of open-source core architecture.
    We solicited comments on these suggested functionalities and other 
additional functionalities that quality measure tools should ideally 
have particularly in the context of the possible expanding availability 
of standardized and interoperable data (for example, standardized EHR 
data available via FHIR-based APIs).
    We are also interested whether and how this more open, agile 
strategy may facilitate broader engagement in quality measure 
development, the use of tools developed for measurement for local 
quality improvement, and/or the application of quality tools for 
related purposes such as public health or research.
(c) Building a Pathway to Data Aggregation in Support of Quality 
Measurement
    Using multiple sources of collected data to inform measurement 
would reduce data fragmentation (or, different pieces of data regarding 
a single patient stored in many different places). Additionally, we are 
considering expanding and establishing policies and processes for data 
aggregation and measure calculation by third-party aggregators that 
include, but are not limited to, HIEs and clinical registries. Health 
IT vendors that meet the requirements of a Qualified Clinical Data 
Registries (QCDRs) and qualified registries that report quality 
measures for eligible clinicians in the MIPS program are potential 
examples \169\ at section IV.A.3.g. of this final rule and can also 
support measure reporting.
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    \169\ Calendar Year (CY) 2021 Physician Fee Schedule Final Rule: 
Finalized (New and Updated) Qualified Clinical Data Registry (QCDR) 
and Qualified Registry Policies, https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1362/QCDR%20and%20QR%20Updates%202021%20Final%20Rule%20Fact%20Sheet.pdf.
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    We solicited feedback on aggregation of data from multiple sources 
to inform measurement and potential policy considerations. We also 
solicited feedback on the role data intermediaries can and should play 
in CMS quality measure reporting in collaboration with providers, and 
how we can best facilitate and enable aggregation.
(d) Potential Future Alignment of Measures Across Reporting Programs, 
Federal and State Agencies, and the Private Sector
    We are committed to using policy levers and working with 
stakeholders to solve the issue of interoperable data exchange and to 
transition to full digital quality measurement. We are considering the 
future potential development and multi-staged implementation of a 
common portfolio of dQMs across our regulated programs, agencies, and 
private payers. This common portfolio would require alignment of: (1) 
Measure concepts and specifications including narrative statements, 
measure logic, and value sets; and (2) the individual data elements 
used to build these measure specifications and calculate the measure 
logic. Further, the required data elements would be limited to 
standardized, interoperable data elements to the fullest extent 
possible; hence, part of the alignment strategy will be the 
consideration and advancement of data standards and implementation 
guides for key data elements. We would coordinate closely with quality 
measure developers, Federal and State agencies, and private payers to 
develop and to maintain a cohesive dQM portfolio that meets our 
programmatic requirements and that fully aligns across Federal and 
State agencies and payers to the extent possible.
    We intend for this coordination to be ongoing and allow for 
continuous refinement to ensure quality measures remain aligned with 
evolving healthcare practices and priorities (for example, PROs, 
disparities, and care coordination), and track with the transformation 
of data collection, alignment with health IT module updates including 
capabilities and standards adopted by ONC (for example, standards to 
enable APIs). It would focus on the quality domains of safety, 
timeliness, efficiency, effectiveness, equitability, and patient-
centeredness. It would leverage several existing Federal and public-
private efforts including our Meaningful Measures 2.0 Framework; the 
Federal Electronic Health Record Modernization (Department of Defense 
and Veterans Affairs [DoD/VA]); the Agency for Healthcare Research and 
Quality's Clinical Decision Support Initiative; the Centers for Disease 
Control and Prevention's Adapting Clinical Guidelines for the Digital 
Age initiative; Core Quality Measure Collaborative, which convenes 
stakeholders from America's Health Insurance Plans (AHIP), CMS, 
National Quality Forum (NQF), provider organizations, private payers, 
and consumers and develops consensus on quality measures for provider 
specialties; and the NQF-convened Measure Applications Partnership 
(MAP), which recommends measures for use in public payment and 
reporting programs. We would coordinate with HL7's ongoing work to 
advance FHIR resources in critical areas to support patient care and 
measurement such as social determinants of health. Through this 
coordination, we would identify which existing measures could be used 
or evolved to be used as dQMs, in recognition of current healthcare 
practice and priorities.
    This multi-stakeholder, joint Federal, State, and industry effort, 
made possible and enabled by the pending advances towards true 
interoperability, would yield a significantly improved quality 
measurement enterprise. The success of the dQM portfolio would be 
enhanced by the degree to which the measures achieve our programmatic 
requirements for measures, as well as the requirements of other 
agencies and payers.
    We solicited feedback on initial priority areas for the dQM 
portfolio given evolving interoperability requirements (for example, 
measurement areas, measure requirements, tools, and data standards).

[[Page 65382]]

We also seek to identify opportunities to collaborate with other 
Federal agencies, States, and the private sector to adopt standards and 
technology-driven solutions to address our quality measurement 
priorities across sectors.
(5) Solicitation of Comments
    As noted previously, we solicited input on the future development 
of the following:
(a) Definition of Digital Quality Measures
    We solicited feedback on the following as described in section 
IV.A.1.c. of this final rule:
     Do you have feedback on the dQM definition?
     Does this approach to defining and deploying dQMs to 
interface with FHIR-based APIs seem promising? We also welcome more 
specific comments on the attributes or functions to support such an 
approach of deploying dQMs.
(b) Use of FHIR for Current eCQMs
    We solicited feedback on the following as described in section 
IV.A.1.c. of this final rule:
     Do you agree that a transition to FHIR-based quality 
reporting can reduce burden on health IT vendors and providers? Please 
explain if you do not agree.
     Would access to near real-time quality measure scores 
benefit your practice? How so?
     What parts of the current CMS QRDA IGs cause the most 
burden (please explain the primary drivers of burden)?
     In what ways could a CMS FHIR Reporting IG be crafted to 
reduce burden on providers and vendors?
(c) Changes Under Consideration To Advance Digital Quality Measurement
    Actions in Four Areas to Transition to Digital Quality Measures by 
2025.
     We solicited feedback on the following as described in 
section IV.A.1.c. of this final rule:
    ++ Do you agree with the goal of aligning data needed for quality 
measurement with interoperability requirements? What are the strengths 
and limitations of this approach? Are there specific FHIR 
Implementation Guides suggested for consideration?
    ++ How important is a data standardization approach that also 
supports inclusion of PGHD and other currently non-standardized data?
    ++ What are possible approaches for testing data quality and 
validity?
     We solicited feedback on the following as described in 
section IV.A.1.c. of this final rule:
    ++ What functionalities, described in section (4)(b) or others, 
should quality measure tools ideally have in the context of the pending 
availability of standardized and interoperable data (for example, 
standardized EHR data available via FHIR-based APIs)?
    ++ How would this more open, agile strategy for end-to-end measure 
calculation facilitate broader engagement in quality measure 
development, the use of tools developed for measurement for local 
quality improvement, and/or the application of quality tools for 
related purposes such as public health or research?
     We solicited feedback on the following as described in 
section IV.A.1.c. of this final rule:
    ++ What are key policy considerations for aggregation of data from 
multiple sources being used to inform measurement?
    ++ What role can or should data aggregators play in CMS quality 
measure reporting in collaboration with providers? How can CMS best 
facilitate and enable aggregation?
     We solicited feedback on the following as described in 
section IVA.1.c. of this final rule:
    ++ What are initial priority areas for the dQM portfolio given 
evolving interoperability requirements (for example, measurement areas, 
measure requirements, tools)?
    ++ We also seek to identify opportunities to collaborate with other 
Federal agencies, States, and the private sector to adopt standards and 
technology-driven solutions to address our quality measurement 
priorities and across sectors.
    Commenters should consider provisions in the CMS Interoperability 
and Patient Access final rule (85 FR 25510), CMS CY 2021 PFS final rule 
(85 FR 84472), and the ONC 21st Century Cures Act final rule (85 FR 
25642).
    We plan to continue working with other agencies and stakeholders to 
coordinate and to inform any potential transition to dQMs by 2025. 
While we will not be responding to specific comments submitted in 
response to this Request for Information in the CY 2022 PFS final rule, 
we will actively consider all input as we develop future regulatory 
proposals or future subregulatory policy guidance. Any updates to 
specific program requirements related to quality measurement and 
reporting provisions may be addressed through separate and future 
notice-and-comment rulemaking, as necessary.
    We thank commenters for the feedback received through this request 
for information. We may consider this information to inform future 
rulemaking.
d. Closing the Health Equity Gap in CMS Clinician Quality Programs--
Request for Information (RFI)
    Persistent inequities in health care outcomes exist in the United 
States, including among Medicare patients.\170\ In recognition of 
persistent health disparities and the importance of closing the health 
equity gap, we request information on revising several related CMS 
programs to make reporting of health disparities based on social risk 
factors and race and ethnicity more comprehensive and actionable for 
hospitals, providers, and patients. The following is part of an ongoing 
effort across CMS to evaluate appropriate initiatives to reduce health 
disparities. Feedback will be used to inform the creation of a future, 
comprehensive, RFI focused on closing the health equity gap in CMS 
programs and policies (86 FR 25554 through 255561).
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    \170\ Ochieng N, Cubanski J, Neuman T, Artiga S, Damico A. 
Racial and Ethnic Health Inequities and Medicare. KFF. February 
2021.
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    Belonging to a racial or ethnic minority group; living with a 
disability; being a member of the lesbian, gay, bisexual, transgender, 
and queer (LGBTQ+) community; living in a rural area; or being near or 
below the poverty level, is often associated with worse health 
outcomes.171 172 173 174 175 176 177 178 Such disparities in 
health outcomes are the result of number of factors, but importantly 
for CMS programs, although not the sole determinant, poor access and 
provision of lower quality health care contribute to health 
disparities. For instance, numerous studies have shown

[[Page 65383]]

among Medicare beneficiaries, racial and ethnic minority individuals 
often receive lower quality of care, report lower experiences of care, 
and experience more frequent hospital readmissions and procedural 
complications.179 180 181 182 183 184
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    \171\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for 
Medicare Beneficiaries by Race and Site of Care. JAMA. 
2011;305(7):675-681.
    \172\ Lindenauer PK, Lagu T, Rothberg MB, et al. Income 
Inequality and 30 Day Outcomes After Acute Myocardial Infarction, 
Heart Failure, and Pneumonia: Retrospective Cohort Study. British 
Medical Journal. 2013;346.
    \173\ Trivedi AN, Nsa W, Hausmann LRM, et al. Quality and Equity 
of Care in U.S. Hospitals. New England Journal of Medicine. 
2014;371(24):2298-2308.
    \174\ Polyakova, M., et al. Racial Disparities In Excess All-
Cause Mortality During The Early COVID-19 Pandemic Varied 
Substantially Across States. Health Affairs. 2021; 40(2): 307-316.
    \175\ Rural Health Research Gateway. Rural Communities: Age, 
Income, and Health Status. Rural Health Research Recap. November 
2018.
    \176\ https://www.minorityhealth.hhs.gov/assets/PDF/Update_HHS_Disparities_Dept-FY2020.pdf.
    \177\ www.cdc.gov/mmwr/volumes/70/wr/mm7005a1.htm.
    \178\ Poteat TC, Reisner SL, Miller M, Wirtz AL. COVID-19 
Vulnerability of Transgender Women With and Without HIV Infection in 
the Eastern and Southern U.S. Preprint. medRxiv. 
2020;2020.07.21.20159327. Published 2020 Jul 24. doi:10.1101/
2020.07.21.20159327.
    \179\ Martino, SC, Elliott, MN, Dembosky, JW, Hambarsoomian, K, 
Burkhart, Q, Klein, DJ, Gildner, J, and Haviland, AM. Racial, 
Ethnic, and Gender Disparities in Health Care in Medicare Advantage. 
Baltimore, MD: CMS Office of Minority Health. 2020.
    \180\ Guide to Reducing Disparities in Readmissions. CMS Office 
of Minority Health. Revised August 2018. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
    \181\ Singh JA, Lu X, Rosenthal GE, Ibrahim S, Cram P. Racial 
disparities in knee and hip total joint arthroplasty: An 18-year 
analysis of national Medicare data. Ann Rheum Dis. 2014 
Dec;73(12):2107-15.
    \182\ Rivera-Hernandez M, Rahman M, Mor V, Trivedi AN. Racial 
Disparities in Readmission Rates among Patients Discharged to 
Skilled Nursing Facilities. J Am Geriatr Soc. 2019 Aug;67(8):1672-
1679.
    \183\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for 
Medicare Beneficiaries by Race and Site of Care. JAMA. 
2011;305(7):675-681.
    \184\ Tsai TC, Orav EJ, Joynt KE. Disparities in surgical 30-day 
readmission rates for Medicare beneficiaries by race and site of 
care. Ann Surg. Jun 2014;259(6):1086-1090.
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    We are committed to achieving equity in health care outcomes for 
Medicare beneficiaries by supporting providers in quality improvement 
activities to reduce health inequities, enabling them to make more 
informed decisions, and promoting provider accountability for health 
care disparities.\185\ For the purposes of this rule, we are using a 
definition of equity established in Executive Order 13985, issued on 
January 25, 2021, as ``the consistent and systematic fair, just, and 
impartial treatment of all individuals, including individuals who 
belong to underserved communities who have been denied such treatment, 
such as Black, Latino, and Indigenous and Native American persons, 
Asian Americans and Pacific Islanders and other persons of color; 
members of religious minorities; lesbian, gay, bisexual, transgender, 
and queer (LGBTQ+) persons; persons with disabilities; persons who live 
in rural areas; and persons otherwise adversely affected by persistent 
poverty or inequality.'' \186\ We note this definition was recently 
established and provides a useful, common definition for equity across 
different areas of government, although numerous other definitions of 
equity exist.
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    \185\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
    \186\ https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government.
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    Our ongoing commitment to closing the equity gap in CMS quality 
programs is demonstrated by a portfolio of programs aimed at making 
information on the quality of health care providers and services, 
including disparities, more transparent to consumers and providers. The 
CMS Equity Plan for Improving Quality in Medicare outlines a path to 
equity which aims to support Quality Improvement Network Quality 
Improvement Organizations (QIN-QIOs); Federal, State, local, and tribal 
organizations; providers; researchers; policymakers; beneficiaries and 
their families; and other stakeholders in activities to achieve health 
equity.\187\ The CMS Equity Plan for Improving Quality in Medicare 
focuses on three core priority areas which inform our policies and 
programs: (1) Increasing understanding and awareness of health 
disparities; (2) developing and disseminating solutions to achieve 
health equity; and (3) implementing sustainable actions to achieve 
health equity.\188\ The CMS Quality Strategy \189\ and Meaningful 
Measures Framework \190\ also include elimination of racial and ethnic 
disparities as central principles. Our efforts aimed at closing the 
health equity gap to date have included providing transparency of 
health disparities, supporting providers with evidence-informed 
solutions to achieve health equity, and reporting to providers on gaps 
in quality as follows:
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    \187\ Centers for Medicare & Medicaid Services Office of 
Minority Health. The CMS Equity Plan for Improving Quality in 
Medicare. 2015-2021. https://www.cms.gov/About-CMS/Agency-Information/OMH/OMH_Dwnld-CMS_EquityPlanforMedicare_090615.pdf.
    \188\ Centers for Medicare & Medicaid Services Office of 
Minority Health. The CMS Equity Plan for Improving Quality in 
Medicare. https://www.cms.gov/About-CMS/Agency-Information/OMH/OMH_Dwnld-CMS_EquityPlanforMedicare_090615.pdf.
    \189\ Centers for Medicare & Medicaid Services. CMS Quality 
Strategy. 2016. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
    \190\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.
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     The CMS Mapping Medicare Disparities Tool which is an 
interactive map which identifies areas of disparities and is a starting 
point to understand and investigate geographic, racial and ethnic 
differences in health outcomes for Medicare patients.\191\
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    \191\ https://www.cms.gov/About-CMS/Agency-Information/OMH/OMH-Mapping-Medicare-Disparities.
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     The Racial, Ethnic, and Gender Disparities in Health Care 
in Medicare Advantage Stratified Report, which highlights racial and 
ethnic differences in health care experiences and clinical care, 
compares quality of care for women and men, and looks at racial and 
ethnic differences in quality of care among women and men separately 
for Medicare Advantage plans.\192\
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    \192\ https://www.cms.gov/About-CMS/Agency-Information/OMH/research-and-data/statistics-and-data/stratified-reporting.
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     The Rural-Urban Disparities in Health Care in Medicare 
Report which details rural-urban differences in health care experiences 
and clinical care.\193\
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    \193\ Centers for Medicare & Medicaid Services. Rural-Urban 
Disparities in Health Care in Medicare. 2019. https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural-Urban-Disparities-in-Health-Care-in-Medicare-Report.pdf.
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     The Standardized Patient Assessment Data Elements for 
certain post-acute care Quality Reporting Programs, which now includes 
data reporting for race and ethnicity and preferred language, in 
addition to screening questions for social needs (84 FR 42536 through 
42588)
     The CMS Innovation Center's Accountable Health Communities 
Model which includes standardized collection of health-related social 
needs data.
     The Guide to Reducing Disparities which provides an 
overview of key issues related to disparities in readmissions and 
reviews set of activities which can help hospital leaders reduce 
readmissions in diverse populations.\194\
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    \194\ Guide to Reducing Disparities in Readmissions. CMS Office 
of Minority Health. Revised August 2018. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
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     The CMS Disparity Methods which provide hospital-level 
confidential results stratified by dual eligibility for condition-
specific readmission measures currently included in the Hospital 
Readmissions Reduction Program (see 84 FR 42496 through 42500 for a 
discussion of using stratified data in additional measures).
    These programs are informed by reports by the National Academies of 
Science, Engineering and Medicine (NASEM) \195\ and the Office of the 
Assistant Secretary for Planning and Evaluation (ASPE) \196\ which have 
examined the influence of social risk factors on several of our quality 
programs. In this RFI, we discuss

[[Page 65384]]

initiatives specific to further bridging the health equity gap within 
the MIPS track of the Quality Payment Program.
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    \195\ National Academies of Sciences, Engineering, and Medicine. 
2016. Accounting for Social Risk Factors in Medicare Payment: 
Identifying Social Risk Factors. Washington, DC: The National 
Academies Press. https://doi.org/10.17226/21858.
    \196\ https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
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    In Appendix 2: Improvement Activities of this final rule, we 
discussed an improvement activity titled ``create and implement an 
anti-racism plan''. This improvement activity acknowledges it is 
insufficient to gather and analyze data by race, and document 
disparities by different population groups. Rather, it emphasizes 
systemic racism is the root cause for differences in health outcomes 
between socially defined racial groups. Further, we also proposed to 
modify five existing improvement activities to address health equity. 
We note that some improvement activities within our current Inventory 
already aim to improve equity. We believe further modifying them can 
more explicitly link the activity to health equity without changing the 
core activity. In other cases, our proposals to modify an activity 
fundamentally shifts the activity to focus on health equity 
specifically.
    Additionally, in the CY 2022 PFS proposed rule (86 FR 39439 through 
39446), we proposed to update the complex patient bonus formula. We 
specifically refer to ASPE's second report, Social Risk and Performance 
in Medicare's Value-Based Purchasing Programs, which was publicly-
released in May 2020.\197\ The second report builds on the analyses 
included in the initial report and provides additional insight for 
addressing risk factors in MIPS and other value-based payment programs. 
More specifically, the report has a 3-pronged strategy approach to: 
Measure and report quality; set high, fair quality standards; and 
reward and support better outcomes for beneficiaries with social risk. 
As a part of this 3-pronged strategy, the report supports use of the 
complex patient bonus in MIPS, explaining that it is well supported 
because this policy gives additional points to clinicians with a higher 
share of medically and socially complex patients and does not lower the 
standard of care. Hence, although, ASPE's reports to Congress support 
the use of a complex patient bonus at the final score level, we respond 
to other findings reported in other literature studies by identifying 
ways to make the complex patient bonus more targeted for clinicians 
caring for high risk and complex patients and to mitigate differences 
in resources that affect MIPS scores. Hence, the proposed formula is 
based on standardized scores and to reward only those clinicians who 
fall in higher quintiles in order to focus the bonus on those serving a 
higher proportion of more complex and vulnerable patients.
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    \197\ Social Risk and Performance in Medicare's Value-Based 
Purchasing Programs. ASPE Second Report. May 2020. https://aspe.hhs.gov/pdf-report/second-impact-report-to-congress.
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    Lastly, we acknowledge that small practices within the MIPS program 
often face challenges in many ways. More specifically, as noted in 
section IV.A.3.e.(2) of this final rule, the Quality Payment Program 
gives an advantage to large organizations because such organizations 
have more resources invested in the infrastructure required to track 
and report measures to MIPS (82 FR 53776). In response to the feedback 
on the potential burden on small practices, we have established special 
policies available for small practices including the small practice 
bonus and special scoring policies. For example, in the CY 2018 QPP 
final rule (82 FR 53682 through 53683), we established a significant 
hardship exception for small practices for the Promoting 
Interoperability performance category. To further alleviate the burden 
on small practices and reduce this disparity between large and small 
practices, we proposed in section IV.A.3.d.(4) to automatically 
redistribute the Promoting Interoperability performance category weight 
for any small practice that does not submit data for the performance 
category, and in section IV.A.3.e.(2), we proposed different 
redistribution weights for small practices.
    We are committed to advancing health equity by improving data 
collection to better measure and analyze disparities across programs 
and policies.\198\ We have been considering, among other things, 
expanding our efforts to provide stratified data for additional social 
risk factors and measures, optimizing the ease-of-use of the results, 
enhancing public transparency of equity results, and building towards 
provider accountability for health equity. We solicited public comments 
on two potential future expansions of the CMS Disparity Methods, 
including: (1) Future potential stratification of quality measure 
results by race and ethnicity, and (2) improving demographic data 
collection.
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    \198\ Centers for Medicare Services. CMS Quality Strategy. 2016. 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
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(1) Future Potential Stratification of Quality Measure Results by Race 
and Ethnicity
    The Administration's Executive Order on Advancing Racial Equity and 
Support for Underserved Communities Through the Federal Government 
directs agencies to assess potential barriers that underserved 
communities and individuals may face to enrollment in and access to 
benefits and services in Federal programs. As summarized previously, 
studies have shown that among Medicare beneficiaries, racial and ethnic 
minority persons often experience worse health outcomes, including more 
frequent hospital readmissions and procedural complications. We are 
considering expanding the disparity methods to include stratification 
of the condition/procedure-specific readmission measures by race and 
ethnicity. The 1997 Office of Management and Budget (OMB) Revisions to 
the Standards for the Collection of Federal Data on Race and Ethnicity, 
outlines the racial and ethnic categories which may potentially be used 
for reporting the disparity methods, which we note are intended to be 
considered as social and cultural, and not biological or genetic.\199\ 
The 1997 OMB Standard lists five minimum categories of race: (1) 
American Indian or Alaska Native; (2) Asian; (3) Black or African 
American; (4) Native Hawaiian or Other Pacific Islander; (5) and White. 
In the OMB standards, Hispanic or Latino is the only ethnicity category 
included, and since race and ethnicity are two separate and distinct 
concepts, persons who report themselves as Hispanic or Latino can be of 
any race.\200\ Another example, the ``Race & Ethnicity--CDC'' code 
system in PHIN Vocabulary Access and Distribution System (VADS) \201\ 
permits a much more granular structured recording of a patient's race 
and ethnicity with its inclusion of over 900 concepts for race and 
ethnicity. The recording and exchange of patient race and ethnicity at 
such a granular level can facilitate the accurate identification and 
analysis of health disparities based on race and ethnicity. Further, 
the ``Race & Ethnicity--CDC'' code system has a hierarchy that rolls up 
to the OMB

[[Page 65385]]

minimum categories for race and ethnicity and, thus, supports 
aggregation and reporting using the OMB standard. ONC includes both the 
CDC and OMB standards in its criterion for certified health IT 
products.\202\ For race and ethnicity, a certified health IT product 
must be able to express both detailed races and ethnicities using any 
of the 900 plus concepts in the ``Race & Ethnicity--CDC'' code system 
in the Public Health Information Network (PHIN) Vocabulary Access and 
Distribution Systems (VADS), as well as aggregate each one of a 
patient's races and ethnicities to the categories in the OMB standard 
for race and ethnicity. This approach can reduce burden on providers 
recording demographics using certified products.
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    \199\ Executive Office of the President Office of Management and 
Budget, Office of Information and Regulatory Affairs. Revisions to 
the standards for the classification of Federal data on race and 
ethnicity. Vol 62. Federal Register. 1997:58782-58790.
    \200\ https://www.census.gov/topics/population/hispanic-origin/about.html.
    \201\ https://phinvads.cdc.gov/vads/ViewValueSet.action?id=67D34BBC-617F-DD11-B38D-00188B398520.
    \202\ See https://www.healthit.gov/isa/representing-patient-race-and-ethnicity. For more information about the certification 
criterion for ``Demographics'' in the ONC Health IT Certification 
program, see https://www.healthit.gov/test-method/demographics.
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    Self-reported race and ethnicity data are the gold standard for 
classifying an individual according to race or ethnicity. However, CMS 
currently does not consistently collect self-reported race and 
ethnicity for the Medicare program, but instead gets the data from the 
Social Security Administration (SSA) and the data accuracy and 
comprehensiveness have proven challenging despite capabilities in the 
marketplace via certified health IT products. Historical inaccuracies 
in Federal data systems and limited collection classifications have 
also contributed to the limited quality of race and ethnicity 
information in our administrative data systems.\203\ In recent decades, 
to address these data quality issues, we have undertaken numerous 
initiatives, including updating data taxonomies and conducting direct 
mailings to some beneficiaries to enable more comprehensive racial and 
ethnic identification.204 205 Despite those efforts, studies 
reveal varying data accuracy in identification of racial and ethnic 
groups in Medicare administrative data, with higher sensitivity for 
correctly identifying white and Black individuals, and lower 
sensitivity for correctly identifying individuals of Hispanic ethnicity 
or of Asian/Pacific Islander (API) and American Indian/Alaskan Native 
race.\206\ Incorrectly classified race or ethnicity may result in 
overestimation or underestimation in the quality of care received by 
certain groups of beneficiaries.
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    \203\ Zaslavasky AM, Ayanian JZ, Zaborski LB. The validity of 
racial and ethnic codes in enrollment data for Medicare 
beneficiaries. Health Services Research, 2012 Jun (47) (3 Pt 2): 
1300-21.
    \204\ Filice CE, Joynt KE. Examining Race and Ethnicity 
Information in Medicare Administrative Data. Med Care. 2017; 
55(12):e170-e176. doi:10.1097/MLR.0000000000000608.
    \205\ Eicheldinger, C., & Bonito, A. (2008). More accurate 
racial and ethnic codes for Medicare administrative data. Health 
Care Financing Review, 29(3), 27-42.
    \206\ Zaslavsky AM, Ayanian JZ, Zaborski LB. The validity of 
race and ethnicity in enrollment data for Medicare beneficiaries. 
Health Serv Res. 2012 Jun;47(3 Pt 2):1300-21.
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    We continue to work with public and private partners to better 
collect and leverage data on social risk to improve our understanding 
of how these factors can be better measured in order to close the 
health equity gap. Among other things, we have developed an Inventory 
of Resources for Standardized Demographic and Language Data Collection 
\207\ and supported collection of specialized International 
Classification of Disease, 10th Edition, Clinical Modification (ICD-10-
CM) codes for describing the socioeconomic, cultural, and environmental 
determinants of health, and sponsored several initiatives to 
statistically estimate race and ethnicity information when it is 
absent.\208\ The Office of the National Coordinator for Health 
Information Technology (ONC) included social, psychological, and 
behavioral standards in the 2015 Edition health information technology 
certification criteria (2015 Edition), providing interoperability 
standards (LOINC [Logical Observation Identifiers Names and Codes] and 
SNOMED CT [Systematized Nomenclature of Medicine--Clinical Terms]) for 
financial strain, education, social connection and isolation, and 
others. Additional stakeholder efforts underway to expand capabilities 
to capture additional social determinants of health data elements 
include the Gravity Project to identify and harmonize social risk 
factor data for interoperable electronic health information exchange 
for EHR fields, as well as proposals to expand the ICD-10 
(International Classification of Diseases, Tenth Revision) z-codes, the 
alphanumeric codes used worldwide to represent diagnoses.\209\
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    \207\ Centers for Medicare & Medicaid Services. Building an 
Organizational Response to Health Disparities Inventory of Resources 
for Standardized Demographic and Language Data Collection. 2020. 
https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Collection-Resources.pdf.
    \208\ https://pubmed.ncbi.nlm.nih.gov/18567241/, https://pubmed.ncbi.nlm.nih.gov/30506674/, Eicheldinger C, Bonito A. More 
accurate racial and ethnic codes for Medicare administrative data. 
Health Care Financ Rev. 2008; 29(3):27-42. Haas A, Elliott MN, 
Dembosky JW, et al. Imputation of race/ethnicity to enable 
measurement of HEDIS performance by race/ethnicity. Health Serv Res. 
2019; 54(1):13-23. doi:10.1111/1475-6773.13099.
    \209\ https://aspe.hhs.gov/pdf-report/second-impact-report-to-congress.
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    While development of sustainable and consistent programs to collect 
data on social determinants of health can be considerable undertakings, 
we recognize that another method to identify better race and ethnicity 
data is needed in the short term to address the need for reporting on 
health equity. In working with our contractors, two algorithms have 
been developed to indirectly estimate the race and ethnicity of 
Medicare beneficiaries (as described further in the next section). We 
believe that using indirect estimation can help to overcome the current 
limitations of demographic information and enable timelier reporting of 
equity results until longer term collaborations to improve demographic 
data quality across the health care sector materialize. The use of 
indirect estimated race and ethnicity for conducting stratified 
reporting does not place any additional collection or reporting burdens 
on hospitals as these data are derived using existing administrative 
and census-linked data.
    Indirect estimation relies on a statistical imputation method for 
inferring a missing variable or improving an imperfect administrative 
variable using a related set of information that is more readily 
available.\210\ Indirectly estimated data are most commonly used at the 
population level (such as the hospital or health plan-level) where 
aggregated results form a more accurate description of the population 
than existing, imperfect data sets. These methods often estimate race 
and ethnicity using a combination of other data sources which are 
predictive of self-identified race and ethnicity, such as language 
preference, information about race and ethnicity in our administrative 
records, first and last names matched to validated lists of names 
correlated to specific national origin groups, and the racial and 
ethnic composition of the surrounding neighborhood. Indirect estimation 
has been used in other settings to support population-based equity 
measurement when self-identified data are not available.\211\
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    \210\ IOM. 2009. Race, Ethnicity, and Language Data: 
Standardization for Health Care Quality Improvement. Washington, DC: 
The National Academies Press.
    \211\ IOM. 2009. Race, Ethnicity, and Language Data: 
Standardization for Health Care Quality Improvement. Washington, DC: 
The National Academies Press.
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    As described earlier, we previously supported the development of 
two such methods of indirect estimation of race

[[Page 65386]]

and ethnicity among Medicare beneficiaries. One indirect estimation 
approach developed by our contractor uses Medicare administrative data, 
first name and surname matching, derived from the U.S. Census and other 
sources, with beneficiary language preference, State of residence, and 
the source of the race and ethnicity code in Medicare administrative 
data to reclassify some beneficiaries as Hispanic or API.\212\ In 
recent years, we have also worked with another contractor to develop a 
new approach, the Medicare Bayesian Improved Surname Geocoding (MBISG), 
which combines Medicare administrative data, first and surname 
matching, geocoded residential address linked to the 2010 U.S. Census, 
and uses both Bayesian updating and multinomial logistic regression to 
estimate the probability of belonging to each of six racial/ethnic 
groups.\213\
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    \212\ Bonito AJ, Bann C, Eicheldinger C, Carpenter L. Creation 
of New Race-Ethnicity Codes and Socioeconomic Status (SES) 
Indicators for Medicare Beneficiaries. Final Report, Sub-Task 2. 
(Prepared by RTI International for the Centers for Medicare and 
Medicaid Services through an interagency agreement with the Agency 
for Healthcare Research and Policy, under Contract No. 500-00-0024, 
Task No. 21) AHRQ Publication No. 08-0029-EF. Rockville, MD, Agency 
for Healthcare Research and Quality. January 2008.
    \213\ Haas, A., Elliott, M. et al (2018). Imputation of race/
ethnicity to enable measurement of HEDIS performance by race/
ethnicity. Health Services Research, 54:13-23 and Bonito AJ, Bann C, 
Eicheldinger C, Carpenter L. Creation of New Race-Ethnicity Codes 
and Socioeconomic Status (SES) Indicators for Medicare 
Beneficiaries. Final Report, Sub-Task 2. (Prepared by RTI 
International for the Centers for Medicare and Medicaid Services 
through an interagency agreement with the Agency for Healthcare 
Research and Policy, under Contract No. 500-00-0024, Task No. 21) 
AHRQ Publication No. 08-0029-EF. Rockville, MD, Agency for 
Healthcare Research and Quality. January 2008.
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    The MBISG model is currently used to conduct the national, 
contract-level, stratified reporting of Medicare Part C and D 
performance data for Medicare Advantage Plans by race and 
ethnicity.\214\ Validation testing reveals concordance of 0.88-0.95 
between indirectly estimated and self-report among individuals who 
identify as White, Black, Hispanic and API for the MIBSG version 2.0 
and concordance with self-reported race and ethnicity of 0.96-0.99 for 
these same groups for MBISG version 2.1.215 216 The 
algorithms under consideration are considerably less accurate for 
individuals who self-identify as American Indian/Alaskan Native or 
multiracial.\217\ Indirect estimation can be a statistically reliable 
approach for calculating population-level equity results for groups of 
individuals (such as the hospital-level) and is not intended, nor being 
considered, as an approach for inferring the race and ethnicity of an 
individual.
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    \214\ The Office of Minority Health (2020). Racial, Ethnic, and 
Gender Disparities in Health Care in Medicare Advantage, The Centers 
for Medicare and Medicaid Services, (pg vii). https://www.cms.gov/About-CMS/Agency-Information/OMH/research-and-data/statistics-and-data/stratified-reporting.
    \215\ The Office of Minority Health (2020). Racial, Ethnic, and 
Gender Disparities in Health Care in Medicare Advantage, The Centers 
for Medicare and Medicaid Services, (pg vii). https://www.cms.gov/About-CMS/Agency-Information/OMH/research-and-data/statistics-and-data/stratified-reporting.
    \216\ MBISG 2.1 validation results performed under contract #GS-
10F-0012Y/HHSM-500-2016-00097G. Pending public release of the 2021 
Part C and D Performance Data Stratified by Race, Ethnicity, and 
Gender Report, available at https://www.cms.gov/About-CMS/Agency-Information/OMH/research-and-data/statistics-and-data/stratified-reporting.
    \217\ Haas, A, Elliott, MN, Dembosky, JW, et al. Imputation of 
race/ethnicity to enable measurement of HEDIS performance by race/
ethnicity. Health Serv Res. 2019; 54: 13- 23. https://doi.org/10.1111/1475-6773.13099.
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    However, despite the high degree of statistical accuracy of the 
indirect estimation algorithms under consideration, there remains the 
small risk of unintentionally introducing measurement bias. For 
example, if the indirect estimation is not as accurate in correctly 
estimating race and ethnicity in certain geographies or populations it 
could lead to some bias in the method results. Such bias might result 
in slight overestimation or underestimation of the quality of care 
received by a given group. We believe this amount of bias is 
considerably less than would be expected if stratified reporting was 
conducted using the race and ethnicity currently contained in our 
administrative data. Indirect estimation of race and ethnicity is 
envisioned as an intermediate step, filling the pressing need for more 
accurate demographic information for the purposes of exploring 
inequities in service delivery, while allowing newer approaches, as 
described in the next section, for improving demographic data 
collection to progress. We are interested in learning more about, and 
solicited comments about, the potential benefits and challenges 
associated with measuring hospital equity using an imputation algorithm 
to enhance existing administrative data quality for race and ethnicity 
until self-reported information is sufficiently available.
(2) Improving Demographic Data Collection
    Currently self-reported race and ethnicity data are the gold 
standard for classifying an individual according to race or ethnicity. 
The CMS Quality Strategy outlines our commitment to strengthening 
infrastructure and data systems by ensuring that standardized 
demographic information is collected to identify disparities in health 
care delivery outcomes.\218\ Collection and sharing of a standardized 
set of social, psychological, and behavioral data by clinicians, 
including race and ethnicity, using electronic data definitions which 
permit nationwide, interoperable health information exchange, can 
significantly enhance the accuracy and robustness of our equity 
reporting.\219\ This could potentially include expansion to additional 
social factors, such as language preference and disability status, 
where accuracy of administrative data is currently limited. We are 
mindful that additional resources, including data collection and staff 
training may be necessary to ensure that conditions are created whereby 
all patients are comfortable answering all demographic questions, and 
that individual preferences for non-response are maintained.
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    \218\ Centers for Medicare & Medicaid Services. CMS Quality 
Strategy. 2016. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
    \219\ The Office of the National Coordinator for Health 
Information Technology. United States Core Data for Interoperability 
Draft Version 2. 2021. https://www.healthit.gov/isa/sites/isa/files/2021-01/Draft-USCDI-Version-2-January-2021-Final.pdf.
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    We note that clinicians participating in the Medicare Promoting 
Interoperability Program must use certified EHR technology (CEHRT) that 
has been certified to the 2015 Edition of health IT certification 
criteria. As noted previously, the certification criterion for 
Demographics under the 2015 Edition (at 45 CFR 170.315(a)(5)) supports 
collection of data using both the OMB standards for collecting data on 
race and ethnicity, as well as the more granular ``Race & Ethnicity--
CDC'' standard. In the 2020 ONC 21st Century Cures Act final rule, ONC 
also adopted a new framework for the core data set which certified 
health IT products must exchange, called the United States Core Data 
for Interoperability (USCDI) (85 FR 25669). The USCDI incorporates the 
demographic data and associated code sets finalized for the 2015 
Edition certification criteria.
    As noted previously, ONC also finalized a certification criterion 
in the 2015 Edition which supports a certified health IT products 
ability to collect social, psychological, and behavioral data (at 45 
CFR 170.315(a)(15)). However, this functionality is not included as 
part of the certified EHR technology required by the Promoting 
Interoperability performance category. While the technical 
functionality exists to achieve the gold standard of data

[[Page 65387]]

collection, we understand challenges and barriers exist in using the 
technologies with these capabilities.
    We are interested in learning about, and solicited comments on, 
current data collection practices by hospitals to capture demographic 
data elements (such as race, ethnicity, sex, sexual orientation and 
gender identity (SOGI), language preference, tribal membership, and 
disability status). Further, we are interested in potential challenges 
facing clinicians with collecting a minimum set of demographic data 
elements in alignment with national data collection standards (such as 
the standards finalized by the Affordable Care Act \220\) and standards 
for interoperable exchange (such as the United States Core Data for 
Interoperability incorporated into certified health IT products as part 
of the 2015 Edition of health IT certification criteria \221\). 
Advancing data interoperability through collection of a minimum set of 
demographic data collection, and incorporation of this demographic 
information into quality measure specifications, has the potential for 
improving the robustness of the disparity method results, potentially 
permitting reporting using more accurate, self-reported, information, 
such as race and ethnicity, and expanding reporting to additional 
dimensions of equity, including stratified reporting by disability 
status.
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    \220\ https://minorityhealth.hhs.gov/assets/pdf/checked/1/Fact_Sheet_Section_4302.pdf.
    \221\ https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
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    Therefore, based on our current and newly proposed policies, we 
solicited comments on other efforts we can take within the MIPS program 
to further bridge the equity gap. We plan to continue working with 
ASPE, clinicians, the public, and other key stakeholders on this 
important issue to identify policy solutions to achieve the goals of 
attaining health equity for all patients and minimizing unintended 
consequences. We look forward to receiving feedback on these topics and 
note for readers that responses to the RFI will not directly impact 
payment decisions. We also note our intention for additional RFI or 
rulemaking on this topic in the future. While we will not be responding 
to specific comments submitted in response to this Request for 
Information in the CY 2022 PFS final rule, we will actively consider 
all input as we develop future regulatory proposals or future 
subregulatory policy guidance.
    We thank commenters for the feedback received through this request 
for information. We may consider this information to inform future 
rulemaking.
2. Definitions
    At Sec.  414.1305, we proposed definitions of the following terms:
     Collection type (revision).
     Meaningful EHR user for MIPS (revision).
     MIPS determination period (revision).
     MIPS eligible clinician (revision).
     Multispecialty group (addition).
     MVP Participant (addition).
     Population health measure (addition).
     QCDR measure (addition).
     Single specialty group (addition).
     Special status (addition).
     Subgroup (addition).
     Submission type (revision).
    These terms and definitions are discussed in detail in the relevant 
sections of this final rule.
3. MIPS Program Details
a. MIPS Eligibility
(1) MIPS Eligible Clinician Definition
    In the CY 2017 Quality Payment Program final rule (81 FR77040 
through 77041), we defined a MIPS eligible clinician at Sec.  414.1305, 
as identified by a unique billing TIN and NPI combination used to 
assess performance, as any of the following (excluding those identified 
at Sec.  414.1310(b)): A physician (as defined in section 1861(r) of 
the Act), a PA, NP, and CNS (as such terms are defined in section 
1861(aa)(5) of the Act), a CRNA (as defined in section 1861(bb)(2) of 
the Act), and a group that includes such clinicians. We established at 
Sec.  414.1310(b) and (c) that the following are excluded from this 
definition per the statutory exclusions defined in section 
1848(q)(1)(C)(ii) and (v) of the Act: (1) QPs; (2) Partial QPs who 
choose not to report on applicable measures and activities that are 
required to be reported under MIPS for any given performance period in 
a year; (3) low-volume threshold eligible clinicians; and (4) new 
Medicare-enrolled eligible clinicians. In accordance with sections 
1848(q)(1)(A) and (q)(1)(C)(vi) of the Act, we established at Sec.  
414.1310(b)(2) that eligible clinicians (as defined at Sec.  414.1305) 
who are not MIPS eligible clinicians have the option to voluntarily 
report measures and activities for MIPS. Additionally, we established 
at Sec.  414.1310(d) that in no case will a MIPS payment adjustment 
apply to the items and services furnished during a year by eligible 
clinicians who are not MIPS eligible clinicians, as described in Sec.  
414.1310(b) and (c), including those who voluntarily report on 
applicable measures and activities specified under MIPS. In this final 
rule, we are finalizing our proposal to amend Sec.  414.1305 to revise 
the definition of a MIPS eligible clinician, as identified by a unique 
billing TIN and NPI combination used to assess performance, to include 
certified nurse midwives (CNMs) (as defined in section 1861(gg)(2) of 
the Act) and clinical social workers (as defined in section 1861(hh)(1) 
of the Act).
    Section 1848(q)(1)(C)(i)(II) of the Act provides the Secretary with 
discretion, beginning with the 2021 MIPS payment year, to specify 
additional eligible clinicians (as defined in section 1848(k)(3)(B) of 
the Act) as MIPS eligible clinicians. Such clinicians may include 
physical therapists, occupational therapists, or qualified speech-
language pathologists; qualified audiologists (as defined in section 
1861(ll)(3)(B) of the Act); CNMs (as defined in section 1861(gg)(2) of 
the Act); clinical social workers (as defined in section 1861(hh)(1) of 
the Act); clinical psychologists (as defined by the Secretary for 
purposes of section 1861(ii) of the Act); and registered dietitians or 
nutrition professionals. Therefore, in the CY 2019 PFS proposed rule 
(83 FR 35883 through 35884), we proposed to amend Sec.  414.1305 to 
revise the definition of a MIPS eligible clinician, as identified by a 
unique billing TIN and NPI combination used to assess performance, to 
mean any of the following (excluding those identified at Sec.  
414.1310(b)): A physician (as defined in section 1861(r) of the Act); a 
PA, NP, and CNS (as such terms are defined in section 1861(aa)(5) of 
the Act); a CRNA (as defined in section 1861(bb)(2) of the Act); 
beginning with the 2021 MIPS payment year, a physical therapist, 
occupational therapist, clinical social worker (as defined in section 
1861(hh)(1) of the Act), and clinical psychologist (as defined by the 
Secretary for purposes of section 1861(ii) of the Act. In addition, we 
solicited comments on specifying qualified speech-language 
pathologists, qualified audiologists, CNMs, and registered dietitians 
or nutrition professionals as MIPS eligible clinicians beginning with 
the 2021 MIPS payment year.
    After consideration of comments we received, we finalized to revise 
our proposal in the CY 2019 PFS final rule (83 FR 59722 through 59727) 
and amend Sec.  414.1305 to revise the definition of a MIPS eligible 
clinician, as identified by a unique billing TIN and NPI combination 
used to assess

[[Page 65388]]

performance, to mean any of the following (excluding those identified 
at Sec.  414.1310(b)): A physician (as defined in section 1861(r) of 
the Act); a PA, NP, and CNS (as such terms are defined in section 
1861(aa)(5) of the Act); a CRNA (as defined in section 1861(bb)(2) of 
the Act); beginning with the 2021 MIPS payment year, a physical 
therapist, occupational therapist, qualified speech-language 
pathologist; qualified audiologist (as defined in section 
1861(ll)(3)(B) of the Act); clinical psychologist (as defined by the 
Secretary for purposes of section 1861(ii) of the Act); and registered 
dietician or nutrition professional; and a group that includes such 
clinicians.
    In the CY 2022 PFS proposed rule (86 FR 39349 through 39350), we 
proposed to amend Sec.  414.1305 to revise the definition of a MIPS 
eligible clinician, as identified by a unique billing TIN and NPI 
combination used to assess performance, to include CNMs (as defined in 
section 1861(gg)(2) of the Act) and clinical social workers (as defined 
in section 1861(hh)(1) of the Act). The new definition would mean any 
of the following (excluding those identified at Sec.  414.1310(b)): A 
physician (as defined in section 1861(r) of the Act); a PA, NP, and CNS 
(as such terms are defined in section 1861(aa)(5) of the Act); a CRNA 
(as defined in section 1861(bb)(2) of the Act); beginning with the 2021 
through 2023 MIPS payment years, a physical therapist, occupational 
therapist, qualified speech-language pathologist; qualified audiologist 
(as defined in section 1861(ll)(3)(B) of the Act); clinical 
psychologist (as defined by the Secretary for purposes of section 
1861(ii) of the Act); and registered dietician or nutrition 
professional; beginning with the 2024 MIPS payment year, CNMs (as 
defined in section 1861(gg)(2) of the Act); clinical social workers (as 
defined in section 1861(hh)(1) of the Act); and a group that includes 
such clinicians.
    In order to assess whether these additional eligible clinicians 
(CNMs and clinical social workers) could successfully participate in 
MIPS, we evaluated whether there would be sufficient measures and 
activities applicable and available for each of the additional eligible 
clinician types. We finalized in the CY 2018 Quality Payment Program 
final rule (82 FR 53780) that having sufficient measures for the 
quality performance category means having sufficient measures 
applicable and available such that we can calculate a quality 
performance category percent score for the MIPS eligible clinician 
because at least one quality measure is applicable and available to the 
clinician. For the improvement activities performance category, we 
believe that all MIPS eligible clinicians have sufficient activities 
applicable and available, as they are broadly applicable. We focused 
our analysis on the quality and improvement activities performance 
categories because these performance categories require submission of 
data. For the Promoting Interoperability performance category, we do 
not believe that clinical social workers would have sufficient measures 
applicable and available to them. We refer readers to section 
IV.A.3.d.(4)(h)(iv) of this final rule, where we discuss our proposed 
policy to automatically assign a zero percent weighting for the 
Promoting Interoperability performance category for the clinical social 
workers. However, we stated in the proposed rule (86 FR 39426) that for 
the CNMs we do believe they would have sufficient Promoting 
Interoperability measures applicable and available to them as many of 
them have participated in the Medicaid EHR Incentive Program and have 
experience with the adoption or use of CEHRT. Therefore, the CNMs score 
would not be reweighted automatically for the Promoting 
Interoperability performance category. However, under Sec.  
414.1380(c)(2)(i)(C)(2), if a clinician believes they were subject to 
extreme and uncontrollable circumstances that caused their CEHRT to be 
unavailable, they may apply for a hardship exception for the Promoting 
Interoperability performance category. We did not focus as part of our 
analysis on the cost performance category because we are only able to 
assess cost performance for a subset of eligible clinicians--
specifically, those who are currently eligible as a result of not 
meeting any of the current exclusion criteria. We do not believe there 
are cost measures that would apply to the care that clinical social 
workers or CNMs tend to provide. The current set of episode-based 
measures in the cost performance category focuses on a range of acute 
inpatient medical conditions and procedures, and the two population-
based cost measures assess inpatient and primary care. Therefore, we 
anticipate the cost category would be reweighted in accordance with 
Sec.  414.1380(c)(2) for the majority of these clinician types. The 
impact of the cost performance category for these additional eligible 
clinicians would continue to be considered but is currently not a 
decisive factor for successful participation in MIPS. From our 
analysis, we found that improvement activities would generally be 
applicable and available for each of the additional eligible clinician 
types. For the quality performance category, we found that the 
additional eligible clinician types would have sufficient MIPS quality 
measures applicable and available. Since the CY 2019 PFS final rule, we 
have increased the quality measures that we believe are applicable to 
clinical social workers to 15 quality measures, which includes 2 
outcome measures and 8 high priority measures. In the CY 2021 PFS final 
rule (85 FR 85069 through 85071), we finalized a Clinical Social Worker 
Specialty Measure Set. For CNM, we believe there are 7 quality measures 
which includes 2 outcome measures and 5 high priority measures 
available for reporting in the CY 2022 performance period. In Appendix 
1, Table Group BA of this final rule, we are adopting a Certified 
Nurse-Midwives Specialty Set. In addition, we received correspondence 
from the clinical social workers national associations requesting to be 
included in MIPS. Finally, amending the definition of a MIPS eligible 
clinician to include clinical social workers and CNMs would align with 
Sec.  414.1305 definition of an eligible clinician utilized by MIPS 
APMs for eligibility determinations.
    We solicited comments on our proposal.
    We received public comments on MIPS eligibility. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported including clinical social 
workers as MIPS eligible clinicians beginning January 1, 2022. One 
commenter stated their belief that clinical social workers should be 
regarded as core members of the clinical care team and becoming MIPS 
eligible clinicians promotes shared responsibility among the entire 
care team. Another commenter stated their belief that clinical social 
workers are an important part of the oncology care team. Another 
commenter referenced that there should be clear guidelines on how 
clinical social workers will be able to work with physicians on care 
coordination efforts and navigate interoperability issues. A few 
commenters stated their support of adding CNMs as MIPS eligible 
clinicians as of the CY 2022 performance period. One commenter 
suggested working with the NQF to determine social work and CNM 
metrics.
    Response: We will work to develop educational materials for 
clinical social workers to help them successfully participate in MIPS. 
While we believe

[[Page 65389]]

that there are sufficient quality measures for clinical social workers 
and CNMs, we plan to continue to work with NQF to determine if 
additional measures are appropriate and to make sure that these 
measures evolve over time.
    Comment: One commenter did not support adding CNMs as a MIPS 
eligible clinician type as they believe that CNMs provide a majority of 
obstetrics related services and may not qualify for the low-volume 
threshold due to limited services they would provide to Medicare 
populations. Another commenter did not support adding clinical social 
workers as MIPS eligible clinician type because, as they stated, they 
believe that there is limited relevance in the categories of MIPS for 
clinical social workers. A few commenters suggested deferring the MIPS 
eligibility of clinical social workers by one additional year due to 
concerns related to the PHE and further burden.
    Response: Clinicians and practices must exceed the low-volume 
threshold to be eligible for MIPS; therefore, if a CNM is below the 
threshold, they would not be required to participate in MIPS. As for 
clinical social workers, we did find that there are sufficient measures 
and activities that would be applicable and available for them (86 FR 
39350). We also did receive a comment from the clinical social workers 
national association requesting that clinical social workers be 
included in MIPS. In regards to the concerns about the PHE, we note 
that we have a number of flexibilities in place for MIPS eligible 
clinicians that are impacted by the COVID-19 pandemic, and refer 
readers to our COVID-19 resources on our website at https://qpp.cms.gov/resources/covid19.
    Comment: One commenter suggested recognition of pharmacists' care 
contributions as they stated under MIPS there is no mechanism for 
attributing pharmacists' contributions to achieving metrics, and 
further suggested that a significant number of measures are related to 
or impacted by medications and would benefit from appropriate 
medication use and pharmacist-provided services.
    Response: We agree that pharmacists are an important component of 
the health care system but are unable to include them in MIPS since 
pharmacists are not included in the definition of a MIPS eligible 
clinician at section 1848(q)(1)(C) of the Act.
    Comment: One commenter supported the expansion of MIPS eligible 
clinician types as it will facilitate the program's growth as quality 
and performance measurement become an increasingly valuable piece of 
information in evaluating provider networks offered by health plans. 
The commenter added that when this information is made available to 
consumers, it will aid in the identification of high-performing 
providers using a consistent and evidence-based standard.
    Response: We thank the commenter for their support of our proposal 
and will continue to post performance data on Compare Tools.
    After consideration of public comments, we are finalizing our 
proposal to amend Sec.  414.1305 to modify the definition of a MIPS 
eligible clinician, as identified by a unique billing TIN and NPI 
combination used to assess performance, to mean any of following 
(excluding those identified at Sec.  414.1310(b)): For the 2019 and 
2020 MIPS payment years, a physician (as defined in section 1861(r) of 
the Act); a PA, NP, and CNS (as such terms are defined in section 
1861(aa)(5) of the Act); a CRNA (as defined in section 1861(bb)(2) of 
the Act); for the 2021 through 2023 MIPS payment years, a physical 
therapist, occupational therapist, qualified speech-language 
pathologist; qualified audiologist (as defined in section 
1861(ll)(3)(B) of the Act); clinical psychologist (as defined by the 
Secretary for purposes of section 1861(ii) of the Act); and registered 
dietician or nutrition professional; for the 2024 MIPS payment year and 
future years, a CNMs (as defined in section 1861(gg)(2) of the Act); 
clinical social workers (as defined in section 1861(hh)(1) of the Act); 
and a group that includes such clinicians.
(2) MIPS Performance Period
    In the CY 2019 PFS final rule (83 FR 59745 through 59747) we 
finalized to amend Sec.  414.1320(d)(1) that for purposes of the 2022 
MIPS payment year and future years, the performance period for the 
quality and cost performance categories will be the full calendar year 
(January 1 through December 31) that occurs 2 years prior to the 
applicable MIPS payment year. In addition, we finalized at Sec.  
414.1320(d)(2) that for purposes of the 2022 MIPS payment year and 
future years, the performance period for the improvement activities 
performance category will be a minimum of a 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.
    In the CY 2021 PFS final rule (85 FR 84873), we finalized the 
performance period for the quality and cost performance categories at 
Sec.  414.1320(d)(1) as follows: Beginning with the 2023 MIPS payment 
year, the performance period for the quality and cost performance 
categories is the full calendar year (January 1 through December 31) 
that occurs 2 years prior to the applicable MIPS payment year, except 
as otherwise specified for administrative claims-based measures in the 
MIPS final list of quality measures described in Sec.  414.1330(a)(1). 
However, the quality, cost, and improvement activities performance 
period for the 2022 MIPS payment year, formerly at Sec.  414.1320(d), 
was inadvertently deleted, and the amended language regarding 
administrative claims measures was not expressly retroactive. We 
recognize that the application of this policy for the 2020 MIPS 
performance period would be retroactive. To the extent that the 
application of this policy for the 2020 MIPS performance period will be 
retroactive, 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 will be contrary to the public interest. We believe that 
failure to reinstate the inadvertently deleted language retroactively 
will be contrary to the public interest because the performance period 
establishes the timespan for the collection of performance data, 
assessment of performance, and computation of the MIPS payment 
adjustment, to which clinicians have already committed valuable time 
and resources. In addition, many of the MIPS policies such as the MIPS 
determination period and the low-volume threshold determinations 
utilize the performance period as an integral part of the policy, 
without which we will be unable to operate the MIPS program as required 
by statute. Therefore, we solicited comments on our technical amendment 
to reinstate the inadvertently deleted language, with a modification to 
state ``For purposes of . . .'' rather than ``Beginning with . . .''. 
The proposed text stated, for purposes of the 2022 MIPS payment year, 
the performance period for: (1) The quality and cost performance 
categories is the full calendar year (January 1 through December 31) 
that occurs 2 years prior to the applicable MIPS payment year; and (2) 
The improvement activities performance categories is a minimum of a 
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 (86 FR 39350 through

[[Page 65390]]

39351). Lastly, we proposed to redesignate current Sec.  414.1320(d) 
through (g) to Sec.  414.1320(e) through (h), respectively.
    We did not receive public comments on these proposals, and we are 
finalizing them as proposed: For purposes of the 2022 MIPS payment 
year, the performance period for: (1) The quality and cost performance 
categories is the full calendar year (January 1 through December 31) 
that occurs 2 years prior to the applicable MIPS payment year; and (2) 
The improvement activities performance category is a minimum of a 
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 are redesignating current Sec.  414.1320(d) through 
(g) to Sec.  414.1320(e) through (h), respectively.
(3) Modifications to Small Practice Groups Reporting Medicare Part B 
Claims Measures
    In the CY 2019 PFS final rule (83 FR 59753), we established that 
beginning with the 2019 performance period, Medicare Part B Claims will 
be an available collection type and submission type for the quality 
performance category for small practices reporting as individuals or a 
group. We also stated that in circumstances where only Medicare Part B 
claims were submitted, that we intended on calculating the quality 
performance category for the practice as both a group and as 
individuals and apply the quality performance category score that is 
the greater of the two. We considered requiring an election for 
assessment as a group but believed this would be unduly burdensome on 
small practices (83 FR 59752).
    Although we stated we would take the highest of the individual or 
group score for MIPS eligible clinicians in small practices, we now 
recognize that this policy has had an unintended impact for clinicians 
in a small practice who did not submit Medicare Part B quality claims 
and would not otherwise be eligible for MIPS. Once we receive a 
Medicare Part B submission, both an individual score and a group score 
is created. Once a group score is created, a clinician who was 
individually excluded from MIPS for being under the low-volume 
threshold, may now be eligible if the group exceeds the low-volume 
threshold. These clinicians will receive the MIPS final score based on 
the Medicare Part B submissions, even if the group did not intend to 
report to MIPS as a group. While we still perform an analysis to only 
provide to the clinicians the highest final score available, clinicians 
who are only MIPS eligible by the act of exceeding the low volume 
threshold as a group are receiving final scores that are unintended. 
This issue will continue to be further exacerbated as the performance 
threshold continues to increase, so does the likelihood that a final 
score from the quality performance category alone (or quality and cost 
as cost does not have submission requirements) could be below the 
performance threshold for a group. We therefore now believe it is 
important for the group to clearly signal its intention to report to 
MIPS as a group before we expand potential eligibility to other members 
of the group.
    We have existing policies under MIPS that require clinicians to 
indicate to us when to utilize a group submission. For example, in the 
CY 2019 PFS final rule (83 FR 59862), we stated that submission of data 
on improvement activities or Promoting Interoperability measures will 
indicate that the clinicians in that group wanted to be scored as a 
group for the purposes of facility-based measurement. Therefore, we 
believe a similar policy would be appropriate for small practices to 
indicate they wish to submit Medicare Part B claims for a group quality 
performance category score. We proposed that starting with the CY 2022 
MIPS performance period/2024 MIPS payment year, small practices, 
excluding those participating in MIPS as part of a virtual group, must 
submit data as a group in any performance category to indicate that 
they wish to be scored as a group for Medicare Part B claims (86 FR 
39351). This means a group will need to submit data as a group to the 
improvement activities, Promoting Interoperability performance 
categories, or to the quality performance category via another 
submission mechanism as a group (for example, a group that submits MIPS 
CQMs in addition to Medicare Part B claims data). Once the group 
submits data to MIPS as a group, we will consider any available 
Medicare Part B claims measure submissions in calculating their quality 
performance category score.
    We believe using the choice to submit data as a group will indicate 
the group's intention to participate and be measured as a group. The 
proposal would preserve and respect the choices made by clinicians and 
groups by not inadvertently expanding eligibility unwittingly to other 
clinicians. We note that this proposal will not apply to small 
practices participating in MIPS as part of a virtual group, because 
clinicians signal their intent to be scored as a virtual group through 
the virtual group election process.
    We received public comments on our proposal for modifications to 
small practice groups reporting Medicare Part B claims measures. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters supported our proposal to have small 
practices to submit data as a group in any performance category 
starting in the CY 2022 performance period to indicate that they wish 
to be scored as a group for Medicare Part B claims. One commenter 
suggested that we apply this policy retroactively to the 2020 and 2021 
performance periods.
    Response: We appreciate the support for this proposal. 
Unfortunately, we are not able to apply this policy retroactively 
because we did not propose to do so. Further we believe that if applied 
retroactively, it would harm certain MIPS eligible clinicians by 
reducing their payment adjustments.
    Comment: One commenter questioned the intersection of the proposed 
policy requiring small practice groups reporting on Medicare Part B 
claims measures to report for the improvement activities or promoting 
interoperability performance category as a group to be assessed as a 
group, and the policy that deals with circumstances where a clinician 
has more than one final score. This commenter encouraged CMS to retain 
the policy that allows clinicians to receive the better of the two 
results (scoring as an individual or a group) for their final score. 
This commenter noted that small practices who submit measures via 
Medicare Part B claims have significant challenges predicting their 
final MIPS scores while those using registries are able to analyze 
their data before submission and predict a final score.
    Response: We thank the commenter for their support. We note that 
the final score hierarchy still provides the MIPS eligible clinician 
with their highest final score, with a few exceptions. More details on 
this policy is available in section IV.A.3.f. of this final rule.
    After consideration of public comments, we are finalizing this 
policy as proposed. Specifically, starting with the CY 2022 MIPS 
performance period/2024 MIPS payment year, small practices, excluding 
those participating in MIPS as part of a virtual group, must submit 
data as a group in any performance category to indicate that they wish 
to be scored as a group for Medicare Part B claims.

[[Page 65391]]

b. Transforming MIPS: MIPS Value Pathways
(1) Overview
    We are moving to MIPS Value Pathways (MVPs) to improve value, 
reduce burden, inform patient choice in selecting clinicians, and 
reduce barriers to facilitate movement into APMs (84 FR 40732 through 
40734 and 85 FR 84844 through 84845). We intend to promote high value 
care by paying for health care services by linking performance on cost, 
quality, and the patient's experience of care. The MVP framework will 
move MIPS forward on the path to value by connecting the MIPS 
performance categories, better informing and empowering patients to 
make decisions about their healthcare, and by helping clinicians to 
achieve better outcomes using robust and accessible healthcare data and 
interoperability.
    Stakeholders have supported the MVP framework and our MVP guiding 
principles, which aim to reduce complexity and burden, move towards 
more meaningful measurement, capture the patient voice, and move to 
higher value care (84 FR 62946 and 85 FR 84845). We believe MVP 
reporting will reduce selection burden with choosing MIPS quality 
measures and improvement activities to submit; reduce reporting burden 
by requiring submission of fewer MIPS quality measures than the 
traditional MIPS participation method; and further align across 
performance categories the measures and activities identified by 
specialists and patients as being meaningful and relevant. We believe 
MVPs developed in coordination with stakeholders with an established 
process in which clinician and patient perspectives are incorporated 
(85 FR 84850) can result in more meaningful performance data, reduced 
complexity of the MIPS program, and lowered clinician burden to 
participate.
    MVPs will make MIPS more meaningful by allowing a more cohesive 
participation experience; by standardizing performance measurement of a 
specialty, medical condition, or episode of care; and by reducing the 
siloed nature of the traditional MIPS participation experience. We 
intend for MVPs to drive value and help clinicians and practices 
prepare to take on and manage financial risk, as in Advanced APMs, as 
they build out their quality infrastructure components (measurement 
tracking, performance improvement processes, interoperability and data 
information systems) that align with the MIPS performance categories 
and gain experience with cost measurement (84 FR 40733). Performance 
measure reporting for specific populations, such as in MVPs, encourages 
practices to build an infrastructure with capabilities to compile and 
analyze population health data, a critical capability in assuming and 
managing risk. The experience with MVPs, in which there is aligned 
measurement of quality (of care and experience of care) and cost, 
continuous improvement/innovation within the practice, and efficient 
management and transfers of information will help clinicians deliver 
higher value care and remove barriers to APM participation. Combining 
linked performance measures and activities with more standardization of 
measures in MVPs will produce data that can better assist patients in 
comparing clinician performance and selecting clinicians from which to 
seek care. As more clinicians have applicable MVPs, the performance 
data available to patients will expand, and in the future, information 
for specialists in multispecialty groups will become more available on 
our Compare Tools, enabling patients to make more informed choices for 
their care.
    We continue our efforts to improve the healthcare of Medicare 
patients by allowing clinicians to focus on providing care for their 
patients and report on measures and activities that best reflect their 
care. As we finalize our initial MVP implementation policies in this 
final rule, we continue to consider critical factors that will 
contribute to and demonstrate MVP success and the desired 
characteristics of the future overall MVP portfolio. We look forward to 
continuing to work with stakeholders to improve the program and 
implement the vision of MVPs.
(2) MVP Framework and Implementation Considerations
    In the CY 2022 PFS proposed rule (86 FR 39352 through 39355), we 
requested public comments regarding several issues involving the 
overall implementation of MVPs and how we can most effectively meet our 
MVP goals, which include driving value and care improvements. We 
outlined in the CY 2022 PFS proposed rule several MVP framework and 
implementation considerations, as well as limitations and challenges we 
are working with stakeholders to address. As discussed in previous 
rules (CY 2020 PFS proposed and CY 2021 PFS final rules (84 FR 40732 
through 40734, 85 FR 50279 and 85 FR 84844 through 84845 
respectively)), our MVP framework calls for linking the MIPS quality, 
cost, and improvement activities performance categories with a 
foundation of the Promoting Interoperability and population health 
claims-based measures. We noted that we are considering how to best 
implement an MVP portfolio that balances our MVP goals for 
transformative change and our five MVP guiding principles (85 FR 84845) 
within current capabilities. We noted there are constraints related to 
the ability to implement significant program changes including 
statutory restrictions on the structure of MIPS, and limitations of the 
current quality and cost measure inventories.
(a) MVP Framework Request for Comments
    Stakeholders have largely supported our MVP goals, but a few 
commenters continue to voice concerns regarding whether our goals to 
drive value, reduce burden, and derive comparative data can be achieved 
via the MVP framework (85 FR 84845 through 84847). We noted in the CY 
2022 PFS proposed rule that the statutory requirements at section 1848 
of the Act may constrain our ability to adopt certain changes (86 FR 
39353). These requirements include but are not limited to: The use of 
four MIPS performance categories (quality, cost, improvement activities 
and Promoting Interoperability); setting the performance threshold; the 
call for measures and annual quality measure selection process; and the 
prescribed performance category weights. Conversely, the statute does 
provide limited flexibilities in some other areas, so we are interested 
in exploring any existing MIPS flexibilities that will assist us in 
implementing MVPs. As we begin MVP implementation, a portfolio of MVPs 
will be developed with a focus on our end goals while adhering to 
statutory requirements.
    We requested comments on more innovative approaches to help achieve 
our desired MVP results that we should consider as we build our MVP 
portfolio (86 FR 39353 through 39354). MVPs aim to improve value, 
reduce burden, help patients compare clinician performance to inform 
patient choice in selecting clinicians, and reduce barriers to movement 
into APMs. We received several comments with feedback on MVP portfolio 
concepts, overall types of MVPs the portfolio should include, quality 
and cost measure considerations for meeting MVP objectives, and 
approaches to measuring and driving value. While we are not summarizing 
and responding to the comments we received in this final rule, we thank 
the commenters for their responses and may take them into account as we 
develop

[[Page 65392]]

future policies for the MVPs. We also are interested in continuing to 
engage with stakeholders on additional ways to drive value, engage the 
patient perspective, stimulate practice improvement processes, and 
reduce burden in the MIPS program, through our MVP framework. For 
example, in the context of MVPs, we are interested in solutions that 
drive care improvements, measure value through meaningful performance 
measurement, and reduce burden across all 4 MIPS categories. We are 
considering how measure development approaches and technology, such as 
Fast Healthcare Interoperability Resources (FHIR) and dQMs, can help us 
meet our MVP objectives and improve health equity. We intend to 
continue a dialogue with stakeholders on these important MVP topics and 
may consider convening public forums, webinars, and office hours or 
using additional opportunities such as the pre-rulemaking process to 
further understand what is important to clinicians, patients, and 
stakeholders and obtain further input as we develop our MVP portfolio.
    Our approach to developing the portfolio of MVPs must balance 
objectives for having MVPs available for the diverse range of MIPS 
eligible clinicians, the variety of health conditions affecting 
Medicare patients, and the patient's needs for relevant, meaningful 
information. While the proposals finalized in this final rule 
demonstrate important progress toward realizing the MVP guiding 
principles (86 FR 39354), challenges remain for CMS in developing an 
overall portfolio of MVPs that achieves our vision for MVPs. As we 
finalize our first set of MVPs and begin to implement our guiding 
principles, we continue to strive to fully implement MVPs and an 
overall MVP portfolio to drive value, obtain comparative performance 
data, and elevate the patient voice while reducing clinician burden.
    We thank commenters for their responses to our above-referenced 
requests for comment in the proposed rule. We may consider these 
responses to inform future rulemaking.
(b) MVP Participant
(i) MVP Participant Definition
    As we look ahead to implementing MVPs, we believe it is important 
to clearly define who can participate in MIPS through MVPs. We believe 
that defining MVP participation will help stakeholders better 
understand how our policies affect them, as well as provide clarity and 
simplicity for readers.
    At Sec.  414.1305 we have previously finalized definitions for a 
MIPS eligible clinician, group, and APM Entity. While we did not 
propose to change these definitions, and are using these existing 
terms, we sought to clarify who can participate in MVPs. We proposed a 
new opportunity for clinicians to participate in MVPs, as a subgroup. 
We refer readers to section IV.A.3.b.(3)(b)(ii) of this final rule, 
where we discuss our proposal to define a subgroup. In addition, we 
believe it would be helpful to distinguish the types of groups that 
participate in MIPS, and how they could participate in MVPs. Therefore, 
we refer readers to section IV.A.3.b.(3)(b) of this final rule, where 
we discuss our proposals to define single specialty group, 
multispecialty group, and special status, to provide further clarity 
for stakeholders as they seek to understand how they can participate in 
MVPs.
    In keeping with MVPs broader aim of cohesive participation, at 
Sec.  414.1305 we proposed the term MVP Participant to mean: An 
individual MIPS eligible clinician, multispecialty group, single 
specialty group, subgroup, or APM Entity that is assessed on an MVP in 
accordance with Sec.  414.1365 for all MIPS performance categories. For 
the CY 2025 MIPS performance period/2027 MIPS payment year and future 
years, MVP Participant means an individual MIPS eligible clinician, 
single specialty group, subgroup, or APM Entity that is assessed on an 
MVP in accordance with Sec.  414.1365 for all MIPS performance 
categories. The proposed definition of MVP Participant accounts for the 
gradual transition to requiring multispecialty groups to form subgroups 
if they want to report MVPs. We believe this is important because 
multispecialty groups report on the same set of measures, which may not 
be relevant or meaningful to all specialists that participate within 
the multispecialty group, to make improvements in the care they provide 
to patients. We refer readers to section IV.A.3.b.(2)(c) of this final 
rule for discussion of subgroup implementation, including requiring 
multispecialty groups forming subgroups to report MVPs. We recognize 
that in some limited instances, there are specific policy proposals 
that are more narrow or expansive than the term MVP Participant allows 
for. In those cases, we will continue to clarify which specific 
participants a given policy applies to, rather than using the new term. 
For example, if we have policies regarding what is required during 
subgroup registration, as discussed below, we would specify that these 
policies would be specific to subgroups rather than use the term MVP 
Participants. In another example, as discussed in section 
IV.A.3.b.(4)(d)(vi) of this final rule, we proposed Promoting 
Interoperability performance category scoring policies that apply to 
individual MIPS eligible clinicians, groups, and APM Entities, but do 
not apply to subgroups. In this example, we would clarify that the 
policy applies to MVP Participants, except subgroups. In addition, if 
we determine a given policy proposal is applicable to groups, 
regardless of whether they are single specialty or multispecialty, we 
may simply refer to them as groups. We believe stakeholders would 
welcome the simplicity that using the term MVP Participant would 
provide. It is an important step forward for the program that would 
promote clarity and consistency of policy drafting and compliance by 
stakeholders. We solicited public comment on the proposal.
    The following is a summary of the comments we received on the MVP 
participant definition and our responses.
    Comment: One commenter supported the proposed MVP participant 
definition, specifically supporting the inclusion of multispecialty 
groups to participate as subgroups. Several commenters supported the 
proposal to implement voluntary subgroup reporting in the CY 2023 
performance period. The commenters expressed their appreciation for 2 
years of voluntary subgroup reporting for multispecialty groups and 
believed that subgroup reporting encourages representation of 
specialists within a group and allows clinicians to report measures 
meaningful to their practice as part of a multispecialty group. One 
commenter expressed their opinion that subgroup reporting is essential 
for clinicians in multispecialty groups and believed that under the 
current group reporting option, specialists in multispecialty groups 
are unable to use MIPS performance feedback to improve patient care 
since the reported measure set chosen by the group does not reflect the 
care provided by the specialists. Another commenter appreciated CMS for 
tackling the operational and implementation hurdles to implement 
subgroup reporting.
    Response: We thank the commenters for their support. To clarify, as 
described at Sec.  414.1305, the proposed MVP participant definition 
would not allow for multispecialty group reporting indefinitely. As 
described in section IV.A.3.b.(2)(c)(ii) of this final rule, the 
finalized policy requires, multispecialty groups to form subgroups in 
order to

[[Page 65393]]

report MVPs, beginning with the CY 2026 performance period.
    Comment: Several commenters did not support the proposed definition 
of an MVP participant, specifically the proposed exclusion of 
multispecialty practices from being able to report an MVP at the group 
level beginning in the CY 2025 performance period due to the burden 
associated with having to form subgroups given the limited timing in 
which they have to prepare for subgroup reporting, particularly during 
the PHE. They noted that requiring these groups to report by subgroups 
will increase burden and diminish the effectiveness of subgroup 
reporting.
    Response: We disagree. While we understand the increased reporting 
burden to multispecialty practices related to forming and reporting as 
subgroups, we believe that subgroup reporting would lead to clinicians 
in a multispecialty group reporting on measures and activities that are 
meaningful to their practice. We understand that requiring 
multispecialty groups to report by subgroups will increase burden, but 
believe the benefits of requiring multispecialty groups to report 
through subgroups justify the burden and will not diminish the 
effectiveness of subgroup reporting. The data submitted by 
multispecialty groups for quality reporting is not always directly 
attributable to every clinician within that multispecialty group. For 
example, we do not believe a nephrologist in a multispecialty group can 
make meaningful improvements in the care they provide based on the 
primary care measure data that is submitted on behalf of their 
multispecialty group. It is difficult to ascertain whether specialists 
can make improvements in the care they provide, leading to improved 
patient outcomes, when the data submitted does not directly represent 
the care they provide. Therefore, we believe there is value in pursuing 
subgroup reporting, particularly for multispecialty groups and that the 
MVP participant definition should effectuate this transition. As 
described in the CY 2022 PFS proposed rule (86 FR 39357), the intent of 
the subgroup reporting proposals is to move away from large 
multispecialty groups reporting on the same set of measures, which may 
not be relevant or meaningful to all specialists that participate 
within a multispecialty group. Data submitted at the subgroup level 
would provide increased data granularity that patients and caregivers 
could use in making data-driven decisions regarding the involvement of 
specialists in their care. In addition, we believe that transitioning 
multispecialty groups to subgroup reporting will address some of the 
inherent gaming risks that are apparent when we have multi-specialty 
groups report on measures that are not necessarily representative of 
the care provided by all clinicians within the group, where clinicians 
in a group may rely on the performance of other clinicians (of a 
different specialty) within the group to meet quality reporting 
requirements. While our intent is to solve for the potential gaming 
risks associated with group reporting through our subgroup policies, we 
do continue to support clinicians who practice leveraging the team-
based care model and plan to address team-based care through future 
rulemaking. We understand that multispecialty groups may need 
additional time to prepare for this transition and transitioning during 
the PHE is difficult, for those that are not prepared to make a 
transition during the PHE, they can continue to report traditional 
MIPS. However, we do encourage multispecialty practices to adopt 
subgroup reporting practices as early as feasible, to allow clinicians 
sufficient time to orient themselves to MVP policies and reporting 
ahead of the eventual sunset of traditional MIPS.
    Comment: One commenter recommended CMS should explore options to 
allow multispecialty groups to report the same MVP instead of requiring 
them to form subgroups to report an MVP.
    Response: We disagree. The intent of the subgroup reporting is to 
move away from large multispecialty groups reporting on measures that 
are not relevant or meaningful to the specialists that participate 
within a multispecialty group. From the MIPS perspective, we believe 
there is more value from a quality improvement standpoint or 
opportunity to improve patient outcomes through subgroup reporting than 
through multispecialty group reporting. We do acknowledge there may be 
circumstances where more than one subgroup within a multispecialty 
group could select and report on the same MVP, if the MVP is relevant 
and applicable to the clinicians within the subgroups. While our intent 
is to have more meaningful reporting and solve for the potential gaming 
risks associated with group reporting through our subgroup policies, we 
do continue to support clinicians who practice leveraging the team-
based care model and plan to address team-based care through future 
rulemaking.
    Comment: One commenter suggested that CMS work with stakeholders to 
understand the issues and barriers to subgroup reporting before making 
them mandatory. The commenter also does not believe there will be 
sufficient MVPs available by 2025 to accommodate multispecialty groups.
    Response: We have continued to solicit stakeholder feedback on the 
MVP framework, including subgroup reporting for the past few years. In 
the CY 2020 PFS final rule (84 FR 62946 through 62948) we solicited 
public comments on the MVP framework. We have held several listening 
sessions, through the CMS Quality Conference related to the MVP 
framework and subgroup reporting. In addition, on January 7th, 2021 we 
held a MVP Town Hall in which we also listened to stakeholder feedback 
on our MVP vision at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1290/MIPS%20Value%20Pathways%20Town%20Hall%20Slide%20Deck.pdf. 
We continue to be open to understanding stakeholders' points of view 
with regards to MVPs and subgroup reporting. We believe our policy 
proposals already include enough flexibility to allow multispecialty 
groups to determine when they are prepared to transition to MVP 
reporting, and ultimately subgroup reporting. We acknowledge that it is 
unlikely that we will have MVPs available for all clinicians who 
participate in MIPS by the CY 2025 performance period. As we continue 
to expand the portfolio of MVPs available over the next few years, 
clinicians within a multispecialty group that do not have a relevant 
MVP for reporting could continue to report through traditional MIPS. We 
plan to time any future proposal to sunset traditional MIPS with the 
implementation of an appropriate portfolio of MVPs that are relevant to 
specialists that participate in the MIPS program.
    We understand that stakeholders such as multispecialty groups, 
healthcare organizations, and vendors are rightfully prioritizing the 
care of patients during the PHE, which may impact the timing of when 
they can prepare for and implement subgroup reporting. Since it is 
unclear as to when the COVID-19 PHE may ultimately end, we believe it 
is sufficient to delay mandatory subgroup by 1 year. The additional 
year serves as a buffer to allow multispecialty groups, healthcare 
organizations, and vendors time to plan and prepare to transition to 
subgroup reporting. This is in addition to the proposed 2-year period 
in which subgroup reporting would be voluntary, giving multispecialty 
groups 3 years in total to transition to subgroup reporting. We intend 
on continuing to monitor the PHE, and would address the mandatory

[[Page 65394]]

subgroup reporting timeline through future rulemaking if we believe 
additional delay is needed-depending on the status of the PHE and other 
relevant circumstances at the time. Therefore, after consideration of 
public comments, we believe it is appropriate to delay the requirement 
for multispecialty groups to form subgroups in order to report MVPs by 
1 year. We are finalizing the definition of MVP participant with 
modification at Sec.  414.1305 to mean: an individual MIPS eligible 
clinician, multispecialty group, single specialty group, subgroup, or 
APM Entity that is assessed on an MVP in accordance with Sec.  414.1365 
for all MIPS performance categories. For the CY 2026 MIPS performance 
period/2028 MIPS payment year and future years, MVP Participant means 
an individual MIPS eligible clinician, single specialty group, 
subgroup, or APM Entity that is assessed on an MVP in accordance with 
Sec.  414.1365 for all MIPS performance categories. Table 43 serves to 
summarize which MVP Participants can report an MVP in the future:
[GRAPHIC] [TIFF OMITTED] TR19NO21.066

(ii) Opt-In Participants, Voluntary Participants, and Virtual Groups
    As discussed in the CY 2022 PFS proposed rule (86 FR 39355), we 
proposed that for the implementation of MVPs, certain clinicians would 
not be able to participate. These include, voluntary reporters, opt-in 
eligible clinicians, and virtual groups, who would have their 
participation in MVPs delayed. We refer readers to section 
IV.A.3.b.(3)(c)(iv) of this final rule for discussion of the 
participation rates of opt-in and voluntary participants.
    The following is a summary of the comments we received on our 
proposal to exclude opt-in participants, voluntary participants and 
virtual groups from the MVP participant definition and our responses.
    Comment: A few commenters did not support the exclusion of opt-in 
participants, voluntary participants, and virtual groups from the 
definition of MVP participants. They believed that allowing these 
clinicians to participate in MVP reporting would help them prepare for 
the potential sunset of traditional MIPS and would allow voluntary 
reporters to gain experience with MVP reporting. One commenter shared 
their belief that excluding these clinicians could potentially hinder 
the development and refinement of MVPs.
    Response: We understand the need for opt-in participants, voluntary 
participants, and virtual groups to prepare for the potential sunset of 
traditional MIPS by experiencing and orienting themselves to MVP 
policies and reporting; however, we disagree with the commenters that 
these clinician types should not be excluded from the definition of an 
MVP participant for the time being. As described in section 
IV.A.3.b.(3)(c)(iv) of this final rule, based on historical data, a 
significantly low number of clinicians have utilized the opt-in, 
voluntary, and virtual group participation options in MIPS. We believe 
there are several considerations, such as implementation burden for 
stakeholders and CMS, value of MVP reporting for these clinicians 
versus burden, scoring policies, etc. that must be addressed prior to 
allowing clinicians in these categories to participate in reporting 
MVPs. Additionally, we believe we need to consider the downstream 
impacts of including these clinicians when considering the intersection 
of subgroups and virtual groups. As described at Sec.  414.1305 of this 
final rule, a subgroup is defined as a subset of a group which contains 
at least one MIPS eligible clinician and is identified by a combination 
of the group TIN, subgroup identifier, and each eligible clinician's 
NPI and will not be applicable for clinicians in a virtual group 
because a virtual group is a combination of two or more TINs, resulting 
in exclusion of clinicians in virtual groups from participating as 
subgroups for reporting MVPs. Additionally, we acknowledge the 
potential for multispecialty virtual groups and the issue of whether 
they would need to be required to form subgroups in order to report 
MVPs, similar to multispecialty groups. Overall, there are several 
factors that need to be planned for before we consider the inclusion of 
these clinician types. We do intend on revisiting this policy through 
future rulemaking and prior to the beginning of MVP reporting. We 
request stakeholder feedback on how to mitigate these implementation 
issues to expand the MVP participant definition to include these 
clinician types. Lastly, we disagree that excluding these clinician 
types could potentially hinder the development and refinement of MVPs. 
We do not believe there is a mutually exclusive relationship between 
the MVP development and maintenance processes and the exclusion of opt-
ins, voluntary participants, or virtual groups. MVPs are developed 
around specific clinical conditions, specialties, procedures, or 
episodes of care and are not developed exclusively for these clinician 
types.
    After consideration of public comments, we are finalizing this 
policy as proposed.
(d) MVP and Subgroup Implementation Timeline
(i) MVP Implementation Timeline
    Since the finalization of the MIPS Value Pathways framework through 
the CY 2020 PFS final rule (84 FR 62946 through 62949), stakeholders 
have provided feedback on our implementation timeline through multiple 
methods, including public comment through rulemaking, meetings, and the 
MVP Town Hall that held in January 2021. Associated resources related 
to the MVP Town Hall are available for stakeholder review through the 
Quality Payment Program Resource Library are available at https://qpp.cms.gov/resources/webinars.
    Through the MVP Town Hall, we have heard stakeholders encourage 
MVPs be implemented through a

[[Page 65395]]

gradual process that provides MVP participants and third-party 
intermediaries with time to adapt to the changes in policy, 
requirements, and programming updates that would need to occur in 
technological systems. Therefore, we believe it is appropriate to delay 
the implementation and availability of the MVPs, as described in 
Appendix 3: MVP Inventory of this final rule, until the 2023 
performance period/2025 MIPS payment year, of the MIPS program. We 
proposed at Sec.  414.1365(a)(1), that for the 2023 MIPS performance 
period/2025 MIPS payment year, and future years, we use MVPs included 
in the MIPS final inventory of MVPs established by CMS through 
rulemaking to assess performance for the quality, cost, improvement 
activities, and Promoting Interoperability performance categories. 
Based on the discussion above, we proposed for the CY 2023 MIPS 
performance period/2025 MIPS payment year, MVP reporting is voluntary.
    In addition to proposing a timeline in which MVPs would be first 
available, we also believe it is important to be transparent with the 
agency's current vision and solicited public comments on the timing of 
how long MVP reporting should be voluntary, the transition to mandatory 
MVP reporting, and the timing for when we should sunset traditional 
MIPS. While we have heard from stakeholders their request for us to 
maintain both reporting methods, traditional MIPS and MIPS Value 
Pathways, we believe it is not a feasible option long term, because of 
the operational burden, complexity, and costs associated with 
simultaneously maintaining both versions of the program.
    We have also heard from stakeholders (through the MVP Town Hall and 
from Health Affairs \222\) the importance in continuing this shift to 
value through MVPs, and doing so by providing as much transparency as 
possible. In order to foster transparency with our thinking, we 
solicited public comments on a transition timeline, and are planning to 
provide stakeholders with information to make informed decisions about 
their eventual transition to MVP reporting. We believe it is critical 
to establish a timeline for the awareness of all stakeholders (such as 
MVP participants, third-party intermediaries, and health systems) so 
they can plan their work accordingly to coincide with this timeline.
---------------------------------------------------------------------------

    \222\ ``Medicare Should Transform MIPS, Not Scrap It,'' Health 
Affairs Blog, March 2, 2021. DOI: 10.1377/hblog20210226.949893.
---------------------------------------------------------------------------

    As such, we outline a timeline in which MVP implementation could 
occur. As stated above, we proposed at Sec.  414.1365(a) that the first 
year MVP reporting be available is the CY 2023 MIPS performance period/
2025 MIPS payment year. Through the remainder of the timeline outlined 
in Table 44, we seek to lay out our beliefs for the future of the MIPS 
program, for purposes of transparency, and solicited public comments. 
We believe moving forward with voluntary MVP reporting in the initial 
years would provide MVP participants sufficient time to prepare for 
mandatory MVP reporting. Therefore, as outlined below, we considered 
MVP reporting would be voluntary for the CY 2023 through the CY 2027 
MIPS performance periods/2025 through the 2029 MIPS payment years. 
Furthermore, we plan for potential future mandatory MVP reporting to 
coincide with the sunset of traditional MIPS.
[GRAPHIC] [TIFF OMITTED] TR19NO21.067

    As previously described, maintaining both traditional MIPS and MVPs 
is not a feasible long-term approach for the agency. As such, we are 
thinking of sunsetting traditional MIPS by the end of the CY 2027 
performance period/2029 MIPS payment year. We like to note that we did 
not propose the timeframe in which MVP reporting would no longer be 
voluntary (by the end of the CY 2027 performance period/2029 MIPS 
payment year), and the future sunset of traditional MIPS at this time; 
any proposal to sunset traditional MIPS would be made in future 
rulemaking. Our discussion of the MVP implementation timeline is an 
effort to be transparent with our long-term vision of the MIPS program.
    We solicited public comments on this incremental timeline to 
transition to mandatory MVP reporting, including the timing of the 
sunset of traditional MIPS. Specifically, are there concerns with this 
timeline? Is there an alternative timeline we should consider and why? 
In addition, what factors should CMS monitor to determine stakeholder's 
readiness to sunset traditional MIPS and transition to MVPs? We 
understand that some clinicians who participate in MIPS practice in 
highly specialized clinical areas and subspecialties, where they may 
believe there is not an MVP applicable to their highly specialized 
practice. Therefore, we also solicited comments on what should happen 
in instances where highly specialized

[[Page 65396]]

clinicians cannot identify an applicable and relevant MVP.
    The following is a summary of the comments we received on the MVP 
implementation timeline and our responses.
    Comment: Several commenters supported a gradual transition to and 
implementation of MVPs. One commenter supported the proposal to 
introduce MVPs and a subgroup reporting option in 2023. The commenter 
appreciated CMS identifying innovative approaches to measuring value 
through MVPs, and supported CMS in soliciting stakeholder 
recommendations on changes to established MVPs for patient-facing and 
non-patient facing specialties, through the MVP maintenance process.
    Response: We thank the commenters for their support.
    Comment: One commenter voiced their appreciation of the delay to 
implement MVPs until 2023 and suggests CMS to finalize this policy as 
proposed. The commenter commended CMS for developing the MVP framework 
to create a more cohesive MIPS program and believes it will facilitate 
more meaningful comparison of care by allowing providers to report on 
fewer, more relevant measures.
    Response: We thank the commenter for their support.
    Comment: Several commenters supported CMS' move to MVPs including 
the proposal to offer MVPs as an optional reporting pathway beginning 
in the 2023 performance period. The commenters commended CMS for 
listening to stakeholders during the creation of the MVP process, and 
introducing the MVP framework as an optional reporting method initially 
and not a mandatory reporting method.
    Response: We thank the commenters for their support.
    Comment: Some commenters voiced support for MVPs but suggested that 
CMS consider delaying the implementation of the MVPs until 2024 or 
later after the end of the PHE. A few commenters stated that initial 
voluntary reporting would allow clinicians and groups to familiarize 
with the structure and scoring of MVPs, evaluate the proposed MVPs and 
adopt and prepare for reporting an MVP.
    Response: We disagree with the commenters that there is a need to 
further delay the implementation of MVPs. While we certainly understand 
the need to consider the impact to clinicians and organizations during 
the PHE, we have built in some flexibilities into our policy proposals. 
The delayed implementation of the proposed MVPs to the CY 2023 
performance period/CY 2025 MIPS payment year, as described in section 
IV.A.3.b.(2)(c)(i), is intended to provide organizations, clinicians, 
and third-party intermediaries with additional time to prepare for MVP 
reporting. In addition, we have also proposed flexibility to allow for 
voluntary reporting of MVPs at the onset of implementation. This 
flexibility allows organizations and clinicians to determine whether 
they are ready to make the transition to MVP reporting or continue to 
report traditional MIPS, considering their resources that are dedicated 
to caring for patients during the PHE. Since we did not propose a 
definitive timeframe to which MVP participants must transition to MVP 
reporting or to sunset traditional MIPS, we believe our proposed 
policies include sufficient flexibilities for organizations and 
clinicians. In addition, we agree with commenters who state that the 
initial voluntary reporting would provide MVP participants time to 
familiarize themselves with MVP policies and prepare to adopt and 
report MVPs that are relevant to their practice.
    Comment: One commenter recommended that CMS wait to implement MVPs 
until a FHIR-based approach to quality measurement can be deployed. The 
commenter stated this will aid in the transition to MVPs by lowering 
the cost of multiple program transitions and potentially lower the cost 
of reporting.
    Response: We disagree with the commenter that we should wait to 
implement MVPs until a FHIR-based approach to quality measurement is 
deployed. We understand the value in pursuing FHIR to reduce reporting 
burden and potentially lowering costs, however, we believe it is 
important to continue to take gradual steps, through the implementation 
of MVPs, to transform the MIPS program to one of value--where 
clinicians are able to report on measures and activities relevant to 
their practice, utilize the results to make improvements in the care 
provided, and continue to keep our work patient centric. The MVP 
framework was established prior to the efforts to implement FHIR for 
quality measurement began. The use of a FHIR-based approach to quality 
measurement reporting will require additional system development, 
testing, and notice and comment rulemaking before it is ready to be 
implemented.
    After consideration of public comments, we are finalizing these 
policies as proposed. We did not propose the remainder of the MVP 
implementation timeline, and sought public comment on our thinking. We 
received several comments regarding the future of the MIPS program and 
the sunset of traditional MIPS. We thank the commenters for their 
feedback that may be taken into consideration for future rulemaking.
(ii) Subgroup Implementation Timeline
    In the CY 2021 PFS final rule (85 FR 84845), we signaled our intent 
to implement subgroup reporting by finalizing modifications to the MVP 
guiding principles. We refer readers to section IV.A.3.b.(3) of this 
final rule for detailed discussion of subgroup proposals; and to 
section IV.A.3.b.(3)(b) of this final rule and Sec.  414.1305 for the 
definitions of groups, multispecialty groups, single specialty groups, 
and subgroups.
    From our understanding, groups may be made up of a single specialty 
or of multiple specialties. We do not believe that single specialty 
groups, should be required to form subgroups in order to report MVPs. 
In this scenario, we believe that a single specialty group would be 
able to report on the same set of relevant and applicable measures for 
all clinicians within the group, and would be able to ascertain results 
that may lead to improvements in the patient care provided. Therefore, 
for now, we do not anticipate the need to require single specialty 
groups to form subgroups in order to report an MVP.
    The intent of the subgroup reporting proposals is to move away from 
large multispecialty groups reporting on the same set of measures, 
which may not be relevant or meaningful to all specialists that 
participate within a multispecialty group. In addition, we have heard 
from stakeholders over the past few years that large multispecialty 
groups tend to submit data that is not necessarily representative of 
all the clinicians that make up that group. For example, a group from a 
large hospital system, may include various specialties such as primary 
care, oncology, surgery, anesthesia, and radiology that submit data to 
CMS on primary care quality measures. We are concerned that these type 
of group submissions do not accurately reflect the performance of all 
clinicians within the group, and does not provide all clinicians with 
results that leads to quality improvement in the care provided. In 
addition, we do not believe that the other specialties within the group 
can make data-driven improvements in the quality of patient care 
provided, when only primary care measure data is submitted to CMS; and 
the results of that data submission is only relevant to the primary 
care clinicians. From the patient and caregiver perspective, only 
receiving

[[Page 65397]]

information on primary care measures when searching for a specialist is 
not helpful. Data submitted at the subgroup level will provide 
increased data granularity that patients and caregivers could use in 
making data-driven decisions regarding the involvement of specialists 
in their care. In addition, we believe that transitioning 
multispecialty groups to subgroup reporting will address some of the 
inherent gaming risks that are apparent when we have multi-specialty 
groups report on measures that are not necessarily representative of 
the care provided by all clinicians within the group, where clinicians 
in a group may rely on the performance of other clinicians (of a 
different specialty) within the group to meet quality reporting 
requirements. We anticipated that multispecialty groups will need some 
time to familiarize and prepare themselves for subgroup reporting.
    We refer readers to section IV.A.3.b.(2)(b)(i) of this final rule, 
where we discuss the finalized MVP Participant definition as modified 
based on public comment. Pursuant to the finalized MVP Participant 
definition, multispecialty groups and single specialty groups may 
report as groups or choose to form subgroups to report MVPs for the CY 
2023 through the CY 2025 performance period/2025 through the 2027 MIPS 
payment years. In addition, beginning with the CY 2026 MIPS performance 
period/2028 MIPS payment year, multispecialty groups would no longer be 
able to report MVPs. This will mean that if a multispecialty group 
would like to report MVPs, beginning with the CY 2026 MIPS performance 
period/2028 MIPS payment year, they could only do so if they form 
subgroups. We believe this span of time will give multispecialty groups 
time to familiarize themselves and prepare for subgroup reporting. We 
encourage multispecialty groups to monitor the implementation of MVPs 
to determine when to adopt subgroup reporting and transition to MVPs. 
We encourage groups to adopt MVP and subgroup reporting as early as 
possible to provide some time to work through any inadvertent 
operational issues they may encounter as MVP participants prepare for 
the future of the MIPS program. While we understand that groups may 
choose between MVP reporting and continuing to participate through 
traditional MIPS, we highly encourage groups to submit via subgroups if 
applicable in the first few years of MVP reporting. We believe early 
adoption of MVPs and subgroup reporting is important for stakeholders, 
as this will allow clinicians to acclimate to MVP reporting in the 
event we sunset traditional MIPS in the future.
    We understand that some clinicians practice utilizing a team-based 
care approach, through a multispecialty group. We believe that MVP 
reporting can continue to foster the utilization of team-based care 
through subgroup reporting. As such, we describe in section 
IV.A.3.b.(4)(b)(i)(A) of this final rule, that MVPs may be developed to 
reflect the team-based care approach used during an episode of care.
    In addition, we believe that the delayed implementation of 
subgroups to the CY 2023 MIPS performance period/2025 MIPS payment year 
provides third party intermediaries with sufficient time to adapt to 
the changes in policy, requirements, and programming updates that would 
need to occur in technological systems to support subgroup reporting. 
We encourage the early adoption of subgroup reporting to allow groups 
to gain experience with the future state of the program.
    A finalized timeline to implement subgroup reporting is outlined in 
Table 45.
[GRAPHIC] [TIFF OMITTED] TR19NO21.068

    As we continue to expand the portfolio of MVPs available over the 
next few years, MIPS eligible clinicians, groups, and APM entities that 
do not have a relevant MVP for reporting could continue to report 
through traditional MIPS. We plan to time the sunset of traditional 
MIPS with the implementation of an appropriate portfolio of MVPs that 
are relevant to specialists that participate in the MIPS program. Until 
that time, there may be instances where some clinicians in a 
multispecialty group may have a relevant MVP available for reporting, 
while other clinicians within that same multispecialty group may not. 
In this scenario, the clinicians within the multispecialty group that 
have an MVP available may form a subgroup to report the MVP, while the 
group continues to report traditional MIPS. We refer readers to section 
IV.A.3.b.(3) of this final rule for additional discussion of subgroup 
proposals.
    We believe there is a need for multispecialty groups to transition 
to subgroup reporting in order to align with the goals of MVP 
reporting. That is, to provide more direct attribution of quality 
measure data and results to all clinicians that participate in the 
program rather than relying on quality reporting results that can only 
be attributed to a few clinicians within the group. This direct 
attribution will lead to more valuable, meaningful, and actionable 
results that contribute to patient care and improvement. We refer 
readers to sections IV.A.3.b.(3) and IV.A.3.b.(4)(d) of this final rule 
for discussion of the finalized subgroup and MVP reporting 
requirements.
(e) Subgroups Reporting the APM Performance Pathway (APP)
    In the CY 2021 PFS final rule (85 FR 84859 through 84866), we 
finalized the availability of the APM Performance Pathway beginning 
with the CY 2021 performance period. Specifically, we finalized that 
individual MIPS eligible clinicians who are participants in MIPS APMs 
may report through the APP at the individual level (85 FR 84860). 
Furthermore, we finalized that groups and APM Entities may report 
through the APP on behalf of constituent MIPS eligible clinicians (85 
FR 84860). Because we already identify the MIPS eligible clinicians who 
are MIPS APM participants based on Participation Lists

[[Page 65398]]

for each APM, it is unnecessary to require MIPS APM participants to 
register as subgroups for purposes of reporting the APP. We use 
Participation Lists to identify each individual APM participant for 
purposes of MIPS APM participation, as well as application of the 
Improvement Activities credit for APM participants; beginning with 
performance year 2023, we will use Participation Lists to identify the 
MIPS eligible clinicians within a group TIN that should be included in 
the subgroup of APM participants for purposes of reporting the APP.
(f) Catalyst for Reporting MVPs
(i) Background
    Through the MIPS Value Pathways framework, finalized in the CY 2020 
PFS final rule (84 FR 62946 through 62949), stakeholders provided 
feedback, specifically questioning what incentives would MVP 
Participants have to report on MVPs, when they have the choice to 
report traditional MIPS instead. We have heard these questions raised 
through multiple methods, including public comment through rulemaking, 
meetings, and the MVP Town Hall that was held in January 2021. Through 
rulemaking, we have proposed MVP policies that we believe act as 
catalysts to encourage MVP Participants to transition to MVP reporting. 
This includes reduced reporting requirements, as described in section 
IV.A.3.b.(4)(d) of this final rule, allowing MVP Participants to report 
on a smaller, more cohesive subset of measures and activities that are 
relevant to a given clinical topic, condition, procedure, or episode of 
care. In addition, as described in section IV.A.3.b.(5)(d)(ii) of this 
final rule, we are finalizing our proposal to provide MVP Participants 
who report on MVPs with enhanced performance feedback that allows for 
meaningful comparison to similar clinicians and provides more useful 
information to make improvements in the care provided.
    Additionally, we understand that clinicians have other requirements 
that must be met to maintain their licensure and as appropriate board 
certification status. In many instances, clinicians must comply with 
Continuing Medical Education (CME) requirements and/or Maintenance of 
Certification (MOC) requirements. We believe that any alignment between 
what clinicians must do to maintain their licensures/board 
certifications and reporting MVPs would be beneficial by reducing 
burden in terms of the various requirements clinicians must comply 
with. Therefore, in some cases, it seems possible that offering CME 
credit or credit towards MOC could be connected with MVPs. We encourage 
accrediting organizations such as specialty societies, to work with MVP 
submitters and consider whether CME credit or credit towards MOC could 
be offered for reporting MVPs. We believe by allowing clinicians to 
receive CME credit for MVP reporting, there is potential for there to 
be a reduction in the administrative burden clinicians face when trying 
to balance meeting CMS program requirements with the requirements of 
medical licensing or certification.
    The incentives for clinicians to report on MVPs in lieu of 
traditional MIPS may encourage early adoption of MVPs and allows those 
clinicians to gain experience with the future state of the program. We 
believe that creating incentives to report MVPs may help MVP 
participants familiarize themselves with MVP reporting requirements, 
particularly in cases where clinicians identify an available MVP as 
relevant to their practice. Through public comment stakeholders have 
expressed their desire for additional incentives for clinicians to 
choose to report MVPs over traditional MIPS. We refer readers to 
section IV.A.3.b.(5) of this final rule where we discuss considerations 
of additional incentives through future rulemaking.
(ii) Public Reporting of MVP Data
    We have heard from stakeholders who expressed hesitancy to partake 
in the initial transition to MVP reporting citing concerns with what 
results may be publicly reported. We refer readers to section 
IV.A.3.i.(1) of this final rule for discussion of our public reporting 
proposals related to MVP data and subgroup reporting.
(3) Subgroup Composition
(a) Overview
    In the CY 2022 PFS proposed rule (86 FR 39355 through 39358), we 
proposed to establish subgroup reporting as an option for MVP 
Participants and for those individuals and entities who choose to 
report the APP. Additionally, we proposed: (1) Definitions for 
subgroup, single specialty group, multispecialty group, and special 
status; (2) subgroup eligibility requirements; and (3) application of 
low-volume threshold and special status designations for subgroups (86 
FR 39360 through 39363). We refer readers to section IV.A.3.b.(4) of 
this final rule, for details on our finalized policies regarding: (1) 
Subgroup reporting requirements; (2) subgroup election process; and (3) 
subgroup identification. In section IV.A.3.b.(5) of this final rule, we 
detail our finalized policies on subgroup scoring.
    We refer readers to the CY 2022 PFS proposed rule (86 FR 39359) for 
information on the background of subgroup reporting and discussion of 
our proposed policies.
(b) Definitions of a Single Specialty Group, Multispecialty Group, 
Subgroup, and Special Status
    A group is currently defined at Sec.  414.1305 as a single TIN with 
two or more eligible clinicians (including at least one MIPS eligible 
clinician), as identified by their individual NPI, who have reassigned 
their billing rights to the TIN. As discussed in section 
IV.A.3.b.(3)(b)(iii) of this final rule, we proposed to use certain 
characteristics of the group to determine eligibility and special 
status of the clinicians in the subgroup. To provide clarity, we 
proposed definitions for single specialty groups, multispecialty 
groups, subgroups, and special status.
(i) Single Specialty and Multispecialty Groups Definitions
    We proposed to add to Sec.  414.1305 to include that a single 
specialty group is a group as defined at Sec.  414.1305 that consists 
of one specialty type as identified by eligible clinicians in the 
Medicare Provider Enrollment, Chain, and Ownership System (PECOS) 
(https://pecos.cms.hhs.gov/). In the proposed rule (86 FR 39360), we 
shared our belief that using clinician specialty information from PECOS 
would allow us to align data sources and create greater consistency 
within the program given that PECOS specialty information is publicly 
reported on Care Tools.\223\
---------------------------------------------------------------------------

    \223\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/About-Physician-Compare-An-Overview.
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    We also proposed to add to Sec.  414.1305 to include that a 
multispecialty group is a group as defined at Sec.  414.1305 that 
consists of two or more specialty types as identified by eligible 
clinicians in the Medicare Provider Enrollment, Chain, and Ownership 
System (PECOS). As discussed in section IV.A.3.b.(2)(c)(ii) of this 
final rule, beginning in the CY 2026 performance period/2028 MIPS 
payment year, multispecialty groups will be required to form subgroups 
to report MVPs.
    Additionally, we refer readers to the CY 2022 PFS proposed rule (86 
FR 39360), where we discussed the subgroup reporting options for 
clinicians involved in care across multiple specialties or who may have 
more than one PECOS specialty

[[Page 65399]]

designation. At this time, we do not have limitations on which 
specialty will be considered the primary specialty. However, we will be 
taking stakeholder feedback into consideration as we craft policies for 
limiting subgroup composition in the future.
    We received public comments on the proposed definitions for single 
specialty and multispecialty groups. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters expressed concerns about the use of the 
PECOS clinician specialty designation to determine the composition of a 
group or a subgroup. A few commenters shared their concern that PECOS 
primary specialty designations in many instances do not align with the 
scope of care provided by a clinician and specifically do not represent 
the care provided by clinicians in subspecialties. A few commenters 
recommended that CMS determine specialty by analyzing claims data, 
specifically specialty taxonomy codes, because they believed that 
taxonomy codes offer a deeper level of specificity than PECOS specialty 
codes which could make it clearer which specialties would want to 
report on a given MVP. One commenter specifically shared their belief 
that using PECOS to determine clinician specialty may result in the 
exclusion of NPs, PAs, and other clinician types due to the designation 
options within PECOS.
    Response: As articulated in the CY 2022 PFS proposed rule (86 FR 
39365 through 39366), we recognize there are advantages and 
disadvantages with using PECOS to make specialty determinations. We 
thank the commenters for sharing their concerns about the use of PECOS 
clinician specialty designations to determine the composition of a 
group or subgroup. We recognize that specialty codes on claims data may 
offer additional information regarding the primary specialty of 
clinicians in a subgroup. We currently utilize both PECOS and claims 
data in the Quality Payment Program. For example, we use claims data 
for determining clinician eligibility for the MIPS program and use 
PECOS for identifying specialty information on the Compare Tools for 
doctors and clinicians. Given that PECOS specialty information is also 
publicly reported on Compare Tools, its use would advance our desire to 
maintain consistency across the program. Additionally, we agree with 
the commenter on the importance of ensuring that NPs, PAs, and other 
clinician types are not excluded from MVP reporting due to their 
primary designation within PECOS. Therefore, we are finalizing the 
proposed definitions of single specialty group and multispecialty group 
with modifications as described in more detail below. We believe that 
it is critical for CMS to continue to explore the most appropriate data 
sources and options which can be used to determine whether a group is 
single specialty or multispecialty, as well as across the MIPS program 
(for example, when making eligibility determinations, for public 
reporting).
    Comment: One commenter recommended that CMS define a multispecialty 
group as a group that consists of five or more specialty types as 
identified by eligible clinicians in PECOS because they believe 
requiring single specialties to form individual subgroups would be 
exorbitantly burdensome for large, multispecialty practices which they 
believe would have to form 50 or more subgroups.
    Response: We thank the commenter for their feedback. As discussed 
in the proposed rule (86 FR 39365 through 39366), we solicited comments 
on the criteria for defining mandatory subgroup reporting and if a 
subgroup should be limited to a single specialty. As discussed in 
section IV.A.3.b.(2)(c)(ii) of this final rule, beginning in the CY 
2026 performance period/2028 MIPS payment year, multispecialty groups 
will be required to form subgroups to report MVPs. To clarify, we did 
not propose to require any criteria for the composition of subgroups at 
this time, including limiting subgroup reporting to a single specialty; 
however, we will be taking public comments into consideration as future 
subgroup proposals are created. We agree with the commenter that we 
would not want to create a scenario where a practice would have to 
create a subgroup for every specialty and subspeciality. As we move 
from traditional MIPS to MVP reporting, we currently believe defining a 
multispecialty group as two or more specialties offers simplicity for 
stakeholders to understand their status.
    After consideration of public comments, we are finalizing our 
proposal to define single specialty groups and multispecialty groups, 
with modifications. Specifically, we are removing the reference to the 
use of PECOS within the definitions for single specialty and 
multispecialty groups at Sec.  414.1305 to allow CMS to explore the 
data sources and options that can be used across the program, including 
for identifying primary specialty designations. Given the feedback from 
commenters, as well as the fact that we utilize both PECOS and claims 
data in the Quality Payment Program, we do not believe that it is 
appropriate to specify PECOS as the sole data source for determining 
specialty information of groups at this time. We recognize that the 
attribution of a specialty is complex, and we want to avoid unintended 
consequences that may arise from the use of one data source over 
another data source when making such attributions.
    We also recognize there are different ways for a clinician to 
identify their specialty and that this results in different information 
available to CMS (for example, different specialty information 
available under PECOS and claims data). We believe we need additional 
time to explore the potential data sources (for example, PECOS and 
claims) and options that can be used across the program, including for 
identifying primary specialty designations. Analyzing existing data 
sources, such as PECOS or claims data, as well as other options will 
help us ensure we have accurate data on eligible clinicians. We intend 
to assess available data and systems to ensure that the data is recent 
and accurately reflects the scope of care provided by clinicians.
    Therefore, we are finalizing at Sec.  414.1305 that a single 
specialty group consists of one specialty type. We are finalizing at 
Sec.  414.1305 that a multispecialty group consists of two or more 
specialty types. We encourage stakeholders to provide feedback on their 
experience with CMS use of separate data sources for MIPS eligibility 
determination (claims data) and public reporting on Care Compare (PECOS 
data). Additionally, we request stakeholder feedback on alternate data 
sources that CMS could consider in addition to the existing data 
sources (claims data and PECOS) utilized in MIPS.
(ii) Subgroup Definition
    We proposed to define a subgroup at Sec.  414.1305 as a subset of a 
group which contains at least one MIPS eligible clinician and is 
identified by a combination of the group TIN, the subgroup identifier, 
and each eligible clinician's NPI. Groups would identify their 
affiliated subgroups, and those subgroups would submit data on the MVPs 
which are clinically meaningful to MIPS eligible clinicians within a 
subgroup or their patients. We proposed at Sec.  414.1318(b) to state 
that except as provided under Sec.  414.1317(b), each MIPS eligible 
clinician in the subgroup receives a final score based on the 
subgroup's combined performance assessment. Additionally, we proposed 
to amend Sec.  414.1310(e)(1) to state that except as provided under

[[Page 65400]]

Sec. Sec.  414.1315(a)(2), 414.1317(b), 414.1318(b), and 414.1370(f)(2) 
each MIPS eligible clinician in the group receives a final score based 
on the group's combined performance assessment. With the inclusion of 
the exception provided under Sec.  414.1318(b), this would allow for an 
exception for subgroups to receive a final score based on the 
subgroup's combined performance.
    As discussed in the CY 2022 PFS proposed rule (86 FR 39361), it is 
possible that more than one final score could be associated with a TIN/
NPI for a performance period, and in those situations and as finalized 
in section IV.A.3.f.(5) of this final rule, we will apply a final score 
hierarchy for purposes of determining the MIPS payment adjustment for 
that TIN/NPI. As finalized in section IV.A.3.b.(2)(c)(ii) of this final 
rule, beginning with the CY 2026 performance period/2028 MIPS payment 
year, multispecialty groups will be required to form subgroups for 
reporting MVPs. We believe this will offer clinicians the opportunity 
to participate in MIPS more meaningfully and will allow patients to 
have more granular and meaningful information when selecting an 
eligible clinician. Additionally, we refer readers to the CY 2022 PFS 
proposed rule for discussion around balancing increased data 
granularity with team-based care and measuring performance at the 
subgroup level (86 FR 39361).
    As discussed in section IV.A.3.b.(4)(d)(vi) of this final rule, 
MIPS eligible clinicians in groups who do not have an MVP relevant to 
their practice would participate in traditional MIPS through group 
reporting or as an individual. If their group reports through 
traditional MIPS or an MVP, the clinicians could receive their group's 
score, if their group submits data. If the group chooses not to report, 
a MIPS eligible clinician can report as an individual and receive their 
individual score. While subgroup reporting of MVPs would be voluntary 
for multispecialty groups until the CY 2026 performance period/2028 
MIPS payment year, these groups will continue to report to MIPS for the 
eligible clinicians (as identified by NPI) under their TIN, including 
clinicians reporting through subgroups, which is discussed in section 
IV.A.3.b.(4)(d) of this final rule.
    We received public comments on the proposed definition for 
subgroups. The following is a summary of the comments we received and 
our responses.
    Comment: A few commenters supported our proposal for the 
implementation of subgroup reporting. The commenters shared their 
belief that the subgroup data would allow for better choice of care by 
patients and provide additional information for clinicians to improve 
quality of care provided. One commenter believes subgroup reporting 
would be crucial to MVPs as it would facilitate meaningful 
participation for specialists within multispecialty groups, especially 
clinicians in group practices who are part of episode-based care.
    Response: We agree collecting subgroup-level data would allow for 
better choice of care by patients and provide additional information to 
clinicians to improve the quality of care they provide. We also believe 
this policy will allow specialists to participate in the MIPS program 
more meaningfully.
    Comment: A few commenters expressed concern that subgroup reporting 
may undermine the efficiencies and advantages of the group practice 
model, specifically detracting from team-based care.
    Response: We agree there are tradeoffs that must be considered in 
the development and implementation of subgroup reporting policies. In 
addition, we believe transitioning multispecialty groups to subgroup 
reporting will address some of the inherent gaming risks that are 
apparent when we have multi-specialty groups report on measures which 
are not necessarily representative of the care provided by all 
clinicians within the group, where clinicians in a group may rely on 
the performance of other clinicians (of a different specialty) within 
the group to meet quality reporting requirements. While we intend 
subgroup reporting to be meaningful and relevant to the scope of care 
provided by the clinicians in the subgroup and allow patients to obtain 
clinician information at a more granular level, we continue to support 
clinicians who practice medicine leveraging the team-based care model 
and plan to address team-based care through future rulemaking. We 
believe clinicians would be able to participate in the MIPS program 
more meaningfully if they report measures which are aligned with their 
scope of care--where specialists directly contribute to the measures 
and activities they report on. We also encourage the continuation of 
team-based care and do not intend to prohibit or limit team-based care 
through the MVP and subgroup policies. Therefore, as discussed in 
section IV.A.3.i.(1) of this final rule, we believe clinician 
participation in subgroups would provide meaningful performance 
feedback for clinicians and also allow patients to choose clinicians 
relevant to their clinical condition or care needs.
    We also agree with commenters that there are many advantages of 
group practice, and it is critical that team-based care must be 
accounted for in both subgroup and MVP reporting. Therefore, as 
finalized in section IV.A.3.b.(2)(c)(ii) of this final rule, we are 
delaying the implementation of mandatory subgroup reporting of MVPs 
from CY 2025 performance period/2027 MIPS payment year to CY 2026 
performance period/2028 MIPS payment year. We believe the additional 
time will allow us to craft subgroup reporting policies which will help 
increase the data available to patients for choosing clinicians, 
increase the meaningfulness of QPP, and support team-based care.
    Comment: One commenter requested that CMS clarify what it means by 
stating that groups will continue to report to MIPS for their eligible 
clinicians in their group, including the eligible clinicians who report 
to MIPS through subgroups.
    Response: In section IV.A.3.b.(2)(c)(ii) of this final rule, we 
finalized the proposal that beginning with the CY 2026 performance 
period/2028 MIPS payment year, multispecialty groups will only be able 
to participate in MVP reporting as subgroups. We anticipate there would 
not be an applicable MVP for all clinicians by the CY 2026 performance 
period/2028 MIPS payment year. Therefore, those clinicians who do not 
have a relevant MVP available for reporting would continue to report 
through traditional MIPS. As we transition to mandatory subgroup 
reporting, including a State where subgroups may report the Promoting 
Interoperability measures at the subgroup level, we recognize there 
will be duplicative reporting during this time to ensure no clinicians 
are left behind and policies are achievable. Therefore, during the 
initial years of subgroup reporting, the affiliated group will continue 
to include subgroup reporters in their traditional MIPS submission 
across all four performance categories. We refer readers to Sec.  
414.1310(e) and the CY 2018 Quality Payment Program final rule (82 FR 
53592 through 53593) for a description of our previously established 
policies regarding group reporting.
    After consideration of public comments, we are finalizing these 
proposals as proposed.
(iii) Special Status Definition
    In the CY 2018 Quality Payment Program final rule, we finalized 
definitions for special status

[[Page 65401]]

determinations for ambulatory surgical center (ASC)-based MIPS eligible 
clinicians, facility-based MIPS eligible clinicians, Health 
Professional Shortage Areas (HPSA), hospital-based MIPS eligible 
clinicians, non-patient facing MIPS eligible clinicians, rural area, or 
small practice status and codified at Sec.  414.1305 definitions for 
each (82 FR 53479 through 53586). We often refer informally to these as 
``special status''; however, we have not previously defined what 
``special status'' means. Therefore, we proposed to add to Sec.  
414.1305 and define that special status means that a MIPS eligible 
clinician: (1) Meets the definition of an ASC-based MIPS eligible 
clinician, facility-based MIPS eligible clinician, hospital-based MIPS 
eligible clinician, non-patient facing MIPS eligible clinician, or is 
in a small practice; or (2) is located in an HSPA or rural area. We 
believe that defining special status will help clinicians better 
understand the application of subgroup policies.
    Comment: One commenter supported the proposed definition of special 
status because they believe that clinicians who provide their services 
in ASCs should not be penalized for lack of access to health 
information technology. They also shared their belief that this aligns 
with Congressional intent under Section 16003 of the 21st Century Cures 
Act.
    Response: We thank the commenter for their support.
    After consideration of public comments, we are finalizing the 
proposal as proposed.
(c) Subgroup Eligibility
    As described in section IV.A.3.b.(2)(c)(ii) of this final rule, we 
proposed voluntary subgroup reporting for clinicians beginning with the 
CY 2023 performance period/2025 MIPS payment year and to define 
subgroup as a subset of a group which contains at least one MIPS 
eligible clinician and is identified by a combination of the group TIN, 
the subgroup identifier, and each eligible clinician's NPI. During the 
initial years of MVP implementation, we recognize that there may be an 
inadequate number of MVPs available for clinicians to participate as 
subgroups. In the proposed rule, we proposed: (1) Application of a low-
volume threshold; (2) application of special status designation; and 
(3) subgroup inclusions and exclusions (86 FR 39361). Additionally, we 
solicited comments on subgroup composition and limitations.
(i) Application of Low-Volume Threshold
    We considered whether a low-volume threshold for clinicians 
participating in subgroup reporting should be calculated at the group 
or subgroup level. In consideration of stakeholder feedback and to 
minimize changes in eligibility determination for clinicians, we 
believe it would be optimal to determine the low-volume threshold for 
clinicians participating in a subgroup at the group level. As we 
implement subgroup reporting and as clinicians and groups familiarize 
themselves with this new participation option, we believe we should 
limit the complexity of the program to the extent that is feasible.
    At Sec.  414.1305, one of the ways we determine MIPS eligibility is 
by defining how the low-volume threshold is applied to individual 
clinicians and groups. We determine eligibility for MIPS during two 
different eligibility periods, which include an assessment of: (1) 
Those who have allowed charges for covered professional services less 
than or equal to $90,000; (2) those who provide covered professional 
services to 200 or fewer Part B-enrolled individuals; and (3) those who 
provide 200 or fewer covered professional services to Part B-enrolled 
individuals (83 FR 59735) provided by the clinician and group during 
that time-period. Therefore, we proposed at Sec.  414.1318(a)(1) that 
except as provided under Sec.  414.1318(a)(2), for a MIPS payment year, 
determinations of meeting the low-volume threshold criteria and special 
status for subgroups are determined at the group level as provided 
under Sec. Sec.  414.1305 and 414.1310.
    We solicited public comments on this proposal. As MVPs continue to 
evolve, we anticipate increased opportunities for clinician 
participation in subgroups, and we also solicited feedback from 
stakeholders if we should reevaluate, in the future, MIPS eligibility 
for clinician participation in subgroups at the subgroup level.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters supported the proposal of applying a 
group's low-volume threshold determination to clinicians in subgroups. 
One commenter believes finalizing the low-volume threshold 
determination at the group level for subgroup participants would 
generally rule out the possibility that multispecialty groups would 
then exclude clinicians from the program.
    Response: We agree with the commenters that assessing the low-
volume threshold at the group level would ensure many clinicians are 
continued to be eligible clinicians in the program.
    Comment: One commenter shared their concern that some clinicians 
may not meet the low-volume threshold by themselves under a scenario 
where each specialty is required to form and report through subgroup 
reporting. The commenter shared their belief that MVP reporting for 
clinicians in small subgroups may not be beneficial for such clinicians 
and their patients due to inadequate patient outcomes volumes, and 
therefore, these clinicians should be excluded from MVP reporting. They 
recommended that CMS instead apply the low-volume threshold at the 
subgroup level because they believe this would help alleviate burden in 
large, multispecialty practices and ensure that the subgroup data that 
patients receive is a valid representation of the care provided.
    Response: We understand the commenter's first concern to be that 
applying the low-volume threshold at the subgroup level would exclude 
some clinicians who would otherwise be eligible to participate in MIPS. 
We acknowledge the commenter's concern that subgroup reporting would be 
burdensome and may not be beneficial due to insufficient patient 
volume. We agree with the commenter that subgroup reporting may be 
burdensome, however, we believe that subgroup reporting will provide 
information about the clinicians at a more granular level to patients, 
enabling informed decision making for their care needs. We believe that 
the benefits of providing patients with more information about 
clinicians outweighs the detriments of the increased reporting burden. 
We also believe that through subgroup reporting, clinicians will 
receive performance feedback relevant to the care provided, making the 
MIPS program more meaningful to both clinicians and patients. To 
further clarify, we proposed to continue low-volume threshold 
determinations at the group level, which we believe helps simplify our 
subgroup policies, limiting confusion around participation status in 
MIPS. We believe if we determined the low-volume threshold at the 
subgroup level that this could have unintended consequences such as 
excluding clinicians from participating in MIPS. We believe by 
participating in MIPS, clinicians are incentivized to provide higher 
quality care at a lower cost, which benefits patients. Additionally, we 
believe assessing the low-volume threshold at the subgroup level could

[[Page 65402]]

create loopholes whereby clinicians do not report. This could limit a 
patient's access to more granular clinician data and could have adverse 
effects on their care, which is contrary to the goals of MVPs and 
subgroup reporting. Additionally, as finalized in section 
IV.A.3.b.(5)(b)(i) of this final rule, for MVP measures to be scored, 
case minimums are applied and can be reweighted. We believe we will 
have to find ways for smaller subgroups to meet case minimum on certain 
quality measures and look forward to working with stakeholders over the 
coming rulemaking cycles on this issue. We refer readers to this 
section for more details and discussion of this policy.
    After consideration of public comments, we are finalizing this 
policy as proposed.
(ii) Application of Special Status Designation
    Groups in MIPS could have their data submission requirements and 
scoring affected by special statuses outside of their underlying 
eligibility for MIPS. Each of these special statuses, described in 
section IV.A.3.b.(3)(b)(iii) of this final rule, are determined at the 
time of eligibility determinations.
    We proposed at Sec.  414.1318(a)(1) for a MIPS payment year, 
determinations of meeting the low-volume threshold criteria and special 
status, as defined at Sec.  414.1305, for subgroups is determined at 
the group level as provided under Sec.  414.1310. We believe it is 
necessary to explain how special status determinations would work in 
the context of subgroup reporting. For example, a large, multispecialty 
group may include subgroups of clinicians that meet the requirements 
for small practice status, or non-patient facing status, or facility-
based status. While we are certain some existing groups could have 
subgroups that could be eligible at the subgroup level for special 
status designation as described in section IV.A.3.b.(3)(b)(iii) of this 
final rule, we do not believe that this determination should be made at 
the subgroup level at this time. We want to deter construction of 
subgroups that would inappropriately create special status exemptions, 
such as subgroups of 15 or fewer clinicians in a large group. Overall, 
we believe this should help limit the complexity of the program as we 
implement this new participation option.
    We refer readers to the CY 2022 PFS proposed rule for discussion of 
our plan to not establish limits, at this time, on the number of 
subgroups that a clinician can be part of (86 FR 39362). We will 
monitor the ways in which clinicians form subgroups and will revisit 
this issue in future rulemaking if we discover that clinician 
participation in multiple subgroups is not what we intended.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters supported the proposal to apply a 
group's special status designation to clinicians in subgroups because 
they believe it would continue the traditional MIPS exemption policies 
and offer simplicity for multispecialty statuses, so they are not 
tracking special status determinations for each subgroup.
    Response: We thank the commenters for their support.
    Comment: A few commenters requested CMS clarify what special status 
designation means for healthcare systems, hospitals, and practices 
which include clinicians with different types of special status 
designations (hospital-based, non-patient facing, small practice, etc.) 
under the same TIN.
    Response: In the CY 2018 Quality Payment Program final rule (82 FR 
53579 through 53586), we finalized definitions for special status 
determinations for ASC-based MIPS eligible clinicians, facility-based 
MIPS eligible clinicians, HPSA, hospital-based MIPS eligible 
clinicians, non-patient facing MIPS eligible clinicians, rural area, or 
small practice status and codified at Sec.  414.1305 definitions for 
each. We did not propose a change to how these determinations are made 
in traditional MIPS or under MVPs. We clarify that our proposal 
described above would extend these special status designations to 
subgroup participants so practices would not have to keep track of 
these designations at a subgroup level. To further clarify our intent, 
we interpret the commenters' reference to ``healthcare systems' to mean 
an organization or entity consisting of a group of affiliated hospitals 
or practices. We note that special status designations are not 
applicable to healthcare systems and are assigned by CMS to MIPS 
eligible clinicians at the individual or group level (available via the 
NPI lookup on qpp.cms.gov). Additionally, we note that all the special 
statuses could apply at the individual or group level, which we believe 
helps account for different types of eligible clinicians who provide 
health care under the same practice.
    Comment: One commenter did not support the proposal for special 
status designation to be assessed at the group level for subgroup 
participants because they believed participation in MVPs may be more 
difficult for some clinicians if there are no relevant measures or 
activities available in an MVP.
    Response: We believe the commenter misinterpreted the proposed 
policy for the application of special status designation and may have 
confused it with our MVP reporting policies regarding the availability 
and applicability of measures and activities under MVPs, described 
under section IV.A.3.b.(4) of this final rule.
    After consideration of public comments, we are finalizing this 
policy as proposed.
(iii) Subgroup Composition Limitations
    In the CY 2022 PFS proposed rule, we did not propose to require any 
criteria for the composition of subgroups at this time (86 FR 39362). 
However, we solicited comments on criteria that we could consider in 
the future, such as in the CY 2023 PFS rulemaking cycle. We received 
many comments, and we thank commenters for their feedback. We will take 
these comments into consideration for future rulemaking.
(iv) Subgroup Inclusions and Exclusions
(A) Subgroup Eligibility--Participants in MIPS APMs
    We refer readers to the CY 2022 PFS proposed rule (86 FR 39362 
through 39363), where we discuss subgroup reporting eligibility for 
MIPS APM participants, including how clinicians in APM Entities cannot 
form a subgroup across multiple TINs at this time. We thank the 
commenters who provided public comment on potential considerations for 
allowing APM Entities to form subgroups across multiple TINs and will 
take this feedback into consideration in future rulemaking.
(B) Subgroup Exclusions--Opt-In Eligible Clinicians and Voluntary 
Participants
    Based on historical data, a significantly low number of clinicians 
have utilized the following participation options in MIPS: Virtual 
groups; opt-in eligible clinicians; and voluntary reporters. For 
example, if the number of opt-in eligible clinicians remains the same 
as estimated in the CY 2021 PFS final rule (85 FR 85015), we anticipate 
that an estimated 0.3 percent of the total number of MIPS eligible 
clinicians would fit into this category. We believe that there are 
several operational considerations, such as implementation burden for 
stakeholders and CMS, value of subgroup reporting for these clinicians 
versus burden, scoring policies, etc. that must be addressed prior to 
allowing clinicians in these categories to participate as subgroups

[[Page 65403]]

for reporting MVPs. Additionally, we believe that the definition of a 
subgroup consisting of one TIN, as in section IV.A.3.b.(3)(b)(ii) of 
this rule, would not be applicable for clinicians in a virtual group 
because a virtual group is a combination of two or more TINs, resulting 
in exclusion of clinicians in virtual groups from participating as 
subgroups for reporting MVPs.
    Therefore, beginning in the CY 2023 performance period/2025 MIPS 
payment year, we proposed at Sec.  414.1318(a)(2) that an individual 
clinician or group electing to participate in MIPS as an eligible 
clinician in accordance with Sec.  414.1310(b)(1)(iii)(A) or Sec.  
414.1310(b)(2) is not eligible to participate as a subgroup. As we 
consider transitioning to MVPs and retiring traditional MIPS, we will 
revisit subgroup eligibility for opt-in eligible clinicians, voluntary 
participants and clinicians in virtual groups in future years. We also 
solicited feedback from stakeholders on whether clinicians in these 
categories should be allowed to form subgroups in future years, and if 
there are additional criteria that should be established.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter did not support our proposal to exclude opt-
in eligible clinicians, virtual groups, and voluntary reporters from 
subgroup reporting in the CY 2023 performance period/2025 MIPS payment 
year because they believe allowing these clinician types would help 
them prepare for the potential sunset of traditional MIPS.
    Response: We acknowledge that we will continue to take these types 
of clinicians into consideration as we continue to build out our 
subgroup policies in future rulemaking. Additionally, based on 
historical data, opt-in clinicians, voluntary reporters, and virtual 
groups make up less than 5 percent of the total number of MIPS eligible 
clinicians. We believe excluding these clinicians from subgroup 
reporting would allow CMS to streamline MVP reporting and focus on MVP 
development for a majority of the clinicians, while reducing burden and 
complexity for these clinicians during the initial years of MVP 
implementation. However, as MVP implementation continues, we will 
reassess if these exclusions should be continued.
    After consideration of public comments, we are finalizing this 
policy as proposed.
(d) Subgroup Examples
    In Appendix 3: MVP Inventory of this final rule, we are finalizing 
seven MVPs for implementation in the CY 2023 performance period/2025 
MIPS payment year. We have provided examples below to show how eligible 
clinicians could choose to participate as subgroups for reporting MVPs 
if these MVPs are finalized. These examples are not intended to be 
exhaustive of the eligible clinician types that could participate as 
subgroup.
    Example 1: A group is composed of all anesthesiologists. In this 
example, all the clinicians in the group have the same primary 
specialty designation, which is an example for a single-specialty 
group. We would not anticipate that they would wish to form subgroups 
but could report the Patient Safety and Support of Positive Experiences 
with Anesthesia MVP as a group.
    Example 2: Table 46 illustrates an example of subgroup reporting 
for a group consisting of anesthesiologists, orthopedic surgeons, and 
CRNAs. In this example, the group could form a total of three 
subgroups. The anesthesiologists and CRNAs could form either one or two 
subgroups for reporting the proposed Patient Safety and Support of 
Positive Experiences with Anesthesia MVP as described in Table G: 
Proposed Patient Safety and Support of Positive Experiences with 
Anesthesia MVP Beginning with the CY 2023 performance period/2025 MIPS 
payment year of Appendix 3: MVP Inventory of this final rule. We 
believe the measures and activities included in this MVP would be most 
applicable to clinicians who provide anesthesia services to patients 
within the surgical setting, are considered anesthesiologists, or are 
other qualified anesthesia professionals. For instance, the 
anesthesiologists and the CRNAs could form separate subgroups for 
reporting on applicable measures and activities in the MVP. 
Alternatively, the CRNAs and the anesthesiologists could report on the 
applicable measures and activities in the MVP as one subgroup if this 
aligns better with how the subgroup would practice and they all report 
the same measures and activities. The orthopedic surgeons in the group 
could then form a separate subgroup to report the applicable measures 
and activities in the proposed Improving Care for Lower Extremity Joint 
Repair MVP.
BILLING CODE 4120-01-P

[[Page 65404]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.069

BILLING CODE 4120-01-C
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter disagreed with the subgroup reporting 
example detailed in Table 33 of the proposed rule, which illustrated 
how different clinicians could form subgroups and report on the same 
proposed MVP, Patient Safety and Support of Positive Experiences with 
Anesthesia. The commenter believes that CMS described how 
anesthesiologists and nurse anesthetists could report different 
anesthesia measures and that QCDR measures do not apply to nurse 
anesthetists. This commenter shared that both the physician 
anesthesiologist and the nurse anesthetist can, in most cases, report 
the same quality measures and that there are entities who report QCDR 
measures to MIPS for their nurse anesthetist clients.

[[Page 65405]]

    Response: In the illustrative subgroup example under Table 33 of 
the proposed rule, we provided an example of how different subgroups 
could report a given MVP. We appreciate the commenter for sharing that 
CRNAs and anesthesiologists can mostly report the same quality measures 
and QCDR measures. We believe that the commenter misunderstood our 
interpretation of subgroup reporting for CRNAs and anesthesiologists in 
the example. As described in the proposed rule (86 FR 39363), we note 
the example was not intended to be exhaustive of the measures and 
activities reported by CRNAs and anesthesiologists. We further clarify 
that the example was an illustration of the different ways we 
anticipate the CRNAs and anesthesiologists could report together on the 
same MVP. We acknowledge that in many cases, CRNAs and 
anesthesiologists can and do report the same measures, including QCDR 
measures.
(e) Third-Party Intermediaries for Subgroup Reporting
    As described in section IV.A.3.h.(2)(b) of this final rule, we are 
finalizing at Sec.  414.1400(a)(1) for third-party intermediaries to 
implement MVPs and subgroup reporting options for MIPS eligible 
clinicians starting with the CY 2023 performance period/2025 MIPS 
payment year. Since subgroups will be implemented concurrently with 
MVPs, we believe that it is important that all third-party 
intermediaries support subgroup reporting in order for clinicians to 
meaningfully report MVPs. We refer readers to section IV.A.3.h.(2)(b) 
of this final rule for additional details on requirements for third-
party intermediaries supporting MVPs and subgroups.
(f) Public Reporting of Subgroup Performance Information
    As described in section IV.A.3.i.(1) of this final rule, we are 
finalizing to delay public reporting of subgroup performance 
information by an additional year. This policy would result in the 
public reporting of subgroup performance information beginning with the 
CY 2024 performance period/2026 MIPS payment year and each performance 
period/MIPS payment year thereafter. We refer readers to section 
IV.A.3.i.(1) of this final rule for additional details on the finalized 
policies related to public reporting of subgroup performance 
information on the compare tool.
(g) Future Vision of Subgroups
    In the CY 2022 PFS proposed rule (86 FR 39365 through 39366), we 
described our vision for the future of subgroup reporting and requested 
public comment on several policy issues we will consider for future 
rulemaking. We solicited feedback on: (1) Our vision for data 
granularity; (2) how subgroup group reporting could function if 
traditional MIPS is retired; (3) considerations for limiting subgroup 
reporting to a single specialty; and (4) a request for information on 
the future vision of subgroup reporting.
    To emphasize the main points of our request for comment, under our 
vision for data granularity, we shared our belief that additional data 
granularity will help clinicians and patients in making informed health 
care decisions. Furthermore, additional data granularity would allow 
CMS to have additional information that we can use to assess gaps in 
health equity.
    In considering how sunsetting traditional MIPS will impact subgroup 
reporting, since we are finalizing the MVP participant timeline 
proposal as described in section IV.A.3.b.(2)(c)(ii) of this rule, 
multispecialty groups would have to report more than 1 MVP beginning in 
the CY 2026 performance period/2028 MIPS payment year. We reiterate our 
belief that in order to meet the goals of MVPs, provide enhanced 
performance feedback to clinicians, and ensure more granular 
information is publicly available for patients, multispecialty groups 
must form subgroups to report MVPs. Additionally, we do not believe 
there will be an MVP that will be applicable to all types of clinicians 
within multispecialty groups. However, as we work to implement MVPs, we 
anticipate we will create additional policies to set the rules for how 
all clinicians will be able to meaningfully participate in the program 
if traditional MIPS is no longer available.
    In considering limitations to subgroup reporting, and specifically, 
limiting subgroup reporting to a single specialty, we restate our 
belief that without establishing limitations to subgroup composition 
prior to implementation, we will not meet the desired programmatic 
goals of MVPs. We believe in many ways this would replicate our 
concerns with the current state in traditional MIPS. We considered 
limiting subgroups to a single specialty, setting a threshold for 
clinician specialty composition to allow some degree of flexibility 
under a subgroup, establishing specialty families that would be allowed 
to form subgroups, and limiting MVP reporting to approved specialties 
and clinician types rather than placing limits to the subgroup 
composition itself. As MVPs are implemented, we will consider 
establishing criteria for how subgroups can be formed for eligible 
clinicians, group practices, and third-party intermediaries time to 
make system and workflow updates.
    Additionally, we reiterate our belief that team-based care is an 
essential element to providing high-quality care to patients and 
acknowledge some of the subgroup policies could be construed to create 
competition within groups. It is not our intention to create 
competition, rather, we believe as MVPs continue to be created and 
evolve, we will include MVPs that are focused on team-based care for 
some specialties.
    We received many comments for our consideration on the vision for 
data granularity, impact of the sunsetting of traditional MIPS for 
subgroup reporters, limiting subgroup composition to a single 
specialty, and future vision of subgroup reporting. We thank commenters 
for their feedback and will take these comments into consideration in 
future rulemaking.
(4) MVP Requirements
(a) Overview
    In the CY 2020 PFS final rule (84 FR 62948), we finalized at Sec.  
414.1305 that MIPS Value Pathway means a subset of measures and 
activities established through rulemaking. We describe our vision for 
MVPs to connect the four performance categories while using a 
foundational layer of population health claims-based measures and 
interoperability, on which to build, quality, cost, and improvement 
activity linkages. In the CY 2021 PFS final rule (85 FR 84849 through 
84859), we finalized a set of MVP development criteria and a process to 
receive MVP candidates from stakeholders. In the CY 2022 PFS proposed 
rule (86 FR 39367 through 39377), we proposed to establish additional 
MVP related policies to support the implementation and availability of 
MVPs. In this section, we discuss our proposed: (1) Refinements to the 
MVP development criteria; (2) a maintenance process for established 
MVPs; (3) MVP reporting requirements; and (4) the MVP registration 
process.
(b) MVP Development and Maintenance
(i) MVP Development Criteria
(A) General MVP Structure
    As discussed in the CY 2022 PFS proposed rule (86 FR 39367), from 
the time the CY 2021 PFS final rule

[[Page 65406]]

published, we have solicited feedback from several stakeholders who 
have submitted MVP candidates for CMS consideration utilizing the MVP 
candidate solicitation process (85 FR 84854 through 84856). Through 
this feedback, we have understood that the quality and patient 
improvement priorities of specialists may differ based on the way they 
practice. There are clinicians who practice utilizing a team-based 
approach, involving several clinicians of different specialties working 
together and for that reason, find quality reporting that reflects that 
approach more meaningful. Team-based health care is defined by the 
National Academy of Medicine as ``the provision of health services to 
individuals, families, and/or their communities by at least two health 
providers who work collaboratively with patients and their caregivers--
to the extent preferred by each patient--to accomplish shared goals 
within and across settings to achieve coordinated, high-quality care.'' 
\224\ Other clinicians may be specialized in a manner where they focus 
on a limited number of procedures.
---------------------------------------------------------------------------

    \224\ Mitchell, P., M. Wynia, R. Golden, B. McNellis, S. Okun, 
C.E. Webb, V. Rohrbach, and I. Von Kohorn. 2012. Core principles & 
values of effective team-based health care. NAM Perspectives. 
Discussion Paper, National Academy of Medicine, Washington, DC. 
https://doi.org/10.31478/201210c.
---------------------------------------------------------------------------

    For these reasons, we believe there are various ways to approach 
MVP development, and the method utilized would be dependent on the 
topic measured by the MVP. One method is to construct MVPs in a manner 
that is broad, for example, addressing cancer care comprehensively 
versus the creation of MVPs for each unique diagnosis of cancer care. 
Another method is to construct MVPs in a more granular manner, for 
example, addressing a specific procedure, such as hip and knee 
arthroplasty. A third approach is to structure MVPs in a manner that 
reflects the team-based healthcare model. This approach considers the 
patient's care from a holistic perspective, involving various 
clinicians as needed. One such example is around surgical care, which 
involves several clinician types, such as surgeons and 
anesthesiologists. We believe this approach captures the patient 
experience and outcomes in a manner that is meaningful, that would 
result in patient improvement. In the CY 2021 PFS final rule (85 FR 
84850), we finalized MVP development criteria that accounts for the 
development of MVPs collaboratively by multiple specialties for this 
reason. We believe that the team-based healthcare model has an impact 
to patient outcomes and encourage the use of this approach, as 
feasible, when developing MVPs.
    As described in the CY 2022 PFS proposed rule (86 FR 39370) and in 
section IV.A.3.b.(4)(b)(ii) of this final rule, we discuss a proposed 
maintenance process for MVPs. In instances where an MVP is initially 
implemented, for example, to address a specific procedure, and there is 
opportunity to evolve the MVP over time to reflect the team-based 
healthcare model, we would strongly encourage and work towards that 
transition.
    However, we do understand there is not a ``one size fits all'' MVP 
structure that is suitable for all specialties and believe the use of 
one of the structure methodologies is appropriate for MVP development.
(B) Selection of Measures and Improvement Activities Within an MVP
    As described above, in the CY 2021 PFS final rule (85 FR 84849 
through 84850), we established a set of criteria for use in the 
development and selection of MVPs. Specifically, we had finalized that 
we were not prescriptive on the number of quality measures that are 
included in an MVP (85 FR 84850). In the CY 2022 PFS proposed rule (86 
FR 39370 through 39372), we proposed reporting requirements for MVPs, 
and discussed the allowance of clinician choice in selecting which 
quality measures and improvement activities to report, as described in 
detail below in section IV.A.3.b.(4)(d) of this final rule. We believe 
that it is important to provide clarity in our expectations of the 
number of quality measures and improvement activities that are 
available for an MVP Participant to choose.
    As discussed in the CY 2022 PFS proposed rule (86 FR 39367 through 
39368), an MVP should include a sufficient number of quality measures 
and improvement activities to allow MVP Participants to select measures 
and report them to meet the reporting requirements outlined in sections 
IV.A.3.b.(4)(d)(ii) and IV.A.3.b.(4)(d)(iv) of this final rule. To the 
extent feasible, MVPs should include a maximum of 10 quality measures 
and 10 improvement activities, to offer MVP Participants some choice 
without being overwhelming. However, we understand that the total 
number of measures and activities available in an MVP would depend on 
the MVP structure. For example, as described in Appendix 3: MVP 
Inventory of the proposed rule (86 FR 39892 through 39895), we proposed 
the Optimizing Chronic Disease Management MVP that includes 9 quality 
measures and 12 improvement activities. Chronic disease can broadly 
encompass several conditions; therefore, we have selected measures and 
improvement activities that are closely aligned to the topic and offer 
clinicians some choice. We refer readers to Appendix 3: MVP Inventory 
for discussion of our proposed MVPs.
(aa) Requirement of Outcomes or High Priority Measures
    As described in the CY 2022 PFS proposed rule (86 FR 39370 through 
39371), we proposed MVP quality reporting requirements, that are 
similar to the requirements of traditional MIPS under Sec.  414.1335. 
We discuss a proposal to require the reporting of one outcome measure 
or high priority measure (if an outcome measure is not available). 
Accordingly, we believe it is important to modify the previously 
finalized MVP development criteria (85 FR 84849 through 84859), where 
we describe the criteria for including quality measures in an MVP. We 
believe we need to update the criteria to ensure MVPs are developed in 
a manner that accounts for this proposed quality reporting requirement.
(AA) Outcomes Measures Requirement
    In the CY 2022 PFS proposed rule (86 FR 39370 through 39371), we 
proposed that beginning with the CY 2022 MIPS performance period/2024 
MIPS payment year, MVPs must include at least one outcome measure that 
is relevant to the MVP topic, so MVP Participants are measured on 
outcomes that are meaningful to the care they provide. In addition, 
beginning with the CY 2022 MIPS performance period/2024 MIPS payment 
year, each MVP that is applicable to more than one clinician specialty 
should include at least one outcome measure that is relevant to each 
clinician specialty included. This is important since MVPs are proposed 
to be constructed in a manner that may include one or more clinician 
specialties, as described above in section IV.A.3.b.(4)(b)(i)(A) of 
this final rule, and there should be outcome measures included in the 
MVP that are relevant to each clinician specialty.
    We anticipate over the next few years, there may be opportunities 
where outcomes-based measures are developed and can be reported 
utilizing the administrative claims collection type. For example, in 
the CY 2021 PFS final rule (85 FR 85049 through 85051), we finalized 
the Risk-standardized complication rate (RSCR) following elective 
primary total hip arthroplasty (THA) and/or total knee arthroplasty 
(TKA) for Merit-based Incentive

[[Page 65407]]

Payment Systems (MIPS) outcome-based administrative claims measure. We 
proposed to allow the inclusion of outcomes-based administrative claims 
measures within the quality component of an MVP. We believe these 
measures can be used to meet the outcome measure requirement discussed 
under the MVP reporting requirements in section IV.A.3.b.(4)(d)(ii) of 
this final rule. We solicited comments on these proposals.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the requirement for MVPs to 
include at least one outcome measure.
    Response: We thank the commenters for their support.
    After consideration of public comments, we are finalizing our 
policies as proposed.
(BB) Exception When None Are Available
    As described in the CY 2021 PFS final rule (85 FR 84850), we are 
aware that not all specialties and subspecialties may have outcome 
measures currently available to them in the MIPS program. We are aware 
of this measurement gap, and believe it is appropriate to allow for the 
use of high priority measures when outcome measures are not available.
    In the CY 2022 PFS proposed rule (86 FR 39368), we proposed that 
beginning with the CY 2022 MIPS performance period/2024 MIPS payment 
year, in instances when outcome measures are not available, each MVP 
must include at least one high priority measure that is relevant to the 
MVP topic, so MVP Participants are measured on high priority measures 
that are meaningful to the care they provide. In addition, beginning 
with the CY 2022 MIPS performance period/2024 MIPS payment year, each 
MVP must include at least one high priority measure that is relevant to 
each clinician specialty included. This is important since MVPs are 
proposed to be constructed in a manner that may include one or several 
clinician specialties, as described above in section 
IV.A.3.b.(4)(b)(i)(A) of this final rule. As previously established at 
Sec.  414.1305, we define high priority measures to include outcome 
(including intermediate-outcome and patient-reported outcome), 
appropriate use, patient safety, efficiency, patient experience, care 
coordination, or opioid-related quality measures.
    We continue to encourage stakeholders to utilize our established 
pre-rulemaking processes, such as the Call for Measures: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rulemaking, to develop outcome measures 
relevant to their specialty if outcome measures currently do not exist 
and for eventual inclusion in an MVP. We encourage, to the extent 
feasible, the inclusion of several outcome and/or high priority 
measures, if available and relevant to the MVP topic. The inclusion of 
several measures would allow clinicians to have some choice in 
selecting the most relevant outcome or high priority measure that is 
meaningful to their specific practice. We solicited comments on these 
proposals.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the requirement for MVPs to 
include a high-priority measure if an outcome measure is not available.
    Response: We thank the commenters for their support.
    After consideration of public comments, we are finalizing our 
policies as proposed.
(bb) Encouragement To Include Patient-Centered Measures
    In the CY 2021 PFS final rule (85 FR 84850), we finalized MVP 
development criteria that takes into consideration the patient voice. 
Specifically, we finalized MVP development and selection criteria that 
considers the inclusion of (to the extent feasible), patient-reported 
outcome measures, patient experience measures, and/or patient 
satisfaction measures. Through interactions with stakeholders and 
presentations, we have referred to these measures as patient-centered 
measures.
    As described in the CY 2022 PFS proposed rule (86 FR 39368), we did 
not propose any revisions to our previously finalized policy, however, 
we believe it is important that we rely on a consistent understanding 
of patient-centered measures. Health Affairs \225\ stated the following 
with respect to such measures, ``Measures should be patient-centered 
and incorporate new approaches to assessing patient health status and 
patient experience. Such measures include assessment of clinical 
outcomes, patient-reported outcome measures, as well as new approaches 
to evaluation of patient experience.''
---------------------------------------------------------------------------

    \225\ Higgins, A., D. Safran, N. Fiore, E. Murphy, M. McClellan. 
2019. Pathway To Patient-Centered Measurement For Accountability. 
Health Affairs Blog, Health Affairs. https://www.healthaffairs.org/do/10.1377/hblog20190910.733376/full/.
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    We acknowledge that our existing portfolio of patient reported 
outcome measures is limited and may not be applicable to all 
specialties and subspecialties. We continue to encourage stakeholders 
to utilize our established pre-rulemaking processes, such as the Call 
for Measures, described in the CY 2020 PFS final rule (84 FR 62953 
through 62955) to develop patient reported outcome measures relevant to 
their specialty. In addition, we encourage measure stewards of new and 
existing quality measures in MIPS to consider updating their measures 
to include the patient centered approach through the measure 
maintenance cycle or the development of new measures.
    We solicited and received public comments on whether there are 
other aspects of patient measurement that should be considered as a 
part of the patient-centered measures definition. We thank commenters 
for the feedback received through this request for information. We may 
consider this information to inform future rulemaking.
(cc) Requirements for QCDR Measures Considered for an MVP
    In the CY 2021 PFS final rule (85 FR 84857 through 84859), we 
finalized that QCDR measures that were approved in the previous year 
may be considered for inclusion within an MVP. In addition, we 
finalized at Sec.  414.1400(b)(3)(v)(C)(4) that QCDR measures should be 
fully tested at the clinician level prior to the QCDR measure being 
included in an MVP. We refer readers to the CY 2021 PFS final rule (85 
FR 84857 through 84859) for the specific policies that were previously 
finalized. In the CY 2022 PFS proposed rule (86 FR 39368 through 
39369), we clarified when we would expect a QCDR to prove that their 
QCDR measure is fully tested before it is implemented within an MVP. 
QCDRs must self-nominate as a QCDR and submit QCDR measures for CMS 
consideration within the 60-day self-nomination period that begins on 
July 1st of the calendar year prior to the applicable performance 
period and ending on September 1 of the same year. In order to 
determine whether a QCDR measure may be finalized within an MVP, we 
will need to receive QCDR measure testing data for review by the end of 
the self-nomination period, that is no later than September 1 of the 
year prior to the applicable performance period. We encourage, as 
feasible, that QCDRs share testing data for their fully tested QCDR 
measures at the time of MVP candidate submission which may be prior to 
the September 1st deadline. If a QCDR is unable to submit testing data 
to demonstrate that their QCDR measure is fully tested at the clinician 
level by end of the self-nomination period (September 1st) or does not

[[Page 65408]]

otherwise meet our requirements, we will not finalize the inclusion of 
the QCDR measure within an MVP.
(C) Foundational Layer
    In the CY 2020 PFS final rule (84 FR 62947 through 62948), we 
establish that the implementation of a foundational population health 
core measure set using administrative claims-based quality measures 
that can be broadly applied to communities or populations can result in 
MVPs that provide more uniformity in how the program measures 
population health, reduce clinician reporting burden, focuses on 
important public health priorities, and increases the value of MIPS 
performance data. In addition, we discuss our beliefs that 
interoperability is also a foundational element that would apply to all 
clinicians, regardless of MVP, for whom the Promoting Interoperability 
performance category is required. Furthermore, we also discuss the 
importance of the integration of population health measures and 
Promoting Interoperability measures into MVPs, as they provide a degree 
of standardization across all clinician types and promotes an 
infrastructure on which to assess and improve value-based care.
(aa) Population Health Measure
    In the CY 2021 PFS final rule, we discuss the inclusion of 
population health measures calculated from administrative claims-based 
data as a part of the foundational layer of MVPs, in an effort to 
improve patient outcomes, reduce reporting burden and costs, and better 
align with clinician quality improvement efforts. We refer readers to 
the CY 2021 PFS final rule (85 FR 84856 through 84857) where we discuss 
population health. In the CY 2022 PFS proposed rule (86 FR 39369), we 
proposed: (1) To define the term population health measure; and (2) 
update the population health measure inventory.
(AA) Proposed Definition
    In the 2020 CMS Quality Measure Development Plan- 2020 Population 
Health Environmental Scan and Gap Analysis Report (https://www.cms.gov/files/zip/2020-mdp-population-health-e-scan.zip), we conducted an 
environmental scan to identify gaps in population health measurement 
within MIPS, specifically for use in the foundational layer of MVPs. 
Through this environmental scan and gap analysis, we have settled on a 
definition of ``population health measure''. In addition, as described 
in the ``Roadmap for Promoting Health Equity and Eliminating 
Disparities'': https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=86046, developed by the National 
Quality Forum, health equity continues to be a priority for the agency, 
we believe it is important to include the measurement of health 
disparities when measuring population health.
    In the CY 2022 PFS proposed rule (86 FR 39369), we proposed to 
codify this at Sec.  414.1305, such that a population health measure 
means a quality measure that indicates the quality of a population or 
cohort's overall health and well-being, such as, access to care, 
clinical outcomes, coordination of care and community services, health 
behaviors, preventive care and screening, health equity, or utilization 
of health services. We solicited comments on this proposal.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters recommended that additional information 
be provided in the definition to clarify the intended use and 
attribution approaches to ensure transparency as to CMS' intent for 
population health measures. One commenter expressed concern for the 
size of the population or cohort in the proposed definition for 
population health measures.
    Response: The proposed definition of population health was not 
intended to be comprehensive, and intentionally is flexible. With 
regards to the attribution, and the size of the population or cohort, 
we believe these areas may vary depending on the clinical topic of 
measurement. Standardization of the attribution does not take into 
consideration the various specialties that participate in MIPS and 
instances where certain specialties should not be attributed to a 
population health measure. Furthermore, standardization of a cohort or 
population size may lead to certain population health conditions being 
excluded from measurement because the cohort size is not sufficient. We 
do not believe it is appropriate to limit population health measurement 
this way. To account for instances where MVP participants may not be 
attributed to a certain population health measure or when MVP 
participants may not treat enough patients to meet the population or 
cohort size within the measure, we have proposed scoring rules for 
population health measures accordingly. We refer readers to the CY 2022 
PFS proposed rule (86 FR 39378 through 39379) and section 
IV.A.3.b.(5)(b)(i)(B) of this final rule for discussion of the 
population health scoring rules.
    Comment: Several commenters expressed concerns with the population 
health measures proposed for MVPs, because commenters believe that the 
measures are too broad and are outside of the control of the clinician. 
One commenter expressed the belief that the inclusion of population 
health measures in the foundational layer is essentially creating an 
entire new MIPS category which is outside the intent of the MACRA 
legislation. Another commenter believes that population health measures 
move the MVP away from incorporating the patient's voice, measuring 
clinical conditions and outcomes, and generating real-time feedback.
    Response: The population health measures capture outcomes important 
to patients (that is, hospitalizations for acute illness) and thus 
provide meaningful information to clinicians so they can improve their 
practice. Although administrative claims measures use outcomes that are 
not directly reported by patients, they measure clinical outcomes that 
are central to patient well-being since avoidance of acute 
hospitalization is an important goal of care. They can thus generate 
feedback to help improve care. We anticipate sharing measure scores 
with clinicians scored on the measure, in addition to tying 
reimbursement payment adjustments to these scores, will encourage 
clinicians to improve care quality and patient outcomes. Each measure 
is fully tested to ensure that it reflects the quality of care provided 
by clinicians held accountable for care of their assigned patients.
    We disagree with commenters that the inclusion of population health 
measures in the foundational layer is essentially creating an entire 
new MIPS category. The population health measures are still considered 
quality measures, and as described in section IV.A.3.b.(5)(b)(i)(B) of 
this final rule, are scored and incorporated into the quality score. 
Therefore, their use does not create a new performance category, 
rather, the foundational layer of MVPs was created to ensure that 
important areas of measurement would be reflected within all MVPs.
    We also disagree that population health measures move the MVP away 
from incorporating the patient voice, measuring clinical conditions and 
outcomes, and generating real time feedback. We believe MVPs can be 
multi-faceted in covering these important areas, and believe there is 
importance in measuring the health of communities through population 
health

[[Page 65409]]

in addition to the value in including the patient voice. In addition, 
MVPs are expected to be developed to cover clinical conditions that are 
important to the specialties that participate in the program and would 
include outcome measures to the extent available. Furthermore, as 
discussed in the CY 2022 PFS proposed rule (86 FR 39383), we proposed 
to provide enhanced performance feedback to MVP participants within the 
annual performance feedback that is currently provided through 
traditional MIPS. We do not believe that reporting on population health 
measures will impede our ability to provide enhanced performance 
feedback to MVP participants. At this time, we are not able to provide 
real time or performance period feedback, as there are complexities 
that need to be mitigated.
    Comment: Several commenters do not support the use of 
administrative claims-based measures in any of the MVPs. They are 
concerned that many of the existing administrative claims-based 
measures have not been tested at the physician level and are based on a 
retrospective analysis of claims and do not provide granular enough 
information for physicians to make improvements in practice. Overall, 
they do not believe that administrative claims-based measures will be 
appropriate in all MVPs. One commenter believes that the measures 
should focus on the domain of care that is most relevant to the care 
the physician provides. One commenter requested confirmation that each 
measure has a high level of reliability and is fully tested to ensure 
that the measure can appropriately be assigned to specific physicians 
or groups. Another commenter recommends the administrative claims-based 
measures be voluntary.
    Response: We disagree. The administrative claims-based measures in 
MIPS have been tested and have been put forth through the Measures 
Application Partnership (MAP) process through the National Quality 
Forum. Each measure is fully tested at the clinician level to ensure 
that it reflects the quality of care provided by clinicians held 
accountable for care of their assigned patients. While there may be 
instances where administrative claims-based measures include a lookback 
period, many in MIPS are based on performance period dates, that is 
January 1 through December 31. We refer readers to the CY 2021 PFS 
final rule (85 FR 85045) and the CY 2022 PFS proposed rule (86 FR 3600 
through 39602) for discussion of the data collection periods for these 
measures.
    We believe administrative claims measures capture information 
related to outcomes that is important to patients (that is, 
hospitalizations for acute illness) and thus provide meaningful 
information to clinicians so they can improve their practice. Although 
administrative claims measures use outcomes that are not directly 
reported by patients, they measure clinical outcomes that are central 
to patient well-being since avoidance of acute hospitalization is an 
important goal of care. They can thus generate feedback to help improve 
care.
    Overall, we believe administrative-claims based measures, such as 
the population health measures should be included as a facet of MVP 
measurement, across all MVPs. The clinical topics covered in the 
population health measures are applicable to most clinicians. However, 
as described in the CY 2022 PFS proposed rule (86 FR 39378), we are 
aware there may be instances where the population health measures 
cannot be calculated, and had proposed to adopt our scoring policies 
used in traditional MIPS for MVPs, we would exclude the measure from 
the total achievement points and the total available points if the 
administrative claims measure does not have a benchmark or meet the 
case minimum requirement in accordance with Sec.  
414.1380(b)(1)(i)(A)(2)(ii).
    We also proposed at Sec.  414.1365(d)(3)(i)(A) that except as 
provided in paragraph (d)(3)(i)(A)(1) each selected population health 
measure that does not have a benchmark or meet the case minimum 
requirement is excluded from the MVP participant's total measure 
achievement points and total available measure achievement points. The 
population health measures in the MIPS program are fully tested, with a 
reliability of 0.4 with a minimum attributed case size of 20. We 
consider these measures to be of moderate reliability and believe the 
reliability thresholds for these measures are sufficient for these 
measures to be included as quality measures within the MIPS program. In 
the CY 2017 Quality Payment Program final rule (81 FR 77169 through 
77171), we identified reliability levels between 0.4 to 0.7 as moderate 
and reliability levels above 0.7 as high. We aim to measure quality 
performance for as many clinicians as possible, and limiting measures 
to reliability of 0.7 would result in fewer individual clinicians with 
quality performance category measures. In addition, a 0.4 reliability 
threshold ensures moderate reliability for most MIPS eligible 
clinicians or group practices that are being measured on quality.
    We disagree with the commenter who recommended that administrative-
claims based measures, such as the population health measures, be 
voluntary. Population health measurement has been purposefully included 
in the foundational layer of all MVPs to be broadly applied to 
communities or populations and provide more uniformity in how the 
program measures population health, reduces clinician reporting burden, 
and focus on important public health priorities.
    After consideration of public comments, we are finalizing our 
policy as proposed.
(BB) Population Health Measures Inventory
    In the CY 2022 PFS proposed rule (86 FR 39369) we discussed the 
population health measure inventory, and the expansion of the number of 
population health measures available in the foundational layer of MVPs. 
We also discussed and encouraged stakeholders to pursue population 
health measure development. As discussed in Appendix 1: MIPS Quality 
Measures of this final rule, we proposed to include the Clinician and 
Clinician Group Risk-standardized Hospital Admission Rates for Patients 
with Multiple Chronic Conditions in the MIPS program. As discussed in 
Appendix 3: MVP Inventory, this measure was proposed for inclusion as 
an additional population health measure for MVP reporters to choose 
from as part of the Foundational Layer. We refer readers to Appendix 3: 
MVP Inventory for the comments received on the specific population 
health measures and our responses.
(bb) Promoting Interoperability
    In the CY 2021 PFS final rule (85 FR 84849 through 84850), as a 
part of the MVP development criteria, we had finalized that MVPs must 
include the full set of Promoting Interoperability measures. Any 
updates made to the set of Promoting Interoperability measures through 
traditional MIPS will apply to the MVPs. Therefore, we refer readers to 
section IV.A.3.d.(4) of this final rule where we discuss Promoting 
Interoperability performance category policies.
(D) Health Equity Measures in MVPs-Request for Information (RFI)
    In the CY 2022 PFS proposed rule (86 FR 39369) we requested 
information regarding the incorporation of health equity measures in 
MVPs. We thank

[[Page 65410]]

commenters for the feedback received through this request for 
information. We may consider this information to inform future 
rulemaking.
(ii) Maintenance Process for MVPs
    As described in the CY 2022 PFS proposed rule (86 FR 39370), we 
believe it is important that we implement a maintenance process for 
established MVPs. Independent of the implementation of MVPs; the 
individual measures typically undergo annual updates and maintenance 
for several reasons. These updates may include technical coding 
updates, changes to clinical guidelines, or modifications to various 
aspects of the measure specification (such as the numerator or 
denominator). It will be important that we monitor when changes are 
made to individual measures to ensure that the updated measure is 
relevant and should be maintained within the MVP.
    Therefore, beginning with the CY 2023 MIPS performance period/2024 
MIPS payment year, we proposed an annual maintenance process for 
finalized MVPs. In order to ensure that various stakeholder 
perspectives are also considered, we proposed a solicitation process to 
solicit stakeholder recommendations for potential updates to 
established MVPs. Under this proposal, beginning in January of the year 
prior to the performance period, stakeholders could submit their 
recommendations to revise established MVPs. We would accept stakeholder 
input on a rolling basis. Any changes to MVPs will be addressed through 
future notice and comment rulemaking, for example, suggesting the 
addition or removal of a quality measure or improvement activity. If 
changes are made to existing individual measures and activities, they 
would be made under the traditional MIPS performance category policies 
and criteria for measures and activities and those changes would be 
reflected within the MVP. We would be unable to communicate with a 
stakeholder about whether or not their recommendations are accepted 
ahead of rulemaking, and we would ultimately decide whether updates to 
the established MVPs should be made. Additional logistical information, 
such as where to submit recommendations would be provided through the 
QPP resource library and listserv messaging, prior to the opening of 
the solicitation process. We stated in the proposed rule that we would 
consult with the stakeholders who originally nominated the MVP about 
any publicly recommended changes to that MVP. To be clear, the annual 
maintenance process for finalized MVPs would be separate from the new 
MVP candidate solicitation process that was described in the CY 2021 
PFS final rule (85 FR 84854 through 84856). We solicited comments on 
these proposals.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters believe that it would be beneficial to 
have all relevant specialties and clinician types provide feedback on 
any MVP changes, because commenters believe it would generate more buy 
in and foster collaboration. A few commenters expressed concern for our 
process to only consult with stakeholders who submitted the MVP 
regarding changes to the MVP and suggested soliciting recommendations 
from major contributory stakeholders. Another commenter believes that 
involving multiple stakeholders in the maintenance of MVPs would make 
the process more transparent and nimbler to ensure that MVP owners do 
not unnecessarily prevent appropriate modifications of the MVP from 
taking place.
    Response: We agree that it would be beneficial to have all relevant 
specialties and clinician types provide feedback on potential changes 
to established MVPs. To clarify, as discussed in the CY 2022 PFS 
proposed rule (86 FR 39370), we intend to solicit recommendations for 
potential changes to established MVPs from all interested parties 
through an MVP maintenance process, and not just from those 
stakeholders that submitted the MVP through the initial development 
process. In addition, the initial implementation of an MVP and any 
potential changes to an established MVP (for example, the addition or 
removal of measures) would need to be proposed and finalized in future 
notice-and-comment rulemaking which enables all interested parties to 
voice their opinions through the public comment process on any proposed 
changes to an MVP. We are also open to exploring additional options as 
to how we can better engage with a broader cohort of stakeholders on 
MVP maintenance. We would make the determination as to which MVP 
updates will be proposed and finalized and which will not.
    Comment: A few commenters urged CMS to align the MVP maintenance 
process with timelines for MIPS and QCDR measure updates to minimize 
the burden on MVP developers.
    Response: The timeline for MVP maintenance will coincide with our 
MIPS rulemaking timelines. As described in the CY 2022 PFS proposed 
rule (86 FR 39370), any changes to MVPs would be addressed through 
future notice and comment rulemaking. Unfortunately, we are not able to 
align with the QCDR self-nomination timeline (July 1st to September 
1st) as it does not align with the rulemaking timeline. However, as 
described in the CY 2022 PFS proposed rule (86 FR 39368 through 39869) 
we are mindful of the QCDR self-nomination timeline when considering 
the inclusion of new QCDR measures in existing MVPs. In order to 
determine whether a QCDR measure may be finalized within an MVP, we 
will need to receive QCDR measure testing data for review by the end of 
the self-nomination period, that is no later than September 1st of the 
year prior to the applicable performance period. If a QCDR is unable to 
submit testing data to demonstrate that their QCDR measure is fully 
tested at the clinician level by the end of the self-nomination period 
or does not otherwise meet our requirements, we will not finalize the 
inclusion of the QCDR measure within an MVP.
    After consideration of public comments, we are finalizing our 
policies as proposed.
(c) Establishing a Portfolio of MVPs
    In the CY 2022 PFS proposed rule (86 FR 39879 through 39907), we 
proposed seven MVPs on the following topics: Rheumatology, Stroke Care, 
Ischemic Heart Disease, Chronic Disease Management, Emergency Medicine, 
Lower Extremity Joint Repair, and Anesthesia. We refer readers to 
Appendix 3: MVP Inventory of this final rule for a full description of 
each MVP, proposal rationales, summary of public comments and our 
responses. We anticipate that the portfolio of MVPs will continue to 
grow over the next few years. Through the review of data received 
through MIPS reporting for the 2019 performance period, we have 
identified the ten specialties who have the most participants in the 
MIPS program. These specialties include primary care, emergency 
medicine, diagnostic radiology, anesthesiology, cardiology, obstetrics 
and gynecology, orthopedic surgery, psychiatry, general surgery, and 
ophthalmology.
    We believe it is important to develop MVPs that address these 
specialties, amongst the other specialties that participate in the 
program. We are, however, aware of the limited availability of relevant 
cost measures for all specialties and subspecialties. We refer readers 
to the CY 2022 PFS proposed rule (86 FR 39402 through 39405) and 
section IV.A.3.d.(2)(c) of this final rule, for discussion of the 
proposed cost measure development by external

[[Page 65411]]

stakeholders process, where we discuss a potential strategy to mitigate 
the issue of a limited inventory of cost measures that will potentially 
remove barriers for MVP implementation.
    To support MVP development efforts over the next few years, and to 
ensure we build out a comprehensive MVP portfolio, we intend to 
identify additional MVP priority areas for development and include 
those within our guidance materials for the MVP candidate submission 
process: https://qpp.cms.gov/mips/mips-value-pathways/submit-candidate.
(d) MVP Reporting Requirements
(i) Overview
    We have reviewed the existing reporting requirements under 
traditional MIPS and believe that by changing the reporting 
requirements for MVPs, we would reduce reporting burden. We believe MVP 
reporting would allow for measurement that is more meaningful by 
requiring clinicians to report on measures and activities that 
comprehensively reflect an episode of care or clinical condition. We 
have heard from stakeholders the importance of having a choice when 
reporting. In this section, we discuss our proposals for MVP reporting 
requirements and subgroup reporting limitations for the Quality 
performance category; Cost performance category; Improvement Activities 
performance category; and the foundational layer-, which consists of 
the Promoting Interoperability performance category, and the population 
health measures.
(ii) Quality Reporting Requirements in MVPs
    As described in the CY 2022 PFS proposed rule (86 FR 39370), since 
MVPs would include cohesive and complementary subsets of measures and 
activities that are relevant and to a given specialty, we believe that 
MVP Participants would report on measures that provide more meaningful 
and actionable results. MVP Participants would have the opportunity to 
select from a subset of measures within an MVP. Furthermore, as 
discussed above, we believe it is important to continue to require the 
reporting of outcome and high priority measures in MIPS. Therefore, at 
Sec.  414.1365(c)(1), we proposed that except as provided in paragraph 
Sec.  414.1365(c)(1)(i), an MVP Participant must select and report, if 
applicable, 4 quality measures, including 1 outcome measure (or, if an 
outcome measure is not available, 1 high priority measure, included in 
the MVP, excluding the population health measure required under 
paragraph (c)(4)(ii). We discuss in section IV.A.3.b.(4)(b)(i)(B) of 
this final rule, that there may be instances where MVPs are developed 
to include outcomes-based administrative claims measures within the 
quality component of an MVP, where those measures are not considered to 
be population-health based. In such instances, we believe it would be 
appropriate to allow MVP Participants to select to be calculated on the 
outcomes-based administrative claims measure, at the time of MVP 
registration, and to allow that measure to meet the outcome measure 
requirement of MVP quality reporting.
    In addition, we have concerns about the ability of small practices 
to report all required measures in the MVP quality performance category 
when they select Medicare Part B claims measures as a collection type. 
In cases when an MVP includes fewer than 4 Medicare Part B claims 
measures, an MVP Participant in a small practice would need to report 
an additional collection type which would add reporting burden. We are 
concerned that small practices do not have the same resources to meet 
the quality reporting requirement of 4 measures if the MVP does not 
include 4 Medicare Part B claims measures. We want to establish policy 
that does not penalize a small practice for submitting an MVP. 
Therefore, we proposed at Sec.  414.1365(c)(1)(i) that paragraph Sec.  
414.1365(c)(1), does not apply to a small practice that reports on an 
MVP that includes fewer than 4 Medicare Part B claims measures, 
provided that the small practice reports each such measure that is 
applicable. We solicited comments on these proposals and refer readers 
to section IV.A.3.b.(5)(b)(i) of this final rule for details on the MVP 
quality scoring proposals.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported a reduction in the number of 
quality measures within the MVP reporting option as compared with 
traditional MIPS because commenters believe that this would lead to a 
reduced burden for clinicians.
    Response: We thank the commenters for their support.
    Comment: One commenter supports the use of administrative claims 
measures to meet outcome-based measure requirements.
    Response: We thank the commenter for their support.
    Comment: One commenter urged CMS to develop MVPs that can be 
reported using only one collection type in order to reduce burden and 
maximize the number of MIPS eligible clinicians that can report MVPs.
    Response: We disagree. We believe that limiting the number of 
collection types that are available for reporting an MVP would not be 
beneficial. If we were to only utilize one collection type in the 
reporting, fewer clinicians may be able to report the MVP if they are 
not using the collection type reflected in the MVP. Since MVPs include 
a focused selection of quality measures, MVP participants may select 
four measures to report on utilizing the collection types in which the 
measure is available, one of the four measures must be an outcome 
measure, or a high priority measure if an outcome is not available. We 
currently utilize measures that are implemented through one of the 
following collection types: MIPS CQMs; eCQMs; Medicare Part B Claims; 
and QCDR measures. As described above, we have concerns about the 
ability of small practices to report all required measures in the MVP 
quality performance category when they select Medicare Part B claims 
measures as a collection type. In cases when an MVP includes fewer than 
4 Medicare Part B claims measures, an MVP Participant in a small 
practice will need to report an additional collection type which will 
add reporting burden. We are concerned that small practices do not have 
the same resources to meet the quality reporting requirement of 4 
measures if the MVP does not include 4 Medicare Part B claims measures. 
We proposed to establish policy that does not penalize a small practice 
for submitting an MVP. As described in CY 2022 PFS proposed rule (86 FR 
39370 through 39371). we proposed at Sec.  414.1365(c)(1)(i) that 
paragraph (c)(1), does not apply to a small practice that reports on an 
MVP that includes fewer than 4 Medicare Part B claims measures, 
provided that the small practice reports each such measure that is 
applicable.
    Comment: One commenter expressed concern that MIPS eligible 
clinicians will be required to participate in a registry in order to 
report an MVP because the commenter believes this would be a 
significant cost burden.
    Response: To clarify, MVP participants are not required to 
participate in a registry in order to report an MVP. All the MVPs are 
reportable without the use of a third party intermediary, it is to the 
MVP participant's discretion whether or not they would like to use a 
registry to report. The only instance where an MVP participant would be 
required to report through a QCDR however, would be if they'd like to 
report on a QCDR measure that is available in the MVP. We note

[[Page 65412]]

that QCDR measures are only reportable via a QCDR that is approved to 
support said QCDR measures.
    Comment: One commenter recommended CMS ensure that MVPs across 
specialties are equitable.
    Response: We agree with the commenter. We have established MVP 
development requirements to ensure that all MVPs are developed 
utilizing the same criteria. In addition, we believe Interoperability 
and population health are important areas that should apply across all 
MVPs through the foundational layer. In addition, as described in 
section IV.A.3.b.(4)(d) of this final rule, all MVP participants are 
held to the same reporting requirements (with the exception of small 
practices if they have fewer Part B Claims measures to report on) to 
support that MVPs amongst MVP participants are fair and equitable.
    Comment: A few commenters expressed concern for the lack of choice 
within the quality performance category under MVPs. One commenter 
expressed the belief that it should be up to the MIPS eligible 
clinician to select appropriate measures, rather than having a limited 
set of measures. One commenter recommends adding as many eCQMs into 
each MVP as possible since eCQMs have been encouraged and incentivized 
by CMS in the past. Another commenter urged CMS to allow MIPS eligible 
clinicians to submit additional outcome or high priority measures and 
receive bonus points.
    Response: We disagree with the commenters who believe there is a 
lack of choice within the quality performance category under MVPs. A 
focused selection of quality measures have been curated based on 
consideration of clinical relevance and feedback from stakeholders. 
Over the past 5 years of traditional MIPS, as well as in precursor 
programs such as Physician Quality Reporting System (PQRS), we have 
found that clinicians, groups, practice administrators tend to select 
measures they believe they will perform the best on and not necessarily 
measures that would lead to improvements in the care provided. That has 
led to many measures that have topped out status, providing little to 
no value to clinicians, nor leading to improved patient outcomes. While 
we believe it is important that MVP participants have choice in the 
measures they report, we believe the level of choice should be narrowed 
to focus in on measures that are directly and clinically relevant to 
the topic being measured, and intend on identifying such measures 
through groupings within MVPs. We agree that eCQMs should be included 
in MVPs where feasible, dependent on whether the eCQM is clinically 
relevant to the topic being measured. We encourage stakeholders to 
submit more than the required number of outcome or high priority 
measures if they can. As described in section IV.A.3.b.(5), when MVP 
participants submit more than the required number of measures, only the 
highest scored measures will count towards the quality final score. We 
are currently not offering bonus points for the reporting of additional 
measures, however as discussed in section IV.A.3.b.(5) of this final 
rule, we are open to exploring additional incentives to report MVPs 
through future rulemaking.
    After consideration of public comments, we are finalizing our 
policies as proposed.
(iii) Cost Reporting Requirements in MVPs
    As described in the CY 2022 PFS proposed rule (86 FR 39371), as 
MVPs are implemented and available for reporting, each MVP would only 
include cost measures that are relevant and applicable to the MVP 
topic. Therefore, the number of cost measures in a given MVP may vary 
depending on the clinical topic of the MVP. An MVP may include the 
episode-based cost measures that are relevant to the topic, total per 
capita cost measure (TPCC), and/or Medicare Spending Per Beneficiary 
Clinician (MSPB Clinician) measure. As such, we proposed at Sec.  
414.1365(c)(2) that an MVP Participant is scored on the cost measures 
included in the MVP they select and report. To be clear, MVP 
Participants would not submit data for the cost measures; they would be 
calculated by CMS using administrative claims data, as in traditional 
MIPS. We solicited comments on this proposal. We did not receive any 
comments and are finalizing the proposal as proposed. In addition, we 
refer readers to section IV.A.3.b.(5)(b)(ii) of this final rule for 
details of the MVP cost scoring policies and Appendix 3: MVP Inventory 
for a summary of the comments we received and our responses related to 
individual cost measures.
(iv) Improvement Activity Requirements in MVPs
    Similar to the quality performance category within MVPs, we also 
believe the improvement activities performance category should provide 
clinicians with an opportunity to select from a subset of improvement 
activities within an MVP that are relevant to the clinical topic being 
measured. Therefore, in the CY 2022 PFS proposed rule (86 FR 39371), we 
proposed at Sec.  414.1365(c)(3), that MVP Participant who reports an 
MVP, must report one of the following: Two medium-weighted improvement 
activities; one high-weighted improvement activity; or participation in 
a certified or recognized patient-centered medical home (PCMH) or 
comparable specialty practice as described at (82 FR 53652) and at 
Sec.  414.1380(b)(3)(ii). We note that these proposed MVP improvement 
activity requirements are reduced in comparison to what is required in 
traditional MIPS (82 FR 53652) under which we generally require two 
high-weighted activities, one high-weighted and two medium-weighted 
activities, four medium-weighted activities, or participation in a 
certified or recognized patient-centered medical home (PCMH) or 
comparable specialty practice. We believe reduced reporting 
requirements are necessary to support adoption of and reduce burden for 
implementation of MVPs. We solicited comments on this proposal and 
refer readers to section IV.A.3.b.(5)(b)(iii) of this final rule for 
proposals related to MVP improvement activities scoring and discussion 
of why improvement activities are double-weighted under MVP reporting.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported double weighted improvement 
activities for MVP reporters. One commenter believes that this would 
allow for a more cohesive participation experience.
    Response: We thank the commenters for their support.
    Comment: A few commenters requested that CMS provide more 
flexibility in MVP reporting requirements, including providing 
automatic credit for the Improvement Activities performance category. 
One commenter believes that a commitment to improvement is inherent in 
many of the measures in MIPS.
    Response: We disagree that additional flexibilities are needed 
within the reporting requirements. We do not believe there is value in 
offering automatic credit for the improvement activities performance 
category. Improvement activities are meant to have a complimentary 
relationship to the quality measures and cost measures included in an 
MVP. We do not believe automatic credit will lead to improved patient 
outcomes or improvements in the care provided to patients. Lastly, as 
described in section 1848(q)(2) of the Act, we are required to have 
four performance categories: Quality,

[[Page 65413]]

improvement activities, cost, and promoting interoperability. We 
believe there are other ways to incentivize clinicians and groups to 
report MVPs, and refer readers to section IV.A.3.b.(5) of this final 
rule for further discussion of future considerations of incentives.
    After consideration of public comments, we are finalizing our 
policies as proposed
(v) Reporting Requirements for the Foundational Layer
(A) Promoting Interoperability
(aa) Reporting Requirements
    As described in the CY 2021 PFS final rule (85 FR 84849 through 
84853), all MVPs should include the entire set of Promoting 
Interoperability measures, as a part of the foundational layer. We do 
not intend to establish different reporting requirements for Promoting 
Interoperability for MVPs from what is established under traditional 
MIPS. Therefore, in the CY 2022 PFS proposed rule (86 FR 39371), we 
proposed at Sec.  414.1365(c)(4)(i) that an MVP Participant, is 
required to meet the Promoting Interoperability performance category 
reporting requirements described at Sec.  414.1375(b). We solicited 
comments on this proposal and refer readers to section 
IV.A.3.b.(5)(b)(iv) of this final rule for details of the policies for 
MVP Promoting Interoperability scoring and reweighting.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters requested that CMS adopt different 
requirements for the Promoting Interoperability performance category 
within MVPs. One commenter urged CMS to use the MVP framework as an 
opportunity to provide clinicians with flexibility to demonstrate 
meaningful use in more innovative ways that account for differences in 
practices. One commenter requested that CMS include a menu of yes/no 
measures similar to the improvement activities performance category. 
Another commenter recommended that MVPs support meeting national 
standards that enable the bidirectional movement of health data across 
the digital environment through the Promoting Interoperability 
performance category.
    Response: While we did not propose different reporting requirements 
for the Promoting Interoperability performance category in the first 
wave of MVPs, we are continuing to refine the composition of MVPs and 
may incorporate these suggestions in future rulemaking. In addition, we 
disagree that solely relying on measures that require a ``yes/no'' 
response would be sufficient for the Promoting Interoperability 
performance category. In the CY 2019 PFS final rule (83 FR 59785 
through 59796) we finalized a performance-based scoring methodology for 
the Promoting Interoperability performance category that recognizes 
MIPS eligible clinicians who push themselves on measures that are most 
applicable to how they deliver patient care and increase health 
information exchange through interoperability. While we do have several 
yes/no measures in the Promoting Interoperability performance category, 
we do not believe using only ``yes/no'' measures would enable us to 
distinguish varying performance levels among MIPS eligible clinicians.
    Comment: One commenter requested that CMS provide flexibilities for 
certain types of clinicians, such as non-patient facing clinicians, for 
the Promoting Interoperability performance category in general within 
MIPS because the commenter believes these clinicians often have 
difficulties meeting the requirements of the Promoting Interoperability 
performance category.
    Response: Our current policy under Sec.  414.1380(c)(2)(i)(C) is to 
reweight the Promoting Interoperability performance category for non-
patient facing MIPS eligible clinicians as defined under Sec.  
414.1305, which includes groups and virtual groups that have more than 
75 percent of clinicians as non-patient facing. This policy will apply 
under MVPs, as discussed in section IV.A.3.b.(5)(c)(i)(B)(aa) of this 
final rule.
    Comment: One commenter suggested that in MVPs, the Promoting 
Interoperability performance category measures shift to yes/no 
attestation rather than percentages because some measures may not be 
applicable to a clinician's practice or different thresholds may be 
more appropriate.
    Response: We disagree. Beginning with the CY 2019 performance 
period/CY 2021 MIPS payment year (83 FR 59785 through 59796) we 
implemented a performance-based scoring methodology to encourage 
clinicians to push themselves on measures that are the most applicable 
to how they deliver care to patients. We believe that having Promoting 
Interoperability performance category measures that require a 
numerator/denominator response allows clinicians to differentiate 
themselves from other clinicians by recognizing higher achievement on 
these measures. Our goal has been to enable clinicians to focus more on 
patient care and health data exchange through interoperability.
    Many measures have exclusions available for instances where a 
measure is not applicable to the clinician's practice.
    After consideration of public comments, we are finalizing our 
policies as proposed.
(bb) Subgroup Limitations
    As described in the CY 2022 PFS proposed rule (86 FR 39371 through 
39372), we believe that subgroups should be assessed using subgroup 
level data to the extent that it is operationally feasible. However, 
through the MVP Town Hall (85 FR 84846), we heard from stakeholders 
that some clinicians would need additional time to resolve operational 
challenges, including challenges related to configuration of EHR 
systems. Given these operational challenges, as well as other 
considerations specific to the Promoting Interoperability performance 
category, we believe that each subgroup should submit their affiliated 
group's data for the Promoting Interoperability performance category 
and receive a score based on that data. We acknowledge that requiring 
each subgroup to submit their affiliated group's data could result in 
duplicative reporting of the same data if their affiliated group also 
reports as a group for the Promoting Interoperability performance 
category. However, we believe that this approach is the most 
appropriate way to address the operational challenges identified by 
stakeholders and other issues specific to the Promoting 
Interoperability performance category. For instance, requiring 
clinicians to report Promoting Interoperability by subgroup may 
initially disincentivize clinicians from choosing to report MVPs as it 
may exacerbate the reporting burden and use of resources by a smaller 
cohort of clinicians. Furthermore, the Promoting Interoperability 
measures are applicable to many clinician types and are not designed to 
be specialty specific like the quality measures, therefore, it is 
unclear whether an advantage of assessing Promoting Interoperability 
performance on a subgroup of clinicians exists. Other performance 
categories include specialty specific measures, where assessment of 
performance at the subgroup level may be more meaningful. Therefore, we 
proposed at Sec.  414.1365(c)(4)(i)(A) that for the CY 2023 and 2024 
MIPS performance periods/2025 and 2026 MIPS payment years, to require 
an MVP Participant that is a subgroup to submit its affiliated group's 
data for the Promoting Interoperability performance category. The 
submission of the affiliated group's data will be on the subgroup's 
behalf. If the affiliated group chooses to report as

[[Page 65414]]

a group for the Promoting Interoperability performance category, the 
group still will be required to submit its own data separately and in 
accordance to the reporting rules for groups.
    We refer readers to the CY 2022 PFS proposed rule (86 FR 39371 
through 39372) for the discussion of subgroup limitations.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the reporting of Promoting 
Interoperability data for the affiliate group for subgroups.
    Response: We thank the commenters for their support.
    After consideration of public comments, we are finalizing the 
policy as proposed.
(B) Population Health Measures
    As described in the CY 2017 Quality Payment Program final rule (81 
FR 77130 through 77136) we had received public comment that not all 
population health measures are applicable or attributable to all 
specialties. In order to mitigate this concern, we discuss our proposal 
in the CY 2022 PFS proposed rule (86 FR 39372), at Sec.  
414.1365(c)(4)(ii), that an MVP Participant is scored on 1 population 
health measure in accordance with paragraph Sec.  414.1365(d)(1). To be 
clear, the population health measure calculation does not contribute to 
the required reporting of four quality measures, as described at Sec.  
414.1365(c)(1) and in section IV.A.3.b.(4)(d)(ii) of this final rule. 
Since the aforementioned population health measures are administrative 
claims based, they do not require data submission from clinicians. 
Therefore, it is important that an election period is established in 
which MIPS eligible clinicians, groups, subgroups, and APM entities 
would identify which MVP and population health measure they intend to 
report. We refer readers to the proposed registration process below and 
intend to provide additional guidance through subregulatory means.
    In crafting our proposal, we also considered the alternative where 
we would note require MVP participants to select which population 
health measure to be calculated on. Under this alternative considered, 
we would require and calculate both population health measures and 
apply the higher score to the quality score. While we thought this 
approach would reduce some of the burden associated with requiring this 
selection at the time of MVP registration, we ultimately decided to 
proposed to allow MVP participants to select which population health 
measure to be calculated on. As discussed above, this selection process 
is being proposed in an effort to mitigate some of the previously 
stated concerns stakeholders had with these measures.
    We solicited comments on our proposal as discussed above and refer 
readers to section IV.A.3.b.(5)(b)(i)(B) of this final rule for details 
on the scoring of population health measures.
    We received public comments on the reporting requirements of the 
population health measures. The following is a summary of the comments 
we received and our responses.
    Comment: One commenter supported the use of cross-cutting, claims-
based, population-level measures in the foundational layer of MVPs and 
recommended that CMS prioritize use of outcome measures with an 
evidence-based and tested risk adjustment methodology to ensure 
meaningful comparisons between clinicians and groups.
    Response: We thank the commenter for their support and will take 
their recommendations into consideration.
    After consideration of public comments, we are finalizing our 
policies as proposed.
(vi) Subgroup Reporting
(A) Subgroup Reporting Overview
    As discussed in the CY 2022 PFS proposed rule (86 FR 39372 through 
39373) and section IV.A.3.b.(3)(a) of this final rule, subgroup 
reporting would provide an avenue for clinician teams within a larger 
group to be able to submit MVPs that are clinically relevant to them 
and would be a first step in allowing more granular clinician 
information to be made available to patients. To generate more 
clinically relevant and granular information about clinician 
performance, we believe that subgroups should be assessed using 
subgroup level data to the extent that it is operationally feasible. We 
anticipate more granular data would be available for patients, 
clinicians, and other stakeholders through a three-pronged approach of 
mandatory subgroup reporting, broad use of standards-based APIs that 
leverage the FHIR standard and the creation and use of dQMs as 
discussed in section IV.A.1.c. of this final rule. We believe that 
subgroups should report data for the quality and improvement activities 
performance categories as a subgroup. The cost performance category 
does not require data submission; however, as described in section 
IV.A.3.b.(5)(b)(ii) of this final rule, we believe cost data should be 
assessed at the subgroup level as well.
(B) Subgroup Reporting Limits
    As described in section IV.A.3.b.(2)(c)(i) of this final rule, we 
proposed voluntary reporting of MVPs as a gradual approach to prepare 
stakeholders through the transition plan for MIPS before eventually 
requiring reporting through an MVP or the APP. As a part of the 
transition, we discuss our intention to continue to offer reporting 
through traditional MIPS at the group level, as discussed in section 
IV.A.3.b.(2)(c)(i) of this final rule, to allow clinicians and groups 
additional time to continue reporting in traditional MIPS while we work 
expand the inventory of MVPs over the next few years.
    While we intend to allow for this flexibility through the 
transition, we believe that groups should only form subgroups if they 
are reporting through an MVP or the APP and not through traditional 
MIPS. As such, we proposed at Sec.  414.1318(c)(2) that individual 
eligible clinicians that elect to participate in MIPS as a subgroup 
will have their performance assessed at the subgroup level across all 
of the MIPS performance categories based on an MVP in accordance with 
Sec.  414.1365, and on the APP in accordance with Sec.  414.1367, as 
applicable. Subgroups that are MVP Participants must adhere to an 
election process described in Sec.  414.1365(b). This includes MIPS 
eligible clinicians who are APM participants that choose to report on 
an MVP as a subgroup. We believe encouraging the subgroup reporting in 
MVPs is an important step to help MVP Participants transition to MVP 
reporting in the future.
    As stated in the CY 2021 PFS final rule (85 FR 84846), we 
envisioned subgroup reporting would be implemented for multispecialty 
groups reporting MVPs. A subset of a TIN could form a subgroup if they 
are part of the same TIN, but could not form a subgroup if they are 
part of different TINs. For example, a group consisting of a single 
billing TIN that contains a number of participants in the same APM 
Entity, could form a subgroup to report an MVP or the APP. However, an 
APM Entity could not select eligible clinicians who are part of 
different TINs, based on their specialty, and report as a single 
subgroup. Due to operational and technical issues described above, we 
do not believe it is feasible to permit MIPS eligible clinicians in 
multiple TINs to form a subgroup to report MVPs or the APP. We 
solicited public comment on whether there are strategies we should 
consider to enable formation of

[[Page 65415]]

subgroups comprised of MIPS eligible clinicians from multiple billing 
TINS to report MVPs or the APP.
    We did not receive public comments on this proposal, and are 
finalizing it as proposed.
(vii) MVP Reporting Requirements Summary
    Table 47 summarizes the finalized MVP reporting requirements:
    [GRAPHIC] [TIFF OMITTED] TR19NO21.070
    
(e) Third Party Intermediaries Reporting MVPs
    We believe it is also important to ensure that third party 
intermediaries have the capabilities to support MVPs. We refer readers 
to section IV.A.3.h.(2)(b) of this final rule for proposals related to 
requiring third party intermediaries to support MVP and subgroup 
reporting.
(f) MVP Participant Registration
    As described in our proposals in the CY 2022 PFS proposed rule (86 
FR 39373 through 39376), we strive to limit administrative burden and 
offer as much flexibility as possible. With this principle in mind, we 
proposed steps that an MVP Participant must take to inform CMS of their 
participation and submission options, with certain exceptions for when 
the method of collection requires the information in advance of the 
performance period or we do not have any discretion (such as in virtual 
groups). We believe that a registration process will be easiest and the 
most efficient option for MVP Participants and CMS to accurately 
capture: (1) MVP selection; (2) population health measure selection; 
(3) administrative claim-based quality measure selection; and (4) 
subgroup participation.
(i) Registration Timeline
(A) General Timeline
    We refer readers to the CY 2022 PFS proposed rule (86 FR 39373 
through 39374) for discussion of the considerations that went into 
development of the registration timeline. We proposed at Sec.  
414.1365(b)(1), that to report an MVP, an MVP Participant must register 
for the MVP, and if applicable, as a subgroup during a period that 
begins on April 1 and ends on November 30 of the applicable CY 
performance period or a later date specified by CMS. Under this 
proposal, to report the CAHPS for MIPS survey associated with an MVP, a 
group, subgroup, or APM entity must complete their registration by June 
30 of such performance period or a later date specified by CMS.
    We believe the benefits of aligning MVP registration, MVP 
population health measure selection, and subgroup registration during 
the performance period, outweigh the limitations of performance period 
registration. Through the MVP town hall, we have heard stakeholders 
indicate that a registration period that is held during the performance 
period is limiting because it provides clinicians with less time to 
decide which MVP they would like to report or make changes to their 
selection. However, we believe that this would encourage clinicians to 
identify important MVP topics early on in the performance period, in 
which they can focus their quality improvement efforts on. Also, this 
would allow us sufficient time to identify clinician participation in 
subgroups and provide more granular and meaningful subgroup performance 
feedback to inform quality improvement and patient choice resulting in 
clinician assessment on more information relevant to their subgroups, 
such as targeted administrative claims quality measures and cost 
measures.
    In addition, we believe that the proposed registration period would 
allow more flexibility in the creation of subgroups that represent 
clinical alignment and to add or remove clinicians from the subgroup, 
or

[[Page 65416]]

otherwise, make changes to their participation status in subgroups, 
before the end of the registration period.
    We solicited public comments on our proposals as discussed above.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the registration timeline for 
MVPs, including the CAHPS for MIPS registration timeline. One commenter 
shared their belief that CMS proposed a large enrollment window that 
should give MVP participants the opportunity to determine the most 
appropriate MVP for their practice.
    Response: We thank the commenters for their support.
    Comment: A few commenters recommended that CMS open the MVP 
registration period on January 1 of the performance period instead in 
April to allow for more flexibility, especially for MVP participants 
who would like to register for more than one MVP and be able to assess 
which MVP may be the most appropriate.
    Response: We considered beginning the registration period on 
January 1st of the performance period, but we believe that doing so 
would cause stakeholders undue burden considering in January 
stakeholders may be in the midst of data submission for the prior 
performance period. We understand that the data submission period may 
be a busy time for organizations and practices. Therefore, we proposed 
for the registration period to begin in April, once the data submission 
period is over. While the registration period will not open until April 
1st, MVP participants may start to evaluate and determine which MVP 
they would like to report much earlier, once the final rule is 
published. We plan to continue to assess this registration timeline, 
along with all other MVP policies, and make any necessary changes, as 
needed through future rulemaking.
    We note that, as described in the CY 2022 PFS proposed rule (86 FR 
39374), MVP participants may select one MVP at the time of MVP 
registration, and may not make changes to their registration after the 
close of the registration period. Through the CY 2022 PFS proposed rule 
(86 FR 39374), we had solicited public comment on, if MVP participants 
would be interested in selecting multiple MVPs at the time of 
registration and the value in this allowance. We will consider any 
feedback received under consideration for future rulemaking.
    Comment: A few commenters did not support the proposed registration 
timeline of April to November and recommended that CMS allow MVP 
participants to register at the time of data submission for the given 
year they report the MVP. One commenter believed that clinicians and 
subgroups will need additional flexibility as they shift from 
traditional MIPS reporting to MVP reporting.
    Response: We disagree. We believe MVP participants should register 
prior to the data submission period in order to give our systems a 
sufficient amount of time to track the MVP for which participants would 
be eligible for the purposes of providing enhanced feedback. That is 
why we proposed the MVP registration window to encompass eight months 
of the performance period, to allow MVP participants sufficient time to 
identify and register for an MVP that is relevant to their practice. In 
addition, On January 7, 2021, we held the MVP Town Hall (85 FR 74729) 
(https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1290/MIPS%20Value%20Pathways%20Town%20Hall%20Slide%20Deck.pdf) in which 
stakeholders overwhelmingly voiced their preference for an earlier 
registration period. We believe participants who are ready to 
transition to MVP reporting will take the time to select a relevant MVP 
and understand the reporting requirements expected under MVPs before 
reporting.
    Comment: One commenter requested CMS to consider the opportunity 
for MVP participants to change their registration status and switch 
from MVP reporting to traditional MIPS after the MVP registration 
deadline for the 2023 and 2024 MIPS performance periods. The commenter 
believes that such flexibility may be necessary in instances where a 
practice discovers that the MVP measures are not supported by its EHR 
vendor.
    Response: We agree. As described in section IV.A.3.b.(5)(c)(i) of 
this final rule, MVP participants may register for an MVP then decide 
to report traditional MIPS instead; or may report the MVP and also 
choose to report measures and activities through traditional MIPS. We 
have finalized in section IV.A.3.f.(5) of this final rule, a scoring 
hierarchy that would account for MIPS eligible clinicians and groups 
reporting both traditional MIPS and an MVP. We believe this flexibility 
is important while MVP reporting is initially voluntary, to give 
stakeholders time to adjust their workflows and prepare for an eventual 
transition to mandatory MVP reporting when traditional MIPS sunsets. We 
refer readers to section IV.A.3.f.(5) of this final rule for additional 
discussion of the scoring hierarchy policies.
    Comment: One commenter recommended that CMS offer clear guidance on 
the expectations for MVP participants, specifically requesting targeted 
communications to the clinicians that qualify for a given MVP and 
detailed information on how the registration process will work.
    Response: We agree. As technically feasible, we intend on providing 
additional information and resources regarding the registration process 
after the final rule is published and prior to the beginning of the 
registration period to allow stakeholders sufficient time to prepare.
    After consideration of public comments, we are finalizing our 
policies as proposed.
(B) Exception for MVP Participants That Want to Report the CAHPS for 
MIPS Survey Measure
    Currently, as finalized in the CY 2017 Quality Payment Program 
final rule (81 FR 77072), groups that register to administer the CAHPS 
for MIPS survey measure prior to the registration deadline could cancel 
their registration or change their CAHPS for MIPS survey selection 
before the close of registration on June 30th. In the CY 2022 PFS 
proposed rule (86 FR 39374), we proposed at Sec.  414.1365(b)(1) that 
in order for an MVP Participant to report the CAHPS for MIPS survey 
measure associated with an MVP, a group, subgroup, or APM entity will 
need to register by the same deadline as the CAHPS for MIPS 
registration, which is June 30 of the applicable 12-month performance 
period (81 FR 77072).
    Under this proposal, clinicians participating in subgroups or 
groups reporting on the CAHPS for MIPS survey measure within an MVP 
would be unable to make any changes to their participation in the CAHPS 
for MIPS survey beginning July 1 of the applicable performance period. 
We note that clinicians in subgroups who do not intend to report the 
CAHPS for MIPS measure would still be able to make changes to their 
participation status in subgroups before the registration period ends 
on November 30th. We solicited public comments on these proposals.
    We did not receive public comments on these proposals and are 
finalizing them as proposed.
(ii) MVP Participant Registration Requirements
    We believe there are certain elements of information that are 
important to include at the time of MVP registration. Specifically, we 
proposed at Sec.  414.1365(b)(2)(i) and (ii), that at the time of 
registration, an MVP Participant

[[Page 65417]]

must submit the following information, as applicable: (1) Each MVP 
Participant must select an MVP, 1 population health measure included in 
the MVP, and if applicable, any outcomes-based administrative claims 
measure on which the MVP Participant intends to be scored; (2) Each 
subgroup must submit a list of each TIN/NPI associated with the 
subgroup which identifies each individual eligible clinician NPI in the 
applicable subgroup for the group TIN and a plain language name for the 
subgroup. The following subsections discuss each of these elements.
(A) MVP Selection
    To accurately capture who is participating in MVP reporting, it is 
important to establish the use of identifiers to identify what is 
intended to be reported, and by whom. We intend to publish a list of 
MVPs that have been finalized in rulemaking in the prior year, with 
identifiers available for a given performance period on the QPP 
Resource Library, prior to the start of the registration period, along 
with registration guidance. Therefore, we proposed that the MVP 
Participants must select a specific MVP, at the time of registration, 
as described at proposed Sec.  414.1365(b)(2)(i). Under this proposal, 
MVP Participants would not be able to submit or make changes to the 
MVPs they select after the close of the registration period, and 
therefore, would not be allowed to report on an MVP they did not 
register for. We solicited comments on this proposal.
    We did not receive public comments on our proposal, and are 
finalizing it as proposed. We have solicited public comment on whether 
MVP participants would be interested in the ability to select multiple 
MVPs at the time of registration. We thank commenters for the feedback 
received. We may consider this information to inform future rulemaking.
(B) Population Health Measure Selection
    Similarly, we plan to publish a list of the population health 
measures that have been finalized for a given performance period on the 
QPP Resource Library. We plan for this to occur prior to the start of 
the registration period, along with posting registration guidance. As 
discussed in section IV.A.3.b.(4)(d)(v)(B) of this final rule, we 
proposed that MVP Participants who report an MVP, must submit one 
population health measure of their choice from the list of finalized 
population health measures within the foundational layer of the MVPs. 
The two proposed and previously finalized population health measures 
are both administrative claims based, and do not require physical data 
submission by clinicians. Therefore, in order for this selection to be 
tracked, we proposed at Sec.  414.1365(b)(4)(i) that MVP Participants 
would be required to select this population health measure at the time 
of registration. Under this proposal, MVP Participants would not be 
able to submit or make changes to the selected population health 
measure after the close of the registration period. In addition, MVP 
Participants would not be able to successfully register to report an 
MVP if they do not select a population health measure, as the 
registration would be considered incomplete. We solicited comments on 
this proposal.
    We did not receive public comments on this proposal, and are 
finalizing it as proposed.
(C) Outcomes-Based Administrative Claims Measure Selection
    Within the MIPS quality performance category quality measure 
portfolio, there are some MIPS quality measures that are outcomes-based 
and utilize the administrative claims-based collection type. There are 
instances in which these measures are not identified as population 
health measures. For example, because the measure related to a specific 
procedure such as hip and knee arthroplasty we do not define this as 
population health since it does not necessarily impact the health of a 
population. While these measures may not be population health measures, 
they still reflect important clinical concepts and practices that are 
important to clinicians and lead to improved patient outcomes. 
Therefore, we believe it is important to not exclude these measures 
from MVPs. Depending on the MVP topic, these quality measures may be 
applicable and relevant to the topic being measured. In addition, 
administrative claims-based measures reduce reporting burden placed on 
clinicians because CMS calculates these measures utilizing 
administrative claims data. As such, we proposed at Sec.  
414.1365(b)(2)(i) that the MVP Participant must select any outcomes-
based administrative claims measures on which the MVP Participant 
intends to be scored. As discussed in section IV.A.3.b.(4)(d)(ii) in 
this final rule, we proposed at Sec.  414.1365(c)(1) that an MVP 
Participant must select and report 4 quality measures, including 1 
outcome measure (or, if an outcome measure is not available, 1 high 
priority measure), included in the MVP. As applicable, an outcomes-
based administrative claims measure, may be selected at the time of MVP 
registration to meet the outcome measure requirement (excluding the 
population health measures required under Sec.  414.1365(c)(4)(ii)). We 
solicited comments on this proposal.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter supported the inclusion of administrative 
claims measures but expressed concern about the availability of these 
measures to anesthesiologists.
    Response: We appreciate the commenter's support. We understand that 
the availability of administrative claims-based measures is currently 
limited. We will continue to assess the feasibility of developing 
additional administrative claims-based measures, and can evaluate the 
feasibility of developing such measures for specialties such as 
anesthesia.
    After consideration of public comments, we are finalizing our 
policies as proposed.
(D) Subgroup Participants
    As part of the registration process, to accurately capture all the 
clinicians participating in a subgroup, we proposed at Sec.  
414.1365(b)(2)(ii) that each subgroup must submit: (1) A list of each 
TIN/NPI associated with the subgroup, which should identify each 
individual eligible clinician NPI in the applicable subgroup for the 
group TIN; and (2) the subgroup's name in a plain language manner.
    We believe that the subgroup names would help communicate the 
specialty, location, or other relevant information which would be 
displayed on the Compare Tools, helping stakeholders differentiate 
between subgroups. We plan to provide additional guidance for the 
template in subregulatory guidance for the nomenclature of subgroups 
and intend to provide a template and guidance to clinicians and 
practices on the use of plain language for naming subgroups. For 
example, a subgroup which consists of oncologists in the Mayberry 
location of one overall group TIN who chooses to report the Oncology 
MVP could be called Mayberry Oncology.
    Upon successful registration submission, we would assign a unique 
subgroup identifier. This subgroup identifier would be separate from 
the individual NPI identifier, the group TIN identifier, and the MVP 
identifier, discussed in this final rule. We would maintain the same 
identifier year over year, as applicable. In scenarios where a 
subgroup's makeup changes, which will be identified at the time of 
registration, we will issue the subgroup

[[Page 65418]]

a new identifier. We believe this identifier is also needed to allow 
third-party intermediaries to capture and submit performance data for 
clinicians participating in subgroup reporting as discussed in section 
IV.A.3.b.(4)(f)(ii)(D) of this final rule.
    We solicited public comments on these proposals. Additionally, we 
solicited feedback on if there are any additional operational 
considerations or recommendations for the implementation of this policy 
for future consideration.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter requested that CMS offer clear and detailed 
guidance on subgroup registration and reporting requirements. Another 
commenter expressed concerns about identifying clinicians in the 
appropriate subgroup and recommended a process to rectify unintentional 
mistakes in the subgroup registration process.
    Response: We intend on offering clear guidance regarding the 
registration process, including the process of subgroup registration. 
As described above in section IV.A.3.b.(4)(d)(v)(A)(bb) of this final 
rule, and at Sec.  414.1365(c)(4)(i)(A) that for the CY 2023 and 2024 
MIPS performance periods/2025 and 2026 MIPS payment years, an MVP 
Participant that is a subgroup is required to submit its affiliated 
group's data for the Promoting Interoperability performance category. 
Through the registration process, subgroups may make changes to their 
elections and rectify any unintentional mistakes before the close of 
the registration period. We thank the commenter for their 
recommendation that we should establish a process to rectify 
unintentional mistakes, that perhaps are identified after the 
registration period closes. We will take it into consideration as we 
plan for the establishment of the registration process.
    After consideration of public comments, we are finalizing our 
policies as proposed.
(iii) Summary of the Overall Registration Process
    Table 48 presents a comprehensive perspective of the overall 
finalized registration timeline:
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR19NO21.071

    Table 49 presents a crosswalk of the various clinician types, the 
information expected at the time of registration, and a reminder of the 
finalized MVP reporting requirements.

[[Page 65419]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.072

BILLING CODE 4120-01-C
(5) Scoring MVP Performance
(a) Overview of MVP Scoring
    In the CY 2022 PFS proposed rule (86 FR 39377 and 39378), we 
described previous feedback we received on the CY 2020 PFS proposed 
rule and during the MVP Town Hall on January 7, 2021 related to how we 
should address scoring policies as we transition to MVPs (86 FR 39377). 
In general, we proposed policies to score MVPs similar to policies 
established for traditional MIPS, including, without limitation, the 
methodology to score MVP Participants based on their performance on 
measures and activities in the four performance categories; the use of 
performance standards for each of the performance categories; policies 
for calculation of achievement and improvement scores; and calculation 
of the final score. We stated that we aimed to ensure our methodology 
to convert the scores of measures and activities into a final score 
balanced the statutory requirements and goals of the program with ease 
of use, stability, and meaningfulness to MIPS eligible clinicians. We 
also stated that our proposed scoring methodology would allow for 
accountability and alignment across the performance categories and 
minimize burden on MIPS eligible clinicians. We also noted that we 
believed these proposed scoring policies would ensure the meaningful 
evaluation of performance of MVP Participants based on measures and 
activities in the MVP, and that several of the proposed MVP specific 
scoring policies would support our identified goal to simplify the 
program by offering MVPs that link clinically relevant measures and 
activities, which are meaningful to clinicians, patients, and the 
program (86 FR 39378).
    We proposed at Sec.  414.1365(d)(1) that an MVP Participant that is 
not an APM Entity is scored on measures and activities included in the 
MVP in

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accordance with paragraphs Sec.  414.1365(d)(1) through Sec.  
414.1365(d)(3) (86 FR 39378). We also proposed at Sec.  414.1365(d)(1) 
that an MVP Participant that is an APM Entity is scored on measures and 
activities included in the MVP in accordance with Sec.  414.1317(b) (86 
FR 39378). Additionally, we proposed 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 39378). Lastly, 
we proposed at Sec.  414.1365(d)(3) that an MVP Participant is scored 
under MIPS in four performance categories (86 FR 39378).
    We solicited public comments on these proposals.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters expressed the belief that, given the 
complexity of the program and multiple participation options, alignment 
of scoring policies with traditional MIPS will be essential to reducing 
burden on clinicians, especially small practices, as they familiarize 
themselves with MVPs and prepare for their eventual mandatory 
participation.
    Response: We thank the commenters for their support.
    Comment: A few commenters did not support our proposal to align MVP 
scoring with traditional MIPS. One commenter recommended a wholesale 
departure from traditional MIPS that offers a true onramp for 
clinicians to Alternative Payment Models (APMs). Another commenter 
recommended that CMS should develop a scoring methodology for MVPs that 
is more team-based, holding teams accountable for patient event rates, 
Patient Reported Outcomes Measures, and meeting patients' goals and 
expectations. The commenter supported attestation for quality measures, 
rather than measuring performance against a benchmark.
    Response: We believe it is important, whenever possible, to build 
on the scoring that is familiar to clinicians to reduce confusion and 
complexity as we transition into MVPs. We are interested in supporting 
clinicians in the transition to APMs and believe that MVPs are an 
important step in gaining experience with submitting and scoring a 
cohesive set of measures and activities. We evaluated all traditional 
MIPS scoring policies and maintained those that are required under 
section 1848(q)(2) of the Act such as requirements to measure 
achievement and improvement of the quality and cost of care, and those 
policies that supported the goals of transitioning to MVPs. We believe 
that it is appropriate to adopt policies that are different from 
traditional MIPS policies in cases where different policies support the 
goals of our transition to MVPs. We have signaled the importance of 
incorporating the patient voice in MVPs; specifically, in the CY 2021 
PFS final rule (85 FR 84850), we finalized MVP development and 
selection criteria that considers the inclusion of (to the extent 
feasible), patient-reported outcome measures, patient experience 
measures, and/or patient satisfaction measures. Furthermore, as 
measures for patient voice and Patient Reported Outcome Measures are 
added to MVPs we believe that no special scoring policies are needed. 
Our inventory of cost measures, which continues to expand, includes 
episode-based measures that can be used in MVPs when linked with 
meaningful quality outcome measures and improvement activities. We are 
required under section 1848(q)(3)(B) of the Act to use performance 
standards for measures and activities, and we have identified 
benchmarks to measure achievement of quality and cost measures, rather 
than relying on attestation. Additionally, when measures are compared 
to a benchmark, we can provide performance information to patients 
seeking care, as well as to clinicians to improve care. We are not 
aware of any scoring policies necessary for certain types of 
clinicians, including clinicians who are part of team-based risk 
bearing entities. We believe our MVP scoring policies hold clinicians 
accountable by scoring them against performance standards using 
relevant measures for the four performance categories. We look forward 
to hearing stakeholder feedback on scoring policies to determine if 
different approaches are needed in the future.
    Comment: A few commenters recommended incentives for clinicians to 
report MVPs, including scoring policies that allow for MVPs to be 
reported during an informational period without scoring or scoring that 
will `hold harmless' or ensure that no negative payment adjustments 
will be applied for any clinician reporting an MVP.
    Response: The MIPS statute requires us to measure performance for 
purposes of determining a payment adjustment, using data from four 
performance categories, in a budget neutral manner. We believe that 
MVPs offer incentives in terms of requiring fewer measures and 
activities tied to a specialty or medical condition that can offer 
clinicians a more cohesive experience. In the CY 2022 PFS proposed 
rule, we discussed the delay in the implementation timeline to allow 
for a gradual process that provides MVP participants and third-party 
intermediaries with time to adapt to the changes in policy, 
requirements, and programming updates that would need to occur in 
technological systems (86 FR 39355 through 39356). We believe the 
delayed timeline should allow clinicians to change clinical workflows 
and be able to submit and be assessed on MVPs. We do not have 
discretion to have a ``hold harmless'' approach for clinicians 
reporting an MVP, and furthermore do not believe this approach would be 
appropriate. We do not intend for the MVP reporting option to be a 
mechanism to avoid a negative payment adjustment; but instead as an 
approach to improve value, reduce burden, inform patient choice in 
selecting clinicians, and reduce barriers to facilitate the movement 
into APMs. We also do not want to introduce bonuses for reporting MVPs 
or other incentives that may mask performance and artificially inflate 
final scores. However, we are evaluating additional incentives that 
align with our scoring policies and the goals of MVPs. We anticipate 
addressing any incentives through future notice and comment rulemaking.
    Comment: Several commenters indicated that scoring policies should 
break down the silos between the four performance categories and that a 
single measure or activity should be scored in multiple performance 
categories. One commenter recommended that if a measure submitted by a 
QCDR encompasses actions for more than one performance category, 
scoring policies should provide automatic credit in the quality, 
Promoting Interoperability, and improvement activities categories. 
Commenters expressed the belief that this would allow better cohesion 
within the program, rather than having four separate categories. 
Commenters also believed that this would serve as an incentive to 
report an MVP and result in a reduction of reporting burden.
    Response: We note that the MIPS statute requires the use of four 
performance categories (which we refer to as the quality, cost, 
improvement activities, and Promoting Interoperability performance 
categories) in determining the composite performance score (which we 
refer to as the final score). We refer readers to our discussion of the 
intent of MVPs (85 FR 84844) to make MIPS more meaningful by allowing a 
more cohesive participation experience by connecting

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activities and measures from the four MIPS performance categories 
relevant to a patient population, standardizing performance measurement 
of a specialty or a medical condition, and reducing the siloed nature 
of the traditional MIPS participation experience. We also refer 
commenters to the CY 2021 PFS final rule, where we finalized MVP 
development criteria, including a criterion that assesses the extent to 
which the measures and activities in the MVP link to one another, as 
well as another criterion that assesses the extent to which improvement 
activities complement and/or supplement the quality action rather than 
duplicating it (85 FR 84849 through 84853). We believe that it is 
important that MVPs include measures and activities from the four 
performance categories that are complementary, and note that we do 
currently have improvement activities and measures that include related 
concepts. However, in addition to being required by statute, we believe 
each of the four performance categories offers value, and therefore, we 
do not at this time believe automatic credit for a performance category 
or assigning points to multiple performance categories for the 
submission of a single measure or activity would be appropriate. We 
invite further feedback from stakeholders on how offering multi-
category credit will increase the information available to patients and 
improve patient outcomes. Our goals include providing comparative data 
to patients and caregivers who are evaluating clinician performance and 
making choices about their care (86 FR 39353) and we believe this is 
best achieved through the use of the four performance categories.
    We did not receive any comments on proposals to score an MVP 
Participant that is an APM Entity.
    After consideration of public comments, we are finalizing these 
policies as proposed.
(b) Performance Category Scores
(i) Scoring the Quality Performance Category in MVPs
(A) Scoring Based on Achievement
    In the CY 2022 PFS proposed rule (86 FR 39378 through 86 FR 39379), 
we proposed to maintain scoring policies finalized in traditional MIPS 
for MVPs to leverage meaningful scoring policies and retain stable 
scoring for MVP Participants. We refer readers to Sec.  
414.1380(b)(1)(i) for details on our policies for scoring performance 
on quality measures for traditional MIPS (81 FR 77276 through 77307, 82 
FR 53694 through 53701, 83 FR 59841 through 59856, 84 FR 63011 through 
63019, and 85 FR 84904 through 84906). Our proposed policies for 
scoring quality in traditional MIPS are described in further detail in 
the CY 2022 PFS proposed rule (86 FR 39439 through 39437). We refer 
readers to the CY 2022 PFS proposed rule (86 FR 39432 through 39434) 
for our proposals to remove the 3-point floor for Class 1 and Class 2 
measures for the CY 2022 performance year/2024 MIPS payment year for 
traditional MIPS, and to provide a score from 5 to 10 points in the 
first two performance periods a measure is used in MIPS for Class 4 
measures (new measures). We proposed to align with these policies as 
well to maintain consistency between MVPs and traditional MIPS (86 FR 
39378).
    We proposed at Sec.  414.1365(d)(3)(i) that, except as provided in 
paragraphs (d)(3)(i)(A)(1) and (B), the quality performance category 
score for MVP Participants is calculated in accordance with Sec.  
414.1380(b)(1) based on measures included in the MVP.
    We did not receive any comments on our proposal, and we are 
finalizing it as proposed.
(B) Population Health Measures
    In the CY 2022 PFS proposed rule, we proposed that we would score 
the selected measure according to Sec.  414.1365(d)(3)(i) (86 FR 
39378). Since we proposed to adopt our scoring policies used in 
traditional MIPS for MVPs, we also proposed that we would exclude the 
selected measure from the total achievement points and the total 
available points if the measure does not have a benchmark or meet the 
case minimum requirement in accordance with Sec.  
414.1380(b)(1)(i)(A)(2)(ii) (86 FR 39378). We proposed at Sec.  
414.1365(d)(3)(i)(A) that, except as provided in paragraph 
(d)(3)(i)(A)(1), each selected population health measure that does not 
have a benchmark or meet the case minimum requirement is excluded from 
the MVP Participant's total measure achievement points and total 
available measure achievement points (86 FR 39378).
    We also proposed at Sec.  414.1365(d)(3)(i)(A)(1) that subgroups 
are scored on each selected population health measure that does not 
have a benchmark or meet the case minimum requirement based on their 
affiliated group score, if available (86 FR 39378). We stated that we 
believed this is appropriate because we believe it is important for 
subgroups to be scored on population health measures, and we believe 
that the groups score will be reflective of the subgroup's performance 
on population health measures. We are concerned about the ability of 
subgroups to meet the case minimum for an administrative claims measure 
and are interested in including population health measures in the 
subgroup's score for the MVP. Therefore, we also proposed at Sec.  
414.1365(d)(3)(i)(A)(1) that, if the subgroup's affiliated group score 
is not available, each population health measure is excluded from the 
subgroup's total measure achievement points and total available measure 
achievement points (86 FR 39378).
    In the CY 2022 PFS proposed rule, we also noted our concern about 
scoring individual clinicians on population health measures (86 FR 
39378 through 39379). Because population health measures have measured 
the quality of a population or cohort's overall health and well-being, 
we historically have required a minimum reliability standard of 0.4 
which for most measures equates to a high case minimum in order to be 
scored. We believe it will be common that a solo practitioner, or an 
individual clinician that is part of a group but chooses to be scored 
as an individual clinician will not be scored on population health 
measures. In these scenarios, we proposed that each population health 
measure would be excluded from the subgroup's total measure achievement 
points and total available measure achievement points in accordance 
with Sec.  414.1380(b)(1)(i)(A)(2)(ii). Historically, we have not 
combined performance for the individual clinician with performance from 
the group, and therefore, have concerns with using the group score for 
individual clinicians who cannot be scored for population health 
measures. We understand there may be concerns from stakeholders on 
scoring individual clinicians on broad population health measures. 
However, we solicited comment on approaches to scoring individual 
clinicians on population health measures given the importance of these 
measures.
    We solicited comments on our proposals for scoring population 
health measures in MVPs. The following is a summary of the comments we 
received and our response:
    Comment: One commenter did not support the use of population health 
measures for clinicians and stated they should be used as measures for 
APMs or facility-level quality measurement. The commenter recommended 
that if population health measures are used that they should not be 
scored and that the resulting data should be used only to provide 
clinicians with confidential feedback.

[[Page 65422]]

    Response: We believe that we should score population health 
measures, when there is a sufficient case volume and a benchmark, for 
all MVP Participants, which includes MIPS eligible clinicians, groups, 
and APM entities (see section IV.A.3.b.(2)(c)(i) of this final rule). 
In the CY 2020 PFS final rule (84 FR 62947 through 62948), we 
established the implementation of a foundational population health core 
measure set that can be broadly applied to communities or populations 
and can result in MVPs that provide more uniformity in how the program 
measures population health, reduces clinician burden, focuses on 
important public health priorities, and increases the value of MIPS 
performance data. We believe that it is important to score population 
health measures as part of the foundational layer of the MVP when 
clinicians submitting an MVP can be scored on the selected population 
health measure.
    Comment: A few commenters recommended that CMS not score individual 
clinicians on population health measures because individual clinicians 
may not have the infrastructure and resources required to positively 
influence population health measure outcomes. One commenter recommended 
that scoring for population health measures should not be implemented 
in a way that would penalize MVP Participants' quality performance 
category scores if the case minimum was not met.
    Response: As discussed in section IV.A.3.b.(4)(b)(i)(C)(aa)(AA) of 
this final rule, we are finalizing our proposal to define a population 
health measure at Sec.  414.1305 as a quality measure that indicates 
the quality of a population or cohort's overall health and well-being, 
such as access to care, clinical outcome, coordination of care and 
community services, health behaviors, preventive care and screening, 
health equity, or utilization of health services. MVPs include a 
cohesive set of measures and activities, including a foundational layer 
of population health measures. We believe that clinicians will select 
an MVP with an understanding that performance on all of the measures 
and activities will be used to determine a final score. We also believe 
that MVP Participants that meet the case minimum for the selected 
population health measure will have the infrastructure and resources to 
influence the population health measure.
    We believe it is appropriate to score all MVP Participants, 
including individual clinicians, on population health measures using 
scoring policies for MVPs that align with our finalized policies for 
traditional MIPS and note that population health measures will be 
scored only if there is a benchmark or the case minimum is met. We have 
proposed that we exclude the selected measure from the total 
achievement points and total available points if the measure does not 
meet the case minimum or have a benchmark. We believe this approach to 
scoring which focuses on performance of measures that meet the 
standards for case minimum does not penalize MVP Participants, 
including individual clinicians, who have insufficient case volume to 
allow measurement.
    After consideration of public comments, we are finalizing our 
policies as proposed.
    We did not receive public comments on our proposal that subgroups 
are scored on each selected population health measure that does not 
have a benchmark or meet the case minimum requirement based on their 
affiliated group score, if available. We are finalizing this policy as 
proposed.
(C) Outcomes-based Administrative Claims Measures
    In the CY 2022 PFS proposed rule (86 FR 39479), we proposed at 
Sec.  414.1365(d)(3)(i)(B) that MVP Participants receive zero measure 
achievement points for each selected outcomes-based administrative 
claims measure that does not have a benchmark or meet the case minimum 
requirement (86 FR 39379). This aligns with our proposal to score Class 
2 measures in traditional MIPS (86 FR 39432). If the clinician selects 
the outcomes-based administrative claims measure, which can be 
calculated and submits more than three measures including an additional 
outcome or high priority measure, scores from the highest four measures 
including one outcome or high priority measure would be used to 
determine the quality performance category score. Please see the CY 
2022 PFS proposed rule (86 FR 39379 through 39380) for an example of 
scoring for outcomes-based administrative claims measures under this 
proposal. We solicited public comments on this proposal.
    We did not receive any public comments on this proposal and are 
finalizing it as proposed.
(D) Scoring for MVP Participants That Do Not Meet the Quality 
Performance Category Requirements
    In the CY 2022 PFS proposed rule (86 FR 39379), we described our 
rationale for why we do not believe we need a validation process to 
determine the availability and applicability of measures for MVP 
Participants because MVPs will focus on a condition or specialty, and 
we believe MVPs will be selected and reported because of the MVP 
applicability to their practice and patients. We refer readers to the 
CY 2022 PFS proposed rule (86 FR 393870 through 39380) for an example 
of scoring the quality performance category for an MVP.
(ii) Scoring the Cost Performance Category in MVPs
    In the CY 2022 PFS proposed rule (86 FR 39380), we proposed to use 
the methodology established for traditional MIPS to score the cost 
performance category for MVPs, including the proposed revisions to that 
methodology described in the CY 2022 PFS proposed rule (86 FR 39437). 
We refer readers to Sec.  414.1380(b)(2)(i) through (v) for our 
previously finalized policies to score the cost performance category 
for traditional MIPS based on achievement and improvement when the case 
minimum specified under Sec.  414.1350(c) is met or exceeded and CMS 
has determined a benchmark. We proposed at Sec.  414.1365(d)(3)(ii) 
that the cost performance category score is calculated for an MVP 
Participant using the methodology at Sec.  414.1380(b)(2)(i) through 
(v) and the cost measures included in the MVP that they select and 
report. We also noted that we intend to monitor for reporting of MVPs 
to ensure MVPs reflect the clinical nature of the MVP Participants that 
report (86 FR 39380). We solicited public comments on this proposal.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter voiced concern that multispecialty groups 
may take advantage of the option to report for the entire group at the 
subgroup level and select an MVP for which the group does not meet the 
case minimum for the cost measures to avoid being scored on the cost 
performance category.
    Response: We understand the potential gaming concern voiced by the 
commenter and will monitor how multispecialty groups report and are 
scored on MVPs. Although an entire multispecialty group cannot report 
as a single subgroup, we acknowledge that, initially, multispecialty 
groups will have the option to either participate in traditional MIPS 
as a group, to report a specific MVP as a group, or to form subgroups 
to report MVPs that are more meaningful to their scope of practice. As 
finalized in section IV.A.3.b.(2)(c)(ii) of this final rule, 
multispecialty groups will have to form subgroups in order to report an 
MVP beginning with the CY

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2026 performance period/2028 MIPS payment year. We plan to monitor how 
often the cost performance category is reweighted for MVP participants 
in order to assess whether it may be possible that large multispecialty 
groups are reporting MVPs as subgroups in order to avoid being scored 
on the cost performance category.
    After consideration of public comments, we are finalizing at Sec.  
414.1365(d)(3)(ii) that the cost performance category score is 
calculated for an MVP Participant using the methodology at Sec.  
414.1380(b)(2)(i) through (v) and the cost measures included in the MVP 
that they select and report.
(iii) Scoring the Improvement Activities Performance Category in MVPs
    Under traditional MIPS, we score improvement activities by 
assigning each improvement activity a weight, either high-weight or 
medium-weight, and by assigning 10 points for each medium-weighted 
improvement activity and 20 points for each high-weighted improvement 
activity. We refer readers to Sec.  414.1380(b)(3) for details on 
scoring the improvement activities performance category for traditional 
MIPS. Additionally, we refer the reader to Sec. Sec.  414.1317(b)(3) 
and 414.1380(b)(3)(i), which provide that a MIPS eligible clinician 
participating in an APM receives a score of at least 50 percent in the 
improvement activities performance category. As a result, an APM entity 
that reports an MVP will receive an improvement activities performance 
category score of at least 50 percent.
    In the CY 2022 PFS proposed rule (86 FR 39380), we proposed at 
Sec.  414.1365(d)(3)(iii) that the improvement activities performance 
category score is calculated based on the submission of high- and 
medium-weighted improvement activities. We also proposed that MVP 
Participants would receive 20 points for each medium-weighted 
improvement activity and 40 points for each high-weighted improvement 
activity required under Sec.  414.1360 on which data is submitted in 
accordance with Sec.  414.1325 or for participation in a certified or 
recognized patient-centered medical home (PCMH) or comparable specialty 
practice, as described at Sec.  414.1380(b)(3)(ii). Therefore, to 
receive a score of 40 points, or full credit, an MVP Participant would 
be required to submit one high-weighted improvement activity or two 
medium-weighted improvement activities included in the MVP.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter supported the proposal for scoring 
improvement activities in MVPs.
    Response: We thank the commenter for their support.
    Comment: A few commenters did not support the proposal to assign 20 
points for each medium-weighted improvement activity and 40 points for 
each high-weighted improvement activity. One commenter believed that 
different scoring policies for traditional MIPS and MVPs will add 
complexity to the program.
    Response: We acknowledge the commenter's concern about complexity 
in the program and note that we are still scoring high-weighted and 
medium-weighted activities and the approach is not unfamiliar to 
clinicians. We believe the reduced requirements for the improvement 
activities performance category will incentivize clinicians to report 
MVPs by reducing burden, since fewer improvement activities are 
required to receive a full score for the category.
    Comment: One commenter recommended that MVP developers identify 
improvement activities associated with using clinical data relevant to 
the MVP and recommended a scoring approach for improvement activities, 
including a graduated scale based on the MVP's potential impact on 
PROMs or care complications.
    Response: We believe that a standardized approach to scoring is 
needed to provide consistency and to reduce complexity. We also have 
concerns and believe that a graduated scoring approach would introduce 
additional and unnecessary complexity to attestation, which would be 
confusing for clinicians accustomed to being scored by attestation on 
medium-weighted and high-weighted improvement activities. We believe 
that it is important, whenever possible, to build on the scoring 
approach is familiar to clinicians to reduce confusion and complexity 
as we transition into MVPs. We evaluated all traditional MIPS scoring 
policies and maintained those that are required by statute. 
Additionally, we believe that it is appropriate to adopt policies that 
are different from MIPS policies in cases where different policies 
support the goals of our transition to MVPs.
    Comment: A few commenters recommended that CMS should award 
automatic credit for the improvement activities performance category, 
and potentially other performance categories, to reduce burden, 
simplify requirements and scoring for MVPs, and potentially serve as an 
incentive to submit MVPs.
    Response: We do not believe it would be appropriate to provide 
automatic credit for any of the performance categories. Instead, we 
have finalized our proposal to provide full credit for MVP participants 
who report one high-weighted or two medium-weighted improvement 
activities or who participate in a certified or recognized patient-
centered medical home or comparable specialty practice (please see 
section IV.A.3.b.(4)(d)(iv) of this final rule for more details). We 
are concerned about whether providing automatic credit would further 
our goals of improving patient outcomes, as this approach limits the 
data and information available and would reduce the impact of a 
performance category, all four of which we believe provide value. MVPs 
are complementary sets of measures and activities that are meaningful 
to clinicians. We have previously stated our belief in the importance 
of the clinician experience with MVPs, including through an aligned 
measurement of quality and cost, continuous improvement/innovation 
within the practice, and efficient management and transfer of 
information that will help remove barriers to APM participation (85 FR 
84844 and 84845).
    We believe each of the four performance categories offers value, 
and therefore, we do not at this time believe automatic credit for any 
category would be appropriate. We are concerned and would invite 
further feedback from stakeholders on how offering multi-category 
credit will increase the information available to patients and improve 
patient outcomes. Our goals include providing comparative data to 
patients and caregivers in evaluating clinician performance and making 
choices about their care (86 FR 39352 and 39353) and we believe this is 
best achieved through the use of the four performance categories. The 
improvement activities performance category is an important component 
of the MVP. We believe we should use the improvement activities 
performance category scoring established in traditional MIPS and 
continue scoring high-weighted and medium weighted improvement 
activities that support the linked activities and measures specified 
within the MVP.
    We believe that incentives already exist in MVPs, including reduced 
reporting requirements, as described in section IV.A.3.b.(4)(d) of this 
final rule, which allow MVP Participants to report on a smaller, more 
cohesive subset of

[[Page 65424]]

measures and activities that are relevant to a given clinical topic, 
condition, or episode of care, as well as enhanced performance 
feedback, as described in section IV.A.3.b.(5)(d) of this final rule.
    Comment: One commenter recommended we provide improvement activity 
credit for clinicians involved in testing QCDR measures that are 
undergoing testing for inclusion in MVPs.
    Response: We appreciate suggestions for improvement activities that 
might be meaningful for MVP and recommend that the improvement activity 
be nominated during the Annual Call for Activities.
    After consideration of public comments, we are finalizing this 
proposal as proposed.
(iv) Scoring the Promoting Interoperability Performance Category in 
MVPs
    In the CY 2022 PFS proposed rule (86 FR 39380 through 39381), we 
proposed to use the scoring methodology established for the Promoting 
Interoperability performance category in traditional MIPS, as proposed 
to be revised in of the CY 2022 PFS proposed rule (86 FR 39409 through 
39428), for MVP Participants, with the exception that subgroups would 
be scored based on their affiliated group's Promoting Interoperability 
performance category data. The Promoting Interoperability performance 
category is a foundational layer of MVPs that uses limited, connected 
complementary sets of measures that are meaningful to clinicians. The 
scoring methodology for the Promoting Interoperability performance 
category recognizes the importance of promoting adoption and use of 
CEHRT to support quality improvement, interoperability, and patient 
engagement and provides an important approach to scoring that we 
proposed to use for MVPs. Therefore, we proposed at Sec.  
414.1365(d)(3)(iv) to calculate the Promoting Interoperability 
performance category score for an MVP Participant using the methodology 
at Sec.  414.1380(b)(4), except as provided at Sec.  
414.1365(d)(3)(iv)(A).
    We solicited public comments on this proposal.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter supported the proposed scoring for the 
Promoting Interoperability performance category and efforts to keep 
approaches as consistent as possible across MVPs and traditional MIPS.
    Response: We thank the commenter for their support.
    Comment: A few commenters recommended different scoring 
flexibilities for the Promoting Interoperability performance category 
for MVP Participants. Examples recommended include assigning all 
available points to any clinician who achieves 50 points or more, 
providing credit to clinicians who demonstrate meaningful use of EHRs 
in more innovative ways specific to the clinician's group composition, 
assigning points for infrastructure and experience with health 
information technology, allowing clinicians to attest to using 2015 
Edition CEHRT, and providing full credit for the Promoting 
Interoperability performance category for PCMH recognition.
    Response: As we established in the CY 2021 PFS final rule (85 FR 
84849 through 84853), we believe all MVPs should include the entire set 
of Promoting Interoperability measures, as part of the foundational 
layer of MVPs. We do not believe that MVPs should introduce complexity 
through special scoring rules such as assigning full points to any MVP 
Participant who achieves 50 or more points in the Promoting 
Interoperability performance category, and that scoring should be based 
on the methodology established for traditional MIPS. As stated 
previously (86 FR 39381) we believe that the current scoring 
methodology recognizes the importance of promoting adoption and use of 
CEHRT to support quality improvement, interoperability, health 
information exchange and patient engagement. In regard to reducing the 
requirements of the Promoting Interoperability performance category to 
an attestation to the use of 2015 Edition CEHRT or achieving PCMH 
recognition, we refer readers to our earlier discussion of establishing 
interoperability as a foundational element of MVPs and the importance 
of using a uniform set of measures that would apply to all clinicians, 
regardless of MVP, for whom the Promoting Interoperability performance 
category is required (84 FR 62948). We believe that merely requiring an 
attestation regarding the use of 2015 Edition CEHRT would not align 
with our desire to recognize differences in performance on Promoting 
Interoperability performance category measures.
    After consideration of public comments, we are finalizing at Sec.  
414.1365(d)(3)(iv) to calculate the Promoting Interoperability 
performance category score for an MVP Participant using the methodology 
at Sec.  414.1380(b)(4), except as provided at Sec.  
414.1365(d)(3)(iv)(A).
    We proposed at Sec.  414.1365(c)(4)(i)(A) to require subgroups to 
submit their affiliated group's data for the Promoting Interoperability 
performance category. We proposed at Sec.  414.1365(d)(3)(iv)(A) that 
if a subgroup does not submit its affiliated group's data for the 
Promoting Interoperability performance category, the subgroup will 
receive a score of zero for the Promoting Interoperability performance 
category.
    We solicited public comments on these proposals.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported our proposed scoring for 
Promoting Interoperability for MVP participants. One commenter 
recommended that CMS carry over numerous other scoring policies that 
keep approaches as consistent as possible across MVPs and traditional 
MIPS as we introduce subgroups.
    Response: We thank the commenters for their support. We will 
continue to review opportunities to align scoring between MVPs and 
MIPS.
    Comment: A few commenters did not support our proposal to require 
subgroups to submit their affiliated group's Promoting Interoperability 
data. One commenter indicated that groups may use multiple EHRs, and 
that if subgroups using a single EHR could report their own Promoting 
Interoperability performance category data, it would increase 
flexibilities in subgroup requirements. One commenter voiced concerns 
that non-patient facing clinicians would need to submit their 
affiliated group's Promoting Interoperability performance data, rather 
than have the Promoting Interoperability performance category 
reweighted. The commenter stated their preference to have the Promoting 
Interoperability performance category reweighted for non-patient-facing 
clinicians.
    Response: As described in the CY 2022 PFS proposed rule (86 FR 
39371), for MVPs, we proposed to require that each subgroup submit 
their affiliated group's data for the Promoting Interoperability 
performance category and receive a score based on that data because we 
heard from stakeholders that some clinicians would need additional time 
to resolve operational challenges to submit subgroup level data for the 
Promoting Interoperability performance category. We believe that, until 
MIPS eligible clinicians are able to resolve these operational 
challenges, the benefit of requiring subgroups to submit their 
affiliated group's data outweighs the benefit of any flexibility that 
can be

[[Page 65425]]

afforded from subgroups submitting their own Promoting Interoperability 
data, such as commenter's concern that groups may use multiple EHRs and 
subgroups using a single EHR could report their own Promoting 
Interoperability performance category data. In section 
IV.A.3.b.(5)(c)(i)(B) of this final rule, we finalized that a subgroup 
may receive reweighting independent of the affiliated group in certain 
circumstances, but non-patient facing status is not one of those 
circumstances. In section IV.A.3.b.(3)(c)(ii) of this final rule, we 
finalized that we determine special status (such as non-patient facing 
status) for a subgroup at the group level, not at the subgroup level.
    After consideration of public comments, we are finalizing at Sec.  
414.1365(c)(4)(i)(A) to require subgroups to submit their affiliated 
group's data for the Promoting Interoperability performance category 
and are also finalizing at Sec.  414.1365(d)(3)(iv)(A) that if a 
subgroup does not submit its affiliated group's data for the Promoting 
Interoperability performance category, the subgroup will receive a 
score of zero for the Promoting Interoperability performance category.
(v) Facility-Based Scoring
    We believe facility-based MIPS eligible clinicians and groups 
should have the same opportunities to submit MVPs as other MIPS 
eligible clinicians and groups. In the CY 2022 PFS proposed rule (86 FR 
39381), we proposed 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). In this case, we would use the highest final score 
according to our policies at Sec.  414.1380(e)(6)(vi).
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the policy to allow facility-
based scoring for MVP Participants, because the policy aligns with 
traditional MIPS policies and accommodates the complex nature of 
physicians' contracting and business agreements.
    Response: We appreciate the commenters' support.
    After consideration of public comments, we are finalizing the 
policy as proposed.
(c) Calculating the Final Score in MVPs
(i) Final Score Calculation
    In the CY 2022 PFS proposed rule (86 FR 39381), we proposed at 
Sec.  414.1365(e) that the final score is calculated for an MVP 
Participant using the same scoring methodology at Sec.  414.1380(c) 
unless otherwise indicated in Sec.  414.1365(e).
    We solicited public comment on the proposal.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter supported our approach to calculate the 
final score for an MVP Participant who is not an APM entity using the 
same methodology established for traditional MIPS.
    Response: We thank the commenter for their support.
    Comment: One commenter voiced concerns that scoring for subgroups 
might be confusing for some clinicians, in terms of understanding when 
the subgroup performance is scored versus when the affiliated group 
performance is scored for population health and Promoting 
Interoperability measures.
    Response: We have tried to use the same scoring methodology 
established in traditional MIPS where appropriate, with few 
differences. To ensure that subgroups can be scored on the foundational 
layers of the MVP, data from the affiliated group will be used for 
population health and Promoting Interoperability measures. We believe 
data from the group will be reflective of subgroup performance for the 
foundational layers of MVPs. The subgroup will be scored on the 
subgroup data for the cost performance category, improvement activities 
performance category and the quality performance category (except for 
the population health measure which will be assessed on the affiliated 
group data since that is part of the foundational layer). We will 
continue to provide future communication on how subgroups can 
participate in MVPs through routine communication channels, including 
but not limited to issuing emails and notices on the QPP website, 
qpp.cms.gov.
    After consideration of public comments, we are finalizing the 
proposal as proposed.
(A) General Performance Category Weights
    In the CY 2022 PFS proposed rule (86 FR 39381), we proposed at 
Sec.  414.1365(e)(1) to use the performance category weights 
established for traditional MIPS and described at Sec.  414.1380(c)(1) 
to calculate the final score for an MVP Participant that is not an APM 
Entity. We also proposed at Sec.  414.1365(e)(1) to use the performance 
category weights established for APM Entities and described at Sec.  
414.1317(b) to calculate the final score for an MVP Participant that is 
an APM Entity.
    We solicited public comments on these proposals and did not receive 
any.
    We are finalizing as proposed at Sec.  414.1365(e)(1) to use the 
performance category weights established for traditional MIPS and 
described at Sec.  414.1380(c)(1) to calculate the final score for an 
MVP Participant that is not an APM Entity. We are also finalizing as 
proposed at Sec.  414.1365(e)(1) to use the performance category 
weights established for APM Entities and described at Sec.  414.1317(b) 
to calculate the final score for an MVP Participant that is an APM 
Entity.
(B) Flexibility for Weighting Performance Categories
(aa) Reweighting Performance Categories for MVPs
    For MVP Participants, we proposed reweighting policies that 
generally align with our current policies for traditional MIPS with a 
few minor modifications (86 FR 39381). We proposed at Sec.  
414.1365(e)(2)(i) that for an MVP Participant that is not an APM 
Entity, a scoring weight different from the weights described at Sec.  
414.1380(c)(1) will be assigned to a performance category, and its 
weight as described at Sec.  414.1380(c)(1) will be redistributed to 
another performance category or categories, in the circumstances 
described at Sec. Sec.  414.1380(c)(2)(i)(A)(2) through (9), and 
414.1380(c)(2)(i)(C). As discussed in the CY 2022 PFS proposed rule, 
for MVP Participants, we do not believe there will be cases where no 
measures in the quality performance category are available and 
applicable and can be scored (86 FR 39381). Therefore, we stated that 
we do not believe the traditional MIPS policy for reweighting the 
quality performance category when no quality measures can be scored as 
specified at Sec.  414.1380(c)(2)(i)(A)(1) should be applicable to MVP 
Participants. We also proposed at Sec.  414.1365(e)(2)(i) that for an 
MVP Participant that is an APM Entity, the performance category weights 
will be redistributed in accordance with Sec.  414.1317(b).
    We proposed 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. In addition, we proposed at Sec.  
414.1365(e)(2)(ii) that if reweighting is not applied to the affiliated 
group, the subgroup may receive reweighting

[[Page 65426]]

independent of the affiliated group in the following circumstances, for 
the reasons discussed in the CY 2022 PFS proposed rule (86 FR 39381). 
We proposed at Sec.  414.1365(e)(2)(ii)(A) that a subgroup may submit 
an application to CMS demonstrating that it was subject to extreme and 
uncontrollable circumstances and receive reweighting in accordance with 
Sec.  414.1380(c)(2)(i)(A)(6) and (c)(2)(i)(C)(2). Under this proposal, 
we proposed that in the event that a subgroup submits data for a 
performance category, the scoring weight described at Sec.  
414.1380(c)(1) would be applied and its weight would not be 
redistributed. We also proposed at Sec.  414.1365(e)(2)(ii)(B) that a 
subgroup would receive reweighting if CMS determines, based on 
information known to the agency prior to the beginning of the relevant 
MIPS payment year, that data for the subgroup are inaccurate, unusable 
or otherwise compromised due to circumstances outside of the control of 
the subgroup and its agents, in accordance with Sec.  
414.1380(c)(2)(i)(A)(9) and (c)(2)(i)(C)(10).
    We requested public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters supported the use of the reweighting 
policies established in traditional MIPS for MVPs that are submitted by 
an MVP Participant that is not an APM Entity, including reweighting of 
the Promoting Interoperability performance category when applicable. 
One commenter recommended that CMS evaluate if automatic reweighting of 
performance categories unnecessarily and unfairly excludes clinicians, 
such as physical therapists from participating in MVPs.
    Response: We believe the reweighting policies allow all MVP 
Participants that have sufficient measures and activities applicable 
and available to be scored fairly on their performance. We do not 
believe that our reweighting policies exclude clinicians from 
participating in MVPs. Rather, the reweighting policies allow 
clinicians to receive reweighting if they are impacted by a qualifying 
extreme and uncontrollable event and do not submit data.
    Comment: One commenter supported the reweighting policy to not 
reweight the quality performance category in MVPs because no quality 
measures can be scored.
    Response: We thank the commenter for their support.
    After consideration of public comments, we are finalizing these 
proposals and the regulation text at Sec.  414.1365(e)(2) as proposed.
(C) Redistributing Performance Category Weights
    In the CY 2022 PFS proposed rule (39381 through 39382), we proposed 
to redistribute the performance category weights for MVPs in accordance 
with the redistribution policies we proposed for traditional MIPS in 
the CY 2022 PFS proposed rule (86 FR 39448). We proposed at Sec.  
414.1365(e)(2)(iii) that for an MVP Participant that is not an APM 
Entity, a scoring weight different from the weights described at Sec.  
414.1380(c)(1) will be assigned to a performance category, and its 
weight as described at Sec.  414.1380(c)(1) will be redistributed to 
another performance category or categories, in accordance with Sec.  
414.1380(c)(2)(ii). We also proposed at Sec.  414.1365(e)(2)(iii) that 
for an MVP Participant that is an APM Entity, the performance category 
weights will be redistributed in accordance with Sec.  414.1317(b).
    We solicited public comments on these proposals.
    We did not receive public comments on these proposals. We are 
finalizing these proposals and the regulation text at Sec.  
414.1365(e)(2)(iii) as proposed.
(D) Complex Patient Bonus
    We refer the reader to Sec.  414.1380(c)(3) and to the proposed 
rule (86 FR 39439 through 39446) for our previously established and 
proposed policies on applying a complex patient bonus. In the CY 2022 
PFS proposed rule (86 FR 39382), we proposed at Sec.  414.1365(e)(4) to 
add a complex patient bonus to the final score for an MVP Participant 
in accordance with Sec.  414.1380(c)(3).
    We solicited public comments on this proposal.
    Comment: One commenter supported the use of the traditional MIPS 
complex patient bonus scoring policies for MVPs.
    Response: We thank the commenter for their support.
    After consideration of public comments, we are finalizing as 
proposed at Sec.  414.1365(e)(4) to add a complex patient bonus to the 
final score for an MVP Participant in accordance with Sec.  
414.1380(c)(3).
    We refer readers to the CY 2022 PFS proposed rule (86 FR 39382) for 
an example of the final score calculation for MVPs.
(d) Enhanced Performance Feedback in MVPs
(i) Background
    In the CY 2018 Quality Payment Program final rule (82 FR 53799 
through 53801), we finalized that under section 1848(q)(12)(A)(i) of 
the Act, on an annual basis, we will provide confidential feedback to 
MIPS eligible clinicians and groups on their performance. Currently, in 
traditional MIPS, clinicians are not required to submit data throughout 
the performance period. Instead, data is submitted through the 
submission period that follows the performance period, as described at 
Sec.  414.1325(e). In addition, current performance feedback includes 
measure-level performance data and scores, activity-level scores, and 
category comparison.
    In the CY 2020 PFS final rule, we indicated a commitment to the 
transformation of MIPS to allow for streamlined, cohesive reporting 
through MVPs that would result in enhanced and timely feedback (84 FR 
62945). Through previous rulemaking cycles, we have heard from 
stakeholders that clinicians are interested in receiving feedback 
reports from CMS throughout the year rather than annually to allow 
clinicians to review and make improvements where appropriate. Other 
stakeholders have expressed interest in receiving feedback which 
includes comparative data to other practices of similar size, location, 
and specialty. Stakeholders have indicated this is also key to put 
performance in perspective, particularly if performance evaluation and 
payment adjustments are contingent on the performance of other 
clinicians (84 FR 63057 through 63058).
(ii) Enhanced Performance Feedback in MVPs
    In the CY 2022 PFS proposed rule, we explained that we considered 
two options for providing enhanced performance feedback (86 FR 39383). 
The first option is to provide comparative performance feedback, 
comparing the performance of like clinicians who report on the same 
MVP, which provides more granular comparison than is currently 
available. The second option is to provide performance feedback during 
the performance period to provide more timely and actionable feedback, 
but require clinicians to submit earlier. This option may require a 
significant investment of resources, including both time and money for 
CMS, third party intermediaries, and clinicians.
    Therefore, beginning with the CY 2023 performance period/CY 2025 
MIPS payment year, we proposed the first option described--to include 
comparative performance feedback within the annual performance feedback 
we provide for MVP Participants, comparing the performance of similar 
clinicians who report on the same MVP.

[[Page 65427]]

The comparative feedback would only be available to those who report on 
MVPs and will be incorporated into the annual performance feedback that 
we currently provide in traditional MIPS.
    We solicited public comments on this proposal.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the proposal to provide 
comparative feedback to clinicians who submit MVPs.
    Response: We thank commenters for the support.
    Comment: A few commenters had concerns that it is premature to 
offer feedback to clinicians on performance on MVPs, because MVPs are 
still under development, clinicians are still gaining experience with 
the use of population and cost measures and may not benefit from 
enhanced feedback. Commenters indicated that clinicians also have the 
burden of transitioning to digital quality measures (dQMs) and will not 
have resources to receive and understand enhanced performance feedback.
    Response: We believe that MVPs provide an opportunity for enhanced 
feedback for MVP Participants, because MVPs allow for comparison to 
other MVP Participants who submitted the same MVP. We plan to provide 
enhanced feedback to MVP Participants beginning with the first 
performance period the MVP participation option is available (CY 2023 
performance period/CY 2025 MIPS payment year). We do not believe it is 
premature to offer feedback after an MVP is submitted, particularly as 
the information is provided to the MVP participant only and is not 
publicly reported. As clinicians begin to adopt MVPs we will provide 
feedback in as timely a manner as possible and we anticipate that 
feedback reports will help clinicians become familiar with population 
health and cost measure data, as well as the other elements of the MVP. 
We acknowledge the concern that clinicians will be transitioning to 
dQMs, and while it is not required that clinicians review and use the 
feedback on MVPs, we continue to believe that feedback on MVPs will be 
a valuable source of information regarding performance. The comparative 
performance data from MVPs on connected measures and activities may 
help MVP Participants target potential gaps in care related to the MVP 
and focus needed changes in clinical workflow to address care gaps.
    Comment: A few commenters wanted clarification on whether all 
clinicians that participate in the MVP would be compared to all 
clinicians who submitted the MVP, or if neurologists who participate in 
a stroke care MVP would be compared to other neurologists in the MVP.
    Response: We will provide comparative feedback on performance of 
clinicians within a group or subgroup submitting an MVP to all other 
clinicians who reported the same MVP, which provides more granular 
comparison than is currently available under traditional MIPS. However, 
we do not plan to provide comparative feedback that is specialty 
specific for MVP Participants.
    After consideration of public comments, we are finalizing our 
policy that beginning with the CY 2023 performance period/CY 2025 MIPS 
payment year, we will include comparative performance feedback within 
the annual performance feedback we provide for MVP Participants, 
comparing the performance of similar clinicians who report on the same 
MVP. The comparative feedback will only be available to those who 
report on MVPs and will be incorporated into the annual performance 
feedback that we currently provide in traditional MIPS.
(iii) Request for Information for Future Consideration
    As described in the CY 2020 PFS proposed rule (84 FFR 40733 through 
40734), stakeholders have requested that they be provided with 
actionable feedback. To gain a better understanding, we solicited 
comments from stakeholders to elaborate on what they consider to be 
``actionable''. Would this include CMS identifying in the annual 
performance feedback areas of improvement based on how a clinician 
scores on a measure? Is there unintended burden to stakeholders such as 
third party intermediaries and EHR vendors associated with receiving 
``actionable'' feedback? For example, this could include financial 
burden from system changes or operational burden on changes to 
workflows.
    We thank commenters for the feedback received through this request 
for information. We may consider this information to inform future 
rulemaking.
b. APM Performance Pathway
(1) Overview
    In the CY 2021 PFS final rule (85 FR 84859), we finalized the APM 
Performance Pathway (APP), which was designed to provide a predictable 
and consistent MIPS reporting option to reduce reporting burden and 
encourage continued APM participation. The APP is available for 
reporting by any submitter type, with the exception of Virtual Groups.
(2) MIPS Performance Category Scoring
(a) Quality Performance Category
    In the CY 2021 PFS final rule, we finalized our proposal to use the 
measures listed in Table 50 for purposes of quality performance 
category scoring for the APP.
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    In the CY 2021 PFS final rule, we finalized the inclusion of the 
CMS Web Interface as an option for Shared Savings Program ACOs to 
report quality for the 2021 performance period only, and this quality 
reporting option would no longer be available beginning with the CY 
2022 performance period. However, as we explained in the CY 2022 PFS 
proposed rule (86 FR 39384), since the CY 2021 PFS final rule, we have 
received stakeholder feedback that the transition away from reporting 
the CMS Web Interface measures to the reporting of eCQMs/MIPS CQMs is 
more technologically difficult for some ACOs than originally 
anticipated, particularly under the extraordinary circumstances of the 
PHE for COVID-19. In light of this feedback, we proposed to extend the 
CMS Web Interface as a means of reporting quality under the APP for 
Shared Savings Program ACOs for performance years 2022 and 2023.
    Under this proposal, for performance year 2022, Web Interface 
reporting would work in the same manner as for performance year 2021, 
where ACOs would have the option of reporting either the CMS Web 
Interface, the APP eCQM/MIPS CQM measure set, or both.
    In addition, we proposed that for the 2023 performance year, we 
would score

[[Page 65429]]

Web Interface submissions only for ACOs that have also submitted at 
least one eCQM/MIPS CQM measure from the APP measure set. While we 
stated in the proposed rule that we understand that there may be 
barriers to ACOs transitioning away from the CMS Web Interface along 
the timeline originally contemplated, we further explained that we 
believe it is important to continue to encourage and incent that 
transition. By extending the CMS Web Interface for the 2022 and 2023 
performance years, as proposed, we would give ACOs additional time to 
familiarize themselves with the eCQM/MIPS CQM measures and the data 
aggregation and submission processes. However, we also stated our 
belief that by proposing to limit the continued use of the CMS Web 
Interface in the 2023 performance year only to those ACOs that also 
attempt an eCQM/MIPS CQM submission, we would continue to move these 
ACOs and their ACO participants towards CMS' goal of more complete and 
uniform reporting requirements for all MIPS participants.
    In the proposed rule, we noted that for both performance year 2022 
and performance year 2023, ACOs would continue to have the opportunity 
to report on both the eCQMs/MIPS CQMs and the CMS Web Interface 
measures, and to have their MIPS quality performance category score 
based on the submission that receives a higher score. We stated our 
belief that these proposed policies would help to encourage ACOs to 
move towards eCQM/MIPS CQM reporting in a low-risk environment where 
they will have the opportunity to continue to rely on measures reported 
through the CMS Web Interface for purposes of quality performance 
scoring as they become familiar with the eCQM/MIPS CQM submission and 
scoring process.
    We solicited comments on these proposals.
    Comment: Many commenters supported our proposal to extend the CMS 
Web Interface reporting option for Shared Savings Program ACOs during 
the 2022 and 2023 performance years.
    Response: We thank commenters for their support. We agree that 
given the complexity of the shift from the selective beneficiary 
sampling method of the CMS Web Interface to the use of all-patient data 
for reporting eCQM/MIPS CQMs, it is prudent to ensure that ACOs, their 
ACO participants, and vendors have sufficient time to implement the 
technology and workflows necessary to make this transition a success.
    Comment: Some commenters supported the extension of the use of the 
Web Interface for Shared Savings Program ACOs, but believed that 
requiring reporting on at least one eCQM/MIPS CQM in 2023 as a 
prerequisite to scoring those Web Interface measures created the same 
level of burden as fully transitioning to eCQM/MIPS CQMs in that year. 
They recommended that the proposed requirement that ACOs report a 
minimum of one eCQM/MIPS CQM in 2023 should not be implemented.
    Response: We understand commenters to mean that they believe that 
the majority of the burden is in developing the technical capabilities 
to report on these measures, and not in the data collection and 
reporting itself. Therefore, by including this requirement in 
performance year 2023, we would be imposing a deadline to have 
completed the transition to the new reporting framework before 
stakeholders believe they would be ready.
    In light of these concerns, we are not finalizing our proposal to 
require a single eCQM measure to be reported in 2023 in order to be 
eligible for Web Interface scoring. Instead, we are finalizing at 
policy to continue the 2021 policy including use of the CMS Web 
Interface for Shared Savings Program ACOs into MIPS performance years 
2022 and 2023. In addition, in response to comments received on our 
comment solicitation in the CY 2022 PFS proposed rule (86 FR 39269), we 
are also extending the use of the CMS Web Interface as a reporting 
option under the APP into MIPS performance year 2024.
    For the CY 2021 MIPS performance period, we limited the use of the 
Risk-standardized, All-cause Unplanned Admissions for Multiple Chronic 
Conditions for ACOs (MCC for ACOs) measure to ACOs because, at that 
time, we were still investigating the question of whether it would be 
appropriate to include the Risk-standardized, All-cause Unplanned 
Admissions of Multiple Chronic Conditions for MIPS (MCC for MIPS) 
measure in the generally applicable MIPS quality measure set. However, 
in the CY 2022 PFS proposed rule (86 FR 39385), we proposed to add the 
MCC for MIPS measure into the MIPS quality measure set beginning with 
the CY 2022 MIPS performance period, as discussed in Appendix 1 of this 
final rule.
    We also proposed to replace the MCC for ACOs measure with the MCC 
for MIPS measure within the APP beginning with the 2022 MIPS 
performance period. We explained that this change would continue our 
transition towards alignment of quality measure data reported by MIPS 
eligible clinicians who are not participants in APMs and those who are, 
as discussed in the CY 2021 PFS final rule (85 FR 84859). We stated our 
belief that the MCC for MIPS measure is a valuable tool in assessing 
quality performance, with no additional reporting burden, and is 
therefore an asset to the APP measure set as well. By replacing the MCC 
for ACOs measure with the MCC for MIPS measure, we would have the 
opportunity to capture performance on this measure for additional MIPS 
eligible clinicians who are not participants in ACO-based APMs.
    We also stated our belief that it is important to remove the MCC 
for ACOs measure from the APP in order to reduce the potential for 
confusion around performance scores and feedback for MIPS eligible 
clinicians who might otherwise have been scored on both measures with 
differing results.
    We solicited comments on our proposal to include the measures 
listed in Table 40 of the proposed rule (86 FR 39386) in the quality 
measure set for the APP for the 2022 MIPS performance period.
    The following is a summary of the comments we received on the 
proposed APP quality measure set and our responses.
    Comment: One commenter noted that it is also important to consider 
smaller groups and individual MIPS eligible clinicians who may not meet 
the case minimums or who are unfamiliar with the measures in early 
years and stressed that flexibility for these providers will be 
important.
    Response: We recognize that smaller groups may not meet case 
minimums to report on this measure, but reiterate that in such a case, 
the group would have the measure excluded from its total measure 
achievement points and total available measure achievement points in 
accordance with Sec.  414.1367(c)(1)(i), and would not be negatively 
affected by the inability to score this measure. We also reiterate that 
APM participants are no longer required to be scored for purposes of 
MIPS as part of their APM, but may report using any MIPS measures or 
pathways that would otherwise be available to them. It is our intention 
that these policies will provide all MIPS eligible clinicians with 
flexibility to report on the measures that are most relevant to their 
specific practice.
    Comment: A few commenters raised questions about the proposed 
change from the MCC for ACOs measure to the MCC for MIPS measure. 
Commenters noted the difference in patient population between the MCC 
for ACOs measure, which relies on data for

[[Page 65430]]

Medicare beneficiaries assigned to the ACO, to the MCC for MIPS 
measure, which uses all Medicare beneficiary data and requested that 
CMS reconsider the use of the MCC for MIPS measure in scoring ACOs.
    Response: We recognize that there is a difference in the patient 
population used to calculate the MCC for MIPS measure relative to the 
patient population for the MCC for ACOs measure. Like all other quality 
measures in the MIPS program (with the exception of the CMS Web 
Interface, claims, and administrative claims measures), the MCC for 
MIPS is a measure intended to capture reporting on all patients seen by 
the eligible clinicians being scored. The goal of this transition 
towards all-beneficiary and all-payer data is to produce a more 
comprehensive picture of the care being provided by the eligible 
clinicians participating in ACOs to all Medicare beneficiaries and 
patients within their care. This way, beneficiaries will be better 
positioned to compare performance of various clinicians and empowered 
to make better choices for their own health care.
    Therefore, we are finalizing our proposal to add the MCC for MIPS 
measure to the APP measure set, and to remove the MCC for ACOs measure.
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d. MIPS Performance Category Measures and Activities
(1) Quality Performance Category
(a) Background
    We refer readers to Sec. Sec.  414.1330 through 414.1340 and the CY 
2018 Quality Payment Program final rule (82 FR 53626 through 53641) for 
our previously established policies regarding the quality performance 
category.
    In the proposed rule, we proposed to:
     Maintain the data completeness criteria threshold of at 
least 70 percent for CY 2021 and CY 2022 performance periods/2023 and 
2024 MIPS payment years, and increase the data completeness criteria 
threshold to at least 80 percent for the CY 2023 performance period/
2025 MIPS payment year.
     Extend the availability of the CMS Web Interface as a 
collection and submission type for the CY 2022 performance period/2024 
MIPS payment year.
     Make changes to the MIPS quality measure set as described 
in Appendix 1 of this final rule, including addition of new measures, 
updates to specialty sets,

[[Page 65432]]

removal of existing measures, and substantive changes to existing 
measures.
     Establish criteria for determining whether a measure 
change is considered substantive starting with the CY 2022 performance 
period.
     Beginning with the CY 2021 performance period/2023 MIPS 
payment year CAHPS for MIPS survey, Medicare Shared Savings Program 
(Shared Savings Program) Accountable Care Organizations (ACOs) are 
required to administer the CAHPS for MIPS Survey and report via the 
Alternative Payment Model (APM) Performance Pathway (APP). We proposed 
refinements to our policies for administration of the CAHPS for MIPS 
survey to align with certain policies that previously applied to the 
CAHPS for ACOs survey.
(b) Data Submission Criteria
(i) Submission Criteria for Quality Measures Excluding the CMS Web 
Interface and CAHPS for MIPS
    In the CY 2017 Quality Payment Program final rule, we established 
the submission criteria for quality measures (excluding the CMS Web 
Interface measures and the CAHPS for MIPS survey measure) at Sec.  
414.1335, which requires a MIPS eligible clinician, group, or virtual 
group that is reporting on Qualified Clinical Data Registry (QCDR) 
measures, MIPS clinical quality measures (MIPS CQMs), electronic CQMs 
(eCQMs), or Medicare Part B claims measures to submit data on at least 
6 measures, including at least 1 outcome measure (81 FR 77100 through 
77114). If an applicable outcome measure is not available, then a MIPS 
individual eligible clinician, group, or virtual group will report on 1 
other high priority measure. If there are fewer than 6 measures that 
apply to a MIPS eligible clinician, group, or virtual group, then 
reporting on each applicable measure is required. For MIPS eligible 
clinicians, groups, and virtual groups that report on a specialty or 
subspecialty measure set (as designated in the MIPS final list of 
quality measures established by CMS through rulemaking), they are 
required to submit data on at least 6 measures within the set, 
including at least 1 outcome measure. If an applicable outcome measure 
is not available, then a MIPS individual eligible clinician, group, or 
virtual group will report on 1 other high priority measure. If a 
specialty or subspecialty measure set contains fewer than 6 measures or 
if fewer than 6 measures within the measure set apply to a MIPS 
eligible clinician, group, or virtual group, then reporting on each 
applicable measure is required. In addition to the assessment of 
performance based on submitted data for at least 6 measures (all 
measures if there are fewer than 6 measures that are applicable), 
performance is also assessed on administrative claims measures. CMS 
automatically evaluates and calculates administrative claims measures 
for individual MIPS eligible clinicians, groups, and virtual groups if 
the case minimum requirement of the measure is met.
    We noted in the CY 2022 PFS proposed rule that, with each year of 
program implementation, we continue to assess means for creating a more 
cohesive and meaningful participation experience in MIPS that improves 
value and reduces clinician burden. As the program evolves, we want to 
enable a seamless transition from participation in traditional MIPS to 
the preliminary onset of voluntary participation in MVPs to the 
required participation in MVPs. Transitioning from traditional MIPS to 
MVPs improves the participation experience of MIPS by having the 
program be more relevant to a clinician's scope of practice and 
meaningful to patient care. One element that we assessed in preparation 
for the transition from traditional MIPS to MVPs regards the 
utilization of outcomes-based administrative claims measures to reduce 
the reporting burden under MIPS, particularly the allowance of outcome-
based administrative claims measures to be applied as the required 
outcome measure requirement under traditional MIPS (in general, 6 
measures, including 1 outcome measure) and MVPs (in general, 4 measures 
as outlined in section IV.A.3.b.(4)(d)(ii) of this final rule).
    In the CY 2022 PFS proposed rule, we noted that since the inception 
of MIPS under the Quality Payment Program, we established 
administrative claims measures that are automatically evaluated and 
calculated for individual MIPS eligible clinicians, groups, and virtual 
groups if the case minimum requirement of the measure is met (81 FR 
77130 through 77136). The reporting burden is reduced for individual 
MIPS eligible clinicians, groups, and virtual groups when CMS conducts 
the assessment and calculations of administrative claims measures (81 
FR 77134). A subset of the administrative claims measures are outcome-
based measures (and in some cases, are also population health 
measures), which focus on the improvement of patient health outcomes. 
We want to further reduce the reporting burden by allowing outcome-
based measures (not applicable to administrative claims measures that 
are considered population health measures) to fulfill the outcome 
measure requirement as more of such measures are implemented in MIPS, 
when applicable. For the CY 2022 performance period/2024 MIPS payment 
year, we proposed the following outcome-based administrative claims 
measure under MIPS: Risk-Standardized Acute Unplanned Cardiovascular-
Related Admission Rates for Patients with Heart Failure for the Merit-
based Incentive Payment System (see Table Group A of Appendix 1 of this 
final rule).
    In the CY 2022 PFS proposed rule, we proposed at Sec.  
414.1365(c)(1) to allow an administrative claims measure that is 
outcome-based (not applicable to administrative claims measures that 
are population health measures), if applicable, to be selected at the 
time of MVP registration as a measure to meet the outcome measure 
requirement starting with the CY 2023 performance period/2025 MIPS 
payment year. The outcomes-based administrative claims measure would be 
applicable and relevant to the specific MVP, and as a result, included 
as 1 of the measures available within an MVP. If an outcomes-based 
administrative claims measure was selected during the MVP registration 
process, the measure will meet the outcome-based measure reporting 
requirement and count as 1 of the 4 minimum required measures if the 
MVP Participant meet the case minimum requirement for the 
administrative claims measure; otherwise, the administrative claims 
measure would receive a score of zero points and the MVP Participant 
would not meet the minimum reporting requirement of 4 measures. 
However, if the MVP Participant selects an outcomes-based 
administrative claims measure available within the MVP and report on 4 
measures, the MVP Participant would meet the minimum reporting 
requirement of 4 measures if it was determined that the case minimum 
requirement for the outcomes-based administrative claims measure was 
not met. We believe that such approach reduces reporting burden and 
allows for a more cohesive and meaningful participation experience that 
focuses on measures that are more relevant to a clinician's scope of 
practice while preventing gaming/misuse of selecting an outcomes-based 
administrative claims measures to be assessed and scored on for 
purposes of MVP participation.
    As stated in the CY 2022 PFS proposed rule, we analyzed the 
allowance and utilization of outcome-based administrative claims 
measures

[[Page 65433]]

(not applicable to administrative claims measures that are population 
health measures) to be applied to fulfill the outcome measure 
requirement within traditional MIPS, it became apparent that the 
implementation of such a policy would pose challenges and obstacles. We 
assessed 3 options. For the first option, we assessed the potential 
implementation of outcomes-based administrative claims measures to 
fulfill the outcome requirement utilizing a registration system, 
similar to the proposal for MVPs. For traditional MIPS, a registration 
process would require the individual MIPS eligible clinicians, groups, 
and virtual groups to elect to have an outcomes-based administrative 
claims measure be calculated and scored to fulfill the outcome measure 
requirement as part of the 6 minimum required measures. Prior to an 
individual MIPS eligible clinician, group, or virtual group making such 
an election via a registration process, it would be imperative for a 
registration process to only permit an individual MIPS eligible 
clinician, group, or virtual group to register if eligible (meets case 
minimum requirement) for an outcome-based administrative claims measure 
(not applicable to administrative claims measures that are population 
health measures) to be calculated and scored. Such registration process 
would need to be able to identify which individual MIPS eligible 
clinicians, groups, and virtual groups would be eligible for an 
outcome-based administrative claims measure to fulfill the outcome 
measure requirement as part of the required minimum of 6 measures, 
which would prevent the potential for gaming and enable individual MIPS 
eligible clinicians, groups, and virtual groups to know in advance of 
the submission period if they would need to report on a minimum of 5 
measures instead of a minimum of 6 measures; we believe that this 
approach would reduce burden.
    In addition, for cases in which the case minimum of the outcomes-
based administrative claims measure would not be met, and therefore, 
could not be calculated, we have considered whether the denominator 
should be reduced and performance assessment and scoring would be based 
on 5 measures instead of 6 measures (or less measures if, initially, 
there were fewer than 6 applicable measures or fewer than 6 measures 
available within a measure set), which would reduce the reporting 
burden under traditional MIPS. However, we recognize that if our 
policy--an election process, via a registration system, to have an 
outcome-based administrative claims measure as 1 of the required 
minimum of 6 measures--includes an element for a denominator reduction, 
we believe that our policy would pose the potential risk for gaming. We 
would want to prevent the potential for gaming--knowingly selecting an 
outcome-based administrative claims measures during registration that 
is not applicable to a practice or specialty, which would result in not 
meeting the case minimum requirement to be calculated and scored on 
such measure, and thus, having performance assessed on 5 measures 
instead of 6 measures (or less measures if, initially, there were fewer 
than 6 applicable measures or fewer than 6 measures available within a 
measure set).
    As we assessed such approach, we believed that there would not be 
sufficient parameters/safeguards to ensure that only individual MIPS 
eligible clinicians, groups, and virtual groups eligible for an 
outcome-based administrative claims measure calculation would be able 
to register. We would seek to prevent the potential for gaming by 
minimizing the number of individual MIPS eligible clinicians, groups, 
and virtual groups not eligible for an outcome-based administrative 
claims measure calculation to make such election. However, as we 
conducted our assessment, we determined that it would not be 
technically possible to develop a registration system based on 
applicable outcomes based administrative claims measure data for the 
applicable performance period to identify if a MIPS eligible clinician, 
group, or virtual group is eligible for an outcome-based administrative 
claims measure calculation given that such data would not be readily 
available until several months after the end of an applicable MIPS 
performance period. Without having an ability to identify MIPS eligible 
clinicians, groups, and virtual groups eligible for an outcome-based 
administrative claims measure calculation for registration purposes 
based on data from the applicable performance period in order to 
prevent gaming, we believed that the implementation of a policy to 
allow for an outcome-based administrative claims measure to be applied 
as 1 of the minimum required 6 measures would pose risk to the 
integrity of the program. For the second option, we assessed the 
potential for automatically calculating an outcome-based administrative 
claims measure, if applicable, for individual MIPS eligible clinicians, 
groups, and virtual groups participating in traditional MIPS. For the 
implementation of such a policy, we would use the status quo of 
requiring the submission of the minimum of 6 measures (or less measures 
if fewer than 6 measures were applicable or fewer than 6 measures were 
available within a measure set) (81 FR 77100 through 77114) in addition 
to automatically calculating an applicable outcome-based administrative 
claims measure. We would calculate a score for a total of 7 measures (6 
required measures and outcome-based administrative claims measure), but 
performance for the quality performance category would be based on 6 
measures with the highest score, which would include an outcome-based 
measure.
    For option 2, we would not be reducing the reporting burden given 
that the reporting requirements would remain as status quo, but instead 
of us applying all administrative claims to all MIPS eligible 
clinicians as an addition to their quality performance category 
denominator, we would be replacing the outcome measure requirement, 
with an available outcomes-based administrative claims measure, if it 
can be applied. Under this approach, we would not be able to 
objectively decipher the intent of a MIPS eligible clinician, group, or 
virtual group (without a formal process to signify an election) as to 
whether or not they would want to have the outcome-based administrative 
claims measure automatically calculated and applied as 1 of the 6 
minimum required measures. To not objectively know the intension of a 
MIPS eligible clinician, group, or virtual group, the following 
scenario could arise under option 2. For example, a MIPS eligible 
clinician, group, or virtual group submitted 5 measures, it is unclear 
if it was intentional to only submit 5 measures with the expectation 
that the MIPS eligible clinician, group, or virtual group sought to be 
evaluated on the outcomes-based administrative claims measure or if the 
submission of 5 measures was a result of a MIPS eligible clinician, 
group, or virtual group of not meeting the minimum of 6 required 
measures and thus, receive zero points for 1 of the 6 required 
measures.
    After assessing the first 2 aforementioned options, we assessed a 
third option that would address concerns regarding the first 2 options. 
For option 3, we assessed the utilization of historical data (for 
example, previous MIPS performance period data) given that applicable 
performance period data would not be readily available to be included 
as part of a registration process. The use of historical data for an 
outcome-based administrative claims measure as the means for 
eligibility

[[Page 65434]]

determinations within a registration system would only permit 
individual MIPS eligible clinicians, groups, and virtual groups 
identified as eligible for the calculation of an outcome-based 
administrative claims measure. Such option would allow an individual 
MIPS eligible clinician, group, or virtual group to select the 
application of an outcome-based administrative claims measure during a 
registration process, which would allow CMS to identify the individual 
MIPS eligible clinicians, groups, and virtual groups electing to have 
such measure applied as 1 of the minimum-required 6 measures that meets 
the outcome-based measure requirement. We believe that historical data 
would be able to adequately and reliably identify individual MIPS 
eligible clinicians, groups, and virtual groups eligible for an 
outcome-based administrative claims measure calculation, which we 
anticipate could be available during the applicable MIPS performance 
period, as technically feasible. We believe that by providing this 
historical information to individual MIPS eligible clinicians, groups, 
and virtual groups would provide pertinent information to make a 
determine if they would be selecting an outcome-based administrative 
claims measure during a registration process to be applied as 1 of the 
minimum-required 6 measures. We believe this approach could minimize 
gaming and individual MIPS eligible clinicians, groups, and virtual 
groups would know that they would need to select a minimum of 5 
(instead of 6) other measures to meet the reporting requirements for 
the quality performance category. The potential drawback to this option 
is it would only be available for individual MIPS eligible clinicians, 
groups, and virtual groups who participated in MIPS for a prior 
performance period, so not all clinicians would benefit under this 
option. However, if technically feasible, the utilization of historical 
data from the outcome-based administrative claims measure would be able 
to reduce the reporting burden and would align with the similar 
proposed process for MVPs. Although we did not make a proposal for the 
implementation of such policy, we requested feedback from stakeholders 
regarding how the automatic calculation of an outcome-based 
administrative claims measure and have it applied as 1 of the minimum 6 
required measures, particularly the outcome-based measure requirement, 
and if such option is a policy that would be advantage for them as they 
participate in traditional MIPS. We actively seek the engagement of our 
stakeholders as we assess means for reducing the reporting burden and 
enhance the experience of participating in traditional MIPS.
    Thus, we solicited public comment on the means for being able to 
implement such a policy. Are there other options that we should 
consider in determining how to implement such a policy? Are there other 
ways we would be able to identify which individual MIPS eligible 
clinicians, groups, and virtual groups are eligible for an outcomes-
based administrative measure calculation to ensure that only those that 
are eligible are able make such an election? Should we consider the use 
of historical data that would allow the predetermination and 
identification of MIPS eligible clinicians, groups, and virtual groups 
eligible for an outcome-based administrative claims measure? How would 
we be able to determine if a MIPS eligible clinician, group, or virtual 
group would like to have an automatic calculation of an outcome-based 
administrative claims measure conducted on their behalf outside of a 
registration process? Are there other challenges that we should be 
aware of as we continue to assess a means for developing and 
implementing such a policy?
    We thank commenters for the feedback received. The information 
provided may inform future rulemaking.
(c) Data Completeness Criteria
(i) CY 2021 Performance Period (2023 MIPS Payment Year)
    In the CY 2020 PFS final rule, we established the data completeness 
criteria at Sec.  414.1340(a)(3) and (b)(3) for the CY 2020 performance 
period/2022 MIPS payment year, which determined that MIPS eligible 
clinicians and groups submitting quality measures data on QCDR 
measures, MIPS CQMs, eCQMs, or Medicare Part B claims measures must 
submit data on at least a 70 percent of the MIPS eligible clinician or 
group's patients that meet the measure's denominator criteria, 
regardless of payer. In regard to the data completeness criteria 
established for Medicare Part B claims measures for the CY 2020 
performance period/2022 MIPS payment year, we found that the policy 
established at Sec.  414.1340(b)(3) erroneously reflected the data 
completeness criteria only applicable to QCDR measures, MIPS CQMs, and 
eCQMs, which requires data submission to pertain to patients that meet 
the measure's denominator criteria, regardless of payer (all-payer). It 
is not possible for Medicare Part B claims data to include all-payer 
patients; the submission of data for Medicare Part B claims measures 
can only account for Medicare Part B patients. Since the implementation 
of MIPS, the data completeness criteria for Medicare Part B claims 
measures has pertained to the applicable Medicare Part B patients seen 
during an applicable MIPS performance period. The issue with the policy 
established at Sec.  414.1340(b)(3) in the CY 2020 PFS final rule for 
Medicare Part B claims measures only pertains to the type of patient 
population for data submission purposes and not the threshold 
established for data completeness of at least 70 percent. Thus, we 
proposed to modify the data completeness threshold criteria established 
at Sec.  414.1340(b)(3) for the CY 2020 performance period/2022 MIPS 
payment year retroactively, effective January 1, 2020, in accordance 
with section 1871(e)(1)(A)(ii) of the Act. We believe that failure to 
apply the change retroactively will be contrary to the public interest 
because it will require individual eligible clinicians, groups, and 
virtual groups to meet data completeness criteria (the submission of 
patient data for all-payers) for Medicare Part B claims measures that 
is not possible. We believe that it is imperative for individual 
eligible clinicians, groups, and virtual groups to be certain as to the 
true criteria used to measure data completeness for Medicare Part B 
claims measures. For the CY 2021 performance period/2023 MIPS payment 
year, we proposed to modify the data completeness criteria established 
at Sec.  414.1340(b)(3) to be as follows: MIPS eligible clinicians and 
groups submitting quality measures data on Medicare Part B claims 
measures must submit data on at least 70 percent of the applicable 
Medicare Part B patients seen during the performance period to which 
the measure applies for MIPS payment year 2022.
    In the CY 2021 PFS proposed and final rules, we inadvertently 
omitted a proposal that would have otherwise extended our existing 
policy to determine the data completeness criteria for the CY 2021 
performance period/2023 MIPS payment year; we only included a reference 
to the data completeness criteria of at least 70 percent for the CY 
2021 performance period/2023 MIPS payment year as it relates to the 
scoring policies for class 1 measures as outlined in Table 49 of the CY 
2021 PFS proposed and final rules (85 FR 50309 and 85 FR 84906). Thus, 
in the CY 2022 PFS proposed rule, we proposed to establish the data 
completeness criteria for the CY 2021 performance period/2023 MIPS

[[Page 65435]]

payment year retroactively, effective January 1, 2021, in accordance 
with section 1871(e)(1)(A)(ii) of the Act (86 FR 39390). We noted our 
belief that failure to apply the change retroactively will be contrary 
to the public interest because it could be construed as permitting the 
submission of incomplete, inaccurate, or otherwise comprised data, 
which would have a detrimental effect on the performance data used for 
calculating MIPS payment adjustments and public reporting. For the CY 
2021 performance period/2023 MIPS payment year, we proposed at Sec.  
414.1340(a)(3) to maintain the data completeness criteria threshold of 
at least 70 percent, in which MIPS eligible clinicians and groups 
submitting quality measures data on QCDR measures, MIPS CQMs, or eCQMs 
will need to submit data on at least a 70 percent of the MIPS eligible 
clinician or group's patients that meet the measure's denominator 
criteria, regardless of payer; and at Sec.  414.1340(b)(3) to establish 
the data completeness criteria threshold of at least 70 percent, in 
which MIPS eligible clinicians and groups submitting quality measures 
data on Medicare Part B claims measures must submit data on at least 70 
percent of the applicable Medicare Part B patients seen during the CY 
2021 performance period to which the measure applies for MIPS payment 
year 2023.
    We stated our belief that it is imperative to establish the data 
completeness criteria for the CY 2023 MIPS payment year in this final 
rule and any failure to apply the updated data completeness criteria 
retroactively would be contrary to the public interest as such omission 
presents ambiguity and a potential notion for an array of 
interpretations. We believe that it is in the public interest to 
retroactively apply the updated data completeness threshold as it would 
ensure that all MIPS eligible clinicians participating in MIPS for the 
CY 2021 performance period/2023 MIPS payment year, whether at the 
individual, group, or virtual group levels, would be aware that there 
is a definitive data completeness criteria for the CY 2021 performance 
period and any data submitted for the quality performance category 
would need to meet the data completeness criteria. We noted that such 
approach would: Establish the data completeness criteria prior to the 
timeframe in which data submission will occur (first 3 months of CY 
2022), which would enable MIPS eligible clinicians participating in 
MIPS at the individual, group, or virtual group levels to prepare their 
data submission to meet the updated data completeness criteria; and 
ensure that all data submitted for the quality performance category 
would meet the same criteria (that is, specific data completeness 
threshold of at least 70 percent of a MIPS eligible clinician or 
group's patient population that meets the measure's denominator 
criteria for QCDR measures, MIPS CQMs, and eCQMs; or specific data 
completeness threshold of at least 70 percent of the applicable 
Medicare Part B patients seen during the CY 2021 performance period for 
Medicare Part B claims measures) versus an unspecified, interpretive 
data completeness threshold that could result in various threshold 
ranges and inconsistent reported patient populations such as portion of 
submitted data be a representative of all patient (all-payer) data 
while the remaining portion of submitted data be a representative of 
only Medicare patient data, which would provide data integrity, 
usability, and reliability to assess the performance of MIPS eligible 
clinicians at the individual, group, or virtual group level in a manner 
that is consistent and enable performance data to be comparable to the 
applicable historical benchmarks that have been established for the 
various measures.
    We solicited public comment on our proposal to maintain the data 
completeness criteria threshold of at least 70 percent for the CY 2021 
performance period/2023 MIPS payment year. We received public comments 
regarding the proposal. The following is a summary of the public 
comments received.
    Comment: Most commenters supported the proposal to maintain the 
data completeness criteria threshold of at least 70 percent for the CY 
2021 performance period/2023 MIPS payment year.
    Response: We appreciate the support from commenters.
    Comment: A few commenters did not support the proposal to maintain 
the data completeness criteria threshold of at least 70 percent for the 
CY 2021 performance period/2023 MIPS payment year and indicated that it 
is difficult for some clinicians to meet the data completeness 
criteria. The commenters recommended that the data completeness 
threshold be decreased to 60 percent for the CY 2021 performance 
period/2023 MIPS payment year.
    Response: Due to the retroactive effect of our proposal, we believe 
it would be most appropriate to maintain the 70 percent data 
completeness criteria that had been adopted for the prior year. 
Interested parties that reviewed our data completeness standards for 
prior years and our statements in the CY 2021 PFS proposed rule and 
final rule regarding the completeness standard for class 1 measures 
during the CY 2021 performance period could most reasonably have 
expected that we would maintain a 70 percent data completeness criteria 
threshold. We do not agree with commenters that the data completeness 
criteria threshold for the CY 2021 performance period/2023 MIPS payment 
year should be decreased to a threshold established for the CY 2019 
performance period/2021 MIPS payment year. When the data completeness 
criteria threshold increased from at least 60 percent to at least 70 
percent for the CY 2020 performance period/2022 MIPS payment year (84 
FR 62952), it was based on an analysis of data completeness rates from 
the submission of data from the CY 2017 performance period (84 FR 
62951), in which the data analyzed demonstrated that it would be 
generally feasible for MIPS eligible clinicians and groups to achieve a 
higher data completeness threshold of at least 70 percent. Absent 
further analysis, we believe it is most appropriate to maintain the 
standard of at least 70 percent for the data completeness threshold.
    After consideration of the public comments, we are finalizing our 
proposal as proposed at Sec.  414.1340(a)(3) and 414.1340(b)(3) to 
maintain the data completeness criteria threshold of at least 70 
percent for the CY 2021 performance period/2023 MIPS payment year.
(ii) CY 2022 MIPS Performance Period (2024 MIPS Payment Year)
    In the CY 2017 and CY 2018 Quality Payment Program final rules, we 
note that we would increase the data completeness criteria threshold 
over time (81 FR 77121 and 82 FR 53632). Starting with the CY 2020 
performance period/2022 MIPS payment year, we increased the data 
completeness criteria from at least 60 percent to at least 70 percent 
and as noted above, we proposed to maintain the data completeness 
criteria threshold of at least 70 percent for the CY 2021 performance 
period/2023 MIPS payment year. We continue to believe that it is 
important to incrementally increase the data completeness criteria as 
MIPS eligible clinicians, groups, and virtual groups gain experience 
with MIPS. However, with the COVID-19 PHE that started during the CY 
2020 performance period/2022 MIPS payment year and continued into the 
CY 2021 performance period/2023 MIPS payment year, we believe that it 
will be

[[Page 65436]]

appropriate to continue to maintain the data completeness criteria of 
at least 70 percent for the CY 2022 performance period/2024 MIPS 
payment year as healthcare systems across the country have been 
overwhelmed and strained by the COVID-19 PHE.
    In order to not place further undue burden as MIPS eligible 
clinicians, groups, and virtual groups navigate through the COVID-19 
pandemic, we proposed for the CY 2020 performance period/2022 MIPS 
payment year:
     At Sec.  414.1340(a)(3) to maintain the data completeness 
criteria threshold of at least 70 percent, in which MIPS eligible 
clinicians and groups submitting quality measures data on QCDR 
measures, MIPS CQMs, or eCQMs will need to submit data on at least a 70 
percent of the MIPS eligible clinician or group's patients that meet 
the measure's denominator criteria, regardless of payer, for the CY 
2022 performance period/2024 MIPS payment year; and
     At Sec.  414.1340(b)(3) to maintain the data completeness 
criteria threshold of at least 70 percent, in which MIPS eligible 
clinicians and groups submitting quality measures data on Medicare Part 
B claims measures must submit data on at least 70 percent of the 
applicable Medicare Part B patients seen during the CY 2022 performance 
period to which the measure applies for MIPS payment year 2024.
    We solicited public comment on our proposals to maintain the data 
completeness criteria threshold of at least 70 percent for the CY 2022 
performance period/2024 MIPS payment year. We received public comments 
regarding the proposal. The following is a summary of the public 
comments received.
    Comment: Most commenters supported the proposal to maintain the 
data completeness criteria threshold of at least 70 percent for the CY 
2022 performance period/2024 MIPS payment year.
    Response: We appreciate the support from commenters.
    Comment: A few commenters did not support the proposal to maintain 
the data completeness criteria threshold of at least 70 percent for the 
CY 2022 performance period/2024 MIPS payment year and indicated that it 
is difficult for some clinicians to meet the data completeness 
criteria. The commenters recommended that the data completeness 
threshold be decreased to 60 percent for the CY 2022 performance 
period/2024 MIPS payment year.
    Response: We do not agree with commenters that the data 
completeness criteria threshold for the CY 2022 performance period/2024 
MIPS payment year should be decreased to a threshold established for 
the CY 2019 performance period/2021 MIPS payment year. When the data 
completeness criteria threshold increased from at least 60 percent to 
at least 70 percent for the CY 2020 performance period/2022 MIPS 
payment year (84 FR 62952), it was based on an analysis of data 
completeness rates from the submission of data from the CY 2017 
performance period (84 FR 62951), in which the data analyzed 
demonstrated that it would be generally feasible for MIPS eligible 
clinicians and groups to achieve a higher data completeness threshold 
of at least 70 percent. Absent further analysis and further information 
from the commenters explaining why it would be difficult to meet a data 
completeness criteria threshold of at least 70 percent, we believe it 
is most appropriate to maintain the standard of at least 70 percent for 
the data completeness threshold; we believe that maintaining the 
current standard provides MIPS eligible clinicians, groups, and virtual 
groups with additional time to obtain more experience in meeting this 
standard and prepare for a future incremental increase in the data 
completeness criteria threshold.
    After consideration of the public comments, we are finalizing our 
proposal as proposed at Sec.  414.1340(a)(3) and (b)(3) to maintain the 
data completeness criteria threshold of at least 70 percent for the CY 
2022 performance period/2024 MIPS payment year.
(iii) CY 2023 Performance Period (2025 MIPS Payment Year)
    We believe that the incorporation of higher data completeness 
thresholds in future years ensure a more accurate assessment of a MIPS 
eligible clinician's performance on quality measures and avoid any 
selection bias. We have encouraged all MIPS eligible clinicians to 
perform the quality actions associated with the quality measures on 
their patients. 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. The data 
completeness 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.
    Since the inception of the program, we have provided notice to MIPS 
eligible clinicians, groups, and virtual groups in order for them to 
take the necessary steps to prepare for higher data completeness 
thresholds in future years. In a similar manner, we are providing 
advance notice that we intend to increase the data completeness 
criteria threshold for the CY 2023 performance period/2025 MIPS payment 
year. We proposed: At Sec.  414.1340(a)(4) to increase the data 
completeness criteria threshold from at least 70 percent to at least 80 
percent, in which MIPS eligible clinicians and groups submitting 
quality measures data on QCDR measures, MIPS CQMs, eCQMs, or Medicare 
Part B claims measures will need to submit data on at least a 80 
percent of the MIPS eligible clinician or group's patients that meet 
the measure's denominator criteria, regardless of payer, for the CY 
2023 performance period/2025 MIPS payment year; and at Sec.  
414.1340(b)(4) to increase the data completeness criteria threshold 
from at least 70 percent to at least 80 percent, in which MIPS eligible 
clinicians and groups submitting quality measures data on Medicare Part 
B claims measures must submit data on at least 80 percent of the 
applicable Medicare Part B patients seen during the CY 2023 performance 
period to which the measure applies for MIPS payment year 2025. We 
believe that MIPS eligible clinicians, groups, and virtual groups will 
be provided with adequate time to prepare for the data completeness 
criteria threshold to increase.
    We solicited public comment on our proposal to increase the data 
completeness criteria threshold from at least 70 percent to at least 80 
percent for the CY 2023 performance period/2025 MIPS payment year. We 
received public comments regarding the proposal. The following is a 
summary of the public comments received.
    Comment: A few commenters supported the proposal to increase the 
data completeness criteria threshold from at least 70 percent to at 
least 80 percent for the CY 2023 performance period/2025 MIPS payment 
year.
    Response: We appreciate the support from commenters.
    Comment: Most commenters did not support the proposal to increase 
the data completeness criteria threshold to at least 80 percent for the 
CY 2023 performance period/2025 MIPS payment year. Some commenters 
requested that CMS implement a more gradual increase of the data 
completeness criteria threshold, with one commenter urging CMS to not 
increase the data completeness threshold above 80 percent. A few 
commenters expressed concerns that the data completeness criteria 
threshold should not be increased amidst the COVID-19 PHE or as they 
prepare to

[[Page 65437]]

transition to MVPs and digital quality measures. A few commenters 
indicated that the increasing of the data completeness criteria 
threshold would make it more difficult for some MIPS eligible 
clinicians, groups, and virtual groups to meet the requirement, 
particularly small and rural practices. One commenter stated that it is 
difficult for some MIPS eligible clinicians to meet a data completion 
rate for patient reported outcome-based measures. Another commenter 
specified that other CMS quality programs have lower data completeness 
criteria thresholds and requested that the data completeness criteria 
threshold for MIPS reflect a lower threshold similar to other CMS 
quality programs.
    Response: We acknowledge the concerns expressed from commenters 
regarding increasing the data completeness criteria threshold amidst 
the COVID-19 PHE that has healthcare systems across the country 
overwhelmed and strained, which may have continued implications that 
expand beyond the CY 2022 performance period/2024 MIPS payment year. 
Thus, we are not finalizing the proposal to increase the data 
completeness criteria threshold to at least 80 percent for the CY 2023 
performance period/2025 MIPS payment year while individual MIPS 
eligible clinicians, groups, and virtual groups recover from the 
unexpected impact of the COVID-19 PHE; instead, we will be maintaining 
the data completeness criteria threshold of at least 70 percent for the 
CY 2023 performance period/2025 MIPS payment year.
    We also believe that maintaining the data completeness criteria 
threshold of at least 70 percent for the CY 2023 performance period/
2025 MIPS payment year is most responsive to stakeholder concerns 
regarding an increase to the data completeness criteria threshold 
amidst the COVID-19 PHE. For the segment of MIPS eligible clinicians, 
groups, and virtual groups experiencing challenges in meeting the 
established data completeness criteria threshold of at least 70 
percent, we believe that the COVID-19 PHE may have the potential to 
exacerbate those challenges. Maintaining the data completeness criteria 
threshold for the CY 2023 performance period/2025 MIPS payment year 
also would reduce burden and provide additional time for MIPS eligible 
clinicians, groups, and virtual groups to adopt the final policy 
changes and recover fiscally from the pandemic, prepare to transition 
to MVPs, which will be available starting with the CY 2023 performance 
period/2025 MIPS payment year. We considered not establishing a data 
completeness criteria threshold policy for the CY 2023 performance 
period/2025 MIPS payment year in this final rule, but we believe that 
it is more beneficial to establish such policy in advance for MIPS 
eligible clinicians, groups, and virtual groups. In establishing data 
completeness criteria thresholds in advance of an applicable 
performance period, we believe it is advantageous to delineate the 
expectations for MIPS eligible clinicians, groups, and virtual groups 
in order for them prepare for a transition to higher data completeness 
criteria threshold when such threshold is increased in the future. We 
believe that by maintaining the data completeness criteria threshold of 
at least 70 percent for the CY 2023 performance period/2025 MIPS 
payment year, the number of MIPS eligible clinicians, groups, and 
virtual groups able to meet a higher data completeness criteria 
threshold in future years would increase. We intend to continuously 
consider feedback from stakeholders as we plan to incrementally 
increase the data completeness criteria threshold and determine which 
performance period to increase the data completeness criteria threshold 
given that the threshold of at least 70 percent will be implemented for 
4 years as of the CY 2023 performance period/2025 MIPS payment year.
    We recognize that the user experience under MIPS varies across a 
continuum and there may be some MIPS eligible clinicians, groups, and 
virtual groups that will experience more challenges than others in 
meeting the reporting requirements for the quality performance category 
under MIPS, particularly MIPS eligible clinicians, groups, and virtual 
groups considered to be small practices for purposes of MIPS (15 or 
fewer clinicians). We note that, in order to enhance the user 
experience for such small practices, we established the Medicare Part B 
Claims collection type. The assessment of performance for such measures 
is based on Medicare Part B claims data, not all-payer claims data. In 
addition, to support the participation of small practices in MIPS, we 
established the small practice bonus, in which 6 measure bonus points 
are applied to the numerator of the quality performance category for 
small practices that submit data on at least one quality measure (83 FR 
59850). As we evolve the implementation of MIPS, we continue to assess 
means for reducing burden and improving user experience.
    In regard to the comment pertaining to challenges meeting the data 
completion rate for patient-reported outcome-based measures, we 
recognize that the user experience varies across a continuum. We do not 
believe that data completeness criteria threshold for patient-reported 
outcome-based measures would pose additional challenges. Such measures 
narrow the patient population to those that would benefit in capturing 
the patient voice. For example, many of the patient-reported outcome-
based measures capture functional assessments that would allow 
clinicians to adjust their treatment plan to improve the outcomes. In 
the instance that the assessments are not completed, data completeness 
would not be impacted, but rather the performance rate would be 
impacted.
    Lastly, we recognize that other CMS quality programs may have 
different data completeness criteria thresholds. While the commenter 
did not specify a CMS quality program or outline specific reporting 
requirements regarding data completeness that differ from MIPS, we 
believe that reporting requirements for CMS quality programs such as 
data completeness criteria, data validation, patient population 
eligible for a measure, measure specification requirements, case 
minimum standards, or measure exclusions or exceptions are not directly 
comparable across CMS quality programs. We believe that it is not 
accurate to characterize one element of a reporting requirement such as 
data completeness criteria threshold with an assertion that an 
overarching reporting burden for a CMS quality program is reduced if a 
standard differed from the data completeness criteria threshold of at 
least 70 percent established under MIPS. We note that reporting 
requirements may not only differ across CMS quality programs, but 
reporting requirements may differ by measure within a program. Thus, we 
believe that the reporting requirements such as the data completeness 
criteria threshold under other CMS quality programs should not be a 
factor in determining the data completeness threshold for MIPS as 
reporting requirements for other CMS quality programs are not directly 
comparable to the reporting requirements established under MIPS.
    Furthermore, we believe that it is critical to increase data 
completeness thresholds over time to more accurately assess a MIPS 
eligible clinician's performance on quality measures and prevent any 
selection bias. A data completeness criteria threshold of less than 100 
percent reduces burden and accommodates operational issues that may 
arise during data collection within the initial years of the program. 
We have previously provided notice to MIPS eligible clinicians in order 
for them to

[[Page 65438]]

take the necessary steps to prepare for higher data completeness 
criteria thresholds in future years (82 FR 53632, 83 FR 59758, and 84 
FR 62951). We want to ensure that an appropriate, yet achievable, data 
completeness criteria threshold is applied to all eligible clinicians 
participating in MIPS.
    Comment: A few commenters that did not support the increase of the 
data completeness criteria threshold of at least 80 percent for the CY 
2023 performance period/2025 MIPS payment year indicated that some 
groups, virtual groups, and APM Entities such as ACOs rely on multiple 
EHR systems or use a combination of EHR systems and registries for 
submitting data to MIPS and ACOs. One commenter requested that CMS 
consider an allowance for groups, TINs within virtual groups, and TINs 
within ACOs using multiple EHR systems to submit data from each EHR to 
CMS and for CMS to aggregate the data for such groups. The commenter 
indicated placing this responsibility on such groups increases the cost 
of such reporting.
    Response: We interpret the comments received to address the 
technological challenges that some groups, virtual groups, and APM 
Entities such ACOs experience as they transition from the reporting 
requirements for the CMS Web Interface to meeting the reporting 
requirements for eCQMs and/or MIPS CQMs. These challenges include 
reporting all-payer data in lieu of reporting only Medicare patient 
data under the CMS Web Interface and meeting higher data completeness 
criteria.
    We recognize that there are technical and operational dynamics that 
groups, virtual groups, and APM Entities such ACOs must address, 
particularly the transition of multiple EHR systems to code and capture 
all-payer data that meets the data completeness criteria for eCQMs and/
or MIPS CQMs. To ease the burden of transitioning to using an 
alternative collection type and/or submission type, we are extending 
the 70 percent data completeness criteria threshold, as described 
above. We refer readers to section IV.A.3.d.(1)(d) of this final rule 
regarding the proposal to extend the CMS Web Interface.
    Comment: A few commenters indicated that there may be special 
circumstances in which clinicians, groups, and virtual groups 
participating in MIPS should be able to apply for an exemption 
regarding the data completeness criteria, such as the transition from 
one EHR system to another EHR system, which makes it difficult to 
report 12 months of data and meet the data completeness requirement.
    Response: We recognize that there are certain circumstances when a 
MIPS eligible clinician, group, virtual group, or APM Entity may be 
unable to complete reporting to MIPS due to, for example, extreme and 
uncontrollable circumstances, hardship, or the unavailability or 
inapplicability of measures due to practice size or other data 
limitations. Therefore, under the authority provided in section 
1848(q)(5)(F) of the Act, it may be necessary to reweight one or more 
performance categories. We believe our previously established 
reweighting policies account for an array of circumstances that may 
impact the ability to meet reporting requirements for one or more 
performance categories.
    After consideration of the public comments, we are not finalizing 
our proposals at Sec.  414.1340(a)(4) and (b)(4) to increase the data 
completeness criteria threshold from at least 70 percent to at least 80 
percent for the CY 2023 performance period/2025 MIPS payment year, but 
finalizing our proposals with modification at Sec.  414.1340(a)(3) and 
(b)(3) to maintain the 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. Specifically, we are 
finalizing the following proposals with modification:
     At Sec.  414.1340(a)(3), to maintain the data completeness 
criteria threshold of at least 70 percent, in which MIPS eligible 
clinicians and groups submitting quality measures data on QCDR 
measures, MIPS CQMs, or eCQMs will need to submit data on at least a 70 
percent of the MIPS eligible clinician or group's patients that meet 
the measure's denominator criteria, regardless of payer, for the CY 
2021, CY 2022, and CY 2023 performance periods/2023, 2024, and 2025 
MIPS payment years; and
     At Sec.  414.1340(b)(3) to maintain the data completeness 
criteria threshold of at least 70 percent, in which MIPS eligible 
clinicians and groups submitting quality measures data on Medicare Part 
B claims measures must submit data on at least 70 percent of the 
applicable Medicare Part B patients seen during the CY 2021, CY 2022, 
and CY 2023 performance periods to which the measure applies for 2023, 
2024, and 2025 MIPS payment years.
(d) Groups and Virtual Groups Reporting via the CMS Web Interface
    The CMS Web Interface is a collection type through which a group 
and virtual group with 25 or more eligible clinicians may report data 
on a set of pre-determined quality measures. For the CY 2021 
performance period, the total number of CMS Web Interface measures 
required to complete reporting on is 10 CMS Web Interface measures (83 
FR 59756). In the CY 2021 PFS final rule, the CMS Web Interface was 
removed as an available collection and submission type under MIPS 
starting with the CY 2022 performance period (85 FR 84870). In 
addition, starting with the CY 2022 performance period, we revised the 
terms collection type and submission type to no longer include the CMS 
Web Interface measures as an available option. It was our belief that 
the removal of the CMS Web Interface as a collection and submission 
type would reduce the potential burden experienced by groups and 
virtual groups during the COVID-19 PHE. Based on the public comments we 
received on this proposal in the CY 2021 PFS proposed rule, we believed 
that the 1-year delay to remove the CMS Web Interface as a collection 
and submission type would provide stakeholders utilizing the CMS Web 
Interface sufficient time to prepare and transition to an alternative 
collection and/or submission type starting with the CY 2022 performance 
period.
    We noted in the CY 2022 PFS proposed rule that, following the close 
of the data submission period for the CY 2020 performance period (March 
31, 2021), stakeholders utilizing the CMS Web Interface had contacted 
CMS to convey their concerns that technological challenges and resource 
limitations would prevent them from transitioning to an alternative 
collection and/or submission type by the CY 2022 performance period (86 
FR 39391). Also, they emphasized that some practices continued to 
endure a negative fiscal impact resulting from the COVID-19 pandemic 
and need additional time to prepare for a transition to an alternative 
collection and/or submission type. Such CMS Web Interface users 
indicated that if CMS extended the availability of the CMS Web 
Interface for an additional year (the CY 2022 performance period), they 
would have sufficient time to address the technological challenges such 
as the implementation of processes to aggregate data within one EHR 
system or across multiple EHR systems to align with the reporting 
requirements of another collection type (that is, MIPS CQMs or eCQMs), 
build and integrate new health IT infrastructures and systems, 
implement workflows, and train staff on new health IT systems.
    In the CY 2022 PFS proposed rule, we recognized that an adequate 
and sufficient timeframe is a critical factor

[[Page 65439]]

in the success of a group or virtual group transitioning to an 
alternative collection and/or submission type, particularly with such a 
transition occurring amidst the COVID-19 pandemic (86 FR 39391). We 
noted that, as CMS Web Interface users had begun to transition to a 
different collection and/or submission type, the timeframe identified 
by most CMS Web Interface users (starting with the CY 2022 performance 
period) in response to the proposal in the CY 2021 PFS proposed rule 
did not provide adequate time for CMS Web Interface users to fully 
transition to an alternative collection and/or submission type. We 
noted that we considered the concerns expressed by CMS Web Interface 
users such as the technological challenges that they needed to 
overcome, their inability to update systems and workflows in time for 
the CY 2022 performance period, and the cost they bear to mitigate and 
respond to the COVID-19 PHE.
    Due to such concerns, we noted our belief that it is appropriate to 
reduce the burden of groups and virtual groups at this time by 
extending the availability of the CMS Web Interface as a collection and 
submission type for the CY 2022 performance period. We recognized that, 
while groups and virtual groups are on a continuum regarding their 
technological readiness to transition to a different collection type, 
we believed that the availability of the CMS Web Interface for the CY 
2022 performance period would reduce burden by providing additional 
time, and would enable more groups and virtual groups to successfully 
transition to another collection type by the start of the CY 2023 
performance period. Moreover, we wanted to ensure that groups utilizing 
the CMS Web Interface were prepared to participate in MIPS as it 
evolves from traditional MIPS to MVPs. We noted that such groups could 
begin voluntary participation in an MVP as MVPs become available 
starting with the CY 2023 performance period.
    Thus, we proposed at Sec.  414.1325(c)(1) to remove the CMS Web 
Interface measures as a collection type/submission type starting with 
the CY 2023 performance period. Additionally, we proposed at Sec.  
414.1305 to modify the definition of the terms collection type and 
submission type to remove the CMS Web Interface measures as an 
available option starting with the CY 2022 performance period/2024 MIPS 
payment year. We proposed to modify the definition of ``collection 
type'' 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); QCDR measures; Medicare Part B claims 
measures; for the CY 2017 through CY 2022 performance periods/2019 
through 2024 MIPS payment years, CMS Web Interface measures; the CAHPS 
for MIPS Survey; and administrative claims measures. We proposed to 
modify the definition of ``submission type'' to mean the mechanism by 
which the submitter type submits data to CMS, including, but not 
limited to: Direct; log in and upload; log in and attest; Medicare Part 
B claims; and for the CY 2017 through CY 2022 performance periods/2019 
through 2024 MIPS payment years, the CMS Web Interface.
    For the CY 2022 performance period, the total number of CMS Web 
Interface measures required to complete reporting on will be 10 CMS Web 
Interface measures (83 FR 59713 through 79715 and 59756). In Table 
Group B of Appendix 1 of the CY 2022 PFS proposed rule, we proposed 
modifications to the CMS Web Interface measures and in Table Group D of 
Appendix 1 of the CY 2022 PFS proposed rule, we proposed substantive 
changes to the CMS Web Interface measures. We believe that it is 
necessary for the CMS Web Interface measures to be updated to reflect 
applicable substantive changes for the CY 2022 performance period given 
that the CMS Web Interface measures have remained the same for 3 
consecutive (CY 2019, CY 2020, and CY 2021) performance periods.
    We solicited public comment on our proposals: to extend the 
availability of the CMS Web Interface as a submission and collection 
type for the CY 2022 performance period, which would sunset and remove 
the collection and submission type under MIPS starting with the CY 2023 
performance period; and update the CMS Web Interface measures with 
substantive changes for the CY 2022 performance period as outlined in 
Table Group D of Appendix 1 of the CY 2022 PFS proposed rule. The 
following is a summary of the public comments received regarding the 
proposal to extend availability of the CMS Web Interface as a 
collection and submission type for the CY 2022 performance period. For 
a summary of the comments received pertaining to the proposed 
substantive changes to the CMS Web Interface measures for the CY 2022 
performance period, we refer readers to Table Group D of Appendix 1 of 
this final rule.
    Comment: Most commenters supported the proposal to extend the CMS 
Web Interface for an additional year as a collection and submission 
type and thereby, to allow its use for the CY 2022 performance period. 
The commenters indicated that the additional year would provide them 
with the needed time to transition to a different collection and/or 
submission type.
    Response: We appreciate the support from commenters.
    Comment: Some commenters supported the eventual sunset of the CMS 
Web Interface as a collection and submission type, but recommended that 
CMS extend the availability of the CMS Web Interface by 2 additional 
years, not one. The commenters indicated that such an extension would 
provide groups and virtual groups with more time to transition to 
alternative collection and/or submission types.
    A few commenters expressed concern that the sunset of the CMS Web 
Interface, starting with the CY 2023 performance period, would increase 
undue burden on groups and virtual groups as it would require them to 
invest in resources and staffing to prepare their EHR systems to 
collect and report quality data using a different collection and/or 
submission type such as eCQMs or MIPS CQMs amidst the COVID-19 pandemic 
and PHE. The commenters indicated that as groups and virtual groups 
navigate the COVID-19 pandemic, they are enduring resource and staffing 
(clinical and non-clinical staff) shortages, which exacerbates the 
difficulties of preparing to transition to using an alternative 
collection and/or submission type.
    Response: In considering the concerns expressed by CMS Web 
Interface users such as the technological and staffing challenges that 
they would need to overcome and the fiscal implications they endure 
from mitigating and responding to the COVID-19 PHE, we believe that the 
extended availability of the CMS Web Interface as a collection and 
submission type for one additional year reduces burden and provides 
sufficient time for the transition to different collection and/or 
submission types for the CY 2023 performance period. In assessing a 
timeframe to transition to a new collection, based on an assumption 
that a group or virtual group is not prepared to collect and report 
data using EHR technology, we believe that it would be approximately 18 
months for a group or virtual group to prepare and implement EHR 
technology to report data, which would enable a group or virtual group 
to use a collection/submission type for reporting on eCQMs or MIPS 
CQMs. With the extended availability of the CMS Web Interface, groups 
and virtual

[[Page 65440]]

groups would have more than 18 months to prepare and transition to 
using another collection and/or submission type.
    Comment: One commenter did not support the sunset the CMS Web 
Interface as a collection and submission type. The commenter expressed 
concerns that the transition to utilizing a different collection and/or 
submission type would require the reporting of all-payer data, in which 
data would be pulled from an entire clinical patient population, 
including safety net clinics serving patients with high social 
determinants of health. Also, the commenter indicated that assessment 
of performance based on all-payer data may unfairly lower quality 
scores for some clinicians.
    Response: We recognize that the user experience of meeting 
reporting requirements for the CMS Web Interface differs from the user 
experience of meeting reporting requirements using an alternative 
collection type such as eCQMs and/or MIPS CQMs. We believe that the 
assessment of performance based on all-payer data (compared to 
reporting Medicare patient data only under the CMS Web Interface) and 
data completeness criteria (compared to reporting on a sample of 
Medicare patients for each CMS Web Interface measure) requirements 
accurately assess the performance of a group or virtual group and avoid 
selection bias. We have encouraged all MIPS eligible clinicians to 
perform the quality actions associated with the quality measures on 
their patients. 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. We do not believe 
that the assessment of performance should exclude any segment of a 
patient population based on social determinants of health, but assess 
performance based on an accurate reflection of a patient population. In 
order to further account for the dynamics pertaining to social 
determinants of health, we are seeking to include health equity. As we 
implement and enhance the inventory of quality measures under MIPS, 
health equity is an element we are encouraging for inclusion in measure 
development and would be an item we assess as part of the submission 
process for the annual Call for Quality Measures.
    Based on the information available to us, we do not believe that 
the assessment of all-payer data, including patients with varying 
levels of social determinants of health, will negatively skew 
performance. With measure being risk adjusted and the way in which 
benchmarks are developed, we believe that social determinants of health 
will not inadvertently skew performance. For each collection type, 
specific benchmarks are established using historical data when 
possible, which allows us to account for the differing means of 
implementation of a measure for each collection type. Historical 
benchmarks for QCDR measures, MIPS CQMs, eCQMs, and Medicare Part B 
claims measures are based on historical performance data. As a result, 
the performance of each MIPS eligible clinician, group, or virtual 
group will be assessed relative to their actual performance compared to 
a benchmark that includes all-payer data, when specified in the measure 
and collection type.
    We recognize that some MIPS eligible clinicians, groups, and 
virtual groups will experience more challenges than others in meeting 
the reporting requirements for the quality performance category under 
MIPS, particularly MIPS eligible clinicians, groups, and virtual groups 
considered to be small practices for purposes of MIPS (15 or fewer 
clinicians). We note that, in order to enhance the user experience for 
such small practices, we established the Medicare Part B Claims 
collection type. The assessment of performance for such measures is 
based on Medicare Part B claims data, not all-payer claims data. As we 
evolve the implementation of MIPS, we continue to assess means for 
reducing burden and improving user experience.
    After consideration of the public comments, we are finalizing our 
proposal to sunset the CMS Web Interface measures as a collection type/
submission type. We note that the availability of the CMS Interface as 
a collection type/submission type differs for groups and virtual groups 
participating in MIPS than for APM Entities participating in the Shared 
Savings Program and meeting the APM Performance Pathway reporting 
requirements. While the availability of the CMS Web Interface as a 
collection type/submission type for groups and virtual groups 
participating in MIPS is through the CY 2022 performance period, the 
availability of the CMS Web Interface for APM Entities (specifically, 
Shared Savings Program ACOs meeting the APM Performance Pathway 
reporting requirements only) is through the CY 2024 performance period. 
In section III.J.1.c. of this final rule, we discuss the final policies 
regarding the reporting requirements for Shared Savings Program ACOs 
reporting under the APM Performance Pathway, which include the extended 
availability of the CMS Web Interface as a collection type/submission 
type to the CY 2024 performance period.
    In accordance with our finalized policy, we are finalizing 
conforming amendments to Sec. Sec.  414.1305 and 414.1325(c)(1). 
Specifically, we are finalizing Sec.  414.1305 with modification to 
amend the definition of ``collection type'' 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); 
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; and administrative claims 
measures. Paragraph (1) of the amended definition of ``collection 
type'' provides that for the CY 2021 through CY 2024 performance 
periods/2023 through 2026 MIPS payment years, collection types include 
CMS Web Interface measures for APM Entities reporting through the APM 
Performance Pathway in accordance with Sec.  414.1367. Similarly, we 
are finalizing to amend the definition of ``submission type'' to mean 
the mechanism by which the submitter type submits data to CMS, 
including, but not limited to: Direct; log in and upload; log in and 
attest; Medicare Part B claims; and the CMS Web Interface (except as 
provided in paragraph (5)(i) of this definition, for the CY 2017 
through CY 2022 performance periods/2019 through 2024 MIPS payment 
years). Paragraph (5)(i) of the amended definition of ``submission 
type'' provides that for the CY 2021 through CY 2024 performance 
periods/2023 through 2026 MIPS payment years, submission types include 
the CMS Web Interface for APM Entities reporting through the APM 
Performance Pathway in accordance with Sec.  414.1367. We note that our 
conforming amendments refer to APM Entities rather than Shared Savings 
Program ACOs to maintain consistency with existing regulatory 
terminology. However, no substantive distinction is intended as no APM 
Entities other than Shared Savings Program ACOs report via the CMS Web 
Interface for purposes of the APM Performance Pathway. Finally, we are 
finalizing Sec.  414.1325(c)(1) with modification to remove the 
reference to the sunset of the CMS Web Interface measures as a 
collection type/submission type because Sec.  414.1325(c)(1) is 
expressly listing data

[[Page 65441]]

``submission types'' for groups, and our sunsetting policies are now 
incorporated into the amended definitions of ``collection type'' and 
``submission type''. Accordingly, it is unnecessary to restate them in 
Sec.  414.1325(c)(1).
(e) Selection of MIPS Quality Measures
    Previously finalized MIPS quality measures can be found in the 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 in the CY 2017 Quality Payment Program final rule 
(81 FR 77558 through 77816). Proposed changes to the MIPS quality 
measure set, as described in Appendix 1 of the CY 2022 PFS proposed 
rule, include the following: the addition of new measures; updates to 
specialty sets; removal of existing measures, and substantive changes 
to existing measures. For the CY 2022 performance period, we proposed a 
measure set of 195 MIPS quality measures.
    The new MIPS quality measures we proposed for inclusion in MIPS for 
the CY 2022 performance period and future years can be found in Table 
Group A of Appendix 1 of the CY 2022 PFS proposed rule. For the CY 2022 
performance period, we proposed five new MIPS quality measures, which 
includes 2 administrative claims measures. Also, in Table Group AA of 
Appendix 1, we outlined 1 potential new MIPS quality measure, the 
COVID-19 Vaccination by Clinicians measure, which we intended to 
propose in a future rulemaking cycle. We refer readers to the CY 2022 
PFS proposed rule for our request for information pertaining to the 
COVID-19 Vaccination by Clinicians measure specifications (86 FR 39393 
through 39394; and for reference, available in section IV.A.3.d.(1)(f) 
of this final rule).
    In addition to the establishment of new individual MIPS quality 
measures, we also develop and maintain specialty measure sets to assist 
MIPS eligible clinicians with selecting quality measures that are most 
relevant to their scope of practice. Our proposals for modifications to 
existing specialty sets and new specialty sets were outlined in Table 
Group B of Appendix 1 of the CY 2022 PFS proposed rule. We noted that 
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 7, 2021, we announced that we would be accepting 
recommendations for potential new specialty measure sets or revisions 
to existing specialty measure sets for year 6 of MIPS under the Quality 
Payment Program.\226\ These recommendations were based on the MIPS 
quality measures finalized in the CY 2020 PFS final rule and the 2020 
Measures Under Consideration List; they recommend to add or remove 
current MIPS quality measures from existing specialty sets, or to 
create new specialty sets. All specialty set recommendations submitted 
for consideration were assessed and vetted, and as a result, the 
recommendations that we agree with were proposed in the proposed rule.
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    \226\ CMS, Quality Payment Program listserv, ``CMS is Soliciting 
Stakeholder Recommendations for Potential Consideration of New 
Specialty Measure Sets and/or Revisions to the Existing Specialty 
Measure Sets for the 2022 Program Year of MIPS'' (January 7, 2021).
---------------------------------------------------------------------------

    In addition to establishing new individual MIPS quality measures 
and modifying existing specialty sets and new specialty sets as 
outlined in Tables Group A and Group B of Appendix 1 of the CY 2022 PFS 
proposed rule, we refer readers to Table Group C of Appendix 1 of the 
CY 2022 PFS proposed rule for a list of quality measures and rationales 
for removal. For the CY 2022 performance period, we proposed to remove 
19 MIPS quality measures: 1 MIPS quality measure that is duplicative to 
another current MIPS quality measure; 9 MIPS quality measures that do 
not align with the Meaningful Measure Initiative; 5 MIPS quality 
measures that are no longer stewarded or maintained; and 4 MIPS quality 
measures that are under the topped out lifecycle. We have continuously 
communicated to stakeholders our desire to reduce the number of process 
measures within the MIPS quality measure set. We noted our belief that 
our proposal to remove the quality measures outlined in Table Group C 
of the CY 2022 PFS proposed rule would lead to a more parsimonious 
inventory of meaningful, robust measures in the program, and that our 
approach to removing measures should occur through an iterative process 
that includes an annual review of the quality measures to determine 
whether they meet our removal criteria.
    Lastly, MIPS quality measures with proposed substantive changes can 
be found in Table Group D of Appendix 1 of the CY 2022 PFS proposed 
rule. We proposed substantive changes to 84 MIPS quality measures. 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. Section 1848(q)(2)(D)(i)(II)(cc) 
of the Act requires all substantive measure changes to be proposed and 
identified through notice-and-comment rulemaking. In the CY 2017 
Quality Payment Program final rule (81 FR 77137), we determined that 
substantive changes to measures (that is, measure specifications, 
measure title, and domain modifications) will be identified during the 
rulemaking process while maintenance changes that do not substantively 
change the intent of the measure (that is, updated diagnosis and 
procedure codes, definitions, and changes to patient population 
exclusions) will not be included in the rulemaking process.
    We did not propose any changes to our current approach of 
identifying substantive measure changes during the rulemaking process. 
However, in order to more precisely distinguish between substantive 
measure changes and non-substantive measure changes, we proposed to 
consider the following criteria for determining whether a measure 
change is substantive starting with CY 2022 performance period:
     Whether the change causes the measure to be more 
stringent;
     Whether the change modifies the collection and/or 
submission types applicable to the measure;
     Whether the change impacts the clinical action and/or 
outcome of the measure;
     Whether the change increases the burden of the measure;
     Whether the change modifies the premise and/or objective 
of the measure;
     Whether the change modifies the scope of the measure (such 
as patient population eligible for the measure or measurement period); 
and
     Other relevant criteria as may be identified by CMS on a 
case-by-case basis.
    We noted that any substantive change made to a measure would be 
proposed and identified through notice-and-comment rulemaking. For a 
substantive change to a measure, we only intend to propose and identify 
the substantive change as applicable to the appropriate elements (that 
is, only include substantive changes if it is applicable to the measure 
specifications, collection type(s), measure description, measure title, 
etc.) of the measure through notice-and-comment rulemaking. For 
example, if there is a substantive change to a

[[Page 65442]]

measure in the measure specifications that changes the premise/
overarching objective (that is, a screening measure that is changed to 
include treatment and follow-up) and/or clinical action of the measure, 
such substantive change would be proposed and identified through 
notice-and-comment rulemaking. We do not believe that it is necessary 
to propose or identify through notice-and-comment rulemaking changes to 
a measure that do not meet any of the above substantive change criteria 
for measures (for example, a modification to the title or domain that 
do not change or impact any element of the measure). We generally 
consider such changes to be non-substantive and would be published in 
subregulatory guidance. We noted our belief that it is important to 
provide a clear delineation of substantive changes to be included in a 
rulemaking process versus our previous approach, which generally 
included any changes made to measure specifications, measure titles, 
and domain modifications (81 FR 77137). We found that many changes made 
to measures based on our previous approach were not substantive in 
nature and should not be classified as substantive changes. Thus, we 
believe that establishing the substantive change criteria for measures 
provides further clarity as to what we consider a substantive change, 
particularly as it relates to how a change affects and/or impacts a 
measure. We noted that measures identified as having a substantive 
change would generally have an update to their applicable benchmark. 
For measures that meet the data completeness criteria, but do not have 
a benchmark or meet a case minimum (class 2 measures), we noted that 
they would be scored in accordance to our proposed scoring policy as 
outlined in the CY 2022 PFS proposed rule (86 FR 39433 through 39434).
    In addition, we intended to align the utilization of terminology 
across CMS programs when appropriate and applicable for consistency 
purposes. Since the implementation of MIPS, we have referenced the term 
patient reported outcome as a type of measure, which is similar, but 
not exact to a measure type categorization reference in the CMS 
Blueprint. In order to align the categorization reference of such 
measure type under MIPS with the CMS Blueprint terminology, we are 
modifying how the term is referenced as a measure type under MIPS and 
will reference such measure type as patient-reported outcome-based 
performance measure (PRO-PM) starting with the CY 2022 performance 
period. We believe that such modification does not have any substantive 
implications, but is merely a minor technical change of semantics that 
enables the utilization of consistent terminology across CMS programs 
when referencing such measure type.
    We refer readers to Table Groups A through D of Appendix 1 of this 
final rule for a summary of public comments received regarding the 
proposed changes to the MIPS quality measure set for the CY 2022 
performance period and our final decisions. For the CY 2022 performance 
period, we are finalizing with modification a measure set of 200 MIPS 
quality measures, which includes the following:
     Implementation of 4 new MIPS quality measures (includes 
one administrative claims measure);
     Removal of 13 MIPS quality measures: 1 MIPS quality 
measure that is duplicative to another current MIPS quality measure; 4 
MIPS quality measures that do not align with the Meaningful Measure 
Initiative; 5 MIPS quality measures that are no longer stewarded or 
maintained; and 3 MIPS quality measures that are under the topped out 
lifecycle; and
     Substantive changes to 87 MIPS quality measures.
    We solicited public comment on our proposal to establish measure 
substantive change criteria that would be utilized by CMS to identify 
such measures. The following is a summary of the public comment 
received.
    Comment: One commenter supported the intent and criteria for 
determining whether a substantive change has been made to a quality 
measure and encouraged CMS to consider the definition of a substantive 
change to include any modification to a measure that impacts 
performance scores that may likely be due to the changes in the measure 
construct or coding and not clinician performance.
    Response: We appreciate the support from the commenter. However, 
when we assess whether or not a change to a measure is substantive, the 
factors we consider assess how the measure is changed. We recognize 
that a substantive change may affect performance, but we do not believe 
that an impact to performance scores necessitates for a change to a 
measure to be classified as substantive. We do not believe that it is 
appropriate for the determination of whether or not a measure change is 
substantive to be based on whether performance scores would increase or 
decrease. Rather, we believe that the determination of whether a 
measure change is substantive should pertain to elements of the measure 
and not to the spectrum of performance on the measure. If a change to a 
measure is substantive such as causing the measure to be more 
stringent, we believe that such dynamic reflects a change to an element 
in the measure. If the performance scores increase or decrease due to 
changes in a measure, we believe that performance scores reflect how 
measure requirements are met. As we assess whether or not a change to a 
measure is substantive, the premise of our assessment and analysis 
stems from how a measure is changed such as the construct of a measure, 
coding updates, and if the measure is more stringent or increases 
burden; the premise of our assessment and analysis does not stem from 
whether or not the measure substantive change will impact performance 
because we believe that it is inherent for a measure substantive change 
to have a potential effect on performance. We assess performance based 
on whether or not measure requirements for a clinical quality action is 
met.
    After consideration of the public comment, we are finalizing our 
proposal to establish measure substantive change criteria that will be 
utilized by CMS to identify such measures. CMS will consider the 
following criteria for determining whether a measure change is 
substantive starting with CY 2022 performance period:
     Whether the change causes the measure to be more 
stringent;
     Whether the change modifies the collection and/or 
submission types applicable to the measure;
     Whether the change impacts the clinical action and/or 
outcome of the measure;
     Whether the change increases the burden of the measure;
     Whether the change modifies the premise and/or objective 
of the measure;
     Whether the change modifies the scope of the measure (such 
as patient population eligible for the measure or measurement period); 
and
     Other relevant criteria as may be identified by CMS on a 
case-by-case basis.
(f) Request for Information Regarding the COVID-19 Vaccination by 
Clinicians Measure
    As of July 7, 2021, the Centers for Disease Control and Prevention 
(CDC) reported that there are 33,582,352 cases of coronavirus disease 
2019 (COVID-19) and 603,656 deaths \227\ caused by COVID-19 at the time 
of publication of

[[Page 65443]]

the CY 2022 PFS proposed rule and subject to change. In 2020, COVID-19 
was the third leading cause of death in the United States, exceeded 
only by cancer and heart disease.\228\ Widespread vaccination to 
prevent COVID-19 will be critically important to stemming the morbidity 
and mortality caused by this disease. Three vaccines have received the 
FDA emergency use authorization (EUA) for the prevention of COVID-19 
(Pfizer-BioNTech, Moderna, and Janssen) as of July 7, 2021 (86 FR 
39393). As noted in the CY 2022 PFS proposed rule, the EUA allows the 
Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines to be 
distributed in the United States.\229\ As of July 7, 2021, 331,651,464 
vaccine doses have been administered (86 FR 39393).\230\ However, in 
this final rule, we note that on August 23, 2021, the FDA approved the 
first COVID-19 vaccine. The vaccine has been known as the Pfizer-
BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for 
the prevention of COVID-19 disease in individuals 16 years of age and 
older.\231\
---------------------------------------------------------------------------

    \227\ https://covid.cdc.gov/covid-data-tracker/#cases_totalcases.
    \228\ https://www.scientificamerican.com/article/covid-19-is-now-the-third-leading-cause-of-death-in-the-u-s1/.
    \229\ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine.
    \230\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html.
    \231\ FDA, News Release, ``FDA Approves First COVID-19 Vaccine'' 
(August 23, 2021) located at https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.
---------------------------------------------------------------------------

    To address this urgent PHE, CMS began the development of the COVID-
19 Vaccination by Clinicians measure for MIPS, which would assess the 
percentage of patients aged 18 years and older seen for a visit during 
the measurement period who have ever completed or reported having ever 
completed a COVID-19 vaccination series. The measure would be reported 
by MIPS eligible clinicians as a MIPS CQM to determine the percentage 
of patients seen for a visit during the measurement period who have 
ever completed or reported having ever completed a COVID-19 vaccination 
series, either from the submitting MIPS eligible clinician or another 
MIPS eligible clinician. The measure as specified at the time of 
publication of the CY 2022 PFS proposed rule (see Table Group AA of 
Appendix 1 of the CY 2022 PFS proposed rule) would allow clinicians to 
determine a patient's vaccination status and deliver a vaccine dose, if 
possible and appropriate. The measure is intended to capture whether or 
not clinicians take an appropriate step to ensure that their patients 
are vaccinated. Patients receiving hospice care at any time during the 
measurement period would be excluded from the patient population of 
measure. The measure would allow for an exception if the COVID-19 
vaccination series was not administered, as documented by a MIPS 
eligible clinician, due to patient contraindication, or vaccine 
availability.
    Between November of 2020 and January of 2021, we solicited feedback 
on the measure from measure-specific multi-stakeholder expert 
workgroups, specifically the Measure Application Partnership (MAP) 
coordinated through the National Quality Forum.\232\ While the MAP 
agreed that the COVID-19 Vaccination by Clinicians measure could be an 
important tool to: Support vaccine uptake by collecting valuable 
information from the field, provide feedback to clinicians, and help 
identify where to conduct targeted education and outreach to limit the 
spread of infections, the MAP expressed concerns regarding the 
following elements of the measure: The patient population that would be 
assessed to measure performance (the inclusion of assessing patients 
who received 1 dose of a COVID-19 vaccine versus only assessing 
patients who received a complete COVID-19 vaccination series), and lack 
of available evidence and clinical guidance for vaccine administration 
(the feasibility of implementing the measure given the limited vaccine 
supply and availability, and the potential inconsistencies and 
discrepancies derived from the novelty of data collection and reporting 
for COVID vaccinations). We seek to mitigate such issues by obtaining 
further information and feedback from additional stakeholders. We 
intend to utilize the obtained information and feedback to inform 
measure specification improvements that would be implemented for a 
future performance period.
---------------------------------------------------------------------------

    \232\ http://www.qualityforum.org/map/.
---------------------------------------------------------------------------

    We solicited public comment on the draft COVID-19 Vaccination by 
Clinicians measure specifications, which is available on the Quality 
Payment Program website in the Resource Library located at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1471/Draft%20COVID-19%20Vaccine%20Specs.pdf.
    Specifically, we solicited feedback on the following questions. 
Should the measure assess whether or not patients completed a COVID-19 
vaccination series to capture provision of effective clinical care and 
why? Given that there are differences in the age ranges for patients 
eligible to receive the various COVID-19 vaccinations (Moderna and 
Janssen COVID-19 vaccines are authorized for patients ages 18 years and 
older; Pfizer-BioNTech COVID-19 vaccine is authorized for patients ages 
12 and older; and future COVID-19 vaccines may be approved for other 
age ranges that are implemented after the publication of the CY 2022 
PFS proposed rule), is 18 years and older an appropriate initial age 
threshold for this measure? Given the current COVID-19 PHE and the 
intent of the measure, should this measure be mandatory for reporting 
in a future year? If this measure would be mandated as a required 
measure for reporting purposes under MIPS, what issues or concerns 
would need to be considered and/or mitigated regarding the 
implementation of the measure in a future year? What are the potential 
unintended consequences associated with the potential future 
implementation of the measure as specified in Table Group AA of 
Appendix 1 of the CY 2022 PFS proposed rule and applicable measure 
specifications? What are the feasibility challenges and barriers to 
implementing the measure? What are the potential options and/or 
recommendations that we should consider to address and/or mitigate the 
feasibility challenges and barriers to be experienced during the CY 
2022 performance period/2024 MIPS payment year that could be improved 
upon for the CY 2023 performance period? If this measure would be 
mandated, how would the collection of the measure data be useful after 
the CY 2023 performance period/2025 MIPS payment year?
    We thank commenters for the feedback that we received. We may 
consider such information to inform future rulemaking.
(g) Quality Data Submission Criteria
(i) CAHPS for MIPS Background
    As part of the CY 2021 PFS final rule (85 FR 84718), we finalized a 
policy requiring Medicare Shared Savings Program (Shared Savings 
Program) Accountable Care Organizations (ACOs) to report quality data 
via the Alternative Payment Model (APM) Performance Pathway (APP). 
Beginning with the CY 2021 performance period/2023 MIPS payment year, 
Shared Savings Program ACOs are required to field the Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey 
as part of the APP. We had previously established in the CY 2019 PFS 
final rule that MIPS quality benchmarks will be based on collection 
type, from all available sources,

[[Page 65444]]

including MIPS eligible clinicians and APM Entities, to the extent 
feasible, during the applicable baseline or performance period (83 FR 
59842). Given that Shared Savings Program ACOs will now be required to 
field the CAHPS for MIPS survey as part of the APP, we note that 
beginning with the CY 2022 performance period/2024 MIPS payment year 
CAHPS for MIPS survey, the CAHPS for MIPS benchmarks will be calculated 
based on summary survey measure (SSM) scores from MIPS groups and APM 
entities (including Shared Savings Program ACOs) that fielded the CAHPS 
for MIPS Survey in the applicable baseline or performance period. 
Furthermore, the CAHPS for MIPS SSM scores will be adjusted for patient 
case-mix using a single case-mix adjustment model that incorporates 
data from both MIPS groups and APM entities (including Shared Savings 
Program ACOs) that field the CAHPS for MIPS Survey.
    Beginning with the CY 2022 performance period/2024 MIPS payment 
year for the CAHPS for MIPS survey, to further support the alignment of 
CAHPS for MIPS sampling and scoring procedures between Shared Savings 
Program ACOs and MIPS groups, we proposed in the CY 2022 PFS proposed 
rule to adopt certain policies that had been part of the CAHPS for ACOs 
survey administration process, but had not previously been a part of 
CAHPS for MIPS. These policies fell into 3 broad categories: Sampling, 
case mix adjustment, and scoring. Policies related to certified survey 
vendors rendering the CAHPS for MIPS survey for subgroups were 
discussed in the proposed rule in section IV.A.3.h. (86 FR 39462 
through 39463). We solicited comments on the following proposals 
related to CAHPS for MIPS.
(ii) CAHPS for MIPS Sampling Specifications
    The CAHPS for MIPS Survey is administered to a sample of eligible 
patients for all Shared Savings Program ACOs and for those MIPS groups 
that elect the measure. Prior to drawing the sample, patients are 
excluded from the pool of potential survey recipients (called the 
sampling frame) for a number of reasons, including if they are known to 
have died or are known to be institutionalized. Currently, patients are 
considered institutionalized if 100 percent of their primary care 
charges are associated with an institutionalized setting during the 
sampling period. Starting in performance year 2018 under the Shared 
Savings Program, the CAHPS for ACOs survey additionally flagged 
patients as institutionalized if their last primary care visit during 
the sampling period was associated with an institutional setting. This 
change (called the ``last primary care visit rule'') was made to better 
identify and exclude from the sample, patients likely to be 
institutionalized at the time the survey is fielded, and by extension, 
to improve response rates on the survey. This was of particular 
importance for a few Shared Savings Program ACOs for which large 
portions of their assigned beneficiaries are in nursing homes. Analysis 
of the CY 2020 performance period/2022 MIPS payment year CAHPS for MIPS 
sample found that among the 100 MIPS groups that fielded the survey, 
less than 1 percent of the survey sample would be lost, on average, due 
to the application of this additional criterion to identify 
institutionalized patients. Of the groups fielding the survey in the CY 
2020 performance period/2022 MIPS payment year, only 1 would have been 
excluded from participating in the survey as a result of falling below 
the minimum sampling threshold due to the expanded definition of 
institutionalization. Given these findings, which suggest a minimal 
impact on MIPS group sample sizes and eligibility to field the survey, 
we proposed beginning with the CY 2022 performance period/2024 MIPS 
payment year for the CAHPS for MIPS survey to add the ``last primary 
care visit rule'' as an additional exclusion to sampling for the CAHPS 
for MIPS survey. We explained that we expected this change would better 
identify and exclude from the sample those patients likely to be 
institutionalized at the time the survey is fielded, and by extension, 
would improve response rates on the survey.
    As we explained in the CY 2022 PFS proposed rule, other CMS 
programs use different CAHPS surveys to gather information on patient 
experience in a variety of health care settings. The In-Center 
Hemodialysis (ICH) CAHPS survey is fielded twice per year to patients 
receiving dialysis treatment at an ICH facility. Previously, patients 
sampled for the ICH CAHPS survey during the spring implementation were 
removed from the CAHPS for ACOs sampling frame in an effort to improve 
response rates to the ICH CAHPS Survey and to avoid burdening patients 
with multiple surveys. Analyses of the CY 2019 and 2020 performance 
periods/2021 and 2022 MIPS payment years CAHPS for MIPS sampling frames 
suggest that implementing ICH CAHPS deduplication in CAHPS for MIPS 
would have only minor impacts on most MIPS groups. Of the groups 
fielding the survey in the CY 2020 performance period/2022 MIPS payment 
year, only 1 would have been excluded from participating in the survey 
due to falling below the minimum sampling threshold following ICH CAHPS 
deduplication (the same group that would have been excluded due to the 
``last primary care visit rule'', above). For the CY 2019 performance 
period/2021 MIPS payment year, no participating groups would have been 
excluded. Therefore, we proposed that, beginning with the CY 2022 
performance period/2024 MIPS payment year for the CAHPS for MIPS 
survey, we would remove patients who were sampled for the Spring ICH 
CAHPS survey from the sampling frames for CAHPS for MIPS. We stated 
that we expected this change would have only a minor impact on the 
CAHPS for MIPS sampling frame, but would increase response rates to the 
ICH CAHPS Survey and would avoid burdening patients with multiple 
surveys.
    We received public comments on the CAHPS for MIPS sampling 
specifications. The following is a summary of the comments we received 
and our responses.
    Comment: A few commenters expressed their support for our proposed 
updates to the CAHPS for MIPS sampling specifications.
    Response: We thank the commenter for their support.
    After consideration of the public comments, we are finalizing the 
change to the CAHPS for MIPS sampling specifications as proposed, and 
beginning with the CY 2022 performance period/2024 MIPS payment year 
for the CAHPS for MIPS survey, we will remove patients who were sampled 
for the Spring ICH CAHPS survey from the sampling frames for CAHPS for 
MIPS.
(iii) CAHPS for MIPS Case-Mix Adjustment Model
    Under CAHPS for MIPS, we adjust summary survey measure scores for 
case-mix to promote meaningful comparison of the performance of MIPS 
groups despite differences in their patient populations (81 FR 77120). 
The case-mix adjustment model for CAHPS for MIPS includes the following 
case-mix adjustors: Age; education; self-reported general health 
status; self-reported mental health status; proxy response; Medicaid 
dual eligibility; and eligibility for Medicare's low-income subsidy. 
The CAHPS for ACOs Survey included an additional adjustor, Asian 
language survey, following prior literature that recommended adjustment 
for Asian language surveys to account

[[Page 65445]]

for cultural differences that affect reporting. The CAHPS for MIPS 
case-mix adjustment model has historically not included this adjustor 
because no Asian language surveys have been administered. Because 
Shared Savings Program ACOs are fielding the CAHPS for MIPS survey as 
of the CY 2021 performance period/2023 MIPS payment year, we proposed 
beginning with the CY 2022 performance period/2024 MIPS payment year 
CAHPS for MIPS survey to add use of an Asian language survey as a case-
mix adjustor to the CAHPS for MIPS case-mix adjustment model. As we 
explained in the CY 2022 PFS proposed rule (86 FR 39395), use of an 
Asian language survey has been shown to be significantly associated 
with specific response patterns to a number of survey items that 
contribute to summary survey measures. In particular, Asian language 
survey respondents are generally less likely to use responses at the 
extremes of the scales, which tends to result in lower overall scores 
compared to patients who respond to English-language surveys. 
Therefore, it is important to retain use of Asian language survey as a 
case-mix adjustor for Shared Savings Program ACOs, and also appropriate 
to include it in the case-mix adjustment model for MIPS groups should 
Asian language surveys be completed for these groups in the future. 
Analysis of CY 2019 performance period/2021 MIPS payment year CAHPS for 
MIPS data found that adding the Asian language survey case-mix adjustor 
and pooling data from MIPS groups and Shared Savings Program ACOs for 
the purposes of case-mix adjustment had only a minimal impact on mean 
scores for MIPS groups, with scores increasing slightly as a result.
    We received public comments on the CAHPS for MIPS case-mix 
adjustment model. The following is a summary of the comments we 
received and our response.
    Comment: A few commenters supported the proposal to include the 
Asian language survey adjustor in the CAHPS for MIPS case-mix 
adjustment model.
    Response: We thank the commenter for their support.
    After consideration of the public comments, we are finalizing our 
proposal to add use of an Asian language survey as a case-mix adjustor 
to the CAHPS for MIPS case-mix adjustment model beginning with the CY 
2022 performance period/2024 MIPS payment year CAHPS for MIPS survey.
(iv) Scoring CAHPS for MIPS Summary Survey Measures
    The CAHPS for MIPS survey contains 10 summary survey measures 
(SSMs). Of these, 8 are benchmarked and scored while the other 2 
(Health Status and Functional Status and Access to Specialists) are 
unscored and included for informational purposes only. The latter 2 
measures had previously been scored but were changed to unscored 
starting with the CY 2018 performance period/2020 MIPS payment year (82 
FR 53720). While Health Status and Functional Status was changed to 
unscored because it assesses underlying characteristics of a group's 
patient population and is less of a reflection of patient experience of 
care with the group, the Access to Specialists SSM was changed to 
unscored due to historically low reliability and response rates. At the 
same time this change was made (CY 2018 performance period/2020 MIPS 
payment year), a shorter, streamlined version of the CAHPS for MIPS 
Survey was implemented (82 FR 53632). Since the implementation of the 
shortened survey, which included a reduction in the number of survey 
items that make up the Access to Specialists SSM, response rates and 
reliability for this SSM have improved dramatically, with over 80 
percent of MIPS groups achieving acceptable reliability on this SSM in 
the CY 2018, 2019, and 2020 performance periods/2020, 2021, and 2022 
MIPS payment years, compared to less than 20 percent in the CY 2017 
performance period/2019 MIPS payment year. Therefore, because CMS no 
longer had analytic concerns about scoring the measure, we proposed in 
the CY 2022 PFS proposed rule that beginning with the CY 2022 
performance period/2024 MIPS payment year for the CAHPS for MIPS 
survey, we would once again benchmark and score the Access to 
Specialists measure, which would mean there would be 9 SSMs included in 
the CAHPS for MIPS scoring process, with 1 SSM remaining unscored (86 
FR 39395). We solicited comments on this proposed change to the CAHPS 
for MIPS scoring process.
    We received public comments on the scoring of the CAHPS for MIPS 
summary survey measures. The following is a summary of the comments we 
received and our response.
    Comment: A few commenters supported the proposed change to the 
CAHPS for MIPS scoring process to include the Access to Specialists 
Summary Survey Measure (SSM).
    Response: We thank the commenter for their support.
    After consideration of public comments, we are finalizing our 
proposal that beginning with the CY 2022 performance period/2024 MIPS 
payment year for the CAHPS for MIPS survey, we will once again 
benchmark and score the Access to Specialists measure, which means 
there will be 9 SSMs included in the CAHPS for MIPS scoring process, 
with 1 SSM remaining unscored.
(2) Cost Performance Category
(a) Background
    We refer readers to the CY 2017 and CY 2018 Quality Payment Program 
final rules, and the CY 2019, CY 2020, and CY 2021 PFS final rules (81 
FR 77162 through 77177, 82 FR 53641 through 53648, 83 FR 59765 through 
59776, 84 FR 62959 through 62979, and 85 FR 84877 through 84881, 
respectively) for a description of the statutory basis and existing 
policies pertaining to the cost performance category.
    In the CY 2022 PFS proposed rule (86 FR 39395 through 39406), we 
proposed to add 5 new episode-based measures to the cost performance 
category beginning with the MIPS CY 2022 performance period/2024 MIPS 
payment year, and to update the operational list of care episode and 
patient condition groups and codes. Additionally, we proposed a new 
process for stakeholders to develop cost measures for MIPS. Finally, we 
proposed to establish criteria for determining whether a cost measure 
change is considered substantive starting with the MIPS CY 2022 
performance period/2024 MIPS payment year. These proposals are 
discussed in more detail in the following sections.
(b) 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 category. We would continue to 
evaluate cost measures that are included in MIPS on an ongoing basis 
and anticipate that measures could be added, modified, or removed 
through rulemaking as measure development continues. Any substantive 
changes to a measure would be proposed for adoption in future years 
through notice and comment rulemaking, following review by the Measure 
Applications Partnership (MAP). The MAP is a multi-stakeholder 
partnership that provides guidance to CMS on performance measures for 
use in Federal health programs--more information is available at 
https://

[[Page 65446]]

www.qualityforum.org/Setting_Priorities/Partnership/
Measure_Applications_Partnership.aspx. The MAP provides an additional 
opportunity for an interdisciplinary group of stakeholders to provide 
feedback on whether they believe the measures under consideration are 
applicable to clinicians and complement program-specific statutory and 
regulatory requirements. Through its Measure Selection Criteria, the 
MAP focuses on selecting high-quality measures that address the 
National Quality Strategy's (NQS) three aims of better care, healthy 
people/communities, and affordable care, as well as fill critical 
measure gaps and increase alignment among programs.
    We will take all comments and feedback from both the public comment 
period and the MAP review process into consideration as part of the 
ongoing measure evaluation process. Some modifications to measures used 
in the cost performance category might incorporate changes that would 
not substantively change the measure. Examples of such non-substantive 
changes may include updated telehealth service codes, diagnosis or 
procedure codes or risk adjustors. While we address such changes on a 
case-by-case basis, we generally believe these types of maintenance 
changes are distinct from substantive changes to measures that result 
in what are considered new or different measures. However, as described 
in section 7 of the Blueprint for the CMS Measures Management System 
Version 16.0 (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf), if substantive 
changes to these measures become necessary, we expect to follow the 
pre-rulemaking process for new measures, including resubmission to the 
Measures Under Consideration (MUC) list and consideration by the MAP.
    In sections IV.A.3.d.(2)(b)(ii) through IV.A.3.d.(2)(b)(iii) of 
this final rule, we summarize the new measures that will be included in 
the cost performance category for the MIPS CY 2022 performance period 
and future performance periods. For the new chronic condition episode-
based measures, we provide detail about the measure framework, which 
lets attributed clinicians or clinician groups know the cost of care 
that is clinically related to their management of a patient's chronic 
condition during an episode of care (``episode''). For more information 
regarding the measure development timeline for the new episode-based 
measures, we refer readers to the overview in the CY 2022 PFS proposed 
rule (86 FR 39396 through 39397).
(ii) New Episode-Based Measures for CY 2022 and Future Performance 
Periods
    In this section of this final rule, we discuss the 5 new episode-
based measures, including 2 new chronic condition measures, which we 
proposed to add for the MIPS CY 2022 and future performance periods. 
These measures are listed in Table 52. The acute inpatient medical 
condition and procedural measures are based on the previously 
established framework for episode-based measures, which we described in 
detail in the CY 2019 PFS final rule (83 FR 59767 through 59773).
    Chronic condition episode-based measures expand on the previously 
established framework for episode-based measures to address unique 
factors inherent to the continuous nature of chronic disease care 
management. In section IV.A.3.d.(2)(b)(iii) of this final rule, we 
provide detail about the proposed episode definition and attribution 
methodology for chronic condition episode-based measures. After chronic 
condition episodes are defined and attributed to a clinician group and, 
or individual clinician, we include items and services furnished during 
the episode that are clinically related to the care and management of a 
patient's chronic condition. Items and services may include treatment 
and diagnostic services, ancillary items (such as medical nutrition 
therapy and refining and maintenance of a portable pump for diabetes), 
services directly related to treatment, and those furnished as a 
consequence of care. The two chronic condition measures specified in 
this final rule are calculated using claims data from Medicare Parts A, 
B, and D. Part D costs are included to account for the full range of 
treatment options used to manage chronic conditions. As with Part A and 
B payment standardization, Part D costs are standardized to facilitate 
meaningful comparisons of resource use within the market-based Medicare 
Part D program by accounting for non-clinical variation in costs. For 
more detail, the Part D payment standardization methodology is 
available at https://resdac.org/articles/cms-price-payment-standardization-overview. The Medicare Parts A and B payment 
standardization methodology is also available at https://resdac.org/articles/cms-price-payment-standardization-overview.
    Similar to other episode-based measures, chronic condition measures 
include features intended to ensure a more accurate comparison of costs 
across clinicians. First, we stratify the patient population captured 
by the measure into smaller, clinically similar patient cohorts. For 
example, the Diabetes measure separates patients with type 1 and type 2 
diabetes, and the risk adjustment model is assessed at the level of 
each stratification to ensure that only patients with similar case 
mixes are compared to each other. We note that the term 
``stratification'' will be used to describe a portion of a group in 
relation to the cost performance category and that such term is 
synonymous with the term ``episode sub-group'' used in the cost measure 
specification documents and other documents related to the cost 
performance category. In general, unless otherwise indicated, the term 
``episode sub-group'' used in the cost measure specification documents 
and other documents related to the cost performance category has a 
different meaning than the term ``subgroup'' that we define under Sec.  
414.1305 in this final rule. Second, we standardize episode costs to 
limit observed differences in costs to those that may result from 
health care delivery choices. Third, we exclude unique groups of 
patients from episodes where it may be unreasonable to compare the 
costs of these patients to the whole cohort. Last, the measures account 
for patient characteristics that can influence spending and are outside 
of a clinician's control using risk adjustment. For example, the risk 
adjustment model is run separately for patients with and without 
enrollment in a Part D drug plan to account for differences in costs 
that we might observe between patients enrolled in Part D and those who 
are not. In addition, the risk adjustment model for chronic condition 
episode-based measures specified in this rule account for a patient's 
status as a dual Medicare and Medicaid enrollee. This was based on 
testing demonstrating that dual status had a notable impact on 
performance for the two measures. For more information on the chronic 
condition episode-based measure framework, we refer readers to the 
Chronic Condition Cost Measure Framework located at https://www.cms.gov/files/document/chronic-condition-cost-measure-framework-poster.pdf.
    The specifications for all 5 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 measure consist of a methods document

[[Page 65447]]

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 details about 
components of episode-based measures: Identifying patients receiving 
care, defining an episode-based measure, attributing episodes to 
clinicians and clinician groups, assigning costs, defining exclusions, 
risk adjusting, and calculating measure score. For each measure 
component, the methods document provides detailed methodology 
describing each logic step involved in constructing the measure. For 
the chronic condition episode-based measures, the specifications also 
include an appendix to the methods document which provides additional 
detail on particular components of the measure construction framework, 
including the sub-grouping methodology, episode construction and 
calculation, and attribution to individual clinicians. Second, the 
measure codes list contains the codes used in the measure 
specifications, including the episode triggers, attribution, sub-
groups, assigned items and services, exclusions, and risk adjustors.
    More information about the 5 proposed episode-based measures is 
available in the measure justification forms, the national summary data 
report, and the national summary data report addendum with risk 
adjustment regression results. These documents are available through 
the MACRA Feedback Page (https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Give-Feedback).
    In the CY 2022 PFS proposed rule (86 FR 39395 through 39406), we 
solicited public comments on the 5 proposed episode-based measures, 
which are listed in Table 52.
[GRAPHIC] [TIFF OMITTED] TR19NO21.075

    We summarize and respond to the public comments on the proposed 
episode-based measures, which are listed in Table 52, after the 
discussion of the attribution for the new episode-based measures (that 
is, in section IV.A.3.d.(2)(b)(iii) of this final rule).
(iii) Attribution
    In this section of this final rule, we discuss the attribution 
methodology for the episode-based measures. In the CY 2020 PFS final 
rule (84 FR 62962), we established at Sec.  414.1350(b)(8) that 
beginning with the CY 2020 performance period/2022 MIPS payment year, 
each cost measure is attributed according to the measure specifications 
for the applicable performance period. For the proposed acute inpatient 
medical condition and procedural episode-based measures outlined in 
Table 52, we refer readers to the measure specifications for the 
attribution methodology, available at https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Give-Feedback. For the 
proposed chronic condition measures, we use a new attribution framework 
for identifying and confirming a clinician-patient relationship, which 
we discuss below. For further detail regarding the specific attribution 
methodology for the proposed Asthma/COPD and Diabetes measures, we 
refer readers to the measure specifications for each measure, available 
at https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Give-Feedback.
    For chronic condition episode-based measures, we would attribute 
episodes to the clinician group that renders the services that 
constitute a trigger event, which is identified by the occurrence of 
two claims billed in close proximity by the same clinician group. Both 
claims must have a diagnosis code indicating the chronic disease 
captured by the measure (for example, type 1 or type 2 diabetes for the 
Diabetes episode-based measure). In the CY 2022 PFS proposed rule (86 
FR 39398), we stated that the first claim must have an E/M code for 
primary care services and the second claim must have either another E/M 
code for primary care services or a condition-related HCPCS/CPT code 
for procedure codes related to the treatment or management of the 
chronic condition. In this final rule, for the chronic condition 
episode-based measures (the Asthma/COPD measure and the Diabetes 
measure referenced in Table 52), we are replacing the term ``primary 
care services'' with the term ``outpatient services''. We are 
describing these trigger E/M services as ``outpatient'' rather than 
``primary care'' in order to more accurately characterize the nature of 
the specific E/M codes by referencing the setting rather than a nature 
of care. We believe that the revised terminology will be more readily 
understandable. There are no changes to the codes themselves being used 
in the trigger methodology. We intend to use such revised terminology 
in the chronic condition episode-based measure specifications, and any 
other future measures that use the same set of E/M codes, as well as 
other documents related to the cost performance category starting with 
the CY 2022 performance period/2024 MIPS payment year. 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 
disease. The initiation of the attribution window at the onset of the 
trigger event ensures that costs are attributed only after the start of 
the clinician-patient relationship. We could extend the initial 
attribution window and the clinician group's responsibility by another 
year each time we see additional E/M codes for outpatient services or 
condition-related HCPCS/CPT codes for procedure codes related to the 
treatment or management of the chronic condition that indicate an 
ongoing clinician-patient relationship. Therefore, the resulting total 
attribution window could span multiple years and vary in length for 
different patients. Because the total attribution window could span 
multiple performance periods, we measure it

[[Page 65448]]

incrementally and periodically by dividing it into segments of 
episodes, which we assess in the performance period in which they 
conclude. Dividing the total attribution window into episodes allows us 
to assign costs during the time-period in which the clinician group is 
responsible for the patient's chronic condition care management.
    After we identify the attributed clinician group as described in 
the previous paragraph, we would attribute the episode to individual 
clinician(s). For individual clinicians, we would attribute episodes to 
each MIPS eligible clinician within an attributed clinician group that 
renders at least 30 percent of qualifying services during the episode. 
Qualifying services include E/M codes for outpatient services or 
condition-related HCPCS/CPT codes with a relevant chronic condition 
diagnosis. We would employ two additional checks to confirm the 
qualifying clinician's role in the ongoing management of the patient's 
chronic condition. First, we would check to ensure that the qualifying 
clinician(s) have rendered at least one E/M code for outpatient 
services or condition-related HCPCS/CPT code with a relevant diagnosis 
within 1 year prior to or on the episode start date. This ensures that 
clinicians are not attributed an episode before they have their first 
encounter with the patient. Second, we would check whether the 
clinician(s) have written at least 2 condition-related prescriptions on 
different days to two different patients during the performance period 
plus a one-year lookback period. The use of these prescription billing 
patterns would ensure that we are capturing the clinicians actually 
involved in providing ongoing chronic care management, rather than 
clinicians who may have only refilled a patient's prescription once, as 
a courtesy. MIPS eligible clinicians within an attributed clinician 
group that render at least 30 percent of qualifying services and meet 
the two additional checks are considered for attribution. The 
individual clinician's performance is based on all of the episodes 
attributed to the individual clinician, whereas the clinician group's 
performance is based on all of the episodes attributed to the clinician 
group. If a single episode is attributed to multiple clinicians in a 
single clinician group, the episode is only counted once toward the 
clinician group's performance. Additional detail for this attribution 
methodology is available in the measures specifications for the 
Diabetes and Asthma/COPD measures located on the MACRA Feedback Page at 
https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Give-Feedback.
    To illustrate the attribution rules for chronic condition episode-
based measures, we provide an example of a clinical scenario where 3 
MIPS eligible clinicians (A, B, and C) are part of the same clinician 
group. A patient with type 2 diabetes presents to the clinician group 
to receive services related to their condition. Clinician A bills an 
initial E/M code for outpatient services related to the patient's 
diabetes (for example, an office/outpatient visit related to the 
patient's diabetes). During a follow-up appointment two weeks later, 
Clinician A bills a HCPCS/CPT code for tests related to the patient's 
diabetes. We consider the occurrence of these two services to 
constitute a trigger event indicating the start of a clinician-patient 
relationship. This trigger event opens a 1-year attribution window from 
the date of the initial E/M service and the clinician group that 
rendered the trigger event services would be attributed the Diabetes 
episode. If in this example, there were a total of 10 clinically 
related services captured during the episode, and Clinician A rendered 
5 of those services, Clinician B rendered 2, and Clinician C rendered 3 
of those services, then Clinicians A and C would be considered for 
attribution since they would have rendered at least 30 percent of 
qualifying services for the patient. Clinician B would not be 
considered for attribution. Before attributing the episode to 
Clinicians A and C, we check (i) whether the clinicians billed at least 
1 E/M code for outpatient services or condition-related HCPCS/CPT code 
with a relevant diabetes diagnosis within 1 year prior to or on the 
episode start date and (ii) whether they wrote 2 diabetes-related 
prescriptions on different days for 2 different patients during the 
performance period plus a one-year lookback period. Assuming Clinician 
A met these two checks and Clinician C did not, then only Clinician A 
would be attributed this Diabetes episode. This episode would count 
towards the Diabetes measure's case minimum for Clinician A, but not 
for Clinicians B or C. At the group reporting level, the episode will 
be included in the calculation of the clinician group's measure score 
and would count towards the measure's case minimum for the clinician 
group.
    The MAP considered these new episode-based measures in detail. For 
a full discussion on the MAP's evaluation of the measures, please see 
the description in the CY 2022 PFS proposed rule (86 FR 39399 through 
39401).
    We received public comments on the 5 new episode-based measures 
proposed in the CY 2022 PFS proposed rule (86 FR 39395 through 39403), 
which are listed in Table 52. The following is a summary of the 
comments we received and our responses.
    Comment: Many stakeholders supported our proposal to include the 5 
new episode-based measures in the MIPS program starting with MIPS CY 
2022 performance period/2024 MIPS payment year. One commenter expressed 
appreciation for the transparent and efficient measure development 
process that incorporated input from various stakeholders through 
several different committees. Another commenter supported the 
development of episode-based measures as these include only the costs 
within the reasonable influence of the clinician.
    Response: We thank commenters for their support of the measures and 
the robust measure development process.
    Comment: Several commenters stated that there are no episode-based 
measures applicable to their specialties and also expressed concern 
that the population-based measures are not well-suited to assess the 
care provided within their specialty. Commenters highlighted the 
following specialties as needing cost measures: Occupational 
therapists, rheumatologists, radiologists, emergency clinicians. 
Commenters also provided suggestions of potential measure concepts 
within each respective scope of care. These include breast cancer 
screening or incidental findings from imaging for diagnostic 
radiologists, and a measure for clinical screening, diagnostic testing, 
and stabilization in the emergency department. One commenter believes 
that additional cost measures are needed for retina specialists, and 
another commenter requested the development of a low back pain measure 
to support the Low Back Pain MVP. One commenter urged CMS to develop 
more episode-based cost measures as rapidly as possible to address gaps 
in measurement.
    Response: We thank commenters for their input and will take these 
suggestions into consideration during future waves of measure 
development. One of the criteria that we consider in prioritizing 
measure development is to address measurement gaps. When identifying 
measurement gaps, we consider clinical areas where specialties are not 
captured by the current set of measures. We have started to work on 
addressing these gaps that the commenters have identified. We note

[[Page 65449]]

that while there is no MVP specific to low back pain proposed in the CY 
2022 PFS proposed rule, there are measures under development that 
address the management of low back pain (including the care provided by 
therapists) and focus on emergency medicine care. We expect the 
measures to undergo field testing in early 2022 and encourage 
stakeholders to provide feedback on those measures during that period. 
Future waves of measure development will also consider measurement gaps 
and the needs of potential MVPs. We also take into account other 
factors in measure prioritization, such as the opportunities for 
improvement and the potential for impact by covering a large share of 
Medicare cost. Additionally, we disagree that the population-based 
measures are not well-suited to assess care. As broadly applicable cost 
measures, the total per capita cost and Medicare Spending Per 
Beneficiary Clinician measures encourage clinicians to coordinate with 
other clinicians while treating a patient to improve overall cost 
performance. We also note that stakeholders can engage in their own 
cost measure development to submit measures (please see more 
information on the cost measure development process by stakeholders in 
section IV.A.3.d.(2)(c) of this final rule. As part of this process, we 
would publish materials outlining measurement gaps. Stakeholders can 
find summary of feedback on specific cost measurement gaps in the Wave 
4 Public Comment Summary Report (https://www.cms.gov/files/document/wave-4-public-comment-summary.pdf) available on the MACRA Feedback 
page, and in the July 2021 Physician Cost Measures and Patient 
Relationship Codes TEP Summary Report (https://www.cms.gov/files/document/physician-cost-measures-and-patient-relationship-codes-pcmp-technical-expert-panel-summary-report.pdf) available on the CMS' TEP 
Current Panels website.
    Comment: One commenter stated that the current measure development 
process is structured in a way that requires clinical experts to follow 
a single framework that does not account for the clinical condition or 
patient population, so the commenter disagreed that physician cost, 
quality and value of care can be evaluated using this approach. One 
commenter appreciated that CMS is introducing MIPS Value Pathways to 
better align cost and quality measures.
    Response: We disagree with the commenter that the framework used to 
develop episode-based measures does not take into account the condition 
or patient population of interest. Episodes span a wide range of 
clinician-patient relationships, including acute inpatient conditions 
(for example, pneumonia hospitalization), chronic diseases (for 
example, diabetes management), and procedures (for example, hip 
replacement surgery), and the corresponding cost measure frameworks 
account for the differences in these clinician-patient relationships. 
Additionally, clinical subcommittees provide detailed input on measure 
specifications, which often include the components of the measure 
framework. Currently, there are 5 types of episode groups that serve as 
the basis for cost measures: (i) Procedural; (ii) acute inpatient 
medical condition; (iii) chronic conditions; (iv) therapy; and (v) 
emergency medicine. Please note that the therapy and emergency medicine 
frameworks are currently in development, and will undergo field testing 
in early 2022.
    Additionally, to account for heterogeneity for patients with 
different cost profiles, we use various methods, such as episode 
subgroups (to compare episodes only with other episodes within that 
same episode subgroup), measure-specific risk adjustors (to predict 
expected episode cost based on patient or other characteristics that 
are out of the clinicians' reasonable influence and that may have an 
effect on episode cost), and episode-level exclusions (to remove 
episodes due to events or characteristics observed prior to or during 
the episode). Additionally, episode-based cost measures focus on 
resource use related to the treatment of a specific condition or 
procedure, by only including costs related to the condition under 
evaluation and attribute to multiple clinicians involved in this care, 
promoting collaborative care.
    Finally, we agree with the commenter that to assess value, one 
needs to determine both quality and costs of care, and we appreciate 
the commenter acknowledging that CMS is introducing MIPS Value Pathways 
that would align episode-based measures with related quality measures. 
We agree with the importance of the MVPs as this alignment between 
episode-based measures and related quality measures will help further 
incentivize the transition from FFS to value-based care. As part of the 
new cost measure development process (please see section 
IV.A.3.d.(2)(c) of this final rule for more information), we encourage 
cost measures to be developed in a way that links and aligns cost and 
quality together to drive value, particularly in consideration of MVP 
development, while maintaining CMS priorities and meeting the 
standards/criteria outlined for cost measure development. The episode-
based cost measures provide a nuanced examination of resource use that 
can be used alongside quality metrics to identify opportunities to 
improve the value by capturing costs that are clinically related to the 
care being delivered within a given patient-clinician relationship of 
care delivered to patients.
    Comment: Some commenters stated that the measures should include 
social risk factors in the risk adjustment model. A commenter suggested 
that CMS explore alternative risk adjustment methodologies that do not 
rely on the HCC scores, while another stated that they believed that 
the risk adjustment model has not been adequately developed by CMS for 
cost measures.
    Response: Each measure's risk adjustment model employs a common 
starting point of the CMS-HCC model, but the measure-specific expert 
workgroups considered enhancements to the model through the addition of 
risk factors specifically adapted for each episode group. The measure 
development contractor provided empirical analyses stratifying patient 
(or episode) cohorts of interest to inform the workgroup members' 
considerations of how particular factors should be accounted for in 
each measure's risk adjustment model. Workgroup members also considered 
patient characteristics, factors outside of the influence of the 
attributed clinicians, or any other measure-specific factors that would 
help prevent unintended consequences. We will continue to consider 
incorporating additional data sources in risk adjustment and welcome 
feedback on potential alternatives.
    We consider the inclusion of social risk factors in risk adjustment 
based on the testing results for each measure. The Asthma/COPD and 
Diabetes cost measures include a risk adjustor for dual eligibility. 
This is based on extensive testing during the measure development 
process where these two chronic condition measures showed a greater 
impact from social risk factors than other measures. The measure 
development contractor conducted analyses to assess the impact of the 
following social risk factors: Income, education, employment, race, 
sex, and dual-eligibility status. For the Sepsis, Melanoma Resection, 
and Colon and Rectal Resection measures, the inclusion of social risk 
factors had minimal impact on the measures. For the two chronic 
condition measures, dual eligibility had an impact on the

[[Page 65450]]

measures; the other social risk factors tested had minimal impact 
beyond dual eligibility. Based on these results, we believe that it is 
necessary and appropriate to adjust for dual eligibility for the 
Asthma/COPD and Diabetes cost measures. Discussion of these results can 
be found in the measure justification form for the 5 episode-based 
measure on the MACRA Feedback Page (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html). We will continue to 
monitor the effect of social risk factors on the measures on an ongoing 
basis.
    Comment: Two commenters stated that the attribution method has not 
been adequately developed by CMS for cost measures, but did not provide 
additional detail.
    Response: We appreciate the concern, and note that the attribution 
methodology has been developed with extensive stakeholder input to 
ensure that it captures clinician-patient relationships for the 
specific type of care being assessed. For instance, the attribution 
methodology for the Diabetes and Asthma/COPD measures reflects input 
from a TEP on the overall methodology and from a specific workgroup for 
each of the measures to determine details such as the list of codes to 
identify the start of a care relationship for the condition of focus. 
We encourage stakeholders to review the measure specifications, testing 
materials, and meeting summaries if there are additional concerns about 
the development of the attribution methodology for the cost measures.
    Comment: One commenter stated that the most appropriate level of 
attribution for the measures is at the group practice/clinical team 
level.
    Response: Generally, clinicians participating in MIPS can choose 
whether to report at the individual clinician or clinician group level. 
Thus, we believe it is important to allow for cost assessment at both 
levels of reporting, so the cost measures contain both individual 
clinician and clinician group level attribution methodologies.
    Comment: Several commenters agreed with the comments brought up by 
the MAP (that is, correlations with quality measures, NQF endorsement, 
impact of upstream/high quality care and downstream costs) for the 
Diabetes, Asthma/COPD, and Sepsis measures. One commenter indicated 
that those concerns from the MAP need to be carefully monitored. 
Another commenter urged CMS to make NQF endorsement mandatory prior to 
finalizing any measures in the MIPS program. One commenter expressed 
concern about the cost measures used in the MIPS cost performance 
category in general, and asked CMS to not finalize the 5 new episode-
based measures at this time. Finally, another commenter requested 
additional analyses for all cost measures in development that would 
look into the relationship between the cost and related quality 
measures. The commenter also stated that the cost measures need to be 
more actionable, and that CMS did not directly address one of the MAP's 
concerns for the Asthma/COPD and Diabetes measures on the examples of 
the connection between upstream medical interventions and downstream 
costs, as CMS did not provide any supporting data.
    Response: We believe we have addressed the concerns raised by the 
MAP (as discussed in detail at 86 FR 39399 through 39401 of the 
proposed rule). The MAP's mitigation factors focused largely on 
testing, the results of which are publicly available in the testing 
updates document available on the MACRA Feedback Page (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html). These results directly address the concerns raised by 
the MAP regarding the relationship between cost and quality metrics, 
coding variation for the Sepsis measure, and clarifying that the role 
of cost measures is not to dictate clinical practice but to accurately 
reflect it. To address the MAP's mitigation point of NQF endorsement, 
we plan to submit all 5 episode-based measures to a future endorsement 
cycle; however, NQF endorsement is not required for cost measures to be 
implemented in the program. We believe that the extensive testing 
(including national field testing), expert clinician input, feedback 
from individuals with lived experiences of the conditions in question, 
the NQF's review through the MAP pre-rulemaking process that focuses on 
the use of the measure within a program, and numerous opportunities for 
public comment ensure that the newly developed measures are ready for 
implementation in MIPS. Given this robust development, testing, and 
review processes, we do not believe it appropriate to delay 
implementation for further NQF review.
    We consider the importance of care that is assessed by the 
Diabetes, Asthma/COPD, and Sepsis episode-based measures, the potential 
for these measures to be impactful given the number of episodes, and 
the need for more episode-based measures, and believe that these 
measures play an important role in expanding the MIPS cost measure 
inventory and in moving towards the statutory goal of covering 50 
percent of Medicare Parts A and B spending. Finally, we thank the 
commenter for the suggestion to conduct more extensive analyses looking 
at the relationship between cost and quality measures, including 
examining the correlations for clinicians with low versus high cost or 
quality measure scores. Regarding actionability of the measures and 
providing supporting data to address the MAP's concern about the 
connection between upstream medical interventions and downstream costs, 
we would like to clarify that we gathered input from expert clinicians 
and available literature to outline the opportunities that clinician 
have to take action and improve their performance on the Asthma/COPD 
and Diabetes measures. For more information please see the Measure 
Justification Forms available on the MACRA Feedback Page (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html). This document cites evidence for the measures' focus 
based in clinical guidance and current literature.
    Comment: A few commenters stated that episode-based cost measures 
are more appropriate to measure clinician performance on cost than the 
population-based measures, specifically the total per capita cost 
measure. Specifically, some commenters have concerns over the 
attribution methodology for the population-based measures (total per 
capita cost and Medicare Spending Per Beneficiary Clinician) and the 
lack of control clinicians have over these measures. One commenter 
believes that clinicians could be unfairly penalized for successfully 
improving the utilization of recommended preventive services if total 
per capita costs are measures in the same year as those services are 
provided.
    Response: We continue to believe that the total per capita cost and 
Medicare Spending Per Beneficiary Clinician measures provide an 
important measurement of clinician cost performance (82 FR 53644) and 
that the measures intent to capture broad, overall care plays a 
significant role in MIPS to complement the more granular information 
captured by episode-based measures. By including both episode- and 
population-based measures in the cost performance category, we are able

[[Page 65451]]

to capture more aspects of care and ensure that there is continuity in 
clinician incentives throughout a patient's care trajectory. Both the 
total per capita cost and Medicare Spending Per Beneficiary Clinician 
measures have an important place in cost measurement given that the 
episode-based measures will only apply to a subset of clinicians at 
this time. As broadly applicable cost measures, the total per capita 
cost and Medicare Spending Per Beneficiary Clinician measures encourage 
clinicians to coordinate with other clinicians while treating a patient 
to improve overall cost performance. By holding multiple clinicians 
accountable under the total per capita cost measure, this promotes 
shared responsibility for a patient's care across primary care and 
specialties who tend to provide ongoing care. It also includes a 
specialty adjustment to account for the different scope of care 
provided by primary care clinicians and specialists. We disagree that 
the total per capita cost measure would unfairly penalize a clinician 
for improving the use of preventive services. The total per capita cost 
measure assesses clinicians' performance for one year following an 
attribution event, so these longer attribution windows allow the 
measure to capture the long-term benefits of ongoing primary care 
management that might not be fully realized within a short period. 
Using the example from the comment, preventive care services could 
increase costs when initially provided but could lower costs when 
measured over a sufficiently long time as downstream costs that usually 
result from lack of preventive care may be avoided. Additionally, to 
address stakeholder concerns about clinicians being held accountable 
for care that is outside their control, the Medicare Spending Per 
Beneficiary Clinician measure implemented a set of service exclusions. 
For example, the measure excludes the cost of all hospice services 
occurring at any time during the episode window. There are also a set 
of service exclusions specific to each Major Diagnostic Category (MDC) 
to remove the cost of some unrelated services. The measure also has a 
revised attribution methodology that involves separate attribution 
methods for medical and surgical episodes to identify the clinicians 
who are providing inpatient care. For medical episodes, the measure 
requires that the TIN bill at least 30 percent of inpatient E&Ms to 
focus on clinician groups that play a substantial role in inpatient 
care. For surgical episodes, the measure attribution is based on the 
clinician billing the procedure code. This attribution methodology 
appropriately identifies the clinicians who are providing care and 
reflects the team-based nature of hospital care. Internal medicine 
clinicians have the largest share of episodes (46 percent), followed by 
hospitalists (19 percent).
    Comment: One commenter urged CMS to recognize that the episode-
based measures used in MIPS are valid only for a certain period of 
time, when they are developed, and that these measures do not account 
for the changes in treatments that happen over time.
    Response: We disagree with the comment that cost measures are only 
valid when they are newly developed. All cost measures undergo a 
measure maintenance process (including annual updates and comprehensive 
re-evaluation) that ensures that measures continue to meet program 
goals and priorities. This process balances the need to ensure that 
cost measures continue to meet the measure intent with the priority of 
providing certainty to stakeholders of what a cost measure entails by 
avoiding making unnecessary changes, such as those that are not 
substantiated by evidence. During annual measure updates, we identify 
potential updates and assess the nature of these updates to determine 
the appropriate process for implementing substantive and non-
substantive changes. These updates take into consideration any changes 
in payment policies or clinical practices and treatments based on 
environmental scans, literature searches, stakeholder feedback, and 
empirical testing. The comprehensive re-evaluation process occurs on a 
3-year cycle that is in line with the NQF endorsement maintenance 
processes and aligns with the CMS Blueprint for measure development.
    Comment: One commenter urged CMS to consider a triggering method 
under which chronic condition episodes would not be triggered by an 
inpatient stay, so that costs could be included even when an inpatient 
stay does not occur.
    Response: We appreciate this comment on the newly developed chronic 
condition framework. To clarify, the chronic condition episode-based 
measure framework does not require an inpatient stay to identify the 
start of a clinician-patient relationship. Instead, since chronic 
condition are by definition ongoing, we require two services specific 
to the care of the condition to occur within a certain period of time 
(that is, 180 days). One must be a clinician visit, and the other can 
be either another visit or a service for the treatment of the 
condition. For example, for the Diabetes measure, these codes could be 
(i) an office/outpatient visit where the clinician group confirms the 
patient's type 1 diabetes diagnosis, and (ii) a diabetes self-
management training for the patient's' type 1 diabetes. Please find 
more information on what codes are used to identify the start or 
continuation of a clinician-patient relationship in the measure-
specific codes list files available on the MACRA Feedback page (https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Give-Feedback).
    Comment: A few commenters opposed the inclusion of Medicare Part D 
prescription drug costs in the cost measures, as they stated they 
believe that including those costs would hold attributed physicians 
accountable for factors that are outside of their control, given that 
clinicians are not involved in the negotiations of formularies, 
coverage, and prices. One commenter also opposed the inclusion of 
Medicare Part B prescription drug costs in the cost measures, noting 
that inclusion of those costs would penalize physicians for costs over 
which they have no control.
    Response: During the measure development process, our technical 
expert panel and measure-specific workgroup members recommended the 
inclusion of Part D costs in measures where Part D prescription drugs 
are a primary component of care for the relevant condition (for 
example, the Asthma/COPD, Diabetes, and Sepsis measures). For example, 
our analyses showed this was the case for the Diabetes measure, with 
results showing that 71 example of episodes contained Part D services 
in the episode window and more than 48 percent of episodes including 
Part D services were billed by an attributed clinician. Furthermore, 
analyses showed that approximately 62 percent of clinicians observe a 
change in measure score decile when Part D costs are added to the 
measure. Similarly, measure-specific workgroups have advised on 
including Medicare Part B prescription drugs in measures when 
clinically appropriate.
    Importantly, the measures include Part B and Part D costs that have 
been standardized to remove price variation from non-clinical factors. 
For Part D costs specifically, by removing this variation, the measures 
(and the underlying standardization methodology) address concerns 
expressed by stakeholders during measure field testing that clinicians 
could be penalized during performance measurement for lacking control 
or awareness of drug pricing details set by plan and manufacturer 
negotiations. For

[[Page 65452]]

more detail, 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.
    Comment: One commenter supported the inclusion of the Melanoma 
Resection measure in the MIPS program, as this measure would provide 
dermatologists an opportunity to fully participate in the MIPS program.
    Response: We thank the commenter for their support.
    Comment: A few highlighted the need to ensure that episode-based 
measures do not penalize clinicians for prescribing new and innovative 
medicines. Some commenters specifically stated this concern for the 
Melanoma Resection measure. One stakeholder recommended the removal of 
Lifileucel, a tumor-infiltrating lymphocyte (TIL) cell therapy from the 
measure as it could discourage clinicians from using this drug.
    Response: Lifileucel is not included in the Melanoma Resection 
measure. The measure's focus is on resectable melanoma, not for 
treatment of advanced metastatic disease. For instance, the measure 
does not include any costs of chemotherapy or immunotherapy services.
    More generally, as innovative drugs and treatments become 
available, we consider them on a case-by-case basis for each measure 
and whether they are clinically related to the condition in question 
and whether they are needed to help the measures accurately capture an 
episode of care. As cost measures include other types of care beyond 
direct treatment such as downstream complications, they are able to 
capture improvements that might result from the use of the innovative 
treatments. As with all other aspects of measure development, we 
consider unintended consequences and monitor for these through the 
maintenance processes. Finally, clinician and clinician group 
performance on cost measures is balanced with their performance on 
quality measures at the MIPS score level to capture the overall value 
of care provided to their patients.
    Comment: One commenter supported the inclusion of the Sepsis 
episode-based measure in the MIPS program, as sepsis is an appropriate 
area of focus given the high impact on the patient population and 
Medicare costs.
    Response: We appreciated the commenter's support for the measure.
    Comment: One commenter noted optimism about the Asthma/COPD and 
Diabetes episode-based measures and was looking forward to potential 
endorsement of the measures by NQF.
    Response: We intend to submit the episode-based measures for NQF 
endorsement in a future endorsement cycle.
    Comment: One commenter did not support the inclusion of the Asthma/
COPD measure, and stated they believe it needed additional testing, and 
was complex and difficult to use; therefore, the commenter urged CMS to 
postpone the measure's implementation until 2023. The commenter urged 
CMS to consider the impact of the U.S. West Coast wildfires that placed 
additional burden on physicians caring for beneficiaries with asthma 
and COPD, given that those patients required more intensive resource 
use.
    Response: We believe that the measure is ready for implementation 
as it has undergone a rigorous development, testing, and review 
process. The Asthma/COPD measure was developed over a period of 18 
months involving over 80 technical experts during 4 in-person and 
virtual meetings, input from a panel of patients and caregivers, and a 
national field testing. We continue to welcome feedback on how the 
field-testing period and the development process can be further refined 
to increase clinician familiarity with this and other cost measures. We 
also appreciate the commenter's concerns about the Asthma/COPD measure, 
particularly the increased burden on caring for patients with asthma 
and COPD due to the west coast wildfires. Under the regulations at 
Sec.  414.1380(c)(2)(i)(A), clinicians who are subject to extreme and 
uncontrollable circumstances may submit an application to reweight the 
cost performance category. In the CY 2018 PFS final rule (82 FR 53780 
through 53781), we define ``extreme and uncontrollable circumstance'' 
as '' rare (that is highly unlikely to occur in a given year) events 
entirely outside the control of the clinician and of the facility in 
which the clinicians practices that cause the MIPS eligible clinician 
to not be able to collect information that the clinician would submit 
for a performance category or to submit information that the clinician 
would submit for a performance category for an extended period of 
time.'' Natural disasters, including wildfires, are examples of such 
rare events. For more information, please reference the CMS QPP web 
page (https://qpp.cms.gov/mips/exception-applications#extremeCircumstancesException-2021).
    After consideration of public comments, we are finalizing the 5 
proposed episode-based measures listed in Table 52 as proposed.
(iv) Revisions to the Operational List of Care Episode and Patient 
Condition Groups and Codes
    Section 1848(r) of the Act specifies a series of steps and 
activities for the Secretary to undertake to involve the physician, 
practitioner, and other stakeholder communities 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, 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 
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 stakeholders, 
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 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 stakeholders.
    In December 2016, we published the Episode-Based Measure 
Development for the Quality Payment Program (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Draft-list-of-episode-groups-and-trigger-codes-December-2016.zip) and solicited input on a draft list of 
care episode and patient condition groups and codes as required by 
sections 1848(r)(2)(E) and (F) of the Act. In accordance with section 
1848(r)(2)(G) of the Act, in January 2018, we posted an operational 
list of 8 care episode groups and patient condition groups, which is 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2018-Operational-List-of-Care-Episode-and-Patient-Condition-Codes.zip. Under 
section 1848(r)(5)(A)(iii) of the Act, to evaluate the resources used 
to treat patients with respect to care episode and patient condition 
groups, the Secretary shall, as the Secretary

[[Page 65453]]

determines appropriate, conduct an analysis of resource use with 
respect to care episode and patient condition groups. In accordance 
with this section, we used the 8 care episode groups and patient 
condition groups included in the operational list as the basis for the 
8 episode-based measures that were finalized for use in MIPS in the CY 
2019 PFS final rule (83 FR 59767 through 59773). In the CY 2020 PFS 
final rule (84 FR 62968 through 62969), in accordance with section 
1848(r)(2)(H) of the Act, we revised the operational list beginning 
with CY 2020 to include 10 additional care episode and patient 
condition groups, which served as the basis for the 10 additional 
episode-based measures that were refined based on extensive stakeholder 
input and finalized for use in MIPS in that same final rule (84 FR 
62979). The operational list as revised in the CY 2020 PFS final rule 
is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html.
    Under section 1848(r)(2)(H) of the Act, we proposed to revise the 
operational list beginning with CY 2022 to include 5 new care episode 
and patient condition groups, based on input from clinician specialty 
societies and other stakeholders. These 5 care episode and patient 
condition groups were included in the draft list that we posted in 
December 2016 and refined based on extensive stakeholder input as 
described in the CY 2022 PFS proposed rule (86 FR 39396 through 39397). 
The codes and logic used to define these episode groups are available 
on our MACRA Feedback Page at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html. These care episode and patient 
condition groups serve as the basis for the 5 new episode-based 
measures that we proposed in the CY 2022 PFS proposed rule (86 FR 39397 
through 39398) and finalized for the cost performance category in 
section IV.A.3.d.(2)(b) of this rule. We solicited comments on our 
proposal to revise the operational list to include these 5 new care 
episode and patient condition groups.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter supported the proposal to revise the 
operational list to add 5 new care episode and patient condition groups 
that served as the basis for the 5 new episode-based measure that we 
proposed for the cost performance category in the CY 2022 PFS proposed 
rule.
    Response: We appreciate the commenter's support for this proposal.
    After consideration of public comments, we are finalizing these 
revisions to the operational list as proposed.
(v) Reliability and Case Minimum
    In this section of the rule, we discuss the case minima for the 5 
proposed cost measures, weighing up considerations of reliability 
standards, the tradeoffs between accuracy and reliability, and the 
implications of increasing case minima on the extent to which the 
measure can apply to clinicians participating in MIPS. 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 differences between the clinician and their peer cohort.
    In the CY 2017 Quality Payment Program final rule (81 FR 77169 
through 77171), we identified reliability levels between 0.4 to 0.7 as 
moderate and reliability levels above 0.7 as high. In the CY 2017 
Quality Payment Program final rule, we also identified a threshold of 
0.4 for mean reliability to be applied for measures in the cost 
performance category to ensure moderate reliability. This aligned with 
the reliability threshold applied to measures under the Value Modifier 
program and previous analyses of reliability.\233\ We appreciate the 
concerns commenters had raised that this may be too low and as we 
stated in the CY 2017 Quality Payment Program final rule (81 FR 77169 
through 77171), we continue to work on developing measures with the 
highest level of reliability that is feasible within the MIPS program 
and have since continued to monitor the overall scientific evidence on 
reliability. There are many different interpretations of reliability 
and what these values represent. Studies have pointed to various 
standards to indicate sufficient, adequate, moderate, or good 
reliability across healthcare and other disciplines with performance 
measures and different methods of estimating 
reliability.234 235 236 237 238 239 240 We also monitor the 
evaluation and standards applied throughout the measure endorsement 
processes, and note that the endorsement standards state there is no 
minimum threshold for reliability.\241\ As such, we believe that the 
0.4 threshold for mean reliability continues to be appropriate for 
moderate reliability.
---------------------------------------------------------------------------

    \233\ Mathematica, Inc., ``Memorandum: Reporting Period and 
Reliability of AHRQ, CMS 30-Day and HAC Quality Measures--Revised,'' 
http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/hospital-value-based-purchasing/Downloads/HVBP_Measure_Reliability-.pdf.
    \234\ Portney, L.G. and Watkins, M.P. (2000) Foundations of 
clinical research: Applications to practice. 2nd Edition, Prentice 
Hall Health, Upper Saddle River.
    \235\ Landis, J. Richard, and Gary G. Koch. ``The Measurement of 
Observer Agreement for Categorical Data.'' Biometrics 33, no. 1 
(1977): 159-74. Accessed March 17, 2021. doi:10.2307/2529310.
    \236\ Koo, Terry K., and Mae Y. Li. ``A Guideline of Selecting 
and Reporting Intraclass Correlation Coefficients for Reliability 
Research.'' Journal of Chiropractic Medicine 15, no. 2 (2016): 155-
63. https://doi.org/10.1016/j.jcm.2016.02.012.
    \237\ Adams, J.L., Mehrotra, A., Thomas, J.W. and E.A. McGlynn, 
``Physician Cost Profiling-Reliability and Risk of 
Misclassification,'' New England Journal of Medicine 362 (2010), 
1014-21.
    \238\ Adams, John L., The Reliability of Provider Profiling: A 
Tutorial. Santa Monica, CA: RAND Corporation, 2009. https://www.rand.org/pubs/technical_reports/TR653.html.
    \239\ Taber, Keith S. ``The Use of Cronbach's Alpha When 
Developing and Reporting Research Instruments in Science 
Education.'' Research in Science Education 48, no. 6 (2017): 1273-
96. https://doi.org/10.1007/s11165-016-9602-2.
    \240\ The Department of Education provides the following 
thresholds: ``Reliability of an outcome measure may be established 
by meeting the following minimum standards: (a) internal consistency 
(such as Cronbach's alpha) of 0.50 or higher; (b) temporal 
stability/test-retest reliability of 0.40 or higher; or (c) inter-
rater reliability (such as percentage agreement, correlation, or 
kappa) of 0.50 or higher.'' (What Works Clearinghouse (WWC) 
Standards Handbook v4, p.78).
    \241\ The National Quality Forum (NQF) reviews measures on a 
case-by-case basis, and has endorsed many types of measures with 
reliability ranging from below 0.1 and above 0.9, accepting multiple 
varied reliability testing methods. For example, NQF endorsed the 
Percent of Residents Who Lose Too Much Weight (NQF #0689) facility-
level outcome measure, which had a signal-to-noise ratio of 0.078. 
Alternatively, NQF has also endorsed the Routine Cataract Removal 
with Intraocular Lens (IOL) Implantation (NQF #3509) episode-based 
cost measure with a mean reliability score of 0.94 at the individual 
clinician level and a 10 episode case minimum.
---------------------------------------------------------------------------

    Under section 1848(r)(5)(A) of the Act, to evaluate the resources 
used to treat patients (with respect to care episode and patient 
condition groups), the Secretary shall, as the Secretary determines 
appropriate, conduct an analysis of resource use (with respect to care 
episodes and patient condition groups of such patients) using codes 
reported on claims. Our approach to cost measurement focuses on 
defining clinically homogenous patient conditions and care episodes. 
This ensures that these measures accurately compare clinician 
performance without the results being solely driven by clinical 
differences across episodes.

[[Page 65454]]

While limiting the measure scope to improve homogeneity improves the 
accuracy of assessing cost performance, this also reduces the number of 
episodes per clinician. Fewer episodes per clinician results in lower 
reliability compared with global population measures. However, episode-
based measures balance this concern using selective service assignment; 
only including the costs of services that are clinically related to the 
condition or procedure in the measures' cost calculation improves 
reliability by keeping the ``signal'' while reducing the ``noise.'' 
\242\ Overall, these measures prioritize capturing clinically 
appropriate, homogeneous care episodes over achieving results on 
certain testing mechanisms to meet the statutory objective of episode-
based resource measurement and create more actionable measures for 
clinicians. As such, we continue to evaluate cost measures on a broader 
range of testing, along with the details of measure construction. For 
this reason, we continue to caution against placing too much emphasis 
on reliability results in isolation as we noted in the CY 2018 Quality 
Payment Program proposed rule (82 FR 30050 through 30051).
---------------------------------------------------------------------------

    \242\ See for example Sandhu AT, Do R, Lam J, et al. Development 
of the Elective Outpatient Percutaneous Coronary Intervention 
Episode-Based Cost Measure. Circ Cardiovasc Qual Outcomes. Mar 
2021;14:e006461.
---------------------------------------------------------------------------

    As we discussed in the CY 2018 Quality Payment Program proposed 
rule (82 FR 30050 through 30051), while a higher case minimum generally 
improves measure reliability, these incremental increases must be 
considered against decreases in the coverage of the measure. There are 
several important implications for clinicians and the program. 
Increasing the case minimum reduces the number of clinicians that can 
have their performance assessed by that measure. This can limit the 
applicability of episode-based measures to larger group practices with 
sufficient case volume, leaving smaller practices and individual 
practitioners to be assessed only with population-based cost measures. 
In addition, for measures to have the potential to improve performance, 
they should apply to as many clinicians as can be reliably measured. 
Finally, it is important to recall that clinicians receive a cost 
performance category score which incorporates their scores across all 
applicable cost measures. Adding more measures that can be used in a 
category score increases the amount of data used to calculate the 
category score, which may improve the precision of overall assessment 
of cost performance. Additional measures also allows us to evaluate 
clinicians' cost category performance across a broader range of their 
care practice.
    We examined the reliability of the 5 proposed episode-based 
measures, and Table 53 presents the percentage of TINs and TIN/NPIs 
that meet the 0.4 reliability threshold and the mean reliability for 
TINs and TIN/NPIs at our proposed case minimum for each of the episode-
based measures. We previously established at Sec.  414.1350(c)(4) a 
case minimum of 10 episodes for procedural episode-based measures and 
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 59773 through 59774). For both the proposed Melanoma 
Resection procedural measure and the Sepsis acute inpatient medical 
condition measure, we found that the mean reliability for groups and 
individual clinicians exceeds 0.4 and that the majority of groups and 
individual clinicians meet the 0.4 reliability threshold when applying 
the established case minimum for the respective measure types. For the 
Colon and Rectal Resection procedural measure, at the established 10-
episode case minimum for procedural measures, we found that the mean 
reliability does not exceed 0.4 for individual clinicians and that the 
majority of groups and individual clinicians do not meet the 0.4 
reliability threshold. However, as displayed in Table 53, when the 
measure's case minimum is raised to 20 episodes, the mean reliability 
exceeds 0.4 for both groups and individual clinicians, and the majority 
of groups and individual clinicians meet the 0.4 reliability threshold. 
As such, we proposed to raise the case minimum for the Colon and Rectal 
Resection procedural measure to 20 episodes, and corresponding 
revisions to Sec.  414.1350(c)(4). For the chronic condition measures, 
we proposed at Sec.  [thinsp]414.1350(c)(6), a case minimum of 20 
episodes. At a 20-episode case minimum, the mean reliability for both 
measures exceeds 0.4 for both groups and individual clinicians, and the 
majority of groups and individual clinicians meet the 0.4 reliability 
threshold. We believe that calculating the episode-based measures with 
these case minimums would accurately and reliably measure the 
performance of a large number of clinicians and clinician group 
practices.

[[Page 65455]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.076

    We received public comments on the reliability and case minimums of 
the proposed episode-based measures. The following is a summary of the 
comments we received and our responses.
    Comment: A few stakeholders commented that CMS' use of 0.4 as the 
threshold for mean reliability is insufficient. Commenters urged CMS to 
increase the case minimums for the cost measures, stating that higher 
reliability with fewer clinicians being measured would be preferable.
    Response: We thank the commenters for their feedback. We refer 
stakeholders to 86 FR 39400-39402 of the proposed rule where we discuss 
the 0.4 threshold in detail. As noted, we will continue to monitor the 
scientific evidence on reliability to consider whether the 0.4 
threshold should be increased. At this time, we do not believe that 
there is sufficient evidence to substantiate a change to this 
threshold. In finding a balance between reliability and cost measures 
that have the potential to be impactful, we also consider stakeholder 
feedback about the need for clinicians to be assessed under episode-
based cost measures. Since these measures are designed to be specific 
to a particular type of care, many clinicians would be attributed fewer 
of these episodes than of episodes for global or population-based cost 
measures. Using a moderate reliability threshold ensures the 
reliability of the measures while also guarding against the unintended 
consequences of excluding clinicians from episode-based cost measures.
    After consideration of public comments, we are finalizing the 
proposal to raise the case minimum for the Colon and Rectal Resection 
procedural measure to 20 episodes, and corresponding revisions to Sec.  
414.1350(c)(4), as proposed. We are finalizing at Sec.  
[thinsp]414.1350(c)(6) a case minimum of 20 episodes for the chronic 
condition measures, as proposed.
(c) Process for Cost Measure Development by Stakeholders
(i) Background
    Since 2017, we have conducted extensive stakeholder engagement to 
develop episode-based measures that cover a wide range of procedures, 
conditions, and specialties. This measure development process, as 
described in the CY 2019 PFS final rule (83 FR 59770), involves the 
measure development contractor convening hundreds of clinician experts 
to provide information to prioritize, conceptualize, and specify 
clinically refined cost measures and conducting national field testing 
on an 18-month timeline. The process involves engagement activities 
conducted by the measure development contractor to solicit expert input 
for measure development, gather feedback from individuals with lived 
experiences of the conditions in question, and collect stakeholder 
feedback on draft measure specifications that can inform how the 
measures can be improved. This approach follows CMS' standardized 
approach for developing, implementing, and maintaining measures. There 
are currently 18 episode-based measures in the cost performance 
category (CY 2020 PFS final rule (84 FR 62979)), and we are adding 5 
more as discussed in section IV.A.3.d.(2)(b) of this rule. There are 
also 2 global or population-based measures, the Medicare Spending per 
Beneficiary Clinician measure and the total per capita cost measure 
which were most recently refined in the CY 2020 PFS final rule (84 FR 
62969 through 62977).
    Many stakeholders have expressed support for episode-based 
measurement and for a process that prioritizes clinician involvement 
(as noted in the CY 2018 QPP final rule (82 FR 53645)). In the CY 2021 
PFS final rule (85 FR 84879), we noted that commenters expressed 
interest in expanding the limited inventory of cost measures available 
to assess cost performance applicable to specialties. Commenters 
believed that additional episode-based measures would address gaps in 
cost performance assessment for various specialties. Expanding the 
range of procedures, conditions, and specialties would enable more MIPS 
eligible clinicians from different specialties and sub-specialties to 
have their cost performance assessed under clinically relevant episode-
based measures. An increase in the range of cost measures available in 
MIPS that can be linked with quality measures and improvement 
activities in future MVPs would support the assessment of clinician 
value in providing specific types of care.
    A process outside of the current development process that would 
allow stakeholders to develop cost measures could expand the inventory 
of episode-based measures. However, this process must ensure that any 
cost measures developed are consistent with the goals of MIPS, align 
with CMS priorities, and consistent with the Meaningful Measures 
Framework (more information about the Meaningful Measures Framework can 
be found at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-
Assessment-Instruments/QualityInitiativesGenInfo/

[[Page 65456]]

MMF/General-info-Sub-Page). Episode-based measures developed by 
stakeholders that meet the standards and criteria we outline in section 
IV.A.3.d.(2)(c)(iii) for selecting measures would contribute to the 
target of an estimated 50 percent of expenditures under Parts A and B, 
as described in section 1848(r)(2)(D)(i)(I) of the Act.
    We proposed to establish a process, beginning in CY 2022, for the 
development of cost measures by stakeholders that would ensure that the 
cost performance category has consistency across measures. The sections 
below outline the proposals for the measure prioritization criteria, 
standards for measure construction, pre-rulemaking submission process 
and development support, which altogether comprises our proposed 
process of cost measure development by stakeholders.
(ii) Measure Prioritization Criteria
    As described in the CY 2022 PFS proposed rule (86 FR 39396 through 
39397) of this rule, the current process for prioritizing cost measures 
for development involves the measure development contractor identifying 
candidate clinical areas and episode groups informed by a TEP, patient 
and family engagement perspective, and clinician stakeholders. Criteria 
reflecting TEP input have guided strategic decisions and informed 
clinical subcommittees' considerations for measure prioritization. 
These criteria include:
     Clinical coherence of measure concept (to ensure valid 
comparisons across clinicians).
     Impact and importance to MIPS (including cost coverage, 
clinician coverage, and patient coverage).
     Opportunity for performance improvement.
     Alignment with quality measures and improvement activities 
to ensure meaningful assessments of value.
    To inform cost measure development by stakeholders, we proposed to 
apply these criteria to an environmental scan to identify a list of 
priority areas and suggested measures for development. This would 
ensure that measures developed by stakeholders align with program 
needs, while also providing flexibility for stakeholders to apply their 
own clinical expertise when identifying the most important areas for 
value improvement within the criteria listed above. Stakeholders who 
choose to develop cost measures can access the Blueprint for the CMS 
Measures Management System at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-Blueprint and the 
Meaningful Measures Framework at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page for further information.
    We solicited public comments on the proposed measure prioritization 
criteria, as well as priority areas for future episode-based measure 
development, such as specialties, types of clinical care, or specific 
conditions or procedures that would support proposed or future MVPs.
    The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters were supportive of the proposal to 
establish a new measure development process by stakeholders. One 
commenter expressed support for the new process for cost measure 
development as it would be open to public and would grow the cost 
measure inventory. Another commenter stated that expanding the range of 
cost measures through this process could facilitate the transition away 
from the total per capita cost measure.
    Response: We believe that the population-based measures like total 
per capita cost measure continue to play an important role in MIPS 
alongside episode-based measures. Its focus on primary care is an area 
that affects many beneficiaries with potential for cost improvement.
    Comment: Another commenter suggested that instead of the proposed 
method to develop new cost measures, CMS should involve stakeholders to 
directly edit inclusion, exclusion, and selection criteria for existing 
measures.
    Response: We encourage stakeholders to engage during the 18-month 
measure development process for new measures under development. As part 
of measure development, all stakeholders can participate in the 
national field testing and observe clinical expert workgroup meetings 
via a listen-only line. Stakeholders are also encouraged to provide 
feedback about the specifications of current cost measures in MIPS via 
the QPP Service Center. We would consider these as part of the routine 
measure maintenance process.
    Comment: One commenter was supportive of the current measure 
development process established by CMS, and stated that while it urged 
CMS to work with the specialty societies to develop new measures, it 
was apprehensive of the new process to develop cost measures outside of 
MVPs. To ensure adequate input from specialty societies, the commenter 
encouraged CMS to require any measure developer to demonstrate that 
they have the correct clinical and methodological input during the 
measure development process.
    Response: We thank the commenter for the feedback. We believe that 
the measure criteria outlined in the proposed process for cost measure 
development by stakeholders (86 FR 39403) addresses the need for a 
measure developer to demonstrate clinical coherence of the measure and 
to ensure its alignment with quality measures and improvement 
activities, so that the measure can be incorporated into MVPs. 
Additionally, for a cost measure to be implemented in MVPs, it needs to 
go through the notice-and-comment rulemaking process, as well as the 
MAP's review of the methodological approach and empirical testing 
results of the measures.
    Comment: One commenter urged CMS to consider using other types of 
measures in the MIPS cost performance category as a proxy for cost. 
These could include measures for time spent in the ICU, transfusions, 
ventilator times, or length of stay. Another commenter recommended that 
cost measures do not just assess when there is waste in the system, but 
also promote clinically appropriate utilization of health care 
services, including for clinicians treating significant portions of 
older adults.
    Response: To clarify, cost measures encourage reduction in spending 
by minimizing waste in the system and incentivizing appropriate level 
of utilization of healthcare services for patients. Measures used in 
the cost performance category are intended to be based on care episode 
and patient condition groups, as outlined in section 1848(r)(2) of the 
Act. Using other types of measures as a proxy for cost would not align 
with this direction. In regards to frailty, we continue to explore ways 
to include indicators of frailty in the episode-based measures, where 
appropriate. We are also tracking ASPE's research into validating and 
expanding claims-based algorithms of frailty and functional disability 
for value-based care and payment (more information on the research is 
available on the ASPE's website at https://aspe.hhs.gov/validating-expanding-claims-based-algorithms-frailty-functional-disability-value-based-care-payment).
    Comment: A commenter highlighted the importance of using clinician-
led clinical data registries, in addition to the comprehensive Medicare 
claims data, to support the development of meaningful cost measures.
    Response: We have concerns about the feasibility of calculating 
cost

[[Page 65457]]

measures that use clinical registry data as part of their construction 
and the potential unintended consequences of excluding certain 
clinicians and beneficiaries if registry data is not available. To 
ensure that cost measures incorporated into MIPS are meaningful, 
measures submitted for CMS consideration would be evaluated for 
potential use against the standards for measure construction and 
criteria outlined in section IV.A.3.d.(2)(c)(iii) of this rule, such as 
whether the measure has been tested for reliability and validity.
    Comment: A few commenters stated that specialty societies should be 
involved in the proposed measure development process. One stakeholder 
suggested that all specialty societies that would benefit from the new 
measures should be involved in the development process, while another 
encouraged CMS to partner with specialty societies similar to the 
current cost measure development approach.
    Response: We encourage specialty societies that are interested in 
cost measure development to coordinate and engage with other societies 
that may have common expertise in cost measure concepts. This process 
for cost measure development is separate from CMS' current approach 
where a cost measure development contractor engages with specialty 
societies and other stakeholders.
    Comment: One commenter requested more information on how CMS 
intends to use the prioritization criteria outlined in the proposed 
rule. The commenter also urged CMS to seek input from stakeholders on 
the measurement gaps in the MIPS cost performance category.
    Response: We do not have any additional information on how we 
intend to use the prioritization criteria beyond what was proposed in 
the CY 2022 PFS rule (86 FR 39403). Regarding the stakeholder's second 
comment, we would apply the prioritization criteria to an environmental 
scan that would inform stakeholders of priority areas and suggested 
measures for development. This list would provide flexibility for 
stakeholder to then apply their own clinical expertise when determining 
the most important areas for measure development based on the 
measurement gaps identified by CMS. We also encourage stakeholder to 
reference the Blueprint for the CMS Measures Management System at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-Blueprint and the Meaningful Measures Framework at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page for 
further guidance.
(iii) Standards for Measure Construction
    Our current rigorous cost measure development process has included 
a series of standards that ensure measures are effective in assessing 
clinician cost performance within MIPS. These standards have been 
developed and vetted over time by a standing TEP and further refined 
through discussions with clinical subcommittees and clinician expert 
workgroups convened by the measure development contractor around areas 
of care and specific measures, respectively. For further detail, we 
refer readers to our detailed discussion of the measure development 
process and framework in response to stakeholder comments in the CY 
2019 PFS final rule (83 FR 59770). To ensure that cost measures 
developed by stakeholders meet the same standards applied during the 
current measure development and testing process, we proposed to apply 
the following standards when considering stakeholder developed 
measures:
     Measures must assign services that accurately capture the 
role of attributed clinicians.
     Measures must have clear, ex ante attribution to 
clinicians.
     Measures must be based on episode definitions that have 
clinical face validity and are consistent with practice standards.
     Measures' construction methodology must be readily 
understandable to clinicians.
     Measures must hold clinicians accountable for only the 
costs they can reasonably influence.
     Measures must convey clear information on how clinicians 
can alter their practice to improve measured performance.
     Measures must demonstrate variation to help distinguish 
quality of care across individual clinicians.
     Measure specifications must allow for consistent 
calculation and reproducibility using Medicare claims data.
    To implement these standards and to meet the methodology 
requirements of section 1848(r)(5) of the Act, we believe that it is 
necessary to ensure that measures within the cost performance category 
are consistent and share the same key features. Specifically, cost 
measures must be based on a standard set of measure components informed 
by the standards outlined above. These include: (1) Episode definition 
based on trigger codes that determine the patient cohort; (2) 
attribution; (3) service assignment; (4) exclusions; and (5) risk 
adjustment.
    Regarding item (1) episodes must be defined based on trigger codes 
for services, which are identifiable on Medicare claims, indicate the 
occurrence of the episode, and determine the patient cohort. Trigger 
codes must be based on services, and can incorporate diagnosis and 
other service information to define an episode. The patient cohort may 
be stratified into mutually exclusive stratifications (or ``episode 
sub-groups'') for meaningful clinical comparison to ensure that 
measures fairly compare clinicians with similar patient case-mix. 
Regarding item (2), episodes must be attributed to MIPS eligible 
clinician groups and clinicians who render the trigger services and are 
responsible for the patient's care and management. It is important that 
the attribution methodology allows for the most appropriate clinicians 
who have a significant role in a patient's care to be attributed and 
receive actionable feedback on their performance. Regarding item (3), 
all services that are clinically related to the attributed clinician's 
role in managing patient care must be included. This includes cases 
where the clinician can influence the frequency or intensity of 
services. The measure must include enough services to allow the measure 
to demonstrate that it captures variation in clinician performance. To 
address any potential concern around care stinting, the measure must 
cover a sufficiently long timeframe and broad enough services to 
capture downstream services. This includes expected follow-up care, 
rehabilitation, post-acute care (required if inpatient hospitalizations 
are included) and other support services, as well as complications, 
readmissions, and other consequences of care. Clinically unrelated 
services must not be assigned to the measure. Regarding item (4), 
measures must include applicable exclusions, which can be applied to 
the patient cohort or the episodes. Certain patients must be excluded 
for data cleaning or to ensure completeness of data. For example, 
patients who do not have Medicare as their primary payer or were not 
continuously enrolled in Medicare Parts A and B and not C must be 
excluded as we would not be able to observe their complete care. 
Certain episodes must be excluded to improve episode homogeneity and to 
remove unique groups of patients from the measure in cases where it may 
be impractical or unreasonable to compare the costs of caring for these 
patients to the costs of

[[Page 65458]]

caring for the measure cohort as a whole. Regarding item (5), measures 
must be adjusted for patient risk. Risk adjustment aims to isolate 
variation in clinician costs to only the costs that clinicians can 
reasonably influence by accounting for risk factors. The determination 
of an appropriate risk adjustment approach should be based on empirical 
testing. A base risk adjustment model must include standard risk 
adjustors (Hierarchical Condition Category [HCC] codes, interaction 
variables for certain comorbidities, age, disability status, end-stage 
renal disease status, recent use of institutional long-term care), as 
well as additional measure-specific risk factors. Finally, measures 
must include payment standardized claims data.
    We have outlined in section IV.A.3.d.(2)(b)(iii) of this final rule 
a new methodological framework for assessing the cost of care for 
chronic conditions. This new chronic condition framework meets all the 
standards we outline above, and could serve as a basis for chronic 
condition measures developed by stakeholders that would ensure 
consistency with other MIPS measures. We proposed to apply the 
standards for measure construction and measure components outlined 
above when considering stakeholder-developed measures to ensure that 
these measures follow the same standards as cost measures currently 
used in MIPS.
    We solicited public comments on our proposed standards for measure 
construction and measure components, as well as the challenges that 
stakeholders may encounter in the development of cost measures along 
with any resources that would assist stakeholders in development.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter specifically expressed support for the 
proposed standards for measure construction and measure components.
    Response: We thank the commenter for their support.
    Comment: One commenter pointed out the lack of flexibility in the 
approach to develop cost measures, as under the proposed Standards for 
Measure Construction and the Measure Prioritization Criteria, measure 
developers would be constrained by the structure and scope of existing 
cost measures.
    Response: We believe that it is important for cost measures to 
share key common features for consistency within the performance 
category. These features have been identified through extensive 
stakeholder input as being essential for cost measures to accurately 
reflect care within the reasonable influence of the attributed 
clinician; this in turn is essential for clinicians to be able to make 
practice changes for cost improvement. Having consistency across cost 
measures is important to make it easier for stakeholders to understand 
how they are being assessed on cost and guards against the risks and 
unintended consequences that would result from creating different 
standards for similar types of care. We believe that establishing 
standards and criteria helps provide clarity for stakeholders before 
they begin development, and that this approach achieves an appropriate 
balance between the goal of a coherent cost measure inventory and 
encouraging innovative ways of assessing clinicians on cost 
performance.
    Comment: One commenter urged CMS to use common episode definitions 
across MIPS cost measures and information required by price 
transparency regulations. This would provide consistent information to 
clinicians and patients.
    One commenter requested that episodes use more comprehensive 
definitions by looking at care from the perspective of the patient, 
rather than charges under the control of a single clinician. They also 
emphasized the importance of the team-based nature of care, and stated 
that shared accountability for care should be encouraged by cost 
measures.
    Response: The episode-based measures include the cost of services 
furnished by clinicians providing care that is related to the condition 
or procedure being measured. That is, an episode for a knee 
arthroplasty procedure could include the cost of the surgery performed 
by the orthopedic surgeon, anesthesia services provided by an 
anesthesiologist or CRNA, the cost of walking aids to assist with 
recovery, and physical therapy services provided by a physical 
therapist to help regain function. By including these services, the 
attributed clinician is incentivized to coordinate with these members 
of the care team in providing care for the patient. In these instances, 
common episode definitions would not be appropriate because episode-
based measures require episodes specific to the condition or procedure. 
However, the total per capita cost and Medicare Spending Per 
Beneficiary Clinician measures do address the concern that there should 
be a more comprehensive definitions of cost; these measures are 
designed to be a global cost measure where a clinician is responsible 
for the costs of all services provided to a patient. We therefore 
believe that there is an important role for both global or population-
based cost measures and episode-based cost measures as they have 
different yet complementary measure intents. Finally, given that the 
price transparency regulations are newly implemented, we will continue 
to assess the potential ways to align cost measures and the price 
transparency regulations.
    Comment: One commenter encouraged CMS to add two standards for cost 
measure construction: Actionability and alignment of cost and quality. 
The commenter also stated that field testing must be conducted as part 
of the measure development process, and encouraged CMS to minimize the 
number of cost measures that is in development at one time, to ensure 
stakeholders are able to comprehensively review the measures being 
developed.
    Response: We believe that the standards we would apply when 
considering stakeholder developed measures ensure that the measures 
implemented in MIPS would be actionable, by requiring the methodology 
to be understandable and that the developers convey clear information 
on how clinicians can improve their performance. In addition, 
submissions to the MUC list require measure developers to demonstrate a 
measure's actionability (please see section IV.A.3.d.(2)(c)(iv) for 
more information on MUC submission criteria). Additionally, one of the 
measure construction criteria is alignment with quality measures and 
improvement activities to ensure meaningful assessments of value. We 
agree that field testing is an important step in assessing newly 
developed measures and gathering feedback from stakeholders. We have 
worked to improve our field testing materials and outreach so that 
stakeholders can more easily understand the measures and provide 
meaningful feedback. We will take your suggestion to limit the number 
of cost measures in development at one time into consideration for 
future measure development cycles.
(iv) Cost Measure Submission to the Measures Under Consideration (MUC) 
List and Development Support
    We proposed that cost measures developed by stakeholders for 
potential use in MIPS would undergo the pre-rulemaking process 
described in section 1890A(a) of the Act. More details on the pre-
rulemaking process can be found at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rulemaking. As with the process for the

[[Page 65459]]

call for quality measures, we proposed that the submission process for 
cost measures developed by stakeholders would begin with a Call for 
Cost Measures, where stakeholders would be invited to submit their 
candidate cost measures. We refer readers to the CY 2018 Quality 
Payment Program final rule (82 FR 53635 through 53637) for details on 
the process for quality measure submissions and selection. During the 
Call for Cost Measures period, we would organize webinars and office 
hours to provide stakeholders with information about the process and be 
available to answer questions. We would also provide templates of 
written materials, such as the measure codes lists for stakeholders to 
use. At the end of this period, stakeholders would submit their 
candidate measures for review by completing the required data fields 
required for submission to the MUC list and if approved, measures would 
be placed on the final MUC List, which we publicly post on December 1 
of every year. Measures submitted to the MUC List must be fully 
specified and tested for reliability and validity.
    Submissions to the MUC list must include all required information 
and would be reviewed against a set of inclusion criteria identified 
below to determine whether they should be considered for use in MIPS. 
The inclusion criteria for cost measures developed by stakeholders are 
based on the criteria outlined in the MUC List submission template, as 
well as relevant criteria that the MIPS quality performance category 
follows as indicated in the CY 2020 PFS final rule (84 FR 62953 through 
62954). For purposes of our review, we proposed that stakeholders who 
wish to submit measures must submit measure specification information, 
testing results, and related research to address the following 
inclusion criteria:
     Applicable: There is clinical coherence and comparability 
in clinician treatment; measures ensure alignment with quality 
indicators.
     Feasible: Measures use Medicare claims data; there is a 
high degree of data completeness and limited frequency of missing data.
     Scientifically acceptable: measures are clinically valid 
assessments of cost performance; testing is available for reliability 
at different case minima; beta testing and statistical testing are 
conducted.
     Not be duplicative of existing measures: measures assess 
opportunities and gaps based on CMS priorities and goals; there is an 
assessment of duplicate measures to see which would be the better 
measure.
     Fully developed: measures are fully developed and ready 
for implementation at the time of submission.
     Consistent: the measure is constructed using a methodology 
to assess resource use that is consistent with sections 1848(r)(2) 
through (5) of the Act, consistent with other MIPS cost measures.
     Fulfill a clinical performance gap: environmental scans 
and literature reviews show evidence for measures, performance gaps, 
and opportunities for improvement; there is evidence for measures' 
impact and importance to MIPS.
    We solicited comments on this proposed approach, and challenges 
stakeholders may encounter in the development of cost measures.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter expressed support for holding cost measures 
to the same review and submission process (that is, the pre-rulemaking 
process submission) as the quality measures.
    Response: We thank the commenter for their support.
    Comment: A few commenters expressed concerns that the outlined 
proposal does not address the obstacles faced by potential measure 
developers, mostly noting the challenges in obtaining the necessary 
data. Several other commenters requested that CMS provide greater 
development support, also around data access. One commenter believed 
the proposal would not be successful at creating cost measures for MVPs 
starting in 2025 as the process would be time-consuming and burdensome.
    Response: We appreciate the interest in cost measure development. 
The proposed process for cost measure development by stakeholders is 
intended to align with the process that has been available to 
developers of quality measures. The public can access Medicare claims 
data through the process described on the CMS ResDAC website at https://resdac.org/research-identifiable-files-rif-requests. ResDAC's process 
has multiple safeguards in place to protect the sensitive data that is 
available for researchers. Stakeholders also have access to the 
Physician and Other Supplier Public Use Files (Physician and Other 
Supplier PUFs), which contain information on procedures and services 
provided to Medicare patients by physicians and other healthcare 
professionals in a given year.
    After consideration of public comments, we are finalizing the 
process for cost measure development by stakeholders as proposed.
(d) Substantive Changes Criteria for Cost Measures
    On an annual basis, we review the MIPS measures that have been 
adopted and consider updates to the cost measures. Changes to measures 
are an important part of the measure maintenance process to ensure that 
measures are continuing to function as intended, and may be substantive 
or non-substantive. Section 1848(q)(2)(D)(i)(II)(cc) of the Act 
requires all substantive changes to quality measures to be proposed and 
identified through notice-and-comment rulemaking. Although this section 
of the Act does not establish this requirement for cost measures, we 
believe that similar considerations should apply to cost measures. As 
discussed in prior rulemaking, examples of non-substantive changes to 
cost measures include maintenance changes such as updated diagnosis or 
procedure codes or changes to existing exclusions to the patient 
populations or definitions, while substantive changes to a measure are 
changes that result in what are considered new or different measures 
(83 FR 59767 and 84 FR 62961). As we evaluate existing cost measures to 
determine whether such measures need to be updated, we believe that it 
is important to establish criteria for determining whether a measure 
change is substantive. Thus, we proposed to establish several criteria 
for determining whether a cost measure change is substantive starting 
with the MIPS CY 2022 MIPS performance period/2024 MIPS payment year. 
The criteria include, but are not limited to, the following:
     Whether the change modifies the premise and/or objective 
of the measure;
     Whether the change modifies the scope of the measure (such 
as patient population eligible for the measure or a new category of 
costs); and
     Whether the change to the measure calculation 
significantly impacts how a measure is assessed.
    Certain changes to a measure may affect multiple elements of a 
measure, requiring an overall assessment of the measure specifications. 
The following are some examples of potential substantive and non-
substantive changes:
     Measure objective: The measure objective refers to what is 
being assessed; in general, changes to the measure objective would be 
considered substantive. The question of what is being assessed can 
generally be thought of as: What type of care is the measure

[[Page 65460]]

assessing, who is providing this care, and who is in the patient 
cohort. Specifically, under this criterion, a change to the measure 
objective could include updates to the triggering logic, measure 
exclusions, attribution rules, or other aspects of the specifications. 
While the effect of such updates may also be relevant while considering 
whether the change is substantive or not, the effect is secondary to 
the intention behind changes to the measure. Consider the following 
example: A hypothetical episode-based measure focuses on major joint 
repair, and is updated to cover all joint procedures by adding a range 
of trigger codes. This likely would be a substantive change, as the 
measure would be evaluating different joints and procedures than the 
initial measure objective.
     Types of Costs being Assessed: In general, new rules about 
which costs are being captured by a measure would be considered 
substantive if they change which categories or types of costs are 
included in a measure, and non-substantive if they merely refine how an 
existing category is captured. For example, a change to an episode-
based measure's service assignment rules which adds a new category of 
costs (for example, adding Part D costs to a measure that did not 
previously include any Part D costs) likely would be a substantive 
change. By contrast, a measure update to reflect new codes for existing 
types of codes, for instance, where a code is split into sub-codes for 
greater granularity, likely would be considered non-substantive.
     Risk Adjustment: The purpose of risk adjustment is to 
account for factors outside of the clinician's or clinician group's 
reasonable influence. In certain cases, it is necessary to make changes 
to the risk adjustment model and/or individual risk adjustors to ensure 
that the risk adjustment approach is working as intended. Generally, 
changes to risk adjustment variables and the mechanics of the 
regression would be considered non-substantive if they continue to give 
effect to the measure's intent. However, some changes to the risk 
adjustment approach may be substantive, such as changes to the type of 
risk adjustors used (for example, the addition of non-claims-based 
variables when the model previously only used claims-based data), or 
changes to the stratification that modify the interpretation of what 
the measure score represents.
    We note that there are degrees in any evaluation of whether a 
change is substantive. For instance, there may be important differences 
in the effect of adding one service or code compared to a suite of 
services and codes that we would also consider as part of determining 
whether a change is substantive or not. We believe the proposed 
substantive change criteria for cost measures would help us to 
determine whether a change to a cost measure should be made through 
notice-and-comment rulemaking before it is implemented in MIPS. We 
solicited public comments on our proposed criteria for determining 
whether a change to a cost measure is substantive.
    The following is a summary of the comments we received and our 
responses.
    Comment: Two commenters agreed with an approach for evaluating 
substantive changes to cost measures, and one commenter stated that 
substantive changes (for example, updates to the risk adjustment 
methodology) must go through the pre-rulemaking and rulemaking 
processes. The commenter also suggested that a contractor may 
facilitate this process. Finally, the commenter emphasized that service 
assignment codes and other measure elements should be reviewed 
annually.
    Response: We appreciate the commenters' support for this proposal. 
Currently, contractors can facilitate the process for evaluating 
substantive changes. All cost measures undergo a measure maintenance 
process that includes annual updates, and comprehensive re-evaluation 
to ensure that measures continue to meet program goals and priorities. 
Annually, CMS reviews measures to identify potential updates and assess 
the nature of these updates to determine the appropriate process for 
implementing substantive and non-substantive changes. These updates 
take into consideration any changes in payment policies or clinical 
practices, as well as empirical data. The comprehensive re-evaluation 
process occurs on a 3-year cycle, aligning with the CMS Blueprint for 
measure development. This process draws upon input from clinician 
experts to identify any thorough updates that may be required to 
address stakeholder concerns raised during annual maintenance or to 
make refinements to the measure set.
    Comment: One commenter also encouraged CMS to conduct a year-to-
year analysis examining the impacts on performance scores that occurred 
because of a substantive change versus the actual changes in 
performance.
    Response: We appreciated the commenter's request to conduct an 
analysis to examine the impacts on performance scores that occurred due 
to a substantive change versus the actual changes in performance, and 
note that we do conduct analyses that compare year-to-year changes to 
cost measures as part of regular monitoring.
    After consideration of public comments, we are finalizing the 
criteria for determining whether a cost measure change is substantive 
as proposed.
    The previously established and finalized measures for the cost 
performance category for the CY 2022 performance period/2024 MIPS 
payment year and future periods are summarized in Table 54.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TR19NO21.077


[[Page 65462]]


BILLING CODE 4120-01-C
(3) Improvement Activities Performance Category
(a) Background
    For previous discussions on the general background of the 
improvement activities performance category, we refer readers to the CY 
2017 Quality Payment Program final rule (81 FR 77177 through 77178), 
the CY 2018 Quality Payment Program final rule (82 FR 53648 through 
53661), the CY 2019 PFS final rule (83 FR 59776 through 59777), the CY 
2020 PFS final rule (84 FR 62980 through 62990), and the CY 2021 PFS 
final rule (85 FR 84881 through 84886). We also refer readers to 
Sec. Sec.  414.1305 for the definition of improvement activities and 
attestation, 414.1320 for the performance period, 414.1325 for the data 
submission requirements, 414.1355 for the improvement activity 
performance category generally, 414.1360 for data submission criteria, 
and 414.1380(b)(3) for improvement activities performance category 
scoring.
    We proposed in the CY 2022 PFS proposed rule (86 FR 39405 through 
39409) for the CY 2022 performance period and future years: (1) To 
revise group reporting requirements for the 50 percent threshold to 
address subgroups; (2) to revise the timeframe for improvement 
activities nominated during a PHE; (3) to revise the required criteria 
for improvement activity nominations received through the Annual Call 
for Activities; (4) to suspend activities that raise possible safety 
concerns or become obsolete from the program when this occurrence 
happens outside of the rulemaking process; (5) to add 7 new improvement 
activities, modify 15 existing improvement activities, and remove 6 
previously adopted improvement activities; (6) to revise the ``Drug 
Cost Transparency to include requirements for use of real-time benefit 
tools'' improvement activity; and (7) to add the COVID-19 ``Clinical 
Data Reporting with or without Clinical Trial'' improvement activity.
(b) Group Reporting
    In the CY 2020 PFS final rule (84 FR 62981 through 62988), we 
revised Sec.  414.1360(a)(2) to state that, beginning with the CY 2020 
performance period, each improvement activity for which groups and 
virtual groups submit a yes response in accordance with paragraph 
(a)(1) of this section must be performed by at least 50 percent of the 
NPIs billing under the group's TIN or virtual group's TINs, as 
applicable; and the NPIs must perform the same activity during any 
continuous 90-day period within the same performance period.
    In the CY 2021 PFS final rule (85 FR 84844 through 84849), we 
finalized to update the MIPS Value Pathways guiding principle #2 as 
follows: ``2. MVPs should include measures and activities that will 
result in providing comparative performance data that is valuable to 
patients and caregivers in evaluating MIPS eligible clinician 
performance and making choices about their care; MVPs will enhance this 
comparative performance data as they allow subgroup reporting that 
comprehensively reflects the services provided by multispecialty 
groups.''
    In the CY 2022 PFS proposed rule (86 FR 39372 through 39373), we 
proposed the details of subgroup reporting for MVPs, and we refer 
readers to section IV.A3.b.(2) of this final rule for further details 
regarding the adoption of such policies. We noted in the proposal that, 
in order to implement group requirements in relation to subgroup 
reporting, we must modify our policy regarding group reporting for 
improvement activities. We stated our belief that a 50 percent 
threshold is achievable and appropriate because, if a group or virtual 
group has implemented an improvement activity, the activity should be 
recognized and adopted throughout much of the practice to improve 
clinical practice, care delivery, and outcomes (86 FR 39405). 
Similarly, we stated that it makes sense to allow subgroups to perform 
and attest to their improvement activities separately and apply the 50 
percent threshold within their subgroup. Therefore, we proposed to 
revise Sec.  414.1360(a)(2) to state that, beginning with the CY 2022 
performance period, each improvement activity for which groups and 
virtual groups submit a yes response in accordance with paragraph 
(a)(1) of this section must be performed by at least 50 percent of the 
NPIs that are billing under the group's TIN or virtual group's TINs or 
that are part of the subgroup, as applicable; and the NPIs must perform 
the same activity during any continuous 90-day period within the same 
performance period.
    Over the past year, we have received many inquiries through the 
Quality Payment Program help desk \243\ requesting clarification on how 
to apply the 50 percent threshold to groups. Many clinicians requested 
that their groups be allowed to account for the 50 percent threshold by 
specialty or as subgroups as they have more in common than their groups 
when considering applicable improvement activities. We note that our 
proposal is responsive to these stakeholder requests because it 
provides the ability to attest to improvement activities at the 
subgroup level, including the ability to compose subgroups by specialty 
for reporting MVPs.
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    \243\ The Quality Payment Program help desk tracks, documents, 
and resolves inquiries submitted by MIPS eligible clinicians and 
groups. Stakeholders may submit inquiries to the help desk via 1-
866-288-8292 (Monday-Friday 8 a.m.-8 p.m. ET) or email 
[email protected].
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    We received public comment on our proposal to revise Sec.  
414.1360(a)(2). The following is a summary of the comment we received 
and our response.
    Comment: One commenter supported the proposal to ensure that 
subgroups have the same improvement activities reporting requirements 
as MIPS eligible clinicians in traditional MIPS. The commenter stated 
that aligning requirements ensures that MIPS eligible clinicians 
reporting through a subgroup are meaningfully contributing to an 
improvement activity rather than relying on others in the group to 
receive credit.
    Response: We appreciate the commenter's support of this proposal.
    After consideration of the public comment, we are finalizing this 
policy as proposed.
(c) Improvement Activities Inventory
(i) Annual Call for Activities
    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 (81 FR 77817 through 77830) consisting of 
approximately 95 activities. 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 the 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 70886) 
and the comments received in response to the MIPS and APMs RFI 
regarding the improvement activities performance category.
    For Year 2, we provided an informal process for submitting new 
improvement activities or modifications for potential inclusion in the 
comprehensive improvement activities

[[Page 65463]]

Inventory for the Quality Payment Program Year 2 and future years 
through subregulatory guidance (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Annual-Call-for-Measures-and-Activities-for-MIPS_Overview-Factsheet.pdf). In the CY 
2018 Quality Payment Program final rule (82 FR 53656 through 53659), 
for Year 3 and future years, we finalized a formal Annual Call for 
Activities process for adding possible new activities or providing 
modifications to the current activities in the improvement activities 
Inventory, including the requirement to submit a nomination form 
similar to the one we utilized for Year 2 (82 FR 53656 through 53659). 
In order to submit a request for a new activity or a modification to an 
existing improvement activity, the stakeholder must submit a nomination 
form available at www.qpp.cms.gov during the Annual Call for 
Activities.
(A) Timeframe for the Annual Call for Activities
    We refer readers to the CY 2019 PFS final rule (83 FR 59781 through 
59782) for our most recent policies with respect to the timeframe for 
the Annual Call for Activities. We did not propose any changes to this 
policy for CY 2022. However, we refer readers to section 
IV.A.3.d(3)(c)(i)(B)(aa) of this final rule where we adopt changes to 
the timeframe for nominating new improvement activities during a PHE.
(B) Changes for Nominating New Improvement Activities
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77190), the initial improvement activities Inventory was not based 
on established criteria. Rather, it was compiled via stakeholder input; 
an environmental scan; MIPS and APMs RFI comments; subsequent working 
sessions with AHRQ and ONC; and additional communications with CDC, 
SAMHSA, and HRSA. In the CY 2018 Quality Payment Program final rule (82 
FR 53656 through 53659), we finalized a formal Annual Call for 
Activities process for adding possible new activities or providing 
modifications to the current activities in the improvement activities 
Inventory. We stated that we would use the criteria when selecting 
measures for inclusion in the program. In the CY 2019 PFS final rule 
(83 FR 59778 through 59779), we adopted one new criterion and removed a 
criterion from the improvement activities nomination criteria. We also 
clarified our considerations in selecting improvement activities. In 
the CY 2022 PFS proposed rule (86 FR 39405 through 39408), we proposed: 
(1) Changes to the timeframe for improvement activities nomination 
during a PHE; (2) two new improvement activities criteria; (3) to 
increase the required minimum number of criteria that must be met for 
improvement activities nominations; and (4) to separate required from 
optional criteria for improvement activities nominations. These 
proposals are discussed in detail below.
(aa) Changes to the Timeframe for Nominating New Improvement Activities 
During a PHE
    In the CY 2021 PFS final rule (85 FR 84882 through 84883), we 
finalized an exception to the Annual Call for Activities providing 
that, during a PHE, stakeholders can nominate improvement activities 
outside of the established Annual Call for Activities timeframe. 
Instead of only accepting nominations and modifications submitted 
February 1 through July 1 each year, we adopted a policy to accept 
nominations for the duration of the PHE, as long as the improvement 
activity is still relevant. No other aspect of the Annual Call for 
Activities process was affected (for example, criteria for nominating 
improvement activities, considerations for selection of improvement 
activities, or weighting policies all still apply). We noted that we 
continue to believe that it is important for stakeholders to be able to 
comment on improvement activities. Therefore, any improvement activity 
related to the PHE considered for inclusion in the Inventory will need 
to be finalized through rulemaking.
    In 2020, we used several IFCs to propose necessary policies due to 
the PHE for COVID-19, including adding and modifying the COVID-19 
Clinical Data Reporting with or without Clinical Trial (IA_ERP_3) for 
implementation in the same year. However, we want to be clear that we 
are not limited to implementing policies through IFCs, and those 
vehicles may not be the most timely or feasible for a particular 
situation. In a typical year, we use various fiscal and calendar year 
rules to implement policy (for example, the IPPS, Inpatient Psychiatric 
Facility Prospective Payment System (IPF PPS), OPPS, etc. rules). In 
order to best operationalize our policy for improvement activities 
nominated during a PHE, we proposed to modify our policy such that 
these nominations should be submitted by January 5 of the year in which 
the activity is targeted for implementation, unless otherwise specified 
by CMS, in order to maximize the chance that a potential improvement 
activity could be implemented in the same year via the most timely 
rulemaking vehicle.
    We received public comments on our proposal regarding the 
improvement activities nominations received during a PHE. The following 
is a summary of the comments we received and our responses.
    Comment: A few commenters supported CMS' proposals for nominating 
new improvement activities during the national PHE for COVID-19.
    Response: We appreciate the support of commenters.
    After consideration of public comments, we are finalizing this 
policy as proposed.
(bb) Currently Adopted Criteria
    In the CY 2017 Quality Payment Program final rule (81 FR 77190 
through 77195), we discussed guidelines for the selection of 
improvement activities. In the CY 2018 Quality Payment Program final 
rule (82 FR 53660), we formalized the Annual Call for Activities 
process for Year 3 and future years and added additional criteria: 
Stakeholders should apply one or more of the below criteria when 
submitting nominations for improvement activities. In addition, in the 
CY 2019 PFS final rule (83 FR 59779) we added a ``public health 
emergency as determined by the Secretary'' criterion, and in the CY 
2021 PFS final rule (85 FR 84883 through 84884) we added an ``Include 
activities which can be linked to existing and related MIPS quality and 
cost measures, as applicable and feasible'' criterion. The current 
criteria are listed below.
     Relevance to an existing improvement activities 
subcategory (or a proposed new subcategory);
     Importance of an activity toward achieving improved 
beneficiary health outcomes;
     Importance of an activity that could lead to improvement 
in practice to reduce health care disparities;
     Aligned with patient-centered medical homes;
     Focus on meaningful actions from the person and family's 
point of view;
     Support the patient's family or personal caregiver;
     Representative of activities that multiple individual MIPS 
eligible clinicians or groups could perform (for example, primary care, 
specialty care);
     Feasible to implement, recognizing importance in 
minimizing burden, especially for small practices, practices in rural 
areas, or in areas designated as geographic HPSAs by HRSA;

[[Page 65464]]

     Evidence supports that an activity has a high probability 
of contributing to improved beneficiary health outcomes;
     Include activities which can be linked to existing and 
related MIPS quality and cost measures, as applicable and feasible;
     Include a PHE as determined by the Secretary; or
     CMS is able to validate the activity.
(cc) Proposed Two New Criteria
    We proposed two new criteria beginning with the CY 2022 Annual Call 
for Activities MIPS improvement activities: Activities (1) should not 
duplicate other improvement activities in the Inventory; and (2) should 
drive improvements that go beyond standard clinical practices. 
Regarding the first proposed criterion, we believe that there should 
not be duplicate activities in the Inventory as MIPS eligible 
clinicians could get double credit for doing the same activity. As 
discussed in the CY 2017 Quality Payment Program final rule (81 FR 
77185), while the minimum reporting period for one improvement activity 
is 90 days, the maximum frequency for which an improvement activity may 
be reported is once during the 12-month performance period. It is 
important that stakeholders review the current Inventory to ensure 
there is not a broader improvement activity that MIPS eligible 
clinicians could attest to for the same activity. Regarding the second 
proposed criterion, we believed that improvement activities should 
drive improvements that go beyond standard clinical practices and 
should be innovative, to have the potential for significant patient 
benefit when MIPS eligible clinicians learn and implement the 
activities.
    We received public comments on our proposal regarding the two new 
criteria for considering new improvement activities. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters supported the addition of these 
additional criteria stating that they believe the new criteria will 
ensure high quality improvement activities. Many commenters supported 
the proposal of two new criteria, agreeing that new improvement 
activities should not be duplicative.
    Response: We appreciate the support of these commenters.
    After consideration of public comments, we are finalizing this 
policy as proposed.
(dd) Minimum Requirement
    We have received feedback from stakeholders through the Annual Call 
for Activities process and during the CY 2021 PFS rulemaking process 
that the nomination acceptance process is unclear, stakeholders are 
frustrated by nominating improvement activities that are not accepted, 
and our reasoning for not accepting their nominations is not clear.
    Our current policy requires that stakeholders apply one or more of 
the established criteria when submitting a nomination through the 
Annual Call for Activities process for a new improvement activity (82 
FR 53660). Through past Annual Calls for Activities, we have found that 
many of the nominations that we receive meet the minimum one criterion, 
but are not appropriate for inclusion in the Inventory for other 
reasons. We often receive submissions describing practices that are 
standard and submissions that are too specific to a particular 
specialty. We believe that when evaluating nominations, we should use 
multiple factors in deciding on the selection of submitted improvement 
activities, not all of which can be listed up front. Ultimately, we 
must rely on our internal processes and expertise in determining 
whether or not a nominated improvement activity meets the criteria and 
needs of the program. However, in an effort to increase transparency, 
we have reevaluated our criteria and believe there are a number of 
significant criteria that improvement activity proposals should meet to 
be included in the Inventory. Therefore, beginning with nominations 
submitted during the 2022 nomination period for the Annual Call for 
Activities, we proposed to increase the number of criteria stakeholders 
are required to meet when submitting an activity proposal, from a 
minimum of one to eight criteria, which include the two newly adopted 
criteria described in section IV.A.3.d(3)(c)(i)(B)(cc) of this final 
rule.
    We believed that the following eight criteria, six of which are on 
the current list and two of which were proposed (in italics), should be 
the foundation for all improvement activities:
    1. Relevance to an existing improvement activities subcategory (or 
a proposed new subcategory) (82 FR 53660);
    2. Importance of an activity toward achieving improved beneficiary 
health outcomes (82 FR 53660);
    3. Feasible to implement, recognizing importance in minimizing 
burden, including, to the extent possible, for small practices, 
practices in rural areas, or practices in areas designated as 
geographic HPSAs by the Health Resources and Services Administration 
(HRSA) (82 FR 53660);
    4. Evidence supports that an activity has a high probability of 
contributing to improved beneficiary health outcomes (82 FR 53660);
    5. Can be linked to existing and related MIPS quality, Promoting 
Interoperability, and cost measures as applicable and feasible (85 FR 
84884);
    6. CMS is able to validate the activity (82 FR 53660);
    7. Does not duplicate other improvement activities in the 
Inventory; and
    8. Should drive improvements that go beyond purely common clinical 
practices.
    When we previously finalized the first six criteria in prior 
rulemakings, we did not specifically require activity nominations to 
meet all the criteria. In crafting this proposal, we noted that we are 
seeking to minimize improvement activity nominations that do not meet 
program standards and to increase nominations that will substantively 
contribute to improved patient care and outcomes.
    We also considered whether any of the above proposed required 
criteria should be optional (see section IV.A.3.d(3)(c)(i)(B)(cc) of 
this final rule). Ultimately, we proposed that the above criteria 
should not be optional because we believe these reflect the minimum 
standard for improvement activities in the Inventory and will help 
increase transparency in our decisions.
    We did not receive public comments on this provision, and 
therefore, we are finalizing as proposed.
(ee) Optional Factors
    We proposed that the remaining six previously established factors 
would serve as optional factors beginning with nominations submitted 
during the 2022 nomination period for the Annual Call for Activities as 
we believe they may be relevant to certain nominations, but not all. We 
stated that meeting one or more of the optional factors may increase a 
nomination's chances of being added to the Inventory. The proposed 
optional factors were:
    1. Alignment with patient-centered medical homes (82 FR 53660);
    2. Support for the patient's family or personal caregiver (82 FR 
53660);
    3. Responds to a PHE as determined by the Secretary (83 FR 59779);
    4. Addresses improvements in practice to reduce health care 
disparities (82 FR 53660);
    5. Focus on meaningful actions from the person and family's point 
of view (82 FR 53660); and
    6. Representative of activities that multiple individual MIPS 
eligible clinicians or groups could perform (for

[[Page 65465]]

example, primary care, specialty care) (82 FR 53660).
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter requested that CMS clarify what is 
considered ``standard clinical practice.'' Another commenter stated 
that the criteria of driving improvements that go beyond standard 
clinical practices might be unrealistic. They stated that if there are 
gaps in standard clinical practice that need improvement, those gaps 
should be addressed, particularly for members in niche specialties or 
particularly high risk or vulnerable populations. They believe that the 
current weighting system for Improvement Activities is sufficient to 
help MIPS eligible clinicians prioritize high weight activities that go 
beyond standard clinical practice.
    Response: We thank the commenter for their perspective on standard 
clinical practice. We consider standard clinical practice to be the 
standard of care: Actions that all clinicians should do all the time as 
part of their care. Examples include obtaining an informed consent 
before surgery or counting instruments/suture needles at the end of a 
surgery to ensure nothing was left in the patient. We believe that 
improvement activities should drive improvements that go beyond the 
floor for competent clinical practices and should be innovative, in 
order to have the potential for significant patient benefit when MIPS 
eligible clinicians learn and implement the activities.
    After consideration of public comments, we are finalizing these 
policies as proposed.
(C) Improvement Activity Removal
    In the CY 2020 PFS final rule (84 FR 62988 through 62990), we 
finalized the factors for consideration in removing improvement 
activities from the Inventory. Under this process, we fully examine 
each activity prior to its removal and commenters have an opportunity 
to provide their input during notice-and-comment rulemaking.
(aa) Improvement Activity Suspension Policy
    We noted that a circumstance came to our attention that required us 
to examine the specifics of the improvement activities removal of 
activities policy in relation to the performance period. Following the 
publication of the CY 2021 PFS proposed rule, we became aware that the 
underlying program for one of the improvement activities in the 
Inventory had expired on March 31, 2020. Therefore, MIPS eligible 
clinicians could no longer complete the activity from April 1 through 
December 31, 2020. To avoid any potential confusion or incorrect 
attestation, we removed this activity in the CY 2021 PFS final rule (85 
FR 84885). We stated that this occurrence alerted us to the potential 
that other activities could become obsolete or be impacted by clinical 
practice guideline changes that affect the activity and could 
potentially result in patient harm, and that we may not learn about 
this information during the rulemaking timeframes. Because changes made 
in rulemaking do not apply until the following performance period, this 
timing could affect an improvement activity that needs to be urgently 
addressed.
    As a result, beginning with the CY 2022 performance period, we 
proposed that in the case of an improvement activity for which there is 
a reason to believe that the continued inclusion raises possible 
patient safety concerns or is obsolete, we would promptly suspend the 
improvement activity and immediately notify MIPS eligible clinicians 
and the public through the usual communication channels, such as 
listservs and Web postings. We stated that we would then propose to 
remove or modify the improvement activity as appropriate in the next 
rulemaking cycle.
    We received public comments on the improvement activity removal 
outside of the rulemaking cycle. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters supported our proposal to suspend and 
remove improvement activities that the agency believes raise patient 
safety concerns or are obsolete.
    Response: We thank commenters for their support.
    Comment: One commenter stated that declaring an activity 
``obsolete'' during the performance period seems inappropriate. There 
should be adequate review ahead of the start of the performance period 
to remove any improper activities. Another commenter questioned what 
would happen if a MIPS eligible clinician selects an improvement 
activity and begins implementation and later in the year the 
improvement activity is suspended.
    Response: While it is not our preference to remove improvement 
activities during the performance period, despite our best efforts, we 
may become aware that an improvement activity is obsolete during the 
performance period. Therefore, we believe that it is necessary to be 
able to remove activities during the performance period--especially in 
situations where all or part of the improvement activity is not 
available for MIPS eligible clinicians to utilize. In instances where 
we do remove an improvement activity during the performance period, the 
MIPS eligible clinician completed the activity, they will still be able 
to attest for that activity and will not need to select a different 
improvement activity.
    After consideration of public comments, we are finalizing these 
policies as proposed.
(ii) Changes to the Improvement Activities Inventory
(A) Background
    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 of the CY 2017 Quality Payment Program final rule (81 FR 77177 
through 77199), Tables F and G in the Appendix of the CY 2018 Quality 
Payment Program final rule (82 FR 54175 through 54229), Tables A and B 
in the Appendix 2 of the CY 2019 PFS final rule (83 FR 60286 through 
60303), Tables A, B, and C in the Appendix 2 of the CY 2020 PFS final 
rule (84 FR 63514 through 63538), and Tables A, B, and C in the 
Appendix 2 of the CY 2021 PFS final rule (85 FR 85370 through 85377) 
for our previously finalized improvement activities Inventory. We also 
refer readers to the Quality Payment Program website under Explore 
Measures and Activities at https://qpp.cms.gov/mips/explore-measures?tab=improvementActivities&py=2020 for a complete list of the 
current improvement activities. In this final rule, we are adding 7 new 
improvement activities, modifying 15 existing improvement activities, 
and removing 6 previously adopted improvement activities for the CY 
2022 performance period and future years. We refer readers below and to 
Appendix 2 of this final rule for more details.
(B) Changes to Adopted Improvement Activities
(aa) Changes to the ``Drug Cost Transparency To Include Requirements 
for Use of Real-Time Benefit Tools'' Improvement Activity
    In the CY 2020 PFS final rule (84 FR 63515), we adopted IA_BE_25, 
titled ``Drug Cost Transparency to include requirements for use of 
real-time benefit tools'' beginning with the 2020 performance year and 
for subsequent years. This activity description reads as follows:

[[Page 65466]]

    To receive credit for this improvement activity, MIPS eligible 
clinicians must attest that their practice provides counseling to 
patients and/or their caregivers about the costs of drugs and the 
patients' out-of-pocket costs for the drugs. If appropriate, the MIPS 
eligible clinician must also explore with their patients the 
availability of alternative drugs and patients' eligibility for patient 
assistance programs that provide free medications to people who cannot 
afford to buy their medicine. One source of information for pricing of 
pharmaceuticals could be a real-time benefit tool (RTBT), which 
provides to the prescriber, real-time patient-specific formulary and 
benefit information for drugs, including cost-sharing for a 
beneficiary. (CMS finalized in the Modernizing Part D and Medicare 
Advantage to Lower Drug Prices and Reduce Out of Pocket Expenses final 
rule (84 FR 23832, 23883) that beginning January 1, 2021 Medicare Part 
D plans will be required to implement one or more RTBT(s)).
    Thus, this activity allows a RTBT to be one source of information 
for the pricing of pharmaceuticals, which provides to the prescriber 
real-time patient-specific formulary and benefit information for drugs, 
including cost-sharing for a beneficiary.
    The 2021 Consolidated Appropriations Act (H.R. 116-133, Pub. L. 
116-260) included section 119 in Division CC entitled ``Increasing the 
use of real-time benefit tools to lower beneficiary costs.'' Subsection 
(c) of section 119 includes a provision called ``Inclusion of Use of 
Real-Time Electronic Information in Shared Decision-Making Under 
MIPS.'' This provision amends section 1848(q)(2)(B)(iii)(IV) of the Act 
to require that this subcategory shall include as an activity, for 
performance periods beginning on or after January 1, 2022, the use of a 
RTBT as described in section 1860D-4(o) of the Act. In addition, the 
amendment provides that the Secretary may establish this activity as a 
standalone activity or as a component of another activity.
    In accordance with this statutory requirement, we proposed to 
modify the IA_BE_25 improvement activity such that, beginning with the 
CY 2022 performance period and for subsequent years, the activity will 
require the use of an RTBT. As previously finalized, use of an RTBT was 
optional. We refer readers to Appendix 2 of this final rule for 
additional details regarding our adoption of this policy, including a 
summary of the comments received and our responses.
(bb) Changes to the COVID-19 Clinical Data Reporting With or Without 
Clinical Trial (IA_ERP_3) Improvement Activity
    We refer readers to the March 31 IFC for COVID-19 (85 FR 19276 
through 19277) and the September 2 COVID-19 IFC (85 FR 54848 through 
54851) for a regulatory history of this improvement activity. In the 
September 2 COVID-19 IFC, we extended the modified COVID-19 Clinical 
Data Reporting with or without Clinical Trial improvement activity 
through the CY 2021 performance period due to the continued COVID-19 
infections we were experiencing nationwide. We anticipated the need for 
COVID-19 clinical trials and data collection/sharing through registries 
to continue through CY 2021 at which time we will reassess whether 
there remains a need for additional data sharing or if preventive 
measures and clinical treatments have advanced to the point where these 
types of data are not needed.
    We again proposed to extend the COVID-19 Clinical Data Reporting 
with or without Clinical Trial improvement activity for the CY 2022 
performance period and future years due to the continued COVID-19 
infections we are experiencing nationwide and the need for further 
research. We stated that clinicians will continue to treat 
beneficiaries with COVID-19, and we anticipate the need for COVID-19 
clinical trials and data collection/sharing through registries to 
continue, through CY 2022 and future years. For each year after 2022, 
we intend to reassess whether there remains a need for additional data 
sharing or if preventive measures and clinical treatments have advanced 
to the point where these types of data are not needed. We believe that 
it is important for MIPS eligible clinicians to be able to attest to 
this improvement activity if it is still pertinent. Further, we believe 
that participation in this improvement activity is likely to result in 
improved outcomes by improving the collection of data that MIPS 
eligible clinicians use for the care of their patients as they monitor 
and manage COVID-19. We will continue to reassess whether there remains 
a need for additional data sharing or if preventive measures and 
clinical treatments have advanced to the point where these types of 
data are not needed and will discontinue the activity through notice-
and-comment rulemaking as needed. We also refer readers to Appendix 2 
of this final rule for details regarding our adoption of this policy, 
including a summary of the comments received and our responses.
(4) Promoting Interoperability Performance Category
(a) Background
    Section 1848(q)(2)(A) of the Act includes the meaningful use of 
certified electronic health record technology (CEHRT) as a performance 
category under the MIPS. As required by sections 1848(q)(2) and (5) of 
the Act, the four performance categories of the MIPS shall be 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 Promoting 
Interoperability performance category.
(b) Promoting Interoperability Performance Category Performance Period
    As finalized in the CY 2021 PFS final rule at Sec.  414.1320(g)(1) 
(85 FR 84886), for the 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. Thus, 
for the CY 2024 MIPS payment year, the performance period for the 
Promoting Interoperability performance category is a minimum of any 
continuous 90-day period within CY 2022, up to and including the full 
CY 2022 (January 1, 2022 through December 31, 2022). We did not propose 
any changes to the Promoting Interoperability performance category 
performance period that we established under Sec.  414.1320(g)(1) (85 
FR 84886).
(c) 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
(A) Measure Background
    We have adopted a Query of Prescription Drug Monitoring Program 
(PDMP) measure under the Electronic Prescribing objective. 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), we finalized that the Query of PDMP measure will remain 
optional and eligible for 10 bonus points for the CY 2021 performance 
period/CY 2023 MIPS payment year.

[[Page 65467]]

(B) State PDMPs' Progress and Previous Stakeholder Feedback
    In the CY 2020 and CY 2021 PFS final rules (84 FR 62992 through 
62994 and 85 FR 84887 through 84888), we described the concerns 
expressed by stakeholders that they believed it was premature for the 
Promoting Interoperability performance category to require the Query of 
PDMP measure and score it based on performance. In the CY 2022 PFS 
proposed rule (86 FR 39410) we discussed our support of efforts to 
expand the use of PDMPs, describing federally supported activities 
aimed at developing a more robust and standardized approach to EHR-PDMP 
integration, and additional discussions on the feedback we have 
received from health IT vendors and MIPS eligible clinicians thus far. 
For more detailed information, we refer readers to the CY 2022 PFS 
proposed rule (86 FR 39410).
(C) Measure Changes
    Given current efforts to improve the technical foundation for EHR-
PDMP integration, the continued implementation of the SUPPORT for 
Patients and Communities Act (in particular, its provisions specific to 
Medicaid providers and qualified PDMPs), our ongoing review of 
alternative measure approaches, and stakeholder concerns about the 
current readiness across States for implementation of the existing 
measure, we believe that at least 1 more year is needed prior to 
potentially requiring the Query of PDMP measure.
    While we appreciate the concerns that stakeholders have shared, we 
continue to believe that this measure can play an important role in 
helping to address the opioid crisis. By integrating PDMP data into the 
health record, health care providers can improve clinical decision 
making by utilizing this information to identify potential opioid use 
disorders, inform the development of care plans, and develop effective 
interventions. Maintaining this as an optional measure with bonus 
points signals to the MIPS eligible clinician and vendor community that 
this is an important measure to address a current gap that can help 
spur development and innovation in order to reduce barriers and 
challenges.
    Therefore, in the CY 2022 PFS proposed rule (86 FR 39409 through 
39410), we proposed to maintain the Electronic Prescribing Objective's 
Query of PDMP measure as optional and worth 10 bonus points for the CY 
2022 performance period/CY 2024 MIPS payment year. We received public 
comments on our proposal, and the following is a summary of the 
comments we received.
    Comment: All commenters were supportive of our proposal to maintain 
the Electronic Prescribing Objective's Query of PDMP measure in the CY 
2022 MIPS performance period/CY 2024 MIPS payment year as optional and 
worth 10 bonus points. One commenter shared that PDMP data has the 
capacity to improve patient care, and could aid in addressing the 
opioid crisis. A few commenters shared that 10 bonus points provides 
MIPS eligible clinicians enough incentive for participation.
    Response: We acknowledge that the time required for State programs 
to advance EHR-PDMP integration may vary, and we will continue to 
collaborate with the Office of the National Coordinator for Health 
Information Technology (ONC) to develop additional approaches to 
sharing data with PDMPs. Finalizing this proposal provides at least 1 
additional year for States and other stakeholders to make greater 
progress toward improving interoperability across systems.
    Comment: Several commenters supported our proposal, but suggested 
that this measure should remain optional indefinitely, unless or until 
all States and EHRs share the same functional capabilities. Some 
commenters suggested that the measure remain as a ``yes/no'' 
attestation, rather than being considered as a numerator/denominator 
measure in the future.
    Response: We thank commenters for sharing their suggestions for the 
Query of PDMP measure in the future. We believe the Query of PDMP 
measure will be a useful and informative measure as more State PDMPs 
and EHR systems are effectively integrated. We refer readers to the CY 
2022 PFS proposed rule (86 FR 39410) for an overview of the key efforts 
aimed towards improving the technical approaches to EHR-PDMP 
integration, including the implementation of key provisions from the 
SUPPORT for Patients and Communities Act. We may take commenters' 
feedback under consideration in future rulemaking.
    After consideration of the public comments we received, we are 
finalizing our proposal to maintain the Query of PDMP measure as 
optional and worth 10 bonus points for the CY 2022 performance period/
2024 MIPS payment year. The maximum total points available for the 
Electronic Prescribing Objective will remain at 20 points for the CY 
2022 performance period/2024 MIPS payment year. Last, we received many 
public comments in response to our request for comment in the CY 2022 
PFS proposed rule (86 FR 39410 through 39411) regarding the future of 
the Electronic Prescribing Objective's Query of PDMP measure. We thank 
commenters for this feedback and may consider this information to 
inform future rulemaking.
(ii) Changes to the Provide Patients Electronic Access to Their Health 
Information Measure Under the Provider to Patient Exchange Objective
(A) Background
    In the CY 2019 PFS final rule (83 FR 59812 through 59815), we 
renamed the Patient Electronic Access Objective to the Provider to 
Patient Exchange Objective, which includes the Provide Patients 
Electronic Access to Their Health Information measure. For more 
information about the Provide Patients Electronic Access to Their 
Health Information measure, we refer readers to the following preamble 
discussions in prior rulemaking: 84 FR 62995 and 62999 through 63000, 
83 FR 59812, 82 FR 53674, 81 FR 77228, 80 FR 62841 through 62851, 77 FR 
54007, and 75 FR 44353.
(B) Data Availability Requirement for MIPS eligible clinicians
    The Provide Patients Electronic Access to Their Health Information 
measure requires, for at least one unique patient seen by the MIPS 
eligible clinician: (1) The patient (or the patient-authorized 
representative) is provided timely access to view online, download, and 
transmit his or her health information; and (2) the MIPS eligible 
clinician ensures the patient's health information is available for the 
patient (or patient-authorized representative) to access using any 
application of their choice that is configured to meet the technical 
specifications of the Application Programming Interface (API) in the 
MIPS eligible clinician's CEHRT (84 FR 62999 through 63000 and 82 FR 
53674). In the CY 2022 PFS proposed rule (86 FR 39411 through 39412), 
we proposed to modify this measure to require MIPS eligible clinicians 
to ensure that patient health information remains available to the 
patient (or patient-authorized representative) to access indefinitely 
and using any application of their choice that is configured to meet 
the technical specifications of the API in the MIPS eligible 
clinician's CEHRT. MIPS eligible clinicians would be required to ensure 
this information remains available indefinitely (that is, not merely 
for a defined period of time). The proposed requirement would apply 
beginning with the performance period

[[Page 65468]]

in 2022, and would include all patient health information from 
encounters on or after January 1, 2016.
    Currently, the Provide Patients Electronic Access to Their Health 
Information measure does not specify how long MIPS eligible clinicians 
are required to make patient data available, or to ensure that patient 
data remain available to patients in the event that a MIPS eligible 
clinician switches EHR vendors (81 FR 77228). In an effort to minimize 
stakeholder burden, we wanted to align the date under our proposal for 
making information about encounters available, with the date of service 
start date (January 1, 2016) as finalized in the Patient Access and 
Interoperability final rule (85 FR 25528), and as proposed for the 
Promoting Interoperability Program for eligible hospitals and CAHs in 
the FY 2022 IPPS/LTCH proposed rule (86 FR 25631). As an alternative to 
our proposal, we considered different encounter start dates, such as 
encounters on or after January 1, 2012, or encounters on or after 
January 1, 2019. We believed, however, that a requirement for MIPS 
eligible clinicians to ensure patient health information remains 
available indefinitely, as well as an encounter start date of January 
1, 2016, would provide the most benefit to patients when accessing 
their health information as compared to the burden and costs to MIPS 
eligible clinicians implementing these proposed requirements.
    We sought public comment on our proposal to modify the Provide 
Patients Electronic Access to Their Health Information measure, as well 
as the alternatives we considered and discussed above, and received the 
following comments.
    Comment: One commenter supported our proposal, stating that the 
benefit to patients outweighs the burden to MIPS eligible clinicians.
    Response: We would like to thank this commenter for their support, 
and agree that providing patients (or their patient authorized 
representatives) access to their data is beneficial.
    Comment: Many commenters supported the principle that patients 
should have prompt access to their data with minimal effort, but did 
not support our proposal as it was proposed. Several commenters stated 
that the lack of clarity around key terminology was a main concern. 
Specifically, commenters requested additional clarification on how CMS 
is defining an ``indefinite'' timeline, what specific data would be 
included in ``all patient health information,'' and how we will address 
software platform changes and/or system updates given these terms. 
Last, many commenters asked that we provide exclusions for this measure 
to allow exceptions for those unable to meet the measure requirements, 
as exclusions were not discussed in the proposed rule.
    Response: We agree that patients (or their patient authorized 
representatives) should have access to their data with minimal effort. 
We appreciate the requests from commenters requesting additional 
clarification on the terms used in the proposal, including 
``indefinite'' and ``all patient health information''. We agree with 
commenters that we need to more clearly define what an ``indefinite'' 
timeline entails, as well as to more clearly define what specific data 
should be included in ``all patient health information.'' We agree with 
commenters that we need to consider defining and allowing for 
exclusions as well, with the understanding that there are varying 
limitations between eligible clinicians. We agree that as proposed, 
this modification needs additional clarification, and for these 
reasons, we are not finalizing this proposal at this time. In the 
future, we will be seeking additional feedback from MIPS eligible 
clinicians, in the event that we decide to propose changes to the 
measure in future rulemaking.
    Regarding software platform changes, we would like to note that the 
ONC 21st Century Cures Act final rule established a new criterion, 
``electronic health information export'' at 45 
CFR[thinsp]170.315(b)(10), which requires a certified health IT module 
to electronically export all electronic health information (EHI), as 
defined in Sec.  [thinsp]171.102, that can be stored at the time of 
certification by the product of which the health IT module is a part 
(85 FR 25690 through 25693). A health IT developer of certified health 
IT products, which, at the time presented for certification 
electronically stores EHI, must certify such products to this new 
criterion and make these products available to their customers by 
December 31, 2023. We believe this certified functionality will further 
support the capability to seamlessly transfer electronic health 
information between systems.
    Comment: A few commenters shared concerns regarding potential 
conflict between State laws and our proposed data availability 
requirement, and also potential conflict between State laws and our 
proposed requirement to make ``all patient health information'' 
available. One example shared by commenters is that different States 
have different requirements for data retention (mentioned were 7 and 10 
years), as opposed to our proposal for an ``indefinite'' availability 
period. Another commenter shared that some States have laws requiring 
that physicians withhold certain patient health information from being 
released (specifically, California protected health information laws 
were shared), where our proposal included ``all patient health 
information,'' non-specific of any exclusions. Commenters have 
requested that CMS continue to work alongside ONC and the Patient 
Access and Interoperability teams to ensure that we address these 
discrepancies between State and Federal policy.
    Response: We agree with commenters that we need to continue our 
collaborative efforts with the CMS Patient Access and Interoperability 
team and ONC as we consider how we might address these issues in future 
rulemaking. We also agree with commenters that we need to address 
varying data availability requirements between individual States, 
potential discrepancies between State and Federal policy, and ensure 
that we also account for State protected personal health information. 
For these reasons, we are not finalizing our proposal at this time. 
Instead, we may hold a listening session in the future where we welcome 
feedback as we continue to consider potential revisions to this measure 
amidst the feedback we have received.
    Comment: Many commenters did not support our proposal but offered 
suggestions for CMS to consider. A few commenters suggested that CMS 
consider setting expectations on a forward-looking basis rather than 
taking a retrospective approach. Some commenters suggested that CMS 
consider working more closely with ONC to clearly distinguish between 
USCDI and the larger set of electronic health information as defined in 
the ONC Information Blocking rules. Another commenter requested that 
CMS ensure this policy is aligned with ONC's requirements for certified 
health IT. One commenter suggested that CMS allow for a rolling 
timeframe where 6 years' worth of data are maintained, but that those 
years not be fixed.
    Response: We agree with the commenters' suggestions and will 
continue to collaborate with the CMS Patient Access and 
Interoperability team and ONC, especially regarding the feedback 
commenters shared above. We agree with commenters that it is important 
to distinguish between the data included in the USCDI, which is 
relevant to the Provide Patients Access to their Health Information 
measure, and the information included in the

[[Page 65469]]

electronic health information definition. We agree with commenters that 
additional work is essential on this proposal and will not be 
finalizing it at this time. As mentioned previously, CMS may hold a 
listening session in the future where we welcome additional feedback as 
we consider this measure for future rulemaking.
    After consideration of the public comments we received, we are not 
finalizing our proposed modifications to the Provide Patients 
Electronic Access to Their Health Information measure. We wish to 
emphasize that CMS and HHS strongly believe that a patient's health 
information should remain available to the patient (or patient-
authorized representative) through the technology currently required to 
successfully report on the Provide Patient Access to the Health 
Information measure. We will take commenters' suggestions under 
consideration and will seek further input as we consider whether to 
propose changes to the measure in future rulemaking.
(iii) Modifications to the Public Health and Clinical Data Exchange 
Objective
(A) Background
    In the CY 2019 PFS final rule (83 FR 59795, 59815 through 59817), 
for the Public Health and Clinical Data Exchange Objective, we 
finalized that a MIPS eligible clinician must submit a yes/no response 
for two different public health agencies or clinical data registries 
for any of the five measures associated with the Public Health and 
Clinical Data Exchange objective (Syndromic Surveillance Reporting; 
Immunization Registry Reporting; Clinical Data Registry Reporting; 
Electronic Case Reporting; and Public Health Registry Reporting) to 
earn 10 points for the objective. Failure to report on two different 
public health agencies or clinical data registries or submitting a 
``no'' response for a measure will earn a score of zero. If an 
exclusion is claimed for one measure, but the MIPS eligible clinician 
submits a ``yes'' response for another measure, they will earn the 10 
points for the objective. If a MIPS eligible clinician claims 
exclusions for both measures they select to report on, the 10 points 
will be redistributed to the Provide Patients Electronic Access to 
Their Health Information measure under the Provider to Patient Exchange 
objective.
    Effective responses to public health events, such as the COVID-19 
pandemic, require fast, accurate exchange of data between health care 
providers and Federal, State, tribal, local, and territorial public 
health agencies (PHAs). Health care providers collect these data for 
patient care and PHAs need them to protect the public, whether to track 
an outbreak, initiate contact tracing, find gaps in vaccine coverage, 
or pinpoint the source of a foodborne outbreak.
    While our current approach has encouraged health care systems to 
stand up some of these capabilities, significant gaps remain, and 
absent stronger incentives it will be difficult to stand up the 
comprehensive data exchange needed for future public health response. 
Thus, we believe that a more assertive approach is needed.
(B) Modifications to the Reporting Requirements for the Public Health 
and Clinical Data Exchange Objective
    We proposed in the CY 2022 PFS proposed rule (86 FR 39412 through 
39414) to require two of the measures associated with the Public Health 
and Clinical Data Exchange Objective, beginning with the performance 
period in CY 2022: Immunization Registry Reporting; and Electronic Case 
Reporting. Requiring these two measures will put PHAs on better footing 
for future health threats and a long-term COVID-19 pandemic recovery by 
strengthening two important public health functions: (1) Vaccine 
uptake; and (2) case surveillance. Requiring these measures will enable 
automated case reporting for fast public health response; and local and 
national visibility on immunization uptake so PHAs can tailor vaccine 
distribution strategies.
    The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters agreed with the proposed modifications to 
the reporting requirements for the Public Health and Clinical Data 
Exchange Objective. They stated that the COVID-19 pandemic has 
underscored the value of consistent and high quality reporting of these 
public health measures and the proposed requirements would certainly 
greatly accelerate adoption of reporting for these measures. This 
regulatory requirement, in concert with the increased capabilities for 
such reporting, will better position the U.S. to identify and respond 
to current and future public health challenges. Another commenter 
agreed with the requirement of the Immunization Registry Reporting 
measure and the Electronic Case Reporting measure of the Public Health 
and Clinical Data Exchange objective stating that the recent pandemic 
has highlighted the need for immediate access to patient data for 
greater public health. A commenter supported our proposals stating that 
requiring those measures is an excellent step toward improving real-
time, electronic data exchange from eligible clinicians to public 
health agencies. This will help ensure that public health and clinical 
communities collaborate as a unified health system to act quickly and 
keep our people safe and healthy.
    Response: We thank commenters for their support and we appreciate 
their rationales.
    Comment: One commenter agreed with the value of and need for public 
health data exchange, but added that public health registries and other 
mechanisms for data exchange have not been universally adopted because 
they are not integrated into physicians' clinical workflow and CEHRT 
does not have a user-centered experience for data submission and use of 
these registries. They added that the problem is not that physicians 
are unwilling to report to public health registries, but rather that 
the current process for doing so is overly burdensome and in some cases 
prohibitively expensive.
    Response: We thank the commenter for their feedback, and understand 
that physicians and other clinicians are eager to report to public 
health agencies. The ONC Health IT Certification Program ensures that 
the health care provider's health IT is capable of capturing and 
reporting data to PHAs. Moreover, we note that the eCR Now application 
and platform offered by the CDC and other partners is designed so that 
it operates in the background of the EHR system, using information that 
is captured in the EHR as part of care delivery, and does not interrupt 
the clinician's workflow. Automating the generation and transmission of 
case reports electronically reduces the burden on health care providers 
to accomplish this reporting requirement. To learn more about ways that 
eCR Now works, please visit https://www.cdc.gov/ecr/index.html. We also 
remind readers that there are exclusions available for the Immunization 
Registry Reporting and Electronic Case Reporting measures (83 FR 35929 
through 35930).
    Comment: Some commenters did not support our proposal and urged CMS 
to consider allowing practices to attest to their choice of any two of 
the registries from the objective as the requirements are currently 
structured. One added that allowing practices to choose any two of the 
available registries would enable most practices to be able to attest 
without having to claim an exclusion.
    Response: We believe that letting clinicians choose to report any 
two different public health agencies or clinical data registries for 
the Public

[[Page 65470]]

Health and Clinical Data Exchange objective is no longer effective in 
our current PHE environment. Further, both immunization reporting and 
electronic case reporting are both supported with corresponding ONC 
Certification Criteria (Sec.  170.315(f)(1) and (f)(5)) that were 
finalized in 2015. We proposed the modifications to better prepare the 
healthcare system and public health agencies for future health threats 
and long-term pandemic recovery by strengthening critical public health 
functions through the use of CEHRT.
    Comment: Many commenters urged CMS to delay implementing the 
requirement to report on the Immunization Registry Reporting and 
Electronic Case Reporting measures. One stated that clinicians need at 
least a year to find, register, and implement reporting to a public 
health agency without penalty. Therefore, CMS should, at most, announce 
its intention of implementing this change but delay the implementation 
until the performance year 2023 to give clinicians adequate time to 
meet the new requirements.
    Response: We do not believe that it is necessary to delay these 
requirements. We established multiple exclusions for each measure for 
those MIPS eligible clinicians who may not be able to report on these 
measures due to the scope of their practice (83 FR 59815). We also 
established three levels of active engagement which indicate the 
progress a clinician is making toward sending production data to a 
public health agency (80 FR 62863 through 62864). We remind readers of 
option 1, the first level of active engagement--Completed Registration 
to Submit Data (80 FR 62863 through 62864): The MIPS eligible clinician 
registered to submit data with the PHA or, where applicable, the 
clinical data registry (CDR) to which the information is being 
submitted; registration was completed within 60 days after the start of 
the MIPS performance period; and the MIPS eligible clinician is 
awaiting an invitation from the PHA or CDR to begin testing and 
validation. This option allows MIPS eligible clinicians to meet the 
measure when the PHA or the CDR has limited resources to initiate the 
testing and validation process. MIPS eligible clinicians that have 
registered in previous years do not need to submit an additional 
registration to meet this requirement for each MIPS performance period.
(aa) Immunization Registry Reporting Measure
    Immunizations are considered one of the ten great public health 
achievements and have resulted in declines in cases, hospitalizations, 
deaths, and health care costs associated with vaccine preventable 
diseases.\244\ The benefits and value of immunizations are realized 
when public policy, health systems, and community-based intervention 
efforts are working in coordination. Ensuring the coordination of these 
efforts can achieve high immunization coverage is dependent on the 
availability of timely, accurate, and complete information on 
vaccinations received by individuals in a population.
---------------------------------------------------------------------------

    \244\ Ten Great Public Health Achievements--United States, 2001-
2010 (cdc.gov).
---------------------------------------------------------------------------

    Immunization registries (also called immunization information 
systems, or IIS) are powerful tools that allow collaboration between 
vaccine providers and public health agencies and enable coordination of 
population-based interventions. Immunization registries are 
confidential, population-based, computerized systems that record all 
vaccination doses administered by participating health care providers 
for individuals residing within a particular jurisdiction. At the point 
of clinical care, an immunization registry can provide consolidated 
immunization histories to assist vaccine providers in determining 
appropriate patient vaccinations. At the population level, immunization 
registries provide data on vaccination coverage assessment and program 
operations and in guiding public health action to improve vaccination 
rates.
    Currently, 50 States, the District of Columbia, eight island 
territories, and three cities (New York City, Philadelphia, and San 
Diego) operate an immunization registry. CDC provides technical 
assistance and nationwide leadership to all State immunization 
registries to ensure the optimal use of immunization registries for 
determining vaccination coverage at local, State, and national levels. 
Immunization registries already have connections in place to capture 
administered doses in real-time for a substantial portion of the 
population, a process accelerated over the last 10 years by the 
Medicare and Medicaid Promoting Interoperability Programs. According to 
data from the most recent CDC IIS Annual Report (2019) available, 
immunization registries currently hold demographics and immunization 
data on 95 percent of children 0-6 years, 82 percent of adolescents, 
and 60 percent of adults.\245\ While each State Immunization registry 
currently coordinates with health care providers and EHR systems to 
achieve interoperability and facilitate immunization reporting, varying 
State reporting policies limit the completeness and timeliness of 
records in immunization registries and the optimal use of immunization 
registries for determining vaccination coverage.
---------------------------------------------------------------------------

    \245\ https://www.cdc.gov/vaccines/programs/iis/annual-report-iisar/2019-data.html.
---------------------------------------------------------------------------

    We proposed in the CY 2022 PFS proposed rule (86 FR 39412 through 
39413) to make the Immunization Registry Reporting a required measure 
under the Public Health and Clinical Data Exchange objective of the 
Promoting Interoperability performance category beginning with the CY 
2022 performance period/CY 2024 MIPS payment year as it is critical for 
understanding vaccination coverage both at the jurisdiction level and 
nationwide and identifying where additional vaccination efforts are 
needed. For more information about the Immunization Registry Reporting 
measure, we refer readers to the preamble discussion in prior 
rulemaking at 81 FR 77230. Making standardized reporting to an 
immunization registry a required measure will provide an immediate 
benefit by increasing the COVID-19 vaccination records reported to 
these systems. Making the measure required will also improve the data 
quality of records in immunization registries and facilitate use of 
immunization registries for clinical decision support and tracking of 
vaccine administration and distribution.
    We believe that making the Immunization Registry Reporting measure 
required will increase the reporting of immunization data by health 
care providers to public health agencies. Making the measure required 
is also critical for the COVID-19 vaccination response because it will 
provide a better view of the vaccines administered and distributed at 
national, State and local levels. This is a function that immunization 
registries currently provide for all public vaccines, but is 
particularly important for COVID-19 vaccines. In addition to the COVID-
19 vaccination response is the equally important need for routine 
vaccination coverage to increase. Fear of COVID-19 has caused deferrals 
of routine vaccinations as patients limit their interactions, including 
with their family doctors. More complete data in immunization 
registries as a result of the required measure will also optimize the 
use of immunization registries to determine who has not been 
vaccinated, pockets of under vaccination, and identifying where 
interventions should be focused for routine and emergency response 
vaccines. Requiring the measure will reduce the regulatory and

[[Page 65471]]

administrative burden health care providers experience when exchanging 
information with immunization registries.
    We did not propose any changes to the description of the measure 
including any of the exclusions that we established in CY 2019 PFS 
final rule at 83 FR 59815 through 59817.
    The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters supported our proposal to require the 
Immunization Registry Reporting measure. One stated that significant 
strides have been made in immunization reporting throughout the PHE 
that have enabled those that previously lacked the resources to 
successfully report on this measure to now do so. Another commenter 
strongly supported our proposal and stated that immunization reporting 
plays a critical role in improving vaccination at the point of clinical 
care, at the population health level, and to help address the health 
disparities which have only worsened during the pandemic. They stated 
that requiring the Immunization Registry Reporting measure could: (1) 
Increase reporting of immunization data into a centralized 
jurisdiction-based system--thereby increasing patient data completeness 
and quality in immunization registry reporting, (2) facilitate better 
inter- and intra-State data sharing between other immunization registry 
reporting, health systems, and other HIT systems, and (3) improve 
vaccination uptake and health equity by determining areas of under 
vaccination.
    Response: We thank commenters for their support and we appreciate 
their rationales.
    Comment: A commenter suggested that prior to requiring immunization 
registry reporting, CMS should ensure there are exclusions available if 
there is not a State immunization registry available for providers. 
Additionally, CMS should survey the State immunization registries to 
determine if there is readiness at the State level to conduct this 
level of exchange.
    Response: The following exclusion has been available to MIPS 
eligible clinicians since the CY 2019 performance period/CY 2021 MIPS 
payment year (83 FR 35929): ``Operates in a jurisdiction where no 
immunization registry or immunization information system has declared 
readiness to receive immunization data as of 6 months prior to the 
start of the performance period.'' Every State, in addition to the 
District of Columbia, eight island territories, and three cities (New 
York City, Philadelphia, and San Diego), operate an immunization 
registry. State reporting policies and the capability to receive 
immunization-related data vary across jurisdictions. CDC provides 
financial and technical support to improve data exchange within each 
jurisdiction. CDC publishes the Immunization Information Systems Annual 
Report (IISAR) which provides an assessment of jurisdictions' efforts 
in developing, maintaining, and enhancing IIS activities for a given 
calendar year. CDC has developed an accompanying dashboard which allows 
the user to view a jurisdiction's performance according to 26 domains, 
including interoperability and clinical-decision making.
    After consideration of public comments, we are finalizing our 
proposal to make the Immunization Registry Reporting a required measure 
under the Public Health and Clinical Data Exchange objective of the 
Promoting Interoperability performance category beginning with the CY 
2022 performance period/CY 2024 MIPS payment year.
(bb) Electronic Case Reporting
    Health care providers are required by State law to report certain 
diseases and conditions, a process called case reporting, which 
provides PHAs with data on approximately 120 diseases and conditions of 
public health significance.\246\ Case reporting is a vital and 
longstanding tool that PHAs use to prevent the spread of infectious 
diseases. Case reporting serves as early notification to PHAs for 
potential outbreaks and includes information that enables PHAs to start 
contact tracing and other prevention measures. Case reports also 
include critical clinical information that will not be included in 
syndromic surveillance or laboratory reporting, and can help to 
illuminate the impact of comorbidities, treatments, and variable access 
to care. Information from the case reports can be used to further work 
on social determinants of health and ensure equal access to 
preventative care across populations. Electronic case reporting is the 
automated, real-time, bidirectional exchange of case report information 
between EHRs and PHAs. Electronic case reporting uses standard codes to 
trigger the transfer of relevant clinical data to PHAs for case 
investigation and follow-up. As of March 2021, most States do not 
require electronic submission of case reports as part of their 
regulations and case reporting often occurs through outdated manual 
methods (for example, fax, email, or phone), which results in delays, 
underreporting, and incomplete or inaccurate case data. Manual case 
reporting also imposes burdens on health care providers, taking staff 
time away from patients to submit case reports and comply with State 
reporting requirements. Electronic case reporting allows health care 
providers to fulfill mandated public health reporting requirements 
without imposing additional burden and disrupting the clinical 
workflow. This automated data exchange facilitates faster and more 
efficient disease tracking, case management, and contact tracing. 
Electronic case reporting provides more timely and complete data than 
manual reporting, including data on demographics, comorbidities, 
immunizations, medications, occupation, and other treatments.
---------------------------------------------------------------------------

    \246\ CSTE State Reportable Condition Assessment page: https://www.cste.org/page/SRCA.
---------------------------------------------------------------------------

    Recent efforts by the CDC have sought to significantly improve the 
effectiveness of electronic case reporting through eCR Now, a strategic 
initiative that allows for rapid adoption and implementation of 
electronic case reporting for COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/hcp/electronic-case-reporting.html). As part of 
this initiative, CDC and its partners have developed an eCR Now 
FHIR[supreg] application (app) to establish electronic case reporting 
capability in EHR systems. EHR vendors can also implement the eCR 
functionality within their products to accomplish this reporting. The 
initiative also supports an electronic case reporting infrastructure 
that is helping to advance interoperability. This infrastructure 
supports the transmission of electronic case reports to a shared 
service platform, and not directly to a PHA, which means that any 
health care provider that has established an electronic case reporting 
connection also has a connection with every State PHA, many large local 
health departments, and some territories. This promotes nationwide 
interoperability and increases the availability of data for patients 
who may be traveling or spending time away from their home State. For 
example, if a patient is a resident of one State but seeks care in 
another State, this infrastructure will automatically route the case 
report to both States that would have jurisdiction over this report. 
This increases inter-jurisdictional reporting, allowing for more 
seamless case investigation at the national level. The interoperable 
infrastructure and the use of a standard data format also reduces the 
variability of case report forms across conditions

[[Page 65472]]

and jurisdictions, streamlining reporting forms for EHR vendors and 
health care providers.
    As a result of the CDC effort to scale up eCR for COVID-19, all 50 
States, the District of Columbia, Puerto Rico and 13 large local 
jurisdictions have connected to the shared services platform and are 
currently receiving electronic case reports, with more than 9,400 
healthcare facilities on board and 11.6 million reports for COVID-19 
received by PHAs as of October 5, 2021.\247\ The eCR infrastructure is 
designed to rapidly scale for PHEs, such as COVID-19, and it is enabled 
to currently support data transmission for 99 reportable and notifiable 
conditions. While these are significant advancements, the piecemeal 
approach of encouraging adoption of these tools by individual health 
care providers has not been an effective or efficient means to quickly 
scale this effort nationally as has been needed for the COVID-19 PHE 
response.
---------------------------------------------------------------------------

    \247\ Healthcare Facilities in Production for COVID-19 
Electronic Case Reporting [verbar] CDC.
---------------------------------------------------------------------------

    We believe the uneven adoption of electronic case reporting creates 
a public health vulnerability. We proposed in the CY 2022 PFS proposed 
rule (86 FR 39413 through 39414) to make the Electronic Case Reporting 
measure a required measure under the Public Health and Clinical Data 
Exchange objective of the Promoting Interoperability performance 
category beginning with the performance period in CY 2022. For more 
information about the Electronic Case Reporting measure, we refer 
readers to the preamble discussion in prior rulemaking at 81 FR 77229. 
We believe making this a required measure will accelerate development 
of electronic case reporting capabilities in EHR systems, reduce health 
care administrative burden of complying with State-mandated disease 
reporting requirements, provide regulatory clarity for EHR vendors, and 
improve the timeliness, completeness, and utility of case report data 
for PHAs. We believe that requiring the Electronic Case Reporting 
measure will be feasible and beneficial for MIPS eligible clinicians. 
This change will encourage EHR vendors to make electronic case 
reporting available to their customers, which will make adoption of 
this capability relatively straightforward for MIPS eligible 
clinicians. To meet the CEHRT definition when reporting on this 
measure, in our EHR Incentive Program Stage 3 and Modifications to 
Meaningful Use in 2015 through 2017 final rule (80 FR 62870 through 
62885) we established that health care providers are required to use a 
health IT module certified to the ``Transmission to public health 
agencies--electronic case reporting'' certification criterion at Sec.  
170.315(f)(5) that relates to how the health IT uses structured data 
within an EHR to trigger or indicate the generation of an electronic 
initial case report.\248\ They may then transmit the report in the 
manner specified by the case reporting requirements of the entity to 
which they are transmitting a report.
---------------------------------------------------------------------------

    \248\ For more information about this certification criterion, 
please see the Certification Companion Guide at https://www.healthit.gov/test-method/transmission-public-health-agencies-electronic-case-reporting.
---------------------------------------------------------------------------

    We believe that requiring the Electronic Case Reporting measure 
will not only provide certainty to EHR vendors and facilitate an 
organized and industry-wide rollout of electronic case reporting 
capabilities, but will also reduce burden on health care providers to 
fulfill their public health reporting requirements.
    We did not propose any changes to the description of the Electronic 
Case Reporting measure and the exclusions that we established in the CY 
2019 PFS final rule at 83 FR 59815 through 59817 will remain available.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter reported that their State is not ready for 
electronic case reporting. The State, EHR vendors and the providers 
need more time to adopt the functionality required to do electronic 
case reporting.
    Response: All 50 States, DC, Puerto Rico, and several local public 
health agencies currently receive eCR messages supported under the eCR 
Now Initiative, which can enable successful completion of electronic 
case reporting. Based on information from the CDC and their extensive 
engagement with public health agencies, many public health agencies are 
in the process of updating their websites to reflect their readiness 
for public health measurement requirements in the Promoting 
Interoperability Program, including electronic case reporting.
    For a current list of PHA websites that provide their readiness to 
receive information please see ONC's Interoperability Standards 
Advisory (https://www.healthit.gov/isa/appendix-iv-state-and-local-public-health-readiness-interoperability). If a PHA does not declare 
readiness, then the MIPS eligible clinician can claim an exclusion for 
this measure.
    Comment: One commenter stated that if CMS requires clinicians to 
report to an electronic case reporting registry then a national, State, 
and local listing of available case registries to report on would be 
extremely helpful for organizations/clinicians to reference, ensuring 
they are meeting the requirements of MIPS.
    Response: Electronic case reporting is not submitting to a 
registry. Rather, electronic case reporting replaces the manual disease 
reporting by clinicians to State or local public health agencies 
required under State or local law with the automated, real-time 
exchange of case report information between EHRs and public health 
agencies.
    Comment: Many commenters stated that their EHRs are not certified 
for electronic case reporting. A few commenters stated that this 
measure and the use of the certified capability were not previously 
required, and clinicians may be unable to adopt a newly certified 
capability in a timely way prior to the start of their performance 
period. Commenters stated that requiring the electronic case reporting 
measure may pose issues for clinicians who do not possess the certified 
functionality product for this capability and may have difficulty 
procuring and implementing one by CY 2022. Commenters stated that 
clinicians often have little control over the CEHRT capabilities 
available to them especially when they are provided their CEHRT by a 
larger parent organization.
    A commenter urged CMS to not impose reporting obligations on 
clinicians before the technology can facilitate such reporting. Another 
commenter stated the proposed reporting requirements for clinicians 
will burden EHR developers. Specifically, the commenter stated that the 
time between when the CY 2022 PFS final rule is issued and the start of 
CY 2022 is insufficient for developers to certify and deploy a solution 
for electronic case reporting. The commenter stated that not all of 
their EHR developers' products are certified to electronic case 
reporting. The commenter stated that these developers would need to 
develop, test, certify, and then deploy a certified solution within 
just a few months. The commenter urged CMS to add an exclusion to the 
electronic case reporting measure for instances where a clinician's 
CEHRT is not certified to electronic case reporting at the beginning of 
the performance period.
    Several commenters recommended that CMS consider adding an 
exclusion for this measure for instances where the clinician's CEHRT 
developer does not yet offer products that are certified for electronic 
case reporting. One commenter suggested a 1-year, limited

[[Page 65473]]

exclusion could maintain the primary benefits of requiring the 
electronic case reporting measure while ensuring clinicians do not fail 
to satisfy the requirements of the Promoting Interoperability 
performance category if they are not able to meet the electronic case 
reporting measure.
    Response: We have consulted with ONC, and they report that 
certification to the criterion for electronic case reporting at Sec.  
170.315(f)(5) has increased significantly since the publication of the 
proposed rule, so we do not believe that lack of certification will be 
an impediment to successfully reporting the Electronic Case Reporting 
measure. As ONC clarified earlier this year,\249\ for health IT 
developers that do not already support electronic case reporting, these 
capabilities can be certified to the certification criterion for 
``Transmission to public health agencies--electronic case reporting'' 
at Sec.  [thinsp]170.315(f)(5) by providing their ONC-Authorized 
Certification Body documentation that sufficiently describes how the 
health IT module meets the functional requirements of the criterion 
and/or documentation of electronic case reporting implementation using 
the eCR Now FHIR application and the ability to meet paragraph (i) of 
this criterion. Health IT developers are encouraged to visit the 2015 
Edition Cures Update Certification Companion Guide page (https://www.healthit.gov/test-method/transmission-public-health-agencies-electronic-case-reporting) for more information. With appropriate 
prioritization, we believe health IT developers can rapidly and 
successfully implement electronic case reporting capabilities.
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    While we believe that the adoption of certified technology for 
electronic case reporting by eligible clinicians is achievable in 2022, 
and that the active engagement requirements (80 FR 62863 through 80FR 
62864) and existing exclusions of the measure (83 FR 59815 through 
59817) offer significant flexibilities that can ensure most clinicians 
will be able to meet the measure or claim an exclusion, we acknowledge 
the commenters' concerns about technology and vendor readiness and 
clinicians potentially not being ready to report the measure due to the 
functionality not being certified. Rather than delaying or not 
finalizing the proposal to require the measure, we are establishing a 
new 1-year exclusion for the Electronic Case Reporting measure only for 
the CY 2022 performance period/CY 2024 MIPS payment year: the MIPS 
eligible clinician uses CEHRT that is not certified to the electronic 
case reporting certification criterion at Sec.  170.315(f)(5) prior to 
the start of the performance period they select in CY 2022. By 
requiring the Electronic Case Reporting measure beginning with the CY 
2022 performance period/CY 2024 MIPS payment year, but also adding a 
new exclusion for the CY 2022 performance period/CY 2024 MIPS payment 
year only, we will be able to: (1) Ensure health care providers that 
possess certified functionality adopt and implement this functionality 
before CY 2023; and (2) signal to EHR developers that they must 
prioritize adding electronic case reporting to their products to ensure 
their customers can report on the measure once the exclusion is no 
longer available.
    We believe that the flexibility provided by this additional 
exclusion should provide ample time for MIPS eligible clinicians to 
implement electronic case reporting using available options and for 
health IT developers to ensure that they have successfully completed 
certification.
    Comment: A commenter suggested that prior to requiring the adoption 
of electronic case reporting, CMS needs to engage with ONC, the CDC and 
the vendor community to gauge the ability for electronic case reporting 
to be implemented and utilized by the proposed deadline of CY 2022.
    Response: CMS, ONC, and CDC have worked together to evaluate the 
readiness of the EHR developer community. There are many developers who 
are working towards implementing electronic case reporting capabilities 
and making those capabilities available to their clients. According to 
the Certified Health IT Product List (https://chpl.healthit.gov/) 93 
products are already certified to the electronic case reporting 
certification criterion.
    In addition, vendors can provide electronic case reporting to their 
clients using the eCR Now FHIR app which uses a suite of ONC-required 
standards and backend services that should be invisible to front-line 
clinicians. As discussed in a recent blog, ONC has provided 
clarification that EHR vendors who support the eCR Now FHIR app can be 
certified for electronic case reporting certification criterion by 
providing their ONC-Authorized Certification Body with appropriate 
documentation as specified in the technical explanations and 
clarifications.\250\
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    Comment: One commenter suggested that prior to requiring the 
adoption of electronic case reporting CMS should determine if States 
are willing to move towards electronic data exchange. Many State 
agencies continue to mandate manual reporting. If States continue to do 
this and CMS mandates electronic reporting, physicians will be burdened 
with the need to report in two different formats.
    Response: All 50 States, DC, Puerto Rico, and several local public 
health agencies currently receive electronic case reporting messages. 
In addition, based on conversations that CDC has had with public health 
agencies, there is a limited period of time when public health agencies 
require clinicians to report by sending data through electronic case 
reporting and through traditional means (for example, manual 
reporting). Public health agencies have reported to CDC that they will 
use this time to make modifications to their data systems, onboard 
staff who can review the data, establish policies and processes for 
quality reviews, and ensure that their electronic feeds meet quality 
standards before they can turn off other forms of data transmission. We 
understand that this may place additional burden on MIPS eligible 
clinicians, and we know that many public health agencies are working on 
accelerating their processes to reduce the amount of time in parallel 
production. To help States reduce the amount of time that MIPS eligible 
clinicians need to spend doing dual reporting, CDC has invested heavily 
in helping public health agencies implement eCR. This funding will help 
public health agencies develop processes to turn off manual reporting 
processes and accelerate the quality review of the electronic feeds.
    After consideration of public comments, we are finalizing our 
proposal to require the Electronic Case Reporting measure under the 
Public Health and Clinical Data Exchange objective of the Promoting 
Interoperability performance category beginning with the CY 2022 
performance period/CY 2024 MIPS payment year. We are also establishing 
an additional one-year exclusion for the Electronic Case Reporting 
measure for the CY 2022 performance period/CY 2024 MIPS payment year 
only: The MIPS eligible clinician uses CEHRT that is not certified to 
the electronic case reporting certification criterion at Sec.  
170.315(f)(5) prior to the start of the performance period they select 
in CY 2022.

[[Page 65474]]

(cc) Scoring of the Public Health and Clinical Data Exchange Objective
    We proposed in the CY 2022 PFS proposed rule (86 FR 39414) that 
beginning with the CY 2022 performance period/CY 2024 MIPS payment 
year, a MIPS eligible clinician will receive 10 points for the Public 
Health and Clinical Data Exchange objective if they report a ``yes'' 
response for each of the following required measures: Immunization 
Registry Reporting; and Electronic Case Reporting. In the event that a 
MIPS eligible clinician is able to claim an exclusion for one or more 
of these required measures, we proposed they will receive 10 points for 
the objective if they report a ``yes'' response for one measure and 
claim an applicable exclusion for which they qualify for the remaining 
measure. If the MIPS eligible clinician fails to report on any one of 
the two measures required for this objective or reports a ``no'' 
response for one or more of these measures, we proposed that the MIPS 
eligible clinician will receive a score of zero for the Public Health 
and Clinical Data Exchange objective, and a total score of zero for the 
Promoting Interoperability performance category. If a MIPS eligible 
clinician claims applicable exclusions for which they qualify for both 
required measures, we proposed to redistribute the points associated 
with the objective to the Provider to Patient Exchange objective.
    We proposed in the CY 2022 PFS proposed rule (86 FR 39414) to 
retain the Public Health Registry Reporting, Clinical Data Registry 
Reporting, and Syndromic Surveillance Reporting measures, and to make 
them optional and available for bonus points beginning with the CY 2022 
performance period/CY 2024 MIPS payment year. For more information 
about these measures, we refer readers to the CY 2017 Quality Payment 
Program final rule (81 FR 77229) and the EHR Incentive Program Stage 3 
and Modifications to Meaningful Use in 2015 through 2017 final rule (80 
FR 62818 through 62825). We proposed a MIPS eligible clinician may earn 
5 bonus points if they report a ``yes'' response for either the Public 
Health Registry Reporting measure or the Clinical Data Registry 
Reporting measure or the Syndromic Surveillance Reporting measure. 
Reporting on more than one of these optional measures will not yield 
additional bonus points.
    In connection with our proposal to make these measures optional, we 
proposed to remove the three exclusions that we established in the CY 
2019 PFS final rule at 83 FR 59815 through 59817 for the Public Health 
Registry Reporting measure, Clinical Data Registry Reporting measure, 
and the Syndromic Surveillance Reporting measure.
    We solicited comments on these proposals.
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters supported our proposal to retain the Public 
Health Registry Reporting, Clinical Data Registry Reporting, and 
Syndromic Surveillance Reporting measures, and to make them optional 
and available for bonus points beginning with the performance period in 
CY 2022.
    Response: We appreciate commenters' support for our proposal.
    Comment: One commenter stated that syndromic surveillance has 
played a critical role in evaluating and monitoring many public health 
events in their State, including the COVID pandemic. We strongly 
support submission of syndromic surveillance data from providers and 
believe that providing this as an optional measure in this rule 
strengthens our ability to maintain the robust system into which both 
public health and healthcare facilities have already made significant 
investments.
    Response: We appreciate the support for this proposal.
    Comment: One commenter stated that surveillance data is used to 
monitor short-and long-term health trends and to alert health 
professionals to the important changes in disease trends. Surveillance 
data also provide the basis for determining public health priorities 
and for planning and implementing prevention and control programs.
    Response: While we considered requiring the Syndromic Surveillance 
Reporting measure as we had proposed and subsequently finalized it as a 
required measure for eligible hospitals and critical access hospitals 
participating in the Medicare Promoting Interoperability Program (86 FR 
45472 through 45473), we did not propose it as a required measure for 
MIPS because majority of data comes from emergency departments and only 
a small number of MIPS eligible clinicians practice in that setting.
    Comment: One commenter requested clarification on how bonus points 
for reporting an additional registry measure will be awarded when a 
clinician claims an exclusion for the two measures proposed to be 
required in 2022.
    Response: The five bonus points for reporting an additional 
registry measure can be earned even if exclusions are claimed for the 
two required measures.
    Comment: One commenter supported the allocation of bonus points for 
the Clinical Data Registry Reporting measure, the Public Health 
Registry Reporting measure, and the Syndromic Surveillance Reporting 
measure. However, the commenter stated that the Promoting 
Interoperability performance category and these measures should align 
with congressional intent to incentivize registry reporting. Further 
registry reporting outside of the proposed required measures should be 
worth ten or more bonus points to encourage the use of registry 
reporting.
    Response: We disagree. We chose 5 bonus points to create an 
incentive for clinicians to report an additional measure for the Public 
Health and Clinical Data Exchange objective. We have allocated 10 
points for the two required measures and believe that allocating 5 
points for reporting an additional measure aligns with the scoring of 
the required measures. We are not aware of congressional intent to 
incentivize registry reporting within the Promoting Interoperability 
performance category.
    After consideration of public comments, we are finalizing our 
proposals: Beginning with the CY 2022 performance period/CY 2024 MIPS 
payment year, a MIPS eligible clinician will receive 10 points for the 
Public Health and Clinical Data Exchange objective if they report a 
``yes'' response for each of the following required measures: 
Immunization Registry Reporting; and Electronic Case Reporting. In the 
event that a MIPS eligible clinician is able to claim an exclusion for 
one or more of these required measures, they will receive 10 points for 
the objective if they report a ``yes'' response for one measure and 
claim an applicable exclusion for which they qualify for the remaining 
measure. If the MIPS eligible clinician fails to report on any one of 
the two measures required for this objective or reports a ``no'' 
response for one or more of these measures, the MIPS eligible clinician 
will receive a score of zero for the Public Health and Clinical Data 
Exchange objective, and a total score of zero for the Promoting 
Interoperability performance category. If a MIPS eligible clinician 
claims applicable exclusions for which they qualify for both required 
measures, we will redistribute the points associated with the objective 
to the Provider to Patient Exchange objective.
    The Public Health Registry Reporting, Clinical Data Registry 
Reporting, and Syndromic Surveillance Reporting measures will be 
optional and available for bonus points beginning with the CY

[[Page 65475]]

2022 performance period/CY 2024 MIPS payment year. A MIPS eligible 
clinician may earn 5 bonus points if they report a ``yes'' response for 
either the Public Health Registry Reporting measure or the Clinical 
Data Registry Reporting measure or the Syndromic Surveillance Reporting 
measure. We are removing the three exclusions that we established in 
the CY 2019 PFS final rule at 83 FR 59815 through 59817 for the Public 
Health Registry Reporting measure, Clinical Data Registry Reporting 
measure, and the Syndromic Surveillance Reporting measure.
(d) SAFER Guides
(i) Background
    ONC developed and released the Safety Assurance Factors for EHR 
Resilience Guides (SAFER Guides) in 2014, and later updated them in 
2016. This series of nine user guides support the ability of health 
care providers to address EHR safety.\251\ Collectively, the SAFER 
Guides help health care organizations at all levels, from small 
practices to multi-system chains and tertiary care facilities, to 
conduct self-assessments which optimize the safety and safe use of EHRs 
in the three areas listed in Table 55. The SAFER Guides were intended 
to be utilized by EHR users, developers, patient safety organizations, 
and those who are concerned with optimizing the safe use of health IT. 
By completing an annual self-assessment using the SAFER Guides, 
providers can help develop a ``culture of safety'' within their 
organizations and ensure they are responsible operators of technology 
tools, including certified health IT products, which they utilize in 
the delivery of care. The SAFER Guides are based on the best evidence 
available at the time of publication, which included a literature 
review, expert opinion, and field-testing at a wide range of health 
care organizations, from small ambulatory care practices to large 
health systems.
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    In the case of system disruption, failure, natural disaster, the 
SAFER Guides provide recommended safety practices during planned or 
unplanned EHR unavailability, where end users are unable to access all 
or part of their EHR. Also included are back-up procedures to prevent 
the potential loss of clinical and administrative data, and how to 
utilize paper charting during such downtime. We believe that conducting 
an annual self-assessment starting with the High Priority Practices 
Guide will support consistent safety practices for all EHR users.
    The High Priority Practices Guide identifies ``high risk'' and 
``high priority'' recommended safety practices, intended to optimize 
the safety and safe use of EHRs.\252\ This guide broadly discusses EHR 
safety concerns that are described in greater detail in the subsequent 
8 SAFER Guides. The High Priority Practices Guide is considered the 
first to be completed of the 9 SAFER Guides.
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    \252\ https://www.healthit.gov/sites/default/files/safer/guides/safer_high_priority_practices.pdf.
[GRAPHIC] [TIFF OMITTED] TR19NO21.078

(ii) New SAFER Guides Measure
    We proposed in the CY 2022 PFS proposed rule (86 FR 39414 through 
39416), to add a new SAFER Guides measure to the Protect Patient Health 
Information objective, beginning with the CY 2022 performance period/
2024 MIPS payment year. For this measure, we proposed that a MIPS 
eligible clinician must attest to having conducted an annual self-
assessment using the High Priority Practices 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 accounting for the complete self-assessment 
using the High Priority Practices Guide. We proposed that this measure 
will be required, but it would not be scored, and that reporting 
``yes'' or ``no'' will not affect the total number of points earned for 
the Promoting Interoperability performance category. We believe this 
measure would further enable the electronic exchange of health 
information to improve the quality of health care, such as promoting 
care coordination, as described in section 1848(o)(2)(A)(ii) of the 
Act. We also proposed to add corresponding regulatory text for this 
measure at Sec.  414.1375(b)(2)(ii)(C).
    In order to complete a ``self-assessment'' using the High Priority 
Practices Guide, we expect that each MIPS eligible clinician would 
complete a review and mark the associated checkboxes (fully, partially, 
or not implemented) of recommended practices included at the beginning 
of the Guide. Detailed worksheets with the rationales for, and examples 
of how to implement each recommended practice follow the checklist 
section of the High Priority Practices Guide. These worksheets also 
include likely sources of information where the practice can turn to, 
in order to complete their assessment of a particular practice, as well 
as fillable note fields to record follow-up actions.
    We understand that every organization faces unique circumstances, 
and will implement a particular practice differently. As a result, some 
of the specific examples in the SAFER Guides for recommended practices 
may not be applicable to every organization. A ``self-assessment'' does 
not require an organization to confirm that it has implemented ``fully 
in all areas'' each practice described in a particular SAFER guide, nor 
will an organization be scored on how many of the practices the 
organization has fully implemented. Rather, the intent is for MIPS 
eligible clinicians to regularly

[[Page 65476]]

assess their progress and status on important facets of patient safety.
    The recommended practices in the SAFER Guides are intended to be 
useful for all EHR users, and we recognize that the individuals 
responsible for the proposed annual assessment may vary across 
organizations. An optimal team for completing an annual review of the 
SAFER Guides might include representation from clinicians (including 
physicians, nurses, pharmacists, and allied health staff), and the 
technical staff responsible for implementing and maintaining a 
practice's EHR, as well as data connections with external partners, 
such as an HIE.
    Regarding the frequency of completing the self-assessment for the 
High Priority Practices Guide, we proposed that a MIPS eligible 
clinician must attest to completing their assessment using the High 
Priority Practices Guide on an annual basis, following an initial 
completion of the assessment (some clinicians may have already 
completed an assessment using the SAFER Guides prior to implementation 
of this requirement). We would expect MIPS eligible clinicians to 
revisit this assessment to determine whether any changes have occurred 
for their organization. We believe that requiring MIPS eligible 
clinicians to periodically review this self-assessment would support a 
stronger culture of change management within organizations, and would 
assist organizations in actively understanding and addressing potential 
safety vulnerabilities, which may significantly impact an 
organization's safety posture. We recognize that organizations may be 
at different stages in their progress towards assessing patient safety 
vulnerabilities, and that MIPS eligible clinicians vary in the 
resources that they could devote to an annual self-assessment using the 
High Priority Practices Guide. Gathering this information may be time 
consuming for some, and others may not have the expertise available on 
staff to complete all of the requirements. For MIPS eligible clinicians 
with less experience in these areas, we note that there are a number of 
resources available, which may be able to assist with completing a 
self-assessment.
    We invited public comments on our proposal to require an annual 
self-assessment of the High Priority Practices Guide from MIPS eligible 
clinicians. The following is a summary of the comments we received and 
our responses.
    Comment: Several commenters supported our proposal to require an 
annual self-assessment of the High Priority Practices Guide. Commenters 
stated that this requirement will encourage program participants to 
regularly assess their progress on practices that optimize the safety 
and safe use of EHRs, and others agree that completion of the self-
assessment will promote best practices for the safe use and maintenance 
of health IT by MIPS eligible clinicians.
    Response: We agree that given the opportunity to regularly assess 
progress, the High Priority Practices Guide will help optimize the 
safety and safe use of EHRs, and allow MIPS eligible clinicians the 
opportunity to make improvements as necessary over time.
    Comment: Several commenters supported our proposal, but have 
requested clarification and/or suggestions for improvement. A few 
commenters stated that much of the High Priority Practices Guide 
represents a one-time configuration or verification steps, which for 
many MIPS eligible clinicians, would remain unchanged from year to 
year. One commenter suggested that after the initial review, MIPS 
eligible clinicians should be able to focus subsequent self-assessments 
on areas of the High Priority Practices Guide that have changed or 
require additional focus. Another commenter suggested that CMS and ONC 
collaborate to ensure that all of the SAFER Guides be updated regularly 
to ensure the most current guidance is shared with MIPS eligible 
clinicians. Several commenters requested confirmation that this 
requirement will not be scored, and that an answer of ``yes'' and 
``no'' are both acceptable, without affecting their total scores.
    Response: As discussed above, the completion of the annual self-
assessment would assist organizations in actively understanding and 
addressing potential safety vulnerabilities regularly. The ``self-
assessment'' does not require an organization to confirm that it has 
implemented ``fully in all areas'' each practice, nor will the 
organization be scored on how many of, or to what degree the 
organization has implemented these practices. As commenters have 
mentioned, several components of the High Priority Practices Guide will 
require an initial assessment that may not change significantly unless 
the MIPS eligible clinician has made significant system upgrades or has 
transitioned between systems. Further, we agree that MIPS eligible 
clinicians should focus their efforts on areas of change or improvement 
after having completed the initial assessment, as much of the 
assessment will remain unchanged. Our larger focus is for MIPS eligible 
clinicians to regularly assess their progress and status on important 
facets of patient safety. We would like to thank commenters for their 
suggestions that CMS and ONC coordinate efforts to regularly assess and 
update the SAFER Guides and to consider expanding on Education and 
Outreach efforts. We will continue to collaborate with ONC and take 
these suggestions under consideration. Last, we do confirm that for CY 
2022, both ``yes'' and ``no'' are acceptable, an attestation of ``no'' 
will not alter final scores, and an attestation of ``no'' will not 
affect one's ability to be considered a Meaningful EHR User for MIPS.
    Comment: Few commenters did not support our proposal to require an 
annual self-assessment of the High Priority Practices Guide. One 
commenter expressed concern that the High Priority Practices Guide does 
not improve interoperability, but instead creates additional reporting 
burden on MIPS eligible clinicians. A few commenters have suggested 
that vendors be required to complete the annual assessments and upon 
initial implementation of the health IT, rather than placing the 
additional burden on MIPS eligible clinicians.
    Response: With a central focus on patient safety, we disagree that 
the High Priority Practices Guide does not improve interoperability. We 
would like to remind commenters that the Protect Patient Health 
Information objective is essential to all aspects of meaningful use of 
CEHRT, and ensuring that Patient Health Information is protected and 
secure is a critical element of effectively using EHRs. Under the 
Protect Patient Health Information objective, the High Priority 
Practices Guides measure is one way that we can proactively assess 
individual readiness. For the commenter who raised concerns about the 
additional reporting burdens this measure may present, we appreciate 
this feedback. We would like to reiterate that MIPS eligible clinicians 
are not being scored on this measure in the 2022 performance year, and 
that an attestation of ``yes'' and ``no'' are both acceptable answers, 
and that an answer of ``no'' will not affect the total number of points 
earned for the Promoting Interoperability performance category. Last, 
after the initial self-assessment, eligible clinicians could simply 
confirm that their initial assessment is still accurate, barring vendor 
and/or system updates that may affect the assessment.
    Comment: Several commenters raised concern that CMS did not 
explicitly establish expectations surrounding

[[Page 65477]]

group reporting for this measure. Commenters seek clarification on 
whether each MIPS eligible clinician within the group is required to 
attest to having completed an annual self-assessment of the High 
Priority Practices Guide, or, if existing reporting requirements apply 
to this measure.
    Response: For those who participate in group reporting, the 
existing group reporting policies apply to this measure. We are not 
requiring an annual self-assessment of the High Priority Practices 
Guide from each MIPS eligible clinician within the group.
    After consideration of the public comments we have received, we are 
finalizing our proposal to add the SAFER Guides measure to the Protect 
Patient Health Information objective beginning with the CY 2022 
performance period/CY 2024 MIPS payment year. MIPS eligible clinicians 
must attest to having conducted an annual self-assessment using the 
High Priority Practices 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 accounting for the complete self-assessment using the Guide. 
We are finalizing that in the CY 2022 performance period/CY 2024 MIPS 
payment year, this measure will be required, but it will not be scored, 
and that an attestation of ``yes'' and ``no'' would not affect the 
total number of points earned for the Promoting Interoperability 
performance category. We are also finalizing our proposal to add 
corresponding regulatory text to Sec.  414.1375(b)(2)(ii)(C).
(e) Incrementation of the Numerator and Denominator for Promoting 
Interoperability Performance Category Measures
    In the CY 2019 PFS final rule (83 FR 59799), we summarized a 
comment we received in response to proposals we had made in the CY 2019 
PFS proposed rule concerning the measures for the Promoting 
Interoperability performance category beginning with the performance 
period in 2019. The commenter indicated that for some measures, MIPS 
eligible clinicians and group practices should be able to get credit 
for actions that are taken outside of the 90-day performance period. We 
responded to the comment by stating that since the inception of the 
Quality Payment Program, we have limited the ability to increment the 
numerator and denominator of measures to actions occurring during the 
performance period chosen, with the exception of the Security Risk 
Analysis measure, for which the relevant actions may occur any time 
during the calendar year. We now understand that our response to this 
comment may have caused confusion, and we wish to clarify our response. 
Instead of referring to the inception of the Quality Payment Program, 
we should have stated that the measures we proposed beginning with the 
performance period in 2019 would limit the ability to increment the 
numerator and denominator to actions occurring during the performance 
period chosen, with the exception of the Security Risk Analysis 
measure, for which the relevant actions may occur any time during the 
calendar year. We note an additional exception is the SAFER Guides 
measure (as discussed in section IV.A.3.d.(4)(d) in this final rule) 
because the relevant actions may also occur at any time during the 
calendar year.
(f) Changes to the Scoring Methodology for the 2022 Performance Period
    For ease of reference, Table 56 lists the objectives and measures 
for the Promoting Interoperability performance category for the CY 2022 
performance period/CY 2024 MIPS payment year as revised to reflect the 
policies finalized in this final rule. Table 57 lists the 2015 Edition 
certification criteria required to meet the objectives and measures.
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    Table 58 reflects the scoring methodology for the Promoting 
Interoperability performance category for the performance period in CY 
2022.

[[Page 65484]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.085

BILLING CODE 4120-01-C
    We also refer readers to section IV.A.3.d.(4)(f) of this final 
rule, where we finalized our proposed changes to the regulatory text 
for scoring the Promoting Interoperability performance category at 
Sec.  414.1380(b)(4)(ii).
(g) Actions To Limit or Restrict the Compatibility or Interoperability 
of CEHRT
(i) Background
    Section 106(b)(2) of the Medicare Access and CHIP Reauthorization 
Act of 2015 (Pub. L. 114-10) (MACRA) includes the heading ``Preventing 
Blocking The Sharing Of Information.'' Section 106(b)(2)(A) amended 
section 1848(o)(2)(A)(ii) of the Act to require that, to be a 
meaningful EHR user, a clinician demonstrates (through a process 
specified by the Secretary, such as the use of an attestation) that the 
clinician has not knowingly and willfully taken action (such as to 
disable functionality) to limit or restrict the compatibility or 
interoperability of the certified EHR technology. To implement these 
provisions, we established and codified at Sec.  414.1375(b)(3)(ii) 
attestation requirements for the Promoting Interoperability performance 
category to support the prevention of information blocking, which 
consist of three statements containing specific representations about a 
MIPS eligible clinician's implementation and use of CEHRT. For further 
discussion on these requirements, we refer readers to the CY 2017 
Quality Payment Program final rule (81 FR 77028 through 77035). The 
attestation statements finalized for MIPS eligible clinicians at Sec.  
414.1375(b)(3)(ii) are:
     Statement A: Did not knowingly and willfully take action 
(such as to disable functionality) to limit or restrict the 
compatibility or interoperability of certified EHR technology.
     Statement B: Implemented technologies, standards, 
policies, practices, and agreements reasonably calculated to ensure, to 
the greatest extent practicable and permitted by law, that the 
certified EHR technology was, at all relevant times: (1) Connected in 
accordance with applicable law; (2) compliant with all standards 
applicable to the exchange of information, including the standards, 
implementation specifications, and certification criteria adopted at 45 
CFR part 170; (3) Implemented in a manner that allowed for timely 
access by patients to their electronic health information; and (4) 
Implemented in a manner that allowed for the timely, secure, and 
trusted bi-directional exchange of structured electronic health 
information with other health care providers (as defined by 42 U.S.C. 
300jj(3)), including unaffiliated providers, and with disparate 
certified EHR technology and health IT vendors.
     Statement C: Responded in good faith and in a timely 
manner to requests to retrieve or exchange electronic health 
information, including from patients, health care providers (as defined 
by 42 U.S.C. 300jj(3)), and other persons, regardless of the 
requestor's affiliation or technology vendor.
    Section 4004 of the 21st Century Cures Act added section 3022 to 
the Public Health Service Act (PHSA) (the ``PHSA information blocking 
provision,''), which describes practices by health care providers, 
health IT developers, and HIEs and networks, that constitute 
information blocking, and provides for civil monetary penalties and 
other disincentives for those who engage in information blocking.
    In the ONC 21st Century Cures Act final rule published in the May 
1, 2020 Federal Register, ONC finalized a definition of information 
blocking and identified reasonable and necessary activities 
(``exceptions'') that do not constitute information blocking (85 FR 
25642). For health care providers (as defined in 42 U.S.C. 300jj), 
information blocking means a practice that, except as required by law 
or covered by an exception, is likely to interfere with access, 
exchange, or use of electronic health information; and if conducted by 
a health care provider, such provider knows that such practice is 
unreasonable and is likely to interfere with, prevent, or materially 
discourage access, exchange, or use of electronic health information 
(45 CFR 171.103).
    The 21st Century Cures Act provides for civil monetary penalties 
for any individual or entity that is a developer, network, or exchange 
that has committed information blocking (see section 3022(b)(2)(A) of 
the PHSA). Regarding health care providers, the

[[Page 65485]]

21st Century Cures Act provides that ``Any [health care provider] 
determined by the [HHS] Inspector General to have committed information 
blocking shall be referred to the appropriate agency to be subject to 
appropriate disincentives using authorities under applicable Federal 
law, as the Secretary sets forth through notice and comment 
rulemaking'' (section 3022(b)(2)(B) of the PHSA).
(ii) Changes to the Attestation Statements
    Although there could be some degree of overlap between conduct 
described in the attestation statements under Sec.  414.1375(b)(3)(ii) 
and conduct that could be considered information blocking under section 
3022 of the PHSA and ONC's implementing regulations at 45 CFR 171.103, 
it is important to note these are separate and distinct authorities. 
For instance, the ONC 21st Century Cures Act final rule finalized a 
definition for what constitutes information blocking, and exceptions to 
information blocking that are not reflected in the previously finalized 
attestation statements under Sec.  414.1375(b)(3)(ii). While we 
previously stated in the CY 2017 QPP final rule that these attestations 
statements did not impose ``unnecessary or unreasonable requirements'' 
on health care providers (81 FR 77029), after careful review of these 
attestation statements in light of the information blocking regulations 
at 45 CFR part 171, we believe that statements B and C are no longer 
necessary. Thus, beginning with the performance period in CY 2022, we 
proposed in the CY 2022 PFS proposed rule (86 FR 39423 through 39425) 
to no longer require statements B and C. We believe that the 
similarities between practices described under statements B and C, and 
the practices that could constitute information blocking under section 
3022 of the PHSA and ONC's implementing regulations will create 
confusion for stakeholders. To this point, the practices that could 
constitute information blocking under 45 CFR part 171 are much broader 
than those described in the attestation statements. We discuss specific 
instances of potential confusion below.
    Statement B requires attestation to a series of statements 
regarding the use of certified technology and a designated manner for 
implementing certified technology. For instance, attestations to the 
implementation of technology compliant with the standards for certified 
health IT at 45 CFR part 170, and use of functionality to support 
health information exchange with other health care providers. However, 
as noted above, the definition of information blocking finalized in the 
ONC 21st Century Cures Act final rule is not specific to, nor limited 
to the use of certified technology, which is compliant with certain 
standards or the use of certain functionality. Under the ONC 21st 
Century Cures Act final rule, a health care provider may still be 
determined to have engaged in practices likely to interfere with 
access, exchange, or use of electronic health information (information 
blocking) regardless of whether they are using certified technology.
    Regarding statement C, we stated in the CY 2017 QPP final rule that 
``technical, legal, and other practical constraints may prevent a 
health care provider from responding to some requests to access, 
exchange, or use electronic health information in a health care 
provider's certified EHR technology'' (81 FR 77033). Subsequently, in 
the ONC 21st Century Cures Act final rule, ONC established a set of 
reasonable and necessary activities that are not considered information 
blocking when responding to a request for EHI. The reasonable and 
necessary activities established under the ONC 21st Century Cures Act 
final rule now provide more specific direction to health care providers 
when responding to a request for EHI than the general ``technical, 
legal, and other practical constraints,'' which we described in the CY 
2017 QPP final rule. Accordingly, we believe that continuing to require 
statement C may introduce confusion for those health care providers who 
are obligated to comply with the regulations finalized in the ONC 21st 
Century Cures Act final rule when responding to a request for EHI.
    In order to distinguish the attestation required by section 
106(b)(2)(A) of MACRA from information blocking under section 3022 of 
the PHSA, we further proposed in the CY 2022 PFS final rule (86 FR 
39423 through 39425) to modify the headings of Sec. Sec.  
414.1375(b)(3) and (b)(3)(ii), add Sec.  414.1375(b)(3)(iii), and 
modify the definition of ``meaningful EHR user for MIPS'' under Sec.  
414.1305 to specify that the clinician does not knowingly and willfully 
take action (such as to disable functionality) to limit or restrict the 
compatibility or interoperability of CEHRT, which reflects the language 
used in section 106(b)(2)(A) of MACRA. In addition, we proposed to no 
longer require attestation statements B and C beginning with the CY 
2022 MIPS performance period/CY 2024 MIPS payment year and we proposed 
corresponding regulatory text amendments at Sec.  414.1375(b)(3)(ii) 
and (iii). We finalized a similar proposal for the Medicare Promoting 
Interoperability Program in the FY 2022 IPPS/LTCH PPS final rule (86 FR 
45481 through 45482).
    We received public comments on our proposal to remove Statements B 
and C under Sec.  414.1375(b)(3)(ii), beginning with the CY 2022 MIPS 
performance period/2024 MIPS payment year, and here are our responses.
    Comment: All commenters supported our proposal to no longer require 
Statements B and C under Sec.  414.1375(b)(3)(ii). Commenters shared 
appreciation for our efforts to eliminate duplicative reporting burden, 
eliminate redundancies, and our efforts towards streamlining our 
requirements.
    Response: We would like to thank commenters for their support.
    Comment: One commenter requested that CMS remain involved with the 
information blocking issue, as challenges will continue to persist. 
Another commenter shared a similar concern, and further urged that CMS 
seek public comment prior to introducing any ``appropriate 
disincentives'' in the future.
    Response: We do consider Information Blocking an important issue, 
and believe that in finalizing this policy, we are addressing concerns 
regarding improving clarity and reducing redundancies. We will take the 
suggestion of seeking public comment prior to introducing any 
``appropriate disincentives'' for future rulemaking.
    After consideration of the public comments, we are finalizing our 
proposal to modify the headings of Sec. Sec.  414.1375(b)(3) and 
414.1375(b)(3)(ii), add Sec.  414.1375(b)(3)(iii), and to modify the 
definition of ``meaningful EHR user for MIPS'' under Sec.  414.1305 to 
specify that the clinician does not knowingly and willfully take action 
(such as to disable functionality) to limit or restrict the 
compatibility or interoperability of CEHRT, which reflects the language 
used in section 106(b)(2)(A) of MACRA. In addition, we are finalizing 
our proposal to no longer require attestation statements B and C 
beginning with the CY 2022 performance period/CY 2024 MIPS payment 
year, and we are finalizing our proposed corresponding regulatory text 
amendments at Sec. Sec.  414.1375(b)(3)(ii) and (iii).
(h) Additional Considerations
(i) Reweighting the Promoting Interoperability Performance Category for 
MIPS Eligible Clinicians in Small Practices
    We previously established under Sec.  414.1380(c)(2)(i)(C)(9) a 
significant

[[Page 65486]]

hardship exception for MIPS eligible clinicians in small practices as 
defined in Sec.  414.1305. In the CY 2018 Quality Payment Program final 
rule (82 FR 53682 through 53683), we established that we will reweight 
the Promoting Interoperability performance category to zero percent of 
the MIPS final score for MIPS eligible clinicians who qualify for this 
hardship exception. We established that a MIPS eligible clinician 
seeking to qualify for this exception must submit an application to us 
demonstrating that there are overwhelming barriers that prevent them 
from complying with the requirements for the Promoting Interoperability 
performance category, and that the exception is subject to annual 
renewal. In the CY 2018 Quality Payment Program final rule (82 FR 53579 
through 53581), we also established that we will determine the size of 
small practices by utilizing claims data. This policy was further 
modified in the CY 2019 PFS final rule (83 FR 59727 through 59730) so 
that beginning with the CY 2021 MIPS payment year, a small practice is 
a TIN consisting of 15 or fewer eligible clinicians during the MIPS 
determination period.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30076), 
we stated that we believed that special consideration should be 
available for MIPS eligible clinicians in small practices based on 
concerns previously identified by commenters, including small practices 
not being able to afford the upfront investments (including investments 
in EHR technology), and small practices not adopting EHRs due to the 
administrative and financial burden. Although some commenters requested 
that we automatically apply the proposed hardship exception to 
clinicians in small practices, at the time we disagreed and stated that 
we believed that many small practices will be able to successfully 
report for the Promoting Interoperability performance category (82 FR 
53683).
    We have been monitoring the submission of data for the Promoting 
Interoperability performance category by small practices and individual 
clinicians who are part of a small practice, and the numbers remain low 
despite the no-cost technical assistance we offered small practices 
through the Small, Underserved, and Rural Support Initiative. Data from 
CY 2019 revealed that of the 49,278 clinicians in small practices who 
were scored as an individual for MIPS, 84 percent of them did not 
submit Promoting Interoperability performance category data and did not 
apply for a small practice hardship exception application even though 
they may have qualified for the exception. Among clinicians who did not 
qualify for Promoting Interoperability performance category 
reweighting, only 29 percent of small practices compared to 61 percent 
of practices with more than 15 clinicians billing under the practice's 
TIN submitted data for the Promoting Interoperability performance 
category. Although we had expected many small practices would be able 
to successfully report data for the Promoting Interoperability 
performance category, we are concerned to see such low numbers of them 
either reporting data or applying for the small practice hardship 
exception, as such inaction would result in a score of zero for this 
performance category.
    We want to support small practices and help them successfully 
participate in MIPS. As our analysis of the data suggests that 
successfully participating in the Promoting Interoperability 
performance category may be particularly challenging for small 
practices, in the CY 2022 PFS proposed rule (86 FR 39424 through 39425) 
we proposed a modification of our policy. Beginning with the CY 2022 
performance period/CY 2024 MIPS payment year, we proposed to no longer 
require an application for clinicians and small practices seeking to 
qualify for the small practice hardship exception and reweighting. We 
proposed instead to assign a weight of zero percent to the Promoting 
Interoperability performance category and redistribute its weight to 
another performance category or categories (as discussed further in 
section IV.A.3.e. of the proposed rule) in the event no data is 
submitted for any of the measures for the Promoting Interoperability 
performance category by or on behalf of a MIPS eligible clinician in a 
small practice. We proposed that if data is submitted for a MIPS 
eligible clinician in a small practice, they will be scored on the 
Promoting Interoperability performance category like all other MIPS 
eligible clinicians, and the performance category will be given the 
weight prescribed by section 1848(q)(5)(E) of the Act. We proposed the 
small practice significant hardship exception still will be subject to 
annual renewal, and we will verify whether a practice meets the 
definition of a small practice under Sec.  414.1305 on an annual basis. 
We proposed corresponding revisions to Sec.  414.1380(c)(2)(i)(C)(9).
    While we proposed this policy at this time, it is not our intention 
that this policy be in place for the long term, but rather only for a 
few years, as we would like to increase participation of small 
practices in the Promoting Interoperability performance category. We 
sought comment on potential options to increase small practice 
participation in the Promoting Interoperability performance category.
    We proposed that in the case of an APM Entity that also meets the 
definition of a small practice, we will continue applying the Promoting 
Interoperability performance category reporting and exception 
requirements at the group level, as described at Sec.  414.1317. 
However, if the APM Entity is composed of a single TIN which itself 
meets the definition of a small practice, all TINs within the APM 
Entity (that is, the single TIN) will be eligible for this exception, 
and therefore, the Promoting Interoperability performance category will 
be reweighted for the APM Entity and the performance category 
reweighting described above will be applied.
    We received public comments on the proposal to automatically 
reweight the Promoting Interoperability performance category for MIPS 
eligible clinicians in small practices. The following is a summary of 
the comments we received and our responses.
    Comment: Several commenters supported the proposal to automatically 
reweight the Promoting Interoperability performance category for MIPS 
eligible clinicians in small practices. Several commenters stated that 
they believe that it will reduce the administrative burden for small 
practices. Other commenters suggested that MIPS eligible clinicians in 
small practices have not applied for the hardship exception because 
they are not aware of it or because it is a burden to apply. Several 
commenters stated that small practices have not applied due to resource 
constraints. One commenter stated that MIPS eligible clinicians in 
small practices do not apply because they are afraid of being audited.
    Response: We thank commenters for their support and agree the 
proposal may reduce administrative burden for small practices that face 
overwhelming barriers that prevent them from complying with the 
requirements for the Promoting Interoperability performance category.
    Comment: One commenter applauded CMS' continued flexibility for 
small practices and believed the availability of hardship exceptions 
for small practices for the Promoting Interoperability performance 
category is necessary, but they do not agree with CMS' proposal to 
automatically reweight the Promoting Interoperability performance 
category for small practices. This proposal removes an incentive for 
practices to move towards the adoption of EHRs

[[Page 65487]]

which has been CMS' goal for many years. In line with CMS' messaging, 
their organization has also been pushing their membership towards EHR 
adoption to comply with MIPS reporting and the increasing requirements 
to avoid a negative payment adjustment. Because of this, they expressed 
concerns that this proposal sends the wrong message to practices newly 
adopting EHRs and practices with EHRs who have been diligently working 
to meet the requirements of this category. Another commenter did not 
support the proposal to automatically reweight Promoting 
Interoperability performance Category for small practices. They believe 
small practices should have to request reweighting. The Promoting 
Interoperability performance category has encouraged clinics of all 
sizes to engage their patients through the use of technology, such as 
patient portals and use of HIEs, improving access to care. By 
reweighting Promoting Interoperability performance Category, clinics 
may disable or neglect these features to the determent of the patient 
experience. They suggested that CMS consider reducing the number of 
measures within the Promoting Interoperability performance category for 
these smaller clinics, such as 2 or 3 measures, instead of a total 
reweight of 0 for all the measures.
    Response: We understand these concerns and we stated in the CY 2022 
PFS proposed rule (86 FR 39425) that it is not our intention for this 
policy to be in place for the long term. Too many small practices 
neglect to apply for the small practice hardship exception so we 
believe that putting this automatic reweighting policy in place in 
concert with increased outreach will help to reduce administrative 
burden for small practices. As we intend this policy to be temporary we 
hope that there will still be an impetus for small practices to strive 
to adopt CEHRT and report on the Promoting Interoperability performance 
category. We remind readers that if a small practice submits data for 
the Promoting Interoperability performance category, the data will be 
scored and the Promoting Interoperability performance category will not 
be reweighted. We appreciate the suggestion to reduce reporting 
requirements for small practices, and this is something that we may 
consider in future rulemaking.
    Comment: One commenter urged CMS to use several methods to 
communicate in clear and unambiguous language that if the small 
practice submits data for the Promoting Interoperability performance 
category that the reweighting will be cancelled. Another commenter 
requested that CMS undertake an extensive educational campaign, 
partnering with specialty societies, to ensure that all small practices 
and their vendors are aware of this automatic reweighting and the fact 
that if they report any data for the Promoting Interoperability 
performance category, they will receive a Promoting Interoperability 
performance category score and not be reweighted.
    Response: We thank commenters for these suggestions. We intend to 
include this policy in our educational materials and work with 
specialty societies to help disseminate this information.
    We received comments in response to the questions we posed in the 
CY 2022 PFS proposed rule (86 FR 39425) related to small practice 
participation in the Promoting Interoperability performance category. 
We will analyze all of the comments that we received and may use them 
to inform future rulemaking and outreach initiatives.
    After consideration of public comments, we are finalizing our 
proposal such that beginning with the CY 2022 performance period/CY 
2024 MIPS payment year, we will no longer require an application for 
clinicians and small practices seeking to qualify for the small 
practice hardship exception and reweighting. We will assign a weight of 
zero percent to the Promoting Interoperability performance category and 
redistribute its weight to another performance category or categories 
(as discussed further in section IV.A.3.e.(2)(b) of this final rule) in 
the event no data is submitted for any of the measures for the 
Promoting Interoperability performance category by or on behalf of a 
MIPS eligible clinician in a small practice. If data is submitted for a 
MIPS eligible clinician in a small practice, they will be scored on the 
Promoting Interoperability performance category like all other MIPS 
eligible clinicians, and the performance category will be given the 
weight prescribed by section 1848(q)(5)(E) of the Act. The small 
practice significant hardship exception still will be subject to annual 
renewal, and we will verify whether a practice meets the definition of 
a small practice under Sec.  414.1305 on an annual basis. We are making 
corresponding revisions to Sec.  414.1380(c)(2)(i)(C)(9).
(ii) Nurse Practitioners, Physician Assistants, Clinical Nurse 
Specialists, and Certified Registered Nurse Anesthetists
    We established a policy at Sec.  414.1380(c)(2)(i)(A)(5) for the 
performance periods in 2017 through 2021 under section 1848(q)(5)(F) of 
the Act to assign a weight of zero to the Promoting Interoperability 
performance category in the MIPS final score if there are not 
sufficient measures applicable and available to NPs, PAs, CRNAs, and 
CNSs. We will assign a weight of zero only in the event that an NP, PA, 
CRNA, or CNS does not submit any data for any of the measures specified 
for the Promoting Interoperability performance category, but if they 
choose to report, they will be scored on the Promoting Interoperability 
performance category like all other MIPS eligible clinicians and the 
performance category will be given the weighting prescribed by section 
1848(q)(5)(E) of the Act.
    As in past years, we intend to use data from prior performance 
periods to further evaluate the participation of NPs, PAs, CRNAs, and 
CNSs in the Promoting Interoperability performance category and 
consider for subsequent years whether the measures specified for this 
category are applicable and available to these MIPS eligible 
clinicians. We have analyzed the data submitted for the 2017 
performance period for the Promoting Interoperability performance 
category and have discovered that the vast majority of MIPS eligible 
clinicians submitted data as part of a group. Although we are pleased 
that MIPS eligible clinicians utilized the option to submit data as a 
group, it does limit our ability to analyze data at the individual NPI 
level. For the 2017 performance period, approximately 4 percent of MIPS 
eligible clinicians who are NPs, PAs, CRNAs, or CNSs submitted data 
individually for MIPS, and more than two-thirds of them did not submit 
data for the Promoting Interoperability performance category. For the 
2018 performance period, we reported that of the MIPS eligible 
clinicians who are NPs, PAs, CRNAs, or CNSs and submitted data 
individually, approximately 34 percent submitted data for the Promoting 
Interoperability performance category. However, after further review 
and the refinement of our analytics it was revealed that the percentage 
was not 34 percent but was 24 percent of MIPS eligible clinicians who 
are NPs, PAs, CRNAs, or CNSs that submitted data individually for the 
Promoting Interoperability performance category. For the 2019 
performance period, of the MIPS eligible clinicians who are NPs, PAs, 
CRNAs, or CNSs and submitted data individually, approximately 30 
percent submitted data individually for the Promoting Interoperability 
performance category, a modest increase from 2018. We continued our 
reweighting policy in 2020 but have not yet analyzed the data

[[Page 65488]]

to determine what proportion of MIPS eligible clinicians who are NPs, 
PAs, CRNAs, or CNSs that submitted data individually for MIPS also 
submitted data for the Promoting Interoperability performance category.
    We believe that having these clinician types using CEHRT and 
submitting data for the Promoting Interoperability performance category 
is important for increased interoperability and data exchange. We are 
exploring the possibility that these clinician types are able to submit 
data but are choosing not to due to our current reweighting policies. 
In the future we may use other factors besides the submission data to 
determine whether to continue to reweight the Promoting 
Interoperability performance category for these clinicians. We 
solicited comments as to whether these clinician types are using CEHRT 
and are able to submit data on the measures for the Promoting 
Interoperability performance category.
    While we are encouraged by the increasing numbers of NPs, PAs, 
CRNAs, and CNSs submitting data for the Promoting Interoperability 
performance category, we believe that the low numbers warrant the 
continued reweighting of the Promoting Interoperability performance 
category for NPs, PAs, CRNAs, and CNSs for the CY 2022 performance 
period/CY 2024 MIPS payment year. Thus, in the CY 2022 PFS proposed 
rule (86 FR 39425 through 39426), we proposed to continue the existing 
policy for the CY 2022 performance period/CY 2024 MIPS payment year and 
proposed to revise Sec.  414.1380(c)(2)(i)(A)(5), which is being 
redesignated as Sec.  414.1380(c)(2)(i)(A)(4)(ii), to reflect the 
proposal.
    We did not receive comments on our proposal. We are finalizing our 
proposal to continue the existing policy to reweight the Promoting 
Interoperability performance category for NPs, PAs, CRNAs, and CNSs for 
the CY 2022 performance period/2024 MIPS payment year and have revised 
Sec.  414.1380(c)(2)(i)(A)(5), which is being redesignated as Sec.  
414.1380(c)(2)(i)(A)(4)(ii). We thank commenters for their responses to 
our requests for comment and may consider this information to inform 
future rulemaking.
(iii) Physical Therapists, Occupational Therapists, Qualified Speech-
Language Pathologists, Qualified Audiologists, Clinical Psychologists, 
and Registered Dieticians or Nutrition Professionals
    In the CY 2020 PFS final rule (84 FR 63003 through 63004), we 
adopted a policy at Sec.  414.1380(c)(2)(i)(A)(4) to apply the same 
policy we adopted for NPs, PAs, CNSs, and CRNAs to other types of MIPS 
eligible clinicians who are NPPs (physical therapists, occupational 
therapists, qualified speech-language pathologist, qualified 
audiologists, clinical psychologists, and registered dieticians or 
nutrition professionals) for the performance period in 2020. We stated 
that because many of these clinician types were or are not eligible to 
participate in the Medicare or Medicaid Promoting Interoperability 
Program, we have little evidence as to whether there are sufficient 
measures applicable and available to them under the Promoting 
Interoperability performance category. We extended this policy for the 
performance period in 2021 (85 FR 84895). As these clinicians were 
first eligible to participate in MIPS in the CY 2020 performance 
period/CY 2022 MIPS payment year, we have not yet analyzed the data to 
inform a potential modification to our current policy and do not 
anticipate a completed analysis being available prior to the release of 
this final rule. In the CY 2022 PFS proposed rule (86 FR 39426) we 
proposed to continue the existing policy of reweighting the Promoting 
Interoperability performance category for physical therapists, 
occupational therapists, qualified speech-language pathologist, 
qualified audiologists, clinical psychologists, and registered 
dieticians or nutrition professionals for the CY 2022 performance 
period/2024 MIPS payment year. We proposed to revise Sec.  
414.1380(c)(2)(i)(A)(4), which is being redesignated as Sec.  
414.1380(c)(2)(i)(A)(4)(i), to reflect this proposal.
    We received public comments on the proposal to continue the 
existing policy of reweighting the Promoting Interoperability 
performance category for Physical Therapists, Occupational Therapists, 
Qualified Speech-Language Pathologists, Qualified Audiologists, 
Clinical Psychologists, and Registered Dieticians or Nutrition 
professionals. The following is a summary of the comments we received 
and our responses.
    Comment: One commenter fully supported reweighting the Promoting 
Interoperability performance categories for these clinicians. In 
addition to similar difficulties in data capture as NPs, PAs, etc., 
many of the measures are not clinically applicable to these specific 
clinicians. Some would not prescribe medications (nutrition 
professionals), administer vaccines (immunization registry reporting) 
and/or reconcile certain clinical data. Although we believe many of 
these professionals are an integral part of the patient's care team, we 
do not believe they should be required to individually report Promoting 
Interoperability performance category data.
    Response: We appreciate the support of the commenter.
    Comment: One commenter appreciated CMS extending the reweighting 
policy for the Promoting Interoperability performance category data for 
occupational therapy practitioners for CY 2022 performance period/CY 
2024 MIPS payment year. Non-physician clinicians are still at a 
disadvantage because not all Promoting Interoperability performance 
category data are applicable to their practices. The commenter 
requested that CMS review measure applicability and adjust measure 
requirements to allow for NPP reporting if the Promoting 
Interoperability performance category data is to become a requirement 
in future years.
    Response: As we have stated previously, we will continue to monitor 
the participation of NPPs in the Promoting Interoperability performance 
category. We will use this data to inform future policy proposals.
    Comment: Commenters requested that CMS confirm that psychologists 
and certain other non-physician eligible clinicians will continue to 
have the Promoting Interoperability performance category reweighted to 
zero given that they never had the opportunity to receive Federal funds 
to invest in EHRs. It is critical that all psychologists, including 
those in practices with more than 15 eligible clinicians, continue to 
have the Promoting Interoperability performance category reweighted to 
zero unless they choose to report Promoting Interoperability 
performance category measures or are provided with Federal funding to 
invest in EHRs.
    Response: We proposed (86 FR 39426) and are finalizing our proposal 
to continue to reweight clinical psychologists for the Promoting 
Interoperability performance category for the CY 2022 performance 
period/CY 2024 MIPS payment year.
    After consideration of public comments, we are finalizing our 
proposal to continue the existing policy of reweighting the Promoting 
Interoperability performance category for physical therapists, 
occupational therapists, qualified speech-language pathologist, 
qualified audiologists, clinical psychologists, and registered 
dieticians or nutrition professionals for the CY 2022 performance 
period/2024 MIPS payment year. We are finalizing our revisions at Sec.  
414.1380(c)(2)(i)(A)(4),

[[Page 65489]]

which is being redesignated as Sec.  414.1380(c)(2)(i)(A)(4)(i).
(iv) Clinical Social Workers and Certified Nurse-Midwives (CNMs)
    We proposed at 86 FR 39426 to add clinical social workers and CNMs 
to the definition of a MIPS eligible clinician. These clinician types 
were 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 not eligible for 
Medicaid EHR incentive payments and thus may lack experience with the 
adoption or use of CEHRT. CNMs were eligible for the Medicaid EHR 
incentive payments, and the majority did earn incentives. For the CY 
2022 performance period/CY 2024 MIPS payment year, we proposed in the 
CY 2022 PFS proposed rule (86 FR 39426) to apply the same Promoting 
Interoperability reweighting policy we adopted previously for NPs, PAs, 
CNSs, CRNAs, and other types of MIPS eligible clinicians to clinical 
social workers as we believe that there may not be sufficient Promoting 
Interoperability performance category measures that are applicable and 
available to clinical social workers. We will assign a weight of zero 
only in the event that a clinical social worker does not submit data 
for any of the measures specified for the Promoting Interoperability 
performance category. We proposed to add Sec.  
414.1380(c)(2)(i)(A)(4)(iii) to reflect this proposal for clinical 
social workers.
    We believe there are sufficient measures applicable and available 
to CNMs under the Promoting Interoperability performance category 
because of their experience with the Medicaid Promoting 
Interoperability Program. Many of them have adopted CEHRT and earned a 
Medicaid incentive payment, and the measures for the Medicaid Promoting 
Interoperability Program generally are the same or slightly modified 
versions of the Promoting Interoperability performance category 
measures. Thus, we did not propose to apply the same Promoting 
Interoperability reweighting policy we adopted previously for NPs, PAs, 
CNSs, CRNAs, and other types of MIPS eligible clinicians to CNMs. 
However, we solicited comments on whether there are in fact sufficient 
measures applicable and available to CNMs under the Promoting 
Interoperability performance category, and whether barriers exist that 
prevent CNMs from complying with the requirements of the Promoting 
Interoperability performance category and may warrant reweighting. Like 
other types of MIPS eligible clinicians, a CNM may be able to qualify 
for a significant hardship exception from and reweighting of the 
Promoting Interoperability performance category under the existing 
policies at Sec.  414.1380(c)(2)(i)(C), depending on their 
circumstances.
    We received public comments on reweighting the Promoting 
Interoperability performance category for clinical social workers and 
CNMs. The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the reweighting of the 
Promoting interoperability performance category for clinical social 
workers and added that they do not prescribe medications or administer 
vaccines.
    Response: We appreciate the support for our proposal and remind 
readers that if clinical social workers choose to submit data for the 
Promoting interoperability performance category they will be scored and 
not reweighted.
    Comment: A few commenters expressed their opposition to requiring 
CNMs to report for the Promoting Interoperability performance category 
as CMS reweights all other non-physician clinicians eligible under 
MIPS. They acknowledged CMS' rationale for not applying the same 
Promoting Interoperability reweighting policy previously adopted for 
NPs, PAs, CNSs, CRNAs, and other types of MIPS eligible clinicians to 
CNMs given that they were an eligible professional type under the 
Medicaid EHR Incentive Program, but stated that NPs were also eligible 
professional types under that Program and have been reweighted for the 
Promoting Interoperability performance category since the CY 2017 
performance period/CY 2019 MIPS payment year. They requested that CMS 
also reweight CNMs.
    Response: When we established the reweighting policy for NPs, we 
stated that their low numbers of participation in the Medicaid EHR 
Incentive Program may have indicated that the EHR Incentive Program 
measures were not applicable or available to them. (81 FR 77243 through 
77244). For CNMs, we believe that there are sufficient measures 
applicable and available. Many CNMs have adopted CEHRT and earned 
Medicaid EHR Incentive Program/Medicaid Promoting Interoperability 
Program payments. Further the measures under these Medicaid Programs 
are the same or slightly modified versions of those required for the 
MIPS Promoting Interoperability performance category. We did request 
comments on whether barriers exist that prevent CNMs from complying 
with the requirements of Promoting Interoperability performance 
category but we did not receive any comments related to barriers.
    After consideration of public comments, we are finalizing our 
proposals as proposed. For the CY 2022 performance period/CY 2024 MIPS 
payment year, we will apply the same Promoting Interoperability 
reweighting policy we adopted previously for NPs, PAs, CNSs, CRNAs, and 
other types of MIPS eligible clinicians to clinical social workers as 
we believe that there may not be sufficient Promoting Interoperability 
performance category measures that are applicable and available to 
clinical social workers. We will assign a weight of zero only in the 
event that a clinical social worker does not submit data for any of the 
measures specified for the Promoting Interoperability performance 
category and we are adding Sec.  414.1380(c)(2)(i)(A)(4)(iii) to 
reflect this policy.
(i) Technical Corrections to the Regulations
    In the CY 2019 PFS final rule (83 FR 59798 through 59817), we 
adopted objectives and measures for the Promoting Interoperability 
performance category that will apply beginning with the performance 
period in 2019. The requirement for MIPS eligible clinicians to report 
on these objectives and measures can be found under Sec.  
414.1375(b)(2). In the CY 2021 PFS rulemaking, we inadvertently 
neglected to update this provision of the regulation text, although our 
intention was a continuation of the policy we established for the CY 
2021 and 2022 MIPS payment years. We proposed a technical correction to 
Sec.  414.1375(b)(2)(ii) to specify that the reporting requirements 
apply beginning with the 2021 MIPS payment year. We solicited comments 
on this proposal.
    We did not receive public comments on this proposal, and therefore, 
we are finalizing as proposed.
(j) Requests for Information (RFI)
    The CY 2022 PFS proposed rule contained the following RFIs (86 FR 
39427 through 39428):
     Request for Information on Additional Objectives Adopting 
FHIR[supreg]-based API Standards
     Request for Information on a Patient Access Outcomes 
Measures
     Request for Information on Clinical Notes
    We thank commenters for their responses to these requests for 
information. We may consider this

[[Page 65490]]

information to inform future rulemaking.
(5) APM Entity Level Participation for MIPS Eligible Clinicians 
Participating in MIPS APMs
(a) Overview
    In the CY 2021 PFS final rule (85 FR 84896), we finalized our 
policy to terminate the APM scoring standard effective January 1, 2021, 
and to retain certain APM Entity group reporting policies that were 
established and finalized for reporting and scoring under MIPS 
beginning with the CY 2021 MIPS performance period. Therefore, we 
redesignated, in part, the regulation that describes APM Entity group 
determinations, from Sec.  414.1370(e) to Sec.  414.1317, and titled 
that section ``APM Entity Groups.''
(b) APM Entity Level Reporting of Facility-Based Measures
    In the CY 2021 PFS final rule (85 FR 84896), we finalized a policy 
to allow APM Entities to report to traditional MIPS using the same 
quality measures available to other groups, according to all applicable 
MIPS quality scoring policies. It has been brought to our attention 
that we did not make it clear whether APM Entities may be eligible for 
facility-based scoring. In the CY 2022 PFS proposed rule (86 FR 39429), 
we clarified that because facility-based measures are not submitted, 
but rather are collected by CMS using group-level participation scores 
used for the Hospital Value Based Purchasing Program, it would be 
impossible for CMS to calculate a score for a facility-based measure 
that represents the performance of an APM Entity. Therefore, facility-
based scoring is not available to APM Entities under MIPS quality 
scoring rules, as described at Sec.  414.1330. We also noted that 
participants in APM Entities that are eligible for facility-based 
scoring at the individual or group level would still be eligible to 
receive these scores for purposes of individual or group MIPS scoring.
(c) APM Entity Performance Category Weights
    In the CY 2021 PFS final rule (85 FR 84896), we finalized a policy 
to weight the cost performance category at zero percent of the final 
score for APM Entities in MIPS APMs. We codified the weight of the cost 
performance category at Sec.  414.1317(b)(2), but we did not discuss in 
the CY 2021 PFS final rule how the weight that otherwise would have 
applied to the cost performance category will be redistributed among 
the other performance categories. In the CY 2022 PFS proposed rule (86 
FR 39429), for purposes of clarity, we proposed to add to Sec.  
414.1317(b)(2) that the performance category reweighting scenarios 
under Sec.  414.1380(c)(2) apply to an APM Entity.
    We explained that because APM Entities are participating in 
traditional MIPS and generally are being scored according to 
traditional MIPS scoring rules at Sec.  414.1380 unless otherwise 
specified, the performance category reweighting scenarios under Sec.  
414.1380(c)(2) are applicable to APM Entities. Using the 2021 MIPS 
performance period/2023 MIPS payment year as an example, if the cost 
performance category is the only performance category weighted at zero 
percent for an APM Entity, the performance category weights would be as 
follows under Sec.  414.1380(c)(2)(ii)(E): Quality 55 percent, cost 
zero percent, improvement activities 15 percent, and promoting 
interoperability 30 percent. If both cost and promoting 
interoperability are weighted at zero percent, then quality would be 85 
percent and improvement activities would be 15 percent. For the 
remaining reweighting scenarios for the 2021 MIPS performance period/
2023 MIPS payment year, we refer readers to Table 6 under Sec.  
414.1380(c)(2)(ii)(E). The reweighting scenarios applicable to APM 
Entities for the 2022 MIPS performance period/2024 MIPS payment year 
can be found in Table 7 under Sec.  414.1380(c)(2)(ii)(F). We refer 
readers to section IV.A.3.e.2 of this final rule where we discuss our 
proposal to apply the reweighting policy finalized for the 2022 MIPS 
performance period/2024 MIPS payment year at Sec.  
414.1380(c)(2)(ii)(F) to the 2025 MIPS payment year and each subsequent 
MIPS payment year. In the event we establish additional reweighting 
scenarios, they would also apply to APM Entities.
    We did not receive any comments on this proposal and are finalizing 
as proposed.
e. MIPS Final Score Methodology
(1) Performance Category Scores
(a) Background
    For the CY 2022 performance period/2024 MIPS payment year, we 
intend to continue to build on the scoring methodology we finalized for 
prior years. The scoring methodology allows for accountability and 
alignment across the performance categories and minimizes burden on 
MIPS eligible clinicians. We proposed to update many of our scoring 
policies, focusing on removing transition policies. Specifically, we 
proposed to--
     Change certain terminology related to scoring.
     Amend our scoring flexibility policy to include quality 
measures with omitted or deactivated codes in the finalized measure 
specifications.
     Implement benchmarking and topped out scoring policies 
that are responsive to potential low reporting rates for the CY 2020 
performance period/2022 MIPS payment year due to the national PHE for 
COVID-19 and establishing a benchmark when measures are suppressed in 
the baseline period.
     Amend policies for scoring quality measures based on 
achievement and measures that do not meet case minimum or have a 
benchmark and introduce scoring policies for new measures.
     Amend the minimum case requirement policy.
     End the high priority and end-to-end reporting bonuses in 
the quality performance category.
     Continue improvement scoring in the quality performance 
category.
     Implement a scoring flexibility policy for changes that 
impact cost measures during the performance period.
     Revise certain provisions of the regulation text for the 
Promoting Interoperability performance category.
    We did not propose changes to scoring policies for the improvement 
activities performance category.
    We also maintained our approach to how MIPS eligible clinicians are 
scored against performance standards for each performance category, 
receive a final score comprised of their performance category scores, 
and how the final score is calculated according to the final score 
methodology. We refer readers to Sec.  414.1380 for policies on 
scoring.
(b) Terminology Updates
    We proposed updates to Sec.  414.1380 in an effort to more clearly 
and concisely capture previously established policies (86 FR 39429). 
These proposed updates were not intended to be substantive in nature, 
but rather to bring more clarity to the regulatory text. We proposed to 
change the term ``performance category percent score'' to ``performance 
category score'' in Sec. Sec.  414.1380(b)(1)(vi)(C) and (E) related to 
improvement scoring, 414.1380(b)(1)(vii) related to scoring the quality 
performance category score, 414.1380(b)(2)(iii) and (v) related to 
scoring the cost performance category, 414.1380(c) and (c)(2)(ii)(A) on 
calculating the final score and final score reweighting, and

[[Page 65491]]

414.1380(e)(6)(iv) and (v) related to facility-based scoring. Again, 
these changes were not intended to change the underlying policies 
reflected in the regulation text. Initially, the quality and cost 
performance categories used the term ``performance category percent 
score'' because those categories had improvement scoring and have a 
slightly different approach to calculation than the Promoting 
Interoperability and improvement activities performance category. 
However, the terms ``performance category percent score'' and 
``performance category score'' have been used in the same way. For that 
reason, we proposed to consolidate our language and use only the latter 
aforementioned term.
    We received public comments on our terminology updates. The 
following is a summary of those comments.
    Comment: One commenter supported the change in terminology.
    Response: We thank the commenter for their support.
    After consideration of the public comments, we are finalizing this 
proposal as proposed.
(c) Scoring the Quality Performance Category for the Following 
Collection Types: Medicare Part B Claims Measures, eCQMs, MIPS CQMs, 
QCDR Measures, the CAHPS for MIPS Survey Measure and Administrative 
Claims Measures
    We refer readers to Sec.  414.1380(b)(1) for our policies regarding 
quality measure benchmarks, calculating total measure achievement and 
measure bonus points, calculating the quality performance category 
percent 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). We proposed in the CY 2022 PFS proposed rule to 
amend policies finalized in prior years to simplify scoring in MIPS as 
we transition to MVPs (86 FR 39429 through 39430).
(i) Scoring Flexibility for Changes That Impact Quality Measures During 
the Performance Period or Prior to Implementation
    We refer readers to CY 2018, CY 2019, and CY 2021 Quality Payment 
Program final rules (82 FR 53714 through 53716, 83 FR 59845 through 
59847, and 85 FR 84898 through 84901 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 2018 MIPS 
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 noted that we believe 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 2020 
performance period) (82 FR 53716). We refer readers to Sec.  
414.1380(b)(1)(viii) for more on our policy for scoring flexibility for 
ICD-10 changes.
    In the CY 2019 Quality Payment Program final rule (83 FR 59845 
through 59847), we finalized policies beginning with the 2019 
performance period/2021 MIPS payment year to reduce the total available 
measure achievement points from 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 Quality Payment Program final rule, we finalized a 
consolidation of the CY 2018 and CY 2019 scoring flexibilities policy 
that allowed, beginning with the 2021 performance period/2023 MIPS 
payment year, truncation of the performance period or suppression of a 
quality measure 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 (85 FR 84898 through 
84901).
    In previous rules, we noted that we believe that there may be 
instances when there are changes after the final approval of quality 
measures including changes to the measure specification, or updates to 
coding that may lead to misleading results (85 FR 84899). Additionally, 
we believe that there may be instances in which there is an inadvertent 
omission of codes, or inclusion of deactivated codes in the measure 
specifications that do not have the correct status. Typically, codes 
that are contained within the measure specifications either have a 
reimbursable status or a non-reimbursable status that still allows 
processing for purposes of quality reporting programs. We have 
encountered instances where CMS has been alerted that codes have 
inadvertently received an inactive status which results in the 
associated codes not being processed and stored in the National Claims 
History (NCH) database, and therefore, not available for quality 
purposes. As the measure specifications are considered technical 
documents that include several fields such as, but not limited to: The 
numerator, denominator, measure description, denominator exclusions, 
clinical guidance statements, and codes relevant to how the measure 
should be captured. The measure specifications are finalized and 
published in coordination with the final rule, and prior to the start 
of the performance period. An inadvertent omission of codes, or 
inclusion of inactive codes in the measure specifications, may result 
in misleading results by affecting clinicians who submit the measure. 
In these instances, implementation errors could lead to misleading 
performance rates by failure to reflect accurate numerator and/or 
denominator values for calculation of the measure. These are not 
changes that occur during the performance period, but errors that would 
affect the performance period.
    It recently came to our attention through Help Desk inquiries that 
Medicare Administration Carriers (MACs) were rejecting 2021 Part B 
Claims submissions for Quality Measure ID (QID) 001: Hemoglobin A1c 
(HbA1c)

[[Page 65492]]

Poor Control (>9%) and QID 117 Diabetes: Eye Exam due to an inactive 
status for certain CPT II codes. The omission of these claims from the 
total denominator population of the measure could skew scores and lead 
to misleading results. We believe suppression of the measures is 
consistent with current Sec.  414.1380(b)(1)(vii)(A). Information on 
the suppression of the Part B claims collection type of these measures 
for the 2021 MIPS performance period/2023 MIPS payment year was 
announced via the QPP listserv on July 1st, 2021. For more information 
please refer to our website qpp.cms.gov.
    We proposed to amend Sec.  414.1380(b)(1)(vii)(A) to clarify our 
intended policy on instances in which we become aware of changes to the 
active or payable status of the codes and/or implementation errors 
included in the measure specifications as finalized that would lead to 
misleading results. Accordingly, we proposed to revise 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 to provide that for each 
measure that is submitted, if applicable, and impacted by significant 
changes or errors prior to the applicable data submission deadline at 
Sec.  414.1325(e), performance is based on data for 9 consecutive 
months of the applicable CY performance period. If such data are not 
available or CMS determines that they 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. For purposes of paragraph (b)(1)(vii)(A), 
``significant changes or errors'' means changes to or errors in a 
measure that are outside the control of the clinician and its agents 
and that CMS determines may result in patient harm or misleading 
results. Significant changes or errors include, but are not limited to, 
changes to codes (such as ICD-10, CPT, or HCPCS codes) or the active 
status of codes, the inadvertent omission of codes, or inclusion of 
inactive or inaccurate codes; changes to clinical guidelines; or 
measure specifications. We will publish on the CMS website a list of 
all measures scored under paragraph (b)(1)(vii)(A) as soon as 
technically feasible, but by no later than data submission deadline at 
Sec.  414.1325(e)(1).
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters offered additional suggestions. One 
commenter suggested that, for each circumstance, CMS work with 
stakeholders to assess whether it would be appropriate to measure a 
practice on 9 months of data for a quality measure with a 12-month 
performance period. One commenter requested a better way to address 
errors in measures besides suppression and truncation as measure 
stewards need more flexibility to adjust measures with errors. The 
commenter noted that if a measure with an error is suppressed 
immediately and there is no opportunity for the error to be fixed, 
measure stewards will not be incentivized to put forth corrections to 
CMS.
    Response: We thank the commenters for their comments. The policy to 
truncate the performance period to 9 months may be used when there are 
changes in the final quarter of the performance period that are 
substantial enough to significantly impact the measure. In instances in 
which measures include significant changes or errors at the time of 
finalization, we would not have 9 months of appropriate data to assess. 
When these errors come to CMS' attention, the agency works with measure 
stewards to correct the issue. Whether or not the measure can be 
corrected is contingent upon the timing of discovery of the errors. In 
instances in which measures can be corrected, we believe that measure 
stewards are incentivized to correct them in as timely a manner as 
possible to support their presence and use in the program. We also 
believe that measures stewards want their measures in MIPS and will 
work to ensure that their measures are maintained and that errors are 
corrected. We will continue to work with measure stewards both to 
ensure measure specifications are correct before finalization, as well 
as correct any errors that are finalized.
    Comment: A few commenters supported the expanded list of reasons 
that a quality measure may be impacted to include errors included in 
the measure specifications as finalized as cause to suppress or 
truncate a measure. One commenter appreciated that the policy will 
prevent scores from being negatively affected based on changes to 
measures.
    Response: We thank the commenters for their response and their 
support of the edits to the scoring flexibilities policy.
    After consideration of public comments, we are finalizing our 
proposal as proposed by revising 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 to provide that for each measure that is submitted, if 
applicable, and impacted by significant changes or errors prior to the 
applicable data submission deadline at Sec.  414.1325(e), performance 
is based on data for 9 consecutive months of the applicable CY 
performance period. If such data are not available or CMS determines 
that they 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. For purposes of 
paragraph (b)(1)(vii)(A), ``significant changes or errors'' means 
changes to or errors in a measure that are outside the control of the 
clinician and its agents and that CMS determines may result in patient 
harm or misleading results. Significant changes or errors include, but 
are not limited to, changes to codes (such as ICD-10, CPT, or HCPCS 
codes) or the active status of codes, the inadvertent omission of 
codes, or inclusion of inactive or inaccurate codes; changes to 
clinical guidelines; or measure specifications.
    We will publish on the CMS website a list of all measures scored 
under paragraph (b)(1)(vii)(A) as soon as technically feasible, but by 
no later than data submission deadline at Sec.  414.1325(e)(1).
(ii) Quality Measure Benchmarks
    We refer readers to the CY 2017, CY 2018, CY 2019, CY 2020, and CY 
2021 Quality Payment Program final rules (81 FR 77277 through 77282, 82 
FR 53699 through 53718, 83 FR 59841 through 59842, 84 FR 63014 through 
63016, and 85 FR 84901 through 84904) for our previously established 
benchmarking policies.
    In the CY 2017 QPP final rule (81 FR 77277 through 77282), we 
finalized that we will use performance in the baseline period to set 
benchmarks for the quality performance category, with the exception of 
new quality measures, quality measures that lack historical data, or 
where we do not have comparable data from the baseline period, for 
which we will set the benchmarks using performance in the performance 
period. We defined the baseline period to be the 12-month CY, that is, 
2 years prior to the performance period for the MIPS payment year. For 
example, for the CY 2022, the baseline period two performance periods 
prior will be the CY 2020 performance period (81 FR 77277). 
Additionally, we further clarified that CMS can establish benchmarks 
either by the applicable baseline or performance period in the

[[Page 65493]]

CY 2019 PFS final rule (83 FR 59842), where we finalized the 
terminology change amending Sec.  414.1380(b)(1)(ii) to remove the 
mention of each individual benchmark and instead state that benchmarks 
will be based on collection type, from all available sources, including 
MIPS eligible clinicians and APMs, to the extent feasible, during the 
applicable baseline or performance period.
    Because of the flexibility provided to MIPS eligible clinicians to 
allow for no data submission for the 2020 performance period (https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1198/2020%20MIPS%20Automatic%20EUC%20Fact%20Sheet.pdf), we may not have as 
representative of a sample of data as we will have had without the 
national PHE for COVID-19. Therefore, we want to revisit our 
benchmarking policy for the 2022 performance period/2024 MIPS payment 
year similarly to how we revisited the benchmarking policy for the 2021 
performance period/2023 MIPS payment year (85 FR 84901 through 84902). 
We anticipate that we may have a gap in our data due to receiving fewer 
submissions for CY 2020, which could skew the benchmarking results. We 
believe this gap in data could result in different distributions of 
scores from what we normally see; thus, skewing the benchmarks when 
using CY 2020 data as the baseline for the CY 2022 performance period/
2024 MIPS payment year. Additionally, we anticipate that only those not 
experiencing a hardship will submit data, thus skewing benchmarks much 
higher than normal. We ultimately, did not finalize this proposal for 
CY 2021 because analysis of the submitted data from the CY 2019 
performance period/2021 payment period showed that it was suitable for 
use in calculating benchmarks. However, as we know from the events of 
2020, we anticipate that the effects of the national PHE for COVID-19 
may be more significant for the CY 2020 performance period.
    For this reason, we considered two benchmarking options for the CY 
2022 performance period/2024 MIPS payment year. We proposed to use 
performance period benchmarks for the CY 2022 performance period/2024 
MIPS payment year in accordance with Sec.  414.1380(b)(1)(ii). As 
discussed in the CY 2021 PFS final rule (85 FR 84902), this would mean 
that benchmarks for the CY 2022 performance period/2024 MIPS payment 
year are based on the actual data submitted during the CY 2022 
performance period. Last year, we received comments supportive of our 
proposal to use performance period benchmarks citing that the 
performance period benchmarks will capture any changes in care due to 
the national PHE for COVID-19 and avoid unfairly penalizing practices 
for variation in performance compared to data from prior to the 
national PHE for COVID-19 (85 FR 84902 through 84903). We also received 
comments that opposed the use of performance period benchmarks, as 
clinicians would not have advance notice of performance targets. As a 
result, we also considered and sought feedback as an alternative to 
performance period benchmarks, utilizing the historic benchmarks from 
the 2021 MIPS performance period (which are based on submissions for CY 
2019 MIPS performance period/2021 MIPS payment year) for the CY 2022 
performance period/2024 MIPS payment year. We believed that this option 
would allow clinicians to continue to receive advance notice for 
quality performance category measures so that MIPS eligible clinicians 
can set a clear performance goal for these measures for the CY 2022 
performance period/2024 MIPS payment year. However, we remained 
concerned that utilizing outdated data could also potentially result in 
distributions of scores used for benchmarks that no longer reflect the 
standard of care especially as care changes in response to the PHE. 
Additionally, any new or substantively changed measures in the CY 2022 
performance period/2024 MIPS payment year will lack a benchmark, as 
would measures that were suppressed in the CY 2019 performance period/
2021 MIPS payment year alternate baseline period. We noted that we 
would analyze the CY 2020 performance period data and compare the 
distribution of the CY 2020 performance period data to that of previous 
years to assess if we could in fact use data from the CY 2020 
performance period for benchmarks for the CY 2022 performance period/
2024 MIPS payment year and if not, we would evaluate the suitability of 
the alternatives.
    Additionally, we proposed to expand the definition of the baseline 
period. In instances in which a measure is suppressed two performance 
periods prior in the standard baseline period and cannot be used to 
calculate a benchmark, we proposed to use the data from three 
performance periods prior to calculate benchmarks in the event that a 
performance period benchmark cannot be calculated. This will mean that 
for the CY 2022 performance period/2024 MIPS payment year, if a measure 
was suppressed in the 2020 performance period and a performance period 
benchmark could not be calculated using the 2022 performance period 
data because it was not reported by 20 different clinicians or groups 
that met data completeness and case minimum requirements, we would 
calculate a benchmark from performance period data from CY 2019. If a 
measure had undergone a substantive change or was also suppressed in 
the baseline period 3 performance periods prior, we would not use it to 
calculate benchmarks and the measure will be subject to our scoring 
policies for class 2 measures. We would not use benchmarks calculated 
from performance periods that are older than 3 performance periods 
prior. We believed it is important to continue using the most up-to-
date data to drive clinical quality improvement. We believed that this 
policy will reduce burden to clinicians and allow them to continue to 
have performance targets in the event that a measure is suppressed.
    We solicited public comments on our intent to use performance 
period benchmarks for the CY 2022 performance period and to expand the 
baseline period to three performance periods prior for measures that 
are suppressed two performance periods prior. Table 59 reflects a 
summary of the benchmarking hierarchy in our proposal.

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[GRAPHIC] [TIFF OMITTED] TR19NO21.086

    We received public comments to the quality measure benchmarks. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters requested that CMS undertake more analysis 
on the impact of the use of 2019, 2020 and 2021 data on setting 
benchmarks and risk adjustment models before moving forward with its 
proposed policy to use 2022 benchmark data. One commenter supported the 
plan to apply the same process used for evaluating 2019 performance 
year data to 2020 performance year data to determine if data are 
sufficient to establish benchmarks. A few urged CMS to evaluate CY 2021 
data to determine if there are data anomalies that will require the 
avoidance of using that data, as well.
    Response: Based on analysis of CY 2020 performance period/2022 MIPS 
payment year submissions data, we believe there is sufficient data to 
calculate historical benchmarks and do not believe it is necessary to 
use either of the proposed alternative approaches. Overall, despite a 
modest decrease in submission volume, average scores remained 
consistent to those observed in CY 2019 performance period/2021 MIPS 
payment year. The analysis showed minimal to no impact for the Part B 
Claims and MIPS CQM collection types. However, we did see moderate 
distributional effects in 64 measures. We note that these 64 measures 
are less commonly reported and the effects seen are not categorically 
different than the change in the performance distribution that would be 
observed in any given year, although it is possible that the observed 
effects may be greater than they would otherwise be as a result of the 
COVID-19 PHE.
    Ultimately, we believe that the best option available is to use the 
CY 2020 performance period/2022 MIPS payment year data. These data will 
provide clinicians with advance notice of performance targets that are 
more representative samples of performance as a result of the PHE than 
the use of performance period benchmarks. Additionally, we believe that 
data from the CY 2020 performance period/2022 MIPS payment year, which 
is the most recent available dataset, is more appropriate for use than 
the historical benchmarking data from the CY 2019 performance period/
2021 MIPS payment year. We believe that it is important to benchmark 
performance using data that reflects care provided during the PHE. We 
also believe that the CY 2020 performance period/2022 MIPS payment year 
data better represents this care. Data collected during the CY 2019 
performance period was largely not affected by the COVID-19 PHE, rather 
we saw effects during the associated submission period which occurred 
during the first calendar quarter of 2020 which affected the number of 
submissions, but would not reflect a performance period in which 
clinicians were facing the PHE. We note that we could not analyze data 
from the CY 2021 performance period/2023 MIPS payment year as it is not 
currently available. This data will be submitted from the close of the 
performance period through March 31, 2022 (Sec.  414.1325(e)). For this 
same reason we could not use this data to set benchmarks for the CY 
2022 performance period/2024 payment year. We are committed to using 
the most up-to-date representative data available. For that reason, we 
are not finalizing the proposal to use performance period benchmarks 
and will calculate benchmarks according to the standard baseline period 
policy.
    Comment: One commenter suggested that CMS exclude CY 2020 data from 
all future reporting due to COVID-19 and maintain consistency in 
excluding 2020 reporting year data as was proposed in the 2022 
Inpatient Prospective Payment System (IPPS) and Outpatient Prospective 
Payment System (OPPS) regulations.
    Response: We believe the commenter is misunderstanding policies in 
the IPPS and OPPS regulations. In March 2020, prior to either the CY 
2022 OPPS/ASC proposed rule or the FY 2022 IPPS/LTCH PPS proposed rule, 
we issued an extraordinary circumstance exception (ECE) \253\ for a 
number of Q1 and Q2 2020 requirements in hospital pay-for-reporting and 
value-based purchasing programs, including the Hospital Inpatient 
Quality Reporting Program and the Hospital Outpatient Quality Reporting 
Program.
---------------------------------------------------------------------------

    \253\ https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
---------------------------------------------------------------------------

    In the FY 2022 IPPS final rule, we established a measure 
suppression policy in a number of value-based purchasing programs, 
including the Hospital Value-Based Purchasing (VBP) Program, the 
Hospital Readmissions Reduction Program and the Hospital-Acquired 
Conditions Program. This measure suppression policy allowed for

[[Page 65495]]

suppression of measures if we determine that circumstances caused by 
the COVID-19 PHE have affected those measures (86 FR 45266). 
Additionally, for the FY 2022 for Hospital VBP program year, because of 
wide-spread measure suppression, it was finalized that we would not 
calculate total performance scores nor issue any penalties or incentive 
payments as awarding negative or positive incentive payment adjustment 
percentages using TPSs calculated using the current scoring methodology 
would not provide a representative score of a hospital's overall 
performance in providing quality of care during a pandemic (86 FR 
45276). We did not propose any additional policies related to 
suppression or exclusions in the CY 2022 OPPS/ASC proposed rule as the 
comment suggested. We do not believe it will be necessary to exclude CY 
2020 performance period data from MIPS. As stated above, our analysis 
supports the use of CY 2020 performance period/2022 MIPS payment year 
data to calculate quality measure benchmarks.
    Comment: Many commenters supported the use of performance period 
benchmarks. These commenters stated that such benchmarks would be more 
representative of the care provided during the COVID-19 pandemic and 
would be ``more appropriate'' than using historical benchmarks. Many 
commenters agreed with CMS' concern that 2020 performance data may not 
be a representative sample of historic data and benchmarks for 2022 
will be more accurate and reliable. To support the use of performance 
period benchmarks, one commenter encouraged CMS to release the 2021 
performance year benchmarks as soon as possible in 2022. One clinician 
supported providing 2019 historic benchmarks to give clinicians a 
target while the performance period benchmarks are used for scoring.
    Response: We agree that performance period benchmarks would provide 
the most up-to-date data to calculate benchmarks; however, we also 
believe there is significant value in the advance notice of performance 
targets. Participants may have difficulty meeting relevant performance 
targets if they lack advance notice of the target as they may not be 
able to determine the appropriate level of resources necessary to 
achieve the performance target. Participant concerns regarding this 
issue may be particularly acute where performance may result in a 
payment adjustment. We thank the commenters for their suggestions, but 
we believe that it is most appropriate to continue to rely on 
historical benchmarks for the CY 2022 performance period/2024 MIPS 
payment year. We will continue to monitor the impact of the national 
PHE on performance benchmarks. We note that the CY 2019 performance 
period/2021 MIPS payment year benchmarks are currently available in the 
resource library on the QPP website (https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1275/2021%20MIPS%20Quality%20Benchmarks.zip). The historical benchmarks 
based on CY 2020 performance period/2022 MIPS payment year will be 
available prior to the CY 2022 performance period. The CY 2023 
historical benchmarks which are calculated from CY 2021 performance 
period/2023 MIPS payment year data will be available spring/summer of 
CY 2022 at the earliest.
    Comment: Many commenters did not support the use of performance 
period benchmarks because clinicians would not know the benchmarks 
ahead of time and performance period benchmarks would prevent 
meaningful assessment in advance of the performance year and would 
hinder the ability to select measures that will maximize scoring in 
advance of the year. One commenter stated that advanced notice of 
targets is essential to ensure fair and meaningful incentives for high 
quality, efficient health care. One commenter noted that as payment 
consequences associated with MIPS scores increase, it becomes more 
important to provide clinicians with adequate information to enable 
appropriate selection of measures. One commenter stated that any value 
gained by using performance period benchmarks is outweighed by the 
negative impact on clinicians as they would not have benchmarks 
available for comparison and performance improvement.
    Response: As noted above, we agree that the use of performance 
period benchmarks would not allow clinicians the opportunity to fully 
prepare for the respective performance period. We will not finalize the 
use of performance period benchmarks for the CY 2022 performance 
period/2024 MIPS payment year. We believe the use of data from the CY 
2020 performance period/2022 MIPS payment year will be representative 
of performance and allow clinicians advanced notice of performance 
targets to aid in measure selection and help clinicians to work towards 
improvement on quality measures.
    Comment: Many commenters supported using CY 2019 performance 
period/2021 MIPS payment year data to create quality benchmarks since 
clinicians appreciate notice on which measures will have benchmarks and 
the CY 2019 performance period/2021 MIPS payment year data would allow 
clinicians time to review and compare data to drive improvement based 
on the known benchmark. A few commenters noted that, to maintain 
consistency and predictability of MIPS performance through the 
pandemic, CMS should use CY 2019 performance period/2021 MIPS Payment 
year historic data as benchmarks. One commenter supported the use of CY 
2019 performance period/2021 MIPS payment year historic benchmarks as 
EHRs and registries track performance in real time relative to the 
benchmark as the only way for clinicians to determine if there are 
deviations in their quality performance which can occasionally indicate 
real clinical issues, such as complication rates, that need to be 
addressed. One commenter stated that for measures with substantive 
changes since CY 2019, CMS should use the CY 2022 performance year/2024 
MIPS payment year data, that is, use a performance period benchmark, to 
determine the score, but the general use of CY 2019 quality measure 
data for benchmarks would allow clinicians to have some ability to know 
what they are being benchmarked against. One commenter suggested that 
CMS should provide clinicians with historic benchmarks using CY 2019 
performance period/2021 MIPS payment year data and calculate historic 
and performance period benchmarks and use the more favorable to score.
    Response: We agree that the opportunity to review and compare data 
helps to drive improvement against the known benchmark and enables 
clinicians track performance in real time to respond to any clinical 
issues that the data indicates. These benefits provide value to 
clinicians and support their meaningful participation in the program. 
This is ultimately the reason our existing policy establishes the 
preference to use historical benchmarks. In this instance, we believe 
that the use of CY 2020 performance period/2022 MIPS payment year to 
calculate benchmarks better balances issues that arise from using 
historical data than the use of CY 2019 performance period/2022 MIPS 
payment year data. Ultimately, as stated in a previous response, we 
believe that it is most appropriate to base a benchmark on the more up-
to-date historical data and on the historical data that is most 
representative of the current standard of care.
    We agree with the commenters' suggestion that measures suppressed 
in the CY 2019 performance period/2021 payment year should use 
performance

[[Page 65496]]

period data for benchmarking and will apply this approach to measures 
suppressed in the CY 2020 performance period/2022 MIPS payment year, as 
this is our current approach. Historical benchmarks from the CY 2019 
performance period/2021 MIPS payment year are currently available in 
the resource library in the QPP website.
    Comment: A few commenters did not support expanding the definition 
of the baseline period to calculate a benchmark because the underlying 
data would be too retrospective and not reflective of current 
performance and that this approach would not address the concerns of 
using a representative sample of historic data since many of the 
baseline periods would include data from 2019, 2020, and 2021 data--all 
of which are impacted by the COVID-19 pandemic. One commenter 
encouraged CMS to avoid the use of these data for benchmarking 
purposes.
    Response: We believe there is value in the advance notice for 
quality measures, but agree that extending the baseline period would be 
too retrospective and fails to reflect current performance that could 
come as a result in advances in care. For this reason, we are not 
finalizing the proposal to add an alternate historical baseline period 
defined as three performance periods prior.
    Comment: A few commenters supported the proposal to add an 
alternate baseline period of three performance periods prior for 
measures that are suppressed two performance periods prior. One 
commenter suggested that it would be better to use the Alternate 
Historical Baseline Period at level 2 in the proposed benchmarking 
hierarchy and set the Performance Period Benchmark as level 3 since CMS 
has expressed concern that alternate historical benchmarks could become 
too outdated to accurately reflect the current standard of care. Moving 
the Alternate Historical Baseline to level 2 within the proposed 
benchmarking hierarchy would allow CMS to give providers advanced 
notice using historical benchmarks, while still having the discretion 
to use concurrent performance period benchmarks if determined that the 
standard of care has changed too significantly to use the alternate 
historical data.
    Response: We thank commenters for their support, but will not be 
finalizing this proposal for the reasons cited in the previous 
response. Our proposal was to allow for scoring of measures that had 
been suppressed in the baseline period two performance periods prior 
when a performance period benchmark could not be calculated. For the 
reasons stated above, we prefer to use the most-up-to date historical 
data that is available in the program and believe using an alternate 
baseline period of three performance periods prior may be too 
retrospective. We will continue to use our use of performance period 
benchmarks for measures that lack a benchmark in the baseline period.
    After consideration of public comments, we are not finalizing our 
proposal to use performance period benchmarks in the CY 2022 
performance period/2024 MIPS payment year or a historic benchmark 
calculated from CY 2019 performance period data. Instead, we will 
calculate benchmarks from the CY 2020 performance period/2022 MIPS 
payment year data as is our standard policy according to Sec.  
414.1380(b)(1)(ii). Any measures suppressed in the CY 2020 performance 
period/2022 MIPS payment year will have a performance period benchmark 
calculated for scoring purposes. Additionally, we are not finalizing 
our proposal to define an alternative baseline period for benchmarking 
defined as three performance periods priors for measures suppressed in 
the baseline period two performance period prior.
(iii) Assigning Quality Measure Achievement Points
    We refer readers to Sec.  414.1380(b)(1)(i) for more details on our 
current policies for scoring performance on quality measures (81 FR 
77276 through 77307, 82 FR 53694 through 53701, 83 FR 59841 through 
59856, 84 FR 63011 through 63019, and 85 FR 84906 through 84907).
(A) Scoring Measures Based on Achievement
    We previously established at Sec.  414.1380(b)(1)(i) a global 3-
point floor for each scored quality measure, as well as each 
administrative claims measure. MIPS eligible clinicians receive between 
3 and 10 measure achievement points for each submitted measure that can 
be reliably scored against a benchmark, which requires meeting the case 
minimum and data completeness requirements. In the CY 2017 Quality 
Payment Program final rule (81 FR 77282), we established that measures 
with a benchmark based on the performance period (rather than on the 
baseline period) will continue to receive between 3 and 10 measure 
achievement points for performance periods after the first transition 
year. For measures with benchmarks based on the baseline period, we 
stated that we will revisit the 3-point floor in future years. For the 
2021 performance period/2023 MIPS payment year, we maintained the 
application of the 3-point floor for each measure that can be reliably 
scored against a benchmark.
    For the 2022 performance period/2024 MIPS payment year, we proposed 
to remove 3-point floor for each measure that can be reliably scored 
against the benchmark and score the measure from 1 to 10 points. As we 
move towards the MVP framework discussed the CY 2021 PFS final rule (85 
FR 84904), we are moving towards a simplified scoring standard in which 
we can score quality measures from 1 to 10 for measures in MVPs and as 
such will amend the MIPS program to begin promoting this alignment. As 
a result, we previously discussed that we would wait until there is 
further policy development under the MVP framework before removing the 
3-point floor (85 FR 84904). However, with the delay in the 
implementation of MVPs, we will begin the transition to MVPs by 
removing policies established on the transition years of MIPS. We have 
signaled through rulemaking for several years that we would revisit 
policies established during the transition years of the program from 
the legacy programs to MIPS. As the legacy programs have been sunsetted 
for many years now, we believe that it is appropriate to transition the 
MIPS program to its mature state. Additionally, we believe that 
transitioning MIPS to its mature state will serve as a transition 
period to allow clinicians to adjust to the simplified scoring standard 
that we will be using in MVPs.
    Accordingly, we proposed to revise Sec.  414.1380(b)(1)(i) to add 
beginning the 2022 performance period/2024 MIPS payment year, MIPS 
eligible clinicians would receive between 1 and 10 measure achievement 
points (including partial points) for each measure required under Sec.  
414.1335 on which data is submitted in accordance with Sec.  414.1325 
that has a benchmark at paragraph (b)(1)(ii) of this section, meets the 
case minimum requirement at paragraph (b)(1)(iii) of this section, and 
meets the data completeness requirement at Sec.  414.1340 (86 FR 
39432).
    We solicited public comments on our proposal to remove the 3-point 
floor for each measure that can be reliably scored against a benchmark 
for the 2022 performance period/2024 MIPS payment year.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter did not support the removal of the three-
point

[[Page 65497]]

floor and noted that it would likely be an additional challenge for 
practices that are already struggling with the pandemic. Another 
commenter suggested that the proposal to remove the 3-point floor 
should be delayed and should be implemented as part of the CY 2023 
rulemaking process as the pandemic has shifted clinician focus off of 
the mechanics of MIPS and very few clinicians may be ready for such a 
significant change during the CY 2022 performance period.
    Response: We agree that the national PHE for COVID-19 has affected 
the health care sector in unprecedented ways and has understandably 
shifted clinician focus off of participation in MIPS. We agree that 
delaying the implementation of the removal of the 3-point scoring floor 
until the CY 2023 performance period/2025 MIPS payment year would 
recognize this hardship and would avoid harshly penalizing clinicians 
for any changes in performance that may be observed during this time. 
CMS does remain committed to the removal of transition policies and 
moving towards a simplified scoring standard in MVPs.
    Comment: A few commenters opposed the removal of the scoring floor 
along with the higher performance threshold. The commenters requested 
that CMS account for the challenges that will result from an increased 
performance threshold and retain the scoring floor instead of removing 
many of the possibilities of avoiding a negative payment adjustment.
    Response: We agree that removing the scoring floors and raising the 
performance threshold at this time, particularly with the ongoing PHE, 
could present challenges to clinicians. However, we do not want to 
continue masking true performance on quality measures. As discussed in 
section IV.A.3.f.(2) of this final rule, beginning with the CY 2022 
performance period/2024 MIPS payment year, section 1848(q)(6)(D)(i) of 
the Act requires the performance threshold to be 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. 
Accordingly, we proposed to use a performance threshold of 75 points 
which was the mean final score from CY 2017 performance period/2019 
MIPS payment year (86 FR 39454). As this represents an increase of 
about 15 points from the previous year's performance threshold, we 
understand clinicians' concern. For this reason, we are delaying the 
removal of the 3-point scoring floor for measures that can be reliably 
scored against a benchmark until the CY 2023 performance period/2025 
MIPS payment year. We believe this will allow clinicians some leniency 
as we they adjust to a higher performance threshold and continue to 
face the PHE.
    Comment: One commenter stated that CMS should assess scoring 1-10 
points before removing the 3-point floor. The commenter encouraged CMS 
to review how frequently eligible clinicians have performance rates 
that place them below the 3-point floor, particularly clinicians in 
small and rural practices.
    Response: We thank the commenter for their suggestion and will 
perform these analytics. To further assist MIPS eligible clinicians in 
the transition of removing the 3-point scoring floor, we will begin 
providing information on deciles below 3 in our forthcoming benchmark 
file, as technically feasible before the removal of the 3-point floor 
in 2023.
    Comment: One commenter stated that the methodology to estimate the 
quality performance category score and the transition from old scoring 
policies to new are too complicated as clinicians need to understand 
how their scores are calculated and which measures to select to 
optimize performance.
    Response: We believe that removing the 3-point scoring floor and 
scoring measures that can reliably be scored against a benchmark from 
1-10 will make scoring simpler. The 3-point scoring floor was 
established when the performance threshold was 3 points during the 
transition year of the MIPS in order to avoid penalizing clinicians at 
the start of the program (81 FR 77287). As the performance threshold 
has since changed and clinicians have more familiarity with reporting 
through MIPS, this policy is no longer relevant. In order to move 
towards complete and meaningful scoring, scores will be evenly 
distributed across a range from 1 to 10. This allows CMS to more 
accurately distinguish performance amongst clinicians. We believe that 
the changes in quality measure comparison will also provide great 
benefits to clinicians by reducing score inflation in the quality 
performance category and by enabling payment adjustments that reflect 
meaningful distinctions in quality of care. We currently provide a tool 
on the QPP website for clinicians to explore measures and activities to 
aid in measure and activity selection (https://qpp.cms.gov/mips/explore-measures). We offer this tool and provide clinicians with 
performance targets (historical benchmarks) before the start of the 
performance period in order promote transparency in scoring and support 
clinicians in making decisions to support fair and meaningful 
participation in program.
    After consideration of public comments, we are not finalizing the 
policy to remove the 3-point scoring floor as proposed. We are 
finalizing the removal of the 3-point scoring floor for measures that 
can be reliably scored against a benchmark to be implemented in CY 2023 
and revise Sec.  414.1380(b)(1)(i) to add beginning the 2023 
performance period/2025 MIPS payment year, MIPS eligible clinicians 
will receive between 1 and 10 measure achievement points (including 
partial points) for each measure required under Sec.  414.1335 on which 
data is submitted in accordance with Sec.  414.1325 that has a 
benchmark at paragraph (b)(1)(ii) of this section, meets the case 
minimum requirement at paragraph (b)(1)(iii) of this section, and meets 
the data completeness requirement at Sec.  414.1340. We believe that 
delaying the implementation of this policy allows clinicians to 
acclimate to other changes in the program such as the increase of the 
performance threshold and the removal of the scoring bonuses in the 
quality performance category. Additionally, we believe this policy 
provides some flexibility to clinicians in response to the national 
PHE.
(B) Scoring Measures That Do Not Meet Case Minimum, Data Completeness, 
and Benchmark Requirements
    We refer readers to Sec.  414.1380(b)(1)(i)(A) and (B) for more on 
our current scoring policies for a measure that is submitted but is 
unable to be scored because it does not meet the required case minimum, 
does not have a benchmark, or does not meet the data completeness 
requirement (84 FR 63012).
    In the 2017 QPP final rule (81 FR 77288) and the 2018 QPP final 
rule (82 FR 53727), we identified ``classes of measures'' which were 
intended to characterize measures for the ease of discussion. Class 1 
measures are measures that can be scored based on performance because 
they have a benchmark, meet the case minimum and data completeness 
requirements. Class 2 measures are measures that cannot be scored based 
on performance because they do not have a benchmark or do not meet the 
case minimum which is generally 20 cases. Class 3 measures are measures 
that do not meet the data completeness requirement. We also noted that 
policies for Class 2 and Class 3 measures will not apply to measures 
submitted with the CMS Web Interface or administrative claims-based 
measures.

[[Page 65498]]

    In the CY 2022 PFS proposed rule, we proposed to modify how we 
score these measures within MIPS, as we considered policies for 
transitioning to MVPs (86 FR 89433). For class 2 measures, for the 2022 
performance period/2024 MIPS payment year, we proposed to remove 
special scoring policies for measures that meet the data completeness 
requirement but do not have a benchmark, due to fewer than 20 
individual clinicians or groups adequately reporting the measure, or 
meet the case minimum requirement except in the case of small 
practices, for which we will maintain the 3-point floor. Practices of 
other sizes would receive zero points.
    We noted that, as we move to MVPs, we are seeking to simplify 
scoring by removing transition policies. To encourage complete and 
meaningful reporting, we cannot continue to award measure achievement 
points for measures that cannot be reliably scored against a benchmark. 
In a quality measurement program such as MIPS, we noted that it is 
imperative that we can reliably measure performance on clinical quality 
measures to achieve the goals of the program and incentivize clinicians 
that are providing the high-quality care. However, we remained 
concerned that it may be harder for smaller practices to reach case 
minimums, and as such, we are maintaining the 3-point floor policy for 
small practices. We believed that measure selection that is better 
reflective of the care most commonly provided in a practice would 
increase the value of the program by allowing us to score for 
achievement in clinical quality and subsequently drive changes in 
performance on clinical quality measures.
    Measure benchmarks are posted in advance of the MIPS performance 
period and can be used to drive clinician measure selection. While not 
all measures relevant to a clinician's practice may have a historic 
benchmark posted, clinicians have the option to make informed decisions 
about their participation in the MIPS program. Additionally, we believe 
that while clinicians do not have control over the case volume and mix 
that their practices treat, under normal circumstances, they can 
anticipate which measures would be most reflective of the care 
generally provided by said practices. Scoring 3 points for class 2 
measures was established as a policy during the transition years of the 
program, when the performance threshold was 3 points and scoring 3 
points for quality will help clinicians transitioning to the program 
without receiving scores for poor performance. The intent of the policy 
was to provide time for clinicians to acclimate to the scoring standard 
before being held fully accountable for their participation in the 
program (81 FR 77287). As we believe we have provided sufficient time 
for clinicians to acclimate to our reporting requirements and scoring 
practices, we believe that we can hold clinicians accountable for their 
meaningful participation in the program.
    We remain concerned about that case minimums and the availability 
of a benchmark are in some instances out of the control of the 
clinician, but we believe that clinician choice of measure allows us to 
move forward with the removal of transition scoring policies. We note 
that we also have policies in place to account for the calculation of a 
performance period benchmark if a historical benchmark is unavailable. 
Simulations of the effects of this policy show minimal effects of 
removing the 3-point floor as described above, with only a 0.4 point-
decrease in median quality performance category score and 0.2 point-
decrease in mean performance quality performance category score when 
compared to a baseline score that maintains the previously finalized 
class 2 measure scoring policy (86 FR 39433). We noted that we 
considered other approaches to address this issue such as a denominator 
reduction for class 2 measures; however, we remained concerned over the 
potential for gaming under this approach, such as where a clinician 
only selects class 2 measures resulting in their quality performance 
category score being reweighted.
    We did not want this policy to discourage the reporting of new 
measures in the program because they may lack a benchmark or fail to 
meet the case minimum requirement. For this reason, we proposed a 5-
point floor for new measures in the program for all collection types 
for their first 2 years in the program, as well as a new class for 
these measures. Measures in either their first or second performance 
period in the program would be classified as class 4 measures. Measures 
that can be reliably scored against a benchmark because they meet data 
completeness requirement can have a performance period benchmark 
calculated, and meet case minimum requirements would be considered 
class 4a and scored from 5 to 10 measure achievement points. In the 
event that a measure cannot be reliably scored against a benchmark 
because it lacks a benchmark or does not meet case minimum, but meets 
the data completeness requirement, it would be considered class 4b and 
receive a score of 5. Measures that cannot be scored because they do 
not meet the data completeness requirement would remain subject to the 
class 3 measure policy and receive a score of zero for clinicians other 
than small practices, while small practices will continue to receive 
three points.
    We noted our belief that a 5-point floor for new measures would 
allow us to introduce new, applicable measures into the program, by 
reducing the burden to clinicians in selecting them. We also noted our 
belief that this policy was responsive to stakeholder concerns that new 
measures run the risk of lacking enough data to have a benchmark and 
clinicians earning only 3 points according to the current policy on 
measures that cannot be reliably scored against a benchmark. We 
believed that the possibility of earning 5 points for a measure that 
lacks a benchmark will not unfairly penalize clinicians who report on 
new measures. Additionally, clinicians have the possibility of earning 
up to 10 points with the lowest possible score of 5. The 5-point floor 
would only be in place for a measure's first 2 years in the program to 
ease their transition, and will be scored in accordance with policies 
for standard class 1, 2, and 3 measures thereafter, to maintain a 
simplified scoring methodology. In the CY 2017 Quality Payment Program 
final rule, we received comments of support on our proposal to provide 
a scoring floor for new measures citing that a scoring floor for new 
measures would encourage clinicians to report new measures and prevent 
gaming. Commenters were also supportive other approaches to reducing 
the burden of reporting new measures such as reducing the weight of new 
measures in the performance category score (81 FR 77281).
    Accordingly, we proposed to revise Sec.  414.1380(b)(1)(i)(A)(1) to 
provide that except as provided in paragraph (b)(1)(i)(A)(2) and (3) of 
this section, for the 2017 through 2021 CY performance periods/2019 
through 2023 MIPS payment years, MIPS eligible clinicians receive 3 
measure achievement points for each submitted measure that meets the 
data completeness requirement, but does not have a benchmark or meet 
the case minimum requirement. Beginning within the CY 2022 performance 
period/2024 MIPS payment year, MIPS eligible clinicians other than 
small practices receive zero measure achievement points for each such 
submitted measures and small practices receive three measure 
achievement points
    We also proposed to add the policy for new measures at Sec.  
414.1380(b)(1)(i)(C)(1) to provide that beginning with the CY 2022

[[Page 65499]]

performance period/2024 MIPS payment year, MIPS eligible clinicians 
receive between 5 and 10 measure achievement points (including partial 
points) for each measure required under Sec.  414.1335 on which data is 
submitted in accordance with Sec.  414.1325 that has a benchmark at 
paragraph (b)(1)(ii) of this section, meets the case minimum 
requirement at paragraph (b)(1)(iii) of this section, and meets the 
data completeness requirement at Sec.  414.1340. We also proposed to 
add a policy at Sec.  414.1380(b)(1)(i)(C)(2) to provide that for 
purposes of this section ``new measures'' means a quality measure this 
is in its first 2 years in the program.
    We solicited public comments on our proposal to modify the special 
scoring policies for measures that meet the data completeness 
requirement but do not have a benchmark or meet the case minimum 
requirement for the MIPS 2024 payment year and to introduce a 5-point 
scoring floor for new measures in for their first 2 years in the 
program. Table 60 reflects a summary of our proposed policies.
    We received public comments on the scoring measures that do not 
meet case minimum, data completeness, and benchmark requirements. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters did not support the removal of the 3-point 
floor for Class 2 measures, especially while the COVID-19 pandemic is 
ongoing. A few commenters stated that there are often changes to 
quality measure specifications or calculations and as such a benchmark 
cannot be established for these measures and there are groups of all 
sizes that cannot make the case minimum for certain measures and that 
no such groups should receive zero points. One commenter noted that 
this scoring policy would disincentivize the use of these measures as 
the measures would then never accrue enough data for a benchmark, and 
clinicians would hesitate to use them--creating a self-perpetuating 
cycle. One commenter noted that with a measure score of zero points, 
and even with the 3-point floor, there is no incentive for groups to 
branch out and implement workflows to capture data for specialty 
specific measures if no benchmarks are set. One commenter suggested 
that instead of scoring zero points for measures with no benchmarks, 
CMS should provide credit to clinicians who take the time to report on 
more focused measures and contribute to the building of performance 
benchmarks. A few commenters noted that measures without benchmarks for 
multiple years will never get enough data for a benchmark if they are 
scored at zero points. One commenter noted that this could be harmful 
to QCDRs as measures do not always have a benchmark because it is 
submitted by a limited group of specialists. One commenter stated that 
finalizing this policy could lead to important measures being 
overlooked because of the lack of a benchmark. One commenter 
recommended maintaining the 3-point scoring policy for measures that 
were introduced during PY 2020 because of the impacts of the extreme 
and uncontrollable circumstances policies on reporting. A few 
commenters stated the CMS should not make any significant changes to 
scoring policies during the COVID-19 PHE. One commenter stated that CMS 
needs to address the lack of sufficient, relevant measures before 
further reducing scoring for measures not meeting the case minimum or 
benchmark criteria.
    Response: We understand that our current and proposed class 2 
measure policy presents risk in reporting measures, including measures 
that have undergone substantive changes and had their benchmarks reset, 
that may not have a benchmark calculated, or in instances in which a 
clinician or group cannot meet the case minimum requirements. We 
cannot, however, provide scores for measures for which we cannot 
reliably distinguish meaningful differences in performance nor can we 
continue to award points for reporting as MIPS moves out of its 
transition phase. To support meaningful participation in MIPS, we 
provide clinicians with benchmarks in advance, as well as other tools 
to support measure selection (https://qpp.cms.gov/mips/explore-measures). We believe that there is little to no value in maintaining 
underreported measures for which we cannot establish benchmarks, and 
therefore, we cannot score.
    As described in section IV.A.3.h.(1)(d)(iii) of this final rule, 
QCDR measures that do not meet case minimums or cannot have a benchmark 
calculated after their first two performance periods in the program 
must submit a participation plan or run the risk of being removed from 
the program as established in Sec.  414.400(b)(4)(i)(B)(10)(i). We 
proposed the new measure policy to reduce the risk associated with 
reporting new measures that may not receive a benchmark. However, we 
recognize that there are important areas that require measurement such 
as specialty specific measures that may be currently underreported. We 
believe that the new measure policy can help to incentivize reporting 
of more applicable measures over those that are historically 
underreported. We will monitor the effect that these policies have on 
the reporting of specialty specific measures and continue to explore 
alternative scoring solutions to solve for this problem such as MVPs. 
Ultimately, we are delaying implementation of the removal of the 3-
point floor policy until CY 2023 in order to be responsive to clinician 
concerns about reporting through MIPS during the COVID-19 PHE. We 
believe this delay in implementation takes a phased approached to 
simplifying scoring as we transition to MVPs.
    Comment: Many commenters supported maintaining a 3-point floor when 
scoring small practice clinicians on quality measures. One commenter 
supported this proposal as small practices face a greater 
administrative burden when reporting for MIPS and they support any 
effort to lessen this burden on those practices in particular.
    Response: As noted above in section IV.A.3 e.(1)(c)(iii)(A) of this 
final rule, we have decided to maintain the 3-point scoring floor for 
practices of all sizes until the CY 2023 performance period/2025 MIPS 
payment year in response to concerns about the PHE, a higher 
performance threshold, and the removal of quality performance category 
bonuses. We believe this phased approached to simplifying scoring as we 
transition to MVPs by delaying the removal of the scoring floor 
policies while finalizing our proposals to remove the high priority and 
end-to-end electronic bonuses will provide flexibility during the 
COVID-19 PHE. We appreciate the commenters support to maintain the 
scoring floor for small practices.
    Comment: One commenter did not support removing the 3 points for 
many practices while keeping the 3 points for small practices and 
stated that there should not be a difference in the size of practices 
for point allocation. One commenter noted that if a measure now does 
not have a benchmark, a clinician would not get any benefit from 
submitting a measure without a benchmark compared to the 3 points 
provided previously. A few commenters mentioned that measure reporting 
rates are not necessarily an indication of a low value measure, 
particularly for highly specialized procedures or patient populations 
and these trends may instead be a result of program policies that 
disincentivize the uptake of these measures.
    Response: We believe it is important to support small practices so 
that they may meaningfully engage in MIPS. We did not want to penalize 
smaller

[[Page 65500]]

practices that may find it harder to reach case minimums. Additionally, 
we believe that maintaining the 3-point floor on class 2 measures for 
small practices would offset some of the additional challenges to 
reporting that small practices face, that practices of other size do 
not. We understand that removing the 3-point floor makes reporting 
measures that do not have a benchmark riskier for clinicians, we 
however, do not want to continue offering points for reporting. We want 
to award points for high performance and demonstrated improvements in 
clinical care. We will continue to assess our policies and find ways to 
encourage the uptake of high value, but underutilized measures that do 
not involve offering points for reporting.
    Comment: Many commenters supported and appreciated the proposed 5-
point floor for Class 4 measures in their first 2 years of the program 
as it will allow for greater utilization of innovative measures that 
show evidence of driving improvements in care and encourage the use of 
newly developed measures. One commenter recommended that CMS indicate 
and communicate which measures will be considered Class 4 measures so 
clinicians can plan appropriately. One commenter suggested that CMS 
expand this policy to existing measures that may add additional 
collection types. One commenter noted that this policy will incentivize 
the use of QCDR measures and increase the robust nature of the 
measures.
    Response: We agree that providing a scoring floor for new measures 
will incentivize greater utilization of innovative, newly developed 
measures; QCDR measures; and increase the robust nature of the 
measures. We will not apply this policy to measures that have existed 
as a MIPS measure but are being introduced for a new collection type. 
For example, if a measure is currently available as a MIPS CQM and it 
becomes newly available as an eCQM, that would not be considered 
``new'' under this policy. Those changes are considered substantive 
changes, but not new measures as they usually will share the same 
measure ID. CMS will communicate which measures will be considered 
class 4 from Appendix 1 and resources that will be available in the 
resource library on the QPP website.
    Comment: Several commenters requested CMS raise the floor for 
reporting on new measures to 7 points, instead of the proposed 5 to 
ensure that this incentive will be sufficient to encourage practices to 
take the risk of using these measures, which will then allow for 
greater understanding of their evidence base, the ability to ensure 
patient-centeredness, and actionability. A few commenters note that a 
higher incentive will encourage clinicians to take on the risk of 
reporting on a new measure and investing in new protocols and workflow, 
which often require IT and practice redesign costs. A few commenters 
requested that the measures be considered new for 3 years, instead of 
the proposed 2 years. One commenter suggested higher point floors for 
measures that are high priority or outcome measures. A few commenters 
requested that the measures be considered new for 3 years. A few 
additional commenters requested that CMS expand the new measures 
proposal to 4 years, instead of the proposed 2 years, as this would 
prevent ``premature'' removal of meaningful measures from the program 
and would recognize the valuable practice resources that are necessary 
to begin using new measures.
    Response: We agree that a higher 7-point floor would be a greater 
incentive for clinicians to invest in new protocols and workflow in 
order to support reporting on new measures. Additionally, we believe 
that introducing a 7-point floor for new measures could be effective in 
incentivizing the reporting of new measures over topped out measures 
though we had not previously considered the connection between these 
two policies previously. However, 7-points is a high score and we do 
not want to introduce new sources of scoring inflation or gaming into 
the program. For this reason, we believe a phased scoring floor policy 
would be an appropriate solution. This approach would introduce a 7-
point scoring floor for new measures across all collection types in 
their first year in the program, then dropping the scoring floor to 5-
points for measures in their second year in the program. After their 
first 2 performance periods in the program, measures would be subject 
to our standard class 1 and 2 measure policies. We believe this 
approach incentivizes early adoption of new measures, while limiting 
the duration of potential scoring inflation and gaming. Additionally, 
we believe that the eventual mandatory reporting of MVPs would reduce 
the impact of scoring inflation and gaming in MIPS. We will monitor 
these measures to assure that they are having the intended effect and 
not being used to game the program. Policies related to QCDR measures 
in MIPS at Sec.  414.1400(b)(3)(iv)(J) discuss a period of two 
performance periods after which measures may be reassessed. We proposed 
a two-performance period timeframe in which measures will be considered 
class 4 measures in alignment with this previously establish policy 
related to QCDR measures. We will also monitor the application of this 
policy to assure that the 2-performance period new measure period is 
adequate. If analytics supports a longer new measure period, we may 
revisit this topic in later rulemaking.
    Comment: A few commenters requested clarification on the logistics 
of the policy and if it applies to QCDR measures and if this 
methodology only applies to measures in their lifecycle going forward 
or if it would be applied to measures finalized starting in 2021. 
Another commenter suggested that CMS apply this policy retroactively 
for measures introduced in CY 2020 and CY 2021.
    Response: The modified Class 4 measure policy would apply a 7-point 
scoring floor to new measures in their first performance period in the 
program across all collection types including QCDRs and a 5-point 
scoring floor to measures in their second year, thereafter being 
subject to scoring policies for Class1 and 2 measures. We believe this 
policy should begin effective the CY 2022 performance period/2024 MIPS 
payment year, meaning measures new to the program in CY 2022 will 
receive a 7-point scoring floor. We do not believe there is a benefit 
in applying this policy retroactively to CY 2020 or CY 2021 performance 
periods/2022 or 2023 MIPS payment year as a retroactive policy would 
inflate scores without providing the corresponding incentive for 
clinicians to adopt new measures. Additionally, measures in their 
second year in the CY 2022 performance period/2024 MIPS payment year, 
will receive a 5-point scoring floor.
    Comment: One commenter opposed the creation of Class 4 measures as 
practices are already incentivized to submit data for measures that are 
relevant to their practice, and therefore, quickly establish benchmarks 
for a measure.
    Response: We have heard form stakeholders that the possibility that 
new measures or Class 4 may not be reliably scored is a deterrent from 
reporting such measures. We believe that it is important to provide 
incentives to report new measures that so that there is less risk in 
reporting these new measures.
    Comment: One commenter suggested that CMS suppress new measures to 
account for high performance threshold.
    Response: We will not suppress new measures. We seek to encourage 
the reporting of new high-quality measures

[[Page 65501]]

in the program and have delayed the removal of the class 2 measure 
policy to 2023 in order to provide flexibilities in response to the 
PHE, higher performance threshold, and removal of the high priority and 
end-to-end- electronic reporting quality performance category bonuses.
    After consideration of public comments, we are finalizing our 
proposed policies with modification. We will delay the removal of the 
3-point floor for all practice sizes until CY 2023, maintaining it only 
for small practices thereafter and revise Sec.  414.1380(b)(1)(i)(A)(1) 
to provide that except as provided in paragraph (b)(1)(i)(A)(2) and (3) 
of this section, for the 2017 through 2022 CY performance periods/2019 
through 2024 MIPS payment years, MIPS eligible clinicians receive 3 
measure achievement points for each submitted measure that meets the 
data completeness requirement, but does not have a benchmark or meet 
the case minimum requirement. Beginning within the CY 2023 performance 
period/2025 MIPS payment year, MIPS eligible clinicians other than 
small practices receive 0 measure achievement points for each such 
submitted measures and small practices receive 3 measure achievement 
points.
    Additionally, we are modifying our proposal regarding new measures 
at Sec.  414.1380(b)(1)(i)(C) to provide that, beginning with the CY 
2023 performance period/2025 MIPS payment year, for each measure in 
required under Sec.  414.1335 on which data is submitted in accordance 
with Sec.  414.1325 that has a benchmark at paragraph (b)(1)(ii) of 
this section, meets the case minimum requirement at paragraph 
(b)(1)(iii) of this section, and meets the data completeness 
requirement at Sec.  414.1340, MIPS eligible clinicians receive between 
7 and 10 measure achievement points (including partial points) for such 
each measure in its first year in MIPS and between 5 and 10 measure 
achievement points for each such measure in its second year in MIPS. In 
adopting this final policy with modification, we have consolidated 
paragraphs (b)(1)(i)(C)(1) and (2) into a single paragraph 
(b)(1)(i)(C).
    We are also finalizing our policy at Sec.  414.1380(b)(1)(i)(A)(3) 
to provide that, beginning with the CY 2023 performance period/2025 
MIPS payment year, MIPS eligible clinicians receive 7 measure 
achievement points for each submitted measure in its first year in MIPS 
and 5 measure achievement points for each submitted measure in its 
second year in MIPS that meets the data completeness requirement, but 
does not have a benchmark or meet the case minimum requirement.
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BILLING CODE 4120-01-C
(iv) Scoring for MIPS Eligible Clinicians That Do Not Meet Quality 
Performance Category Criteria
    In the CY 2018 Quality Payment Program final rule (82 FR 53732), we 
finalized that, beginning with the 2019 performance period/2021 MIPS 
payment year, we will validate the availability and applicability of 
quality measures only with respect to the collection type that a MIPS 
eligible clinician utilizes for the quality performance category for a 
performance period, and only if a MIPS eligible clinician collects via 
claims only, MIPS CQMs only, or a combination of MIPS CQMs and claims 
collection types. We will not apply the validation process to any data 
collection type that the MIPS eligible clinician does not utilize for 
the quality performance category for the performance period. We sought 
comment on how to modify the validation process for the 2019 
performance period/2021 MIPS payment year when clinicians may submit 
measures collected via multiple collection types.
    In the CY 2019 PFS final rule (83 FR 59847), we finalized a 
proposal to modify our validation process to provide that it only 
applies to MIPS CQMs and the claims collection type, regardless of the 
submitter type chosen. For example, this policy will not apply to eCQMs 
even if they are submitted by a registry. We noted that a MIPS eligible 
clinician may not have available and applicable quality measures. If we 
are unable to score the quality performance category, then we may 
reweight the clinician's score according to the reweighting policies.
    In this year's rule, we proposed to modify our validation process 
to provide that it only applies to MIPS CQMs or the Part B claims 
collection type, but it will not apply in instances when a MIPS 
eligible clinician submits for both collection types. Currently, very 
few reporters report for a combination of Part B claims and MIPS CQMs. 
In CY 2020, of submissions with less than 6

[[Page 65503]]

measures, only 0.08 percent of individual submissions and 0.3 percent 
of group submissions included a combination of Part B claims and other 
submission types. In CY 2019, of submissions with less than 6 measures, 
only 0.094 percent of individual submissions and 0.07 percent of group 
submissions included a combination of Part B claims and other 
submission types. We see that reporting using both collection types is 
an option very few clinicians have chosen to utilize, and consequently 
believe that the associated costs for validation of a combination of 
the both the Part B claims based and MIPS CQM collection types is too 
great in these instances. To align with this reality that very few 
clinicians submit data in this manner, we proposed to update our 
policy.
    We invited public comments to modify our validation process to 
provide that it only applies to MIPS CQMs or the claims collection type 
and not a combination of the two.
    We did not receive public comments on this provision, and 
therefore, are finalizing as proposed.
(v) Assigning Measure Achievement Points for Topped Out Measures
    We refer readers to Sec.  414.1380(b)(1)(iv) for our previously 
finalized policies regarding the identification of topped out measures 
and Sec.  414.1380(b)(1)(iv)(B) for our finalized policies regarding 
the scoring of topped out measures. Under Sec.  414.1380(b)(1)(iv), we 
identify topped out measures in the benchmarks published for each 
Quality Payment Program year. Under Sec.  414.1380(b)(1)(iv)(B), 
beginning with the 2021 MIPS payment year, measure benchmarks (except 
for measures in the CMS Web Interface) that are identified as topped 
out for 2 or more consecutive years will receive a maximum of 7 measure 
achievement points beginning in the second year the measure is 
identified as topped out (82 FR 53726 through 53727).
    We noted in the CY 2021 PFS proposed rule (85 FR 50307) that we 
intended to use performance period benchmarks for the 2021 performance 
period/2021 MIPS payment year, which would mean we will not be able to 
publish measures that are topped out prior to the 2021 MIPS performance 
period. As discussed in that proposed rule (85 FR 50309), this also 
means we would not be able to identify those that have been topped-out 
for 2 or more consecutive years for purposes of the topped out scoring 
of 7 measure achievement points. As we were intending to use 
performance period benchmarks again for the 2022 performance period/
2024 MIPS payment year, these problems would occur again. We believed 
it is still important to retain a topped-out scoring cap of 7 measure 
achievement points so that clinicians have incentives to pick alternate 
measures that are not topped out. We also believed that if a measure 
were not topped out in the 2022 performance period benchmark, then it 
should have the ability to achieve up to 10 measure achievement points.
    In the CY 2022 PFS proposed rule, we proposed to use performance 
period benchmarks again and subsequently needed to adjust the topped-
out measure lifecycle to account for this. Therefore, we proposed as an 
exception to the general rule at Sec.  414.1380(b)(1)(iv)(B) at 
paragraph (b)(1)(iv)(B)(1) that, for the CY 2022 MIPS performance 
period/2024 MIPS payment year, MIPS eligible clinicians would receive 
no more than 7 measure achievement points for each measure (except for 
measures in the CMS Web Interface) for which the applicable benchmark 
were identified as topped out for 2 or more consecutive years based on 
the historical benchmarks published for the CY 2021 MIPS performance 
period and continues to be identified as topped out based on the 
performance period benchmarks published for the CY 2022 MIPS 
performance period/2024 MIPS payment year.
    We believe these two criteria collectively would provide clinicians 
the information to know prior to the CY 2022 performance period/2024 
MIPS payment year which measures would have the topped-out scoring 
applied but will also account for the scenario where a measure is no 
longer topped out. We would not limit the number of measure achievement 
points for measures that have not been topped out for at least 2 years 
as published in the 2021 MIPS performance period/2023 MIPS payment year 
historical benchmarks.
    We invited public comments on our proposal to apply the 7-measures 
achievement point cap to measures that meet the two criteria.
    We received public comments on the assigning measure achievement 
points for topped out measures. The following is a summary of the 
comments we received and our responses.
    Comment: One commenter noted that clinicians want to know which 
measures are topped out before the performance period begins.
    Response: We will continue to provide notice of topped out measures 
according to our standard policy. We are not finalizing our proposal to 
use performance period benchmarks, and therefore, will communicate 
topped out measures before the performance period begins as is 
customary.
    Comment: One commenter supported the policy to provide clinicians 
with additional information to determine which measures are topped out 
prior to the performance period and noted that the policy will ensure 
that clinicians can select meaningful measures and earn maximum points 
on quality measures due to the extraordinary circumstances of the 
COVID-19 pandemic
    Response: We appreciate the commenters for their support for this 
policy based on the intended use of the performance period benchmarks, 
but note that as we are not finalizing the use of performance period 
benchmarks as discussed in section IV.A.3.e.(1)(c)(ii) of this final 
rule. We are not finalizing this proposal.
    Comment: A few commenters requested that the 7-point scoring cap on 
topped out measures be waived for specific measure sets that only have 
topped out measures from which to select. One commenter requested that 
the topped-out scoring cap be suspended as topped out performance may 
not be accurate due to shifting program requirements and COVID-19 
related disruptions in care.
    Response: As MIPS is a performance-based program, we do not believe 
that MIPS eligible clinicians electing to report topped out measures 
should be able to receive the same maximum score as other measures that 
demonstrate variation in performance and room for improvement. 
Therefore, we continue to believe it necessary to maintain the 7-point 
cap for measures identified as topped out, including those belonging to 
measure sets. Additionally, please refer to qpp.cms.gov/about/covid19 
our national PHE for COVID-19 response and flexibilities provided 
within QPP.
    After consideration of public comments, we are not finalizing our 
proposal to revise paragraph (b)(1)(iv)(B)(1). We will instead continue 
our policy that the 7-point cap will be applied to measures (except for 
measures in the CMS Web Interface) that are identified as topped out 
for 2 or more consecutive years, beginning in the second year the 
measure is identified to be topped out.
(vi) Minimum Case Requirements
    We refer readers to Sec.  414.1380(b)(1)(iii) for our previous 
finalized policies regarding case minimum requirements for the quality 
performance category, which establishes the case minimum requirement

[[Page 65504]]

threshold at 20 cases for quality measures, with the exception of 
administrative claims-based measures in the MIPS final list of quality 
measures described in Sec.  414.1330(a)(1). As more measures are 
introduced under MIPS, there may be measures, similar to the 
administrative claims-based measures, that warrant a different case 
minimum requirement from the other quality measures. In Table Group A 
of Appendix 1 of the proposed rule, we proposed to add the following 
quality measure starting with the 2022 MIPS performance period: Person-
Centered Primary Care Measure Patient Reported Outcome Performance 
Measure (PCPCM PRO-PM), which uses a comprehensive and parsimonious set 
of 11 patient-reported items to assess the broad scope of primary care 
(86 FR 39435 and 39436).
    In order to achieve the appropriate reliability of the measure--the 
survey results (adequate number of surveys to provide an accurate 
representation of the MIPS eligible clinician, group, subgroup, virtual 
group, and APM Entity), for each MIPS eligible clinician, group, 
subgroup, virtual group, and APM Entity, a minimum of 30 PCPCM PROM 
instruments per clinician are needed for submission of this measure. 
For MIPS eligible groups, subgroups, virtual groups, and APM Entities 
with 5 or more clinicians, a minimum of 150 PCPCM PROM instruments per 
TIN for each site/location associated with the clinicians' part of the 
group, subgroups, virtual groups, and APM Entities are needed for 
submission of this measure. For TINs with a composition of multiple 
specialty practices at one site/location, a minimum of 150 PCPCM PROM 
instruments per specialty practice within a TIN are needed for 
submission of this measure. If the MIPS eligible group, subgroup, 
virtual group, and APM Entity with 5 or more clinicians encompasses 
multiple sites/locations, each site/location will need to meet the 
PCPCM PROM instruments requirements as noted above. To allow for the 
reliable implementation of PCPCM PRO-PM under MIPS, such measure 
requires a case minimum that exceeds 20 cases.With more measures being 
introduced under MIPS that warrant differing case minimum requirements 
(other than administrative claims-based measures), we proposed to 
modify our minimum case requirements policy to broaden the type of 
measures (to not only include administrative claims-based measures) 
that would have an exception to the minimum case requirement threshold 
of 20 cases and to provide a measure-specific case minimum requirement 
for measures identified and determined on a case-by-case basis by CMS. 
For each measure with a measure-specific case minimum, the minimum case 
requirement is specified in the annual list of MIPS measures. 
Specifically, we proposed to amend Sec.  414.1380(b)(1)(iii) to reflect 
that, except as otherwise specified in the MIPS final list of quality 
measures described in Sec.  414.1330(a)(1), the minimum case 
requirement is 20 cases.
    We invited public comment on our proposal. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters supported including flexibility to enable 
larger case minimum requirements on a measure-by-measure basis to 
ensure measures are reliable and valid, as adequate reliability may not 
always be achieved using a case minimum of 20 patients.
    Response: We are committed to assure reliable and valid quality 
measurement under the MIPS program and will assess our measures and 
policy to assure we are meeting this goal.
    Comment: A few commenters stated that CMS must ensure that the data 
produced yields scores that accurately and consistently represent the 
quality of care provided by an individual clinician and practice and 
believed that the current average reliability threshold of 0.4 is too 
low and the minimum sample size should be increased to a higher number 
to produce a minimum reliability threshold of sufficient magnitude 
(0.7). One commenter cautioned that having too many case minimum 
requirements will add to the complexity and burden and a few commenters 
asked CMS to monitor whether there are increasing numbers of existing 
measures requiring measure specific case minimums and the impact on 
burden.
    Response: We will continue to review measures to ensure they meet 
the reliability threshold of 0.4 as previously establish (81 FR 77287). 
We believe that measures with a reliability of 0.4 with a minimum 
attributed case size of 20 meet the standards for being included as 
quality measures within the MIPS program. We aim to measure quality 
performance for as many clinicians as possible, and limiting measures 
to reliability of 0.7 would result in fewer individual clinicians with 
quality performance category measures. In addition, a 0.4 reliability 
threshold ensures moderate reliability for most MIPS eligible 
clinicians or group practices that are being measured on quality. We 
acknowledge that inclusion of too many case minimum requirements may 
add complexity. However, we believe that the benefit to the program 
from adding measures that require additional case minimum standards for 
effective implementation justifies the burden created by the additional 
complexity. We will continue to listen to stakeholder feedback and 
monitor the effects of this policy on burden.
    After consideration of public comments, we are finalizing our 
amendment at Sec.  414.1380(b)(1)(iii) to reflect that, except as 
otherwise specified in the MIPS final list of quality measures 
described in Sec.  414.1330(a)(1), the minimum case requirement is 20 
cases.
(vii) Incentives to Report High-Priority Measures
    We refer readers to current Sec.  414.1380(b)(1)(v)(A) for our 
previously finalized policies regarding incentives to report high 
priority measures. In the CY 2017 Quality Payment Program final rule 
(81 FR 77293), we established the scoring policies for high priority 
measure bonus points to encourage the selection of additional high-
priority and outcome measures that impact beneficiaries and were 
closely aligned to our measurement goals. In the CY 2019 PFS final rule 
(83 FR 59850), we discontinued awarding measure bonus points to CMS Web 
Interface reporters for reporting high priority measures since CMS Web 
Interface reporters have no choice in measures.
    We stated in the CY 2019 PFS proposed and final rules (83 FR 35950 
and 59851) that as part of our move towards fully implementing high 
value measures, we believe that bonus points for high priority measures 
for all collection types may no longer be needed. We noted in the CY 
2019 PFS final rule (83 FR 59851) that measure bonus points were 
created as transition policies which were not meant to continue through 
the life of the program. We believe with the finalized framework for 
transforming MIPS through MVPs (84 FR 62948), we will find ways in the 
future to emphasize high priority measures without needing to 
incentivize with bonus points.
    In the CY 2022 PFS proposed rule, we proposed to end the high-
priority measure bonus points. As we move to MVPs we are simplifying 
our scoring by ending transition policies that were established in the 
initial years of the program. We have signaled for many years now that 
this policy was temporary and would be removed from the program. As we 
transition to a new State, we anticipate that there will no longer be a 
need to incentivize high-

[[Page 65505]]

priority measures by usage of bonus points in MIPS and MVPs as we 
increase the share of high-priority measures in the program.
    We proposed to end measure points for reporting high priority 
measures beginning the 2022 performance period/2024 MIPS payment year. 
Accordingly, we proposed to revise Sec.  414.1380(b)(1)(v)(A) to 
provide that for the 2017 through 2021 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 
with the 2019 performance period/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 measure 
bonus points.
    We invited public comments on our proposal to end measure bonus 
points for reporting high priority measures beginning the 2022 
performance period/2024 MIPS payment year.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters asked to delay the removal of the high-
priority bonus by at least one year, until the CY 2023 performance 
period, due to the COVID-19 pandemic impacts and since the performance 
threshold is also increasing this year. Many commenters suggested 
keeping the bonus in place until final MVP measure sets are available 
as this would be less disruptive to eligible clinicians with few 
quality performance measures and who depend on bonus points to 
successfully participate in the MIPS program. One commenter noted that 
the pandemic took clinician focus off of the mechanics of MIPS and few 
clinicians will be prepared for the removal of the high priority bonus. 
One commenter suggested that a delay in removal of the bonus would 
ensure a less disruptive transition to a higher performance threshold. 
Another commenter suggested that CMS do a phased-out removal of these 
bonuses in consideration of the performance threshold.
    Response: We agree that the national PHE of COVID-19 has resulted 
in a reduced focus by clinicians from the mechanics of MIPS to 
providing effective care in response to the PHE. We also understand 
that clinicians are worried about their performance in the program as a 
result of the proposal to increase the performance threshold. We remain 
committed to addressing stakeholder feedback, while working towards the 
goals of the program.
    As previously noted in section IV.A.3.e.(1)(c)(iii). of this final 
rule, we have decided to delay the removal of the 3-point floor until 
the CY 2023 performance period/2025 MIPS payment year, but will move 
forward with the removal of the bonuses in the quality performance 
category. We believe that this provides a phased approach to removing 
the transition policies to which clinicians have become accustomed, 
while also moving towards the program goal of reducing sources of 
scoring inflation and being able to score based on meaningful 
distinctions in performance on quality measures. We will not maintain 
bonuses until MVP measures set are available. MVP measure sets are in 
development and will be introduced overtime. We are aiming to simplify 
MIPS scoring ahead of MVPs so as to develop scoring s provide 
incentives to report MVPs as discussed in section IV.A.3.b.(5)(a) of 
this final rule. We cannot continue to support reporting strategies 
that rely on bonus points awarded for reporting. We note that we have 
signaled for years that the measure bonus and scoring floor policies 
were intended to support the transition to MIPS and would be removed 
(86 FR 39436). In order to be responsive to the challenges of the 
COVID-19 PHE, we are maintaining the policies related to the scoring 
floors, but will continue through future rulemaking to remove these 
transition policies and the scoring inflation they introduce.
    Comment: Many commenters opposed the removal of the high-priority 
bonus. A few commenters noted that the bonus serves as an incentive to 
report important measures, recognizes clinicians for their efforts to 
meet CMS' priorities, and provides clinicians extra help in meeting the 
increased performance threshold. One commenter stated that the bonus 
helps make up for what is lost based on limited measure selection if a 
clinician only has topped out measures from which to choose. One 
commenter noted that small practices are reliant on the bonus points 
and are otherwise not able to have scores that reflect the quality care 
small practices provide. One commenter requested the bonuses remain in 
place for small practices given the continued inequities between small 
and large practices and to help level the playing field and to 
encourage continued small practice participation. A few commenters 
noted that given the impacts of the COVID-19 pandemic the bonuses 
should remain in place to provide additional assistance. One commenter 
noted that as the program gets harder, clinicians need more assistance 
in achieving the threshold to avoid a penalty.
    Response: We understand that receiving bonus points for submitting 
high-priority measures has eased clinicians' participation in the 
program and supported their adoption of high priority measures. That 
was the intent of offering bonus points at the start of the program (81 
FR 77292). Now that it has been several years, we believe clinicians 
should be familiar with the areas that CMS considers high priority and 
familiar with reporting them. Ultimately, these bonuses have fulfilled 
their purpose and a high proportion of clinicians and groups report on 
high-priority measures. CMS wishes to measure performance on clinical 
quality measures and some types of bonus points can mask performance, 
and therefore, we want to use them judiciously such as to provide a 
scoring floor for new measures and incentivize reporting in MVPs. As 
the program transitions to MVPs, we will focus on providing incentives 
to report through MVPs. Reporting strategies that solely use bonus 
points for reporting to offset lower performance or topped out measure 
selection are not compatible with the intent of a performance-based 
program. We understand that with the removal of the quality performance 
category level bonus points and increase in the performance threshold, 
clinicians are concerned about receiving negative payments. We 
ultimately believe these scoring changes will enable fairer scoring 
that will benefit many clinicians, including those in small practices. 
Additionally, we believe the impact of this policy is partially 
mitigated by the maintenance of small practice bonus points within the 
quality performance category, as well as the Complex Patient Bonus for 
all MIPS eligible clinicians. To ease the transition to the new 
policies and to be responsive to hardships caused by the COVID-19 PHE, 
we are maintaining the 3-point scoring floor until CY 2023, but we are 
removing the high priority measure bonus points. We believe this 
decision will lead to fairer and simpler scoring that clinicians will 
ultimately benefit from.
    Comment: One commenter requested feedback reports that include 
detailed information about which and how many bonus points were earned 
as a result of high priority measures.
    Response: We currently provide information about the total number 
of bonus points added to the quality performance category score as part 
of

[[Page 65506]]

the final feedback reports that are available to all MIPS eligible 
clinicians.
    Comment: One commenter suggested CMS finalize greater 
accommodations for small practices, such as applying a separate small 
practice bonus to the MIPS final score rather than limit the small 
practice bonus to the quality performance category or increasing the 
size of the existing small practice bonus. Commenters also recommended 
that CMS allow small practices to continue to receive bonus points for 
reporting high priority measures or reporting measures using end-to-end 
electronic reporting.
    Response: We are committed to ensuring the small practices are able 
to fairly participate in MIPS. As the commenter noted, we currently 
offer measure bonus points for small practices at quality performance 
category score level (83 FR 59847). For the reasons stated in the CY 
2019 PFS final rule, we believe a small practice bonus specific to the 
quality performance category is preferable for the CY 2019 performance 
period/2021 MIPS payment year and future years (83 FR 59847). Data 
analytics suggest that the removal of the high priority and end-to-end 
electronic reporting measure bonus points for all practices would help 
small practices by reducing scoring inflation at the quality 
performance category level by reducing the over-utilization of these 
measure bonus points by larger practices that have the resources to 
report additional measures. A greater proportion of larger practices 
receive high priority measure bonus points and reach the measure bonus 
point cap when compared with practices of all other sizes and solo and 
small practitioners utilize these points and reach the measure bonus 
point cap the least. We will continue to monitor the performance of 
small practices in MIPS and make the appropriate interventions, as well 
as develop MVPs to facilitate the meaningful participation of small 
practices in MVPs which may include increasing the size of the existing 
small practice bonus.
    Comment: One commenter noted that without the high priority bonus, 
clinicians may opt to submit data for fewer measures leading to smaller 
datasets for benchmarking and public reporting. The commenter requested 
that CMS add a new opportunity for clinicians to earn points to 
encourage such reporting, such as higher bonuses for performance 
improvement or incentives for reporting extra measures.
    Response: We understand that clinicians may submit data for fewer 
measures as a result of this policy and that this may affect datasets 
available for benchmarking and public reporting, but do not believe 
these changes will be significant. We will monitor the effect that this 
has on benchmarking however, we will not be instituting new bonuses in 
MIPS. As we move to MVPs we are moving to simplify scoring in MIPS and 
focus on incentives for reporting through MVPS.
    After consideration of public comments, we are finalizing our 
proposal as proposed.
(viii) Incentives To Use CEHRT To Support Quality Performance Category 
Submissions
    Section 1848(q)(5)(B)(ii)(I) of the Act requires the Secretary to 
encourage MIPS eligible clinicians to report on applicable quality 
measures through the use of CEHRT and qualified clinical data 
registries. Section 1848(q)(5)(B)(ii)(II) of the Act requires that the 
Secretary shall treat such clinicians as satisfying the clinical 
quality measures reporting requirement described in section 
1848(o)(2)(A)(iii) of the Act if they report such measures through the 
use of such EHR technology for a given performance period. In the CY 
2017 Quality Payment Program final rule (81 FR 77297), we established 
the measure bonus point and bonus cap for using CEHRT for end-to-end 
electronic reporting. We refer readers to Sec.  414.1380(b)(1)(v)(B) 
for our previously finalized policies regarding measure bonus points 
for end-to-end electronic reporting. We believe that with the framework 
for transforming MIPS through MVPs discussed in the CY 2020 PFS 
proposed rule (84 FR 40739) and the CY 2021 PFS proposed rule (85 FR 
50279 through 50285), we will find ways to encourage the use of CEHRT 
for reporting quality measures without needing to incentivize the use 
of CEHRT for end-to-end electronic reporting with bonus points. In the 
CY 2018 Quality Payment Program final rule (82 FR 53636), we encouraged 
stakeholders to consider electronically specifying their quality 
measures as eCQMs, to encourage clinicians and 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 life of the 
program.
    In the CY 2022 PFS proposed rule, we proposed to end measure bonus 
points for end-to-end electronic reporting. We noted that as we move to 
MVPs we are simplifying scoring by removing many of the transition 
policies that we established in the early years of the program. We 
believe it is imperative to remove transition policies in order to 
develop a stronger MVP program and promote alignment between MIPS and 
MVPs. As stated in previous rulemaking, we are working to develop ways 
to encourage the use of CEHRT for electronic reporting without offering 
measure bonus points. Measure bonus points introduce scoring inflation 
into the program and preclude our ability to accurately compare 
clinicians' clinical quality. As the program works to focus on the 
quality of care provided to beneficiaries, we intend to score for 
performance on measures and not for reporting. Additionally, we 
believed that we can fulfill the statutory requirement at sections 
1848(q)(5)(B)(ii)(I) of the Act to encourage the usage of CEHRT, 
through other means. As a program and across the Department of Health 
and Human Services, we are working towards the goal of all measures 
within MIPS being digital by 2025 through a movement towards the 
inclusion of more digital quality measures (dQMs), emphasizing 
approaches to electronic data sharing that utilize the FHIR standard. 
As part of these approaches we intended to further leverage the use of 
electronic reporting from CEHRT for all quality measurement completed 
in the MIPS program including measurement and reporting facilitated by 
third party intermediaries such as QCDRs and plan to further address 
this issue through rulemaking in future years. We are also giving 
preference to dQMs including eCQMs in our annual call for measures. 
More information on dQMs and the FHIR standard is available in section 
IV.A.1.c. of this final rule, information on the call for measures and 
CMS measurement needs and priorities is available at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1313/2021%20Call%20for%20Measures%20and%20Activities%20Toolkit.zip, and 
https://www.cms.gov/files/document/cms-measurement-priorities-and-needs.pdf, respectively. Furthermore, over the past few years, we have 
reduced the availability and limited who can submit data for the 
Medicare Part B claims collection type to only small practices. We note 
that the Medicare Part B claims collection type is not an electronic 
means of submission. We solicited comments on other methods that we 
could use to encourage the use of CEHRT for electronic reporting (86 FR 
39436 and 39437).
    Accordingly, we proposed at Sec.  414.1380(b)(1)(v)(B) that for the 
2017 through 2021 performance period/2019 through 2023 MIPS payment 
years,

[[Page 65507]]

MIPS eligible clinicians would receive 1 measure bonus point for each 
measure (except claims-based measures) submitted with end-to-end 
electronic reporting for a quality measure under certain criteria 
determined by the Secretary. Beginning in the 2022 performance period/
2024 MIPS payment year, MIPS eligible clinicians will no longer receive 
measure bonus points for submitting using end-to-end electronic 
reporting.
    We invited public comments on our proposal to end measure bonus 
points for end-to-end electronic reporting beginning in the 2022 
performance period/2024 MIPS payment year. The following is a summary 
of the comments we received and our responses.
    Comment: Many commenters opposed the removal of the end-to-end 
reporting bonus as electronic reporting remains a priority for CMS; 
bonus points provide an incentive to report through end-to-end 
reporting, which is often costly; and bonus points help the clinicians 
reach the increasing performance threshold. A few commenters noted that 
practices should be awarded for going above and beyond in their quality 
reporting. A few commenters opposed the removal of these bonus 
achievement points considering the COVID-19 PHE, MVP reporting 
beginning in performance year 2023, and the move to digital quality 
measurement by 2025. Many commenters believed that an incentive is 
still required to encourage the use of CEHRT for electronic reporting. 
One commenter noted that the bonus should be maintained during the 
transition to dQMs. One commenter stated that many hospitals and some 
entities are still not providing clinicians with access to medical 
record information and some EMR vendors are still not in compliance 
with the ability to provide adequate clinical data. One commenter 
stated that the bonus furthers the goal of the program and provides 
more useable real-world data while encouraging clinicians to sign up 
with QCDRs. One commenter suggested that CMS apply bonus points at the 
composite score level providing some consistency to providers. One 
commenter noted that maintaining the bonus would help combat problems 
obtaining appropriate differentiation among practice performance due to 
clinical quality measure selection bias. A few commenters expressed 
concern with the removal of the bonus negatively impacting specialists' 
scores given that the diminished scoring opportunities are not due to 
changes in performance. One commenter requested that all electronic 
measures be eligible for end-to-end reporting bonus points, even if 
there is an eCQM equivalent.
    Response: As MIPS transitions to MVPs, our priority is to simplify 
scoring and score for performance rather than for reporting. We believe 
that the use of CEHRT adds value for clinicians and will work to 
develop other ways that encourage its use as we move to MVPs and 
digital quality measurement. We recognize concern about the effects of 
the PHE and increase in the performance threshold, and therefore, are 
maintaining our 3-point scoring floor policy to ease clinicians' 
transition to simplified scoring as we move towards MVPs. We do not 
believe that using CEHRT for electronic reporting is going above and 
beyond as the commenter suggests, nor do we believe that reporting via 
end-to-end electronic reporting still requires awarding bonus points. 
Rather we believe it is important to facilitate high quality clinical 
care and the ability to participate in this program meaningfully as 
such will no longer provide incentives for reporting in MIPS as we 
transition to MVPs. We understand the commenter's concerns about data 
blocking and/or hospitals not sharing data with Third Party 
Intermediaries and will continue to work with partners across HHS to 
explore ways to address this issue. The end-to-end electronic reporting 
bonus has been active throughout the last few years of MIPS. While we 
intended it to encouraged some clinicians to transition to an 
electronic data submission mechanism, our assumption was that the 
applicable clinicians would have transitioned by now. Additionally, we 
believe that clinicians who have made the transition to an electronic 
data submission mechanism likely will not make the decision to revert 
back to a manual/claims-based option. Furthermore, we do not believe it 
is necessary or appropriate to apply this bonus at the final score 
level. As mentioned in the previous section of this final rule, 
reporting strategies that solely use bonus points for reporting to 
offset lower performance or topped out measure selection are not 
compatible with the intent of a performance-based program. We will 
continue to try and find other solutions to the diminished scoring 
opportunities for specialists through MVPs.
    After consideration of public comments, we are finalizing our 
proposal as proposed.
(ix) Improvement Scoring for the MIPS Quality Performance Category 
Score
    We refer readers to Sec.  414.1380(b)(1)(vi)(C)(4) for more on our 
current for the 2020 through 2023 MIPS payment years, which provides 
for the purpose of improvement scoring that we will assume a quality 
performance category achievement percent score of 30 percent in the 
previous year if a MIPS eligible clinician earned a quality performance 
category score less than or equal to 30 percent in the previous year.
    In the CY 2022 PFS proposed rule, we proposed to continue our 
previously established policy for improvement scoring for the 2022 
performance period/2024 MIPS payment year and to revise Sec.  
414.1380(b)(1)(vi)(C)(4) to remove the phrase ``2020 through 2023 MIPS 
payment years'' and adding in its place the phrase ``beginning the 2018 
performance period/2020 MIPS payment year'' to indicate that for each 
MIPS payment year after 2020, we would assume a quality performance 
category achievement percent score of 30 percent in the previous year 
if a MIPS eligible clinician earned a quality performance category 
score less than or equal to 30 percent in the previous year. 
Specifically, for the 2022 performance period/2024 MIPS payment year, 
we would compare the MIPS eligible clinician's quality performance 
category achievement percent score for the 2022 performance period/2024 
MIPS payment year to an assumed quality performance category 
achievement percent score of 30 percent if the MIPS eligible clinician 
earned a quality performance score less than or equal to 30 percent for 
the 2021 performance period/2023 MIPS payment year.
    We did not receive public comments on this proposal, and we are 
finalizing as proposed.
(d) Cost Performance Category
(i) Scoring Flexibility for Changes That Impact Cost Measures During 
the Performance Period
    We refer readers to Sec.  414.1380(b)(2) for our policies regarding 
scoring for the cost performance category and to previous rules where 
these policies were finalized, including the CY 2017 Quality Payment 
Program final rule (81 FR 77308 through 77311), the CY 2018 Quality 
Payment Program final rule (82 FR 53748 through 53752), the CY 2019 PFS 
final rule (83 FR 59856), and the CY 2021 PFS final rule (85 FR 84877 
through 84880). In Sec.  414.1380(b)(2)(v), we finalized that a cost 
performance category score is not calculated if a MIPS eligible 
clinician or group is not attributed any cost measures for the 
performance period because the clinician or group has not met the 
minimum case volume specified by CMS for any of the cost measures or a

[[Page 65508]]

benchmark has not been created for any of the cost measures that would 
otherwise be attributed to the clinician or group.
    We have identified that there is a need for additional flexibility 
in calculating the scores for cost measures to account for the impact 
of changing conditions that are beyond the control of MIPS eligible 
clinicians and groups. This flexibility would allow us to ensure that 
clinicians are not impacted negatively when performance is affected not 
due to the care provided, but due to external factors. Thus, beginning 
with the 2022 MIPS performance period/2024 MIPS payment year, we 
proposed a policy to provide scoring flexibility in instances where 
changes during a performance period impede the effective measurement of 
resource use. We stated that we believe that there may be instances 
when there are rapid or unprecedented changes to the delivery of 
healthcare services that are reflected in administrative claims data 
used to calculate cost measures. In the CY 2022 PFS proposed rule (86 
FR 39437), we provided the example of the COVID-19 PHE and referred 
readers to section IV.A.3.e.(2)(b)(ii)(A) of the proposed rule, where 
we summarized our assessment of the impact of COVID-19 on the 
calculation of cost measure scores for the 2020 performance period. In 
this discussion, we concluded that due to the unique and rapid changes 
to healthcare in the COVID-19 pandemic, which significantly affected 
service utilization and the underlying data used to calculate cost 
measures, we could not reliably calculate scores for the cost measures 
that adequately capture and reflect clinician performance for 2020. 
This example demonstrated that the assessment of costs could be impeded 
by substantial changes to clinical practice and service utilization, 
and result in misleading or inaccurate results.
    We noted (86 FR 39438) that we would determine whether such 
external changes impede the effective measurement of resource use by 
considering factors including: The extent and duration of the changes, 
and the conceptual and empirically tested relationship between the 
changes and each measure's ability to accurately capture clinician cost 
performance. Empirical testing could include assessing whether there 
are rapid or unprecedented changes to patient case volume or case mix, 
and the extent to which this could lead to misleading or inaccurate 
results. We noted that substantial changes in service utilization may 
not impede our ability to accurately calculate a cost measure score. 
Consider for example the case of a hypothetical measure that includes 
the cost of a series of procedures to treat the condition being 
measured. Due to advances in clinical knowledge, the procedures are 
declared to no longer be appropriate to treat the condition during a 
performance period. This would hypothetically lead to rapid and 
substantial changes in the services captured in the measure in that 
performance period; however, these changes will not necessarily lead to 
misleading or inaccurate results as the measure will be appropriately 
capturing the costs of care for that condition and appropriately 
reflecting changes in clinician practice. We stated that we would 
assess this empirically for each measure, as we believe that even 
widespread external changes to service utilization could have a range 
of different impacts across measures as they focus on diverse types of 
care. For example, a hypothetical national shortage of blood products 
may lead to the suspension of elective surgeries. This may not affect 
the care patterns for a particular outpatient screening or preventative 
care procedure, meaning that a hypothetical cost measure focused on 
that outpatient procedure would still accurately reflect clinician cost 
performance.
    While we can monitor the impact of these changes during the 
performance period, we noted (86 FR 39438) that there is an inherent 
delay between the time we can identify trends in administrative claims 
data and when we can test for potential impact on the cost measures, 
due to the claims run-out period necessary to ensure that data included 
in our analyses reflect final claims for all services in episodes. To 
ensure sufficient case volume, we expected that we would not be able to 
properly test the full impact of external changes on the cost measures 
until after the end of the performance period in which the changes 
occurred. Thus, we would not be able to determine whether a cost 
measure should be suppressed due to changes in the performance period 
until after the completion of the performance period. To allow 
sufficient time for claims data query and investigatory work to test 
for potential impacts on cost measure calculations, we expected that we 
would reach a conclusion as to whether a cost measure should be 
suppressed and notify clinicians affected by the suppression no later 
than when performance feedback is issued for the performance period. We 
believed this will not put undue burden on clinicians since cost 
measures are calculated by CMS using administrative claims data without 
any additional data submission by clinicians.
    Accordingly, we proposed to add Sec.  414.1380(b)(2)(v)(A) to 
provide that beginning with the 2024 MIPS payment year, if data used to 
calculate a score for a cost measure were impacted by significant 
changes during the performance period, such that calculating the cost 
measure score would lead to misleading or inaccurate results, then the 
affected cost measure would be excluded from the MIPS eligible 
clinician's or group's cost performance category score. We proposed 
that, for the purposes of this paragraph (b)(2)(v)(A), ``significant 
changes'' are changes external to the care provided, and that CMS 
determines may lead to misleading or inaccurate results. Significant 
changes include, but are not limited to, rapid or unprecedented changes 
to service utilization, and will be empirically assessed by CMS to 
determine the extent to which the changes impact the calculation of a 
cost measure score that reflects clinician performance.
    We solicited comments on this proposal.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the addition of the policy to 
suppress a cost measure for a MIPS eligible clinician or group in 
instances where changes during a performance period impede the 
effective measurement of resource use. One commenter stated that the 
unpredictability of the pandemic makes it difficult to understand the 
impact on cost. The commenter stated that CMS should assess whether 
clinicians can reasonably be scored on the cost performance category. 
Another commenter suggested that CMS consider national disasters, such 
as wildfires and hurricanes, as significant changes warranting measure 
suppression. One commenter stated that CMS should evaluate scoring 
variation year-to-year to determine if it can be attributed to changes 
in performance and investigate whether a measure should be suppressed 
due to factors outside of the control of the physician.
    Response: We recognize the impact that the pandemic has on 
clinicians and continue to monitor its effects on cost measures to 
ensure that clinicians' performance is being fairly assessed. In 
addition, we conduct regular monitoring of cost measures, to assess 
year-to-year changes in patterns of care and analyze whether certain 
circumstances or events impact clinicians' performance on

[[Page 65509]]

measures. These monitoring efforts can help to inform whether a future 
event, such as a natural disaster, could warrant measure suppression.
    Comment: One commenter urged CMS to delay the application of any 
new episode-based measures to a TIN's final MIPS score for the first 2 
years of applicability. The believe applying these measures without 
adequate prior information or data on an ongoing basis furthers the 
burden on clinicians and TIN's.
    Response: We disagree with the commenter that delaying the 
application of new episode-based measures for 2 additional years after 
their incorporation into the MIPS cost performance category would 
reduce the burden on clinicians (TIN-NPIs) or clinician groups (TINs). 
We note that the episode-based measures are claims-based, so there is 
no submission burden for MIPS eligible clinicians, groups, and virtual 
groups. Additionally, the measure specifications that describe the 
steps for constructing the measures and contain the medical codes used 
in that methodology are publicly available during the measure 
development and notice-and-comment rulemaking processes. Thus, MIPS 
eligible clinicians, groups, and virtual groups have the opportunity to 
understand the measure specifications, including what costs are 
included in each episode, prior to the implementation of such measures 
in MIPS.
    We further believe that newly developed measures generally would be 
ready for implementation in MIPS beginning with the performance period 
following the publication of the final rule in which they are adopted 
for the cost performance category. The episode-based measures are 
developed with extensive involvement of clinician experts, including 
clinicians from the attributed specialties, as well as other clinicians 
involved in the relevant care continuum for each measure, who make 
informed recommendations based on empirical data. Throughout the 
measure development and implementation processes, we work to help 
clinicians get familiar with the new measures through ample education 
and outreach activities, and also encourage them to provide feedback on 
the measure specifications (we refer readers to 86 FR 39396 and 39397 
for more information on the development process for new episode-based 
measures). For example, for the 5 new episode-based measures that we 
proposed for inclusion in MIPS in the CY 2022 PFS proposed rule, 
stakeholders had an opportunity to observe all clinical expert 
workgroup meetings via a listen-only line, as well as participate in 
the national field-testing activities on the measures in the summer of 
2020. Additionally, the measures were published in the Measures Under 
Consideration (MUC) list in December 2020, and the measure 
specifications and testing results were later available for public 
comments during the NQF's pre-rulemaking process and as part of the CY 
2022 PFS proposed rule (86 FR 39397 through 39401). Given that the 5 
new episode-based measures are ready for implementation in MIPS and 
that these measures play an important role in expanding the MIPS cost 
measure inventory, we believe that a delay in the application of those 
measures is not appropriate and would only prevent the performance of a 
MIPS eligible clinician, group, and virtual group from being assessed.
    After consideration of public comments received, we are finalizing 
this policy as proposed.
(e) Promoting Interoperability Performance Category
    For our previously established policies regarding scoring the 
Promoting Interoperability performance category, we refer readers to 
Sec.  414.1380(b)(4), the CY 2017 Quality Payment Program final rule 
(81 FR 77216 through 77227), the CY 2018 Quality Payment Program final 
rule (82 FR 53663 through 53670), the CY 2019 PFS final rule (83 FR 
59785 through 59796), the CY 2020 PFS final rule (84 FR 63020) and the 
CY 2021 PFS final rule (85 FR 84893 through 84894). We also refer 
readers to Sec.  414.1375 and the CY 2017 Quality Payment Program final 
rule (81 FR 77199 through 77245), the CY 2018 Quality Payment Program 
final rule (82 FR 53663 through 53688), the CY 2019 PFS final rule (83 
FR 59785 through 59820), and the CY 2021 PFS final rule (85 FR 84886 
through 84895 for our previously established policies regarding the 
Promoting Interoperability (formerly the advancing care information) 
performance category generally.
    In the CY 2019 PFS final rule, we established a new performance-
based scoring methodology for the Promoting Interoperability 
performance category that applies beginning with the 2019 performance 
period/2021 MIPS payment year (83 FR 59787 through 59796). The scoring 
methodology is codified at Sec.  414.1380(b)(4)(ii); however, the 
regulation text refers only to the 2021 and 2022 MIPS payment years, 
and does not mention subsequent years. We proposed to revise Sec.  
414.1380(b)(4)(ii) for consistency with the previously established 
policy, by indicating that the methodology applies beginning with the 
2019 MIPS performance period/2021 MIPS payment year and continuing to 
subsequent years. We proposed to revise Sec.  414.1380(b)(4)(ii) to 
remove ``for the 2021 and 2022 payment years'' and add in its place 
``beginning with the 2019 performance period/2021 MIPS payment year'' 
and remove the word ``six'' to provide that beginning with the 2019 
performance period/2021 MIPS payment year, a MIPS eligible clinician's 
Promoting Interoperability performance category score equals the sum of 
the scores for each of the required measures and any applicable bonus 
scores, not to exceed 100 points.
    In addition, for the 2020 performance period/2022 MIPS payment 
year, each optional measure in the Promoting Interoperability 
performance category was worth five bonus points (84 FR 63003), and for 
the 2021 performance period/2023 MIPS payment year, each optional 
measure was worth ten bonus points (85 FR 84894). In the proposed rule, 
we proposed that the Query of Prescription Drug Monitoring Program 
measure would be worth 10 bonus points; we also proposed that 
submission of a ``yes'' for the Public Health Registry Reporting 
measure or the Clinical Data Registry Reporting measure or the 
Syndromic Surveillance Reporting measure would be worth 5 bonus points 
(86 FR 39438). To reflect these policies, we proposed a change to Sec.  
414.1380(b)(4)(ii)(C) to reflect that the optional measures are worth 
five or ten bonus points, as specified by CMS.
    We solicited comments on this proposal.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter supported the proposal to revise the 
language to reflect that optional measures are worth 5 or 10 bonus 
points.
    Response: We thank the commenter for their support.
    After consideration of public comments, we are finalizing our 
proposal as proposed.
(2) Calculating the Final Score
    For a description of the statutory basis and our policies for 
calculating the final score for each MIPS eligible clinician, we refer 
readers to Sec.  414.1380(c) and the discussion in the CY 2017 and CY 
2018 Quality Payment Program final rules, and the CY 2019, CY 2020, and 
CY 2021 PFS final rules (81 FR 77319 through 77329, 82 FR 53769 through 
53785, 83 FR 59868 through 59878, 84 FR 63020 through 63031, 85 FR 
84908 through 84917, respectively) on final score calculations, 
performance category

[[Page 65510]]

weights, reweighting the performance categories, and the complex 
patient bonus.
    As described in more detail in the following sections, we:
     Proposed to continue doubling the complex patient bonus 
for the CY 2021 performance period/2023 MIPS payment year, as was 
previously finalized with a cap of 10 bonus points for the CY 2020 
performance period/2022 MIPS payment year (86 FR 39439 through 39440).
     Proposed to revise the complex patient bonus formula, 
which currently provides a bonus to all MIPS eligible clinicians, 
groups, virtual groups, and APM entities who submit data for at least 
one MIPS performance category, so that beginning with the CY 2022 
performance period/2024 MIPS payment year the complex patient bonus 
better targets clinicians who treat a higher caseload of more complex 
and high-risk patients (86 FR 39442 through 39446).
     Solicited comments on potential circumstances where we may 
not be able to reliably calculate a score for any of the cost measures 
as described under Sec.  414.1380(c)(2)(i)(A)(2). Additionally, we note 
that we are reweighting the cost performance category for the CY 2020 
performance period/2022 MIPS payment year because we have concluded 
there are not sufficient measures and activities applicable and 
available for us to score any clinicians on performance due to the 
national PHE for COVID-19 (86 FR 39446 through 39448).
     Proposed to continue performance category weight 
redistribution policies finalized for the CY 2022 performance period/
2024 MIPS payment year (86 FR 39448).
     Proposed policies for redistributing the weight of the 
performance categories for small practices (86 FR 39448 through 39449).
     Clarify how our application-based and automatic extreme 
and uncontrollable circumstances policies intersect (86 FR 39450).
     Proposed a new policy to determine the MIPS final score 
for clinicians and groups who are eligible for facility-based 
measurement (86 FR 39450 through 39452).
(a) Complex Patient Bonus
(i) Background
    Section 1848(q)(1)(G) of the Act requires us to consider risk 
factors in our MIPS scoring methodology. Specifically, it provides that 
the Secretary, on an ongoing basis, shall, as the Secretary determines 
appropriate and based on an individual's health status and other risk 
factors, assess appropriate adjustments to quality measures, cost 
measures, and other measures used under MIPS; and assess and implement 
appropriate adjustments to payment adjustments, final scores, scores 
for performance categories, or scores for measures or activities under 
MIPS. In doing so, the Secretary is required to take into account the 
relevant studies conducted under section 2(d) of the Improving Medicare 
Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-
185, October 6, 2014) and, as appropriate, other information, including 
information collected before completion of such studies and 
recommendations. In the CY 2018 Quality Payment Program final rule, 
under the authority in section 1848(q)(1)(G) of the Act, we established 
at Sec.  414.1380(c)(3) a complex patient bonus of up to 5 points to be 
added to the final score for the 2020 MIPS payment year (82 FR 53771 
through 53776). In subsequent rulemaking, we continued the complex 
patient bonus at Sec.  414.1380(c)(3) for the 2021, 2022, and 2023 MIPS 
payment years (83 FR 59870, 84 FR 63023, and 85 FR 84910, 
respectively). Additionally, we finalized for the 2022 MIPS payment 
year at Sec.  414.1380(c)(3)(iv) that the complex patient bonus will be 
calculated under the existing formulas in paragraphs (c)(3)(i) and 
(ii), and the resulting numerical value will then be multiplied by 2 
(85 FR 84911 through 84913). We refer readers to these final rules for 
additional details on the background, statutory authority, policy 
rationale, and previously finalized calculation of the complex patient 
bonus.
    We intended for this bonus to serve as a short-term strategy to 
address the impact patient complexity may have on MIPS scoring while we 
continue to work with stakeholders on methods to account for patient 
risk factors. The overall goal, when considering a bonus for complex 
patients, is two-fold: (1) To protect access to care for complex 
patients and provide them with excellent care; and (2) to avoid placing 
MIPS eligible clinicians who care for complex patients at a potential 
disadvantage while we review the completed studies and research to 
address the underlying issues. We used the term ``patient complexity'' 
to consider a multitude of factors that describe and have an impact on 
patient health outcomes; such factors include the health status and 
medical conditions of patients, and social risk factors. We believe as 
the number and intensity of these factors increase for a single 
patient, the patient may require more services, more clinician focus, 
and more resources to achieve health outcomes similar to those who have 
fewer factors. In developing the policy for the complex patient bonus, 
we assessed whether there was a MIPS performance discrepancy by patient 
complexity using two well-established indicators in the Medicare 
program: Medical risk as measured through Hierarchical Condition 
Category (HCC) risk scores, and social risk as measured through the 
proportion of patients that is dually eligible for Medicare and 
Medicaid (82 FR 53771 through 53776).
(ii) Complex Patient Bonus for the CY 2021 Performance Period/2023 MIPS 
Payment Year
    In the CY 2022 PFS proposed rule (86 FR 39439 through 39440), we 
proposed to modify the complex patient bonus for the CY 2021 
performance period/2023 MIPS payment year in response to the PHE for 
COVID-19. In the CY 2020 PFS final rule, we finalized a policy to 
continue the complex patient bonus for the CY 2020 performance period/
2022 MIPS payment year (84 FR 63021 through 63023). However, due to the 
national PHE for COVID-19 during performance period 2020, we noted in 
the CY 2021 PFS proposed rule that we need to re-evaluate the 
previously established policy for the complex patient bonus for the CY 
2020 performance period/2022 MIPS payment year (85 FR 50311). We refer 
readers to the CY 2021 PFS proposed rule (85 FR 50311 through 50313) 
for further details on how the PHE for COVID-19 impacts care delivery 
both directly and indirectly. We acknowledged there are direct effects 
of COVID-19 for those patients who tested positive for SARS-CoV-2 and 
indirect effects of COVID-19 for other patients whose care was impacted 
because of the PHE, including increased complexity and barriers such as 
postponing care, accessing care in a different way (for example, via 
telecommunications), and disruptions to lab results and medications, 
which are not accounted for in our existing final score calculations 
using these complexity indicators.
    Considering both these direct and indirect effects, we finalized 
Sec.  414.1380(c)(3)(iv) (85 FR 84913), under which the complex patient 
bonus is calculated for the CY 2022 MIPS payment year pursuant to the 
existing formulas in paragraphs (c)(3)(i) and (ii), and the resulting 
numerical value is then multiplied by 2 but cannot exceed 10.0. The 
doubled numerical value

[[Page 65511]]

(subject to the 10-point cap) is added to the final score.
    We noted we had made significant progress against COVID-19. While 
we are encouraged by the progress, we believed that there may be some 
direct and indirect effects from the PHE that could affect the CY 2021 
performance period/2023 MIPS payment year. In particular, through the 
third quarter of CY 2021, we had high COVID cases in multiple 
regions.\254\ Additionally, we cannot quantify the effect of 
beneficiaries who delayed care because of the PHE and are now seeking 
care.
---------------------------------------------------------------------------

    \254\ https://www.nytimes.com/interactive/2021/us/covid-cases.html.
---------------------------------------------------------------------------

    Because of the concerns of the direct and indirect effects of the 
COVID-19 PHE, we proposed to continue doubling the complex patient 
bonus as described at Sec.  414.1380(c)(3)(iv) for the CY 2023 MIPS 
payment year, and we proposed corresponding revisions to the regulation 
text at Sec.  414.1380(c)(3)(iv). The doubled numerical value (subject 
to the 10-point cap) will be added to the final score. Since the COVID-
19 cases and deaths have decreased throughout the year, we considered 
applying a smaller multiplier (like 1.5 for a cap of up to 7.5 points) 
or to not apply a multiplier at all. However, we believe doubling the 
complex patient bonus is appropriate given the continuation of the 
national PHE for COVID-19 into the 2021 MIPS performance period, the 
potential direct and indirect effects of COVID-19 on care delivery and 
care postponement, and additional uncertainties. We solicited comments 
on this proposal and whether a different multiplier should be applied 
as we plan to consider the options based on public comment.
    We received public comments on the doubling of the complex patient 
bonus for the CY 2021 performance period/2023 MIPS payment year. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters supported the doubling of the complex 
patient bonus for CY 2021 performance period/2023 MIPS payment year due 
to the impacts of the ongoing national PHE for COVID-19. A few 
commenters suggested that CMS continue to double the complex patient 
bonus in CY 2022 given the continuation of the national PHE for COVID-
19.
    Response: We appreciate commenters' support of this proposal. As 
noted in section IV.A.3.e.(2)(a)(iii)(B) of this final rule, we have 
revised the formula for CY 2022 performance period/2024 MIPS payment 
year in efforts to better acknowledge complex patients treated by MIPS 
eligible clinicians.
    Comment: One commenter opposed CMS' proposal to continue doubling 
the complex patient bonus for the CY 2021 performance period/2023 MIPS 
payment year saying that MIPS eligible clinicians have had over a year 
to adapt to the changes caused by the national PHE for COVID-19.
    Response: While we are encouraged by the progress made against 
COVID-19, we believe that there continues to be direct and indirect 
effects from the PHE that could affect the CY 2021 performance period/
2023 MIPS payment year for reasons stated in the CY 2021 PFS final rule 
(85 FR 84913).
    After consideration of public comments, we are finalizing the 
proposal to continue doubling the complex patient bonus as described at 
Sec.  414.1380(c)(3)(iv) for the CY 2021 performance period/2023 MIPS 
payment year, and the corresponding revisions to the regulation text at 
Sec.  414.1380(c)(3)(iv). The doubled numerical value (subject to the 
10-point cap) will be added to the final score.
(iii) Complex Patient Bonus Beginning With the CY 2022 Performance 
Period/2024 MIPS Payment Year
(A) Complex Patient Bonus Background and Analysis
    As discussed in the CY 2021 PFS final rule (85 FR 84908), we 
intended the complex patient bonus as a short-term solution to address 
the impact patient complexity may have on MIPS scoring. However, during 
the development of the CY 2021 PFS final rule, we did not have 
sufficient information available to develop a long-term solution to 
account for patient risk factors in MIPS that we could include as a 
finalized policy for the CY 2021 performance period/2023 MIPS payment 
year. In the CY 2020 PFS proposed and final rules, we considered 
whether newly available data from the Quality Payment Program still 
supported the complex patient bonus at the final score level (84 FR 
40793 through 40795). More specifically, within the data analysis, we 
did not observe a consistent linear relationship for any reporting type 
or complexity measure, HCC risk score or dual proportion (84 FR 63021 
through 63023). However, we only had a few years of data and believed 
more recent data may bring different results than the findings we 
explained in detail in the CY 2020 PFS final rule. We refer readers to 
the CY 2020 PFS final rule for further details on the methodology and 
findings (84 FR 63021 through 63023).
    Further, section 1848(q)(1)(G) of the Act requires us to consider 
the relevant studies conducted under section 2(d) of the IMPACT Act 
and, as appropriate, other information, including information collected 
before completion of such studies and recommendations. We refer readers 
to section IV.A.3.e.(2)(a)(iii)(A) of the CY 2022 PFS proposed rule (86 
FR 39440 through 39441) for discussion on HHS Assistant Secretary for 
Planning and Evaluation's (ASPE) first report (released in December 
2016) and ASPE's second report (released in June 2020). Further, we 
noted in the CY 2021 PFS final rule (85 FR 84909) that as we continue 
to review the findings from the report, we intend to consider its 
recommendations, along with any updated data that would become 
available, for future rulemaking. In the CY 2021 PFS final rule (85 FR 
84909), we also noted we plan to continue working with ASPE, the 
public, and other key stakeholders on this important issue to identify 
longer term policy solutions that achieve the goals of attaining health 
equity for all beneficiaries, and minimizing unintended consequences, 
and would propose modifications to the complex patient bonus in future 
rulemaking as appropriate.
    Under Sec.  414.1380(c)(3), the complex patient bonus is calculated 
as follows. For MIPS eligible clinicians and groups: [The average HCC 
risk score assigned to beneficiaries (under the HCC risk adjustment 
model established by CMS under section 1853(a)(1) of the Act) seen by 
the MIPS eligible clinician or seen by clinicians in a group] + [the 
dual eligible ratio x 5]. For APM entities and virtual groups: [The 
beneficiary weighted average HCC risk score for all MIPS eligible 
clinicians, and if technically feasible, TINs for models and virtual 
groups which rely on complete TIN participation within the APM entity 
or virtual group, respectively] + [the average dual eligible ratio for 
all MIPS eligible clinicians, and if technically feasible, TINs for 
models and virtual groups which rely on complete TIN participation, 
within the APM entity or virtual group, respectively, x 5].
    For the CY 2022 PFS proposed rule, we explored alternative 
calculation methodologies to modify the complex patient bonus formula 
based on several factors including stakeholder feedback, updated data 
analysis, and implications from ASPE reports to Congress. We also 
reviewed a series of literature recently published utilizing the 2017 
MIPS performance period data. We refer readers to section 
IV.A.3.e.(2)(a)(iii)(A) of the CY 2022 PFS proposed rule (86

[[Page 65512]]

FR 39441) for the detailed discussion on the Johnston KJ, Hockenberry 
JM et al. article \255\ which found that the current complex patient 
bonus formula appears unlikely to mitigate the most regressive effects 
of MIPS. Further details in section IV.A.3.e.(2)(a)(iii)(A) (86 FR 
39441) of the CY 2022 PFS proposed rule also highlighted the two other 
research studies we considered related to how risk scores, specifically 
related to HCCs, differ between both rural and urban areas.
---------------------------------------------------------------------------

    \255\ Johnston KJ, Hockenberry JM et al. (Sept 2020) 
``Clinicians With High Socially At-Risk Caseloads Received Reduced 
Merit-Based Incentive Payment System Scores'' HEALTH AFFAIRS 39, NO. 
9 (2020): 1504-1512.
    Khullar D, Schpero WL, et al. (Sept 2020) ``Association between 
Patient Social Risk and Physician Performance Scores in the First 
Year of the Merit-based Incentive Payment System'' JAMA. 2020; 324 
(10):975-983.
---------------------------------------------------------------------------

    While ASPE's reports to Congress support the use of a complex 
patient bonus at the final score level, we also acknowledge the 
findings reported in the published literature by identifying ways to 
make the complex patient bonus more targeted for clinicians caring for 
high risk and complex patients and to mitigate differences in resources 
that affect MIPS scores. Once it became available, we reviewed the 2018 
MIPS actual data to see if we could replicate the findings and 
identified some structural issues within the current complex patient 
bonus formula. We refer readers to section IV.A.3.e.(2)(a)(iii)(A) of 
the CY 2022 PFS proposed rule (86 FR 39441 through 39442) for the 
details on the updated analysis.
    In summary, our updated analyses using actual 2018 MIPS scored data 
found that clinicians who have a higher share of complex patients have 
lower final scores, on average, prior to the assignment of the complex 
patient bonus than other clinicians. Additionally, our analyses showed 
that there is little evidence of association between the complex 
patient risk indicators (HCC and dual proportion) and MIPS final scores 
among the clinicians with a lower share of complex patients. We also 
noted, based on the above analysis using actual 2018 MIPS scored data 
for clinicians scored as individuals and groups examined separately, 
the median raw final scores for engaged clinicians in the calculated 
top complex patient bonus quintile were more than 10 points less than 
the median raw final score of those in the bottom complex patient bonus 
quintile. Specifically, the median raw final scores for engaged 
clinicians in the top complex patient bonus quintile were 82.33 for 
groups and 60.76 for individuals compared to median raw scores of 94.36 
for groups and 81.28 for individuals in the lowest quintile. 
Additionally, when we compared the median raw final scores for engaged 
clinicians in the calculated middle complex patient bonus quintile to 
the highest quintile, we still observed a difference in median raw 
final scores of greater than 10 points for both individuals and groups. 
Table 61 shows 2018 median MIPS raw final scores for the engaged 
individuals and groups within the lowest, middle and highest complex 
patient bonus (CPB) quintiles.
[GRAPHIC] [TIFF OMITTED] TR19NO21.088

    We found while the two risk indictors, dual proportion and HCC risk 
score, were correlated substantially, each has a different scale. For 
example, the dual proportion has a natural upper bound of 1 whereas the 
HCC risk score does not. The distribution of each risk indicator around 
its mean and median is also different. Given these findings, we have 
identified areas within the complex patient bonus that can be improved. 
Most importantly, the complex patient bonus formula used through the CY 
2021 performance period/2023 payment year gave bonus points to 
clinicians not adversely affected by social risk and medical risk of 
their patients and does not sufficiently account for clinicians who 
treat patients who are high-risk and/or medically complex.
(B) Updates to the Complex Patient Bonus Beginning With the CY 2022 
Performance Period/2024 MIPS Payment Year
    Based on the ASPE report and our analyses, we proposed to revise 
the complex patient bonus by--(1) limiting the bonus to clinicians who 
have a median or higher value for at least one of the two risk 
indicators (HCC and dual proportion); (2) standardizing the 
distribution of the two risk indicators so that the policy can target 
clinicians who have a higher share of socially and/or medically complex 
patients; and (3) providing one overall complex patient bonus cap at 10 
bonus points. To accomplish this, we included five separate proposals 
to update our complex patient bonus for the CY 2022 performance period/
2024 MIPS payment years and future performance periods/MIPS payment 
years. We note that in section IV.A.3.e.(2)(a)(iii)(B) of this final 
rule, we use the term ``clinician(s)'' to generally refer to those 
individuals and entities that these proposals apply to, including MIPS 
eligible clinicians, groups, subgroups, APM entities, and virtual 
groups. First, we proposed to add to Sec.  414.1380(c)(3) that, similar 
to our current policy, beginning with the CY 2022 MIPS performance 
period/CY 2024 MIPS payment year, provided that a MIPS eligible 
clinician, group, subgroup, virtual group or APM entity submits data 
for at least one MIPS performance category for the applicable 
performance period for the MIPS payment year, a complex patient bonus 
will be added to the final score for the MIPS payment year, if 
applicable, as described in paragraph (c)(3)(v) through (c)(3)(viii). 
Second, we proposed at Sec.  414.1380(c)(3)(v) that beginning with the 
CY 2022 MIPS performance period/CY 2024 MIPS payment years, the

[[Page 65513]]

complex patient bonus is limited to MIPS eligible clinicians, groups, 
subgroups, APM entities, and virtual groups with a risk indicator at or 
above the risk indicator calculated median. Third, we proposed the 
revised formulas at Sec.  414.1380(c)(3)(vi). For MIPS eligible 
clinicians, groups, and subgroups, the complex patient bonus components 
are calculated as follows for the specific risk indicators: Medical 
complex patient bonus component = 1.5 + 4 * associated HCC standardized 
score calculated with the average HCC risk score assigned to 
beneficiaries (pursuant to the HCC risk adjustment model established by 
CMS under section 1853(a)(1) of the Act) seen by the MIPS eligible 
clinician or seen by clinicians in a group or subgroup; social complex 
patient bonus component = 1.5 + 4 * associated dual proportion 
standardized score. The components are added together to calculate one 
overall complex patient bonus. A standardized score for each risk 
indicator is determined based on the mean and standard deviation of the 
raw risk indicator score and provides a standardized measurement of how 
far each risk score is from the mean: (raw risk indicator score - risk 
indicator mean)/risk indicator standard deviation. Fourth, we proposed 
the revised formulas at Sec.  414.1380(c)(3)(vii). For APM entities and 
virtual groups, the complex patient bonus components are calculated as 
follows for the specific risk indicators: Medical complex patient bonus 
component = 1.5 + 4 * the beneficiary weighted average HCC risk 
standardized score for all MIPS eligible clinicians, and if technically 
feasible, TINs for models and virtual groups which rely on complete TIN 
participation within the APM entity or virtual group, respectively; 
social complex patient bonus component = 1.5 + 4 * the average dual 
proportion standardized score for all MIPS eligible clinicians, and if 
technically feasible, TINs for models and virtual groups which rely on 
complete TIN participation, within the APM entity or virtual group, 
respectively. The components are added together to calculate one 
overall complex patient bonus. A standardized score for each risk 
indicator is determined based on the mean and standard deviation of the 
raw risk indicator score and provides a standardized measurement of how 
far each risk score is from the mean: (raw risk indicator score - risk 
indicator mean)/risk indicator standard deviation. Finally, we proposed 
at Sec.  414.1380(c)(3)(viii) that beginning with the CY 2022 MIPS 
performance period/CY 2024 MIPS payment years, the complex patient 
bonus cannot exceed 10.0 and cannot be below 0.0.
(aa) Continuing the Requirement To Submit Data and To Use the Same Risk 
Indicators
    Under the first proposal, beginning with the CY 2022 performance 
period/2024 MIPS payment years, we proposed at Sec.  414.1380(c)(3) to 
continue the requirement to submit data for at least one MIPS 
performance category for the applicable performance period for the MIPS 
payment year for a MIPS eligible clinician, group, subgroup, virtual 
group or APM entity to receive a complex patient bonus added to the 
final score for the MIPS payment year, if applicable, as described in 
paragraphs (c)(3)(v) through (viii).
    As discussed below in section IV.A.3.e.(2)(a)(iii)(B)(cc) of this 
final rule, the proposals at Sec.  414.1380(c)(3)(vi) and (vii) include 
complex patient bonus components within the formulas proposed beginning 
with the CY 2022 performance period/2024 MIPS payment year to account 
for social and medical risk, while still using our current established 
risk indicators of dual proportion and HCC risk scores, respectively. 
We also continue to believe that applying this bonus at the final score 
is appropriate because caring for complex and vulnerable patients can 
affect all aspects of a practice and not just specific performance 
categories.
    We requested public comments on the proposal to continue the 
requirement that a MIPS eligible clinician, group, subgroup, virtual 
group or APM entity must submit data for at least one MIPS performance 
category for the applicable performance period for the MIPS payment 
year to receive a complex patient bonus added to the final score for 
the MIPS payment year, if applicable.
    However, we did not receive public comments on this proposal, and 
we are finalizing as proposed.
(bb) Cutoff at the Median for Complex Patient Bonus Beginning With the 
CY 2022 Performance Period/2024 MIPS Payment Year
    Beginning with the CY 2018 performance period/2020 MIPS payment 
year, a complex patient bonus was added to the final score for the MIPS 
payment year for all MIPS eligible clinicians, groups, virtual groups 
and APM entities if they submitted data for at least one MIPS 
performance category for the applicable performance period for the MIPS 
payment year (Sec.  414.1380(c)(3)). We did not include any requirement 
that clinicians had to attain a certain threshold to receive the 
complex patient bonus. Under the second proposal, we proposed at Sec.  
414.1380(c)(3)(v), beginning with the CY 2022 MIPS performance period/
CY 2024 MIPS payment, the complex patient bonus would be limited to 
MIPS eligible clinicians, groups, subgroups, APM entities, and virtual 
groups with a risk indicator at or above the risk indicator calculated 
median. This proposal limits the component for social risk to 
clinicians with a dual proportion value at or above the median dual 
proportion, and it limits the component for medical risk to clinicians 
with an HCC score value at or above the median HCC score. Those at or 
above the median for a risk indicator will get complex bonus points for 
that risk indicator component. To ensure the points are impactful and 
provided specifically to clinicians treating higher numbers of 
medically and socially complex patients, we proposed to provide bonus 
points beginning at the respective calculated medians.
    Both medical and social factors within the newly proposed 
methodology, discussed in section IV.A.3.e.(2)(a)(iii)(B)(bb) of this 
final rule, will have separate medians and distributions calculated to 
provide more transparent bonuses to directly target those clinicians 
who treat a higher caseload of high-risk and complex patients. Both the 
dual proportion and the HCC risk indicators attributed to each 
clinician will be calculated in the same manner as under our current 
policy (for more information about the current policy, see the CY 2018 
Quality Payment Program final rule (82 FR 30135)).
    To determine the median for the respective risk indicator (HCC and 
dual proportion), we proposed to use the risk indicators associated 
with the final score assigned to a clinician from the prior performance 
period for all engaged MIPS clinicians, which we stated means those who 
have submitted data for at least one MIPS performance category or are 
facility-based. We inadvertently did not include this proposal in 
regulatory text in the CY 2022 PFS proposed rule (86 FR 39443), but for 
clarity, we are adding the following text to Sec.  414.1380(c)(3)(v) in 
this final rule: To determine the median for the respective risk 
indicator (HCC and dual proportion), risk indicators associated with 
the final score assigned to a clinician from the most recent prior 
performance period, for all those who have submitted data for at least 
one MIPS performance category or are facility-based, are used. For 
example, the medians from the CY 2021

[[Page 65514]]

performance period, calculated using the associated risk indicators 
from the CY 2021 performance period, would be compared to the CY 2022 
MIPS performance period risk indicator values to determine who would be 
eligible for a CY 2022 performance period/2024 MIPS payment year 
complex patient bonus. We stated that we would also use this same final 
score distribution to determine the standardized score discussed in the 
proposed rule (86 FR 39444). These statistics would be applied to the 
applicable performance period values of the risk indicators for each 
clinician to calculate the social and medical risk component scores for 
the MIPS performance period. We stated that we believe we need a 
prospective determination of the median, and standardized score from a 
prior performance period where the final scores are already resolved.
    In our proposal, only those clinicians with risk indicator scores 
at or above the median for either one or both risk indicators will 
receive complex patient bonus points. Based on this final rule 
regulatory impact analysis (see section VI.F.18. of this final rule), 
we estimate 64 percent of clinicians will receive a complex patient 
bonus because there is not 100 percent overlap in the clinicians that 
are at or above the median for both risk indicators. Approximately 36.3 
percent of engaged clinicians will not receive any complex patient 
bonus points, as they are below the median for both the HCC risk score 
and the dual proportion. We believe this number is appropriate as we 
will be targeting the complex patient bonus points to clinicians 
treating a higher caseload of highly complex patients.
    Additionally, the complex patient bonus points will be more 
impactful as the difference in awarded bonus points between those with 
high caseloads of complex patients and those with low caseloads, will 
be greater. We believe establishing a cutoff point at the median, as 
opposed to the mean, is appropriate given the median is less impacted 
by outlier cases since the median is simply the middle value. We 
considered whether to use the mean, instead of the proposed median, but 
estimated that will result in about 50 percent of clinicians no longer 
receiving any complex patient bonus points because outliers could 
increase the mean.
    In the CY 2022 PFS proposed rule (86 FR 39443), we acknowledged 
that alternate approaches could be used to target the bonus at 
clinicians with higher caseloads of complex patients. For example, we 
considered using a different distribution of risk indicator scores, 
such as one from an earlier performance period, so clinicians could 
know their scores in advance, or through using a distribution that 
includes individual clinician scores and counts group scores, APM 
Entity scores, virtual group scores, and, starting in the CY 2023 MIPS 
performance period/2025 MIPS payment year, subgroup scores only once, 
so the group, APM Entity, virtual group, or subgroup score is not 
weighted by the number of clinicians in the group, APM Entity, virtual 
group, or subgroup. We also considered building risk benchmarks based 
on our current quality measure benchmark methodology (81 FR 77282 and 
82 FR 53718) to determine the number of complex patient bonus points. 
Under that methodology, risk indicator scores higher than the decile in 
which the median risk factor lies would receive complex patient bonus 
points and all of the clinicians in the top decile would receive 5 
points for each risk indicator. We solicited comments on alternate 
approaches for calculating the complex patient bonus.
    We received public comments on our proposal to limit the complex 
patient bonus to MIPS eligible clinicians, groups, subgroups, APM 
entities, and virtual groups with a risk indicator at or above the risk 
indicator calculated median beginning in the CY 2022 MIPS performance 
period/2024 MIPS payment. The following is a summary of the comments we 
received and our responses.
    Comment: A few commenters support CMS' proposal to set the cutoff 
at the median for complex patient bonus points.
    Response: We thank the commenters for their feedback and support.
    Comment: Several commenters opposed CMS' proposal to use the cutoff 
at the median for the individual risk indicators. A few commenters were 
concerned that the proposed methodology would disadvantage rural 
practices. One of the commenters was specifically concerned about rural 
areas having lower HCC due to coding differences and recommended that 
CMS utilize the median HCC risk indicator at both the national and 
regional levels and determine eligibility using the lower of the two 
scores. A few commenters noted that utilizing the median as a cutoff 
may introduce a ``cliff'' in which practices with small differences in 
risk factor scores could experience very different complex patient 
bonuses. Other commenters suggested that having the cutoff below the 
median would result in unintended consequences and discourage 
clinicians from treating complex patients.
    Several commenters advised that CMS proceed very cautiously before 
eliminating the bonus for those clinicians who have relatively few 
complex patients versus those clinicians who have a larger number of 
such patients. Finally, one commenter suggested that CMS continue the 
already established complex patient bonus formula and provide complex 
patient bonus points to all clinicians.
    Response: We believe the structure of the formula prevents a major 
cliff from occurring at the median as those right below the median and 
those right above median do not experience very different complex 
patient bonuses. Within the formula, the standardized score is based on 
the mean, which, at this time, is higher than the median. The additive 
component of 1.5 allows clinicians with standardized scores between the 
median and the mean to receive between zero and 1.5 points for each 
risk indicator, thus slowly increasing the number of bonus points as 
clinicians' standardized scores increase. For example, if the dual 
proportion risk indicator median is 0.2 and the dual proportion risk 
indicator mean is 0.23, a clinician with an associated standardized 
score of -0.25 (0.25 standard deviations below the mean, but still 
above the median), the clinician will receive a complex patient bonus 
equal to 1.5 + 4 * (-0.25) which equals 0.5 for the dual proportion 
component. We note that CMS will continue to monitor the impact of our 
policy for those clinicians who will no longer receive the complex 
patient bonus under the revised formula, but at this time, we continue 
to support targeting the bonus to make the points more impactful. We 
believe that generating a risk score at a regional or State level may 
be beneficial, however, there are complexities and technicalities that 
would need to be addressed such as defining the appropriate region, 
addressing circumstances when groups or individuals practice across 
multiple regions or States, and assessing how much of the score is 
national versus regional. Additionally, our analysis regarding the 
impact of the revised formula on rural areas showed that while there is 
no significant difference between rural and non-rural TIN/NPIs at the 
payment adjustment level, we do see differences in HCC scores that 
align with the literature findings discussed at section 
IV.A.3.e.(2)(a)(iii)(A) of the CY 2022 PFS proposed rule (86 FR 33441). 
As this topic is complex, we will monitor and consider changes in the 
future, if necessary, based on available data. Further, we disagree 
having the

[[Page 65515]]

cutoff at the median would discourage clinicians from treating complex 
patients because they have always treated those patients even prior to 
CMS establishing the complex patient bonus. We continue to believe the 
goal of the bonus for complex patients is two-fold: (1) To protect 
access to care for complex patients and provide them with excellent 
care; and (2) to avoid placing MIPS eligible clinicians who care for 
complex patients at a potential disadvantage while we review the 
completed studies and research to address the underlying issues. 
Finally, we do not believe that we should continue to use the previous 
formula given that the revised formula more precisely targets 
clinicians caring for high risk and complex patients and better 
mitigates differences in resources that affect MIPS scores.
    After consideration of public comments, we are finalizing at Sec.  
414.1380(c)(3)(v), beginning with the CY 2022 MIPS performance period/
CY 2024 MIPS payment year, the complex patient bonus is limited to MIPS 
eligible clinicians, groups, subgroups, APM entities, and virtual 
groups with a risk indicator at or above the risk indicator calculated 
median. To determine the median for the respective risk indicator (HCC 
and dual proportion), risk indicators associated with the final score 
assigned to a clinician from the most recent prior performance period, 
for all those who have submitted data for at least one MIPS performance 
category or are facility-based, are used.
(cc) Revised Complex Patient Bonus Formulas Beginning With the CY 2022 
Performance Period/2024 MIPS Payment Year
    Under the third proposal, we proposed at Sec.  414.1380(c)(3)(vi) 
that beginning with the CY 2022 MIPS performance period/CY 2024 MIPS 
payment, for MIPS eligible clinicians, groups, and subgroups, that the 
complex patient bonus components would be calculated as follows for the 
specific risk indicators: Medical complex patient bonus component = 1.5 
+ 4 * associated HCC standardized score calculated with the average HCC 
risk score assigned to beneficiaries (pursuant to the HCC risk 
adjustment model established by CMS under section 1853(a)(1) of the 
Act) seen by the MIPS eligible clinician or seen by clinicians in a 
group or subgroup; social complex patient bonus component = 1.5 + 4 * 
associated dual proportion standardized score. The components are added 
together to calculate one overall complex patient bonus. A standardized 
score for each risk indicator is determined based on the mean and 
standard deviation of the raw risk indicator score and provides a 
standardized measurement of how far each risk score is from the mean: 
(raw risk indicator score-risk indicator mean)/risk indicator standard 
deviation. For example, we will use the mean and standard deviation 
from the CY 2021 MIPS performance period and the indicator assigned in 
the CY 2022 MIPS performance period to determine the clinician's 
standard score for the CY 2022 performance period/2024 MIPS payment 
year.
    Under the fourth proposal, we also proposed at Sec.  
414.1380(c)(3)(vii), beginning with the CY 2022 MIPS performance 
period/CY 2024 MIPS payment years, for APM entities and virtual groups, 
that the complex patient bonus components would be calculated as 
follows for the specific risk indicators: Medical complex patient bonus 
component = 1.5 + 4 * the beneficiary weighted average HCC risk 
standardized score for all MIPS eligible clinicians, and if technically 
feasible, TINs for models and virtual groups which rely on complete TIN 
participation within the APM entity or virtual group, respectively; 
social complex patient bonus component = 1.5 + 4 * the average dual 
proportion standardized score for all MIPS eligible clinicians, and if 
technically feasible, TINs for models and virtual groups which rely on 
complete TIN participation, within the APM entity or virtual group, 
respectively. The components are added together to calculate one 
overall complex patient bonus. A standardized score for each risk 
indicator is determined based on the mean and standard deviation of the 
raw risk indicator score and provides a standardized measurement of how 
far each risk score is from the mean: (raw risk indicator score-risk 
indicator mean)/risk indicator standard deviation.
    The mean and standard deviation statistics will be used along with 
the performance period values of the risk indicators for each clinician 
to calculate the standardized score used to calculate the social and 
medical risk component scores for the MIPS payment year. For example, 
if the raw dual proportion score calculated for a clinician is 0.25, 
the dual proportion mean (from the prior performance period) is 0.23, 
and the dual proportion standard deviation (from the prior performance 
period) is 0.15, the clinician's standardized score will be (0.25-
0.23)/0.15 = 0.13. We believe that the standardized score calculation 
is appropriate as it is typically used to understand how far the raw 
risk indicator scores fall from the mean. We noted that those with a 
mean score will have a standardized score of zero, and those with a 
standardized score of 1 are one standard deviation above the mean. 
Those below the mean will have a negative standardized score. The 
proposed formulas will also provide bonus points to clinicians who have 
a negative risk indicator standardized score and fall between the 
calculated median and mean for the respective risk indicator and to 
those who fall at or above the mean and thus have a positive risk 
indicator standardized score. As noted in section 
IV.A.3.e.(2)(a)(iii)(B)(bb) of the final rule, at Sec.  
414.1380(c)(3)(vi) and (vii), the new bonus components will use 
respective means to calculate standardized scores to then calculate and 
provide bonus points for clinicians with risk indicators, HCC and dual 
proportion, at or above the median, to capture medical and social risk, 
separately. For each of the two component calculations, higher 
standardized scores above the mean would be associated with more bonus 
points. For example, a clinician with a standardized score of zero (the 
mean value) for each risk indicator, HCC and dual proportion, will 
receive bonus points for each component that is equivalent to the 
constant, additive factor within the new formula, 1.5. The proposed 
formulas acknowledged complexity without creating a large cliff between 
those who are just below the median and those who have a marginally 
higher caseload of complex patients. The bonus, as proposed, would 
increase proportionally with the increased number of complex patients a 
clinician is treating and/or the degree of patient complexity. For 
example, we did not want to provide those who fall at the mean 1.5 
bonus points, and then provide 10 bonus points to those who only have 
only a slightly higher caseload. Hence, we intended to incorporate a 
standardized score multiplied by 4 to ensure the score got 
proportionally higher as complexity increases.
    The additive factor of 1.5 ensures that all clinicians at or above 
the mean for the social complex patient bonus calculation, based on 
dual proportion, will receive at least 1.5 complex patient bonus points 
and all clinicians at or above the mean for the medical complex patient 
bonus calculation, based on HCC risk score, will receive at least 1.5 
complex patient bonus points. Further, the additive factor of 1.5 will 
allow clinicians between the median and mean to still receive complex 
patient bonus points. For example, if the dual proportion risk 
indicator median is 0.2

[[Page 65516]]

and the dual proportion risk indicator mean is 0.23, a clinician with 
an associated standardized score of -0.1 (0.1 standard deviations below 
the mean, but still above the median), the clinician will receive a 
complex patient bonus equal to 1.5 + 4 * (-0.1) which equals 1.1 for 
the dual proportion component. If the dual proportion risk indicator 
calculated for a clinician falls below the median, they will receive 
zero complex patient bonus points for the dual proportion component. 
Based on the standardized score calculation, if the dual proportion 
risk indicator calculated for a clinician falls above the mean, they 
will receive complex patient bonus component points greater than the 
additive factor of 1.5 for the dual proportion component.
    We believe this formula avoids a major complex patient bonus points 
cliff that could be created by providing the clinicians right above the 
cutoff point significant bonus points compared to the clinicians right 
below the cutoff point (who do not receive any complex patient bonus 
points). We acknowledge those who fall below the median will no longer 
receive any complex patient bonus points, per proposal at Sec.  
414.1380(c)(3)(v) that for the CY 2022 performance period/2024 MIPS 
payment years and future MIPS performance periods/MIPS payment years, 
the complex patient bonus is limited to MIPS eligible clinicians, 
groups, subgroups, APM entities, and virtual groups with a risk 
indicator at or above the risk indicator calculated median.
    We received public comments on our proposal to revise the complex 
patient bonus formula. The following is a summary of the comments we 
received and our responses.
    Comment: Many commenters supported CMS' proposal to revise the 
complex patient bonus formula for the CY 2022 performance period/2024 
MIPS and future payment years to better account for care delivered to 
highly complex patients.
    Response: We thank the commenters for their support and feedback.
    Comment: A few commenters suggested some modifications to revise 
the proposed formulas. One commenter suggested that the proposed 
methodology for standardizing the scores for risk indicators is overly 
sensitive to outliers. Rather, they suggested that CMS standardize risk 
indicators using the median instead of the mean. The commenter also 
suggested that we use a more robust measure of variation than the 
standard deviation. Another commenter suggested that CMS standardize 
the dual eligible ratio using the median value in each State, rather 
than the median or mean at a national level. More specifically, the 
commenter suggested this given that the dual eligible ratio for a 
clinician varies depending on the number of Medicaid-eligible 
beneficiaries attributed to clinician which may be lower if a State has 
not expanded Medicaid. Finally, another commenter suggested that CMS 
increase the average HCC score for clinician based on the proportion of 
patients living in rural areas.
    Response: We acknowledge that Medicaid eligibility criteria vary 
across States, and this could impact the number of dual-eligible 
patients attributed to a clinician. We also understand that there may 
be advantages to having an average HCC score for clinicians based on 
the proportion of patients living in rural areas. More specifically due 
to the potential coding differences between rural and non-rural areas 
as noted in the Tyler Malone, Denise Kirk et al. study \256\ which 
indicated that Medicare beneficiaries in rural counties have lower 
average CMS-HCC risk scores compared to urban counties despite previous 
research suggesting that rural populations are sicker than urban 
populations. However, it may be misleading to create a median value for 
a State when a clinician or group may practice in multiple locations 
across different State lines. More specifically, we note that 
clinicians providing patient care as part of a clinical team may 
practice in different locations under the same group (TIN) which would 
make it difficult for us to assign a State-based dual eligible ratio. 
Additionally, dually-eligible patients may seek care across State 
lines, adding to the complexity. We are interested in exploring these 
suggestions further through future rulemaking but would need to do 
extensive modeling to rule out unintended consequences, identify 
appropriate data sources, and assess whether the advantages outweigh 
the additional complexity. We will continue to evaluate dual proportion 
to see if any additional modifications are needed. We would also be 
interested in hearing from stakeholders the best way to resolve these 
challenges in the future.
---------------------------------------------------------------------------

    \256\ UNC Rural Health Research Program, ``CMS Hierarchical 
Condition Category (HCC) 2014 Risk Scores Are Lower for Rural 
Medicare Beneficiaries than for Urban Beneficiaries,'' December 
2020.
---------------------------------------------------------------------------

    Further, the proposed policy standardizes each risk indicator (HCC 
risk score and dual proportion) using the mean and standard deviation. 
Specifically, the proposed policy used the standardized score formula 
of (risk indicator-mean of risk indicator)/standard deviation of risk 
indicator. We conducted a preliminary analysis that uses the median 
instead of the mean and the median absolute deviation (MAD) instead of 
the standard deviation for each risk indicator (HCC risk score and dual 
proportion) to create the standardized score. We used Year 5 final RIA 
data to calculate the values of the median and the MAD. The MAD first 
takes the absolute difference between a risk indicator value and the 
median of the risk indicator and then takes the median of the absolute 
differences. In other words, MAD = median (absolute difference (risk 
factor-median of the risk factor)) and the standardized score would be 
calculated using (risk indicator-median of risk indictor)/MAD of risk 
indicator.
    Based on the analysis, we observed that the MAD is smaller than the 
standard deviation, used in our proposed rule's analysis, for each risk 
indicator. More specifically, using the median and MAD, the standard 
score is, on average, more than twice the value when compared to using 
the mean and standard deviation. Given that the standardized scores 
would be larger using the median and MAD to standardize, we 
recalibrated the multiplier as the initial multiplier was 4 but would 
effectively become 8 or more with the larger standardized scores. 
Additionally, if we use the median to standardize, clinicians at the 
risk indicator median would receive, at minimum, the initial constant 
(1.5 in the proposed formula). Because of these two reasons, when 
conducting our analysis, the proposed formula for the complex patient 
bonus (which is currently 1.5 + 4 * standardized score) needed to be 
recalibrated for our analysis to avoid unintended consequences.
    We conducted our analysis using the median and the MAD to 
standardize and we used the formula 0.25 + 2 * standardized score for 
each risk indicator. We used 0.25 as the additive component to provide 
those at the median for each risk indicator with a non-zero amount of 
bonus points that would also not create a cliff. We used 2 as the 
multiplicative component to provide a bonus that gets proportionally 
higher as complexity increases while also accounting for the larger 
size of the standardized score. Using this formula, the number of 
clinicians receiving complex patient bonus points decreases slightly 
due to changes in entity type and clinicians would receive slightly 
fewer complex patient bonus points compared to the proposed formula.

[[Page 65517]]

However, the adjusted standardization method using the median and the 
MAD and associated formula did not have any major impact on the overall 
distribution and no impact of outliers was detected.
    Comment: One commenter supported CMS' proposal to use the current 
risk indicators including HCC and dual eligibility. A few commenters 
requested that CMS look at additional risk indicators to account for 
additional complexities within the complex patient bonus formula. 
Specifically, a few commenters suggested that CMS consider clinical 
data to capture comorbidities and alternatives to dual eligibility to 
capture social risk. A few commenters suggested that CMS consider using 
other data such as Z-codes and indices (for example, Social 
Vulnerability Index, Community Needs Index, etc.).
    Response: We thank the commenters for their support and suggestions 
and will take them into consideration as we continue updating the 
complex patient bonus in future years. We note that, although the ASPE 
report \257\ found dual eligibility to be a reliable indicator of 
social risk, we understand there may be some limitations. However, we 
are not aware of data sources and/or methodologies to account for other 
social indicators such as income and education that are readily 
available for all Medicare beneficiaries that would be more complete 
indices of a patient's complexity. Further, we continue to believe that 
average HCC risk scores are a valid proxy for medical complexity that 
are also used by other CMS programs. Therefore, we have decided to 
continue to pair the HCC risk score with the proportion of dually 
eligible patients to create a more complete complex patient indicator 
than can be captured using HCC risk scores alone. We will evaluate 
additional, more comprehensive options, such as Z-codes and indices, in 
future years based on any updated data or additional information, 
including to better account for social risk factors while minimizing 
unintended consequences and consider these as we move forward.
---------------------------------------------------------------------------

    \257\ ASPE. Second Report to Congress on Social Risk and 
Medicare's Value-Based Purchasing Programs. June 29, 2020. https://aspe.hhs.gov/pdf-report/second-impact-report-to-congress.
---------------------------------------------------------------------------

    After consideration of public comments, we finalize the proposal at 
Sec.  414.1380(c)(3)(vi) that beginning with the CY 2022 performance 
period/CY 2024 MIPS payment, for MIPS eligible clinicians, groups, and 
subgroups, the complex patient bonus components are calculated as 
follows for the specific risk indicators: Medical complex patient bonus 
component = 1.5 + 4 * associated HCC standardized score calculated with 
the average HCC risk score assigned to beneficiaries (pursuant to the 
HCC risk adjustment model established by CMS under section 1853(a)(1) 
of the Act) seen by the MIPS eligible clinician or seen by clinicians 
in a group or subgroup; social complex patient bonus component = 1.5 + 
4 * associated dual proportion standardized score. The components are 
added together to calculate one overall complex patient bonus. A 
standardized score for each risk indicator is determined based on the 
mean and standard deviation of the raw risk indicator score and 
provides a standardized measurement of how far each risk score is from 
the mean: (raw risk indicator score-risk indicator mean)/risk indicator 
standard deviation.
    We also finalize the proposal at Sec.  414.1380(c)(3)(vii), 
beginning with the CY 2022 performance period/2024 MIPS payment years, 
for APM entities and virtual groups, the complex patient bonus 
components are calculated as follows for the specific risk indicators: 
Medical complex patient bonus component = 1.5 + 4 * the beneficiary 
weighted average HCC risk standardized score for all MIPS eligible 
clinicians, and if technically feasible, TINs for models and virtual 
groups which rely on complete TIN participation within the APM entity 
or virtual group, respectively; social complex patient bonus component 
= 1.5 + 4 * the average dual proportion standardized score for all MIPS 
eligible clinicians, and if technically feasible, TINs for models and 
virtual groups which rely on complete TIN participation, within the APM 
entity or virtual group, respectively. The components are added 
together to calculate one overall complex patient bonus. A standardized 
score for each risk indicator is determined based on the mean and 
standard deviation of the raw risk indicator score and provides a 
standardized measurement of how far each risk score is from the mean: 
(raw risk indicator score-risk indicator mean)/risk indicator standard 
deviation.
(dd) Cap for the Complex Patient Bonus Beginning With the CY 2022 
Performance Period/2024 MIPS Payment Year
    When we originally established the complex patient bonus policy in 
the CY 2018 Quality Payment Program final rule (82 FR 53774), we 
finalized at Sec.  414.1380(c)(3)(iii) that the complex patient bonus 
cannot exceed 5.0. At that time, our data analysis estimated a decrease 
in simulated scores of 5.4 points (for individuals who report 6 or more 
quality measures) and 4.5 points (for groups) from the top quartile to 
the bottom quartile for the average patient HCC risk scores and 4.8 
points (for individuals who report 6 or more quality measures) and 4.5 
points (for groups) from the top quartile to the bottom quartile for 
the dual proportion. Therefore, we believed a cap for the complex 
patient bonus of 5 points was supported by the data and was sufficient 
to compensate for the estimated differences in performance based on HCC 
risk scores and dual proportion (82 FR 53773). In CY 2019, CY 2020, and 
CY 2021 PFS final rules, we continued to believe that the 5-point cap 
was appropriate given that we had not updated our prior analyses (83 FR 
58769 through 59870, 84 FR 63021 through 63023, 85 FR 84908 through 
84913, respectively). However, based on our updated analyses using 
actual 2018 MIPS scored data, described above, about 5 percent of 
clinicians scored as group or individual had a complex patient bonus 
that would have been more than 5-points had the cap not been in place. 
The complex patient bonus cap of 5-points (82 FR 53773 through 53776) 
affects clinicians who are most likely carrying higher caseloads for 
patient complexity, which is inconsistent with the intent of the 
policy, and we no longer believe we should maintain the overall cap of 
5-points. As discussed in section IV.A.3.e.(2)(a)(iii)(A) of this final 
rule, our updated analyses using actual 2018 MIPS scored data also 
found that clinicians with a higher caseload of complex patients have 
lower final scores, by more than 10 points on average, prior to the 
assignment of the complex patient bonus than clinicians with lower 
caseloads of complex patients. We believe, with a cap of 10 bonus 
points, we are targeting the bonus to address the differences in final 
scores these clinicians face more appropriately without capping at a 
larger number, such as 15 or 20 bonus points, which could result in 
inappropriate score inflation and masking of poor performance. A cap of 
fewer than 10 bonus points would not address the differences in the 
observed raw final scores and would not adequately address the need to 
provide more equity within our scoring system for those clinicians 
treating higher caseloads of socially and/or medically complex 
patients. We did consider lower caps, such as 5 or 7 bonus points, or 
higher caps, such as 20 bonus points, but for the reasons described 
above, we proposed the cap of 10 bonus points. However, if future 
analyses and more recent data show differences in raw

[[Page 65518]]

final scores that differ from our previous findings, we would consider 
proposing in future rulemaking the use of a cap that aligns with new 
findings.
    As discussed in section IV.A.3.e.(2)(a)(iii)(B)(cc) of this final 
rule, we proposed the formulas as: Risk indicator complex patient bonus 
component = 1.5 + 4 * associated risk indicator standardized score. The 
formula, as proposed, has a multiplier of 4. We also considered a 
multiplier of 2 with a cap of 5 bonus points which results in a lower 
final score mean and median but does not change the number of 
clinicians receiving a complex patient bonus when compared to the 
proposed policy. We do not believe that this alternate approach would 
produce a bonus impactful enough to overcome the differences seen at 
the final score level when comparing complex patient bonus quintiles. 
We solicited feedback on this alternate approach and additional 
alternate approaches we should consider.
    Under the fifth proposal, we proposed at Sec.  414.1380(c)(3)(viii) 
that beginning with the CY 2022 MIPS performance period/CY 2024 MIPS 
payment year, the complex patient bonus cannot exceed 10.0 and cannot 
be below 0.0. Based on the proposed formulas at Sec.  
414.1380(c)(3)(vi) and (vii), the social complex patient bonus 
component (using dual proportion standardized score) and the medical 
complex patient bonus component (using HCC risk score standardized 
score) will be added together to calculate one overall complex patient 
bonus. Then, based on the proposal at Sec.  414.1380(c)(3)(viii) the 
complex patient bonus will then be capped at the 10 points overall.
    For example, if a clinician's dual proportion standardized score is 
1.5, their complex patient bonus social risk component is 1.5 + 4 * 
1.25 = 6.5. If their HCC risk score standardized score is 0.25, their 
complex patient bonus medical risk component is 1.5 + 4 * 0.25 = 2.5. 
The two complex patient bonus components are then added together to 
total 9 complex patient bonus points for this clinician. Had the total 
been above 10 bonus points, the 10-point cap would have applied and the 
clinician would have received 10 complex patient bonus points added to 
their final MIPS score.
    We solicited feedback on whether we should use the multiplier of 4 
and cap of 10 bonus points as proposed, a multiplier of 2 and cap of 5 
bonus points as discussed as an alternative, or if we should consider 
additional options and rationale for the complex patient bonus formula 
and bonus cap, such as a cap of 7 or 20 bonus points.
    We received public comments on the cap for the complex patient 
bonus. The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the proposal to place the 
complex patient bonus cap at 10 points, similarly to how it was capped 
for the previous 2 years due to the policy to double the previously 
established 5-point cap in response to the impacts of the national PHE.
    Response: We thank the commenters for their support and feedback.
    Comment: A few commenters suggested that CMS increase the complex 
patient bonus cap from 10 points to 20 points. One commenter 
specifically suggested that CMS scale the formula so that individual 
clinicians in the upper quintile can receive at least 15 complex 
patient bonus points.
    Response: At this time, we do not believe we need to increase the 
complex patient bonus cap from 10 points to 20 points or provide at 
least 15 complex patient bonus points to the upper quintile. We 
believe, with a cap of 10 bonus points, we are appropriately targeting 
the bonus to address the differences in final scores these clinicians 
face without capping at a larger number. Fifteen bonus points would 
contribute to the final score the same amount of points as the entire 
Improvement Activities performance category. However, if future 
analyses and more recent data show differences in raw final scores that 
differ from our previous findings, we would consider proposing in 
future rulemaking the use of a cap that aligns with new findings.
    After consideration of public comments, we finalize the proposal at 
Sec.  414.1380(c)(3)(viii) that beginning with the CY 2022 MIPS 
performance period/CY 2024 MIPS payment year, the complex patient bonus 
cannot exceed 10.0 and cannot be below 0.0.
    In summary, we finalized the five separate proposals for the CY 
2022 performance period/2024 MIPS payment year and future MIPS 
performance periods/MIPS payment years as follows:
     Finalized as proposed at Sec.  414.1380(c)(3), by adding, 
beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment 
year, provided that a MIPS eligible clinician, group, subgroup, virtual 
group or APM entity submits data for at least one MIPS performance 
category for the applicable performance period for the MIPS payment 
year, a complex patient bonus will be added to the final score for the 
MIPS payment year, if applicable, as described in paragraphs (c)(3)(v) 
through (viii).
     At Sec.  414.1380(c)(3)(v), beginning with the CY 2022 
MIPS performance period/CY 2024 MIPS payment year, we finalized as 
proposed the complex patient bonus is limited to MIPS eligible 
clinicians, groups, subgroups, APM entities, and virtual groups with a 
risk indicator at or above the risk indicator calculated median. To 
determine the median for the respective risk indicator (HCC and dual 
proportion), risk indicators associated with the final score assigned 
to a clinician from the most recent prior performance period, for all 
those who have submitted data for at least one MIPS performance 
category or are facility-based, are used.
     At Sec.  414.1380(c)(3)(vi), beginning with the CY 2022 
MIPS performance period/CY 2024 MIPS payment year, we finalized as 
proposed for MIPS eligible clinicians, groups, and subgroups, the 
complex patient bonus components are calculated as follows for the 
specific risk indicators: Medical complex patient bonus component = 1.5 
+ 4 * associated HCC standardized score calculated with the average HCC 
risk score assigned to beneficiaries (under the HCC risk adjustment 
model established by CMS under section 1853(a)(1) of the Act) seen by 
the MIPS eligible clinician or seen by clinicians in a group or 
subgroups; social complex patient bonus component = 1.5 + 4 * 
associated dual proportion standardized score. The components are added 
together to calculate one overall complex patient bonus. A standardized 
score for each risk indicator is determined based on the mean and 
standard deviation of the raw risk indicator score and provides a 
standardized measurement of how far each risk score is from the mean: 
(raw risk indicator score-risk indicator mean)/risk indicator standard 
deviation.
     At Sec.  414.1380(c)(3)(vii), we finalized as proposed 
that beginning with the CY 2022 MIPS performance period/CY 2024 MIPS 
payment year, for APM entities and virtual groups, the complex patient 
bonus components are calculated as follows for the specific risk 
indicators: Medical complex patient bonus component = 1.5 + 4 * the 
beneficiary weighted average HCC risk standardized score for all MIPS 
eligible clinicians, and if technically feasible, TINs for models and 
virtual groups which rely on complete TIN participation within the APM 
entity or virtual group, respectively; social complex patient bonus 
component = 1.5 + 4 * the average dual proportion standardized score 
for all MIPS eligible clinicians, and if technically feasible, TINs for 
models and virtual groups which rely on complete TIN participation, 
within the APM entity or

[[Page 65519]]

virtual group, respectively. The components are added together to 
calculate one overall complex patient bonus. A standardized score for 
each risk indicator is determined based on the mean and standard 
deviation of the raw risk indicator score and provides a standardized 
measurement of how far each risk score is from the mean: (raw risk 
indicator score-risk indicator mean)/risk indicator standard deviation.
     At Sec.  414.1380(c)(3)(viii), beginning with the CY 2022 
MIPS performance period/CY 2024 MIPS payment year, we finalized as 
proposed the complex patient bonus cannot exceed 10.0 and cannot be 
below 0.0.
    In addition to the proposals we made, we also considered the 
alternative of continuing the use of the complex patient bonus 
formulas, as previously finalized at Sec.  414.1380(c)(3)(i) and (ii), 
along with the 5.0 point cap as previously finalized at Sec.  
414.1380(c)(3)(iii) for the CY 2022 MIPS performance period/CY 2024 
MIPS payment year. We solicited comment on that alternative and have 
addressed the comments we received above under section 
(IV.A.3.e.(2)(a)(iii)(B)(bb)) of this final rule.
(b) Final Score Performance Category Weights
(i) General Weights
    Section 1848(q)(5)(E)(i) of the Act specifies weights for the 
performance categories included in the MIPS final score: In general, 30 
percent for the quality performance category; 30 percent for the cost 
performance category; 25 percent for the Promoting Interoperability 
performance category; and 15 percent for the improvement activities 
performance category. For more of the statutory background and 
descriptions of our current policies, we refer readers to the CY 2017 
through CY 2018 Quality Payment Program final rules, and CY 2019 
through CY 2021 PFS final rules (81 FR 77320 through 77329, 82 FR 53779 
through 53785, 83 FR 59870 through 59878, and 84 FR 62950 through 
62959, 85 FR 84898 through 84908, respectively). Table 62 summarizes 
the weights established in prior rulemaking (85 FR 84913) for each 
performance category for the CY 2022 performance period/2024 MIPS 
payment year and each subsequent MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TR19NO21.089

(ii) Flexibility for Weighting Performance Categories
    Under section 1848(q)(5)(F) of the Act, if there are not sufficient 
measures and activities applicable and available to each type of MIPS 
eligible clinician involved, the Secretary shall assign different 
scoring weights (including a weight of zero) for each performance 
category based on the extent to which the category is applicable to the 
type of MIPS eligible clinician involved and for each measure and 
activity with respect to each performance category based on the extent 
to which the measure or activity is applicable and available to the 
type of MIPS eligible clinician involved.
    Under section 1848(q)(5)(B)(i) of the Act, in the case of a MIPS 
eligible clinician who fails to report on an applicable measure or 
activity that is required to be reported by the clinician, the 
clinician must be treated as achieving the lowest potential score 
applicable to such measure or activity. In this scenario of failing to 
report, the MIPS eligible clinician generally would receive a score of 
zero for the measure or activity, which would contribute to the final 
score for that MIPS eligible clinician. Under certain circumstances, 
however, a MIPS eligible clinician who fails to report could be 
eligible for an assigned scoring weight of zero percent and a 
redistribution of the performance category weights. For a description 
of our existing policies for reweighting performance categories, please 
refer to Sec.  414.1380(c)(2) and the CY 2021 PFS final rule (85 FR 
84914 through 84916).
(A) Reweighting the Cost Performance Category
    Under Sec.  414.1380(c)(2)(i)(A), we will assign a different weight 
to a performance category and redistribute its prescribed weight to 
another performance category or categories in certain circumstances 
where we determine there are not sufficient measures and activities 
applicable and available under section 1848(q)(5)(F) of the Act. For 
the cost performance category, this includes circumstances where we 
cannot reliably calculate a score for the cost measures which 
adequately captures and reflects the performance of a MIPS eligible 
clinician (see Sec.  414.1380(c)(2)(i)(A)(2)). In the CY 2018 Quality 
Payment Program final rule (82 FR 53780), for the cost performance 
category, we noted in the proposed rule we had stated that we continue 
to believe having sufficient measures applicable and available means 
that we can reliably calculate a score for the cost measures which 
adequately captures and reflects the performance of a MIPS eligible 
clinician, and that MIPS eligible clinicians who are not attributed 
enough cases to be reliably measured should not be scored for the cost 
performance category. We noted (82 FR 53780) we had established a 
policy in the CY 2017 Quality Payment Program final rule that if a MIPS 
eligible clinician is not attributed enough cases for a measure (in 
other words, has not met the required case minimum for the measure), or 
if a measure does not have a benchmark, then the measure will not be 
scored for that clinician (81 FR 77323). We stated (82 FR 53780) if we 
do not score any cost measures for a MIPS eligible clinician in 
accordance with this policy, then the clinician would not receive a 
cost performance category percent score. In the CY 2022 PFS proposed 
rule (86 FR 39446 through 39448), we solicited comments on potential 
circumstances where we may not be able to reliably calculate a score 
for any of the cost measures which adequately captures and reflects the 
performance of a MIPS eligible clinician, and may assign a different

[[Page 65520]]

weight to the cost performance category and redistribute its prescribed 
weight to another performance category or categories. We stated that we 
are interested in comments on circumstances that could affect all MIPS 
eligible clinicians, as well as those that could affect a subset of 
MIPS eligible clinicians or individual MIPS eligible clinicians. We 
noted the cost performance category reweighting provision at Sec.  
414.1380(c)(2)(i)(A)(2) is distinct from the measure suppression policy 
proposed in section IV.A.3.e.(1)(d)(i) of the proposed rule, as it 
applies to the performance category as a whole and not on a measure-by-
measure basis.
    In the CY 2022 PFS proposed rule (86 FR 39447), we discussed our 
responses to commenters' concerns in the CY 2021 PFS final rule 
regarding the potential for COVID-19 to impact cost measures and our 
analyses of whether we could reliably calculate scores for the cost 
measures for the 2020 performance period. We noted that because we 
determined we cannot reliably calculate scores for the cost measures 
that adequately capture and reflect the performance of MIPS eligible 
clinicians, we announced via email communication (subject: CMS 
Reweighting 2020 MIPS Cost Performance Category) on May 20, 2021, in 
accordance with Sec.  414.1380(c)(2)(i)(A)(2), we will assign a weight 
of 0 percent to the cost performance category for the CY 2020 
performance period/2022 payment year and redistribute the prescribed 
weight of 15 percent to another performance category or categories, as 
established at Sec.  414.1380(c)(2)(ii)(D). We noted as with all 
measures, we continue to monitor the evolving impact of COVID-19.
    We stated in the CY 2022 PFS proposed rule (86 FR 39447) that we 
recognize there may be additional circumstances where we may not be 
able to reliably calculate a score for any of the cost measures within 
the cost performance category that adequately captures and reflects the 
performance of a MIPS eligible clinician, which could include external 
factors beyond the control of clinicians. Similar to the Measure 
Suppression Factors proposed and subsequently finalized in the FY 2022 
IPPS/LTCH PPS rulemaking (86 FR 25473, 45301), we stated that such 
external factors may include significant national shortages or rapid or 
unprecedented changes in: (1) Healthcare personnel; (2) medical 
supplies, equipment, or diagnostic tools or materials; or (3) patient 
case volumes or patient case mix.
    We solicited comments on whether these external factors should 
inform our future decision-making on whether to reweight the cost 
performance category under Sec.  414.1380(c)(2)(i)(A)(2). We also 
solicited comments on whether there are other external factors we 
should consider, or other circumstances in general that could affect 
our ability to reliably calculate a score for the cost performance 
category as described under Sec.  414.1380(c)(2)(i)(A)(2). We received 
public comments on these external factors. The following is a summary 
of the comments we received and our responses.
    Comment: Several commenters supported CMS considering additional 
external factors in future decision-making on whether to reweight the 
cost performance category under Sec.  414.1380(c)(2)(i)(A)(2).
    Response: We thank the commenters for their support.
    Comment: One commenter recommended that CMS specifically consider 
whether events will impact multiple performance periods and whether 
medical guidelines (such as the changing COVID-19 vaccination schedule) 
are being updated. One commenter recommended CMS consider small 
practices and practices with low volume when determining whether to 
reweight the cost performance category. A few commenters recommended 
reweighting decisions be based, in part, on an assessment of whether an 
external event impacts patterns of care or a clinician's ability to 
control complications, admissions, and readmissions.
    Response: We appreciate the commenters' suggestions for external 
factors or other circumstances we should consider. We recognize that 
certain circumstances can affect clinicians and clinician groups across 
multiple performance periods, and we intend to assess each performance 
period to determine whether clinicians' performance has been affected 
by external factors that are not within their control. We also agree 
about the importance of monitoring potential impacts for small 
practices and practices with low volume of cases and note that setting 
a case minimum for a measure helps to ensure that practices have a 
sufficient case volume to be reliably scored on a measure. We continue 
to apply the appropriate case minimum for each measure as part of 
monitoring and testing for the impact of external events. Additionally, 
to address a stakeholder's comment on the importance of assessing 
whether external events impact patterns of care or a clinician's 
ability to control complications, admissions, and readmissions, we note 
that as part of our regular monitoring of the cost measures, we run 
empirical analyses to assess changes in patterns of care and evaluate 
whether certain circumstances or events impact clinicians' performance 
on measures. This assessment would help us to determine if these 
circumstance or events warrant cost performance category reweighting. 
This monitoring would include empirical analyses to compare cost 
performance across years. Depending on the specific measure, this may 
include the cost of complications, admissions, and readmissions.
    After consideration of the public comments we received, we intend 
to consider the following three factors, in addition to any other 
factors that may be relevant in the future, when we make a 
determination as to whether we can reliably calculate a score for the 
cost performance category that adequately captures and reflects the 
performance of a MIPS eligible clinician, as described under Sec.  
414.1380(c)(2)(i)(A)(2): Significant national shortages or rapid or 
unprecedented changes in: (1) Healthcare personnel; (2) medical 
supplies, equipment, or diagnostic tools or materials; or (3) patient 
case volumes or patient case mix. We offer the following examples to 
illustrate each of these three factors.
     Factor 1: A significant national shortage or rapid or 
unprecedented change in healthcare personnel could mean that there is a 
systematic decrease in medical services being provided and similar 
impacts on data availability.
     Factor 2: A rapid and unprecedented national change in 
medical supplies, equipment, or diagnostic tools or materials could 
mean a rapid and systematic change in the way medical care is provided, 
which might result in distortions to resource use measurement.
     Factor 3: A rapid and unprecedented national change in the 
number and case mix of patients receiving medical services could mean 
that the measure cannot be reliably calculated due to systemic 
decreases in case counts and data available for risk adjustment.
(iii) Redistributing Performance Category Weights
    In the CY 2017 through CY 2018 Quality Payment Program final rules, 
and CY 2019 through CY 2021 PFS final rules (81 FR 77325 through 77329, 
82 FR 53783 through 53785, 83 FR 59876 through 59878, 84 FR 63027 
through 63031, and 85 FR 84914 through 84916), and at Sec.  
414.1380(c)(2)(ii), we established policies for redistributing

[[Page 65521]]

the weights of the performance categories in the event that a scoring 
weight different from the generally applicable weight is assigned to a 
category or categories.
    In CY 2021 PFS final rule, we finalized a policy for redistributing 
the performance category weights for the CY 2022 performance period/
2024 MIPS payment year and noted that we planned to revisit our 
redistribution policies in future rulemaking and may consider 
redistributing more weight to the cost performance category after 
clinicians have more experience with cost being weighted at 30 percent 
(85 FR 84914). While we still intend to redistribute more weight to the 
cost performance category in future years, we believe it will be 
beneficial to establish the redistribution policies for the CY 2023 
performance period/2025 MIPS payment year and future years to provide 
as much notice as possible to clinicians and other stakeholders. Hence, 
we proposed to apply the redistribution policy finalized for the CY 
2022 performance period/2024 MIPS payment year at Sec.  
414.1380(c)(2)(ii)(F) to the 2025 MIPS payment year and each subsequent 
MIPS payment year, and we proposed corresponding revisions to Sec.  
414.1380(c)(2)(ii)(F). We still plan to revisit our redistribution 
policies in future rulemaking after clinicians have more experience 
with cost being weighted at 30 percent and gain more experience with 
our newly proposed MVPs.
    We solicited public comments on this proposal.
    We received public comments on the redistribution policy. The 
following is a summary of the comments we received and our responses.
    Comment: A few commenters supported CMS' proposal to continue the 
redistribution policies for future MIPS performance periods/MIPS 
payment years.
    Response: We thank the commenters for their support and feedback.
    After consideration of public comments, we finalize our proposal to 
apply the redistribution policy finalized for the CY 2022 performance 
period/2024 MIPS payment year at Sec.  414.1380(c)(2)(ii)(F) to the 
2025 MIPS payment year and each subsequent MIPS payment year, and we 
finalize the proposed corresponding revisions to Sec.  
414.1380(c)(2)(ii)(F).
[GRAPHIC] [TIFF OMITTED] TR19NO21.090

Our finalized redistribution policies for the CY 2025 MIPS payment year 
and each subsequent MIPS payment year are included in Table 63. We note 
that not all the redistribution scenarios described in Table 63 will 
apply to MIPS eligible clinicians in small practices. Please refer to 
Table 64 for the redistribution policy for small practices.
(A) Redistributing Performance Category Weight for Small Practices
    Clinicians and groups who work in small practices are a crucial 
part of the health care system. The Quality Payment Program provides 
options designed to make it easier for these clinicians and groups to 
report on performance and quality and participate in advanced 
alternative payment models for incentives. We have heard directly from 
clinicians in small practices that they face unique challenges related 
to financial and other resources, environmental factors, and access to 
health information technology. We heard from many commenters that the 
Quality Payment Program gives an advantage to large organizations 
because such organizations have more resources invested in the 
infrastructure required to track and report measures to MIPS (82 FR 
53776). In response to the feedback on the potential burden on small 
practices, we have established special policies available for small 
practices including the small practice bonus and special scoring 
policies. For example, in the CY 2018 QPP final rule (82 FR 53682 
through 53683), we established a significant hardship exception for 
small practices for the Promoting Interoperability performance 
category.
    In this section of the rule, we discuss how we would redistribute 
the Promoting Interoperability performance category weight for small 
practices. Within the reweighting policy for the CY 2022 performance 
period/2024 MIPS payment year, the Promoting Interoperability 
performance category weight is redistributed fully to the quality 
performance category, unless the

[[Page 65522]]

quality performance category is weighted at zero percent. In general, 
our reweighting policies have emphasized the quality performance 
category over the improvement activities performance category. We have 
noted it is important to prioritize performance on measures that show a 
variation in performance such as quality measures, rather than the 
activities under the improvement activities performance category, which 
are based on attestation of completion (85 FR 84914). We believe this 
helps reduce incentives to not report measures for the quality 
performance category in circumstances when a clinician may be able to 
report but chooses not to do so. However, given stakeholder input and 
recently published literature, we believe there could be other reasons 
why a small practice would not report quality measures. One recent 
article \258\ stated that physicians in larger group practices, 
multispecialty practices, or participating through alternative payment 
models had higher MIPS scores, possibly reflecting such practices' 
greater infrastructure and resources to collect, analyze, and report 
measures to CMS. We have also heard directly from clinicians in small 
practices that they face unique challenges related to financial and 
other resources and access to health information technology. Many 
commenters have shared their belief that the Quality Payment Program 
gives an advantage to large organizations because such organizations 
have more resources invested in the infrastructure required to track 
and report measures to MIPS (82 FR 53776). Indeed, 85 percent of 
clinicians who are not engaged with MIPS (who do not submit data) are 
clinicians in small practices (85 FR 85018), which we believe may be 
due to their limited resources. Given infrastructure and resource 
limitations within small practices, we believe it is appropriate to 
place more emphasis on a performance category that poses a reduced 
reporting burden such as the improvement activities performance 
category. We proposed that for small practices, as defined at Sec.  
414.1305, when the Promoting Interoperability performance category is 
reweighted, the quality performance category will be weighted at 40 
percent, the cost performance category will be weighted at 30 percent, 
and the improvement activities performance category will be weighted at 
30 percent. When both the cost performance category and the Promoting 
Interoperability performance category are reweighted, the quality 
performance category will be weighted at 50 percent and the improvement 
activities performance category will be weighted at 50 percent. We plan 
to revisit this redistribution policy in future rulemaking and may 
consider redistributing more weight to the cost performance category 
after clinicians have more experience with cost being weighted at 30 
percent.
---------------------------------------------------------------------------

    \258\ Johnston KJ, Wiemken TL et al. (Sept 2020) ``Association 
of Clinician Health System Affiliation with Outpatient Performance 
Ratings in the Medicare Merit-based Incentive Payment System'' JAMA. 
2020; 324(10):984-992.
---------------------------------------------------------------------------

    We anticipate that our proposal noted in the two rows in Table 64 
will greatly assist small practices by providing further flexibilities 
to help with our goal of increasing engagement across the MIPS program 
and to be able to meet the MIPS requirements. Beginning with the CY 
2022 performance period/2024 MIPS payment year, we proposed at Sec.  
[thinsp]414.1380(c)(2)(ii)(G) redistribution policies for small 
practices, as shown in Table 64.
    We solicited public comments on this proposal.
    We received public comments on the redistribution of performance 
category weights for small practices. The following is a summary of the 
comments we received and our responses.
    Comment: Many commenters support CMS' proposal to redistribute the 
Promoting Interoperability weight in efforts to reduce burden on small 
practices.
    Response: We thank the commenters for their support and feedback.
    Comment: A few commenters supported CMS' proposal to redistribute 
the Promoting Interoperability weight for small practices but provided 
additional comments. A few commenters suggested that CMS apply this 
redistribution matrix to all practices particularly given that the 
performance threshold is increasing. A few commenters suggested that 
CMS allow for small practices to choose between reweighting of the 
quality performance category and improvement activities categories to 
50 percent each and the standard reweighting option of quality 
performance category and improvement activities performance category. 
Another commenter suggests that CMS score small practices using both 
redistribution scenarios and apply the higher of the two scores to the 
final score. Finally, one commenter recommended that CMS distribute the 
weight more evenly across the MIPS performance categories.
    Response: We continue to believe that it is appropriate to 
redistribute the Promoting Interoperability performance category weight 
across the quality and improvement activities performance categories as 
proposed for small practices. More specifically, we believe this is 
appropriate, given the infrastructure and resource limitations within 
small practices, to place more emphasis on a performance category that 
poses a reduced reporting burden such as the improvement activities 
performance category. We do not believe it necessary to provide small 
practice clinicians with a choice of which redistribution matrix they 
would like applied since we believe this would add burden by requiring 
small practices to inform CMS as how they would like to be scored--
contradicting our reasoning for establishing this policy. Given the 
additional burden and resource limitations known to impact small 
practices to an extent greater than non-small practice clinicians, we, 
at this time, continue to believe this policy should remain limited to 
small practices. We also choose not to take the higher of the two 
scores for small practices as this may create an unfair advantage 
across MIPS eligible clinicians and we will continue to monitor this 
policy to ensure that there are no inadvertent impacts.
    After consideration of public comments, we finalize the proposed 
redistribution policies for small practices at Sec.  
414.1380(c)(2)(ii)(G), as shown in Table 64, beginning with the CY 2022 
performance period/2024 MIPS payment year.

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Vol. 86

Friday,

No. 221

November 19, 2021

Part II

Book 2 of 2 Books

Pages 65523-66150





 Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Parts 400, 410, 414, et al.



Medicare Program; CY 2022 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Provider Enrollment Regulation Updates; 
and Provider and Supplier Prepayment and Post-Payment Medical Review 
Requirements; Final Rule

Federal Register / Vol. 86 , No. 221 / Friday, November 19, 2021 / 
Rules and Regulations
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AGENCY: 

ACTION: 

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[GRAPHIC] [TIFF OMITTED] TR19NO21.091

(iv) MIPS Reweighting Based on Extreme and Uncontrollable Circumstances
(A) MIPS Applications for Reweighting for the CY 2021 Performance 
Period/2023 MIPS Payment Year Based on Extreme and Uncontrollable 
Circumstances
    We anticipate that the national PHE for COVID-19 will continue 
through CY 2021. Therefore, we remind clinicians that the application-
based extreme and uncontrollable circumstances policy, as described in 
Sec.  414.1380(c)(2)(i)(A)(6) and (c)(2)(i)(C)(2), will be available 
for the CY 2021 performance period/2023 MIPS payment year (85 FR 84916 
through 84917). Please refer to https://qpp.cms.gov/about/covid19?py=2021 for details. The application allows clinicians, groups, 
and virtual groups significantly impacted by the PHE for COVID-19 to 
request reweighting for any or all MIPS performance categories. Under 
this policy, if a clinician, group, or virtual group submits a 
reweighting application and also submits data for a performance 
category for which an application was submitted, the data submission 
will override the application, and the clinician, group, or virtual 
group will be scored on the data submitted.
    Additionally, if an application is submitted for one performance 
category only, and data is submitted for the other 2 performance 
categories, only the performance category for which the application was 
submitted will be reweighted and the other performance categories will 
be scored. We believe this approach maintains a balance of encouraging 
participation in the Quality Payment Program while still providing for 
flexibility in weighting the performance categories for those who have 
been affected by the national PHE for COVID-19. Please refer to https://qpp.cms.gov/about/covid19?py=2021 for more information.
(B) MIPS Reweighting Based on Extreme and Uncontrollable Circumstances; 
Automatic and Application-Based Policies Clarification
    Under the application-based extreme and uncontrollable 
circumstances policy codified at Sec.  [thinsp]414.1380(c)(2)(i)(A)(6) 
for the quality, cost, and improvement activities performance 
categories and at Sec.  414.1380(c)(2)(i)(C)(2) for the promoting 
interoperability performance category, clinicians who are subject to 
extreme and uncontrollable circumstances may submit an application to 
CMS to request reweighting of a performance category or categories. We 
also established an automatic extreme and uncontrollable circumstances 
policy at Sec.  414.1380(c)(2)(i)(A)(8) for the quality, cost, and 
improvement activities performance categories and at Sec.  
414.1380(c)(2)(i)(C)(3) for the promoting interoperability performance 
category, under which we automatically reweight the performance 
categories for clinicians who are located in an area affected by 
extreme and uncontrollable circumstances as identified by us.
    Based on stakeholder inquiries, we recognize not all stakeholders 
understand how individual MIPS eligible clinicians who are eligible for 
reweighting under the automatic extreme and uncontrollable 
circumstances policy and who also submit an application for reweighting 
based on extreme and uncontrollable circumstances are affected by the 
intersection of these policies. Currently, under both the application-
based and automatic extreme and uncontrollable circumstances policies, 
if a MIPS eligible clinician who is located in an area affected by 
extreme and uncontrollable circumstances as identified by CMS submits 
data for any of the MIPS performance categories by the applicable 
submission deadline for the MIPS performance period, they will be 
scored on each performance category for which they submit data, and the 
performance category will not be reweighted to zero percent in the 
final score. Under the automatic extreme and uncontrollable 
circumstances policy, the other performance categories for which data 
was not submitted will remain reweighted to zero percent (82 FR 53898, 
83 FR 59874). Additionally, as described in the CY 2019 PFS final rule 
(83 FR 59874), under the automatic extreme and uncontrollable 
circumstances policy, a MIPS eligible clinician who is located in an 
area affected by extreme and uncontrollable circumstances as identified 
by CMS will

[[Page 65525]]

not be scored on the cost performance category. As we stated in the CY 
2019 PFS final rule (83 FR 59874), if a MIPS eligible clinician is 
located in an affected area, we would assume the clinician does not 
have sufficient cost measures applicable to him or her and assign a 
weight of zero percent to that category in the final score, even if we 
receive administrative claims data that will enable us to calculate the 
cost measures for that clinician.
    The following example is intended to illustrate the intersection of 
the automatic and application-based extreme and uncontrollable 
circumstances policies. A MIPS eligible clinician who is located in an 
area affected by extreme and uncontrollable circumstances as identified 
by CMS and eligible for the automatic extreme and uncontrollable 
circumstances policy submits an application for reweighting based on 
extreme and uncontrollable circumstances. The application requests 
reweighting for the Promoting Interoperability performance category, 
and the clinician submits data for the quality and improvement 
activities performance categories. The clinician will be scored on the 
quality and improvement activities performance categories because they 
submitted data for those categories; the cost performance category is 
reweighted to zero percent under the automatic extreme and 
uncontrollable circumstances policy, as discussed above; and the 
Promoting Interoperability performance category is also reweighted to 
zero percent under the automatic extreme and uncontrollable 
circumstances policy. The application for reweighting was not needed in 
this example to reweight the Promoting Interoperability performance 
category.
    Please refer to https://qpp.cms.gov/about/covid19?py=2021 for more 
information.
(v) Redistributing Performance Category Weights for Facility-Based 
Measurement
(A) Background
    In the CY 2018 Quality Payment Program final rule, we established 
facility-based measurement under section 1848(q)(2)(C)(ii) of the Act 
which provides that the Secretary may use measures used for payment 
systems other than for physicians, such as measures for inpatient 
hospitals, for purposes of the quality and cost performance categories 
(82 FR 53752 through 53767). Scoring under facility-based measurement 
was available for clinicians beginning with the CY 2019 performance 
period/2021 MIPS payment year. We established facility-based 
measurement to better align incentives between facilities and the MIPS 
eligible clinicians who provide services there (82 FR 53753). For more 
background on facility-based measurement, we refer readers to both the 
CY 2018 Quality Payment Program final rule (82 FR 53752 through 53767) 
and the CY 2019 PFS final rule (83 FR 59856 through 59867).
(B) Redistribution of Performance Category Weights Under Facility-Based 
Measurement
    In the CY 2019 PFS final rule, we established that clinicians and 
groups would not need to elect or opt-in to facility-based measurement, 
but instead we would automatically apply facility-based measurement to 
MIPS eligible clinicians and groups who are eligible for facility-based 
measurement and who would benefit by having a higher combined quality 
and cost performance category score (83 FR 59863). In this same final 
rule, we finalized policies for redistributing weight among the 
performance categories for the CY 2019 performance period/2021 MIPS 
payment year under Sec.  414.1380(c)(2)(ii)(C). Under those 
redistribution policies, if the cost performance category is reweighted 
to zero percent of the final score, its weight is redistributed 
entirely to the quality performance category, unless the quality 
performance category is reweighted to zero percent, in which case the 
quality and cost performance category weights would be redistributed to 
the improvement activities and Promoting Interoperability performance 
categories. A clinician or group could have the weight of the cost 
performance category redistributed because they did not meet the case 
minimum for any of the measures in the cost performance category. 
Because facility-based measurement always includes both the quality and 
cost performance categories, it is possible a clinician or group would 
be scored on the cost performance category under facility-based 
measurement but not outside of facility-based measurement. There are 
two common scenarios for a facility-based clinician or group which 
could occur in the CY 2019 performance period/2021 MIPS payment year. 
In the first scenario, a facility-based clinician or group meets the 
case minimum for at least one cost performance category measure and 
receives a cost performance category percent score as defined at Sec.  
414.1380(b)(2). The respective quality and cost scores will be 
multiplied by the available points in the quality performance category 
(45 points) and the available points in the cost performance category 
(15 points) to determine the combined contribution of the quality 
performance category and the cost performance category to the final 
score out of the available 60 points. In the second scenario, a 
facility-based clinician or group does not meet the case minimum for 
any cost performance category measure and the cost performance category 
weight is redistributed to the quality performance category so the 
quality performance category score alone determines the score out of 
the available 60 points. Table 65 shows these two scenarios.
[GRAPHIC] [TIFF OMITTED] TR19NO21.092


[[Page 65526]]


    In the CY 2020 PFS final rule, we established a redistribution 
policy for the CY 2020 performance period/2022 MIPS payment year at 
Sec.  414.1380(c)(2)(ii)(D), for scenarios when the cost performance 
category weight is redistributed to the Promoting Interoperability 
performance category, as well as to the quality performance category 
(84 FR 63028). Under this policy, the weights of the combined quality 
and cost performance categories could be different for a clinician or 
group under facility-based measurement and outside of facility-based 
measurement in circumstances in which the clinician or group was not 
scored on the cost performance category outside of facility-based 
measurement but was scored on all other performance categories. Table 
66 shows the scenario in which the combined weights of the quality and 
cost performance categories differ if cost is included, which occurs 
when the cost performance category is redistributed, and all other 
categories are scored.
[GRAPHIC] [TIFF OMITTED] TR19NO21.093

    We established similar redistribution policies for CY 2021 
performance period/2023 MIPS payment year and CY 2022 performance 
period/2024 MIPS payment year at Sec.  414.1380(c)(2)(ii)(E) and (F) in 
that same rule (84 FR 63029 through 63031), which also described 
situations where the combined weight of the cost and quality 
performance categories was not always consistent. For more on the 
background and proposed policies related to redistribution of 
performance categories, please see section IV.A.3.e.(2)(b)(iii) of this 
final rule.
    Based on inquires we received from clinicians who were eligible for 
facility-based measurement, we believe our policy for determining the 
combined quality and cost performance category scores via facility-
based measurement and outside of facility-based measurement is not 
ideal because it could result in a facility-based clinician or group 
receiving a lower final score than they would otherwise receive outside 
of facility-based measurement. We considered whether this more complex 
consideration of the scores and the weights in the performance 
categories necessitated a reconsideration of an opt-in requirement for 
facility-based measurement. However, we believe that establishing such 
a requirement would create administrative burden for clinicians and 
groups.
    Instead of adding an opt-in requirement, we proposed a new policy 
to determine the MIPS final score for clinicians and groups who are 
eligible for facility-based measurement. We proposed at Sec.  
414.1380(e)(6)(vi)(B) that beginning with the CY 2022 performance 
period/2024 MIPS payment year, the MIPS quality and cost performance 
category scores will be based on the facility-based measurement scoring 
methodology unless a clinician or group receives a higher MIPS final 
score through another MIPS submission. Under this proposed policy, we 
will calculate two final scores for clinicians and groups who are 
facility-based. One score will be based on the clinician or group's 
performance and the weights of the performance categories if facility-
based measurement did not apply, and the other will be based on the 
application of facility-based measurement. The example below shows how 
this proposed policy will apply for a facility-based group that did not 
meet the case minimum for any of the cost measures but was scored on 
all other performance categories.
[GRAPHIC] [TIFF OMITTED] TR19NO21.094

    As a result of this policy, the group in this example will receive 
a final score on the basis of their performance outside of facility-
based measurement because they have obtained a higher final score 
through the combination of their submitted quality measures, submitted 
improvement activities and submitted promoting interoperability 
measures.
    We solicited comments on this proposal.
    We received public comments on the redistribution of performance 
category weights under facility-based measurement. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters supported CMS' proposal to take the 
higher of the two scores when

[[Page 65527]]

determining the final score for facility-based eligible clinicians and 
groups. One commenter suggested that CMS adopt this policy starting 
from CY 2021 performance period/2023 MIPS payment year.
    Response: We thank the commenters for their support and feedback 
and note that, as mentioned in the 2021 Facility-Based Measurement 
Quick Start Guide, because the FY 2022 total performance score from the 
Hospital Value-Based Purchasing Program will be unavailable, we will 
not be able to calculate MIPS facility-based scores for the CY 2021 
MIPS performance period/2023 MIPS payment year.\259\ Please refer to 
https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1293/2021%20MIPS%20Facility%20Based%20Quick%20Start%20Guide.pdf for more 
information.
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    \259\ https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1293/2021%20MIPS%20Facility%20Based%20Quick%20Start%20Guide.pdf.
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    After consideration of public comments, we finalize the proposal at 
Sec.  414.1380(e)(6)(vi)(B) that beginning with the CY 2022 performance 
period/2024 MIPS payment year, the MIPS quality and cost performance 
category scores will be based on the facility-based measurement scoring 
methodology unless a clinician or group receives a higher MIPS final 
score through another MIPS submission.
f. MIPS Payment Adjustments
(1) Background
    For our previously established policies regarding the final score 
used to determine MIPS payment adjustments we refer readers to the CY 
2021 PFS final rule (85 FR 84917 through 84926), CY 2020 PFS final rule 
(84 FR 63031 through 63045), CY 2019 PFS final rule (83 FR 59878 
through 59894), CY 2018 Quality Payment Program final rule (82 FR 53785 
through 53799) and CY 2017 Quality Payment Program final rule (81 FR 
77329 through 77343). In the CY 2022 PFS proposed rule (86 FR 39453 
through 39458), we proposed: (1) To select the mean as our methodology 
for calculating the performance threshold; (2) to establish the 
performance threshold for the 2024 MIPS payment year using 2019 MIPS 
payment year data; (3) to establish the additional performance 
threshold for exceptional performance for the 2024 MIPS payment year; 
and (4) to update the scoring hierarchy to include subgroups. In 
addition, we are including information about our timing for providing 
MIPS performance feedback to clinicians for the performance period in 
2020.
(2) Establishing the Performance Threshold
    Under section 1848(q)(6)(D)(i) of the Act, for each year of MIPS, 
the Secretary shall compute a performance threshold with respect to 
which the final scores of MIPS eligible clinicians are compared for 
purposes of determining the MIPS payment adjustment factors under 
section 1848(q)(6)(A) of the Act for a year. The performance threshold 
for a year must be either the mean or median (as selected by the 
Secretary, and which may be reassessed every 3 years) of the final 
scores for all MIPS eligible clinicians for a prior period specified by 
the Secretary.
    Section 1848(q)(6)(D)(iii) of the Act included a special rule for 
the initial 2 years of MIPS, which requires the Secretary, prior to the 
performance period for such years, to establish a performance threshold 
for purposes of determining the MIPS payment adjustment factors under 
section 1848(q)(6)(A) of the Act and an additional performance 
threshold for purposes of determining the additional MIPS payment 
adjustment factors under section 1848(q)(6)(C) of the Act, each of 
which shall be based on a period prior to the performance period and 
take into account data available for performance on measures and 
activities that may be used under the performance categories and other 
factors determined appropriate by the Secretary. Section 51003(a)(1)(D) 
of the Bipartisan Budget Act of 2018 (Pub. L. 115-123, February 9, 
2018) amended section 1848(q)(6)(D)(iii) of the Act to extend the 
special rule to apply for the initial 5 years of MIPS instead of only 
the initial 2 years of MIPS.
    In addition, section 51003(a)(1)(D) of the Bipartisan Budget Act of 
2018 added a new clause (iv) to section 1848(q)(6)(D) of the Act, which 
includes an additional special rule for the third, fourth, and fifth 
years of MIPS (the 2021 through 2023 MIPS payment years). This 
additional special rule provides, for purposes of determining the MIPS 
payment adjustment factors under section 1848(q)(6)(A) of the Act, in 
addition to the requirements specified in section 1848(q)(6)(D)(iii) of 
the Act, the Secretary shall increase the performance threshold for 
each of the third, fourth, and fifth years to ensure a gradual and 
incremental transition to the performance threshold described in 
section 1848(q)(6)(D)(i) of the Act (as estimated by the Secretary) 
with respect to the sixth year (the 2024 MIPS payment year) to which 
the MIPS applies.
    We have applied these special rules for the past 5 years to provide 
for a gradual and incremental transition to the year 6 performance 
threshold. For further information on established 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 (82 
FR 53787 through 53794), CY 2019 PFS final rule (83 FR 59880 through 
59883), the CY 2020 PFS final rule (84 FR 63031 through 63037), and the 
CY 2021 PFS final rule (85 FR 84919 through 84923). We codified the 
performance thresholds for each of the first 5 years of MIPS at Sec.  
414.1405(b)(4), (5), (6), (7), and (8) as presented in Table 68.

[[Page 65528]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.095

    In the CY 2020 PFS final rule (84 FR 63031 through 63037) at Sec.  
414.1405(b)(7) and (8), we finalized the performance thresholds for the 
2022 and 2023 MIPS payment years at 45 and 60 points, respectively, an 
increase of 15 points each year until the 2024 MIPS payment year, for 
which we estimated that the performance threshold would be 74.01 
points. We believe that this approach effectively provided for a 
gradual and incremental transition to the performance threshold we had 
estimated for the 2024 MIPS payment year, as required by the statute.
    Beginning with the 2024 MIPS payment year, section 1848(q)(6)(D)(i) 
of the Act requires the performance threshold to be 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. That section also provides that the Secretary may reassess 
the selection of the mean or median every 3 years. Thus, we considered 
whether to use the mean or median as the methodology for determining 
the performance threshold. We will use this methodology to determine a 
performance threshold for each of the following 3 years: The 2024 MIPS 
payment year, 2025 MIPS payment year, and 2026 MIPS payment year. We 
would then reassess and establish the methodology (mean or median) that 
we will use for each of the next 3 years (2027 MIPS payment year, 2028 
MIPS payment year, and 2029 MIPS payment year). At the time of drafting 
of this final rule, we have final score data from the CY 2017 
performance period/2019 MIPS payment year through the CY 2020 
performance period/2022 MIPS payment year available to use in our 
assessment of whether to use the mean or median as our methodology for 
the next 3 years. At this time, however, the targeted review process 
(see Sec.  414.1385) for the CY 2020 performance period/2022 MIPS 
payment year has not yet concluded, and the data for the CY 2020 
performance period/2022 MIPS payment year may be subject to change as a 
result of targeted review which began on August 2, 2021, and will 
conclude on November 29, 2021, at 8:00 p.m., eastern standard time. For 
more information on the targeted review process, see our announcement 
sent to our list serve on September 27th, 2021 available at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1631/2020%20Scoring%20Updates_EUC%20Reweighting%20Requests%20Extension_Listserv.pdf.
    We do not believe it would be appropriate to consider mean and 
median final scores from the CY 2020 performance period/2022 MIPS 
payment year for purposes of establishing the performance threshold for 
the 2024 MIPS payment year in this final rule when those scores may be 
subject to change as a result of the targeted review process. 
Furthermore, we are not utilizing final scores from the CY 2020 
performance period/2022 MIPS payment for the creation of our regulatory 
impact analysis model. For a detailed discussion of the RIA 
methodology, including the basis of our decision to not use CY 2020 
performance period/2022 MIPS payment year data, please see section 
VI.F.18.a of this final rule.
    From our review of the data available to us, we have identified the 
mean and median final scores for each of the 2019 through 2021 MIPS 
payment years, as shown in Table 69. These six values represent the 
prior year mean and median final scores that we considered for the 2024 
MIPS payment year performance threshold.
[GRAPHIC] [TIFF OMITTED] TR19NO21.096

    As shown in Table 69, using the median final score gives a possible 
range of performance thresholds from 89.71 points to 99.63 points. 
Given our performance threshold of 60 points in year 5, these values 
would result in an increase of 29.71 points to 39.63 points for year 6. 
Selecting the median of final scores as our methodology would, at a 
minimum, nearly double the annual increase in the performance threshold 
of 15 points that we had from year 2 to year 5 of the program. Section 
1848(q)(6)(D)(iv) of the Act required that we increase the performance 
threshold for each of the third, fourth, and fifth years of MIPS to 
ensure a gradual and incremental transition to the performance 
threshold we estimated with respect to the sixth year of MIPS. In prior 
rules we estimated the year six

[[Page 65529]]

performance threshold to be 74.01 points and used this estimate to 
determine how to gradually raise the performance threshold (83 FR 
59881, 84 FR 63032, 84 FR 40802). Although section 1848(q)(6)(D)(iv) of 
the Act does not require this approach for the sixth year and 
subsequent years of MIPS, we believe that it is appropriate to set the 
performance threshold at a level that is in line with our previous 
estimates for year 6. We believe that continuing the gradual and 
incremental increase into year 6 would provide consistency to our 
stakeholders. After evaluating the possible values shown in Table 69, 
we believe that using the mean as our methodology would continue this 
approach.
    Using the mean final score as the methodology would yield a 
possible range of performance thresholds from 74.65 points to 85.61 
points (rounded to 75 points and 86 points respectively). Given our 
performance threshold of 60 points in year 5, these values would result 
in an increase of 15 points to 26 points for year 6. Given these values 
and our annual performance threshold increases of 15 points for years 2 
to 5 of the program, 75 is the value that is most consistent with the 
gradual and incremental approach that we have elected to continue. 
Therefore, we proposed at Sec.  414.1405(g) 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 Sec.  414.1405(b). This methodology will be 
used for MIPS payment years 2024 through 2026 of the program after 
which we will reassess the methodology for MIPS payment years 2027 
through 2029.
    In addition to selecting the methodology (mean or median), section 
1848(q)(6)(D)(i) of the Act also requires us to specify a prior period 
from which we will use the final scores for all MIPS eligible 
clinicians to calculate the mean or median. As shown in Table 69, the 
mean final scores are 74.65, 87, and 85.61 points for MIPS payment 
years 2019 through 2021 respectively. In previous rules (83 FR 59881, 
84 FR 63032), we used the MIPS payment year 2019 mean final score to 
estimate a performance threshold of 74.01 points for year 6 of the 
program. Our data have been updated to reflect completed targeted 
reviews since the time we made this estimate, and the mean final score 
for the 2019 MIPS payment year is now 74.65 points (see Table 69). This 
value would be an increase of almost exactly 15 points from the MIPS 
payment year 2023 performance threshold of 60 points, which is 
identical to the increases of the previous 3 years and consistent with 
our intention to continue the gradual and incremental approach that has 
been utilized in prior years. After reviewing the available final score 
data, we proposed at Sec.  414.1405(b)(9) to use the MIPS payment year 
2019 as the prior period and the rounded mean final score of 75 points 
as the year 6 performance threshold. When we establish the performance 
threshold for future MIPS payment years in future rulemaking, we will 
reassess using the mean final score for MIPS payment year 2019 as mean 
final scores for subsequent years become available.
    We solicited comments on these proposals, as well as the 
alternative methodology of the median that we considered but did not 
propose. Additionally, we solicited comments on calculating the 
performance threshold using an alternative year's final scores that we 
considered but did not propose.
    We received public comments on establishing the performance 
threshold. The following is a summary of the comments we received and 
our responses.
    Comment: One commenter requested that CMS not roll back or reduce 
the performance threshold from its current value with the transition to 
MVPs in future years. The commenter believes that the extended phase in 
of the performance threshold under traditional MIPS was not necessary 
and had the unintended consequence of clinicians not taking MIPS as 
seriously as they should have. The commenter also stated that any 
phase-in does not advance the goals of transitioning to value-based 
care.
    Response: In future years of the program we will evaluate the data 
available to us and select a performance threshold in accordance with 
the requirements of the statute. The gradual and incremental increase 
in the performance threshold gave clinicians time to anticipate the 
transition to the statutorily mandated methodology for the performance 
threshold beginning in year six. The CY 2022 performance period/2024 
MIPS payment year is the first year of the program where CMS does not 
have additional flexibilities and must set the performance threshold at 
the mean or median of a prior year's final scores, thus ending the 
performance threshold transition period. While we agree with the 
commenter that further phase in of the performance threshold is not 
needed, it is possible the performance threshold numerical value for a 
future year could be lower than the numerical value for the CY 2022 
performance period/2024 MIPS payment year, depending on the final score 
data available.
    Comment: One commenter believes that data from the CY 2019 
performance period/2021 MIPS payment year is a better basis for 
creating performance thresholds than the CY 2017 performance period/
2019 MIPS payment year. The commenter believes that the entire 
structure of the program as far as scoring was very different in 2017 
and that 2019 offers a more accurate picture compared to 2017.
    Response: We understand that the program has undergone 
modifications since the CY 2017 performance period/2019 MIPS payment 
year. However, we have previously stated our intent to use a gradual 
and incremental approach to raising the performance threshold. For 
reference, the mean and median final scores for CY 2019 performance 
period/2021 MIPS payment year are 85.61 and 92.30 respectively and 
would represent an increase in the performance threshold of 25.61 or 
32.3 points. We raised the performance threshold 12 points from CY 2017 
performance period/2019 MIPS payment year to CY 2018 performance 
period/2020 MIPS payment year and raised the performance threshold 15 
points in each subsequent year. We believe that raising the performance 
threshold 15 points in CY 2022 performance period/2024 MIPS payment 
year is consistent with our gradual and incremental approach. We 
recognize that clinicians are facing ongoing difficulties due to the 
PHE, and we believe that choosing the lowest performance threshold 
value available to us would gradually increase the performance 
threshold while minimizing disruption to clinicians during this 
emergency.
    Comment: Several commenters supported setting the performance 
threshold at 75 and using the mean from a prior performance period. 
Some commenters stated the 15-point increase aligns with the gradual 
increase over the last 4 years. One commenter stated it was an 
attainable goal. A few commenters stated this meant having a larger 
budget neutral pool to redistribute funds, but one commenter requested 
more information about impact to their specialty. One commenter 
supported that it was the lowest of the possible options.
    Response: We thank the commenters for their support for setting the 
performance threshold for the CY 2022 performance period/2024 MIPS 
payment year at 75 points, for noting that the 15-point increase is the 
same magnitude as the change in prior years, and for noting that the 
performance threshold selected was the lowest of the

[[Page 65530]]

possible options. Overall information on prior year's final scores can 
be found in the corresponding Quality Payment Program Experience Report 
and specialty specific information can be found in the Public Use File 
in the QPP resource library (https://qpp.cms.gov/resources/resource-library).
    Comment: A few commenters expressed concern with the proposed 
performance threshold, specifically for small practices. A few 
commenters requested setting a separate performance threshold for small 
practices at a value such as 60, or setting the performance threshold 
for other practices higher at 85 points.
    Response: We appreciate this feedback from commenters. However, as 
we previously discussed, the statute requires us to set the performance 
threshold at the mean or median of a prior period's final scores, and 
we do not have the statutory authority to establish a separate 
performance threshold for small practices. We also note that CMS does 
not have the authority to waive the statutory requirements for setting 
the performance threshold using our extreme and uncontrollable 
circumstances policies or section 1135 of the Act. We encourage the 
commenters to look at our estimates of how our proposed policies will 
affect the payment adjustments, broken down by practice size, for the 
MIPS 2024 payment year in our regulatory impact analysis (see section 
VI.F.18.e of this final rule). As shown in the impact analysis, we 
project the discrepancy in payment adjustments between large and small 
practices to shrink as a cumulative result of our policies, including 
raising the performance threshold.
    Comment: Many commenters opposed the proposed performance threshold 
and recommended that CMS lower the performance threshold. Most of these 
commenters requested that CMS explore ways to use its authority to 
adjust the performance threshold beginning with the CY 2022 performance 
period/2024 MIPS payment year. Commenters specifically requested that 
CMS consider emergency authorities under the PHE such as the section 
1135 waiver authority or its Extreme and Uncontrollable Circumstances 
policy. Commenters noted the stress of the continuing pandemic on 
practices; that the proposed performance threshold of 75 points 
represents a significant increase from the 30 points in 2019 or 45 
points for 2020. A few commenters acknowledged that CMS has chosen the 
lowest value possible (75 points), but the commenters believe that 
positive payment adjustments will become more difficult to obtain, 
especially as the COVID-19 pandemic continues. One commenter expressed 
concern that clinicians may become frustrated and lose motivation to 
engage with the MIPS program. Another commenter stated that the steep 
increases in the performance threshold assumes that practices will not 
only perform, as well as they did before COVID-19 but that they will be 
able to perform better than before. Some commenters stated that CMS 
should establish a transitional policy that recognizes the impact of 
the COVID-19 PHE. One commenter appreciated the flexibilities that CMS 
has put in place during the pandemic and urges CMS not to flip a switch 
in 2022 as if the past 3 years have been business as usual. A few 
commenters suggested lower performance threshold levels, including 60, 
50 and 45. One commenter requested that CMS delay the increase to the 
performance threshold until the implementation of MVPs.
    Response: We understand the commenters concern about the stress the 
PHE is putting on practices. However, we do not have the authority to 
set the performance threshold for MIPS payment year 2024 at a value 
other than the mean or median of the final scores with respect to a 
prior period, as required by section 1848(q)(6)(D)(i) of the Act. We 
agree that positive payment adjustments could be more difficult to 
obtain with a higher performance threshold and are actively working to 
keep clinicians engaged with the introduction of MVPs which provide a 
streamlined way for clinicians to participate in the program with a set 
of measures that are relevant to their practice. We understand that the 
performance threshold of 75 represents a steep increase from the pre-
pandemic performance threshold of 45 points, which was applicable for 
the CY 2019 performance period/2021 MIPS payment year. For the past 4 
years we have finalized increases of 15 points. We increased the 
performance threshold from 15 to 30 between the CY 2018 and 2019 
performance periods/2020 and 2021 MIPS payment years, from 30 to 45 
between the CY 2019 and 2020 performance periods/2021 and 2022 MIPS 
payment years, and from 45 to 60 between the CY 2020 and 2021 
performance periods/2022 and 2023 MIPS payment years. We acknowledge 
the commenter's concern that this increase assumes that clinicians will 
not only perform, as well as they did before COVID-19 but that they 
will be able to perform better than before. We note that the proposed 
increase of 15 points is the same as the increase in the previous 3 
years and was based on a gradual and incremental approach to setting 
the performance threshold. As discussed previously, we are statutorily 
required to set the performance threshold for the 2024 MIPS payment 
year at the mean or median of the final scores with respect to a prior 
period, and we do not have the flexibility to choose other values. We 
appreciate the commenter's suggestion to adopt a transitional policy 
for the performance threshold due to the PHE but reiterate that we do 
not have the flexibility to do so due to the statutory requirements 
discussed previously. We also note that CMS does not have the authority 
to waive the statutory requirements for setting the performance 
threshold under section 1135 of the Act.
    Comment: A few commenters opposed the proposed performance 
threshold for specialty related or practice related reasons. A few 
commenters were specifically concerned about groups or specialties that 
can only be measured on two performance categories. One commenter 
expressed their opinion that setting the performance threshold at the 
mean or median of prior final scores of all MIPS eligible clinicians in 
a prior period was an unfair standard for their specialty because they 
are limited in their ability to report under the Promoting 
Interoperability performance category. They stated this limitation 
gives them fewer opportunities to amass points. Another commenter 
stated that their group was unable to report Promoting Interoperability 
performance category measures and would be reweighted in a manner that 
would increase their cost category weight. A different commenter stated 
that they have a limited number of quality measures that they can 
report. As a result, they stated that for groups such as theirs that 
have limited measures and a high-weighted quality category, CMS now 
requires 100 percent quality to meet the performance threshold or 
otherwise they would receive a negative MIPS payment adjustment.
    One commenter expressed concern that CRNAs cannot report 6 of the 
measures in the MIPS Anesthesia Measure set because they do not provide 
relevant services. The commenter suggested CMS should address how 
specialties such as anesthesia can meet the performance threshold, 
perhaps through the use of CAHPS data or by allowing them to report 
additional Improvement Activities.
    Response: We understand that different specialties sometimes face 
challenges with not being able to report

[[Page 65531]]

measures and activities for every performance category. We agree that 
the final scores of these clinicians may be based on fewer categories 
than they would be for a clinician reporting all 4 performance 
categories. However, we remind clinicians that even if their final 
score is based on fewer than 4 performance categories they still have 
the ability to score anywhere from 0 to 100 points for their final 
score, just as a clinician reporting all 4 performance categories 
would. In this way, we do not believe that a performance threshold of 
75 points is disadvantageous to clinicians reporting fewer than 4 
performance categories. As stated below, we also encourage clinicians 
that do not have enough quality measures relevant to their scope of 
practice to work with their specialty societies to provide 
recommendations during the specialty measure set solicitation process 
and to consider reporting a relevant MVP when one becomes available.
    We note, for the commenter who stated that not being able to report 
Promoting Interoperability would cause their group to be reweighted in 
a manner that would increase their cost category weight, that the cost 
category weight would only increase if a group was reweighted for the 
Promoting Interoperability and Quality performance categories. If a 
group is reweighted for the Promoting Interoperability performance 
category only, the cost category weight remains at 30 percent. We 
believe the commenter who stated that they have a limited number of 
quality measures that they can report is referring to the possibility 
that if the weight of other performance categories is redistributed to 
the quality category, a clinician may need to achieve a high score in 
quality in order to exceed the proposed performance threshold of 75 
points. We understand that some clinicians may not have 6 measures in 
the Quality performance category that are relevant to their practice. 
To address this, we have our eligible measure applicability policy 
within the quality performance category to reduce the denominator of 
required measures for the MIPS CQM and Medicare Part B claims 
collection types, in the event that a clinician has less than 6 
applicable measures to report. In this way, clinicians can be scored on 
the quality measures that are relevant to their scope of practice. For 
more information on the eligible measure applicability policy please 
see the CY 2017 through CY 2019 PFS final rules (81 FR 77290 through 
77291, 82 FR 53750 through 53732).
    For the commenter's concerns on the specialty measures available, 
we solicit stakeholder recommendations for new specialty measure sets 
and revisions to existing specialty sets on an annual basis. We urge 
stakeholders to work with their specialty societies to provide 
recommendations during the specialty measure set solicitation process 
(for more information please see the QPP resource library at http://www.qpp.cms.gov). We are also developing MIPS Value Pathways (MVPs) to 
provide clinicians with a simplified method to report measures that are 
relevant to their practice and we encourage them to report an MVP when 
one that is relevant to their scope of practice is available. We thank 
the commenter for their suggestion to expand the use of CAHPS or to 
allow clinicians to report additional improvement activities if they 
cannot report 6 quality measures.
    Comment: Many commenters expressed concern that the proposal to 
increase the performance threshold to 75 points would increase the 
number of clinicians receiving a negative payment adjustment and 
decrease the number of clinicians with positive or neutral adjustments. 
Many commenters also stated their concern that the increase in the 
performance threshold comes with several proposed policies to remove 
bonuses and floors for quality measures and proposals to change quality 
data completeness which may lower the MIPS final score. A few 
commenters requested that CMS reconsider the reporting and scoring 
policies, delay the scoring policies, or gradually phase in the scoring 
changes, especially if CMS finalized the proposed performance 
threshold. One commenter specifically requested continuing current 
scoring for an additional year. A few commenters noted the difficulty 
of achieving the performance threshold now compared to a few years ago 
because of the scoring changes. A few commenters noted the cost of 
participating in MIPS versus the potential incentive. One commenter 
cited a study on the cost to participate in MIPS and expressed concern 
that clinicians would still get negative MIPS payment adjustment after 
these costs due to a premature increase in the performance threshold 
following 3 years of flexibilities due to the COVID-19 PHE.
    Response: We acknowledge the commenters concerns regarding the 
increased burden on clinicians due to the COVID-19 PHE and agree that 
the statutory formula for determining the performance threshold 
beginning with the 2024 MIPS payment year could lead to additional 
clinicians receiving a negative payment adjustment. The MIPS is a 
budget neutral program and is designed in the statute to balance the 
positive payment adjustments of clinicians who score above the 
performance threshold against the negative payment adjustments of 
clinicians whose scores are below the performance threshold. We 
encourage the commenter to look at our estimates of how our proposed 
policies will affect the payment adjustments for the MIPS 2024 payment 
year in our regulatory impact analysis (see section VI.F.18.e of this 
final rule). In light of the continuing burden of the PHE we are making 
changes to some scoring flexibility proposals including postponing the 
removal of the 3-point scoring floor on quality measures and keeping 
the data completeness threshold at 70 percent (see section 
IV.A.3.e.(1)(c)(iii)(B) of this final rule). We are also introducing 
some new flexibilities including a 7-point floor for scoring new 
measures in their first year and a 5-point floor in their second year 
(see section IV.A.3.e.(1)(c)(iii)(B) of this final rule).
    Comment: A few commenters discussed refinements for the performance 
threshold methodology. One commenter suggested CMS determine what the 
mean or median of ``raw'' or ``achievement'' final performance scores 
would be and use that figure to set the 2022 threshold. The commenter 
stated that CMS only uses the base quality measure score, absent any 
bonus points, to determine improvement scoring in the Quality category. 
Therefore, the commenter stated that method could be used in setting 
the performance threshold as well. Another commenter recommended that 
CMS evaluate balancing the reported data from 2019, 2020, and 2021 to 
control for self-selection bias since the commenter believed MIPS 
reporting has been fundamentally voluntary for these performance 
periods. One commenter asked what the agency's intent is with respect 
to performance thresholds and quality benchmark data going forward 
given that CY 2022 performance period/2024 MIPS payment year benchmarks 
will be based on CY 2022 performance period data while CY 2024 
performance period/2026 MIPS payment year benchmarks appear to revert 
to performance period 2017 data. The commenter noted the performance 
threshold is based on CY 2017 performance period data while benchmarks 
are proposed to be based on CY 2022 performance period data.
    Response: We appreciate the commenter's suggestion to use a ``raw'' 
or ``achievement'' score to set the performance threshold; we interpret 
the

[[Page 65532]]

suggestion of ``raw'' or ``achievement'' scores to mean removing any 
performance category bonuses, final score bonuses or improvement 
scoring. We note section 1848(q)(6)(D)(i) of the Act requires us to set 
the performance threshold using composite performance scores, which we 
refer to as the final score as defined under Sec.  414.1305 (81 FR 
77319 through 77320). We do not believe that the statute allows us to 
use ``raw'' or ``achievement'' scores when setting the performance 
threshold. We thank the commenter for the suggestion of balancing the 
scores from 2019, 2020, and 2021 but reiterate that the statute 
requires us to choose the mean or median from a prior period and does 
not allow us to balance scores from multiple years.
    We refer the commenter to section IV.A.3.e(1)(c)(ii) of this final 
rule, where we are not finalizing our proposal to use performance 
period benchmarks and instead we will continue to use historic quality 
benchmarks for the CY 2022 performance period/2024 MIPS payment year 
will be based on CY 2020 performance period data. In regards to the 
comment on using 2017 data for purposes of the CY 2024 performance 
period/2026 MIPS payment year benchmarks, we note that we have not yet 
made any proposals on quality benchmarks for the CY 2024 performance 
period/2026 MIPS payment year.
    Comment: One commenter supported the larger size of positive 
payment adjustments that a higher performance threshold would cause due 
to a greater quantity of money being redistributed through BN, but 
requested more information on the impact to specialties and practices. 
The commenter stated that this information will give societies a 
stronger argument for their membership as to why clinicians should 
continue to participate in MIPS.
    Response: We encourage the commenter to read our projections of the 
impact of the Quality Payment Program Finalized policies on payment 
adjustments for MIPS payment year 2024 in our Regulatory Impact 
Analysis (see section VI.F.18.e of this final rule). We also note that 
CMS publishes a Quality Payment Program Experience Report and Public 
Use File at https://qpp.cms.gov/resources/resource-library. A detailed 
breakdown of a prior year's scores can be found in the QPP Experience 
Report and specialty specific information can be found in the Public 
Use File.
    After consideration of public comments, we are finalizing our 
proposal at Sec.  414.1405(g) 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 Sec.  414.1405(b). We are also finalizing our proposal 
at Sec.  414.1405(b)(9) to use the MIPS payment year 2019 as the prior 
period and the rounded mean final score of 75 points as the year 6 
performance threshold.
(3) Additional Performance Threshold for Exceptional Performance
    Section 1848(q)(6)(D)(ii) of the Act requires the Secretary to 
compute, for each year of the MIPS (beginning with the 2019 MIPS 
payment year and ending with the 2024 MIPS payment year), an additional 
performance threshold for purposes of determining the additional MIPS 
payment adjustment factors for exceptional performance under section 
1848(q)(6)(C) of the Act. For each such year, the Secretary shall apply 
either of the following methods for computing the additional 
performance threshold: (1) The threshold shall be the score that is 
equal to the 25th percentile of the range of possible final scores 
above the performance threshold determined under section 
1848(q)(6)(D)(i) of the Act; or (2) the threshold shall be the score 
that is equal to the 25th percentile of the actual final scores for 
MIPS eligible clinicians with final scores at or above the performance 
threshold with respect to the prior period described in section 
1848(q)(6)(D)(i) of the Act. Under section 1848(q)(6)(C) of the Act, a 
MIPS eligible clinician with a final score at or above the additional 
performance threshold will receive an additional MIPS payment 
adjustment factor and may share in the $500 million of funding 
available for the year under section 1848(q)(6)(F)(iv) of the Act. We 
note that under section 1848(q)(6)(F)(iv) of the Act, funding is 
available for additional MIPS payment adjustment factors under section 
1848(q)(6)(C) of the Act only through the 2024 MIPS payment year, which 
is the sixth year of the MIPS program.
    In the CY 2020 PFS final rule (84 FR 63037 through 63040), we used 
the special rule under section 1848(q)(6)(D)(iii) of the Act to set the 
additional performance threshold at 85 points for the 2022 and 2023 
MIPS payment years. We note that the special rule under section 
1848(q)(6)(D)(iii) of the Act applies only to the initial 5 years of 
MIPS, so we cannot use that rule to establish the additional 
performance threshold for the 2024 MIPS payment year. As noted above, 
under section 1848(q)(6)(D)(ii) of the Act, we may set the additional 
performance threshold at either: (1) The 25th percentile of the range 
of possible final scores above the performance threshold, or (2) the 
25th percentile of the actual final scores for MIPS eligible clinicians 
with final scores at or above the performance threshold with respect to 
the prior period described in section 1848(q)(6)(D)(i) of the Act.
[GRAPHIC] [TIFF OMITTED] TR19NO21.097

    In the CY 2022 PFS proposed rule (86 FR 39453), for illustrative 
purposes, we referenced the possible additional performance thresholds 
shown in Table 70. Note that mean or median refers to the methodology 
for calculation of the performance threshold. As can be seen in Table 
70, the potential values for the additional performance threshold range 
from a low of 81.26 to a high of 100. However, to remain consistent 
with our gradual and incremental approach, we proposed to use the mean 
as our methodology for setting the performance threshold during the 
next 3 years and

[[Page 65533]]

we proposed to use the final score data from MIPS payment year 2019. We 
are finalizing these proposals in section IV.A.3.f.2 of this final 
rule. The selection of the mean for the methodology and final score 
data from the 2019 MIPS payment year leaves us with the options in the 
first column of Table 70 for where we can set the additional 
performance threshold.
    With a performance threshold of 75 points for the 2024 MIPS payment 
year based on final scores for the 2019 MIPS payment year, the 
calculation methods in section 1848(q)(6)(D)(ii) of the Act give us two 
possible options for where we can set the additional performance 
threshold for MIPS payment year 2024. The first calculation method 
(described in section 1848(q)(6)(D)(ii)(I) of the Act), using the range 
of possible final scores above the proposed performance threshold for 
the 2024 MIPS payment year, yields a value of 81.26 points (the 25th 
percentile of the range of 75.01 to 100). The calculation is as 
follows: 75.01 + [(100-75.01) * 0.25] = 81.26. The second calculation 
method (described in section 1848(q)(6)(D)(ii)(II) of the Act), the 
25th percentile of the actual final scores for the 2019 MIPS payment 
year at or above the proposed performance threshold for the 2024 MIPS 
payment year, yields a value of 88.94. For the second calculation 
method, we will apply the 25th percentile calculation of (n+1)p/100 to 
the 2019 MIPS payment year final score data that are at or above 75.
    We considered using each of these methods, but we do not believe 
that it would be appropriate to lower the additional performance 
threshold to 81.26 points from its present value of 85 points. 
Maintaining or increasing the additional performance threshold will 
serve as a greater incentive to clinicians to continue to improve their 
performance on the MIPS measures and activities and to achieve 
exceptional performance. We believe that an additional performance 
threshold of 88.94 points rounded to 89 points is appropriate. This is 
an increase of 4 points from the prior year, which we believe is a 
gradual increase. Therefore, using the second calculation method 
described above, we proposed at Sec.  414.1405(d)(7) to set the 
additional performance threshold for the 2024 MIPS payment year at 89 
points.
    We solicited comments on these proposals, as well as the 
alternative additional performance thresholds listed that we considered 
but did not propose.
    We received public comments on the additional performance threshold 
for exceptional performance. The following is a summary of the comments 
we received and our responses.
    Comment: A few commenters expressed concern about the exceptional 
performance funding under section 1848(q)(6)(F)(iv) of the Act ending 
after the CY 2022 performance period/2024 MIPS payment year. One 
commenter believes that eliminating this funding is contradictory to 
the mission of the Quality Payment Program as it provides an additional 
incentive for improving performance. A few commenters expressed 
concerns about the cost of participating in MIPS and that the majority 
of the MIPS adjustment has been funded from the exceptional performance 
funding under section 1848(q)(6)(F)(iv) of the Act rather than from 
negative payment adjustments. Some commenters requested that CMS work 
with Congress to extend the funding.
    Response: We acknowledge the commenters' concern about the 
exceptional performance funding under section 1848(q)(6)(F)(iv) of the 
Act ending after the CY 2022 performance period/2024 MIPS payment year. 
We acknowledge that in previous years the additional performance 
threshold has funded a large portion of positive MIPS payment 
adjustments. However, we point the commenter to our Regulatory Impact 
Analysis (see section VI.F.18.e of this final rule) where we estimate 
that positive MIPS payment adjustments funded by BN will be much higher 
than in previous years.
    Comment: A few commenters suggested that CMS should consider using 
the section 1135 waiver authority it has under the PHE or its Extreme 
and Uncontrollable Circumstances policy to waive the statutory 
requirement to set the additional performance threshold at either: (1) 
The 25th percentile of the range of possible final scores above the 
performance threshold, or (2) the 25th percentile of the actual final 
scores for MIPS eligible clinicians with final scores at or above the 
performance threshold with respect to the prior period described in 
section 1848(q)(6)(D)(i) of the Act, and instead keep the additional 
performance threshold at 85 points in 2022.
    Response: We note that CMS does not have the authority to waive the 
statutory requirements for setting the additional performance threshold 
using our extreme and uncontrollable circumstances policies or section 
1135 of the Act.
    Comment: One commenter acknowledged the two statutory options CMS 
presented for the additional performance threshold (81.26 and 88.94), 
but urged CMS to use PHE authorities to maintain the additional 
performance threshold at 85 points instead of 89 points. The commenter 
stated that it gives clinicians a final opportunity to qualify for this 
funding and takes into account the unusual operational and clinical 
circumstances present during the COVID-19 pandemic.
    Response: We agree with the commenter that there have been unusual 
operational and clinical circumstances for clinicians during the COVID-
19 pandemic. However, we are not aware of any PHE authorities available 
to CMS that would allow us to set the additional performance threshold 
for the 2024 MIPS payment year at any value other than those resulting 
from the calculation methods described in section 1848(q)(6)(D)(ii) of 
the Act.
    Comment: A few commenters supported the additional performance 
threshold. One commenter stated that the increase to the additional 
performance threshold increases the difficulty but still makes the 
additional positive payment adjustment an attainable goal.
    Response: We thank the commenters for their support.
    Comment: A few commenters supported a lower additional performance 
threshold. Some commenters requested that CMS select the option of 81 
points rather than the proposed 89 points to account for loss of score 
potential due to removal of bonus points in the quality performance 
category and the increased weight of the cost performance category. One 
commenter noted that CMS has the latitude to select 81 points as it 
meets the 25th percentile of possible scores and believes that the 
lower additional performance threshold will incentivize a greater 
number of clinicians. The commenter also noted that choosing a lower 
additional performance threshold will allow CMS to both reward top 
performers in MIPS and incentivize more of them by setting reasonable 
thresholds to reward them for their performance. Other commenters 
requested keeping the additional performance threshold at 85 points.
    Response: We established the additional performance threshold at 85 
points for the 2022 and 2023 MIPS payment years in the CY 2020 PFS 
final rule (84 FR 63037 through 63040). We do not believe that it is 
appropriate to set the additional performance threshold at a lower 
value (81 points) than it was set at for the CY 2020 performance 
period/2022 MIPS payment year nor do we have the authority to keep the 
additional

[[Page 65534]]

performance threshold at 85 points as was requested by the commenter. 
We believe that 89 points is an appropriate value to incentivize the 
highest performing clinicians, given that the threshold has been 85 
points for the past 2 years.
    After consideration of public comments, we are finalizing the 
proposal at Sec.  414.1405(d)(7) to set the additional performance 
threshold for the 2024 MIPS payment year at 89 points.
(4) Example of Adjustment Factors
    Figure A provides an illustrative example of how various final 
scores will be converted to a MIPS payment adjustment factor and 
potentially an additional MIPS payment adjustment factor, using the 
statutory formula and based on our finalized policies for the 2024 MIPS 
payment year. In Figure A, the performance threshold is set at 75 
points. The applicable percentage is 9 percent for the 2024 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 
(negative 9 percent for the 2024 MIPS payment year) 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 there is an exception for a final 
score between zero and one-fourth of the performance threshold (zero 
and 18.75 points based on the performance threshold of 75 points for 
the 2024 MIPS payment year). All MIPS eligible clinicians with a final 
score in this range will receive the lowest negative applicable 
percentage (negative 9 percent for the 2024 MIPS payment year). Second, 
the linear sliding scale line for the positive MIPS payment adjustment 
factor is adjusted by the scaling factor, which cannot be higher than 
3.0.
    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. If the scaling factor is 
above 1.0 but is less than or equal to 3.0, then the MIPS payment 
adjustment factor for a final score of 100 will be greater than 9 
percent.
    Only those MIPS eligible clinicians with a final score equal to 75 
points (which is the finalized performance threshold) will receive a 
neutral MIPS payment adjustment. Because the performance threshold is 
75 points, we anticipate that more clinicians will receive a positive 
adjustment than a negative adjustment and that the scaling factor will 
be less than 1 and the MIPS payment adjustment factor for each MIPS 
eligible clinician with a final score of 100 points will be less than 9 
percent.
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[[Page 65535]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.098

    Table 71 illustrates the changes in payment adjustment based on the 
final policies from the CY 2021 PFS final rule (85 FR 84923 through 
84925) for the 2023 MIPS payment year and the final policies for the 
2024 MIPS payment year, as well as the applicable percent required by 
section 1848(q)(6)(B) of the Act.

[[Page 65536]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.099

(5) Final Score Hierarchy Used in Payment Adjustment Calculation
    In the CY 2021 PFS final rule (85 FR 84917 through 84919), we 
modified the final score hierarchy that applies when more than one 
final score is associated with a TIN/NPI, as displayed in Table 72. 
Beginning with the CY 2021 performance period/2023 MIPS payment year, 
if a TIN/NPI has a virtual group final score associated with it, we use 
the virtual group final score to determine the MIPS payment adjustment. 
If a TIN/NPI does not have a virtual group final score associated with 
it, we use the highest available final score associated with the TIN/
NPI to determine the MIPS payment adjustment.
[GRAPHIC] [TIFF OMITTED] TR19NO21.100


[[Page 65537]]


    In the CY 2022 PFS proposed rule (86 FR 39457), we proposed 
policies applicable to subgroups, including a definition of a subgroup 
at Sec.  414.1305 as a subset of a group which contains at least one 
MIPS eligible clinician and is identified by a combination of the group 
TIN, subgroup identifier, and each eligible clinician's NPI. Each 
clinician in a subgroup would be identifiable by a unique TIN/NPI 
combination just as in any MIPS group or APM Entity. In addition, a 
clinician, group, subgroup, or APM Entity could choose more than one 
MIPS reporting option for a performance period. A clinician, group, 
subgroup, or APM Entity could choose to report through MVPs, 
traditional MIPS, and/or the APP (assuming they are eligible for each 
of these reporting options) for a performance period. As a result, 
there could be more than one final score for a clinician, group, 
subgroup, or APM Entity for a performance period from MVPs, traditional 
MIPS, and/or the APP. Therefore, we proposed to update the scoring 
hierarchy to include subgroups and to specify that the scoring 
hierarchy would apply with respect to any available final score that is 
associated with a TIN/NPI from MVPs, traditional MIPS, and/or the APP. 
The proposed updated scoring hierarchy can be seen in Table 73. We 
solicited comments on this proposal.
[GRAPHIC] [TIFF OMITTED] TR19NO21.101

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    We received public comments on the proposed updated scoring 
hierarchy. The following is a summary of the comments we received and 
our responses.
    Comment: A few commenters requested clarification on the scoring 
hierarchy. One commenter expressed concerns with the modified 
hierarchy, citing the complexity of adding subgroups to MIPS and 
concerns about allowing ACO clinicians to report outside the ACO. The 
commenter recommended that to reduce complexity, ACO performance should 
be evaluated at the ACO level for MIPS evaluations. Another commenter 
noted confusion about how payment adjustments would be calculated and 
applied for clinicians reporting an MVP as part of a subgroup.
    Response: We acknowledge the commenters concern about the 
complexity of the scoring hierarchy for ACO reporters. However, we 
disagree with the recommendation that ACOs only be evaluated at the ACO 
level. CMS is introducing subgroups to collect data at a more granular 
level that will be more useful for beneficiaries to use to make 
informed healthcare decisions. Having data at the subgroup level will 
allow beneficiaries to evaluate performance data, especially 
performance data about specialists, that is more closely related to the 
actual clinicians the beneficiaries may see for their medical care. We 
also note that subgroup scores will not be rolled up to the ACO level. 
If a TIN reports as a subgroup, the subgroup score would only be 
applicable to the NPIs in the subgroup.
    Comment: A few commenters supported the proposed scoring hierarchy. 
Commenters appreciated CMS' intent to select the highest final score 
achieved for a TIN/NPI across the QPP pathways for individual, group 
subgroup or APM entity.
    Response: We thank the commenter for their support.
    Comment: One commenter asked CMS to confirm that a MIPS eligible 
clinician that participates in MVPs via multiple subgroups would 
receive the highest final score that can be attributed to their TIN/NPI 
combination from any reporting option (traditional MIPS, APP reporting, 
or any MVP subgroup reporting) and participation option (as an 
individual, group, subgroup, or APM Entity (with the exception of 
virtual groups).
    Response: The commenter is correct that, with the exception of 
virtual groups, a MIPS eligible clinician will receive the highest 
final score that can be attributed to their TIN/NPI combination from 
the listed reporting options (traditional MIPS, APP, or MVPs) and 
participation options (individual, group, subgroup, or APM entity).
    After consideration of public comments, we are finalizing the 
proposed updated scoring hierarchy as proposed.
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 at a minimum 
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.
    On July 1, 2018, we provided the first performance feedback for the 
Quality Payment Program. The second performance feedback was provided 
on July 1, 2019. In the CY 2021 PFS proposed rule (85 FR 50321), we 
noted that we aim to provide performance feedback on or around July 1 
of each year, but due to the PHE and COVID-19, we estimated that we 
would provide performance feedback for the performance period in 2019 
in late July

[[Page 65538]]

or early August of 2020. The third performance feedback (for the CY 
2019 performance period) was provided on August 5, 2020. In the 
proposed rule, we noted that similar to the CY 2019 performance period, 
due to the PHE for COVID-19, we may provide performance feedback for 
the CY 2020 performance period after July 1, 2021. Although we aim to 
provide performance feedback on or around July 1 of each year, it is 
possible that the release date could be later than July 1 depending on 
the circumstances. We provided performance feedback for the CY 2020 
performance period on August 2 and September 27, 2021. We direct 
readers to qpp.cms.gov for more information.
h. Third Party Intermediaries
    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 through 27595), and the CY 2021 PFS final rule (85 FR 84926 
through 84947) for our previously established policies regarding third 
party intermediaries.
    As discussed in the CY 2022 PFS proposed rule (86 FR 39458), we 
proposed to make several changes: (1) Reorganization and consolidation 
of Sec.  414.1400 generally; (2) new third party intermediaries general 
requirements; (3) new requirements specific to both QCDRs and qualified 
registries; (4) new requirements specific to only QCDRs; and (5) 
remedial action and termination of third parties.
(1) Reorganization and Consolidation of Sec.  414.1400 Generally
    We recognize that many of our policies for third party 
intermediaries are similar or verbatim, and yet in prior rules, we have 
described them separately. To minimize the lengthiness and burden of 
reading our policies, we proposed to consolidate our regulatory text 
under Sec.  414.1400. To be clear, our proposed updates would not 
change previously finalized requirements for third party 
intermediaries, but would bring more clarity and simplicity to the 
regulatory text. These changes are discussed by topic in more detail 
below. We also note that in several places at Sec.  414.1400 the 
regulation text was only updated to reflect both the applicable MIPS 
performance period/MIPS payment year.
(a) Reorganization for Requirements Related to MIPS Performance 
Categories That Must Be Supported by Third Party Intermediaries
    We previously established in the CY 2017 Quality Payment Program 
final rule (81 FR 77363 through 77364), further revised in the Quality 
Payment Program provisions in the CY 2019 and CY 2020 PFS final rules 
((83 FR 60088 and 84 FR 63049 through 63052, respectively), and further 
clarified our requirements for QCDRs, qualified registries, and health 
IT vendors with regards to submitting data for the purposes of the MIPS 
program in the Quality Payment Program provisions in the CY 2021 PFS 
final rule. Our current policy, codified at Sec.  414.1400(a)(2), 
states that, beginning with the CY 2021 performance period/2023 MIPS 
payment year, QCDRs and qualified registries must be able to submit 
data for all of the following MIPS performance categories, and Health 
IT vendors must be able to submit data for at least one of the 
following MIPS performance categories: Except as provided under 
paragraph (a)(2)(ii), QCDRs, qualified registries, and health IT 
vendors must be able to submit data for all of the following MIPS 
performance categories:
     Quality, except:
    ++ The CAHPS for MIPS survey; and
    ++ For qualified registries and Health IT vendors, QCDR measures;
     Improvement activities; and
     Promoting Interoperability, if the eligible clinician, 
group, or virtual group is using CEHRT; however, a third party 
intermediary may be excepted from this requirement if its MIPS eligible 
clinicians, groups or virtual groups fall under the reweighting 
policies at Sec.  414.1380(c)(2)(i)(A)(4) or (5) or (c)(2)(i)(C)(1) 
through (7) or (c)(2)(i)(C)(9)).
    ++ Health IT vendors that do not support MIPS Value Pathways must 
be able to submit data for at least one of the MIPS performance 
categories described in paragraphs (a)(2)(i)(A) through (C) of this 
section.
    ++ Promoting Interoperability, if the eligible clinician, group, or 
virtual group is using CEHRT; however, a third party intermediary may 
be excepted from this requirement if its MIPS eligible clinicians, 
groups or virtual groups fall under the reweighting policies at Sec.  
414.1380(c)(2)(i)(A)(4) or (5) or Sec.  414.1380(c)(2)(i)(C)(1) through 
(7) or Sec.  414.1380(c)(2)(i)(C)(9)).
    In an effort to simplify, we proposed reorganizing the existing 
language at Sec.  414.1400(a)(2). Specifically, we proposed providing 
updates to separately identify and provide clarity to data submission 
requirements since data requirements vary based on third party 
intermediary type and to provide clarification to exceptions to 
Promoting Interoperability for virtual groups and subgroups. We 
proposed the following updates:
     To revise and redesignate existing paragraph at Sec.  
414.1400(a)(2) through (a)(2)(i) to proposed paragraphs Sec.  
414.1400(b)(1)(i) and (c)(1) through (c)(1)(i) to state the following:
     To state at proposed Sec.  414.1400(b)(1)(i), beginning 
with the CY 2021 performance period/2023 MIPS payment year, QCDRs and 
qualified registries must be able to submit data for all of the 
following MIPS performance categories:
     Quality, except:
    ++ The CAHPS for MIPS survey; and
    ++ For qualified registries, QCDR measures.
     Improvement activities; and
     Promoting Interoperability, if the eligible clinician, 
group, virtual group, or subgroup is using CEHRT, unless:
    ++ The third party intermediary's MIPS eligible clinicians, groups, 
virtual groups, or subgroups fall under the reweighting policies at 
Sec.  414.1380(c)(2)(i)(A)(4)(i) through (iii) or (c)(2)(i)(C)(1) 
through (7) or (c)(2)(i)(C)(9)).
     To state at proposed Sec.  414.1400(c)(1), beginning with 
the CY 2021 performance period/2023 MIPS payment year, health IT 
vendors must be able to submit data for the MIPS performance categories 
as follows:
     To state at proposed Sec.  414.1400(c)(1)(i) through 
(c)(1)(i)(B), health IT vendors that support MVPs must be able to 
submit data for all of the MIPS performance categories:
     Quality, except:
    ++ The CAHPS for MIPS survey; and
    ++ QCDR measures;
     Improvement activities; and
     To revise and redesignate existing paragraph at Sec.  
414.1400(a)(2)(iii) to proposed paragraph Sec.  414.1400(c)(1)(i)(C) 
state, Promoting Interoperability, if the eligible clinician, group, 
virtual group, or subgroup is using CEHRT, unless:
    ++ The third party intermediary's MIPS eligible clinicians, groups, 
virtual groups, or subgroups fall under the reweighting policies at 
Sec.  414.1380(c)(2)(i)(A)(4)(i) through (iii) or (c)(2)(i)(C)(1) 
through (7) or (c)(2)(i)(C)(9).
     To revise and redesignate existing paragraph at Sec.  
414.1400(a)(2)(ii) to proposed paragraph Sec.  414.1400(c)(1)(ii) to 
state, health IT vendors that do not support MVPs must be able to 
submit data for at least one of the MIPS

[[Page 65539]]

performance categories described in paragraphs (c)(1)(i) through (iii) 
of this section.
     We proposed to create a new requirement at Sec.  
414.1400(c)(1)(iii) for health IT vendors to support MVPs. For more 
information on this proposal, please refer to section ``proposed new 
requirement for third party intermediaries to support MVPs and the 
APP'' at section IV.A.3.h.(2)(b)(i) of this final rule.
     To move the current Health IT vendor requirements from 
paragraphs Sec. Sec.  414.1400(a)(2)(ii) through (iii) and (d) to a new 
paragraph applicable to Health IT vendor requirements at Sec.  
414.1400(c). This will separately identify and provide clarity to data 
submission requirements specific to Health IT vendors.
     To move the current CMS-approved survey vendor 
requirements from paragraphs (a)(3) and (e) to a new paragraph 
applicable to CMS-approved survey vendor requirements at Sec.  
414.1400(d). We proposed to the redesignate paragraph (a)(3) current 
requirements to paragraph (d)(1) CMS-approved survey vendors may submit 
data on the CAHPS for MIPS survey for the MIPS quality performance 
category. For the current requirements at paragraph (e), we proposed to 
move up those requirements to paragraph (d)(2).
     To redesignate paragraph (a)(4) as paragraph (a)(2).
     To redesignate paragraph (a)(5) as paragraph (a)(3).
    We solicited public comments on our proposals.
    We did not receive public comments on these proposals, and 
therefore, we are finalizing them as proposed.
(b) Reorganization for Requirements Related QCDR and Qualified 
Registries Self-Nomination
    We proposed to consolidate and redesignate the existing language at 
Sec.  414.1400(b)(1) and (c)(1) to proposed Sec.  414.1400(b)(2) to 
reference both QCDR and qualified registries. We proposed this 
consolidation to provide clarity and alignment with the aforementioned 
proposals and consolidate the duplicative criteria of QCDRs and 
qualified registries. As discussed below, we also proposed to 
consolidate and redesignate the performance feedback requirements 
previously at existing Sec.  414.1400(b)(1) and (c)(1) to Sec.  
414.1400(b)(3)(iii). We proposed to state at Sec.  414.1400(b)(2), 
Self-nomination. For the CY 2018 and 2019 performance periods/2020 and 
2021 MIPS payment years, entities seeking to qualify as a QCDR or 
qualified registry must self-nominate September 1 until November 1 of 
the CY preceding the applicable performance period. For the CY 2020 
performance period/2022 MIPS payment year and future years, entities 
seeking to qualify as a QCDR or qualified registry must self-nominate 
during a 60-day period during the CY preceding the applicable 
performance period (beginning no earlier than July 1 and ending no 
later than September 1). Entities seeking to qualify as a QCDR or 
qualified registry for a performance period must provide all 
information required by CMS at the time of self-nomination and must 
provide any additional information requested by CMS during the review 
process. 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.
    We also proposed removing the last two sentences of existing Sec.  
414.1400(b)(1), which are duplicative with existing Sec.  
414.1400(b)(3)(iii). We proposed consolidating this language with 
existing paragraph (b)(3)(iii). We solicited public comments on our 
proposals.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter suggested that we refine the QCDR option 
under MIPS to streamline the self-nomination process, and to provide 
better incentives for organizations, including medical associations, to 
continue to invest in their QCDRs and develop new, meaningful measures 
for specialists to use for MIPS reporting and other clinical and 
research purposes.
    Response: We thank the commenter for their suggestion. We may 
consider it for future rulemaking.
    Comment: One commenter expressed support for the updates that CMS 
has made to the QCDR and qualified registry self-nomination process, 
including the development of the measure submission portal at 
QualityPaymentProgram.cms.gov.
    Response: We thank the commenter for their support.
    After consideration of public comments, we are finalizing these 
policies as proposed.
(c) Reorganization for Requirements Related to QCDR and Qualified 
Registries Conditions for Approval
    We refer readers to existing Sec.  414.1400(b)(2) for QCDR 
conditions for approval and existing Sec.  414.1400(c)(2) for qualified 
registries conditions for approval. In this final rule, we proposed the 
following in order to better organize, consolidate the duplicative 
criteria of QCDRs and qualified registries, and refer to both ``QCDR 
and qualified registry'' instead of one or the other:
     We proposed to redesignate existing paragraph (b)(2) to 
proposed paragraph (b)(3) and to revise the paragraph heading as, 
Conditions for approval.
     We also proposed to update the reference to both QCDR and 
qualified registry in proposed paragraph (b)(3).
     We proposed to revise to include both QCDR and qualified 
registry and redesignate existing paragraph (b)(2)(i) to proposed 
paragraph (b)(3)(i).
     We proposed to revise and redesignate existing paragraph 
(b)(2)(ii) to paragraph (b)(3)(ii). We also proposed to extend our 
policy for collaboration. For more information on this proposal, please 
refer to section ``collaboration of entities to become a QCDR and 
proposal to extend policy for collaboration of entities to become a 
qualified registry'' at section IV.A.3.h.(3)(a)(ii) of this final rule.
     As discussed above, we proposed to consolidate and 
redesignate the performance feedback requirements previously at 
existing Sec.  414.1400(b)(1) and (c)(1) to Sec.  414.1400(b)(3)(iii). 
Furthermore, to consolidate similar performance feedback requirements, 
we also proposed to revise and redesignate existing paragraph 
(b)(2)(iii) to paragraph (b)(3)(iii) to state, beginning with the CY 
2021 performance period/2023 MIPS payment year, require the QCDR or 
qualified registry must to provide performance feedback to their 
clinicians and groups at least 4 times a year, and provide specific 
feedback to their clinicians and groups on how they compare to other 
clinicians who have submitted data on a given measure within the QCDR 
or qualified registry. Exceptions to this requirement may occur if the 
QCDR or qualified registry submits notification to CMS within the 
reporting period promptly within the month of realization of the 
impending deficiency and provides sufficient rationale as to why they 
do not believe they would be able to meet this requirement (for 
example, if the QCDR does not receive the data from their clinician 
until the end of the performance period).
     We proposed to consolidate and redesignate paragraphs 
(b)(2)(iv) and (c)(2)(iii) in their entirety, into a new paragraph 
(b)(3)(v), and to correct a typographical error in which the word 
``MIPS'' was omitted in the first sentence.

[[Page 65540]]

     We proposed to consolidate and redesignate paragraphs 
(b)(2)(v) and (c)(3)(iv), in their entirety, into a new paragraph 
(b)(3)(vi).
    We solicited public comments on our proposals.
    We did not receive public comments on these proposals, and 
therefore, we are finalizing them as proposed.
(d) Reorganization for Requirements Related to QCDR Measures
(i) Reorganization for Requirements Related to QCDR Measures for the 
Quality Performance Category
    We refer readers to existing language at Sec.  414.1400(b)(3) for 
QCDR measures for the quality performance category. We currently define 
``QCDR measure'' at existing Sec.  414.1400(b)(3). We recognize that 
the QCDR measure definition is referred to throughout our policies and 
that it is not specific to Sec.  414.1400(b)(3) or third party 
intermediaries. Therefore, to provide further clarity and to better 
align with the current policy, we proposed moving the QCDR measure 
definition to the definitions section at Sec.  414.1305. We also 
proposed the following revisions to better organize regulation text at 
Sec.  414.1400(b)(4) and to update cross-references to correspond to 
the new section numbers as reflected in this final rule:
     We proposed to redesignate paragraphs (b)(3)(i), 
(b)(3)(i)(A), and (b)(3)(i)(B) to definitions at Sec.  414.1305.
     We proposed to revise and redesignate existing paragraph 
(b)(3)(ii) to proposed paragraph (b)(4)(i) to state, for the CY 2018 
performance period/2020 MIPS payment year and future years, at the time 
of self-nomination an entity seeking to become a QCDR must submit the 
following information for any measure it intends to submit for the 
payment year:
    ++ For MIPS quality measures, the entity must submit specifications 
including the MIPS measure IDs and specialty-specific measure sets, as 
applicable.
    + For QCDR measures, the entity must submit for CMS-approval 
measure specifications including: Name/title of measures, NQF number 
(if NQF- endorsed), 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 approval of any QCDR measure 
specifications, the entity must publicly post the measure 
specifications for that QCDR measure (including the CMS- assigned QCDR 
measure ID) and provide CMS with a link to where this information is 
posted.
     We also proposed adding a header to state, ``QCDR measure 
self-nomination requirements''. We believe adding a heading will help 
readers clearly distinguish QCDR measure self-nomination requirements.
     We proposed moving existing paragraph (b)(3)(iii) in its 
entirety to proposed paragraph (b)(4)(ii) and adding a header to state, 
``QCDR measure submission requirements''. We believe adding a heading 
will help readers clearly distinguish QCDR measure submission 
requirements.
     We proposed moving existing paragraphs (b)(3)(v) through 
(v)(C)(1) in its entirety, to proposed paragraphs (b)(4)(iii) through 
(b)(4)(iii)(A)(3).
     We proposed to revise and redesignate existing paragraph 
at (b)(3)(v)(C)(2) to paragraph (b)(4)(iii)(A)(3)(i) to state, to be 
included in an MVP for the CY 2022 performance period/2024 MIPS payment 
year and future years, a QCDR measure must be fully tested.
     We proposed moving existing paragraph (b)(3)(vii) in its 
entirety, to paragraph (b)(4)(iv).
(ii) Reorganization for Requirements Related to QCDR Measure Approval 
Criteria
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77374 through 77375) and the Quality Payment Program provisions 
in the CY 2020 PFS final rule (84 FR 63059), where we finalized 
existing Sec.  414.1400(b)(3)(v).
    At Sec.  414.1400, we proposed to reorganize and make minor updates 
to the existing requirements at paragraph (b)(3)(v) to proposed 
paragraph (b)(4)(iii). We proposed to reorganize the existing 
requirements so that QCDR measure approval at paragraph (b)(3)(v) is 
discussed before QCDR measure considerations at paragraph (b)(3)(iv). 
Therefore, we proposed the following revisions:
     To revise and redesignate existing paragraph (b)(3)(v) 
``QCDR measure requirement for approval include'' to proposed paragraph 
(b)(4)(iii) and add a heading to state, ``QCDR measure approval 
criteria''. We believe adding a heading will help readers clearly 
distinguish QCDR measure approval criteria. We also proposed to include 
the following updates:
    ++ Move existing paragraph (b)(3)(v) to proposed revised paragraph 
(b)(4)(iii)(A) to state, QCDR measure requirements for approval are.
    ++ Move existing paragraph (b)(3)(v)(A) in its entirety to proposed 
paragraph (b)(4)(iii)(A)(1).
    ++ Move existing paragraph (b)(3)(v)(B) in its entirety to proposed 
paragraph (b)(4)(iii)(A)(2).
    ++ Revise existing paragraphs (b)(3)(v)(C) and (b)(3)(v)(C)(1) to 
proposed paragraph (b)(4)(iii)(A)(3) to state, beginning with the CY 
2022 performance period/2024 MIPS payment year, all QCDR measures must 
meet face validity. To be approved for the CY 2023 performance period/
2025 MIPS payment year, all QCDR measures must be must meet face 
validity for the initial MIPS payment year for which it is approved. 
For subsequent years after being initially approved, all QCDR measures 
must be fully developed and tested, with complete testing results at 
the clinician level, prior to submitting the QCDR measure at the time 
of self-nomination.
    ++ Move existing paragraph (b)(3)(v)(C)(2) in its entirety to 
proposed paragraph (b)(4)(iii)(A)(3)(i).
    ++ Move existing paragraph (b)(3)(v)(D) in its entirety to proposed 
paragraph (b)(4)(iii)(A)(4).
    ++ Move existing paragraph (b)(3)(v)(E) in its entirety to proposed 
paragraph (b)(4)(iii)(A)(5).
    We solicited public comment on our proposals. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters supported the measure requirement for 
face validity testing of measures and stated it should be extended for 
future years. One commenter noted particular concern for the face 
validity testing requirement, as the testing process is arduous and 
funding, staff, and other resources have been significantly reduced due 
to the PHE for COVID-19. A few commenters suggested that CMS delay the 
deadline for full QCDR measure testing to 2023 or later due to the 
impact of COVID-19 on providers and registries. Another commenter 
suggested that CMS limit the face validity testing requirement, stating 
that because the COVID-19 extreme and uncontrollable circumstances 
exception decreased the number of groups reporting to MIPS through 
QCDRs, the face validity testing requirement should be limited to the 
first 2 years for which measures are approved or until 2 years after 
the end of the COVID PHE. Several commenters expressed concerns with 
QCDR measure testing requirements and pointed to the significant burden 
of these requirements. One commenter expressed the belief that a 
barrier to use of QCDR measures is the requirement that they be fully 
tested, which is

[[Page 65541]]

extremely burdensome for QCDR measure owners. Another commenter asked 
for clarification as to what constitutes acceptable measure testing. 
Commenters requested that CMS develop a transparent and consistent 
process for evaluating QCDR testing approaches and results. Commenters 
noted that failure to ease the QCDR requirements may result in 
interested parties opting to not participate in the QCDR program.
    Response: We note that we did not propose to substantively modify 
the measure requirement for face validity and testing in the proposed 
rule, such as to delay these requirements. The existing requirement (85 
FR 84939) at Sec.  414.1400(b)(3)(v)(C)(1) states that, for a QCDR 
measure to approved for the CY 2022 performance period/2024 MIPS 
payment year it must meet face validity. To be approved for the CY 2023 
performance period/2025 MIPS payment year and for each subsequent year, 
a QCDR measure must meet face validity for the initial MIPS payment 
year for which it is approved. Separately, paragraph (b)(3)(v)(C) 
provides that, beginning with the CY 2022 performance period/2024 MIPS 
payment year, a QCDR measure must be fully developed and tested, with 
complete testing results at the clinician level, prior to submitting 
the QCDR measure at the time of self-nomination. In addition, paragraph 
(b)(3)(v)(C)(1) requires that, for each subsequent year, for which a 
QCDR measure is approved, it must be fully tested. We intended our 
proposed reorganization of these standards at paragraph 
(b)(4)(B)(iii)(3) to track these existing requirements.
    In regards to what constitutes acceptable testing and the burden 
associated with, and possible delay of such testing, we refer readers 
to our discussion of this and related issues in past rules (85 FR 27594 
through 27595; 85 FR 84940; 85 FR 84926; 85 FR 84936; 84 FR 63066; 84 
FR 63065 through 63067; 83 FR 59901 through 59902; 82 FR 53805 through 
53806) and guidance documents, including the current CMS Measures 
Management System Blueprint for additional guidance in measure testing 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf.
    Although we did not address any changes to the QCDR measure testing 
requirement at Sec.  414.1400(b)(3)(v)(C)(1) in the CY 2022 PFS 
proposed rule, based on public comments received on our proposals, we 
are considering proposing in next year's rulemaking to further delay 
this requirement for traditional MIPS until the CY 2024 performance 
period/2026 MIPS payment year, instead of the CY 2023 performance 
period/2025 MIPS payment year as previously finalized. We clarify that 
this delay would not modify the existing requirement at paragraph 
(b)(3)(v)(C)(2), to be included in an MIPS Value Pathway for the 2024 
MIPS payment year and future years, a QCDR measure must be fully 
tested.
    Comment: One commenter suggested that CMS provide more meaningful 
credit/incentivization for measure testing participation given the 
difficulty to motivate practices to engage in measure testing. The 
commenter suggested an improvement activity credit for measure testing 
given the difficulty to motivate practices to engage in measure 
testing.
    Response: We thank the commenter for their suggestion. We may 
consider it for future rulemaking. We encourage the commenter to visit 
the 2021 Improvement Activities Inventory for additional guidance on 
improvement activities that focus on QCDR participation at https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/1189/2021%20Improvement%20Activities%20List.zip.
    After consideration of public comments, we are finalizing these 
policies as proposed.
(iii) Reorganization for Requirements Related to QCDR Measure 
Considerations for Approval
    We refer readers to the Quality Payment Program provisions in the 
CY 2019 PFS final rule (84 FR 63198 through 63199), where we finalized 
existing Sec.  414.1400(b)(3)(iv) ``QCDR measure considerations for 
approval.'' We proposed to reorganize and make minor updates to the 
language at existing paragraph (b)(3)(iv) to paragraph (b)(4)(iii)(B). 
We proposed to reorganize the existing requirements so that QCDR 
measure approval at paragraph (b)(3)(v) is discussed before QCDR 
measure considerations at paragraph (b)(3)(iv).
    We also proposed to redesignate existing paragraph (b)(3)(vi) to 
paragraph (b)(4)(iii)(C). Specifically, we proposed the following 
revisions:
     To revise and redesignate existing paragraph (b)(3)(iv) 
``QCDR measure considerations for approval include'' to paragraph 
(b)(4)(iii)(B) ``QCDR measure considerations for approval include, but 
are not limited to''.
     Move existing paragraphs (b)(3)(iv)(A) in its entirety to 
paragraph (b)(4)(iii)(B)(1).
     Move existing paragraph (b)(3)(iv)(B) in its entirety to 
paragraph (b)(4)(iii)(B)(2).
     Move existing paragraph (b)(3)(iv)(C) in its entirety to 
paragraph (b)(4)(iii)(B)(3).
     Move existing paragraph (b)(3)(iv)(D) in its entirety to 
paragraph (b)(4)(iii)(B)(4).
     Move existing paragraph (b)(3)(iv)(E) in its entirety to 
paragraph (b)(4)(iii)(B)(5).
     Move existing paragraph (b)(3)(iv)(F) in its entirety to 
paragraph (b)(4)(iii)(B)(6).
     Move existing paragraph (b)(3)(iv)(G) in its entirety to 
paragraph (b)(4)(iii)(B)(7).
     Revise and consolidate existing paragraph (b)(3)(iv)(G)(1) 
to paragraph (b)(4)(iii)(B)(7)(i) to state that QCDR link their QCDR 
measures as feasible to at least one cost measure, improvement 
activity, or an MVP at the time of self-nomination.
     Revise and redesignate existing paragraph (b)(3)(iv)(G)(2) 
to paragraph (b)(4)(iii)(B)(7)(ii) to state that in cases where a QCDR 
measure does not have a clear link to a cost measure, improvement 
activity, or an MVP, CMS would consider exceptions if the potential 
QCDR measure otherwise meets the QCDR measure requirements and 
considerations.
     Move existing paragraph (b)(3)(iv)(H) in its entirety to 
paragraph (b)(4)(iii)(B)(8).
     Move existing paragraph (b)(3)(iv)(I) in its entirety to 
paragraph (b)(4)(iii)(B)(9).
     Revise and redesignate existing paragraph (b)(3)(iv)(J) to 
paragraph (b)(4)(iii)(B)(10) to state beginning with the CY 2020 
performance period/2022 MIPS payment year, CMS places greater 
preference on QCDR measures that meet case minimum and reporting 
volumes required for benchmarking after being in the program for 2 
consecutive CY performance periods. Those that do not, may not continue 
to be approved.
     Move existing paragraph (b)(3)(iv)(J)(1) in its entirety 
to paragraph (b)(4)(iii)(B)(10)(i).
     Move existing paragraph (b)(3)(iv)(J)(2) to paragraph 
reserve (b)(4)(iii)(B)(10)(ii).
     Move existing paragraph (b)(3)(vi) in its entirety to 
paragraph (b)(4)(iii)(C).
    We solicited public comments on our proposals. The following is a 
summary of the comments we received and our responses.
    Comment: The commenter suggested that we assess whether the limit 
on the number of QCDR measures available (30 measures) should be 
revised.
    Response: We thank the commenter for their suggestion. We may 
consider it for future rulemaking.

[[Page 65542]]

    After consideration of public comments, we are finalizing these 
policies as proposed.
(iv) QCDR Measure Rejection Criteria
    We refer readers to the existing requirements at Sec.  
414.1400(b)(3)(vii). We proposed reorganizing existing requirements at 
paragraph (b)(3)(vii) to proposed paragraph (b)(4)(iv). Therefore, we 
proposed the following revisions:
     To revise and redesignate existing paragraph (b)(3)(vii) 
``QCDR measure rejection criteria'' to paragraph (b)(4)(iv) and add a 
heading to state, QCDR measure rejection criteria. We believe adding a 
heading will help readers clearly distinguish measure rejection 
criteria.
    We also proposed to include the following updates:
     To move existing paragraph (b)(3)(vii) to proposed 
paragraph (b)(4)(iv) to state, QCDR measure rejection criteria. 
Beginning with the CY 2020 performance period/2022 MIPS payment year, 
QCDR measure rejection considerations include, but are not limited to.
     Move existing paragraphs (b)(3)(vii)(A) through (L) in 
their entirety to (b)(4)(iv)(A) through (L).
    We solicited public comments on our proposals.
    We did not receive public comments on these proposals, and 
therefore, we are finalizing them as proposed.
(e) Reorganization for Requirements Related to Remedial Action and 
Termination of Third Party Intermediaries
    We refer readers to Sec.  414.1400(f), the CY 2017 Quality Payment 
Program final rule (81 FR 77548), CY 2019 PFS final rule (83 FR 59908 
through 59910), the CY 2020 PFS final rule (84 FR 63077 through 63080), 
and the CY 2021 PFS final rule (85 FR 84930 through 84937) for 
previously finalized policies for remedial action and termination of 
third party intermediaries. With the proposed updates being made at 
Sec.  414.1400, we proposed to redesignate the following sections:
     We proposed to redesignate current paragraph (f) as 
paragraph (e) and to update cross-references to correspond to the new 
section numbers as reflected in this final rule.
     We also proposed to redesignate current paragraph (g) as 
paragraph (f) and to update cross-references to correspond to the new 
section numbers as reflected in this final rule.
    We solicited public comments on these proposals.
    We did not receive public comments on these proposals, and 
therefore, we are finalizing them as proposed.
(2) Third Party Intermediaries General Requirements
    We refer readers to previously established Sec.  414.1400(a) and 
the CY 2017 Quality Payment Program final rule (81 FR 77363 through 
77364), and as further revised in the CY 2019 PFS final rule (83 FR 
60088), CY 2020 PFS final rule (84 FR 63049 through 63052), CY 2021 PFS 
final rule (85 FR 84926 through 84947) for our established policy 
regarding third party intermediaries general requirements.
    In the CY 2022 PFS proposed rule, we proposed two changes for third 
party intermediaries: (1) Third party intermediary submissions for APM 
Entities; and (2) MIPS performance categories that must be supported by 
third party intermediaries. We also solicited comment on third party 
intermediaries that derive data from CEHRT. These proposals and the 
request for comments are discussed in more detail below.
(a) Third Party Intermediary Submissions for APM Entities
    As finalized in the Quality Payment Program provisions in the CY 
2021 PFS final rule (85 FR 84895), APM Entities now have the option of 
reporting to MIPS on behalf of the MIPS eligible clinicians 
participating in their APM Entity. They have the option of reporting to 
traditional MIPS or via the APP (85 FR 84859). APM Entities have 
historically used Third Party Intermediaries for submitting their 
quality measures to their APMs, rather than to MIPS, however, these 
third party intermediaries now have the opportunity to submit these 
data for purposes of MIPS.
    In the CY 2022 PFS proposed rule, we proposed to add APM Entities 
to Sec.  414.1400(a)(1), expanding the general participation 
requirements of third party intermediaries to third party 
intermediaries reporting to MIPS on behalf of APM Entities in order to 
align reporting requirements for all participants in MIPS.
    We note that the Promoting Interoperability performance category is 
scored for APM Entities based on data submitted by the participant MIPS 
eligible clinicians and groups as described at Sec.  414.1317(b)(1), 
and therefore, would not be required to be submitted by the third party 
intermediary on behalf of the APM Entity.
    We solicited comments on this proposal.
    We did not receive public comments on this proposal, and therefore, 
we are finalizing it as proposed.
(b) MIPS Performance Categories That Must Be Supported by Third Party 
Intermediaries
    We refer readers to previously established Sec.  414.1400(a)(2) and 
the CY 2017 Quality Payment Program final rule (81 FR 77363 through 
77364), and as further revised in the CY 2019 PFS final rule (83 FR 
60088), CY 2020 PFS final rule (84 FR 63049 through 63052), CY 2021 PFS 
final rule (85 FR 84926 through 84947) for our established policy 
regarding the types of MIPS data that third party intermediaries may 
submit.
    In the CY 2022 PFS proposed rule, we proposed new requirements in 
alignment with our proposals in sections IV.A.3.b.(2)(c), 
IV.A.3.b.(4)(e) and IV.A.3.b.(3)(e) of this final rule to adopt MVPs 
and subgroups.
(i) New Requirement for Third Party Intermediaries To Support MVPs and 
the APP
    As described in the Quality Payment Program provisions finalized in 
the CY 2021 PFS final rule (85 FR 84849), MVPs should include measures 
and activities from the quality, cost, improvement activities, and 
Promoting Interoperability performance categories. As described in 
section IV.A.3.b.(2)(c)(i) of this final rule, we discussed our 
proposals related to furthering our transition to MIPS Value Pathways 
(MVPs). As MVPs are implemented, proposed beginning with the CY 2023 
performance period/2025 MIPS payment year, we also proposed the methods 
in which an MVP participant may report on an MVP or the APP. Since 
QCDRs, qualified registries, and health IT vendors are required under 
existing Sec.  414.1400(a)(1) to submit data for quality, improvement 
activities, and promoting interoperability, we believe they would have 
the experience needed to support MVP and APP reporting.
    Therefore, we proposed to create a new requirement at Sec.  
414.1400(b)(1)(ii) to state 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. Additionally, we proposed to 
create a new requirement at paragraph Sec.  414.1400(c)(1)(iii) to 
state that beginning with the CY 2023 performance period/2025 MIPS 
payment year, Health IT vendors must support MVPs that are applicable 
to the

[[Page 65543]]

MVP participants on whose behalf they submit MIPS data. Health IT 
vendors may also support the APP.
    Based off historical participation, we are aware that some third 
party intermediaries (QCDRs and qualified registries) support a single 
specialty or subspecialty, while others support multiple specialties. 
Therefore, we believe that it is not appropriate to expect that all 
third party intermediaries are able to support all MVPs that are 
implemented in the program. Rather, the third party intermediaries 
should identify and support MVPs that are relevant to the clinicians 
and groups they support. We do not believe that CMS-approved survey 
vendors will be able to support MVP reporting, because they are 
historically limited, in that they only support the CAHPS for MIPS 
Survey Measure.
    As discussed in section IV.A.3.b.(2)(c) of this final rule, MVPs 
will start with the CY 2023 performance period/2025 MIPS payment year. 
We believe this delay in implementation will allow third party 
intermediaries sufficient time for programming and system preparation 
for MVP reporting success. We solicited comments on our proposals.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter supported third party intermediaries only 
reporting on the MVPs that reflect their participant needs but 
suggested third-party intermediaries be able to choose which MVPs they 
wish to support. The commenter expressed concerns about MVPs being 
arbitrarily assigned to third-party intermediaries. One commenter noted 
that supporting an entire MVP is very different from supporting the 
inclusion of specific QCDR measures in an MVP and could carry much more 
burden for the registry and sought clarification of whether CMS will 
assign specific MVPs to a QCDR or qualified registry.
    Response: We thank the commenter for their support. At this time, 
CMS does not intend on assigning specific MVPs to a third party 
intermediary. As described in the CY 2022 PFS proposed rule (86 FR 
39462), we proposed at Sec.  414.1400(b)(1)(ii) and (c)(1)(iii) that 
QCDRs, qualified registries, and Health IT vendors must support MVPs 
that are applicable to the MVP participants on whose behalf they submit 
MIPS data. We refer readers to Appendix 3 of this final rule, where 
discuss the MVPs being finalized beginning with the CY 2023 performance 
period/CY 2025 MIPS payment year, around the clinical topics of stroke 
care, heart disease, rheumatology, chronic conditions, emergency 
medicine, anesthesia, and lower extremity joint repair. QCDRs, 
qualified registries, and Health IT vendors that support MVP 
participants, who work in the aforementioned clinical areas will be 
required to support these MVPs, as applicable. Furthermore, we expect 
that QCDRs, qualified registries, and Health IT vendors who support 
MVPs would support all measures and activities, across the quality, PI, 
and improvement activities performance category that are included in 
the MVP (cost measures and population health measures are calculated by 
CMS and do not require data submission by a third party intermediary or 
a clinician). The expectation that the QCDR and qualified registry 
support measures and activities across all three performance categories 
is not new, as these third party intermediaries are currently required 
to do so. We believe allowing QCDRs to only support specific QCDR 
measures in an MVP creates undue burden on the MVP Participant who 
would need to find other means to complete MVP reporting requirements; 
this may deter clinicians from utilizing a third party intermediary. 
For the time being, CMS does not intend on assigning specific MVPs to a 
third party intermediary. It is required for QCDRs, qualified 
registries, and Health IT vendors to identify (CMS approved) MVPs that 
are relevant to the clinicians they support and report on those.
    Comment: One commenter supported third party intermediaries 
supporting MVPs but requested clarification on whether a QCDR would be 
responsible for validating an MVP participant's performance on 
population health measures and/or providing ``enhanced'' performance 
feedback, including performance data comparing the performance of 
similar clinicians who report on the same MVP.
    Response: Third party intermediaries will not be expected to 
validate the performance on the current population health measures, 
since they are administrative claims-based and do not require external 
data submission. The responsibility of identifying the population 
health measure that should be calculated will fall to the MVP 
participant to determine at the time of MVP registration. CMS 
calculates these measures based on administrative claims data. In the 
CY 2022 PFS proposed rule (86 FR 39383), we describe our proposal to 
include comparative performance feedback within the annual performance 
feedback that CMS currently provides under traditional MIPS. While CMS 
intends to provide this enhanced feedback through our existing 
performance feedback processes, QCDRs and qualified registries will 
still be required to provide clinicians they support with performance 
feedback as described at Sec.  414.1400(b)(iii) and (c)(ii), regardless 
of whether the clinician chooses to report through traditional MIPS or 
an MVP.
    Comment: One commenter suggested that CMS mandate that EHR vendors 
support the quality measures in MVPs, otherwise clinicians would be 
forced to join multiple registries with the cost exceeding the maximum 
penalty.
    Response: To clarify, health IT vendors (such as EHRs), QCDRs, and 
qualified registries 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, which do not require external data 
submission to be calculated. In addition, some MVPs may include 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.
    Comment: One commenter expressed concerns about layering another 
auditing requirement on QCDRs and qualified registries when MVPs are 
finalized as this could increase regulatory complexity and result in 
added work and burden without making a significant difference in the 
quality of data submitted. One commenter requested that CMS add more 
detail in future requirements for third-party intermediaries to 
validate data submitted by MVP participants.
    Response: We disagree with the commenter. QCDRs and qualified 
registries are currently required to conduct data validation on data 
that is submitted to CMS for purposes of the MIPS program, to ensure 
the data is true, accurate, and complete. We refer readers to section 
IV.A.3.h.(3)(a)(iii) of this final rule for a detailed discussion of 
those requirements. The current data validation requirements that are 
utilized in traditional MIPS, will also be applied to MVP submissions. 
MVPs are considered a method of reporting under MIPS, but is 
nonetheless a part of the program. Therefore, the requirements and 
expectations remain the same-- QCDRs and qualified registries must 
conduct data validation on data submitted to CMS for purposes of the 
MIPS program, regardless of whether

[[Page 65544]]

the data is submitted under traditional MIPS or through an MVP. In the 
future, data validation information that is covered in the Self-
Nomination Toolkit for QCDRs and qualified registries available at 
https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1083/2021%20Self-Nomination%20Toolkit%20for%20QCDRs%20and%20Qualified%20Registries.zip 
will also include MVPs.
    Comment: One commenter requested clarification on whether QCDRs and 
qualified registries are required or permitted to support the APP, 
stating that the preamble states this is a requirement while the 
regulatory text says that QCDRs and qualified registries may support 
the APP. The commenter opposed a requirement for QCDRs and qualified 
registries to support the APP.
    Response: In the CY 2021 PFS final rule (85 FR 84859), we discussed 
that APM Entities have the option of reporting to MIPS on behalf of the 
MIPS eligible clinicians participating in their APM Entity. 
Additionally, there is an option of reporting to traditional MIPS or 
via the APP. Furthermore, in the proposed rule (86 FR 39462), we 
proposed to add APM Entities to Sec.  414.1400(a)(1), expanding the 
general participation requirements of third party intermediaries to 
third party intermediaries reporting to MIPS on behalf of APM Entities 
in order to align reporting requirements for all. We want to note that 
QCDRs and qualified registries would not be required to support the 
APP, but may do so. If QCDRs and qualified registries would like to 
support the APP, they would need to meet all of the other requirements 
of being a QCDR or qualified registry reporting to MIPS (with the 
exception of PI reporting, which has some exceptions) as described 
above.
    After consideration of public comments, we are finalizing these 
policies as proposed.
(ii) Requirements for All Third Party Intermediaries To Support 
Subgroup Reporting
    As proposed in section IV.A.3.b.(3) of this final rule, subgroup 
reporting would allow clinicians in multispecialty practices to 
participate in MIPS more meaningfully. Since subgroups would be 
implemented concurrently with MVPs, it is important that third party 
intermediaries have the capability to support subgroup reporting of 
MVPs. As described above, we believe QCDRs, qualified registries, and 
health IT vendors would have the capacity to support MVP and APP 
reporting.
    In the CY 2022 PFS proposed rule, we proposed to require QCDRs, 
qualified registries, health IT vendors, and CAHPS for MIPS survey 
vendors to support subgroup reporting, beginning with the CY 2023 
performance period/2025 MIPS payment year. Therefore, we proposed to 
revise Sec.  414.1400(a)(1) to state that MIPS data may be submitted on 
behalf of a MIPS eligible clinician, group, virtual group, subgroup or 
APM Entity by any of the following third party intermediaries: QCDR; 
qualified registry; health IT vendor; or CMS-approved survey vendor. We 
believe it is imperative for all third party intermediaries to be able 
to support subgroup reporting as we envision that to be the future of 
the program.
    While the CAHPS for MIPS survey vendors cannot support MVPs or the 
APP, we believe they can support the reporting of the CAHPS for MIPS 
measure within an MVP and the APP, if a subgroup decides to report on 
that measure. Due to the limited experience, CAHPS for MIPS survey 
vendors have in quality reporting, we do not believe it is feasible for 
them to support MVP reporting since MVP reporting would require 
experience with reporting across the performance categories and the use 
of several collection types for quality reporting. However, there may 
be instances where the CAHPS for MIPS survey measure may be included in 
an MVP. For example, in the Optimizing Chronic Conditions Management 
MVP, as described in Appendix 3: MVP Inventory, of this final rule. In 
such instances, if groups or subgroups would like to report this 
measure, they should be able to utilize a CAHPS for MIPS survey vendor 
to do so. We believe it is important that all third party 
intermediaries support subgroup reporting in order to support 
meaningful quality reporting. We understand that there may be a level 
of burden to third party intermediaries that are required in supporting 
subgroup reporting by requiring them to support another clinician type. 
However, we believe that requiring third party intermediaries to 
support subgroup reporting will allow for clinicians to participate in 
a manner that is more meaningful. We noted in section 
IV.A.3.b.(4)(f)(ii)(D) of this final rule, subgroups would have to 
register through the MVP participant registration process. Third party 
intermediaries would need to be able to track the subgroup identifiers 
and support the data submission process accordingly.
    We solicited comments on our proposal. The following is a summary 
of the comments we received and our responses.
    Comment: A few commenters expressed concern regarding the burden 
for registries to identify and validate subgroup reporting.
    Response: To clarify, as discussed in section 
IV.A.3.b.(4)(f)(ii)(D) of this final rule, subgroups must self-identify 
and register through a registration process in order to be considered a 
subgroup. The subgroup would need to register directly through the MVP 
registration process, that is done separately and not through a third 
party intermediary. Therefore, we believe there is no burden to 
registries to identify the subgroups. As MVP participants such as 
subgroups enroll to use the services of a registry, the subgroup will 
share with the registry their CMS-assigned identifier and a list of 
participants within that subgroup. The registry will need to submit the 
subgroup identifier information with the subgroup's data at the time of 
submission. We understand there may be concerns in scenarios in which 
subgroups inadvertently provide an incorrect subgroup identifier to the 
registry. We will take that into consideration for future rulemaking, 
as we determine whether there are additional system safeguards, such as 
a system rejection of an incorrect identifier can be implemented to 
limit the occurrence of such issues. With regards to data validation, 
all QCDRs and qualified registries will continue to be held to the data 
validation requirements that currently exist, regardless of whether a 
clinician or group decides to participate in MVP reporting or 
traditional MIPS reporting. While we understand there is a level of 
burden associated with data validation, we believe the benefit 
outweighs the burden to ensure that all data submitted to CMS is true, 
accurate, and complete.
    Comment: One commenter suggested that CMS delay its proposal 
requiring third party intermediaries to support subgroup reporting to 
allow more time for registries to implement reporting processes. 
Several commenters expressed concern that subgroup reporting will 
impose a large increase in burden on registries, particularly with 
respect to how registries validate NPIs. A few commenters expressed 
concern that QCDRs may lack the capacity to support subgroup reporting.
    Response: We disagree with the need for further delay. We 
intentionally proposed MVPs and subgroup reporting with a delayed 
implementation to account for the time that clinicians, third party 
intermediaries, and healthcare organizations would need to prepare to 
operationalize MVP and subgroup reporting. We believe the availability 
of subgroup reporting

[[Page 65545]]

should go hand-in-hand with the implementation of MVPs, and therefore, 
should be jointly available beginning with the CY 2023 performance 
period/2025 MIPS payment year. The delayed implementation should 
provide third party intermediaries sufficient time for system and 
operation preparations for subgroup reporting. In addition, we do not 
believe that subgroup reporting will impose a large increase in burden 
to registries. We refer readers to section IV.A.3.b.(3) of this final 
rule, for further discussion of validation requirements. Subgroups are 
derived from their affiliated TINs who would have otherwise reported 
traditional MIPS through a registry.
    After consideration of public comments, we are finalizing this 
policy as proposed.
(c) Request for Comment on Third Party Intermediaries That Derive Data 
From CEHRT
    For third party intermediaries that will be submitting quality 
measure data on behalf of MIPS eligible clinicians, we believe that EHR 
systems will be able to provide measure results for a set of providers 
that are part of a subgroup where required for subgroup reporting. We 
note that the existing CEHRT definition for eligible clinicians at 
Sec.  414.1305 includes the 45 CFR 170.315(c)(4) ``Clinical quality 
measures--filter'' as an optional element. This criterion requires 
health IT to be able to filter CQM results at both patient and 
aggregate levels. Moreover, a Health IT Module must be able to filter 
by a single proposed data element (for example, provider type) or a 
combination of any of the data elements). Historically, the ``Clinical 
quality measures--filter'' at 45 CFR 170.315(c)(4)'' (CQM-filter) 
criterion has been applicable for certified health IT modules 
supporting quality measurement for participants in certain APMs.
    We believe technology certified to this optional criterion could 
support subgroup reporting via third party intermediaries that derive 
data from CEHRT by ensuring that an EHR can produce CQM results 
filtered for a specific group of provider NPIs that are part of a 
subgroup. These filtered CQM results could then be shared with a third 
party intermediary, which provides this data for reporting to CMS. 
However, we also believe health IT developers are offering non-
certified functionality that can effectively support reporting of 
measure results for a subgroup. As a result, we did not propose any 
changes at this time to the language in the CEHRT definition for 
eligible clinicians regarding the ``optional'' status of technology 
certified to the CQM-filter criterion.
    We are interested in general feedback from stakeholders on the 
current capabilities of third party intermediaries that derive data 
from CEHRT to successfully receive and transmit data to CMS for CQMs 
based on subgroups; capabilities of EHR systems to support subgroup 
reporting, including reporting facilitated by third party 
intermediaries, and whether requiring the adoption of technology 
certified to the CQM-filter criterion would help to support subgroup 
reporting; and challenges which entities may face in meeting 
requirements to report on subgroups when deriving data from CEHRT. We 
solicited feedback on this topic.
    Comment: A few commenters responded to CMS' request for information 
regarding CEHRT and third party intermediaries. One commenter urged CMS 
to establish clear expectations and guidelines to ensure data security 
and to define roles and responsibilities for data validation and data 
cleaning. Another commenter recommended that CMS consider making the 
CQM filter criterion mandatory for CEHRT because, otherwise, 
organizations would likely be required to contract with qualified 
registries/QCDRs to submit MIPS data. Another commenter disagreed, 
stating that as a developer of CEHRT that provides CQM functionality, 
they do not believe that the CQM-filer criterion is necessary.
    Response: We thank commenters for the feedback received through 
this request for information. We may consider this information to 
inform future rulemaking.
(3) New Requirements for Both Qualified Clinical Data Registries 
(QCDRs) and Qualified Registries
(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 through 27595), and the CY 2021 PFS final rule (85 FR 84926 
through 84947) for our previously established policies regarding QCDRs 
and qualified registries.
    In the CY 2022 PFS proposed rule, we proposed several changes for 
both QCDRs and qualified registries: (1) New requirement for approved 
QCDRs and qualified registries that have not submitted performance 
data; (2) collaboration of entities to become a QCDR and qualified 
registry; and (3) data validation audit and targeted audit 
requirements. These proposals are discussed in more detail below.
(i) New Requirement for Approved QCDRs and Qualified Registries That 
Have Not Submitted Performance Data
    We require that both QCDRs and qualified registries must have a 
minimum of 25 participants signed up by the prior performance period at 
existing Sec.  414.1400(b)(2) and (c)(2). We refer readers to 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 through 27595), and the CY 2021 PFS final rule (85 FR 84926 
through 84947). We identified a number of QCDRs and qualified 
registries that have continued to self-nominate to become a third party 
intermediary for the MIPS program, but have not submitted clinician, 
group or virtual group data to CMS. As the MIPS program continues to 
mature, we wish to reduce the number of vendors that self-nominate to 
become a qualified vendor, but do not actively participate in the MIPS 
program. We believe that maintaining these vendors who do not actively 
participate does not provide a benefit to the MIPS program, rather it 
creates stakeholder confusion by including these vendors in our 
qualified postings.
    We proposed a two-tiered approach to solve this issue. First, we 
proposed to create a new requirement at Sec.  414.1400(b)(3)(vii) to 
require QCDRs and qualified registries that have never submitted data 
since the inception of MIPS (CY 2017 performance period/2019 MIPS 
payment year) through the CY 2020 performance period/2022 MIPS payment 
year, to submit a participation plan as part of their self-nomination 
for CY 2023. Exceptions to this requirement may occur if data is 
received for the CY 2021 performance period/2023 MIPS payment year. 
Under this scenario, QCDRs and qualified registries would not need to 
submit a participation plan for CY 2023 of the self-nomination period. 
If they do not submit data, their participation plan must be submitted 
as part of self-nomination for CY 2023 and must be accepted by CMS to 
continue to be an approved QCDR or qualified registry.

[[Page 65546]]

    Secondly, we proposed to codify a new requirement at paragraph 
(b)(3)(viii) to state, beginning with the CY 2024 performance period/
2026 MIPS payment year, a QCDR or qualified registry that was approved 
but did not submit any MIPS data for either of the 2 years preceding 
the applicable self-nomination period must submit a participation plan 
for CMS' approval. For example, for the CY 2024 performance period/2026 
MIPS payment year, vendors will be required to have submitted 
performance data for the CY 2021 and 2022 performance periods/2023 and 
2024 MIPS payment years. Under this proposal, the participation plan 
must explain the QCDR's or qualified registry's detailed plans about 
how the vendor intends to encourage clinicians to submit MIPS data to 
CMS through the third party intermediary on behalf of clinicians or 
groups. The vendor must also explain why they should still be allowed 
to participate as a qualified vendor. We note that this proposed 
participation plan was modeled off of the current requirement for QCDR 
measure participation at existing Sec.  414.1400(b)(3)(iv)(J)(1) 
(redesignated to proposed paragraph (b)(4)(iii)(B)(10)(i)). We 
solicited comments on this proposal.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters disagreed with the proposal to require a 
participation plan for approved QCDRs that did not submit data for 2 
years preceding the applicable self-nomination period. One commenter 
stated that the COVID PHE reduced reporting by eligible clinicians to 
QCDRs.
    Response: While we are sympathetic and acknowledge that the impact 
the PHE may have had on reduced reporting, we note that we are 
proposing an incremental approach to assess QCDR data reporting. This 
includes the first proposal which would apply to any QCDR or qualified 
registry that has not submitted data to CMS since the inception of MIPS 
(CY 2017). We believe a QCDR should have been able to report data to 
CMS for years preceding CY 2021. Specifically, we believe a QCDR should 
have been able to report data to CMS for CY 2019. If a QCDR was new in 
CY 2020 and did not submit data to CMS, the QCDR still has CY 2021 to 
report for clinicians which in turn, satisfies this requirement. 
Furthermore, the proposal provides QCDRs and qualified registries the 
opportunity to submit participation plans, which could support the 
decision to allow a QCDR or qualified registry to continue their MIPS 
participation. This plan would outline possible reasons for low/no 
reporting to CMS and the efforts the QCDR plans to take to further 
encourage their clinicians to submit data to CMS. Some examples include 
but are not limited to: A reduction in associated fees, improvement of 
an EHR interface to reduce data extraction burden, expansion of the 
numbers/types of measures the QCDR chooses to report, etc. As such, 
this proposal would not immediately remove a QCDR or qualified registry 
from participating as a third party intermediary. As discussed above, 
we want to reduce the number of vendors that self-nominate to become a 
qualified vendor, but do not actively participate in the MIPS program. 
We believe that maintaining these vendors who do not actively 
participate does not provide a benefit to the MIPS program. We note 
that our goal is to decrease the operational burden on CMS and those 
vendors who do not submit MIPS data to CMS. CMS would decrease its 
operational burden by not having to go through the vetting process of 
these entities or monitor program compliance during the year. 
Additionally, we believe that we can better utilize the resources used 
for vendors that do not submit MIPS data elsewhere to improve the MIPS 
program. Furthermore, vendors who choose not to submit MIPS data to CMS 
are depriving CMS of data that would benefit the MIPS program. Lastly, 
vendors who do not submit data will decrease their burden in the long-
term by not self-nominating year after year.
    Comment: One commenter disagreed with the proposal for QCDRs and 
qualified registries who do not submit data 2 years preceding the 
applicable self-nomination period to submit a participation plan at the 
time of self-nomination. The commenter noted that CMS would also 
require the participation plan to include moving users over to submit 
their MIPS data through the qualified registry. The commenter expressed 
concern that this policy would create significant demand on QCDRs 
specifically, due to the already cumbersome Eligible Measure 
Applicability (EMA) process required for qualified registries. The 
commenter currently uses both the qualified registry and QCDR to 
collect data, however, the commenter only submits the data to CMS 
through the QCDR.
    Response: We disagree with the commenter's interpretation of this 
policy. The intention of the participation plan requirement is to 
explain the QCDR's or qualified registry's detailed plans about how the 
vendor intends to encourage clinicians to submit MIPS data to CMS 
through the third party intermediary on behalf of clinicians or group 
and to explain why they should still be allowed to participate as a 
qualified vendor. The participation plan will not require moving users 
over to submit their MIPS data through the qualified registry and that 
this policy would create significant demand on QCDRs. We note that 
during the CY 2019 MIPS performance period, the Eligible Measure 
Applicability (EMA) process was updated to be applicable to collection 
types (that is, EMA applies to Part B Claims measures and MIPS clinical 
quality measures (CQMs) but does not apply to electronic clinical 
quality measures (eCQMs), QCDR measures, or Web Interface) rather than 
third party intermediaries. As such, EMA does not apply to QCDRs and 
qualified registries as an entity, rather it could apply to MIPS CQMs 
that the QCDR or qualified registry is approved to support. We 
encourage third party intermediaries to participate as a QCDR if they 
intend to self-nominate their own QCDR measures or use another QCDR's 
measures (with permission from the QCDR who owns the measure) or as a 
qualified registry if they plan to support their clients through the 
reporting of CQMs or eCQMs only.
    After consideration of public comments, we are finalizing these 
policies as proposed.
(ii) Collaboration of Entities To Become a QCDR and Proposal To Extend 
Policy for Collaboration of Entities To Become a Qualified Registry
(A) Background
    In the CY 2017 Quality Payment Program final rule (81 FR 77377), we 
finalized to allow collaboration of entities to become a QCDR based on 
our experience with the qualifying entities wishing to become QCDRs for 
performance periods. We stated that we believed our previously 
finalized policy supporting entity collaboration should be continued 
under MIPS. Therefore, we discussed that an entity that may not meet 
the criteria of a QCDR solely on its own, but could do so in 
conjunction with another entity and would be eligible for qualification 
through collaboration with another entity. Additionally, we finalized 
at Sec.  414.1400(b)(2)(ii), specifically for QCDRs, that if the entity 
uses an external organization for purposes of data collection, 
calculation, or transmission, it must have a signed, written agreement 
with the external organization that specifically details the

[[Page 65547]]

responsibilities of the entity and the external organization. The 
written agreement must be effective as of September 1 of the year 
preceding the applicable performance period.
    For example, an entity, such as a specialty society, that needs 
technical support may partner with an outside entity such as a health 
IT vendor to qualify as a QCDR. While entities, such as QCDRs, Health 
IT vendors, and qualified registries, can collaborate with external 
organizations, those entities could only do so to meet requirements to 
be a QCDR. We did not explicitly create a policy for entities to 
collaborate to meet the requirements to be a qualified registry.
(B) Proposal To Extend to Qualified Registries
    We believe we should extend the previously finalized policy to 
apply to entities that wish to collaborate to become a qualified 
registry as well because extending this policy to qualified registries 
would also help smaller specialty societies that may not have the 
resources on their own to become a qualified registry. This will allow 
those societies to be able to partner with other entities to meet the 
definition of a qualified registry. Therefore, in the CY 2022 PFS 
proposed rule, we proposed to revise and redesignate existing paragraph 
(b)(2)(ii) to new paragraph (b)(3)(ii) to state, if the entity seeking 
to qualify as a QCDR or qualified registry uses an external 
organization for purposes of data collection, calculation, or 
transmission, it must have a signed, written agreement with the 
external organization that specifically details the responsibilities of 
the entity and the external organization. The written agreement must be 
effective as of September 1 of the year preceding the applicable 
performance period. For example, an entity, such as a specialty 
society, that needs technical support may partner with an outside 
entity such as a health IT vendor to qualify as a qualified registry. 
We solicited comments on this proposal.
    We did not receive public comments on this proposal, and therefore, 
we are finalizing it as proposed.
(iii) Data Validation Audit and Targeted Audit Requirements
(A) Information Required at the Time of Self-Nomination
    In the CY 2017 Quality Payment Program final rule (81 FR 77366 
through 77367; 81 FR 77383 through 77384) we discussed our expectation 
for QCDRs and qualified registries to conduct validation on the data 
they intend to submit for the MIPS performance period. We also 
discussed that the full self-nomination process would require the 
following: A submission of basic information, a description of the 
process the QCDR and qualified registry will use for completion of a 
targeted audit of a subset of data prior to submission, the provision 
of a data validation plan along with the results of the executed data 
validation plan by May 31 of the year following the performance period. 
Additionally, in the Quality Payment Program provisions in the CY 2021 
PFS final rule (85 FR 84930 through 84937; 85 FR 84944 through 84947) 
at existing Sec.  414.1400(b)(2)(iv) and (v), and (c)(2)(iii) and (iv), 
we finalized the data validation audit requirements as condition for 
approval. While we did finalize the requirements for the data 
validation audits as condition for approval, we did not codify the 
requirements for QCDR and qualified registries to submit data 
validation plan during self-nomination along with the results of the 
executed data validation plan by May 31 of the year following the 
performance period.
    In order to provide clarification and to better align with the 
previously finalized policy (81 FR 77366 through 77367; 81 FR 77383 
through 77384), we proposed to codify the following revisions. As 
stated in previous polices (81 FR 77366 through 77367;81 FR 77383 
through 77384), QCDRs and qualified registries are required to submit 
the results of their data validation plan to CMS by May 31 of the year 
following the performance period. Therefore, we proposed to codify at 
Sec.  414.1400(b)(3)(v)(G)(1) to state that QCDRs and qualified 
registries must conduct validation on the data they intend to submit 
for the applicable MIPS performance period, and provide the results of 
the executed data validation plan by May 31st of the year following the 
performance period.
    Furthermore, QCDRs and qualified registries are required to submit 
their data validation plan explaining their process of data validation 
submission annually during self-nomination, and it must be approved by 
CMS for before use. To provide further clarity and to better align with 
the existing policy (81 FR 77366 through 77367; 81 FR 77383 through 
77384), we also proposed to codify a new requirement at Sec.  
414.1400(b)(3)(iv) to state that, beginning with the CY 2023 
performance period/2025 MIPS payment year, the QCDR or qualified 
registry must submit a data validation plan annually, at the time of 
self-nomination, for CMS' approval, and may not change the plan once 
approved, without the prior approval of the agency.
    As discussed above we proposed to codify at Sec.  
414.1400(b)(3)(iv) to provide further clarity to better align with 
previous policies. Therefore, we proposed to reorganize at Sec.  
414.1400(b)(2)(iv) though (viii) to better align with the above 
changes. We proposed with the following revisions:
     We proposed to revise and redesignate existing paragraph 
(b)(2)(iv) to paragraph (b)(3)(v) to state, that beginning with the CY 
2021 performance period/2023 MIPS payment year, the QCDR or qualified 
registry must conduct annual data validation audits in accordance with 
this paragraph (b)(3)(v).
     We proposed to revise and redesignate existing paragraph 
(b)(2)(iv)(A) to paragraph (b)(3)(vi)(A) to state that, if a data 
validation audit under paragraph (b)(3)(v) identifies one or more 
deficiency or data error, the QCDR or qualified registry must conduct a 
targeted audit into the impact and root cause of each such deficiency 
or data error for that MIPS payment year.
     We proposed to revise and redesignate existing paragraph 
(b)(2)(v) to paragraph (b)(3)(vi) to state that beginning with the CY 
2021 performance period/2023 MIPS payment year, the QCDR or qualified 
registry must conduct targeted audits in accordance with this paragraph 
(b)(3)(vi).
     We proposed to revise and redesignate paragraph (b)(2)(vi) 
to paragraph (b)(3)(vii), to state for the CY 2023 performance period/
2025 MIPS payment year, a QCDR or qualified registry that was approved 
but did not submit any MIPS data for any of the CY 2017 through 2021 
performance periods/2019 through 2023 MIPS payment years must submit a 
participation plan for CMS' approval. This participation plan must 
include the QCDR's detailed plans and changes to encourage eligible 
clinicians and groups to submit data on the low-reported QCDR measure 
for purposes of the MIPS program.
     We proposed to revise and redesignate existing paragraph 
(b)(2)(vii) to paragraph (b)(4)(viii) to state that beginning with the 
CY 2024 performance period/2026 MIPS payment year, a QCDR or qualified 
registry that was approved but did not submit any MIPS data for either 
of the 2 years preceding the applicable self-nomination period must 
submit a participation plan for CMS' approval.

[[Page 65548]]

    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters expressed concerns about the ``overly 
burdensome'' nature and significant cost of the CMS data validation 
audit requirements for third party intermediaries. One commenter 
expressed concerns with the randomized auditing resulting in an 
unintended consequence of increasing burden on small and mid-sized 
group practices because of the low number of participants reporting via 
the qualified registry as individuals. One commenter stated that the 
audit requirements are duplicative, unnecessary, and do not enhance 
data quality and validity because QCDRs already have rigorous internal 
data and quality standards. A few commenters stated that clinicians and 
registries were impacted by the COVID-19 pandemic, specifically that 
dozens of audits were conducted and QCDRs and qualified registries have 
encountered practices struggling to collect and report data while a 
majority of their time and effort has been spent on responding to the 
COVID-19 pandemic.
    Response: While we understand that data validation requires a level 
of effort, time, and cost by the QCDRs and qualified registries, we 
disagree that this causes undue burden. While we acknowledge and 
appreciate the efforts and participation of all group practices of 
varying sizes including small and mid-sized groups, we believe it is 
important to hold all practices to the same standards for data 
validation audits to ensure that all data submitted is true, accurate, 
and complete. As discussed in the CY 2017 Quality Payment Program final 
rule (81 FR 77366 through 77367; 81 FR 77383 through 77384), we expect 
that QCDRs and qualified registries would conduct validation on the 
data they intend on submitting for the MIPS performance period and 
provide the results of the data validation to CMS in the form of a data 
validation execution report by May 31st of the year following the 
performance period. As noted in the CY 2017 PFS final rule (81 FR 77366 
through 77367), we believe it is necessary to establish a requirement 
that QCDRs conduct data validation to ensure they are actively 
monitoring the data they submit to CMS for purposes of a pay-for-
performance program. We also believe it is important for QCDRs to 
validate the data that they intend to submit to us for purposes of the 
MIPS program to ensure that the data submitted is true, accurate, and 
complete (85 FR 84936). We disagree that audit requirements are 
duplicative, unnecessary, and do not enhance data quality and validity 
because QCDRs already have rigorous internal data and quality 
standards. While we appreciate that many QCDRs already have rigorous 
internal data and quality standards, we are not asking QCDRs to 
duplicate work. If QCDRs have their own auditing requirements, they can 
use the same auditing process or combine the efforts to reduce 
duplication as long as they meet the data validation requirements 
specified by the regulation at a minimum (81 FR 77366 through 77367; 81 
FR 77383 through 77384). For example, if a QCDR already audits 10 
percent of their data prior to submission for all performance 
categories, this would meet the 3 percent portion of the data 
validation requirement. Additionally, despite our requirements to have 
validation audits, each year there are still some QCDRs that submit 
inaccurate data. As payment adjustments increase, this could adversely 
affect a practice with respect to their payment because these payment 
calculations were based on inaccurate data submitted to CMS.
    Furthermore, while we do acknowledge that the impact of the PHE for 
COVID-19 may have affected some providers and registries ability to 
conduct audits due to practices struggling to collect and report data 
due to majority of their time and effort being spent on responding to 
the COVID-19 pandemic, as stated above, we believe it is important to 
enforce the requirements for data validation audits to ensure all data 
submitted is true, accurate, and complete. We will continue to assess 
the implications of the PHE for COVID-19 and will consider whether to 
make any policy changes in future rulemaking.
    Comment: One commenter expressed that NCQA data validation 
alleviates the burden on health plans having to perform their own audit 
of data received from an HIE and on providers from having to respond to 
data requests from health plans. This commenter suggested that CMS 
leverage NCQA processes for data validation.
    Response: We thank the commenter for their suggestion. We may 
consider it for future rulemaking.
    After consideration of public comments, we are finalizing these 
policies as proposed.
(4) New Requirements Specific to QCDRs
(a) Background
    We refer readers to Sec.  414.1400(b), the CY 2017 Quality Payment 
Program final rule (81 FR 77374 through 77375), the CY 2018 Quality 
Payment Program final rule (82 FR 53813 through 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 through 
27595), and the CY 2021 PFS final rule (84937 through 84944) for where 
we previously finalized standards and criteria for QCDRs, specifically 
QCDR measure requirements. In this section, we proposed to update 
policies related to QCDR measure rejections.
(b) QCDR Measures
(i) QCDR Measure Rejections
(A) New QCDR Measure Rejection Criteria
    We refer readers to the Quality Payment Program provisions in the 
CY 2020 PFS final rule (84 FR 63070 through 63073) at Sec.  
414.1400(b)(3)(vii) where we have previously adopted QCDR measure 
rejection criteria. In the CY 2022 PFS proposed rule, we proposed to 
add two new criteria: (1) QCDR does not have permission to use a QCDR 
measure; and (2) QCDR not approved or not in good standing. These are 
discussed in more detail below in this section.
(aa) QCDR Does Not Have Permission To Use a QCDR Measure
    In the CY 2018 Quality Payment Program final rule (82 FR 53813 
through 53814), we discussed that beginning with the 2018 performance 
period and for future program years, QCDR vendors may seek permission 
from another QCDR to use an existing measure that is owned by the other 
QCDR. We noted that the QCDR measure owner (QCDR vendor) would still 
own and maintain the QCDR measure, but would allow other QCDRs to 
utilize their measure with proper notification. We intended for this 
policy to help reduce the number of QCDR measures that are similar in 
concept or clinical topic, or duplicative of other QCDR measures that 
are being approved. Additionally, in the Quality Payment Program 
provisions in the CY 2020 PFS final rule (84 FR 63070 through 63073) at 
Sec.  414.1400(b)(3)(vii), we finalized the QCDR measure rejection 
criteria considerations. We noted that these considerations would help 
to ensure that QCDR measures are meaningful and measurable. Although we 
finalized the QCDR measure rejection criteria, we did not codify that 
QCDRs may seek permission from another QCDR to use an existing measure 
that is owned by another QCDR. In order to provide further clarity to 
the existing policies (82 FR 53813 through 53814; 84 FR

[[Page 65549]]

63070 through 63073), we proposed to codify a new requirement and add a 
rejection criterion at Sec.  414.1400(b)(4)(iv)(M) to state, a QCDR 
does not have permission to use a QCDR measure owned by another QCDR 
for the applicable performance period. We solicited comments on this 
proposal.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the proposal to add the 
rejection criterion that ``A QCDR does not have permission to use QCDR 
measure owned by another QCDR for the applicable performance period'' 
because CMS currently allows QCDRs to seek permission from another QCDR 
to report on an existing measure that is owned by the other QCDR, and 
because if a QCDR would like to use an existing QCDR measure that is 
owned by another QCDR, it must obtain permission from the QCDR measure 
owner that it can use the measure for the performance period and 
include proof of such permission in its self-nomination application.
    Response: We thank the commenters for their support.
    After consideration of public comments, we are finalizing this 
policy as proposed.
(bb) QCDR Not Approved or Not in Good Standing
    Additionally, if a QCDR measure owner is not approved or is not in 
good standing, any QCDR measures associated with that QCDR would also 
not be approved. We believe it is important to have an approved QCDR 
measure owner for all approved QCDR measures. This would ensure that 
there is active involvement by the QCDR measure owner so that any 
potential measure issues can be mitigated during the specified MIPS 
performance period. For example, any mid-year guideline changes or 
measure questions would need to be immediately clarified to avoid 
negative impacts to clinicians such as the inability to construct a 
benchmark due to an error in the measure specifications. Therefore, we 
proposed to codify another rejection criterion at Sec.  
414.1400(b)(4)(iv)(N) to state that, if a QCDR measure owner is not 
approved during a given self-nomination period, any associated QCDR 
measures with that QCDR would also not be approved. We solicited 
comments on this proposal.
    We have received inquiries from stakeholders on what can be done in 
circumstances when an active QCDR wishes to use an inactive QCDR's 
measure. We are interested in feedback from stakeholders on what should 
be done in such circumstances. For example, what should happen if 
``QCDR A'' is using ``QCDR B's'' measures in a given performance period 
and ``QCDR B'' is terminated mid performance period? Alternatively, 
what if ``QCDR A'' is using a measure from ``QCDR B'' and ``QCDR B'' 
decides not to self-nominate for the subsequent performance period? 
While ``QCDR A'' could partner with ``QCDR B'' as described at Sec.  
414.1400(b)(3)(ii), are there other policy options we should consider 
to minimize impact to the MIPS eligible clinician who has selected the 
QCDR measure for reporting?
    We solicited comments on the above circumstances. The following is 
a summary of the comments we received and our responses.
    Comment: A few commenters disagreed with the proposal to add a 
rejection criterion requiring permission to use an inactive QCDR's 
measures. One commenter stated that there is no evidence that inactive 
QCDRs are withholding access to these measures. The commenter noted the 
ability of QCDRs to license measures allows QCDRs to ensure the 
appropriate use of their measures and incentivizes organizations to 
invest in developing new and improved measures. The commenter suggested 
that CMS should continue its policy that allows active or inactive QCDR 
measure owners to choose to license their measures only to QCDRs that 
have the experience and expertise to properly implement a measure in a 
particular specialty. Therefore, there is no reason to change CMS' 
current policy under which an active QCDR that wishes to use an 
inactive QCDR's measure can approach the inactive QCDR and the two 
QCDRs can negotiate an agreement regarding the transfer of ownership if 
the active QCDR has the appropriate experience and expertise in QCDR 
measure development. In the event that such agreement cannot be reached 
between the two parties, the inactive QCDR can decline to license 
rights to the QCDR measure. One commenter suggested that CMS require 
that either there be an agreement between the two QCDRs to transfer 
ownership of the measure or that the initial QCDR should maintain their 
measures and license it to other QCDRs.
    Response: We thank the commenters for their comments and 
suggestions. We clarify that if a QCDR measure owner is not approved or 
is not in good standing, any QCDR measures owned or maintained with 
that QCDR would also not be approved. We disagree that the proposal to 
add a rejection criterion requiring permission to use an inactive 
QCDR's measures is not supported by evidence that inactive QCDRs are 
withholding access to these measures. We note that there have been 
instances where active QCDRs have inquired about using QCDR measures of 
inactive QCDR measure stewards. We also disagree that this policy is 
not needed. We believe it is imperative that all QCDR measures in the 
MIPS program have an active QCDR measure steward to provide ongoing 
maintenance and updates to QCDR measures. For example, recently, a QCDR 
who shares their measures with several other QCDRs discovered multiples 
discrepancies, including risk adjustment calculation issues. If they 
had not been an active QCDR and performing quality assurance on these 
QCDR measures, this issue would likely not have been discovered and 
resolved.
    We do agree that the ability of QCDRs to license measures allows 
QCDRs to ensure the appropriate use of their measures and incentivizes 
organizations to invest in developing new and improved measures. We 
also agree that active or inactive QCDR measure owners may choose to 
license their measures only to QCDRs that have the experience and 
expertise to properly implement a measure in a particular specialty. 
Furthermore, this process is consistent with what CMS requires for all 
other measures available for all clinicians to report in the MIPS 
program (the non-QCDR measures). That is, every measure in the program 
needs an active measure steward that agrees to support and maintain the 
measure. A non-active QCDR cannot be compelled to meet this 
requirement.
    In this context, we interpret the commenter's reference to a 
``policy under which an active QCDR that wishes to use an inactive 
QCDR's measure can approach the inactive QCDR and the two QCDRs can 
negotiate an agreement regarding the transfer of ownership'', to apply 
to our statements regarding QCDR licensing as discussed in the CY 2018 
PFS final rule (82 FR 53813). There we noted that, beginning with the 
2018 performance period and for future program years, a QCDR vendor may 
seek permission from another QCDR to use an existing measure that is 
owned by the other QCDR. While we thank the commenter for the 
suggestion to require the transfer of ownership of a measure from an 
inactive QCDR to an active QCDR or that the inactive QCDR should 
maintain the measure and license it to active QCDRs, we note that such 
approaches are beyond the scope of our regulations, which in this case 
is limited to approval and disapproval criteria for QCDRs and

[[Page 65550]]

QCDR measures. We are considering building out additional policies to 
ensure that all QCDR measures that are used/owned are properly 
maintained throughout the performance period.
    After consideration of public comments, we are finalizing this 
policy as proposed.
(5) Remedial Action and Termination of Third Party Intermediaries
    We refer readers to Sec.  414.1400(f), the CY 2017 Quality Payment 
Program final rule (81 FR 77548), CY 2019 PFS final rule (83 FR 59908 
through 59910), the CY 2020 PFS final rule (84 FR 63077 through 63080), 
and the CY 2021 PFS final rule (85 FR 84930 through 84937) for 
previously finalized policies for remedial action and termination of 
third party intermediaries.
    In the Quality Payment Program provisions in the CY 2019 PFS final 
rule (83 FR 59908 through 59910), we discussed that the threshold for 
``inaccurate, unusable or otherwise compromised'' may be met if the 
submitted data includes TIN/NPI mismatches, formatting issues, 
calculation errors, or data audit discrepancies that affect more 3 
percent of the total number of MIPS eligible clinicians or groups for 
which data was submitted by the third party intermediary. We proposed 
to update the existing language at Sec.  414.1400(f)(3)(ii) to broadly 
explain that it is up CMS' discretion on whether third party 
intermediaries' inaccuracies may lead to possible remedial action or 
termination. As discussed earlier, we proposed consolidating and 
redesignating the existing language at Sec.  414.1400(f) as paragraph 
(e) and Sec.  414.1400(g) as paragraph (f) to provide clarity and 
alignment with the aforementioned proposals to consolidate the 
duplicative criteria of QCDRs and qualified registries. Therefore, we 
proposed to revise and redesignate existing language at Sec.  
414.1400(f)(3)(ii) to paragraph (e)(3) to state, contains data 
inaccuracies affecting the third party intermediary's total clinicians 
may lead to remedial action/termination of the third party intermediary 
for future program year(s) based on CMS discretion.
    We did not receive public comments on this policy, and therefore, 
we are finalizing it as proposed.
i. Public Reporting on the Compare Tools Hosted by the U.S. Department 
of Health & Human Services (HHS)
    In the CY 2022 PFS proposed rule, we proposed to amend Sec.  
414.1395(c) to add a 1-year delay of publicly reporting new improvement 
activities and Promoting Interoperability measures and attestations 
reported via MVP. We also proposed a one-time, 1-year delay to 
subgroup-level public reporting, such that subgroup-level public 
reporting will begin with CY 2024 performance information available in 
2025, and each year thereafter, on the Compare Tools hosted by the U.S. 
Department of Health and Human Services (HHS), referred to as ``compare 
tool'' throughout this final rule, available at https://www.medicare.gov/care-compare/ and data.medicare.gov, as technically 
feasible. We proposed to add facility affiliations, beyond the hospital 
affiliations currently displayed on individual profile pages. 
Additional facility affiliations would include: Inpatient 
rehabilitation facilities (IRFs); long-term care hospitals (LTCHs); 
skilled nursing facilities (SNFs); inpatient psychiatric facilities 
(IPFs); home health agencies (HHAs); hospices; and dialysis facilities. 
Finally, we solicited comments on publicly reporting utilization data 
on clinician and group profile pages (86 FR 39466 through 39469).
    For previous discussions on public reporting, we refer readers to 
the CY 2016 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 2021 PFS final rule (85 
FR 84947 through 85 FR 84948) and the Care Compare: Doctors and 
Clinicians Initiative Page at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Compare-DAC.
(1) MVP and Subgroup Public Reporting
    The introduction of MVPs and subgroup reporting provides for new 
types of performance information that are available for public 
reporting, provided they meet the established public reporting 
standards at Sec.  414.1395(b). In consideration of our MVP and 
subgroup performance information public reporting proposals, we wish to 
remind readers that all submitted MIPS performance information is 
available for public reporting (81 FR 77395 through 77397). 
Additionally, we previously finalized at Sec.  414.1395(c) that, for 
each program year, CMS does not publicly report any first-year measures 
for the first 2 years, meaning any measure in its first 2 years of use 
in the quality and cost performance categories. We also note that MIPS 
performance category and composite final scores for MIPS eligible 
clinicians participating in MVPs will continue to be publicly reported 
as required under section 1848(q)(A)(i)(I) of the Act and finalized at 
Sec.  414.1395(a)(1)(i).
    We believe delaying public reporting of certain MVP and subgroup 
performance information provides a catalyst to encourage clinician 
participation in MVPs and subgroups while they familiarize themselves 
with these options. For this reason, we proposed, for individuals, 
groups, and subgroups reporting via MVP, to add a 1-year delay for 
publicly reporting new improvement activities and Promoting 
Interoperability measures and attestations, as technically feasible. 
This means that new improvement activities and Promoting 
Interoperability measures and attestations would be available for 
public reporting at their inception in traditional MIPS, but we would 
delay public reporting of new improvement activities and Promoting 
Interoperability measures and attestations by 1 year after inception 
for those reporting via MVP. We note that improvement activities and 
Promoting Interoperability measures and attestations that have already 
been in MIPS for more than 1 year and become newly available as part of 
an MVP would be available for public reporting in the first year the 
MVP is in the program. That is, non-first year improvement activities 
and Promoting Interoperability measures and attestations that are newly 
part of an MVP would be available for public reporting in the first 
year the MVP is in the program (86 FR 39466 through 39467). Table 74 
further clarifies when this 1-year delay would apply.

[[Page 65551]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.102

    We recognized that under this proposal, we would be further 
delaying the release of performance information for improvement 
activities and Promoting Interoperability measures and attestations 
reported via MVP. Because of this, as a potential incentive, we also 
considered whether to delay public reporting of quality and cost 
measure information reported via MVP by 1 additional year, for a total 
of 3 years. We solicited comments on our proposal to delay public 
reporting of new improvement activities and Promoting Interoperability 
measures and attestations reported via MVP by 1 year, as well as any 
feedback on alternate approaches we should consider spurring clinicians 
to report performance data on MVPs while making performance data 
available for patients on the compare tool. We proposed to amend this 
MVP public reporting policy at Sec.  414.1395(c)(2) to state CMS does 
not publicly report any MVP data on new improvement activities or 
Promoting Interoperability measure, objective, or activity included in 
an MVP for the first year in which it is included in the MVP. We also 
proposed to amend Sec.  414.1395(c)(1) to state that CMS does not 
publicly report any data on new quality or cost measure for the first 2 
years in which it is in the program, after which CMS evaluates the 
measure to determine whether it is suitable for public reporting under 
Sec.  414.1395(b). Currently, Sec.  414.1395(c) refers to these quality 
and cost measures as ``first year measures''. We proposed to change 
``first year measures'' to ``new measures'' (86 FR 39467).
    The introduction of MVPs and subgroup reporting in MIPS provides 
for new types of performance information that are available for public 
reporting, provided they meet the public reporting standards. 
Currently, we display information on profile pages at the individual 
clinician and group level, since this is the level of information we 
provide for and at which patients and caregivers search for on the 
compare tool. To ensure that patients and caregivers have access to 
subgroup performance information, we proposed creating a separate 
workflow from the established ones for individuals and groups, since we 
only display information at the level at which it was publicly reported 
(86 FR 39467). That is, we only publicly report individual-level 
performance information on individual clinician profile pages and 
group-level performance information on group profile pages. We do not 
publicly report group-level performance information on individual 
profile pages or individual-level information on group profile pages, 
as doing so would not be truly representative of either the group's or 
individual's own performance, and we do not want to mislead website 
users. Instead, we would link from the individual or group profile page 
to the corresponding subgroup performance information. That is, we 
proposed to create a subgroup public reporting workflow, in which we 
would indicate with plain language on an individual profile page that 
the clinician reports performance information as part of a subgroup or 
on a group profile page that the group has subgroups for purposes of 
performance information and then link to that subgroup's performance 
information. Future user testing would determine how to best display 
and put in plain language subgroup performance information. Subgroup 
performance information will also be available on http://data.medicare.gov/.
    Subgroups represent a new type of reporting for MIPS, that is 
available for clinicians reporting on MVPs or via the APP. For this 
reason, we also proposed to delay all subgroup-level public reporting 
for 1 year, including measures, activities and attestations across the 
quality, cost, improvement activities, and Promoting Interoperability 
performance categories in order to encourage clinician participation in 
subgroups without the risk of displaying subgroup performance 
information as clinicians familiarize themselves with the option of 
subgroup reporting. This would only be a one-time delay in public 
reporting of subgroup-level information. That is, we would not publicly 
report any CY 2023 subgroup-level measure, attestation, or activity 
performance information; this information would be available for public 
reporting beginning with CY 2024 performance period/2026 MIPS payment 
year. We would publicly report CY 2024 performance period/2026 MIPS 
payment year subgroup information and for each performance period 
thereafter if the information meets our established public reporting 
standards. Since we are moving toward more granular level performance 
information, we believe delaying subgroup public reporting by 1 year 
provides an incentive for subgroup participation and experience. As an 
alternative, we also considered a 1-year public reporting delay of 
performance information for all new subgroups each performance year, as 
technically feasible. For example, subgroups that begin in CY 2023 are 
not eligible for public reporting until CY 2024, subgroups that begin 
in CY 2024 are not eligible for public reporting until CY 2025, and so 
on for each subsequent year. Another alternative we considered was to 
publicly report all subgroup performance information without delay and 
provide new subgroups the opportunity to opt-out, during the preview 
period, of having their performance information publicly reported for 
their first year. Some subgroups may want to have their performance 
information publicly reported and having an overall 1-year delay may be 
a disincentive to subgroup participation. We solicited comments on 
these considerations. We noted that MIPS performance category and 
composite final scores for MIPS eligible clinicians participating in 
MVPs will continue to be publicly reported for those participating in 
subgroups, as required under section 1848(q)(A)(i)(I) of the Act and 
finalized at Sec.  414.1395(a)(1)(i), and will not be delayed by 1 year 
for public reporting.
    We also solicited comments on additional factors that we should 
consider as we look to expand the availability of MVP and subgroup data 
on the compare tools. For example,

[[Page 65552]]

should there be a certain threshold of MVPs available, or clinicians 
participating in MVPs prior to public reporting? For public reporting 
of subgroups, are there factors we should consider to make this 
information usable to the patient but reflective of the subgroups 
characteristics and composition? Should we test an indicator of MVP 
participation for compare tool profile pages to see if this is useful 
information for patients making healthcare decisions? We solicited 
comments on this proposal and additional ways public reporting may 
encourage MVP participation.
    The following is a summary of the comments we received and our 
responses.
    Comments: Several commenters supported the proposal to delay, by 1 
year, the public reporting of new improvement activities and Promoting 
Interoperability measures attestations reported through MVPs. One 
commenter requested clarification as to why new Promoting 
Interoperability measures and attestations would be delayed only for 
MVP participants. While some commenters supported the delay, they 
recommended extending the delay beyond 1 year. Two commenters stated a 
concern that delaying public reporting for MVPs and not traditional 
MIPS may be confusing for patients. One of the commenters recommended 
adding a note to profile pages explaining why there may not be 
performance information. The same commenter also recommended that 
instead of delaying public reporting for MVPs, CMS should allow MVP 
participants to opt-out of public reporting for their first year. 
Another commenter recommended beginning public reporting MVP 
performance information only once MVP reporting becomes mandatory.
    Response: We agree with most commenters that a 1-year delay of new 
improvement activities and Promoting Interoperability measures and 
attestations is an appropriate way to incentivize participation in 
MVPs. We also want to clarify that we proposed this 1-year delay as an 
incentive because new quality and cost measures already have a delay in 
public reporting for the first 2 years of use for clinicians in 
traditional MIPS. This delay is for new improvement activities and 
Promoting Interoperability measures, objectives, and activities in all 
MVPs whether they are new or existing MVPs. We appreciate the 
recommendations to extend the delay beyond 1 year, to allow MVP 
participants to opt-out of public reporting in their first year, and to 
only publicly report performance information reported via MVPs once MVP 
reporting becomes mandatory. We do believe that a 1-year delay is 
enough time to allow clinicians to familiarize themselves with MVPs as 
we do not want to further delay valid performance information that 
consumers can use to make informed healthcare decisions. It is for this 
same reason that we do not want to have MVP participants opt-out of 
public reporting or to delay public reporting of performance 
information reported via MVPs until MVP reporting becomes mandatory. We 
also want to clarify that performance information available via MVPs is 
the same as the performance information available in traditional MIPS 
and that we are required to publicly report performance information 
submitted by MIPS eligible clinicians. We do not believe that a delay 
for MVP participants and not traditional MIPS will be confusing to 
website users. Under traditional MIPS, we delay public reporting of new 
quality and cost measures by 2 years, and this has not caused any 
confusion to date. We also clarify that improvement activities and 
Promoting Interoperability measures and attestations that are already 
in traditional MIPS will be available for public reporting without any 
1-year delay.
    After consideration of public comments, we are finalizing this 
policy as proposed.
    Comment: Several commenters supported the one time, 1-year delay of 
subgroup public reporting, such that subgroup public reporting will 
begin with the availability of CY 2024 performance period/2026 MIPS 
payment year performance information. One commenter recommended 
extending the delay to 3 years.
    Response: We agree that a one-time 1-year delay is enough time for 
participants to familiarize themselves with this subgroup-level 
reporting. We also clarify that CY 2023 performance period/2025 MIPS 
payment year subgroup-level measure, attestation, or activity 
performance information across all MIPS performance categories would 
not be available for public reporting. We would begin publicly 
reporting subgroup-level performance information with CY 2024 
performance period/2026 MIPS payment year, which would be available for 
public reporting in CY 2025. After consideration of the public 
comments, we are finalizing this policy as proposed.
    After consideration of all of the public comments received on MVP 
and subgroup public reporting, we are finalizing all policies in this 
section as proposed. We did not receive any public comments on the 
proposal to create a separate subgroup workflow, and therefore, are 
finalizing it as proposed.
(2) Publicly Reporting APM Performance Pathway Information
    In the CY 2021 Quality Payment Program final rule, we finalized to 
establish an APM performance pathway (APP) beginning in the 2021 MIPS 
performance year. This is an optional MIPS reporting and scoring 
pathway for MIPS eligible clinicians who participate in MIPS APMs. We 
also note that since APP participants are MIPS eligible clinicians, 
their MIPS performance category and composite final scores will be 
publicly reported as required under section 1848(q)(A)(i)(I) of the Act 
and finalized at Sec.  414.1395(a)(1)(i).
    In the CY 2017 Quality Payment Program final rule, we finalized, as 
technically feasible, to use ACO profile pages as a guide to publicly 
reporting more APM data (81 FR 77398). Currently, groups who 
participate in an ACO have an indicator showing their participation, as 
well as a link to the ACO profile page with available performance 
information. User testing has shown that website users find the ACO 
information meaningful and displayed in a user-friendly way. For this 
reason, we plan to continue this approach for APM performance 
information, including that which comes in via the APP, as technically 
feasible. We also solicited comments on alternative ways to publicly 
report performance information reporting via APPs and additional 
considerations to publicly reporting this information (86 FR 39467).
    We did not receive public comments on alternative ways to publicly 
report performance information reported via APPs or any additional 
considerations to publicly reporting this information.
(3) Facility Affiliations
    Compare tool profile pages for clinicians currently provide 
demographic information, including names, addresses, phone numbers, 
medical specialties, APM affiliations, Medicare assignment status, 
board certifications, education and residency, gender, and group and 
hospital affiliations. User testing consistently shows that Medicare 
patients and caregivers find value in these types of information. For 
hospital affiliations, website users have consistently noted the 
importance of understanding up front the relationships clinicians may 
have with facilities where they perform services when searching for a 
clinician. Specifically, patients and caregivers have noted during user 
testing that hospital affiliation is important to them,

[[Page 65553]]

since they may be looking for a clinician to perform a procedure at a 
hospital or want to know the hospitals a clinician could potentially 
admit them if needed. Linking from the clinician profile page to their 
affiliated hospital page has provided a seamless experience for 
patients and caregivers, as they do not need to separately search for 
clinicians and hospitals; rather, they can navigate to a hospital 
profile page directly from the clinician's profile page.
    With these user testing findings in mind, and because the Compare 
Tools include information on a number of other types of facilities 
beyond hospitals, we believe it would benefit patients and caregivers 
to also be able to navigate from clinician profile pages to profile 
pages for other types of facilities such as: IRFs; LTCHs; SNFs; IPFs; 
HHAs; hospices; and dialysis facilities (86 FR 39468).
    Expanding the types of clinician-facility affiliations, beyond 
hospital affiliation, publicly reported would allow us to provide 
additional information about clinicians with or without any hospital 
affiliation but who are affiliated with other types of facilities. User 
testing with patients and caregivers has shown that facility 
affiliations not only for hospitals but also for IRFs, LTCHs, SNFs, 
IPFs, HHAs, hospices, and dialysis facilities would be helpful to their 
healthcare decision-making. Specifically, we proposed adding 
affiliations to clinician profile pages for each of the following types 
of facilities, pending the results of user testing, as applicable and 
technically feasible: IRFs; LTCHs; SNFs; IPFs; HHAs; hospices; and 
dialysis facilities. User testing will determine how to best display 
these affiliations on compare tool clinician profile pages. To 
determine clinician affiliations to these facilities, we would use 
claims data the same way we do to display the hospital affiliations 
currently available on clinician profile pages (77 FR 69165). We build 
the clinician-hospital affiliations based on observing a clinician 
practicing at a given hospital caring for at least three different 
Medicare patients on three different dates of service in the preceding 
6 months, as documented in Medicare claims. We would use similar 
criteria for determining additional facility affiliations. Clinicians 
can email the Quality Payment Program Service Center at http:[email protected]">//www.[email protected] if they believe their facility affiliations are 
displayed incorrectly. We solicited comments on the proposal to add 
affiliations to clinician profile pages for each of the following types 
of facilities and link to the specific facility's page on the compare 
tool: IRFs; LTCHs; SNFs; IPFs; HHAs; hospices; and dialysis facilities. 
Further, we also solicited comment on whether there should be a limit 
on the number of procedures done or conditions treated at a given 
facility to determine clinician-facility affiliations.
    The following is a summary of the comments we received and our 
responses.
    Comments: Several commenters supported adding facility affiliations 
beyond hospital affiliations to clinician profile pages on the compare 
tools. Specifically, these commenters supported the addition of 
affiliations for all facilities proposed, including IRFs, LTCHs, SNFs, 
IPFs, HHAs, hospices, and dialysis facilities. One commenter also 
recommended including clinicians' role as SNF medical directors on 
their profile pages. A few commenters noted concern, with two of these 
commenters opposing the proposal, related to the threshold for 
determining facility affiliations and how CMS would handle a clinician 
with multiple affiliations. These commenters believed that the three 
different Medicare patients on three different dates of service in the 
preceding 6 months threshold may be too low for determining facility 
affiliations. One of the commenters recommended CMS conduct user 
testing to determine how consumers react when a clinician is affiliated 
with multiple facilities or with a facility that has poor quality 
ratings. Another commenter requested clarification on how we plan to 
obtain and verify facility affiliation and noted concern about location 
and specialty accuracy.
    Response: We agree with commenters that adding affiliations to 
facilities beyond hospitals, on clinician profile pages, will aid 
patients in making healthcare decisions. We currently do not have a 
mechanism or source of data for verifying medical director or other 
healthcare administrative roles in SNFs or other types of care 
settings. Rather, if the clinician has filed a claim, it is because 
that clinician is actively treating patients and furnishing healthcare 
services, even if they also have an administrative role. We would not 
have information to report for a medical director or other healthcare 
administrator unless they have filed a claim. We understand the 
commenters concern and will explore alternative data sources that are 
found to be reliable. Regarding the concern about a clinician having 
multiple affiliations, we have user tested clinician profile pages that 
display multiple facility affiliations and have found that if a 
clinician has multiple affiliations, beneficiaries and their caregivers 
consider it important for them to know when making healthcare 
decisions. We also want to note that the threshold for determining 
facility affiliations has been reliable for determining the hospital 
affiliations that are currently on clinician profile pages, which is 
why we proposed using this threshold for the additional facility 
affiliations. We will continue to monitor this process as we expand 
using our currently methodology to affiliate other settings of care to 
clinicians. In response to questions regarding how we plan to obtain 
and verify facility affiliation, we plan to determine additional 
facility affiliations by using claims data in the same way we determine 
the hospital affiliations currently on clinician profile pages. This 
analysis includes reviewing claims for clinicians practicing at a given 
facility caring for at least three different Medicare patients on three 
different dates of service in the preceding 6 months, as documented in 
Medicare claims. Clinicians can email the Quality Payment Program 
Service Center at http:[email protected]">//www.[email protected] with the correct 
information if they believe their facility affiliations are displayed 
incorrectly, as they do today for hospital affiliation. We would then 
manually edit the affiliation on the website. This manual edit would 
remain in effect for 6 months only. To ensure a more permanent change, 
clinicians must update their information in the Medicare Provider 
Enrollment, Chain, and Ownership System (PECOS). For more information, 
clinicians can visit the Care Compare: Doctors and Clinicians 
Initiative Page at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Compare-DAC. Regarding the accuracy of 
clinician specialty and location, we note that this information is 
obtained from the PECOS. We rely on clinicians to ensure that their 
information in PECOS is up to date to ensure the most accurate 
information is publicly reported.
    After consideration of public comments, we are finalizing this 
policy as proposed.
(4) Utilization Data Request for Information
    Under section 104(e) of the Medicare Access and CHIP 
Reauthorization Act of 2015 (MACRA), beginning with 2016, the Secretary 
is required to integrate utilization data information on

[[Page 65554]]

Physician Compare.\260\ To satisfy section 104(e) of the MACRA, we 
previously implemented a policy to begin to include utilization data in 
a downloadable format in late 2017 using the most currently available 
data, and previously finalized that the specific codes to be included 
will be determined via data analysis and reported at the eligible 
clinician level (80 FR 71130). We finalized to continue to include 
utilization data in the downloadable database (81 FR 77398). This 
information continues to be available today on www.data.cms.gov/provider-data.
---------------------------------------------------------------------------

    \260\ Physician Compare is defined at Sec.  414.1305 as 
Physician Compare internet website of CMS (or a successor website).
---------------------------------------------------------------------------

    To date, we have gathered utilization data for procedures from 
physician/supplier Medicare Part B non-institutional claims on certain 
services and procedures and published it in the public use file (PUF) 
file entitled ``Physician and Other Supplier Data.'' These data are 
useful to the healthcare industry, healthcare researchers, and other 
stakeholders who can accurately interpret these data and use them in 
meaningful analyses. However, this information is presented in a 
technical way that is not easily accessible or usable by patients, who 
do not frequently visit data.cms.gov or understand medical procedure 
coding. This information also does not provide detail on the specific 
conditions clinicians treat, though in select cases it may be inferred 
by the clinicians and researchers reviewing this information.
    Section 10331(b)(3) of the Affordable Care Act requires that for 
public reporting, to the extent practicable, to include processes to 
assure that the data made available provides a robust and accurate 
portrayal of a clinician's performance. In our efforts to continue to 
provide patients and caregivers with meaningful information to make 
informed healthcare decisions, we believe utilization data may also 
have a place on clinician and group profile pages, if presented in a 
consumer-friendly way. We envision utilization data on patient-facing 
profile pages providing two main areas of benefit. The first is 
allowing for more granular clinician searches, so that patients not 
only find specific types of clinicians but also those clinicians 
experienced in performing specific types of procedures and/or treating 
specific conditions. The second is providing categories of utilization 
data in a more plain language display that is usable to patients and 
their caregivers. In summary, utilization data could provide 
information to Medicare patients and their caregivers on the specific 
diagnoses clinicians treat and the frequency with which certain 
services or procedures are performed by a clinician or group and/or 
which types of clinicians do not provide certain services.
    For example, someone with severe arthritis of the knee may want to 
search for an orthopedic surgeon who specifically does knee 
replacements. The way the clinician search works currently would only 
show results for ``orthopedic surgeons'' generally. That is, the 
patient would not see which of these clinicians specialize in this 
procedure, and likely would need to spend time calling clinicians to 
ascertain more detail. This could similarly be the case for finding a 
clinician who focuses on treatment of a certain condition. We believe 
indicating which clinicians focus on certain procedures or conditions 
would relieve some of this patient burden, as it would yield more 
specific search results. There are a number of factors that could 
influence how procedure- and condition-specific information is 
determined, which is why we solicited comments on this topic in several 
areas.
    For display purposes, we may wish to apply a minimum experience 
level, such as the number of times a clinician performed a procedure or 
treated a condition, before a clinician profile is annotated to 
indicate experience with the condition or procedure. Regarding the 
methods in which we would identify clinician volume of procedures 
conducted or treat specific conditions, we would need to set a 
threshold for making these assertions. We have considered several 
options. The threshold could be based on the number of times a 
clinician has performed a procedure or treated a condition within a 
certain time-period, or the proportion of the clinician's practice that 
is represented by the procedure or condition. Alternatively, thresholds 
may be devised based on ranking clinicians compared to their peers 
(specialty and geography may be considered when defining peers) in 
volume of procedures performed or frequency with which they treat each 
condition.
    We note also that these approaches utilize Medicare claims data 
only. That is, these data would not include procedures performed or 
conditions treated for patients who have other types of insurance, 
since this information is not available. We also acknowledge that this 
utilization data only represents the care provided to Medicare 
beneficiaries and clinicians offer care to those with other forms of 
insurance. This disclaimer could be added to any data that may be 
publicly reported. We solicited comments on these approaches and 
whether there are any additional ones we should consider.
    Additionally, because the Compare Tools utilize a location-based 
search, national or local thresholds may be appropriate. For example, 
clinicians in urban centers may specialize in a small number of 
procedures that they perform on a weekly basis, while a clinician in a 
rural area might be the most experienced at a given procedure, but not 
have comparable volume to the urban clinician who practices a very 
narrow scope. We solicited comments on these considerations, as well as 
if there are others.
    We also solicited comments on the potential types of utilization 
data that, if publicly reported, could help Medicare patients and their 
caregivers make informed healthcare decisions, as well as on technical 
considerations for presenting a specific affiliation between clinicians 
and diagnoses and/or procedures. Specifically, we solicited comments 
on:
     The types of conditions and procedures that would most 
benefit patients' clinician searches;
     Important features and considerations for clinician 
searches by conditions or procedures;
     The lookback period for Medicare claims in order to 
identify a clinician's volume of procedures balancing frequency with 
recent experience (for example, 6 months, 1 year, 2 years);
     Clinician specialties or conditions with special 
considerations (for example, non-patient facing clinicians);
     The maximum number of conditions treated or procedures 
performed to display on a given clinicians profile page; and
     Methods to set a threshold of treatment volume to display 
that a clinician commonly performs a procedure or treats a condition. 
For example, the threshold could be: (1) The number of times a 
clinician treated a condition or performed a procedure; (2) the total 
scope that a condition or treatment represents in a clinician's 
practice; or (3) the clinician's rank--either overall among all 
clinicians or among a subset of clinicians--in the number of times that 
clinician treated a condition or performed a procedure.
     Any other factors or considerations not listed above.
    We received public comments on considerations for publicly 
reporting utilization data. We thank the commenters' feedback and will 
take these comments into consideration in future years.

[[Page 65555]]

4. Overview of the APM Incentive
(a) Overview
    Under the Quality Payment Program, eligible clinicians who are 
Qualifying APM Participants (QPs) for a year are eligible to receive an 
APM Incentive Payment in the corresponding payment year for payment 
years 2019 through 2024. In the CY 2017 Quality Payment Program final 
rule (81 FR 77480 through 77489), we finalized at Sec.  414.1450(d) 
that this payment is made based on the clinician's QP status in the QP 
Performance Period that is 2 years prior (for example, the 2021 payment 
will correspond to the 2019 performance year), and at Sec.  
414.1450(b)(1) that the payment is equal to 5 percent of the estimated 
aggregate payments for covered professional services in the base period 
(the year between the QP performance and payment years).
    We also finalized at Sec.  414.1450(c)(1) (82 FR 31729) that the 
APM Incentive Payment will go to the TIN associated with the Advanced 
APM Entity through which an eligible clinician becomes a QP during the 
QP Performance Period. In 2019, our first year of making APM Incentive 
Payments, we learned that the amount of time between the QP Performance 
Period (during which QP status is attained) and the QP payment year 
(during which APM Incentive Payments are issued) creates challenges to 
disbursing the payment for some QPs in a routine and efficient manner, 
for example for QPs who may have changed practices in the interim. 
Consistent with section 1833(z) of the Act, QP status is determined 
for, and connected to, an eligible clinician (identified by their NPI) 
for the QP payment year based on their Advanced APM participation 
during the QP Performance Period. In the proposed rule, we stated that 
we do not believe that changes in a QP's practice or TIN in the interim 
year between the QP determination and the QP payment year should affect 
a QP's ability to receive the APM Incentive Payment. To address some of 
the unanticipated challenges we encountered in disbursing the APM 
Incentive Payments, in the CY 2021 PFS final rule, we finalized a 
hierarchy, codified at Sec.  414.1450, that, based on our experience 
and lessons learned in making payments in 2019, provides more ways to 
identify an appropriate TIN to which we can make the APM Incentive 
Payment when a QP has experienced changes in their practice or TIN 
since the performance year in which they attained QP status.
(c) APM Incentive Payment Recipient
    In the 2021 PFS final rule (85 FR 84472), we revised our approach 
to identifying the TIN or TINs to which we make the APM Incentive 
Payment and established a process that enables QPs to provide CMS with 
updated enrollment information that could be used to complete the 
payment in the event our approach does not yield an appropriate TIN or 
TINs to which to send their APM Incentive Payments. The process for 
those QPs to update their information, as well as a preliminary list of 
NPIs to whom it may be applicable, is included in a public notice 
published annually in the Federal Register. We explained in the CY 2021 
PFS final rule that the revised approach would involve looking at a 
QP's relationship with TINs at different, specified periods in time, as 
well as considering the relationships such TINs have with certain APM 
Entities and Advanced APMs. We stated that we believe this revised 
approach enables us to more appropriately identify TINs with which QPs 
currently have relationships to receive other Medicare payments, and 
through which the QPs likely would anticipate receiving their APM 
Incentive Payments. We noted that, when the QP is no longer affiliated 
with the TIN through which they achieved QP status, this approach will 
prioritize identifying an alternate TIN with which the QP is affiliated 
at the time the APM Incentive Payment is made, and to which it is 
appropriate to make the payment. The approach we adopted also serves to 
reduce uncertainty for QPs as they anticipate the APM Incentive 
Payments, as well as potential delays in our ability to make their 
payments.
    To improve and expand the ways we identify the TIN(s) to which we 
make the APM Incentive Payment for a QP in a timely and efficient 
manner, we finalized a policy to sequentially apply a decision 
hierarchy and codified the hierarchy in Sec.  414.1450(c). We apply the 
hierarchy by beginning at the first step, and if we are unable to 
identify one or more TINs with which the QP has a current affiliation 
at this step, we move to the next and successive steps of the hierarchy 
until we do identify one or more TINs with which the QP is affiliated.
    As discussed in the CY 2021 PFS final rule, if we identify more 
than one TIN at the applicable step in the hierarchy, we divide the APM 
Incentive Payment proportionally between the QP's TINs based on the 
relative paid amount for Part B covered professional services that are 
billed through each of the TINs. We proposed to clarify that, when we 
divide the APM Incentive Payment between two or more TINs, we apportion 
the APM Incentive Payment among TINs based on the share of total 
payments for covered professional services made to each TIN in the same 
base year that we use to calculate the APM Incentive Payment for the 
year. To calculate the APM Incentive Payment, we sum the total 
estimated aggregate payments for covered professional services for a QP 
for the base year, which is based on claims submitted for covered 
professional services, as codified at Sec.  414.1450(b)(1) through (3). 
We proposed to codify this policy at Sec.  414.1450(c).
    In the course of making APM Incentive Payments during CY 2020 PFS 
final rule, we explored the possibility of expanding our search at each 
step of the hierarchy at Sec.  414.450(c) to identify potential payee 
TINs that are associated with the QP during the QP payment year. Based 
on our findings, we stated we believe expanding our search in this way 
would enable us to make payments earlier in the calendar year and 
reduce the number of QP NPIs for whom we cannot identify a payee TIN 
using our hierarchy, and thus, rely on our public notice to request 
additional information. Therefore, we proposed to revise the hierarchy 
at Sec.  414.1450(c) so that, using the criterion described in each 
step of our current regulation, we would first seek to identify a TIN 
associated with the QP during the base year, and if no such TIN is 
identified in the base year, we would then seek to identify a TIN 
associated with the QP during the payment year. We have found in many 
instances that there are changes in enrollment information in PECOS for 
a QP over the span of 2 years between the QP performance period and 
payment year. By using enrollment information for the QP during the 
payment year, we are more likely to identify an appropriate TIN to 
which to make the APM Incentive Payment hierarchy. Under the proposal, 
applying the steps in the APM Incentive Payment hierarchy, we would 
make the APM Incentive Payment to one or more solvent TINs associated 
with the QP, identified by paid Medicare Part B claims for covered 
professional services and associated PECOS enrollment information 
during the base period; and if no such TIN is identified, we will make 
the payment to such TINs associated with the QP during the payment 
year. We proposed to codify this policy in the regulation at Sec.  
414.1450(c).
    If no such TIN or TINs can be identified at a particular step, we 
will

[[Page 65556]]

move to the next and successive steps listed in Sec.  414.1450(c)(1) 
through (8) until we identify one or more solvent TINs with which the 
QP is associated, and then would make the APM Incentive Payment to any 
such TIN(s). If more than one TIN is identified at a step based on paid 
claims during the applicable year either the base year or payment year, 
as we explain earlier and proposed to codify in the regulation under 
Sec.  414.1450(c), would divide the APM Incentive Payment 
proportionately among such TINs according to the relative total paid 
amounts for Part B covered professional services to each TIN in same 
the base year we use to calculate the APM Incentive Payment.
    We proposed, for each step in the APM Incentive Payment decision 
hierarchy, we would first search for a payment TIN or TINs associated 
with the QP during the base period. If no such TIN is found during the 
base year, we would search for any TIN or TINs that are similarly 
situated with respect to the criterion at that step in the hierarchy 
and associated with the QP during the payment year. If such a TIN or 
TINs are found, we would make the APM Incentive Payment to such TIN or 
TINs. We will continue at each step in the hierarchy to first attempt 
to identify the relevant base year TIN or TINs associated with the QP 
because, as noted in the proposed rule, we believe such TINs are more 
likely to be associated with the APM Entity through which the QP 
attained their QP status during the QP performance period. However, if 
no such TIN is found in the base year, we would proceed at that step to 
search for a TIN or TINs with which the QP is associated in the payment 
year.
    We explained that we believe this approach creates the greatest 
opportunity to identify and pay an appropriate TIN as efficiently and 
early as possible during the payment year. The proposed change would 
maintain the current hierarchy while adding a sub-step at each level in 
which we would conduct our search based on more current enrollment 
information. The proposed change would allow for the identification of 
an appropriate TIN or TINs at each step by first checking the base 
year, and then checking the payment year before moving on to the next 
step in the process. We stated we believe that by maintaining the 
current hierarchy we would continue to incent Advanced APM 
participation by prioritizing making payments to TINs affiliated with 
Advanced APMs, even if they are not in the same Advanced APM Entity 
through which QP status originally was achieved. For example, we stated 
that we anticipate that many eligible clinicians who earned QP status 
in 2020 through a practice participating in the CPC+ model will join 
the new Primary Care First (PCF) model in 2022.
    In the event the eligible clinician's CPC+ participant TIN is no 
longer active, our proposed modification to the hierarchy would enable 
us to pay the APM Incentive Payment to a TIN participating in the PCF 
model in 2022. We stated that we continue to believe it would be 
appropriate to first identify the relevant base year TIN or TINs at 
each step in of the hierarchy because we believe those TINs are more 
likely to be associated with the APM Entity through which the QP 
attained their QP status during the QPs performance period. However, if 
no TIN is found in the base year, we would proceed to identify any TINs 
associated with the QP in the payment year, and then use the same 
process for the subsequent steps in the hierarchy until we identify one 
or more TINs associated with the QP at a particular step for a 
particular year (base year or payment year). We explained that we 
believe this approach will be a more efficient and expeditious way to 
identify a TIN or TINs to which to make the APM Incentive Payment for 
QPs.
    We solicited comments on this proposal to amend our APM Incentive 
Payment decision hierarchy to include an additional attempt to identify 
and pay, at each step, one or more solvent TINs associated with the QP 
during the payment year when no such TIN is identified for the QP in 
the base year.
    We received several comments on this proposal.
    Comment: We received many public comments in support of this 
approach to identifying payee TINs during the payment year.
    Response: We thank commenters for their support of this policy.
    Comment: We received two public comments advocating that the APM 
Incentive Payment should be paid directly to the ACO or APM Entity.
    Response: We disagree with this comment for several reasons. First, 
the APM Incentive Payment is not earned by the APM Entity in the way a 
shared savings payment may be earned by the ACO under the Shared 
Savings Program. Although QP determinations are in some cases are made 
at the APM Entity group level, QP status is conferred on an individual 
eligible clinician. As a result, the individual QP is excluded from the 
MIPS reporting and payment adjustment requirements, and it is the QP 
who earns the APM incentive payment. Therefore, the payment is 
disbursed for the eligible clinician who is a QP to a TIN that is 
affiliated with the QP, even in instances where the QP is no longer 
affiliated with the APM Entity. The payment is designed as an incentive 
in lieu of the pursuance of a MIPS payment adjustment. CMS makes the 
APM Incentive Payment to one or more TINs to which the QP has 
reassigned their billing rights. Thus, the QP and TIN may resolve 
between themselves the handling of the APM Incentive Payment. Some APM 
Entities are the same as the Medicare enrolled TIN to which QPs have 
reassigned their Medicare payment rights, and to which we would make 
the APM Incentive Payment. Other APM Entities, such as ACOs, are not. 
For these reasons, we do not make the APM Incentive Payment directly to 
an ACO, and we do not believe it would be appropriate to do so.
    Comment: One commenter suggested that we should allow QPs to 
individually identify their preferred payee TIN to receive the APM 
Incentive Payment.
    Response: It would not be practically feasible for every QP to 
individually identify a recipient TIN for the QP incentive payment. Our 
experience working with PECOS and other voluntary systems, including 
our annual public notice, indicate that requiring individual eligible 
clinicians to elect a recipient TIN for the incentive payment could 
cause significant delays in completing the payments. These delays would 
be of such duration that CMS would likely miss the statutory deadline 
of December 31 of the payment year in which we are required to have 
completed these payments. Further, some QPs might never complete the 
prerequisite step, which would make it difficult if not impossible to 
disburse APM Incentive Payments for them. Moreover, eligible clinicians 
are not without an opportunity to indicate to CMS the TINs with which 
they have current billing arrangements. In fact, all Medicare enrolled 
eligible clinicians are required to update their billing information, 
including reassignments within the PECOS system within a specified 
timeframe. By ensuring PECOS is updated at all times, eligible 
clinicians have an opportunity to ensure that if they become QPs for a 
year, the APM Incentive Payment will be received by a TIN to which they 
have reassigned their billing rights. We believe it is both appropriate 
and efficient for clinicians to use the longstanding and required 
processes that are in place to update their billing information, which 
enables us to identify one or more appropriate TINs to which to make 
the APM Incentive Payment. Finally, we have established in regulations 
a payment decision

[[Page 65557]]

hierarchy that specifies how we will identify the TIN or TINs to which 
we will distribute the APM Incentive Payment. One of the main purposes 
for establishing this hierarchy and for updating it this year is to 
provide predictability for eligible clinicians regarding the APM 
Incentive Payment disbursements.
    After consideration of the public comments, we are finalizing our 
proposed update to the APM Incentive Payment decision hierarchy, and 
amending our regulation at Sec.  415.1415(c), as proposed.
c. Advanced APMs
1. Qualifying APM Participant Determination
a. General Overview
    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 in 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).
b. QP Thresholds and Partial QP Thresholds
    Section 1833(z)(2)(B) of the Act describes 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. The All-Payer Combination Option, 
which uses the Medicare Option, as well as an eligible clinician's 
participation in Other Payer Advanced APMs, is applicable beginning in 
the payment year 2021. In the CY 2017 Quality Payment Program final 
rule (81 FR 77433 through 77439) we finalized our policy for the 
Medicare Option as codified at Sec.  414.1430(a) and for the All-Payer 
Option at Sec.  414.1430(b).
    Section 114 of Division CC of the CCA amended section 1833(z)(2)(B) 
of the Act with regard to payment years 2023 and 2024 (which correspond 
respectively to performance years 2021 and 2022), by freezing for such 
years the applicable payment amount and patient count thresholds for an 
eligible clinician to achieve QP status. Specifically, the CAA amended 
section 1833(z)(2)(B) of the Act to continue the QP payment amount 
thresholds that apply in payment years 2021 and 2022 to payment years 
2023 and 2024. Additionally, the CAA amended section 1833(z)(2)(D) of 
the Act to require that, for payment years 2023 and 2024, the Secretary 
use the same percentage criteria for the QP patient count threshold 
that are applied in payment year 2022. As such, the Medicare Option QP 
thresholds for payment years 2023 and 2024 (performance years 2021 and 
2022) will remain at 50 percent for the payment amount method and 35 
percent for the patient count method. The CAA also amended section 
1848(q)(1)(C)(iii) of the Act to extend through payment year 2024 the 
Partial QP thresholds that are established for payment years 2021 and 
2022. Therefore, the Partial QP thresholds for payment years 2023 and 
2024 (performance years 2021 and 2022) will remain at 40 percent for 
the payment amount method and 25 percent for the patient count method. 
For performance years beginning with 2023 (corresponding to payment 
years beginning with 2025) the statute prescribes the QP thresholds for 
the payment amount method, and the QP thresholds we established for the 
patient count method at Sec.  414.1430 will take effect. Specifically, 
for performance years beginning with 2023, the Medicare Option QP 
thresholds will be 75 percent for the payment amount method and 50 
percent for the patient count method. The Partial QP thresholds under 
the Medicare Option will be 50 percent for the payment amount method 
and 35 percent for the patient count method.
    Under the All-Payer Combination Option, the QP thresholds for 
performance years 2021 and 2022 (corresponding to payment years 2023 
and 2024) will be 50 percent for the payment amount method and 35 
percent for the patient count method. The Partial QP thresholds for 
performance years 2021 and 2022 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 threshold percentages under the 
Medicare Option. For performance years 2021 and later (corresponding to 
payment year 2023 and later), the minimum Medicare Option threshold an 
eligible clinician must meet for the All-Payer Combination Option is 25 
percent for the payment amount method or 20 percent under the patient 
count method.
BILLING CODE 4120-01-P

[[Page 65558]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.103

    Although we included proposed amendments to our regulation at Sec.  
414.1430(a)(1) and (2) in the CY 2022 PFS proposed rule to reflect the 
changes made by the CAA to the QP and Partial QP Thresholds under the 
Medicare Option payment amount method, we inadvertently neglected to 
discuss those proposed amendments in the preamble. Additionally, we 
inadvertenly did not include proposed regulation text at Sec.  
414.1430(a)(3) or (4) to reflect the amendments made by the CAA to the 
QP and Partial QP thresholds under the Medicare Option patient count 
method; or to the regulation text at Sec.  414.1430(b) to reflect 
amendments to the All Payer Option payment amount and patient count QP 
and Partial QP thresholds. However, we believe it is preferable to 
revise the regulation text to consistently and accurately reflect the 
statutory threshold percentages for each year in accordance with the 
CAA amendments for both the Medicare Option and All Payer Option and 
for both the payment amount and patient count methods for each of the 
options. Therefore, we are finalizing the proposed amendments to Sec.  
414.1430(a)(1) and (2) and making amendments to Sec.  414.1430(a)(3) 
and (4); and Sec.  414.1430(b)(1) through (4) to reflect the applicable 
statutory threshold percentages as amended by the CAA.
    We received four public comments, all in support of the statutory 
changes to the QP and Partial QP threshold levels. We thank the 
commenters for their input and will implement the amendments made by 
the CAA as discussed and revise the regulation at Sec.  414.1430 as 
proposed.

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 OMB's implementing regulations.
    To fairly evaluate whether an information collection should be 
approved by OMB, PRA section 3506(c)(2)(A) requires that we solicit 
comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our burden estimates.
     The quality, utility, and clarity of the information to be 
collected.
     Our effort to minimize the information collection burden 
on the affected public, including the use of automated collection 
techniques.
    We solicited public comment on each of the required issues under 
section 3506(c)(2)(A) of the PRA for the following information 
collection requirements.

A. Wage Estimates

    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics' May 2020 National Occupational Employment and Wage 
Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 76 presents the mean hourly wage, 
the cost of fringe benefits and overhead (calculated at 100 percent of 
salary), and the adjusted hourly wage.

[[Page 65559]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.104

    For the CY 2019 and CY 2020 PFS final rules, we used the BLS wage 
for ``Physicians and Surgeons'' (occupation code 29-1060) to estimate 
the cost for Physicians. In BLS' most recent set of occupational wage 
rates (dated May 2020) they have discontinued this occupation in their 
wage data. As a result, in order to estimate the burden for Physicians, 
similar to the estimates in the CY 2021 PFS final rule (85 FR 84958), 
we are using a rate of $217.32/hr which is the average of the following 
BLS occupations and adjusted wage estimates.
[GRAPHIC] [TIFF OMITTED] TR19NO21.105

BILLING CODE 4120-01-C
    As indicated, we adjusted BLS' hourly wage estimates by a factor of 
100 percent to obtain the adjusted hourly wage estimate. This is 
necessarily a rough adjustment, both because fringe benefits and 
overhead costs vary significantly from employer to employer, and 
because methods of

[[Page 65560]]

estimating these costs vary widely from study to study. Nonetheless, we 
believe that doubling the hourly wage to estimate total cost is a 
reasonably accurate estimation method.

B. Information Collection Requirements (ICRs)

1. ICRs Requiring Certain Manufacturers To Report Drug Pricing 
Information for Part B (Sec. Sec.  414.802 and 414.806)
    The following provisions will be subject to the standard PRA 
process under OMB control number 0938-0921 (CMS-10110). The standard 
PRA process includes the publication of 60- and 30-day Federal Register 
notices that will provide the public with opportunities for public 
review and comment. We expect to publish the 60-day notice shortly 
after the publication of this final rule.
    The new provisions at Sec. Sec.  414.802 and 414.806 will implement 
new statutory requirements under sections 1847A and 1927 of the Act, as 
amended by section 401 of Division CC, Title IV of the CAA, 2021 (for 
the purposes of this section of this final rule, hereinafter is 
referred to as ``section 401''), which requires manufacturers without a 
Medicaid drug rebate agreement to report ASP information to CMS for 
calendar quarters beginning on January 1, 2022, for drugs or 
biologicals payable under Medicare Part B and described in sections 
1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of the Act, including 
items, services, supplies, and products that are payable under Part B 
as a drug or biological. Specifically, to implement the new reporting 
requirements for manufacturers without Medicaid drug rebate agreements, 
we proposed to modify: (1) The definition of drug at Sec.  414.802; and 
(2) the regulations describing civil money penalties at Sec.  414.806. 
The new requirements will improve the accuracy of reported payment 
limits and limit the use of WAC-based pricing.
    For the purposes of section 401's new reporting requirements, for 
manufacturers without Medicaid drug rebate agreements, confidentiality 
requirements appear in section 1847A(f)(2)(D) of the Act which states 
that the ASP data are confidential and shall not be disclosed by the 
Secretary in a form which discloses the identity of a specific 
manufacturer or wholesaler or prices charged for drugs or biologicals 
by such manufacturer or wholesaler, except--as the Secretary determines 
to be necessary to carry out section 1847A of the Act (including the 
determination and implementation of the payment amount), or to carry 
out section 1847B of the Act; to permit the Comptroller General of the 
United States to review the information provided; to permit the 
Director of the Congressional Budget Office to review the information 
provided; to permit the MedPAC to review the information provided; and 
to permit the Medicaid and CHIP Payment and Access Commission to review 
the information provided.
    For manufacturers with Medicaid drug rebate agreements, 
confidentiality requirements appear in section 1927(b)(3)(D) of the Act 
which states that the ASP data are confidential and shall not be 
disclosed by the Secretary in a form which discloses the identity of a 
specific manufacturer or wholesaler, prices charged for drugs by such 
manufacturer or wholesaler, except--in relevant part, as the Secretary 
determines to be necessary to carry out section 1847A of the Act 
(including the determination of the payment amount), or to carry our 
section 1847B of the Act, to permit the Comptroller General to review 
the information provided, to permit the Director of the Congressional 
Budget Office to review the information provided, and to permit the 
Executive Director of the Medicare Payment Advisory Commission (MedPAC) 
and the Executive Director of the Medicaid and CHIP Payment and Access 
Commission to review the information provided.
    The burden associated with these requirements is the time and 
effort required by manufacturers of drugs and biologicals payable under 
Medicare Part B to prepare and submit the required ASP data to CMS. We 
have previously estimated the burden associated with ASP reporting 
requirements for manufacturers with Medicaid drug rebate agreements. 
Because section 401 extends the ASP reporting requirements to 
manufacturers without Medicaid drug rebate agreements, we are updating 
our burden estimates to account for the additional manufacturers who 
will now be required to report ASP data to us.
    As described in section III.D.1. of this final rule, in considering 
whether to exclude repackagers from the reporting requirements at 
section 1847A(f)(2) of the Act, we conducted analyses to estimate: (1) 
The proportion of repackaged products in our existing ASP data; (2) the 
number of new ASP submissions we can expect as a result of the new 
reporting requirements under section 401; and (3) the proportion of 
those (new) submissions that involve repackaged products.
    Based on our existing ASP data, 547 manufacturers (respondents) 
report ASP data to us. Of these, 331 respondents have products for 
which they are required to submit ASP data, and 216 respondents have 
products for which they currently submit ASP data voluntarily, but will 
now be required to do so under section 1847A(f)(2) of the Act. (331 + 
216 = 547)
    We also estimate that under the new reporting requirements of 
section 401, a total of 568 respondents have products for which they 
will now be required to report ASP data to us. The 568 includes the 216 
respondents (above) and 361 respondents who have products (identified 
by us) for which they will now be required to submit ASP data under 
section 1847A(f)(2) of the Act and did not previously voluntarily 
submit these data to us. There were 9 respondents who voluntarily 
submitted ASP data for some, but not all, of their products identified 
in our analysis. (216 + 361-9 overlap = 568)
    We estimate a total of 740 respondents will report ASP data to us. 
This includes the 547 respondents who currently submit ASP data to us 
(voluntarily, or as currently required), and the 361 respondents who 
have products (identified by us) for which they will now be required to 
submit ASP data under section 1847A(f)(2) of the Act and did not 
previously voluntarily submit these data to us. However, there were 168 
respondents who currently are required to submit ASP data to us, or who 
voluntarily submit ASP data to us, for whom we identified additional 
products that they did not previously submit ASP data, and will now be 
required to submit ASP data for these additional products under the new 
reporting requirements of section 401. (547 + 361-168 overlap = 740)
    These respondents submit ASP data four times per year for a total 
of 2,960 submissions (740 respondents x 4 submissions/year).
    Based on our experience with ASP data reporting, we continue to 
estimate that the time associated with reporting, record keeping, and 
third-party disclosure for ASP data reporting is 13 hours: 10 hours to 
review instructions and search existing data resources and 3 hours to 
gather the data, compile the data, submit via electronic media and 
upload to the automated system. This estimate includes labor costs for 
respondents to extract data from their information systems and to 
compile and submit the ASP data, including signature, to CMS via the 
internet-based automated system and electronic media. This estimate 
also includes the cost of the compact disc (CD) and overnight mail 
service used to report the data,

[[Page 65561]]

time to review instructions, search existing data resources, gather the 
data needed, and complete and review the information collection.
    Based on these analyses and assumptions, we estimate an annual 
burden of 38,480 hours (2,960 submissions/yr x 13 hours per response) 
at a cost of $1,495,332.80 (38,480 hr x $38.86/hr), rounding to 
$1,495,333.
[GRAPHIC] [TIFF OMITTED] TR19NO21.106

    We solicited comment on the likely costs or savings manufacturers 
from this provision.
    We did not receive public comments on the analyses or the 
estimates. We are finalizing the definition of the term ``drug'' at 
Sec.  414.802 as proposed.
2. ICRs Regarding the Medicare Shared Savings Program (Sections 
VI.F.8.a. and b.)
    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 burden 
under the authority of the PRA. Please refer to sections VI.F.8.a. and 
b. of this final rule for a discussion of the impacts associated with 
this rule's changes to the Shared Savings Program's quality reporting 
requirements, quality performance standard, beneficiary assignment 
methodology, repayment mechanism requirements, requirements for 
disclosure of prior participation in the Shared Savings Program by the 
ACO, ACO participants, and ACO providers/suppliers, requirements for 
ACOs to submit sample ACO participant agreements and executed ACO 
participant agreements to CMS, and beneficiary notification 
requirements.
3. ICRs Regarding the Medicare Ground Ambulance Data Collection System 
(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, this collection of information section does not set 
out any burden for the proposed provisions that we are finalizing in 
this final rule. Please see section VI. of this final rule for a 
discussion of the estimated impacts.
    We received no public comments on the collection of information 
requirements for the Medicare Ground Ambulance Data Collection System. 
We are finalizing as proposed.
4. ICRs Regarding the Medicare Diabetes Prevention Program (MDPP) 
Expanded Model (Sec. Sec.  410.79, 414.84, 424.205, and 424.502)
    In section III.L. of this final rule, we finalize policies 
necessary to shorten the Medicare Diabetes Prevention Program (MDPP) 
services period to one (1) year on a prospective basis, amend and 
update the amount of the performance payments for the Core Sessions and 
Core Maintenance Sessions, and make changes to eliminate the ongoing 
maintenance phase for MDPP beneficiaries who start MDPP set of services 
on or after January 1, 2022. In addition, we are finalizing a provision 
to waive the provider enrollment Medicare application fee for all 
organizations enrolling in Medicare as MDPP suppliers during the MDPP 
expanded model on or after January 1, 2022. We expect the finalized 
policies will increase the number of eligible organizations willing to 
enroll as MDPP suppliers. We also anticipate that the shortened service 
period will make MDPP more marketable to beneficiaries in that their 
time commitment is reduced and less intimidating with a 12-month vs. 
24-month service period. We anticipate the shortened MDPP services 
period will reduce the recordkeeping burden for suppliers. 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. Please see section VI. of 
this final rule for a discussion of the estimated impacts.
5. ICRs for Prepayment and Post-Payment Definitions, Documentation 
Request Timeframes, and Payment Denials for Noncompliance With 
Documentation Requests (Sec. Sec.  405.902, 405.903, 405.929, and 
405.930)
    In section III.N.2. of this final rule, we proposed to: (1) Define 
key terms including ``additional documentation,'' ``additional 
documentation request,'' ``post-payment medical review,'' and 
``prepayment medical review;'' (2) codify contractors' authority to 
request additional documentation for prepayment and post-payment review 
within established timeframes; (3) codify timeframes for response to 
requests for documentation; (4) codify result of a failure to comply 
with prepayment or post-payment documentation request(s) by a provider 
or supplier, specifically denial of payment.
    The codification of contractor authority to request additional 
documentation for post-payment reviews, associated timeframes, and 
resulting denials for failure to comply with these requests is not 
subject to the PRA per 5 CFR 1320.3(h)(9). The request for additional 
documentation will be on a case-by-case basis using non-standardized 
follow-up questions.
    With regard to the (1) definitions for ``additional documentation'' 
and ``additional documentation request,'' ``post-payment medical 
review,'' and ``prepayment medical review;'' (2) the codification of 
contractor authority to

[[Page 65562]]

request additional documentation for pre-payment reviews; (3) the 
associated provider and supplier timeframes for providing additional 
documentation from the pre-payment reviews; and (4) possible denials 
for failure to comply with these requests, we do not expect that these 
proposals will affect our information collection burden estimates 
because these policies do not require providers or suppliers to submit 
any more documentation to CMS than what is already approved by OMB 
under control number 0938-0969 (CMS-10417). The regulations simply 
codify certain requirements by clarifying definitions, timeframes, and 
results for noncompliance.
    We did not receive public comments on this provision, and 
therefore, we are finalizing as proposed.
6. ICRs Regarding the Requirement for Electronic Prescribing for 
Controlled Substances for a Covered Part D Drug Under a Prescription 
Drug Plan or an MA-PD Plan (Sec.  423.160(a))
    Pending our finalization of the following provisions, the changes 
will be subject to the standard PRA process under OMB control number 
0938-1396 (CMS-10755) to give stakeholders optimal opportunity to 
comment on our burden for this provision, given how dynamic the burden 
for EPCS is. The standard PRA process includes the publication of 60- 
and 30-day Federal Register notices that will provide the public with 
opportunities for public review and comment. We expect to publish the 
60-day notice shortly after the publication of the final rule.
    The purpose of this provision is to continue to implement section 
2003 of the SUPPORT for Patients and Communities Act, which requires 
that the prescribing of a Schedule II, III, IV, or V controlled 
substance under Medicare Part D be done electronically in accordance 
with an electronic prescription drug program beginning January 1, 2021, 
subject to any exceptions, which HHS may specify. We refer readers to 
the CY 2021 PFS final rule (85 FR 84472) for our previously finalized 
requirements and burden for the first phase of implementing this 
statutory mandate, which required prescribers to use the NCPDP SCRIPT 
2017071 standard for Electronic Prescription for Controlled Substances 
(EPCS) prescription transmissions. The purpose of this final rule is to 
delay the date for CMS to begin taking compliance actions, implement 
certain exceptions to the mandate, and implement a compliance 
threshold.
    In the CY 2021 PFS final rule, we estimated that the one-time 
burden to implement this provision would be 828,750 hours (165,750 
prescribers * 6 hr) at a cost of $36,418,590 (994,500 hr * $36.62/hr). 
We arrived at the estimate of 165,750 prescribers having to implement 
EPCS based on taking the 425,000 Part D prescriber practices, and 
decreasing that amount by 60 percent to account for the 60 percent of 
prescriber practices that likely already had EPCS in place by January 
1, 2021. Based on our current PDE data, we estimate that 70 percent of 
Part D prescribers already conduct EPCS,\261\ which would leave 30 
percent of Part D prescribers that would have to implement EPCS, if we 
did not propose any exceptions to this mandate. We also proposed that 
prescribers writing prescriptions for beneficiaries in long term care 
facilities will have an extension for those prescriptions until January 
1, 2025 along with the following exceptions to the EPCS mandate: (1) 
For prescriptions issued when the prescriber and dispensing pharmacy 
are the same entity; (2) cases where prescribers issue only a small 
number of Part D; (3) cases where a prescriber's NCPDP database address 
is in a geographic service area of an emergency or disaster declared by 
a Federal, State or local government entity; and (4) cases where a 
prescriber has received a CMS-approved waiver. These exceptions will 
result in fewer prescribers being required to conduct EPCS.
---------------------------------------------------------------------------

    \261\ This information is based on PDE data pulled on April 6, 
2021.
---------------------------------------------------------------------------

    Based on our PDE data, we believe that these exceptions will 
substantially decrease the number of prescribers having to implement 
EPCS as a result of this regulation. We have listed the exceptions and 
the estimated number of prescribers falling under each exception in 
Table 79.\262\ We do not anticipate that our proposal to include a 
compliance threshold of 70 percent will have any material effect on the 
impact of this provision. The reason for this is that based on our PDE 
data and conversations with prescribers, we believe that the 30 percent 
or less of the time that prescribers are not e-prescribing is because 
they are unable to e-prescribe, so they would have applied for a 
waiver. Although there are sometimes scenarios where beneficiaries may 
request that their prescriptions not be transmitted electronically, it 
appears as though those circumstances are not enough to make a material 
impact, since beneficiaries often change their views when they are 
given countervailing reasons that the prescriptions should be 
transmitted via EPCS.
---------------------------------------------------------------------------

    \262\ This information is based on PDE data pulled on April 6, 
2021.

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

[[Page 65563]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.107

    Table 79 gives our estimate of the number of prescribers affected 
by our exceptions broken down by the type of exception. As shown in 
Table 79, we estimate that our exceptions will exempt approximately 
582,664 prescribers from the EPCS requirement, which consistutes 
approximately 38 percent of prescribers, since there are an estimated 
1,548,221 Part D prescribers \263\ (582,664/1,548,221). Since the 
number of exempted prescribers from this mandate far exceeds the number 
of prescribers who currently do not e-prescribe controlled substances 
in Part D, we do not expect that the total number of Part D prescribers 
who electronically prescribe controlled substances will increase 
following our implementation of this mandate. As a result, we do not 
believe there will be a measurable impact to the prescriber community 
as a whole, once this provision is finalized.
---------------------------------------------------------------------------

    \263\ This information is based on PDE data pulled on April 6, 
2021.
---------------------------------------------------------------------------

    However, for individual prescribers who have to implement this 
mandate, we expect that the implementation costs will be the same 
amounts that we finalized in the CY 2021 PFS final rule. Based on the 
modeling that we have seen, we have found that EHR companies provide 
the initial set-up of e-prescribing software free of charge, provided 
the prescribers pay the per transaction cost of $1.88 mentioned in the 
CY 2021 PFS final rule. Based on the comments received on our CY 2021 
PFS proposed rule, we understand that implementing EPCS can lead to 
technological glitches, and then fixing those issues. We understand 
that the EHR companies remedy the issues free of charge. However, we 
also understand that such fixes take time away from the medical office 
staff. We estimate that such fixes would take the staff approximately 1 
extra hour from the estimate given in our CY 2020 PFS proposed rule, 
when averaged across all prescribers. As a result, we have changed our 
one-time burden estimate of e-prescribing set-up from 5 hours to 6 
hours per provider, which means a total of 994,500 hours (165,750 
prescribers * 6 hr) at a cost of $36,617,490 (994,500 hr * $36.82/hr), 
since we anticipate that this work will be completed by an 
Administrative Support Worker. In this regard, the impact of this rule 
is plus 1 hour per response, plus 165,750 hours (165,750 prescribers x 
1 hr/response), and $6,102,915 (165,750 hr x $36.82/hr).
    We proposed that prescribers have the ability to apply for a waiver 
from the EPCS requirement, should they be facing circumstances beyond 
their control that prevent them from e-prescribing, and these 
circumstances are not the result of a natural disaster or emergency. 
Due to the high prevalence of EPCS, the miniscule compliance actions 
that we proposed for non-compliance, and the number of prescribers that 
we expect to exempt from the mandate, we only expect to receive about 
100 attestations per year. Although we proposed certain fields be in 
this attestation, these were minimal, and there was no accompanying 
documentation required. (Note, as outlined in section II.Q. of this 
final rule, to meet the standard for a waiver, prescribers must provide 
documentation showing the existence of a circumstance beyond their 
control and that such a circumstance prevents them from conducting 
EPCS.) We expect that each attestation will take 10 minutes (0.1667 hr) 
for a prescriber at $217.32/hr to complete. In aggregate, CMS estimates 
an annual burden for filling out attestations of 16.67 hours (100 
attestations x 0.1667 hr) at a cost of $3,622.72 (16.67 hr x $217.32/
hr). In addition, we solicit comment on any other potential information 
collection implications.
    We received no comments on our proposed burden estimates and 
assumptions, and have finalized our provision as proposed. As a result, 
we are finalizing our burden estimates and assumptions as proposed.

[[Page 65564]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.108

7. ICRs Regarding Open Payments Provisions Included in the CY 2022 PFS 
(42 CFR Part 403)
    The following requirement and burden changes will be submitted to 
OMB for approval under control number 0938-1237 (CMS-10495). The 
following estimates burden changes to the Open Payments final rule at 
Sec. Sec.  403.900 through 403.914 in this final rule.
a. Payment Context Field for Teaching Hospitals
    The mandatory context field is a new requirement for reporting 
entities submitting and attesting to records that are attributed to 
teaching hospitals only. The field will be freeform text entry. We 
estimate that for each applicable manufacturer and applicable group 
purchasing organization (GPO), the inclusion of this field for 
collection and reporting activities will average an additional 6 total 
hours. The applicable instrument for these activities in the current 
PRA package is the ``General-Research-Ownership Submission Data 
Elements''. At the support staff cost per FTE of $42.40/hr, this will 
increase costs by $254.40 (6 hr x $42.40/hr) per applicable 
manufacturer or applicable GPO submitting teaching hospital records. 
However, because we anticipate fewer disputes due to this field, we 
believe it will decrease dispute resolution by 2 total hours for 
support staff at $42.40/hr respectively, reducing costs by $84.80 (2 hr 
x $42.40/hr) per applicable manufacturer and applicable GPO. This 
results in a net increase in burden for each applicable manufacturer 
and applicable GPO submitting teaching hospital records of $169.60 
($254.40-$84.80). In Program Year (PY) 2019, 794 applicable 
manufacturers and applicable GPOs submitted at least one teaching 
hospital record, meaning the increase in burden will be a total of 
3,176 hours (4 hours x 794 reporting entities) at a cost of $42./40/hr 
or a total of $134,662.40 (3,176 x $42.40).
    In addition, we estimate this will reduce teaching hospital dispute 
resolution estimates by 2 hours per support staff FTE at $37.82/hr or 
$75.64 (2 hr x $37.82/hr) per teaching hospital with records attributed 
to them. In PY 2019, 1,202 hospitals had record attributed to them, so 
for teaching hospitals we estimate a total burden reduction of 2,404 
hours at a cost of $90,919.28 (2,404 x $75.64).
    In aggregate, we estimate an annual burden of 772 hours (3,176-
2,404) at a cost of $43,743.12 ($134,662.40-$90,919.28).
b. Optional Annual Recertification
    The annual recertification is voluntary for applicable 
manufacturers or applicable group purchasing organizations. We 
approximate that 15 percent of applicable manufacturers and group 
purchasing organizations, or 240 reporting entities (0.15 [1,595 
applicable manufacturers and applicable GPOs]) will complete and submit 
the proposed optional annual recertification. We anticipate that it 
will be a simple check box form to be included in the AM (Attestation) 
and GPO (Attestation) Annual IC Requirement and the ``Attestation and 
Assumptions Screen Shots'' Instrument in the existing PRA package. We 
estimate that it will take 0.5 hours at $42.40/hr for support staff to 
complete and submit the recertification. In aggregate, we estimate an 
added annual burden of 120 hours (240 entities x 0.5 hr/response) at a 
cost of $5,088 (120 hr x $42.40/hr).
c. Defining a Physician-Owned Distributorship (42 CFR 403.902)
    The new definition is not subject to the PRA since it will not 
revise, add, or remove any collection of information requirements or 
burden.
d. Disallowing Record Deletion Without Reason (Sec.  403.904(a)(3))
    This provision clarifies that entities are not permitted to delete 
records without reason once their timeliness, completeness, and 
accuracy has been attested to. In order to ensure compliance with this 
requirement, a freeform text dialogue box will be added to the system 
when records are deleted that asks the applicable manufacturer or GPO 
to input a reason for the deletion. This will be included in the AM 
(Data collection and submission) and Applicable GPO (Data Collection 
and Submission) IC requirements and the ``Open Payments User Guide'' 
Instrument in the existing PRA package. We anticipate that this will 
take an average of 2 hours at $42.40/hr to input a reason for the 
deletion. In aggregate, we estimate an added annual burden of 80 hours 
(40 applicable manufacturers or GPOs deleting records annually x 2 hr/
response) at a cost of $3,392 (80 hr x $42.40/hr).
e. Disallow Publication Delays of General Payments
    A very small number of general payments are delayed from 
publication by reporting entities every year, and these records will 
simply either be reported as research records instead, or not delayed 
at all. Therefore, we anticipate a negligible burden for this 
provision.
f. Short Term Loans (Sec.  403.902)
    This provision is merely a clarification of an existing requirement 
in regulation text. The purpose of this language is to clarify that the 
exemption for short-term loans from reporting requirements only applies 
for loans of less than 91 cumulative days per calendar year. In other 
words, multiple short-term loans in a calendar year will still meet 
reporting requirements if they add up to 91 days or greater. We do not 
believe this provision will change reporting behavior, and therefore do 
not anticipate an increase in burden.
g. Remove General Ownership Records
    Currently the Open Payments system allows for a reporting entity to 
submit either a general record with a nature of payment category of 
ownership, or an ownership and investment interest record. For Program 
Years 2015-2019, approximately 92 applicable

[[Page 65565]]

manufacturers and GPOs reported records with the nature of payment 
category of ownership. Since reporting these general records as 
ownership records will require the addition of two additional pieces of 
information, we anticipate that it will take these 92 entities an 
additional 3 hours at $42.40/hr to report the two extra fields. In 
aggregate, we estimate an added annual burden of 276 hours (92 entities 
x 3 hr/response) at a cost of $11,702 (276 hr x $42.40/hr). This will 
be included in the AM (Data collection and submission) and Applicable 
GPO (Data Collection and Submission) IC requirements and the ``Open 
Payments User Guide'' Instrument in the existing PRA package.
h. Updated Contact Information (Sec.  403.908(c)(3))
    This provision creates a requirement for reporting entities to keep 
their contact information up to date with CMS. The ability to 
communicate with a reporting entity is important because CMS may need 
to contact the entity in the case of perceived issues with the records. 
Applicable manufacturers and applicable GPOs will only be required to 
update their contact information if the two contacts provided become 
obsolete due to a change in the organization. This will also only apply 
to entities that do not have records to report for 2 years after a 
program year in which they reported. Therefore, we anticipate that it 
will only affect approximately 30 applicable manufacturers and 
applicable group purchasing organizations. We estimate that it will 
take 0.5 hours at $42.40/hr to update the contact information. In 
aggregate, we estimate an added annual burden of 15 hours (30 entities 
x 0.5 hr/response) at a cost of $636 (15 hr x $42.40/hr). This will be 
included in the AM (Data collection and submission) and Applicable GPO 
(Data Collection and Submission) IC requirements and the ``Open 
Payments User Guide'' Instrument in the existing PRA package.
i. Summary
[GRAPHIC] [TIFF OMITTED] TR19NO21.109

8. The Quality Payment Program (QPP) (42 CFR Part 414 and Section IV. 
of This Final Rule)
    The following QPP-specific ICRs reflect this final rule's policy 
changes as well as adjustments to the policies that have been finalized 
in the CY 2017 and 2018 Quality Payment Program final rules (81 FR 
77008 and 82 FR 53568, respectively), the CY 2019, CY 2020, and CY 2021 
PFS final rules (83 FR 59452, 84 FR 62568 and 85 FR 84472, 
respectively).
a. Background
(1) ICRs Associated With MIPS and Advanced APMs
    There is a series of ICRs associated with the Quality Payment 
Program, including for MIPS and Advanced APMs. The MIPS ICRs consist 
of: Registration for virtual groups (see section V.B.8.b of this final 
rule); QCDR self-nomination applications and other requirements (see 
section V.B.8.c.(2) of this final rule); qualified registry self-
nomination applications and other requirements (see section V.B.8.c.(3) 
of this final rule); CAHPS survey vendor applications (see section 
V.B.8.c.(4) of this final rule); Health IT vendors (see section 
V.B.8.c.(5) of this final rule); Open Authorization credentialing and 
token request process (see section V.B.8.d of this final rule); Quality 
Payment Program Identity Management Application Process (see section 
V.B.8.e.(3) of this final rule); quality performance category data 
submission by Medicare Part B claims collection type (see section 
V.B.8.e.(4) of this final rule), QCDR and MIPS CQM collection type (see 
section V.B.8.e.(5) of this final rule), eCQM collection type (see 
section V.B.8.e.(6) of this final rule), MVP Quality submission (see 
section V.B.8.e.(7)(a)(iii) of this final rule), and CMS Web Interface 
collection type (see section V.B.8.e.(8) of this final rule); CAHPS for 
MIPS survey beneficiary participation (see section V.B.8.e.(9) of this 
final rule); group registration for CMS Web Interface (see section 
V.B.8.e.(10) of this final rule); group registration for CAHPS for MIPS 
survey (see section V.B.8.e.(11) of this final rule); MVP registration 
(see section V.B.8.e.(7)(a)(i) of this final rule); subgroups 
registration (see section V.B.8.e.(7)(a)(ii) of this final rule); all 
for quality measures (see section V.B.8.f of this final rule); 
reweighting applications for Promoting Interoperability and other 
performance categories (see section V.B.8.g.(2) of this final rule); 
Promoting Interoperability performance category data submission (see 
section V.B.8.g.(3) of this final rule); call for Promoting 
Interoperability measures (see section V.B.8.h of this final rule); 
improvement activities performance category data submission (see 
section V.B.8.i of this final rule); nomination of improvement 
activities (see section V.B.8.j of this final rule); nomination of MVPs 
(see section

[[Page 65566]]

V.B.8.k of this final rule); and opt-out of Physician Compare for 
voluntary participants (see section V.B.8.o of this final rule).
    The ICRs for Advanced APMs consist of: Partial Qualifying APM 
Participant (QP) election (section V.B.8.m of this final rule); Other 
Payer Advanced APM identification: Payer Initiated and Eligible 
Clinician Initiated Processes (sections V.B.8.n.(1) and V.B.8.n.(2) of 
this final rule); and submission of data for QP determinations under 
the All-Payer Combination Option (section V.B.8.n.(3) of this final 
rule).
(2) Summary of Quality Payment Program Changes: MIPS
    We have included the change in estimated burden for the CY 2022 and 
CY 2023 performance periods/2024 and 2025 MIPS payment years due to the 
finalized policies and information collections in this final rule. The 
finalized policies in this rule impact the burden estimates for the CY 
2022 and CY 2023 MIPS performance periods/2024 and 2025 MIPS payment 
years. However, our currently approved burden estimates for the CY 2021 
performance period (85 FR 84958 through 84998) approved by OMB on May 
28, 2021, included estimated burden due to finalized policies and 
assumptions for the CY 2021 and CY 2022 performance periods/2023 and 
2024 MIPS payment years. The currently approved estimated burden for 
the package does not include the CY 2023 performance period/2025 MIPS 
payment year. To understand the burden implications of the policies 
finalized in this final rule relative to the current package that was 
approved by OMB on May 28, 2021:
     We have subtracted the burden for the policies and 
information collections set forth for the CY 2021 performance period/
2023 MIPS payment year in the CY 2021 PFS final rule (see Table 128).
     We have revised our burden estimates for the CY 2022 
performance period/2024 MIPS payment year due to the finalized policies 
in this rule and changes for continuing the policies and information 
collections set forth in the CY 2021 PFS final rule into the CY 2022 
performance period/2024 MIPS payment year (see Table 129).
     We are setting forth new burden for the CY 2023 
performance period/2025 MIPS payment year (see Table 130), meaning that 
there will be no currently approved figures for these estimates.
    In the CY 2022 PFS proposed rule (86 FR 39479 through 39528), we 
compared our proposed burden estimates for the CY 2022 and 2023 
performance periods/2024 and 2025 MIPS payment years to the CY 2022 
performance period/2024 MIPS payment year in the CY 2021 PFS final rule 
(85 FR 84994). We believe that using the approach described above for 
the final rule will help readers easily understand and follow the 
changes in the estimated burden due to the policies and assumptions in 
the CY 2022 PFS final rule relative to the currently approved burden.
    The following nine MIPS ICRs show changes in burden due to the 
finalized policies in this rule: (1) QCDR self-nomination applications; 
(2) Qualified Registry self-nomination applications; (3) Quality 
performance category data submission by QCDR and MIPS CQM collection 
type; (4) Quality performance category data submission by eCQM 
collection type; (5) Group registration for CMS Web Interface; (6) CMS 
Web Interface submission burden; (7) Reweighting applications for 
Promoting Interoperability and other performance categories; (8) 
Promoting Interoperability performance category data submission; and 
(9) Nomination of improvement activities. In aggregate, we estimate the 
finalized policies will result in a net increase in burden of 3,805 
hours and $358,305 for the CY 2022 performance period/2024 MIPS payment 
year. The remaining changes to our currently approved burden estimates 
are adjustments due to the revised burden assumptions based on the 
updated data available at the time of publication of this final rule.
    We have also added 3 new ICRs (MVP Registration, MVP Quality 
Submissions, and Subgroups Registration) for the associated burden 
related to the policies for implementation of MVPs and subgroups 
beginning with the CY 2023 performance period/2025 MIPS payment year. 
The MVP and subgroup registration ICRs reflect the burden associated 
with the MVP and subgroup registration requirements described in 
section IV.A.3.b(4)(f) of this rule. The MVP quality submission ICR 
reflects the change in burden associated with the requirements for the 
quality performance category of MVPs described in section 
IV.A.3.b(4)(d)(ii) of this rule.
    With these new ICRs and the other policy changes discussed for the 
CY 2022 performance period/2024 MIPS payment year, we estimate the 
finalized policies will result in a net increase in burden of 1,383,049 
hours and $139,501,770 for the CY 2023 performance period/2025 MIPS 
payment year. As discussed above, we are setting forth our estimates 
for the CY 2023 performance period/2025 MIPS payment year as new burden 
with no currently approved estimates for comparison.
    We are not making any changes or adjustments to the following ICRs: 
Registration for virtual groups; CAHPS survey vendor applications; 
Quality Payment Program Identity Management Application Process; group 
registration for CAHPS for MIPS survey; CAHPS for MIPS survey 
beneficiary participation; Open Authorization (OAuth) Credentialing and 
Token Request Process; nomination of MVPs and call for Promoting 
Interoperability measures. See section V.B.8. of this final rule for a 
summary of the ICRs, the overall burden estimates, and a summary of the 
assumption and data changes affecting each ICR.
    The accuracy of our estimates of the total burden for data 
submission under the quality, Promoting Interoperability, and 
improvement activities performance categories may be impacted by two 
primary factors. First, we are unable to predict with absolute 
certainty who will be a QP for the CY 2022 performance period/2024 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 what Partial QPs, who can 
elect whether to report to MIPS, will do in the CY 2022 performance 
period/2024 MIPS payment year compared to the CY 2019 performance 
period/2021 MIPS payment year, and 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.
    In the 2022 PFS proposed rule (86 FR 39480), we discussed a recent 
JAMA article (Khullar, et al., 2021) \264\ which included new data on 
the burden involved in submitting data for the Quality Payment Program. 
We have chosen not to include this data in our estimates because of the 
small sample size included (30 TINs, half of which are APM 
participants, which we do not include in our estimates). In addition, 
the article did not indicate the time

[[Page 65567]]

spent per activity involved in submissions for MIPS, so we are unable 
to determine if the totals in the article represent only the activities 
relevant for regulatory burden or separate the totals for the 
individual ICRs. We solicited comment on our assumptions for estimating 
the burden for clinicians submitting data for the Quality Payment 
Program.
---------------------------------------------------------------------------

    \264\ JAMA Health Forum. 2021;2(5):e210527. doi:10.10001/
jamahealthforum.2021.527.
---------------------------------------------------------------------------

    We did not receive public comments regarding our burden estimates 
for clinicians submitting data in the Quality Payment Program. We are 
finalizing to not include the data from the above referenced article in 
our assumptions.
    We made updates to our figures to correct a few technical errors 
that we observed in the CY 2022 PFS proposed rule.
(3) Summary of Quality Payment Program Changes: Advanced APMs
    For these ICRs (identified above under, ``ICRs Associated with MIPS 
and Advanced APMs''), the changes to currently approved burden 
estimates are adjustments based on updated projections for the CY 2022 
performance period/2024 MIPS payment year. We did not implement any 
changes to the Other Payer Advanced APM identification: Eligible 
Clinician Initiated Process and submission of Data for QP 
determinations under the All-Payer Combination Option ICRs.
(4) Framework for Understanding the Burden of MIPS Data Submission
    Because of the wide range of information collection requirements 
under MIPS, Table 82 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. 
As shown in the first row of Table 82, MIPS eligible clinicians and 
other clinicians voluntarily submitting data will submit data either 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. We want to note 
that we have included subgroups to Table 82 due to the introduction of 
subgroups for clinicians choosing to report MVPs or the APP in the CY 
2023 performance period/2025 MIPS payment year described in section 
IV.A.3.b.(2)(d)(ii) of this final rule. 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 82.
    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. As discussed in section IV.A.3.c. of this final 
rule, for clinicians in APM Entities, the APM Performance Pathway is 
available for both ACO and non-ACOs to submit quality data. 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 2022 performance period/2024 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 section IV.A.3.d.(1)(d) of this final rule, we are 
finalizing to extend the CMS Web Interface as a collection type beyond 
the CY 2022 performance period/2024 MIPS payment year for clinicians 
participating in the Shared Savings Program. Per section 1899 of the 
Act (42 U.S.C. 1395jjj), submissions received from eligible clinicians 
in ACOs are not included in burden estimates for this final rule 
because quality data submissions to fulfill requirements of the Shared 
Savings Program are not subject to the PRA.
    For the Promoting Interoperability performance category, group TINs 
may submit data on behalf of eligible clinicians in MIPS APMs, or 
eligible clinicians in MIPS APMs may submit data individually. For the 
improvement activities performance category, we will assume no 
reporting burden for MIPS APM participants. In the CY 2017 PFS final 
rule, we described 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 receives less than the maximum improvement 
activities performance category score, to date all MIPS APM 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 PFS final rule (82 FR 53841 
through 53844).
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TR19NO21.110

BILLING CODE 4120-01-C
The policies finalized in the CY 2017 and CY 2018 Quality Payment 
Program final rules, the CY 2019, CY 2020, and CY 2021 PFS final rules, 
and continued in this final rule create some additional data collection 
requirements not listed in Table 82. These additional data collections, 
some of which are currently approved by OMB under the control numbers 
0938-1314 (Quality Payment Program, CMS-10621) and 0938-1222 (CAHPS for 
MIPS, CMS-10450), are as follows:
Additional ICRs Related to MIPS Third-Party Intermediaries (See Section 
V.B.8.c)
     Self-nomination of new and returning QCDRs (81 FR 77507 
through 77508, 82 FR 53906 through 53908, and

[[Page 65569]]

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).
     Approval process for new and returning CAHPS for MIPS 
survey vendors (82 FR 53908) (OMB 0938-1222).
     Open Authorization Credentialing and Token Request Process 
(New) (OMB 0938-1314) (see section V.B.8.d).
Additional ICRs Related to the Data Submission and the Quality 
Performance Category (See Section V.B.8.e)
     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.8.g)
     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.8.f, V.B.8.h, V.B.8.j. and V.B.8.k)
     Nomination of improvement activities (82 FR 53922 and 83 
FR 60017 through 60018) (OMB 0938-1314).
     Call for new Promoting Interoperability measures (83 FR 
60014 through 60015) (OMB 0938-1314).
     Call for MIPS quality measures (83 FR 60010 through 60011) 
(OMB 0938-1314).
     Nomination of MVPs (OMB 0938-1314).
Additional ICRs Related to MIPS (See Section V.B.8.o)
     Opt out of performance data display on Physician Compare 
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.8.m and V.B.8.n)
     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 is not implementing 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 making any changes to the virtual group 
election process under that control number.
c. ICRs Regarding Third-Party Intermediaries (Sec.  414.1400)
    The finalized requirements and burden associated with this rule's 
data submission changes related to qualified registries and QCDRs will 
be submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    In section IV.A.3.h. of this rule, we are finalizing policies 
related to the third-party intermediary regulations at Sec.  414.1400. 
Specifically, we are finalizing: (1) Requirement for third-party 
intermediaries to submit MIPS data for APM Entities; (2) requirement 
for QCDRs and qualified registries to support MVPs, QCDRs and qualified 
registries may also support the APP; (3) requirement for all QCDRs and 
qualified registries to support subgroup reporting; (4) requirements 
for approved QCDRs and qualified registries that have not submitted 
performance data; and (5) new QCDR measure rejection criteria. The 
burden associated with each of these topics is discussed separately 
below for qualified registries, QCDRs, and survey vendors.
(1) Background
    Under MIPS, the quality, Promoting Interoperability, and 
improvement activities performance category data may be submitted via 
relevant third-party intermediaries, such as qualified registries, 
QCDRs, and health IT vendors. Data on the CAHPS for MIPS survey, which 
counts as either one quality performance category measure, or towards 
an improvement activity, can be submitted via CMS-approved survey 
vendors. Entities seeking approval to submit data on behalf of 
clinicians as a qualified registry, QCDR, or survey vendor must 
complete a self-nomination process annually.\265\ The processes for 
self-nomination for 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.
---------------------------------------------------------------------------

    \265\ As stated in the CY 2019 PFS final rule (83 FR 59998), 
health IT vendors are not included in the burden estimates for MIPS.
---------------------------------------------------------------------------

(2) QCDR Self-Nomination Applications
    As described below, in this rule we are adjusting the number of 
self-nomination applications based on current data (from 82 to 84), 
change the number of QCDR measures submitted for consideration by each 
QCDR at the time of self-nomination (from 2 to 12), and adjust the 
average time required to submit information for each QCDR measure (from 
2.5 hours to 0.75 hours).
(a) Self-Nomination Process and Other Requirements
    In section IV.A.3.h.(1) of this rule, we are reorganizing and 
consolidating Sec.  414.1400 generally. We assume that this provision 
does not change the existing requirements for third-party 
intermediaries during the self-nomination process. Therefore, we are 
not revising our burden estimates related to these provisions. We refer 
readers to Sec.  414.1400 which states that QCDRs interested in 
submitting MIPS data to us on behalf of a MIPS eligible clinician, 
group, or virtual group will need to complete a self-nomination process 
to be considered for approval to do so. We also refer readers to the CY 
2017 Quality Payment Program final rule (81 FR 77507 through 77508), CY 
2018 Quality Payment Program final rule (82 FR 53906 through 53908), CY 
2019 PFS final rule (83 FR 59998 through 60000), the CY 2020 PFS final 
rule (84 FR 63116 through 63121) and the CY 2021 PFS final rule (85 FR 
84964 through 84969) for our previously finalized requirements and 
burden for self-nomination of QCDRs and nomination of QCDR measures.
    In section IV.A.3.h.(2)(a) of this rule, we are finalizing to add 
APM Entities to Sec.  414.1400(a)(1), and expand the general 
participation requirements of third-party intermediaries, to third-
party intermediaries reporting to MIPS on behalf of APM Entities 
reporting to MIPS in order to align reporting requirements for all 
participants in

[[Page 65570]]

MIPS. We are also finalizing that beginning with the CY 2023 
performance period/2025 MIPS payment year, QCDRs and qualified 
registries must support the APP, and MVPs that are applicable to the 
MVP participants on whose behalf they submit MIPS data. As finalized in 
the CY 2017 PFS final rule, third-party intermediaries currently 
support MIPS data submission on behalf of eligible clinicians (81 FR 
77016). APM Entities have historically used third party intermediaries 
for submitting their quality measures to their APMs. Additionally, 
QCDRs, qualified registries and health IT vendors are required under 
existing Sec.  414.1400(a)(1) to submit data for the quality, 
improvement activities, and Promoting Interoperability performance 
categories in MIPS. Therefore, we anticipate no additional steps being 
added to the self-nomination process as a result of this provision for 
third-party intermediaries to submit MIPS data on behalf of APM 
Entities, and to support measures and activities in MVPs that are 
applicable to the MVP participants on whose behalf they submit MIPS 
data. For this final rule, we assume that there will be no impact on 
the time required for QCDRs to complete either the simplified or full 
self-nomination process because of the above provisions. Additionally, 
we are finalizing to require QCDRs, qualified registries, health IT 
vendors, and CAHPS for MIPS survey vendors to support subgroup 
reporting, beginning with the CY 2023 performance period/2025 MIPS 
payment year. We anticipate that at the time of self-nomination, QCDRs 
would be using a checkbox to indicate their compliance for the 
requirement to support data submission for subgroups beginning with the 
CY 2023 performance period/2025 MIPS payment year. We assume that this 
will not impact the overall time estimated for QCDRs to submit their 
information at the time of self-nomination. Therefore, as discussed in 
the CY 2022 PFS proposed rule (86 FR 84965) we did not make any 
adjustments in the time required for QCDRs during the simplified or 
full self-nomination process because of this provision. However, we 
anticipate that third-party intermediaries will need to make 
administrative changes to their existing workflows for submission of 
MVPs and APP data for clinicians participating as subgroups beginning 
with the CY 2023 performance period/2025 MIPS payment year. We refer 
readers to section VI.F.18.g(2)(f) of this final rule where we discuss 
our impact analysis.
    In section IV.A.3.h.(3)(a)(iii) of this rule, to provide further 
clarity and to better align with the existing policy (81 FR 77366 
through 77367; 81 FR 77383 through 77384), we are finalizing to codify 
that QCDRs, and qualified registries must conduct validation on the 
data they intend to submit for the applicable MIPS performance period 
and provide the results of the executed data validation plan by May 
31st of the year following the performance period. Additionally, we are 
finalizing to codify a new requirement at Sec.  414.1400(b)(3)(iv) to 
state that, beginning with the CY 2023 performance period/2025 MIPS 
payment year, the QCDR or qualified registry must submit a data 
validation plan annually, at the time of self-nomination, for CMS' 
approval, and may not change the plan once approved, without the prior 
approval of the agency. We anticipate that this provision does not make 
any changes to the existing data validation requirements for QCDRs and 
qualified registries. Through this provision, we are codifying the 
finalized policies related to data validation for QCDRs and qualified 
registries in previous rules. In the CY 2022 PFS proposed rule (86 FR 
39483), we did not revise our burden estimates as a result of the above 
provision because the associated burden was captured in the CY 2017 PFS 
final rule (81 FR 77383 through 77384) and the CY 2019 PFS final rule 
(83 FR 59998 through 59999) and submitted to OMB for approval under 
control number 0938-1314 (CMS-10621).
    In section IV.A.3.h(3)(a)(i) of this final rule, we are finalizing 
new requirements for approved QCDRs and qualified registries that have 
not submitted performance data. First, we are finalizing to create a 
new requirement at Sec.  414.1400(b)(3)(vii) to require QCDRs and 
qualified registries that have never submitted data since the inception 
of MIPS (CY 2017 performance period/2019 MIPS payment year) through the 
CY 2020 performance period/2022 MIPS payment year, to submit a 
participation plan as part of their self-nomination for CY 2023. If the 
QCDRs and qualified registries did not submit data, their participation 
plan must be submitted as part of self-nomination for the 2023 self-
nomination period and must be accepted by CMS to continue to be an 
approved QCDR or qualified registry. We are also finalizing to codify a 
new requirement at paragraph Sec.  414.1400(b)(3)(viii) to state that, 
beginning with the CY 2024 performance period/2026 MIPS payment year, a 
QCDR or qualified registry that was approved but did not submit any 
MIPS data for either of the 2 years preceding the applicable self-
nomination period must submit a participation plan for CMS' approval. 
Under this provision, the participation plan must explain the QCDR and/
or qualified registry's detailed plans about how the vendor intends to 
encourage clinicians to submit MIPS data to CMS through the third-party 
intermediary on behalf of clinicians or groups. The vendor must also 
explain why they should still be allowed to participate as a qualified 
vendor.
    Based on our review of the existing list of approved QCDRs that did 
not submit performance data since the inception of MIPS (CY 2017 
performance period/2019 MIPS payment year), we estimate that 
approximately 10 QCDRs will submit participation plans for the CY 2022 
and the CY 2023 self-nomination periods. Similar to our assumptions for 
submission of a Corrective Action Plan (CAP) in the CY 2021 PFS final 
rule (85 FR 84968), we anticipate that the effort involved in 
developing a participation plan including the policies specified in 
this rule and submitting it to CMS is likely to be no more than 3 hours 
for a computer systems analyst at a rate of $95.22/hr. For the CY 2022 
performance period/2024 MIPS payment year, we estimate an annual burden 
of 30 hours (3 hr x 10 participation plans) at a cost of $2,857 (30 hr 
x $95.22/hr) for QCDRs that will need to develop and submit a 
participation plan.
    In section IV.A.3.h.(4) of this rule, we are finalizing to codify 
new requirements that if a QCDR measure owner is not an approved active 
QCDR for a given self-nomination period, that QCDR measure will not be 
available for use. Additionally, we are finalizing to codify a new 
requirement in section IV.A.3.h.(4)(a)(i)(A) of this rule and add a 
rejection criterion at Sec.  414.1400(b)(4)(iv)(M) to state, a QCDR 
does not have permission to use a QCDR measure owned by another QCDR 
for the applicable performance period. It was finalized in the CY 2018 
PFS final rule (82 FR 53813) that beginning with the CY 2018 
performance period/2020 MIPS payment year, QCDR vendors may seek 
permission from another QCDR to use an existing measure that is owned 
by the other QCDR. Additionally, in the CY 2020 PFS final rule (84 FR 
63070 through 63073), we finalized the QCDR measure rejection criteria 
considerations. Specifically, we stated that all previously approved 
QCDR measures and new QCDR measures would be reviewed on an annual 
basis (as a part of the QCDR measure review

[[Page 65571]]

process that occurs after the self-nomination period closes on 
September 1st) to determine whether they are appropriate for the 
program. In the CY 2020 PFS final rule, we indicated to stakeholders 
that as information becomes available in future years, we will revisit 
our assumptions to better reflect the impact of these requirements on 
QCDRs and the quantity of measures annually (84 FR 63118 through 
63119). As discussed in the CY 2019 PFS final rule (83 FR 60000) and CY 
2020 PFS final rule (84 FR 63118), we are not accounting for QCDR 
measure licensing costs as part of our burden estimate.
    Based on the number of QCDR measures submitted at the time of self-
nomination for the CY 2021 performance period/2023 MIPS payment year, 
we assume that 82 QCDRs will submit 984 measures for consideration in 
the CY 2022 performance period/2024 MIPS payment year, approximately 12 
measures per QCDR, on average. We anticipate that out of the 984 
measures, 820 measures will be existing or borrowed measures, 
approximately 10 measures submitted per QCDR self-nomination 
application. The remaining 104 measures will be new measures, 
approximately 2 measures on average per QCDR.
    Using the above assumption that each QCDR submitting measures for 
approval during the self-nomination process will submit approximately 
12 measures (10 existing or borrowed measures + 2 new measures), we 
estimate an increase of 10 measures from the currently approved 
estimate of 2 measures per QCDR. The estimated increase in the total 
number of measures submitted by a QCDR at the time of self-nomination 
is due to the inclusion of the existing or borrowed QCDR measures in 
our assumptions. Additionally, we anticipate that less information is 
needed for a QCDR to submit an existing or borrowed measure for 
approval, therefore, we estimate that the time needed for a QCDR to 
submit an existing or borrowed measure is 0.5 hours, independent of the 
selection of the simplified or full self-nomination process. Consistent 
with our assumption in the CY 2020 PFS final rule (84 FR 63119), we 
continue to estimate that each QCDR will require 2 hours to submit a 
new QCDR measures for approval, independent of the selection of the 
simplified or full self-nomination process. To account for the 
difference in the time for submission of new vs existing QCDR measures 
for approval, we are using the weighted average to estimate the time 
required for QCDR measure submission at the time of self-nomination. 
Therefore, we assume that the weighted average of the time required for 
each QCDR to submit a new or existing or borrowed measure for approval 
during the self-nomination process is 0.75 hours [((2 new measures x 2 
hours) + (10 existing or borrowed measures x 0.5 hours))/total # of 
measures (12)]. Based on the above assumptions, we are finalizing to 
revise our estimates in the amount of time required for a QCDR to 
submit measures during the self-nomination process from a total of 2 
hours to approximately 0.75 hours, a decrease of 1.75 hours from the 
currently approved estimated burden per QCDR measure submission.
    In the CY 2019 PFS final rule, we estimated that it would take 0.5 
hours and 3 hours for a QCDR to submit all the required information 
during the simplified and full self-nomination process, respectively 
(83 FR 59999). Based on our experience with the amount of time needed 
for QCDRs during the 2020 self-nomination period, we assume that the 
estimated time of 3 hours per QCDR for a full self-nomination process 
is an overestimate and therefore, are adjusting our estimated time 
required for the QCDR full-self-nomination process to 2.5 hours, a 
decrease of 0.5 hours. We are not making any adjustments in the amount 
of time needed for simplified self-nomination process.
    For this final rule, we are adjusting the number of QCDRs that 
submitted applications for self-nomination from 90 to 84 based on the 
actual number of applications received during the CY 2021 self-
nomination period for the CY 2022 performance period/2024 MIPS payment 
year, an increase of two applications from the currently approved 
estimate of 82. This is a decrease of 6 from the estimate of 90 
provided in the CY 2022 PFS proposed rule (86 FR 39484). For QCDRs that 
submit measures as part of their self-nomination process, while 
simultaneously accounting for the estimated increase in the number of 
existing or borrowed QCDR measures submitted with the self-nomination 
application and the decrease in the estimated time for the QCDR full-
nomination process, we are finalizing to revise our estimated time for 
the QCDR self-nomination process to a minimum of 9.5 hours [0.5 hours 
for the simplified self-nomination process + (12 measures x 0.75 hr/
measure for QCDR measure submission)] and a maximum of 11.5 hours [2.5 
hours for the full self-nomination process + (12 measures x 0.75 hr/
measure for QCDR measure submission)], an increase of 4 hours at a cost 
of $ 380.88 (4 hr x $95.22/hr) and 3.5 hours at a cost of $333.27 (3.5 
hr x $95.22/hr) from the currently approved burden per respondent 
estimate in the CY 2021 PFS final rule (85 FR 84965).
    Consistent with our assumptions in the CY 2021 PFS final rule (85 
FR 84967), based on updated data for the number of QCDR applications 
submitted during the CY 2020 self-nomination period, we are adjusting 
our estimate that 18 QCDRs will submit targeted audits for the CY 2022 
performance period/2024 MIPS payment year, an increase of 1 from the 
currently approved estimate of 17 targeted audits in the CY 2021 PFS 
final rule (85 FR 84965). This is a decrease of 2 compared to our 
estimate of 20 targeted audits in the CY 2022 PFS proposed rule (86 FR 
39484). Using the currently approved unchanged burden per respondent 
estimate, the estimated burden associated with QCDRs completing 
targeted audits will range from 90 hours (18 audits x 5 hr/audit) at a 
cost of $8,570 (18 audits x $476.10/audit) for the simplified self-
nomination process to 180 hours (18 audits x 10 hr/audit) at a cost of 
$17,140 (18 audits x $952.20/audit) for the full self-nomination 
process (see Table 68 for the cost per audit). We assume that this 
would adjust our burden estimates for targeted audits by +5 hours (+1 
respondents x 5 hr/audit) at a cost of $476 (5 hrs x $95.22/hr) and +10 
hours (+1 respondents x 10 hr/audit) at a cost of $952 (10 hrs x 
$95.22/hr) for the simplified and full self-nomination process, 
respectively. Based on the assumptions discussed in this section, we 
provide an estimate of the total annual burden associated with a QCDR 
self-nominating to be considered ``qualified'' to submit quality 
measures results and numerator and denominator data on behalf of MIPS 
eligible clinicians.
    As shown in Table 83, we assume that the staff involved in the QCDR 
self-nomination process will continue to be computer systems analysts 
or their equivalent, who have an average labor rate of $95.22/hr. Using 
the change in the number of respondents and the estimated time per 
respondent for QCDRs that submit measures for approval during the self-
nomination process, the annual burden for the simplified and full-self 
nomination process will range from 798 hours (84 QCDRs x 9.5 hr) to 966 
hours (84 QCDRs x 11.5 hr) at a cost ranging from $75,986 (798 hr x 
$95.22/hr) and $91,983 (966 hr x $95.22/hr), respectively.
    As shown in Table 83, combined with our adjusted estimate of annual 
burden for targeted audits and the burden for submission of 
participation plans, we are finalizing to revise our estimated

[[Page 65572]]

burden for the QCDR self-nomination process, ranging from 918 hours 
[798 hr (84 QCDRs x 9.5 hr) + 90 hr (18 audits x 5 hr) + 30 hr (10 
participation plans x 3 hr)] at a cost of $87,413 [$75,986 (798 hr x 
$95.22/hr) + $8,570 (18 audits x $476.10/audit) + $2,857 (30 hr x 
$95.22/hr)] for a simplified self-nomination process to 1,176 hours 
[966 hr (84 QCDRs x 11.5 hr) + 180 hr (18 audits x 10 hr) + 30 hr (10 
participation plans x 3 hr)] at a cost of $111,980 [$91,983 (966 hr x 
$95.22/hr) + $17,140 (18 audits x $952.20/audit) + $2,857 (30 hr x 
$95.22/hr)] for the full self-nomination process.
BILLING CODE 4120-01-P
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    As shown in Table 84, for the CY 2022 performance period/2024 MIPS 
payment year, independent of the change to our per response time 
estimate, the estimated increase in 2 respondents from the currently 
approved 82 respondents to 84 results in an increase of between +19 
hours (+2 respondents x 9.5 hrs/respondent for the simplified self-
nomination process) and +23 hours (+ 2 respondents x 11.5 hrs/
respondent for the full self-nomination process) at a cost of between 
+$1,809 (+2 respondents x $904.60/respondent for the simplified self-
nomination process) and +$2,190 (+2 respondents x $1,095.03/respondent 
for the full self-nomination process) (see Table 83 for the cost per 
QCDR).
    Accounting for the change in time required for the QCDR self-
nomination process results in an adjustment of between +328 hours (82 
respondents x +4 hr for the simplified self-nomination process or also 
referred to as minimum burden) at a cost + $31,232 [82 respondents x 
$380.88 (+4 hr x $95.22/hr)/respondent) and +287 hours (82 respondents 
x 3.5 hr for the full self-nomination process or also referred to as 
maximum burden) at a cost of and +$27,328 (82 respondents x $333.27 
(+3.5 hr x $95.22/hr)/respondent). The reason for the increase in 
minimum burden compared to the maximum burden is due to an increase in 
the change in the number of hours required for the simplified self-
nomination process compared to the increase in the number of hours for 
the full self-nomination process.
    In aggregate, when these impacts are combined with the estimate for 
targeted audits and participation plans discussed above, the net impact 
ranges between + 382 hours [19 hr (+2 respondents x 9.5 hrs/respondent) 
+ 5 hr (+1 targeted audit x 5 hrs/audit) + 30 hr (10 participation 
plans x 3 hr/plan) + 328 hr (82 respondents x 4 hr)] at a cost of 
$36,374 ($1,809 + $476 + $2,857 + $31,232) for the simplified self-
nomination process (also referred to as minimum burden) and +350 hours 
[23 hr (+2 respondents x 11.5 hrs/respondent) + 10 hr (+1 targeted 
audits x 10 hrs/audit) + 30 hr (10 participation plans x 3 hr/plan) + 
287 hr (+82 respondents x 3.5 hr)] at a cost of $33,328 [$2,190 (+2 
respondents x $1,095.03/respondent + $952 (10 hr x $95.22/hr) + $2,857 
(30 hr x $95.22/hr) + $27,328 (82 respondents x $333.27/respondent)] 
for the full self-nomination process (also referred to as maximum 
burden) for the CY 2022 performance period/2024 MIPS payment year.
    As discussed above in this section of the rule, we are setting 
forth new burden estimates for the CY 2023 performance period/2025 MIPS 
payment year. Therefore, we estimate the total change in burden for the 
QCDR self-nomination process would be 918 hours at a cost of $87,413 
for the simplified self-nomination process (also referred to as minimum 
burden) and 1,176 hours at a cost of $111,980 for the full self-
nomination process (also referred to as maximum burden). For the 
purposes of calculating estimated change in burden in Tables 128, 129, 
and 130 of this final rule, we use only the maximum burden estimate.

[[Page 65573]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.112

BILLING CODE 4120-01-C
(b) QCDR Measure Requirements
    In the CY 2018 Quality Payment Program final rule (82 FR 53813 
through 53814), we discussed that beginning with the CY 2018 
performance period/2020 MIPS payment year and for future program years, 
QCDR vendors may seek permission from another QCDR to use an existing 
measure that is owned by the other QCDR. Additionally, in the CY 2020 
Quality Payment Program rule (84 FR 63070 through 63073) we finalized 
the QCDR measure rejection criteria considerations.
    In section IV.A.3.h.(4)(a)(i)(A)(aa) of this rule, we are 
finalizing to codify a new requirement and add a rejection criterion 
that a QCDR does not have permission to use a QCDR measure owned by 
another QCDR for the applicable performance period. Additionally, we 
are finalizing to codify new requirements that if a QCDR measure owner 
is not an approved active QCDR for a given self-nomination period, that 
QCDR measure will not be available for use. The inactive QCDR measure 
owner has the option to transfer ownership of the QCDR measure to an 
active QCDR or agree upon terms set forth with the active QCDR allowing 
co-ownership of the QCDR measure. We refer readers to section 
IV.A.3.h.(4)(a)(i)(A) of this rule for additional details on the 
finalized policies for transfer of ownership of QCDR measures. This 
provision is to codify the existing requirements for the QCDR self-
nomination process. We are not adjusting our burden estimates as result 
of this provision because we assume that this does not change the 
requirements, or the time required for a QCDR to submit information for 
a QCDR measure at the time of self-nomination.
    Additionally, we are finalizing to codify another rejection 
criterion at Sec.  414.1400(b)(4)(iv)(N) to state that, if a QCDR 
measure owner is not approved during a given self-nomination period, 
any associated QCDR measures with that QCDR will also not be approved. 
We are not revising our burden estimates as a result of the above 
provision because we assume that there will not be additional 
requirements for QCDRs to submit at the time of self-nomination. This 
is part of the measure specification requirements for QCDRs which 
submit measures for approval during the self-nomination process.
(3) Qualified Registry Self-Nomination Process and Other Requirements
    The requirements and burden associated with this rule's data 
submission changes related to qualified registries will be submitted to 
OMB for approval under control number 0938-1314 (CMS-10621).
    We refer readers to Sec.  414.1400 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. We also 
refer readers to the CY 2017 Quality Payment Program final rule (81 FR 
77507 through 77508), CY 2018 Quality Payment Program final rule (82 FR 
53906 through 53908), CY 2019 PFS final rule (83 FR 59997 through 
59998), CY 2020 PFS final rule (84 FR 63114 through 63116) and the CY 
2021 PFS final rule (85 FR 84967 through 85 FR 84969) for our 
previously finalized requirements and burden for self-nomination of 
qualified registries.
    In section IV.A.3.h.(1) of this rule, we are finalizing 
reorganization and consolidation of Sec.  414.1400 generally. We assume 
that this provision does not change the existing requirements for 
third-party intermediaries during the self-nomination process. 
Therefore, we did not revise our burden estimates related to these 
provisions.
    In section IV.A.3.h.(2)(a) of this rule, we are finalizing to add 
APM Entities to Sec.  414.1400(a)(1), expanding the general 
participation requirements of third-party intermediaries, to third 
party intermediaries reporting to MIPS on behalf of APM Entities 
reporting to MIPS to align reporting requirements for all participants 
in MIPS. We are also finalizing that beginning with the CY 2023 
performance period/2025 MIPS payment year, QCDRs and qualified 
registries must support APP, and MVPs that are applicable to the MVP 
participants on whose behalf they submit MIPS data. As finalized in the 
CY 2017 PFS final rule, third-party intermediaries currently support 
MIPS data submission on behalf of eligible clinicians (81 FR 77016). 
APM Entities have historically used third party intermediaries for 
submitting their quality measures to their APMs. Additionally, QCDRs, 
qualified registries and health IT vendors are required under existing 
Sec.  414.1400(a)(1) to submit data for the quality, improvement 
activities, and promoting interoperability performance categories in 
MIPS. Similar to our discussion for QCDRs above, we anticipate no 
additional steps being added to the qualified registry self-nomination 
process as a result of this provision for third-party intermediaries to 
submit MIPS data on behalf of APM Entities, and to support measures and 
activities in MVPs that are applicable to the MVP participants on whose 
behalf they submit MIPS data. For this final rule, we assume that there 
will be no impact on the time required for qualified registries to 
complete either the simplified or full

[[Page 65574]]

self-nomination process because of the above provisions. Additionally, 
we are finalizing to require QCDRs, qualified registries, health IT 
vendors, and CAHPS for MIPS survey vendors to support subgroup 
reporting, beginning with the CY 2023 performance period/2025 MIPS 
payment year. We anticipate that at the time of self-nomination, 
qualified registries would be using a checkbox to indicate their 
compliance for the requirement to support data submission for subgroups 
beginning with the CY 2023 performance period/2025 MIPS payment year. 
We assume that this would not impact the overall time estimated for 
qualified registries to submit their information at the time of self-
nomination. Therefore, we are not making any adjustments in the time 
required for qualified registries during the simplified or full self-
nomination process because of this provision. However, we anticipate 
that third-party intermediaries would need to make administrative 
changes to their existing workflows for submission of MVPs and APP data 
for clinicians participating as subgroups beginning with the CY 2023 
performance period/2025 MIPS payment year. We refer readers to section 
VI.F.18.g.(2)(f) of this rule where we discuss our impact analysis.
    For this final rule, we are adjusting the number of qualified 
registries that submitted applications for self-nomination from 210 to 
147 based on the number of applications received during the CY 2021 
self-nomination period for the CY 2022 performance period/2024 MIPS 
payment year, a decrease of 36 applications from the currently approved 
estimate of 183. This is also a decrease of 63 from the estimate of 210 
provided in the CY 2022 PFS proposed rule (86 FR 39487). Therefore, we 
are revising our estimates for this information collection related to 
the qualified registry self-nomination process. We are not making any 
new adjustments to the estimated burden per respondent as a result of 
this updated data.
    Based on our estimates in the CY 2021 PFS final rule (85 FR 84967) 
and the updated data received for the number of qualified registries 
that submitted self-nomination applications, we are adjusting the 
estimated number of qualified registries that will submit targeted 
audits for the CY 2022 performance period/2024 MIPS payment year. 
Similar to our assumptions in the CY 2021 PFS final rule (85 FR 84967) 
and based on the updated data received from the CY 2021 self-nomination 
period, we are adjusting our estimate that 46 qualified registries will 
be required to conduct targeted audits, a decrease of 10 from the 
currently approved estimate of 56 in the CY 2021 PFS final rule (85 FR 
84965). Therefore, we estimate the total impact associated with 
qualified registries completing targeted audits will range from 230 
hours (46 registries x 5 hours/audit) at a cost of $21,901 (46 
registries x $476.10/audit) to 460 hours (46 registries x 10 hours/
audit) at a cost of $43,801 (46 registries x $952.20/audit) for the 
simplified and full self-nomination process, respectively (see Table 83 
for the cost per audit). We assume that this would adjust our burden 
estimates for targeted audits by -50 hours (-10 respondents x 5 hr/
audit) at a cost of -$4,761 (-50 hrs x $95.22/hr) and + -100 hours (-10 
respondents x 10 hr/audit) at a cost of -$9,522 (-100 hrs x $95.22/hr) 
for the simplified and full self-nomination process, respectively.
    Using our currently approved time per response estimate of 3 hours, 
the resulting adjustment in burden for QCDRs and qualified registries 
to submit CAPs is 30 hours (10 respondents x 3 hrs/respondent) at a 
cost of $2,857 (30 hours x $95.22/hr).
    In section IV.A.3.h.(3)(a)(i) of this final rule, we are finalizing 
new requirements for approved QCDRs and qualified registries that have 
not submitted performance data. First, we are finalizing to create a 
new requirement at paragraph at Sec.  414.1400(b)(3)(vii) to require 
QCDRs and qualified registries that have never submitted data since the 
inception of MIPS (CY 2017 performance period/2019 MIPS payment year) 
through the CY 2020 performance period/2022 MIPS payment year, to 
submit a participation plan as part of their self-nomination for CY 
2023. Exceptions to this requirement may occur if data is received for 
the CY 2021 performance period/2023 MIPS payment year. Under this 
scenario, QCDRs and qualified registries will not need to submit a 
participation plan for the CY 2023 self-nomination process. If the 
QCDRs and qualified registries did not submit data, their participation 
plan must be submitted as part of self-nomination for the CY 2023 MIPS 
self-nomination period and must be accepted by CMS to continue to be an 
approved QCDR or qualified registry. We are also finalizing to codify a 
new requirement that, beginning with the CY 2024 performance period/
2026 MIPS payment year, a QCDR or qualified registry that was approved 
but did not submit any MIPS data for either of the 2 years preceding 
the applicable self-nomination period must submit a participation plan 
for CMS' approval. Under this provision, the participation plan must 
explain the QCDR and/or qualified registry's detailed plans about how 
the vendor intends to encourage clinicians to submit MIPS data to CMS 
through the third-party intermediary on behalf of clinicians or groups. 
The vendor must also explain why they should still be allowed to 
participate as a qualified vendor.
    Based on our review of the existing list of approved qualified 
registries that did not submit performance data since the inception of 
MIPS (CY 2017 performance period/2019 MIPS payment year), we estimate 
that 19 qualified registries would submit participation plans for the 
CY 2023 self-nomination period. Similar to our assumptions used for 
submission of a CAP in the CY 2021 PFS final rule (85 FR 84968), we 
anticipate that the effort involved in developing a participation plan 
including the policies specified in this rule and submitting it to CMS 
is likely to be no more than 3 hours for a computer systems analyst at 
a rate of $95.22/hr. For the CY 2023 performance period/2025 MIPS 
payment year, we estimate an annual burden of 57 hours (3 hr x 19 
participation plans) at a cost of $5,428 (57 hr x $95.22/hr) for 
qualified registries to develop and submit a participation plan.
    As stated above, based on the number of self-nominations received 
for the CY 2022 performance period/2024 MIPS payment year, we are 
finalizing to adjust the estimated number of qualified registries that 
will self-nominate for the CY 2022 self-nomination period to 147, a 
decrease of 36 from the currently approved estimate of 183 in the CY 
2021 PFS final rule (85 FR 84969). In the CY 2019 PFS final rule, we 
estimated that it would take 3 hours for a qualified registry to submit 
all the required information during the full self-nomination process 
(83 FR 59998). Based on our experience with the self-nomination 
process, we believe that the number of fields needed to be submitted 
for a qualified registry are fewer than those needed for a QCDR. We 
assume that our previous assumption of 3 hours is an overestimate. 
Therefore, we are adjusting the estimated time required for a qualified 
registry submitting a full-self-nomination process to 2 hours, a 
decrease of 1 hour.
    We assume that 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 $95.22/hr. Using 
the change in estimated burden per respondent time, associated with the 
self-nomination process range from a minimum of 0.5 hours to a maximum 
of 2 hours, we

[[Page 65575]]

estimate that the annual burden would range from 74 hours (147 
qualified registries x 0.5 hr) to 294 hours (147 qualified registries x 
2 hr) at a cost ranging from $7,046 (74 hr x $95.22/hr) and $27,995 
(294 hr x $95.22/hr), respectively (see Table 85).
    Both the minimum and maximum burden shown in Table 85 reflect the 
adjustments to the number of respondents due to availability of more 
recent data. Combined with our estimates of burden associated with 
completing targeted audits and developing and submitting participation 
plans and corrective action plans, our total burden estimate ranges 
from 391 hours [74 hr (147 qualified registries x 0.5 hr) + 57 hr (+19 
participation plans x 3 hr/plan) + 230 hr (46 targeted audits x 5 
hours/audit) + 30 hr (10 CAPs x 3 hr) at a cost of $37,232 [$7,046 (74 
hr x $95.22/hr) + $5,428 (57 hr x $95.22/hr) + $21,901 (46 registries x 
$476.10/audit) + $2,857 (30 hours x $95.22/hr)] to 841 hours [294 hr 
(147 qualified registries x 2 hr) + 57 hr (+19 participation plans x 3 
hr/plan) + 460 hr (46 targeted audits x 10 hours/audit) + 30 hr (10 
CAPs x 3 hr)] at a cost of $80,081 [$27,995 (294 hr x $95.22/hr) + 
$5,428 (57 hr x $95.22/hr) + $43,801 (46 registries x $952.20/audit) + 
$2,857 (30 hours x $95.22/hr) for the simple self-nomination process 
(see minimum burden in Table 85) and full self-nomination process (see 
maximum burden in Table 85) respectively.
    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 
quality measures results and numerator and denominator data on MIPS 
eligible clinicians.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR19NO21.113

    As shown in Table 86, for the CY 2022 performance period/2024 MIPS 
payment year, independent of the change to our per response time 
estimate, the estimated decrease in 36 respondents from the currently 
approved 183 respondents to 147 results in a change of -18 hours (-36 
respondents x 0.5 hrs/respondent) at a cost of -$1,714 (-18 hours x 
$95.22/hr) for the simplified self-nomination process and a change of -
72 hours (-36 respondents x 2 hrs/respondent) at a cost of -$6,856 (-72 
hours x $95.22/hr). Accounting for the change in time required for the 
qualified registry self-nomination process results in an adjustment of 
0 hours for the simplified self-nomination process and -183 hours (183 
respondents x -1 hours) at a cost of -$17,425 (-183 hours x $95.22/hr) 
for the full self-nomination process.
    When the above impacts are combined with the estimates for targeted 
audits, participation plans and corrective action plans discussed 
above, the net impact ranges between -11 hours [-18 hr (-36 respondents 
x 0.5 hrs/respondent) + 0 hr +-50 hr (-10 audits x 5 hr/audit) + 57 hr 
(+19 participation plans x 3 hr/plan) + 0 hr)] at a cost of -$1,046 [(-
$1,713 (-18 hours x $95.22/hr) + $0 +-$4,761 (-50 hrs x $95.22/hr) + 
$5,428 (+57 hr x $95.22/hr) + $0)] for the simplified self-nomination 
process and -298 hours [(-72 hr (-36 respondents x 2 hrs/respondent) + 
-183 hr (183 respondents x -1 hours) + -100 hr (-10 audits x 10 hr/
audit) + 57 hr (+19 participation plans x 3 hr) + 0 hr)] at a cost of -
$28,375 [(-$6,856 (-72 hours x $95.22/hr)-$17,425 (-183 hours x $95.22/
hr)-$9,522 (-100 hrs x $95.22/hr) + $5,428 (+57 hr x $95.22/hr) + $0)] 
for the full self-nomination process for the CY 2022 performance 
period/2024 MIPS payment year.
    As discussed above in this section of the rule, we are setting 
forth new burden estimates for the CY 2023 performance period/2025 MIPS 
payment year. Therefore, we estimate the total change in burden for the 
qualified registry self-nomination process would be 391 hours at a cost 
of $37,232 for the simplified self-nomination process and 841 hours at 
a cost of $80,081 for the full self-nomination process. For the 
purposes of calculating estimated change in burden in Tables 128, 129, 
and 130 of this final

[[Page 65576]]

rule, we use only the maximum burden estimate.
[GRAPHIC] [TIFF OMITTED] TR19NO21.114

BILLING CODE 4120-01-C
    We received public comments for our burden estimates related to 
QCDRs and qualified registries. The following is a summary of the 
public comments received for the Quality Payment Program ICRs regarding 
the burden estimates for QCDR and qualified registries.
    Comment: One commenter did not agree with CMS burden estimates for 
audits conducted by QCDRs and qualified registries and shared their 
belief that the time required for a QCDR was two to three-fold more 
than CMS estimates. The commenter shared their concern that our 
estimate does not accurately represent the total amount of time it 
takes for a QCDR or qualified registry to conduct data audits.
    Response: We would like to clarify that our burden estimates 
provided for the QCDR and qualified registry self-nomination process 
are not intended to capture the holistic total annual time for a QCDR 
or a qualified registry to participate in MIPS. Our burden estimate of 
9.5 hours to 11.5 hours for the QCDR and 0.5 hours to 2 hours for the 
qualified registry self-nomination process specifically includes the 
estimated time it takes for a QCDR or qualified registry to populate 
and submit a self-nomination form and QCDR measures, if applicable. 
These burden estimates do not include any time needed to comply with 
third-party intermediary requirements outside of the self-nomination 
process. We believe our burden estimate is a reasonable average across 
all respondents based on our review of the nomination process, the 
information required to complete the nomination form, and the criteria 
required to self-nominate as a QCDR or registry.
    After consideration of public comments, we are not making any 
changes to our estimates of the time required for the QCDR and 
qualified registry self-nomination process.
(4) Survey Vendor Requirements
    In section IV.A.3.h(2)(b)(ii) of this rule, we are finalizing to 
require CAHPS for MIPS survey vendors to support subgroup reporting, 
beginning with the CY 2023 performance period/2025 MIPS payment year. 
Because of this provision, we anticipate no additional steps being 
added to the requirements for CAHPS for MIPS survey vendors to submit a 
participation form and assume there would be no impact on the time 
required for the survey vendors. Therefore, we are not making any 
adjustments in the time required for CAHPS survey vendors to submit 
their information because of this provision. The requirements and 
burden for CAHPS survey vendors to submit data for eligible clinicians 
are currently approved by OMB under control number 0938-1222 (CMS-
10450). Consequently, we are not making any changes to the CAHPS for 
MIPS Survey vendor information collection request under that control 
number.
(5) Health IT Vendors
    In section IV.A.3.h.(2)(b) of this rule, we are finalizing to 
create a new requirement at paragraph Sec.  414.1400(c)(1)(iii) to 
state that, beginning with the CY 2023 performance period/2025 MIPS 
payment year, health IT vendors must support MVPs that are applicable 
to the MVP participants on whose behalf they submit MIPS data. Health 
IT vendors may also support the APP. Additionally, we are finalizing to 
require health IT vendors to support subgroup reporting beginning with 
the CY 2023 performance period/2025 MIPS payment year. We do not 
anticipate any requirement or burden changes as it relates to the 
support of reporting data. As stated in the CY 2019 PFS final rule (83 
FR 59998), health IT vendors are not included in the burden estimates 
for MIPS.
d. ICR Regarding Open Authorization (OAuth) Credentialing and Token 
Request Process
    This rule is not implementing new or revised collection of 
information requirements or burden related to the identity management 
application process. The requirements and burden are currently approved 
by OMB under control number 0938-1314 (CMS-10621). Consequently, we are 
not making any changes to the identity management application process 
under that control number.
e. ICRs Regarding Quality Data Submission (Sec. Sec.  414.1318, 
414.1325, 414.1335, and 414.1365)
(1) Background
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77502 through 77503), CY 2018 Quality Payment Program final rule 
(82 FR 53908 through 53912), CY 2019 PFS final rule (83 FR 60000 
through 60003), CY 2020 PFS final rule (84 FR 63121 through 63124), and 
the CY 2021 PFS final rule (85 FR 84970 through 84974) for our 
previously finalized requirements for data submission for the quality 
performance category.
    Under our current policies, two groups of clinicians must submit 
quality data under MIPS: Those who submit 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

[[Page 65577]]

enrolled to Medicare; are QPs; are partial QPs who elect to not 
participate in MIPS; are not one of the clinician types included in the 
definition for MIPS eligible clinician; or do not exceed the low-volume 
threshold as an individual or as a group.
(2) Changes and Adjustments to Quality Performance Category Respondents
    To determine which QPs should be excluded from MIPS, we used the 
Advanced APM payment and patient percentages from the APM Participant 
List for the final snapshot date for the 2019 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 
2022 performance period/2024 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 CY 2022 
performance period/2024 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 FR 59752). As in the CY 2021 PFS final rule, we 
continue to use CY 2019 performance period/2021 MIPS payment year data 
to estimate the number of respondents in the CY 2022 PFS final rule.
    There may be an undercount in submissions due to the PHE for COVID-
19, because of the automatic extreme and uncontrollable circumstances 
policy, and application-based policy that allowed clinicians to elect 
not to submit during the submission period for the CY 2019 performance 
period/2021 MIPS payment year that we are using to inform our burden 
estimates. Despite this limitation, we believe the data from the CY 
2019 performance period/2021 MIPS payment year is still the best data 
source available as it most accurately reflects the impacts of policies 
finalized in previous rules and trends toward increased group 
reporting.
    In section IV.A.3.d.(1)(d) of this rule, we are finalizing to 
continue the CMS Web Interface measures as a collection type for the CY 
2022 performance period/2024 MIPS payment year. Additionally, we are 
finalizing to sunset the CMS Web Interface measures as a collection 
type/submission type starting with the CY 2023 performance period/2025 
MIPS payment year. In the CY 2021 PFS final rule (85 FR 84981), we 
finalized the sunset of CMS Web Interface as a collection type for the 
CY 2022 performance period/2024 MIPS payment year. We refer readers to 
the CY 2021 PFS final rule for discussion on our assumptions for the CY 
2022 performance period/2024 MIPS payment year, where we estimated a 
burden of zero due to our assumption that all Web Interface respondents 
will alternately utilize either the MIPS CQM and QCDR or eCQM 
collection types. Based on the number of groups that submitted quality 
performance data via the CMS Web Interface in the CY 2019 performance 
period/2021 MIPS payment year, we are not able to ascertain what 
alternative collection type(s) the groups would elect. In order to 
estimate the number of groups that will select each of these collection 
types, we first clustered the number of groups which submitted data via 
the CMS Web Interface collection type during the CY 2019 performance 
period/2021 MIPS payment year by practice size (between 25 and 49 
clinicians, between 50 and 99 clinicians, etc.). Then, for each 
cluster, we allocated these groups to each of the MIPS CQM and QCDR and 
eCQM collection types based on the percent of TINs that submitted MIPS 
data via these two collection types. For example, of the 1,629 TINs 
with a practice size of 25 to 49 clinicians which submitted data for 
the CY 2019 performance period/2021 MIPS payment year, 1,066 (65 
percent) submitted data via the MIPS CQM and QCDR collection type and 
563 (35 percent) submitted data via the eCQM collection type. We 
applied these percentages to the 7 TINs with a practice size of 25 to 
49 clinicians which submitted data via the CMS Web Interface collection 
type for the CY 2019 performance period/2021 MIPS payment year to 
estimate that 4 (7 TINs x 0.56) would elect to submit data via the MIPS 
CQM and QCDR collection type and the remaining 3 (7 TINs x 0.44) would 
elect to submit data via the eCQM collection type. In total, beginning 
with the CY 2023 performance period/2025 MIPS payment year, we estimate 
that 64 of the 114 groups that submitted data via the CMS Web Interface 
collection type for the CY 2019 performance period/2021 MIPS payment 
year will submit quality data via the MIPS CQM and QCDR collection type 
and 50 groups will now submit quality data via the eCQM collection 
type. We note that 114 groups are an increase of 114 from our currently 
approved estimate of 0 groups in the CY 2022 performance period/2024 
MIPS payment year. We also performed this analysis to determine the 
number of clinicians that will be affected and will need to submit 
quality data via an alternate collection type beginning with the CY 
2023 performance period/2025 MIPS payment year. In total, of the 
estimated 45,599 individual clinicians affected by this provision, we 
estimate that 11,432 will submit quality data as part of a group via 
the MIPS CQM and QCDR collection type and 34,167 will submit quality 
data as part of a group via the eCQM collection type. These estimates 
are reflected in Tables 90 and 92 and the associated changes in burden 
are reflected in Tables 91 and 93. In aggregate, as discussed in 
section V.B.8.p. of this final rule, we estimate the provision to 
sunset the CMS Web Interface measures as a collection type/submission 
type will result in a net decrease in quality performance data 
reporting burden while acknowledging the additional financial impacts 
on clinicians as discussed in section VI.F.18.g.(2)(a) of the 
Regulatory Impact Analysis. We assume that 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 2020 and CY 
2021 PFS final rules (84 FR 63122 and 85 FR 84972), 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.8.e.(2) of this final rule, we assume non-ACO APM Entities 
will participate through traditional MIPS and submit as an individual 
or group rather than as an entity. To estimate who will be a MIPS APM 
participant in the CY 2022 performance period/2024 MIPS payment year, 
we used the Advanced APM payment and patient percentages from the APM 
Participant List for the final snapshot date for the 2019 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

[[Page 65578]]

for the CY 2019 performance period/2021 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 burden is excluded from 
this collection of information section but is discussed in the 
regulatory impact analysis section of this final rule because sections 
1899(e) and 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.\266\ Tables 84, 85, 
and 86 explain our revised estimates of the number of organizations 
(including groups, virtual groups, and individual MIPS eligible 
clinicians) submitting data on behalf of clinicians segregated by 
collection type.
---------------------------------------------------------------------------

    \266\ 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.
---------------------------------------------------------------------------

    Table 87 provides our estimated counts of clinicians that will 
submit quality performance category data as MIPS individual clinicians 
or groups in the CY 2022 and CY 2023 performance periods/2024 and 2025 
MIPS payment years based on data from the CY 2019 performance period/
2021 MIPS payment year.
    For the CY 2022 performance period/2024 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, and Web Interface. For the CY 2023 performance 
period/2025 MIPS payment year, respondents will no longer have the 
option to submit quality performance category data via the Web 
Interface. We estimate the burden for collecting data via collection 
type: Medicare Part B claims, QCDR and MIPS CQMs, eCQMs, and the CMS 
Web Interface. 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.
    For the CY 2023 performance period/2025 MIPS payment year, we are 
finalizing in section IV.A.3.b.(2)(c) of this rule that clinicians in 
MIPS will have the option to submit measures and activities in MVPs. We 
refer readers to section IV.A.3.b.(4)(d) of this rule for additional 
details on the reporting requirements for MVPs. For the quality 
performance category of MVPs, we assume that MVP Participants will 
choose to report via the Medicare Part B claims, QCDR, MIPS CQMs, and 
eCQMs collection type. Table 99 of this rule includes the estimated 
burden for collecting data for the quality performance category of 
MVPs.
    As shown in Table 87, using participation data from the CY 2019 
performance period/2021 MIPS payment year, combined with the estimate 
of QPs for the CY 2022 performance period/2024 MIPS payment year, we 
estimate a total of 625,703 clinicians will submit quality data as 
individuals or groups in each of the CY 2022 and CY 2023 performance 
periods/2024 and 2025 MIPS payment years, a decrease of 25,811 
clinicians when compared to our estimate of 651,514 clinicians in the 
CY 2021 PFS final rule (85 FR 84972). For the CY 2022 performance 
period/2024 payment year, we estimate 28,252 clinicians will submit 
data as individuals for the Medicare Part B claims collection type; 
279,247 clinicians will submit data as individuals or as part of groups 
for the MIPS CQM and QCDR collection type; 273,819 clinicians will 
submit data as individuals or as part of groups via eCQM collection 
types; and 44,385 clinicians will submit as part of groups via the CMS 
Web Interface. Compared to the CY 2022 performance period/2024 MIPS 
payment year burden estimated in the CY 2021 PFS final rule (85 FR 
84972), these are decreases from the estimates of 29,273, 295,941, and 
326,300 for Medicare Part B claims, MIPS CQM and QCDR, eCQM, and an 
increase of 44,385 for the CMS Web Interface collection types, 
respectively. These adjustments are due to the availability of updated 
data from the CY 2019 performance period/2021 MIPS payment year and the 
delay in sunsetting the CMS Web Interface from the CY 2022 performance 
period/2024 MIPS payment year to the CY 2023 performance period/2025 
MIPS payment year. For the CY 2023 performance period/2025 MIPS payment 
year, we estimate 25,427 clinicians will submit data as individuals for 
the Medicare Part B claims collection type; 288,637 clinicians will 
submit data as individuals or as part of groups for the MIPS CQM and 
QCDR collection type; 311,326 clinicians will submit data as 
individuals or as part of groups via the eCQM collection type.
    Table 87 provides estimates of the number of clinicians to collect 
quality measures data via each collection type, regardless of whether 
they decide to submit as individual clinicians or as part of groups. 
Because our burden estimates for quality data submission assume that 
burden is reduced when clinicians elect to submit as part of a group, 
we also separately estimate the expected number of clinicians to submit 
as individuals or part of groups.

[[Page 65579]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.115

    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 2019 performance period/2021 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 88 uses methods similar to those described to estimate the 
number of clinicians that will submit data as individual clinicians via 
each collection type in the CY 2022 and CY 2023 performance periods/
2024 and 2025 MIPS payment years. For the CY 2022 performance period/
2024 MIPS payment year, we estimate that approximately 28,252 
clinicians will submit data as individuals using the Medicare Part B 
claims collection type; approximately 40,507 clinicians will submit 
data as individuals using MIPS CQM and QCDR collection type; and 
approximately 40,446 clinicians will submit data as individuals using 
eCQMs collection type. Based on performance data from the CY 2019 
performance period/2021 MIPS payment year, these are decreases of -
1,021, -833, and -1,809 respondents from the currently approved 
estimates of 29,273, 41,340, and 42,255 for the Medicare Part B claims, 
MIPS CQM and QCDR, and eCQM collection types, respectively.
    As shown in Table 88, for the CY 2023 performance period/2025 MIPS 
payment year, we estimate that approximately 25,427 clinicians will 
submit data as individuals using the Medicare Part B claims collection 
type; approximately 36,456 clinicians will submit data as individuals 
using MIPS CQM and QCDR collection type; and approximately 36,401 
clinicians will submit data as individuals using eCQMs collection type. 
As stated above, we are setting forth our estimates for the CY 2023 
performance period/2025 MIPS payment year as new burden with no 
currently approved estimate.

[[Page 65580]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.116

    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 88 are not mutually exclusive.
    Table 89 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 2022 and CY 2023 performance periods/2024 and 
2025 MIPS payment years. We assume that clinicians that submitted 
quality data as groups in the CY 2019 performance period/2021 MIPS 
payment year will continue to submit quality data either as groups or 
virtual groups for the same collection types as they did as a group or 
TIN within a virtual group for the CY 2022 and 2023 performance 
periods/2024 and 2025 MIPS payment years. Specifically, for the CY 2022 
performance period/2024 MIPS payment year we estimate that 11,529 
groups and virtual groups will submit data for the MIPS CQM and QCDR 
collection type on behalf of 243,169 clinicians; 8,127 groups and 
virtual groups will submit for eCQM collection types on behalf of 
249,878 eligible clinicians; and 114 groups will submit data via the 
CMS Web Interface on behalf of 44,385 clinicians. These are decreases 
of -75 and -93 respondents from the currently approved estimates of 
11,604, and 8,220 groups and virtual groups for the MIPS CQM and QCDR 
and eCQM collection types, and an increase of +114 groups from the 
currently approved estimates of 0 groups for the CMS Web Interface 
collection types, respectively.
    As shown in Table 89, for the CY 2023 performance period/2025 MIPS 
payment year we estimate that 10,434 groups and virtual groups will 
submit data for the MIPS CQM and QCDR collection type on behalf of 
313,038 clinicians and 7,359 groups and virtual groups will submit for 
eCQM collection types on behalf of 339,109 eligible clinicians. As 
stated above, we are setting forth our estimates for the CY 2023 
performance period/2025 MIPS payment year as new burden with no 
currently approved estimate. The reason for the difference in estimated 
number of respondents from the estimates for the CY 2022 performance 
period/2024 MIPS payment year described above, is due to the sunset of 
the CMS Web Interface as a collection type and the implementation of 
MVPs beginning with the CY 2023 performance period/2025 MIPS payment 
year. 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 2019 performance period/
2021 MIPS payment year.

[[Page 65581]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.117

    The burden associated with the submission of quality performance 
category data have 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 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. For the CY 2023 performance 
period/2025 MIPS payment year we refer readers to section 
IV.A.3.b.(4)(d) of the rule for the changes related to MVP and subgroup 
reporting requirements. In terms of the quality measures available for 
clinicians and groups to report for the CY 2022 performance period/2024 
MIPS payment year, we are finalizing that the total number of quality 
measures will be 200. The new MIPS quality measures finalized for 
inclusion in MIPS for the CY 2022 performance period/2024 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 finalized for removal can be 
found in Table Group C of Appendix 1. These measures are stratified by 
collection type in Table 90, as well as counts of new, removed, and 
substantively changed measures.

[[Page 65582]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.118

    For the CY 2022 performance period/2024 MIPS payment year, we are 
finalizing a net reduction of 9 quality measures across all collection 
types compared to the 209 measures finalized for the CY 2021 
performance period/2023 MIPS payment year (85 FR 84974). Specifically, 
as discussed in section IV.A.3.d.(1)(e) of this rule, we are finalizing 
to add 1 new administrative claims outcome measure, remove 13 quality 
measures, and make substantive updates to 87 quality measures. We do 
not anticipate that 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. For the change in associated burden related to the provisions 
introducing MVP and subgroup reporting beginning in the CY 2023 
performance period/2025 MIPS payment year, we refer readers to Table 99 
of this section.
(3) Quality Payment Program Identity Management Application Process
    This rule is not implementing any new or revised collection of 
information requirements or burden related to the identity management 
application process. The requirements and burden are currently approved 
by OMB under control number 0938-1314 (CMS-10621). Consequently, we are 
not making any changes to the identity management application process 
under that control number.
(4) Quality Data Submission by Clinicians: Medicare Part B Claims-Based 
Collection Type
    This rule is not implementing any new or revised collection of 
information requirements related to the submission of Medicare Part B 
claims data for the quality performance category. However, we are 
adjusting our currently approved burden estimates based on more recent 
data. For the change in associated burden related to the provisions 
introducing MVP and subgroup reporting beginning in the CY 2023 
performance period/2025 MIPS payment year, we refer readers to Table 99 
of this section.
    The following burden will be submitted to OMB for approval under 
control number 0938-1314 (CMS-10621).
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77501 through 77504), CY 2018 Quality Payment Program final rule 
(82 FR 53912), CY 2019 PFS final rule (83 FR 60004 through 60005), CY 
2020 PFS final rule (84 FR 63124 through 63126) and the CY 2021 PFS 
final rule (85 FR 84975 through 84976) for our previously finalized 
requirements and burden for quality data submission via the Medicare 
Part B claims collection type.
    As noted in Table 88, based on data from the CY 2019 performance 
period/2021 MIPS payment year, we assume that 28,252 individual 
clinicians will collect and submit quality data via the Medicare Part B 
claims collection type. In this rule, we are finalizing to adjust the 
number of Medicare Part B claims respondents from the currently 
approved estimate of 29,273 to 28,252 (a decrease of 1,021) based on 
more recent data and our methodology of accounting only for clinicians 
in small practices who submitted such claims data in the CY 2019 
performance period/2021 MIPS payment year rather than all clinicians 
who submitted quality data codes to us for the Medicare Part B claims 
collection type.
    As shown in Table 91, consistent with our currently approved per 
response time figures, we estimate that the burden of quality data 
submission using Medicare Part B claims will range from 0.15 hours (9 
minutes) for a computer systems analyst at a cost of $14.28 (0.15 hr x 
$95.22/hr) to 7.2 hours for a computer systems analyst at a cost of 
$685.58 (7.2 hr x $95.22/hr). The burden will involve becoming familiar 
with MIPS quality measure specifications.
    Consistent with our currently approved per response time figures, 
we believe that the start-up cost for a clinician's practice to review 
measure specifications is 7 hours, consisting of 3 hours at $114.24/hr 
for a medical and health services manager, 1 hour at $217.32/hr for a 
physician, 1 hour at $48.16/hr for an LPN, 1 hour at $95.22/hr for a 
computer systems analyst, and 1 hour at $40.02/hr for a billing and 
posting clerk. We are not revising our currently approved per response 
time estimates.
    As shown in Table 91, 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 this regard the total 
annual time for the CY 2022 performance period/2024 MIPS payment year 
ranges from 202,002 hours (7.15 hr x 28,252 clinicians) to 401,178 
hours (14.2 hr x 28,252 clinicians). The estimated annual cost (per 
clinician) ranges from $758 [(0.15 hr x $95.22/hr) + (3 hr x $114.24/
hr) + (1 hr x $95.22/hr) + (1 hr x $48.16/hr) + (1 hr x $40.02/hr) + (1 
hr x $217.32/hr)] to a maximum of $1,429.02 [(7.2 hr x $95.22/hr) + (3 
hr x $114.24/hr) + (1 hr x $95.22/hr) + (1 hr x $48.16/hr) + (1 hr x 
$40.02/hr) + (1 hr x $217.32/hr)]. The total annual cost for the CY 
2022 performance period/2024 MIPS payment year ranges from a minimum of 
$21,407,105 (28,252 clinicians x $758)

[[Page 65583]]

to a maximum of $40,372,673 (28,252 clinicians x $1,429.02).
    As shown in Table 91, for purposes of calculating total burden 
associated with the Claims collection type for the CY 2023 performance 
period/2025 MIPS payment year only the maximum burden is used. The 
decrease in the number of annual respondents results in an estimated 
total annual time of 361,063 hours (14.2 hr x 25,427 clinicians) for 
the CY 2023 performance period/2025 MIPS payment year. Using the 
currently approved unchanged estimate for cost per respondent, the 
total annual cost for the CY 2023 performance period/2025 MIPS payment 
year is $36,335,692 (25,427 clinicians x $1,429.02 per respondent).
    Table 91 summarizes our estimated range of total annual burden 
associated with clinicians submitting quality data via Medicare Part B 
claims for both the CY 2022 and CY 2023 performance periods/2024 and 
2025 MIPS payment years.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR19NO21.119

    As shown in Table 91, using the unchanged currently approved hours 
per respondent, we estimate that the burden per respondent for quality 
data submission using the Medicare Part B Claims collection type will 
range from $758 to $1,429.02. The decrease in number of respondents 
from 29,273 to 28,252 results in a total adjustment of between -7,300 
hours (-1,021 respondents x 7.15 hr/respondent) at a cost of -$773,918 
(-1,021 respondents x $758/respondent) and -14,498 hours (-1,021 
respondents x 14.2 hr/respondent) at a cost of -$1,459,029 (-1,021 
respondents x $1,429.02/respondent). For purposes of calculating total 
burden associated with this final rule as shown in Tables 125, 126, 
127, and 128, only the maximum burden is used.
    As shown in Table 92, for purposes of calculating total burden 
associated the CY 2023 performance period/2025 MIPS payment year only 
the maximum burden is used. We are setting forth our CY 2023 
performance period/2025 MIPS payment year estimate as new burden, which 
results in an increase of 361,063 hours (25,427 respondents x 14.2 hr/
respondent) at a cost of $36,355,692 (25,427 respondents x $1,429/
respondent).

[[Page 65584]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.120

BILLING CODE 4120-01-C
(5) Quality Data Submission by Individuals and Groups Using MIPS CQM 
and QCDR Collection Types
    The following requirement and burden will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621).
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77504 through 77505), CY 2018 Quality Payment Program final rule 
(82 FR 53912 through 53914), CY 2019 PFS final rule (83 FR 60005 
through 60006), CY 2020 PFS final rule (84 FR 63127 through 63128), CY 
2021 PFS final rule (85 FR 84977 through 84979) for our previously 
finalized requirements and burden for quality data submission via the 
MIPS CQM and QCDR 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 2023 performance period/2025 
MIPS payment year, we refer readers to Table 99.
    As noted in Tables 84, 85, and 86, and based on data from the CY 
2019 performance period/2021 MIPS payment year, for the CY 2022 
performance period/2024 MIPS payment year, we assume that 279,247 
clinicians will submit quality data as individuals or groups using MIPS 
CQM or QCDR collection types; 52,036 clinicians will submit as 
individuals and the remaining 279,223 clinicians will submit as members 
of 11,527 groups and virtual groups. This is an increase of 10,696 
individuals and a decrease of 32 groups from the estimates of 41,340 
individuals and the 11,559 groups provided in the CY 2021 PFS final 
rule (85 FR 84977). Given that 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 that the burden 
for an individual clinician or group to review measure specifications 
and submit quality data is total of 9 hours at a cost of $922.76 per 
response. This consists of 3 hours at $95.22/hr for a computer systems 
analyst (or their equivalent) to submit quality data along with 2 hours 
at $114.24/hr for a medical and health services manager, 1 hour at 
$95.22/hr for a computer systems analyst, 1 hour at $48.16/hr for an 
LPN, 1 hour at $40.02/hr for a billing clerk, and 1 hour at $217.32/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 that 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 hours) at 
$95.22/hr for a computer systems analyst at a cost of $7.90 (0.083 hr x 
$95.22/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 $922.76/response [(3 hr x 
$95.22/hr) + (2 hr x $114.24/hr) + (1 hr x $217.32/hr) + (1 hr x 
$95.22/hr) + (1 hr x $48.16/hr) + (1 hr x $40.02/hr) + (0.083 hr x 
$95.22/hr)].
    For the CY 2022 performance period/2024 MIPS payment year, in 
aggregate, we estimate a burden of 472,643 hours [9.083 hr/response x 
(40,507 clinicians submitting as individuals + 11,527 groups submitting 
via QCDR or MIPS CQM on behalf of individual clinicians or 52,036 
responses)] at a cost of $ $48,016,739 (52,036 responses x $922.76/
response).
    For the CY 2023 performance period/2025 MIPS payment year, in 
aggregate, we estimate a burden of 425,902 hours [9.083 hr/response x 
(36,456 clinicians submitting as individuals + 10,434 groups submitting 
via QCDR or MIPS CQM on behalf of individual clinicians or 46,890 
responses)] at a cost of $43,268,216 (46,890 responses x $922.76/
response). Based on these assumptions, we have estimated in

[[Page 65585]]

Table 93 the burden for these submissions.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR19NO21.121

    As shown in Table 94, using the unchanged currently approved hours 
per respondent burden estimate, the decrease of 913 respondents from 
52,944 to 52,036 for the CY 2022 performance period/2024 MIPS payment 
year results in a decrease of -8,247 hours (-908 respondents x 9.083 
hr/respondent) and -$837,866 (908 respondents x $922.76/respondent).
    We are setting forth new burden estimates for the CY 2023 
performance period/2025 MIPS payment year, which results in an increase 
of 425,902 hours (46,890 respondents x 9.083 hr/respondent) and 
$43,268,216 (46,890 respondents x $922.76/respondents).

[[Page 65586]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.122

BILLING CODE 4120-01-C
(6) Quality Data Submission by Clinicians and Groups: eCQM Collection 
Type
    The following requirements and burden will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621).
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77505 through 77506), CY 2018 Quality Payment Program final rule 
(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) and 
the CY 2021 PFS final rule (85 FR 84979 through 84980) 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 2023 
performance period/2025 MIPS payment year, we refer readers to Table 99 
of this section.
    Based on CY 2019 performance period/2021 MIPS payment year data, 
for the CY 2022 performance period/2024 MIPS payment year, we assume 
that 322,392 clinicians will elect to use the eCQM collection type; 
40,446 clinicians are expected to submit eCQMs as individuals; and 
8,127 groups and virtual groups are expected to submit eCQMs on behalf 
of the remaining 273,819 clinicians. This is a decrease of 2,109 
individuals and 27 groups from the estimates of 42,555 individuals and 
8,154 groups provided in the CY 2021 PFS final rule (85 FR 84979). We 
expect 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 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 $95.22/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 $114.24/hr for a medical and health services 
manager, 1 hour at $217.32/hr for a physician, 1 hour at $95.22/hr for 
a computer systems analyst, 1 hour at $48.16/hr for an LPN, and 1 hour 
at $40.02/hr for a billing clerk. Overall, we estimate a cost of 
$812.76/response [(2 hr x $95.22/hr) + (2 hr x $114.24/hr) + (1 hr x 
$217.32/hr) + (1 hr x $95.22/hr) + (1 hr x $48.16/hr) + (1 hr x $40.02/
hr)].
    For the CY 2022 performance period/2024 MIPS payment year, in 
aggregate, we estimate a burden of 388,584 hours [8 hr x 48.573 (40,446 
clinicians + 8,127 groups and virtual groups)] at a cost of $39,812,374 
(48,573 responses x $819.64/response). For the CY 2023 performance 
period/2025 MIPS payment year, in aggregate, we estimate a burden of 
350,186 hours [8 hr x 43,773 (36,401 clinicians + 7,372 groups and 
virtual groups)] at a cost of $35,878,102 (43,773 responses x $819.64/
response). Based on these assumptions, we have estimated in Table 95 
the burden for these submissions.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TR19NO21.123

    As shown in Table 96, using the unchanged currently approved hours 
per respondent burden estimate, the decrease of 1,902 respondents from 
50,475 to 48,573 for the CY 2022 performance period/2024 MIPS payment 
year results in a total difference of x15,216 hours at a cost of 
x$1,558,955. For CY 2023 performance period/2025 MIPS payment year, we 
are setting forth our estimate as new burden, which represents an 
increase of 350,184 hours (43,773 respondents x 8 hr/respondent) and 
$35,878,102 (43,773 respondents x $819.64/respondent).

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[GRAPHIC] [TIFF OMITTED] TR19NO21.124

BILLING CODE 4120-01-C
(7) ICRs Regarding Burden for MVP Reporting
    Section IV.A.3.b.(2)(d) of this rule describes provisions related 
to implementing MVPs beginning with the CY 2023 performance period/2025 
MIPS payment year. The MVPs will include the Promoting Interoperability 
performance category as a foundational element and incorporate 
population health claims-based measures, as feasible, along with the 
relevant measures and activities in the quality, cost, and improvement 
activities performance categories. For the CY 2023 performance period/
2025 MIPS payment year, we are finalizing an inventory of seven MVPs 
included in Appendix 3: MVP Inventory of this rule to assess 
performance across MVPs for the quality, cost, improvement activities, 
and Promoting Interoperability performance categories. Additionally, in 
section IV.A.3.b.(2)(b)(i) of this rule, we are finalizing to use the 
term ``MVP Participant'' to refer to clinicians who will choose to 
participate in MIPS for reporting MVPs.
    The following new ICRs reflect the burden associated with the first 
year of data collection related to the implementation of MVPs and 
subgroup reporting in the CY 2023 performance period/2025 MIPS payment 
year as described in section IV.A.3.b.(2)(c) of this rule. The 
requirements and burden associated with the implementation of MVPs and 
subgroups will be submitted to OMB for approval under control number 
0938-1314 (CMS-10621).
    While MVP respondents report on all performance categories, we 
believe that for purposes of data submission, the burden for clinicians 
submitting information for the Promoting Interoperability and 
improvement activities performance categories of MVPs will be 
consistent with the currently approved estimated burden per respondent 
for clinicians submitting data for these performance categories in 
traditional MIPS. We acknowledge that clinicians participating through 
MVPs will have fewer requirements to meet for the improvement activity 
performance category as discussed in section IV.A.3.b.(4)(d)(iv) of 
this final rule. We assume that these requirement changes will not 
significantly lower the burden for clinicians reporting MVPs. 
Therefore, we will not add additional ICRs to capture the burden for 
the Promoting Interoperability and Improvement Activity performance 
categories. For this rule, we are finalizing to create a separate ICR 
for estimating the burden associated with data submission for the 
Quality performance category of MVPs. We considered whether we should 
have a separate ICR to estimate burden for submission of measures and 
activities in the Promoting Interoperability performance category of 
MVPs. Based on our assumption above that the burden for clinicians 
submitting information for these performance categories of MVPs will be 
consistent with the currently approved estimated burden per respondent 
for clinicians submitting data in traditional MIPS, we anticipate that 
the separate ICRs will not be of value to clinicians.
    We solicited comment on our proposal to distinctly estimate burden 
only for data submission in the Quality performance category of MVPs 
and whether we should revise the MVP submission ICR to include all the 
four MIPS performance categories and whether our assumptions on 
Promoting Interoperability and Improvement Activities should be 
modified for MVPs.
    We did not receive public comments on this provision. We are 
finalizing as proposed.
(a) Burden for MVP Quality Submission
    In section IV.A.3.b.(4)(d)(ii) of this rule, we are finalizing to 
implement voluntary MVP reporting beginning with the CY 2023 
performance period/2025 MIPS payment year. Therefore, clinicians 
participating in MIPS will have the option to voluntarily submit data 
using MVPs starting with the CY 2023 performance period/2025 MIPS 
payment year. While we recognize the implementation of MVPs in MIPS 
will result in a burden for registration, we also assume that MVP 
reporting will result in a decline in burden for MVP participants due 
to the finalized changes in the MVP reporting requirements described in 
section IV.A.3.b.(4)(d) of this rule. We anticipate that the clinicians 
choosing to participate in MIPS for reporting MVPs will need to select 
from a reduced inventory of measures and activities for the quality and 
improvement activities performance categories. This reduction in burden 
is described in the quality, improvement activities and Promoting 
Interoperability performance categories sections below.
    For the ICRs related to MVP participants, we used the MIPS 
submission data from the CY 2019 performance period/2021 MIPS payment 
year. Based on our review of the inventory of 7 MVPs in Appendix 3: MVP 
Inventory of this rule and the existing submission trends in MIPS for 
the measures and activities included in these MVPs, we anticipate that 
10 percent of the clinicians who participate in traditional MIPS in the 
CY 2022 performance period/2024 MIPS payment year will report MVPs in 
the CY 2023 performance period/2025 MIPS payment year. Given that MVPs 
are new, voluntary, and represent a

[[Page 65589]]

reduction in burden per response, we believe that we should be 
conservative in estimating the number of clinicians submitting through 
MVPs during the initial year. Given that MVPs are a new mechanism 
available for clinicians, we believe that initial participation numbers 
will be relatively low. In an effort to be conservative in our estimate 
of burden reduction due to MVP reporting and reflect the anticipate low 
uptake by clinicians in the first year of MVP availability, we assume 
that a total of 10 percent of MIPS submitters will become MVP 
participants in the CY 2023 performance period/2025 MIPS payment year.
    As described in section IV.A.3.b.(2)(c)(ii) of this rule, beginning 
with the CY 2023 performance period/2025 MIPS payment year, we are 
finalizing voluntary subgroup reporting within MIPS limited to 
clinicians reporting the MVP or the APP. We recognize the 
implementation of subgroups for clinicians to participate in MVP and 
APP reporting in MIPS will result in additional burden. However, we 
believe that subgroup participation option will allow clinicians in 
certain specialties and subspecialties to report on measures and 
activities meaningful to the scope of care provided. We anticipate that 
public reporting of subgroup performance information will allow 
patients to identify clinicians in multispecialty groups that are 
representative of the care specific to their clinical condition. 
Clinician participation in subgroups is new to MIPS and we do not have 
any historical participation data to estimate the submission burden for 
clinicians who will choose to participate as subgroups for reporting 
the MVP or the APP. We refer readers to section IV.A.3.b.(3) of this 
final rule for details on the provisions related to subgroup 
composition.
    We anticipate that the subgroup reporting option will increase 
reporting and allow clinicians in specialties to report on measures and 
activities meaningful to their practice. Due to the delay in 
implementation of subgroup reporting in the CY 2023 performance period/
2025 MIPS payment year, we anticipate that there is an adequate amount 
of time for clinicians that historically participate in MIPS to 
determine if they will be able to participate as subgroups for 
reporting on the measures and activities in an MVP. However, due to the 
limited number of MVPs available for clinicians to choose, the 
additional burden involved in reporting, and also given the voluntary 
option to participate as subgroups for reporting the MVPs or the APP, 
we anticipate that a relatively small number of clinicians will choose 
to participate as subgroups in the CY 2023 performance period/2025 MIPS 
payment year. Therefore, we assume there will be 20 subgroups reporters 
in the CY 2023 performance period/2025 MIPS payment year. We assume 
that more clinicians will choose to participate as subgroups in future 
years. We solicited comment on our MVP and subgroup reporting 
assumptions for the CY 2023 performance period/2025 MIPS payment year.
    We received public comments on our MVP and subgroup reporting 
assumptions for the CY 2023 MIPS performance period/2025 MIPS payment 
year. The following is a summary of the comments we received and our 
responses.
    Comment: One commenter stated that our estimate that 10 percent of 
eligible clinicians would report as MVP participants in the first year 
of implementation is low. The commenter shared their belief that the 
number of MVP participants would be higher because of the reduced 
reporting burden associated with MVP reporting.
    Response: We thank the commenter for their feedback. We acknowledge 
the commenter's concern that our assumptions for MVP reporting are low. 
We agree with the commenter that MVP reporting is associated with a 
reduction in reporting burden. However, we believe that our estimates 
are appropriate because there would be a limited number of MVPs 
available for all clinicians during the CY 2023 performance period/2025 
MIPS payment year. We expect that there would be increased 
participation in MVP reporting as more MVPs become available for 
clinicians in future years. We plan to revise our estimates for future 
years as more data becomes available.
    After consideration of public comments, we are finalizing our 
proposed estimate for the number of MIPS eligible clinicians that would 
participate in MVP reporting during the CY 2023 performance period/2025 
MIPS payment year.
(i) Burden for MVP Registration: Individuals, Groups and APM Entities
    Beginning with the CY 2023 performance period/2025 MIPS payment 
year, we are finalizing that clinicians interested in participating in 
MIPS through MVP reporting would be required to complete an annual 
registration process described in section IV.A.3.b.(4)(f) of this rule. 
At the time of registration, MVP participants would need to select a 
specific MVP, a population health measure and if administrative claims 
measures are included in the selected MVP, the MVP participants would 
also need to choose an applicable administrative claims measure in the 
MVP. We refer readers to section IV.A.3.b.(4)(f) of this rule for 
additional details on MVP registration requirements.
    Due to the delay in implementation of MVPs to the CY 2023 
performance period/2025 MIPS payment year, we anticipate that there is 
an adequate amount of time for clinicians that historically participate 
in MIPS to determine if the measures and activities in an MVP are 
applicable to the scope of care provided. In Table 97, we estimate that 
the registration process for clinicians choosing to submit MIPS data 
for the measures and the activities in an MVP would require 0.25 hours 
of a computer systems analyst's time, similar to the currently approved 
burden of group registration process for CMS Web Interface finalized in 
the CY 2021 PFS final rule (85 FR 84983) for the CY 2023 performance 
period/2025 MIPS payment year. We assume that the staff involved in the 
MVP registration process will mainly be computer systems analysts or 
their equivalent, who have an average labor cost of $95.22/hour.
    As discussed above, based on data from the CY 2019 performance 
period/2021 MIPS payment year, we assume that approximately 10 percent 
of the clinicians that currently participate in MIPS would submit data 
for the measures and activities in an MVP. Note that we apply this 10 
percent calculation after adding the clinicians who begin submitting 
though the CQM and eCQM collection types due to the sunset of Web 
Interface in the CY 2023 performance period/2025 MIPS payment year. For 
the CY 2023 performance period/2025 MIPS payment year, we assume that a 
total of 25,798 submissions will be received for the measures and 
activities included in MVPs. This total includes our estimate of 20 
subgroup reporters that would also be reporting MVPs in addition to MVP 
reporters who currently participate in MIPS. Therefore, we assume that 
the total number of individual clinicians, groups, subgroups and APM 
Entities to complete the MVP registration process is 12,917. We 
estimate that the total cost to clinicians participating as individuals 
and groups associated with the MVP registration process would be 
approximately $307,465. Table 97 includes our burden assumptions 
related to the MVP registration process for clinicians participating in 
MIPS for

[[Page 65590]]

reporting MVPs as individuals, groups, subgroups, and APM Entities.
[GRAPHIC] [TIFF OMITTED] TR19NO21.125

(ii) Burden for Subgroup Registration
    We are finalizing the proposal to add a separate ICR to estimate 
the burden associated with subgroup registration to capture the 
subgroup registration requirements in section IV.A.3.b.(4)(f)(ii)(D) of 
this rule. In section IV.A.3.b.(3)(b)(ii) of this rule, we finalized 
the definition of a subgroup at Sec.  414.1305 as a subset of a group, 
as identified by a combination of the group TIN, the subgroup 
identifier, and each eligible clinician's NPI. In addition to the 
burden for MVP registration process described above, clinicians who 
choose to form subgroups for reporting the MVPs or the APP will need to 
submit a list of each TIN/NPI associated with the subgroup and a plain 
language name for the subgroup in a manner specified by CMS, described 
in section IV.A.3.b.(4)(f)(ii)(D) of this rule.
    As discussed above, we estimate that clinicians will choose to form 
20 subgroups for reporting the measures and activities in MVPs. 
Additionally, we estimate that clinicians who choose to participate as 
subgroups for reporting MVPs will require a minimum of 0.5 hours per 
subgroup respondent to submit the finalized requirements for subgroup 
registration. We assume that the staff involved in the subgroup 
registration process will mainly be computer systems analysts or their 
equivalent, who have an average labor cost of $95.22/hr.
    We assume that all subgroups would report MVPs, the burden 
associated with subgroup quality reporting will be included with the 
MVP quality reporting ICR. The burden associated with subgroup 
submissions for Promoting Interoperability and improvement activities 
will be included with those ICRs.
[GRAPHIC] [TIFF OMITTED] TR19NO21.126

(iii) Burden for MVP Quality Performance Category Submission
    In the CY 2017 PFS final rule (81 FR 77100 through 77114), we 
established the submission criteria for quality measures (excluding the 
CMS Web Interface measures and the CAHPS for MIPS survey measure) at 
Sec.  414.1335, which requires a MIPS eligible clinician, group, or 
virtual group that is reporting on Qualified Clinical Data Registry 
(QCDR) measures, MIPS clinical quality measures (MIPS CQMs), electronic 
CQMs (eCQMs), or Medicare Part B claims measures to submit data on at 
least six measures, including at least one outcome measure. As 
discussed in section IV.A.3.b.(4)(d)(ii) of this final rule, we 
finalized the proposal that except as provided in paragraph

[[Page 65591]]

Sec.  414.1365(c)(1)(i), an MVP Participant must select and report 4 
quality measures, including 1 outcome measure (or, if an outcome 
measure is not available, 1 high priority measure, included in the MVP. 
The decrease in the number of required measures in the quality 
performance category from 6 to 4 is a two-thirds reduction in the 
number of measures needed for eligible clinicians to submit data for 
the quality performance category in MVPs described in Appendix 3: MVP 
Inventory of this final rule. Therefore, we estimate that the time for 
submitting the measures in the MVP quality performance category would, 
on average, take two-thirds of the currently approved burden per 
respondent for the quality performance category as it does to complete 
a MIPS quality submission through the CQM, eCQM, and Claims submission 
types.
    As described above in this section of the final rule, we estimate 
that 10 percent of the clinicians who participated in MIPS for the CY 
2019 performance period/2021 MIPS payment year would submit data for 
the quality performance category of MVPs beginning with the CY 2023 
performance period/2025 MIPS payment year. We anticipate that there 
would be 20 subgroups reporters in the CY 2023 performance period/2025 
MIPS payment year. As shown in Table 99, we estimate that approximately 
2,825 clinicians would submit data for the MVP quality performance 
category using the Medicare Part B claims collection type; 
approximately 5,210 clinicians and 10 subgroups would submit data using 
MIPS CQM and QCDR collection type; and approximately 4,862 clinicians 
and 10 subgroups would submit data using eCQMs collection type. We want 
to note that we used the same methodologies used in sections 
V.B.8.e.(4), V.B.8.e.(5) and V.B.8.e.(6) to estimate the quality 
submission burden for each collection type. As shown in Table 99, for 
the clinicians and subgroups submitting data for the MVP quality 
performance category, we estimate a burden of 26,670 hours (9.44 hr x 
2,825 clinicians) at a cost of $2,691,329 (2,825 respondents x 952.68/
respondent) for the Medicare Part B claims collection type, 31,163 
hours [5.97 hr x 5,220 (5,210 + 10)] at a cost of $3,211,216 (5,220 x 
615.18/respondent) for the MIPS CQM and QCDR collection type, and 
25,822 hours [5.3 hr x 4,872 (4,862 + 10) respondents] at a cost of 
$2,662,191 (4,872 x 546.43/respondent) for the eCQM collection types.
BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C
(8) Quality Data Submission via CMS Web Interface
    The finalized requirements and burden will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621).
Background
    In the CY 2021 PFS final rule, we finalized our policy to sunset 
the CMS Web Interface measures as a collection type/submission type 
starting with the CY 2022 performance period/2024 MIPS payment year. As 
a result of this provision, for the CY 2022 performance period/2024 
MIPS payment year, we estimated a burden of zero due to our assumption 
that all Web Interface respondents will alternately utilize either the 
MIPS CQM and QCDR or eCQM collection types (85 FR 84981).
    In section IV.A.3.d.(1)(d) of this rule, we are finalizing to 
continue the CMS Web Interface measures as a collection type for the CY 
2022 performance period/2024 MIPS payment year. Additionally, we are 
finalizing to sunset the CMS Web Interface measures as a collection 
type for the CY 2023 performance period/2025 MIPS payment year. For 
this final rule, we estimate burden for the CY 2022 and CY 2023 
performance periods/2024 and 2025 MIPS payment years.
    For the CY 2022 performance period/2024 MIPS payment year, we 
assume that 114 groups will submit quality data via the CMS Web 
Interface based on the number of groups who completed 100 percent of 
reporting quality data via the Web Interface in the CY 2019 performance 
period/2021 MIPS payment year. This is an increase of 114 groups from 
the currently approved number of 0 groups provided in the CY 2021 PFS 
final rule (85 FR 84981 due to the provision to continue with the CMS 
Web Interface as a collection type for the CY 2022 performance period/
2024 MIPS payment year. We estimate that 44,385 clinicians will submit 
as part of groups via this method, an increase of 44,385 from our 
currently approved estimate of 0 clinicians.
    The estimated burden associated with the group submission 
requirements is the time and effort associated with submitting data on 
a sample of the organization's beneficiaries that is

[[Page 65593]]

prepopulated in the CMS Web Interface. Our burden estimate for 
submission includes the time (61 hours and 40 minutes or 61.67 hours) 
needed for each group to populate data fields in the web interface with 
information on approximately 248 eligible assigned Medicare 
beneficiaries and submit the data (we will partially pre-populate the 
CMS Web Interface with claims data from their Medicare Part A and B 
beneficiaries). The patient data either can be manually entered, 
uploaded into the CMS Web Interface via a standard file format, which 
can be populated by CEHRT, or submitted directly. Each group must 
provide data on 248 eligible assigned Medicare beneficiaries (or all 
eligible assigned Medicare beneficiaries if the pool of eligible 
assigned beneficiaries is less than 248) for each measure. In 
aggregate, we estimate a burden for the CY 2022 performance period/2024 
MIPS payment year of 7,030 hours (114 groups x 61.67 hr) at a cost of 
$669,433 (114 groups x $5,872.21/group). For the CY 2023 performance 
period/2025 MIPS payment year, we are finalizing to revise our 
estimated burden to zero due to our assumption that with the finalized 
policy to sunset the CMS Web Interface as a collection type, all Web 
Interface respondents will alternately utilize either the MIPS CQM and 
QCDR or eCQM collection types. Based on the assumptions discussed in 
this section, Table 100 summarizes the finalized estimated burden for 
groups submitting to MIPS via the CMS Web Interface.
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[GRAPHIC] [TIFF OMITTED] TR19NO21.129

(9) Beneficiary Responses to CAHPS for MIPS Survey
    This rule is not implementing any new or revised collection of 
information requirements or burden related to the CAHPS for MIPS 
survey. The CAHPS for MIPS survey requirements and burden are currently 
approved by OMB under control number 0938-1222 (CMS-10450). 
Consequently, we are not making any changes to the CAHPS for MIPS 
Survey process under that control number.
(10) Group Registration for CMS Web Interface
    The finalized requirements and burden will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621).
    In the CY 2021 PFS final rule, we finalized to sunset the CMS Web 
Interface measures as a collection type/submission type starting with 
the CY 2022 performance period/2024 MIPS payment year. As a result, we 
estimated that there will be zero hours and $0 burden for group 
registration for the CMS Web Interface for the CY 2022 performance 
period/2024 MIPS payment year (85 FR 84984). As discussed in section 
IV.A.3.d.(1)(d) of this final rule, we are finalizing to continue the 
CMS Web Interface measures as a collection type for the CY 2022 
performance period/2024 MIPS payment year. We are also finalizing to 
sunset the CMS Web Interface as a collection type starting with the CY 
2023 performance period/2025 MIPS payment year.

[[Page 65594]]

    Groups interested in participating in MIPS using the CMS Web 
Interface for the first time must complete an online registration 
process. After first time registration, groups will only need to opt 
out if they are not going to continue to submit via the CMS Web 
Interface. In Table 102, we estimate that the registration process for 
groups under MIPS involves approximately 0.25 hours at $95.22/hr for a 
computer systems analyst (or their equivalent) to register the group.
    Because we are finalizing to sunset the CMS Web Interface beginning 
with the CY 2023 performance period/2025 MIPS payment year, it is 
possible that fewer groups will elect to register to submit quality 
data for the first time in the performance year prior to the collection 
type/submission type no longer being available; however, we currently 
have no data with which to estimate what the associated reduction may 
be. Consistent with our assumptions in the CY 2021 PFS final rule (85 
FR 84983), we continue to assume that approximately 90 groups will 
elect to use the CMS Web Interface for the first time during the CY 
2022 performance period/2025 MIPS payment year based on the estimated 
number of new registrations during the CY 2021 performance period/2023 
MIPS payment year. As shown in Table 102, we estimate a burden of 23 
hours (90 new registrations x 0.25 hr/registration) at a cost of $2,190 
(22.5 hr x $95.22/hr).
[GRAPHIC] [TIFF OMITTED] TR19NO21.130

    As shown in Table 103, the estimated increase in the number of 
groups registering for the CMS Web Interface collection type to submit 
the MIPS data and the estimated increase in burden per respondent 
results in adjustment to the total time burden of +23 hours (+90 
respondents x 0.25 hr/respondent) at a cost of $2,190 for the CY 2022 
performance period/2024 MIPS payment year. For the CY 2023 performance 
period/2025 MIPS payment year, our finalized burden estimate is zero 
hours and $0.
[GRAPHIC] [TIFF OMITTED] TR19NO21.131

(11) Group Registration for CAHPS for MIPS Survey
    This rule is not implementing any new or revised collection of 
information requirements or burden related to the group registration 
for the CAHPS for MIPS Survey. The CAHPS for MIPS survey requirements 
and burden are currently approved by OMB under control number 0938-1222 
(CMS-10450). Consequently, we are not making any changes to the CAHPS 
for MIPS Survey registration process under that control number.
f. ICRs Regarding the Call for MIPS Quality Measures
    This rule is not implementing any new or revised collection of 
information requirements or burden related to the call for MIPS quality 
measures. However, outside of the rulemaking process we replaced the 
existing tool for stakeholders beginning with the 2021 Annual Call for 
Measures. As described below, to account for the updated tool (MERIT), 
we are finalizing to revise our currently approved burden estimates. 
The updated tool and revised burden will be submitted to OMB under 
control number 0938-1314 (CMS-10621).
    Beginning with the 2021 Annual Call for Measures, we replaced the 
customary Office of the National Coordinator (ONC) Issue Tracking 
System Jira platform that stakeholders

[[Page 65595]]

used to submit candidate quality measure specifications and all 
supporting data files for CMS review with the MUC Entry/Review 
Information Tool (MERIT). For the ONC Issue Tracking System Jira 
platform used by stakeholders, the approved estimated time for a 
practice administrator to identify, propose, and link to a quality 
measure is 0.9 hours and for a clinician to identify, propose, link to 
quality measure, and complete the Peer Review Journal Article form is 
4.6 hours (0.6 hours to identify, propose, and link to quality measure 
(84 FR 63132) and 4 hours to complete the Peer Review Journal Article 
Form (84 FR 63133), with a total estimated time of 5.5 hours per 
quality measure submission. Based on the stakeholder experience with 
the updated tool and additional information collected at the time of 
submission, we estimate that it will add approximately 1.5 hours for 
the practice administrator at $114.24/hr and 0.5 hours at $217.32/hr 
for a clinician to identify, propose, and link the quality measure, and 
reduce approximately 2 hours at $217.32/hr for a clinician to complete 
the Peer Review Journal Article Form, resulting in a new estimated time 
of 2.4 hours for a practice administrator and 3.1 hours for a 
clinician, and an unchanged total estimated time of 5.5 hours per 
quality measure submission. In order to account for the implementation 
of the MERIT tool starting with the 2021 Annual Call for Measures, we 
are revising the estimated time required for a practice administrator 
to identify, propose, and link to a quality measure to 2.4 hours (from 
0.9 hr) and a clinician to identify, propose, link to quality measure, 
and complete the Peer Review Journal Article Form to 3.1 hours (from 
4.6 hr), resulting in a total estimated time of 5.5 hours per quality 
measure submission. Based on the number of submissions received during 
the CY 2020 Call for Quality Measures process, we anticipate receiving 
the same number of 28 submissions during the CY 2021 Call for Quality 
Measures process (84 FR 63132).
    Although the total estimated time of 5.5 hours for completing a 
quality measure submission using the MERIT tool (see Table 104) is the 
same estimated time as the ONC Issue Tracking System Jira platform, we 
need to account for the changes to the individual components of the 
estimated time required by a practice administrator and clinician using 
the MERIT tool. Consistent with our assumptions in the CY 2021 PFS 
final rule (85 FR 84984), we estimate an annual burden of 154 hours (28 
submissions x 5.5 hr/measure). Thus, we are finalizing to adjust our 
estimated annual burden from $30,197 (28 submissions x [(0.9 hr x 
$110.74/hr) + (4.6 hr x $212.78/hr)) to $26,541 (28 measures x [(2.4 hr 
x $114.24/hr) + (3.1 hr x $217.32/hr)]) a difference of -$4,329 for the 
CY 2022 performance period/2024 MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TR19NO21.132

    As shown in Table 105, using our currently approved burden 
estimates, the redistribution of the estimated time needed for the 
clinician and practice administrator as discussed above, we are 
estimating an adjustment of 0 hours at a cost of -$4,329 for the CY 
2022 performance period/2024 MIPS payment year. We are setting forth 
new burden estimates for the CY 2023 performance period/2025 MIPS 
payment year, which results in an increase of $26,541 (28 measures x 
$947.89/respondent).

[[Page 65596]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.133

g. ICRs Regarding Promoting Interoperability Data (Sec. Sec.  414.1375 
and 414.1380)
(1) Background
    For the CY 2022 performance period/2024 MIPS payment year, 
clinicians and groups can submit Promoting Interoperability data 
through direct, log in and upload, or log in and attest submission 
types. With the exception of submitters who elect to use the log in and 
attest submission type for the Promoting Interoperability performance 
category, which is not available for the quality performance category, 
we anticipate that individuals and groups will use the same data 
submission type for both of these 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. 
Although this analysis assesses burden by performance category and 
submission type, we emphasize that MIPS is a consolidated program and 
submission analysis, and decisions are expected to be made for the 
program as a whole.
(2) Reweighting Applications for Promoting Interoperability and Other 
Performance Categories
    The finalized requirements and burden associated with this rule's 
data submission will be submitted to OMB for approval under control 
number 0938-1314 (CMS-10621).
    We refer readers to the CY 2018 Quality Payment Program final rule 
(82 FR 53918 through 53919), CY 2019 PFS final rule (83 FR 60011 
through 60012), CY 2020 PFS final rule (84 FR 63134 through 63135), and 
the CY 2021 PFS final rule (85 FR 84984 through 84985) for our 
previously finalized requirements and burden for 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 who meet the criteria for a 
significant hardship or other type of exception may submit an 
application requesting a zero percent weighting for the Promoting 
Interoperability, quality, cost, and/or improvement activities 
performance categories under specific circumstances (81 FR 77240 
through 77243, 82 FR 53680 through 53686, and 82 FR 53783 through 
53785). Respondents 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 that respondents applying 
for a reweighting of the Promoting Interoperability performance 
category due to extreme and uncontrollable circumstances will also 
request a reweighting of at least one of the other performance 
categories simultaneously and not submit multiple reweighting 
applications.
    Table 106 summarizes the burden for clinicians to apply for 
reweighting of the Promoting Interoperability performance category to 
zero percent due to a significant hardship exception or as a result of 
a decertification of an EHR. Based on the number of reweighting 
applications received by March, 2021 for the CY 2020 performance 
period/2022 MIPS payment year, we assume 20,192 respondents (eligible 
clinicians or groups) will submit a request to reweight the Promoting 
Interoperability performance category to zero percent due to a 
significant hardship or EHR decertification and an additional 22,635 
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. For the CY 2022 performance period/2024 MIPS payment 
year, we estimate that a total of 42,797 reweighting applications will 
be submitted. This is a decrease of 9,302 respondents compared to our 
currently approved estimate of 52,099 respondents (85 FR 84984). This 
decrease is likely due to the provision in section 
IV.A.3.e.(2)(b)(iv)(A) of this rule to automatically reweight the 
Promoting Interoperability performance category for small practices who 
previously had to apply for reweighting. For the CY 2020 performance 
period/2024 MIPS payment year, 13,894 respondents requested reweighting 
due to significant hardship for small practices. Similar to the data 
used to estimate the number of respondents in the CY 2021 PFS final 
rule, our respondent estimate includes a significant number of 
applications submitted as a result of a data issue CMS was made aware 
of and is specific to a single third-party intermediary. While we do 
not anticipate similar data issues to occur in each performance period, 
we do believe future similar incidents may occur and are electing to 
use this data without adjustment to reflect this belief. Similar to our 
assumptions in the CY 2021 PFS final rule (85 FR 84984), our respondent 
estimate does not include reweighting

[[Page 65597]]

applications submitted during the extended period ending November 29, 
2021 due to the PHE for COVID-19, as we do not believe it would be an 
accurate basis of future estimates for reweighting application 
submissions. We assume that, out of our total respondent count of 
42,797 above, we estimate that 22,605 respondents (eligible clinicians 
or groups) will submit a request for reweighting the Promoting 
Interoperability performance category to zero percent due to extreme 
and uncontrollable circumstances, insufficient internet connectivity, 
lack of control over the availability of CEHRT, or as a result of a 
decertification of an EHR.
    In the CY 2021 PFS final rule (85 FR 84984) we discussed that, 
beginning with the CY 2019 performance period/2021 MIPS payment year, 
APM Entities may submit an extreme and uncontrollable circumstances 
exception application for all four performance categories and 
applicable to all MIPS eligible clinicians in the APM Entity group. As 
discussed in this section of this final rule, due to data limitations 
and our inability to determine who will use the APP versus the 
traditional MIPS submission mechanism for the CY 2022 performance 
period/2024 MIPS payment year, we assume ACO APM Entities will submit 
data through the APP and non-ACO APM Entities will participate through 
traditional MIPS, thereby submitting as an individual or group rather 
than as an entity. Therefore, we limited our analysis to ACOs that were 
eligible for an exception due to extreme and uncontrollable 
circumstances during the CY 2020 performance period/2022 MIPS payment 
year and elected not to report quality data. Based on this data, we 
estimate that 30 APM Entities will submit an extreme and uncontrollable 
circumstances exception application for the CY 2022 performance period/
2024 MIPS payment year. Combined with our aforementioned estimate of 
42,797 eligible clinicians and groups, the total estimated number of 
respondents for the CY 2022 performance period/2024 MIPS payment year 
is 42,827.
    Consistent with our assumptions in the CY 2021 PFS final rule (85 
FR 84984-84985), we continue to estimate it will take 0.25 hours for a 
computer system analyst to complete and submit the application. As 
shown in Table 106, we estimate an annual burden of 10,707 hours 
(42,827 applications x 0.25 hr/application) and $1,019,521 (10,707 hr x 
$95.22/hr).
[GRAPHIC] [TIFF OMITTED] TR19NO21.134

    As shown in Table 107, using our currently approved burden 
estimates, the decrease in the estimated number of respondents (from 
52,099 to 42,827 respondents) results in an adjustment of minus 2,318 
hours (9,272 respondents x 0.25 hr/respondent) and minus $220,720 for 
the CY 2022 performance period/2024 MIPS payment year. We are setting 
forth new burden estimates for the CY 2023 performance period/2025 MIPS 
payment year, which results in an increase of 10,707 hours (42,827 
respondents x 0.25 hr/respondent) and $1,019,521 (10,707 hours x 
$95.22/respondents).

[[Page 65598]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.135

(3) Submitting Promoting Interoperability Data
    The requirements and burden associated with this rule's data 
submission will be submitted to OMB for approval under control number 
0938-1314 (CMS-10621).
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77509 through 77511), CY 2018 Quality Payment Program final rule 
(82 FR 53919 through 53920), CY 2019 PFS final rule (83 FR 60013 
through 60014), CY 2020 PFS final rule (84 FR 63135 through 63137), and 
the CY 2021 PFS final rule (85 FR 84985 through 84987) for our 
previously finalized requirements and burden for submission of data for 
the Promoting Interoperability performance category.
    In section IV.A.3.d.(4)(d)(ii) of this final rule, we are 
finalizing the additional requirement that MIPS eligible clinicians 
must attest to conducting an annual assessment of the High Priority 
Guides of the SAFER Guides beginning with the CY 2022 performance 
period/2024 MIPS payment year. Clinicians will complete this 
attestation by checking a box when they submit their Promoting 
Interoperability performance category data. We estimate that this 
requirement will add an additional minute to the current estimated time 
it takes to complete the submission of Promoting Interoperability data. 
In the CY 2022 PFS proposed rule, we assumed no change in estimates as 
result of the proposal to modify the Provide Patients Electronic Access 
to Their Health Information measure to require MIPS eligible clinicians 
to ensure that patient health information remains available to the 
patient (or patient-authorized representative) to access indefinitely 
(86 FR 39509). As discussed in section IV. of this final rule, this 
policy is not being finalized as proposed at this time.
    As shown in Table 108, based on data from the CY 2019 performance 
period/2021 MIPS payment year, we estimate that a total of 51,647 
respondents consisting of 40,172 individual MIPS eligible clinicians 
and 11,475 groups and virtual groups will submit Promoting 
Interoperability data. Since our CY 2021 PFS final rule estimated 
53,636 respondents, this represents a decrease of 1,989 respondents 
(51,647 respondents -53,636 active respondents).
    We assume that MIPS eligible clinicians previously scored under the 
APM scoring standard, as described in the CY 2020 PFS final rule, will 
continue to submit Promoting Interoperability data (84 FR 63006) in a 
similar way through the APP. As a result, we do not anticipate any 
change in burden. Each MIPS eligible clinician in an APM Entity reports 
data for the Promoting Interoperability performance category through 
either their group TIN or individual reporting. Sections 1899 and 1115A 
of the Act (42 U.S.C. 1395jjj and 42 U.S.C. 1315a, respectively) state 
that the Shared Savings Program and the testing, evaluation, and 
expansion of Innovation Center models are not subject to the PRA. 
However, in the CY 2019 PFS final rule, we established that MIPS 
eligible clinicians who participate in the Shared Savings Program are 
no longer limited to reporting for the Promoting Interoperability 
performance category through their ACO participant TIN (83 FR 59822 
through 59823). Burden estimates for this final rule assume group TIN-
level reporting as we believe this is the most reasonable assumption 
for the Shared Savings Program, which requires that ACOs include full 
TINs as ACO participants.
[GRAPHIC] [TIFF OMITTED] TR19NO21.136


[[Page 65599]]


    As discussed in section IV.A.3.b.(2)(c)(ii) of this final rule, we 
will be introducing subgroup reporting in CY 2023 performance period/
2025 MIPS payment year. As we discussed above in this section of the 
final rule, we estimate that there will be 20 subgroup submissions in 
CY 2023 performance period/2025 MIPS payment year, each of which will 
have burden related to the submission of Promoting Interoperability 
data. We have included this burden in Table 109.
[GRAPHIC] [TIFF OMITTED] TR19NO21.137

    With the inclusion of the additional minute (0.02 hr) to attest to 
conducting an annual assessment of the High Priority Guides of the 
SAFER Guides, we are adjusting our estimate of the time required for an 
individual or group to submit Promoting Interoperability data from 2.67 
hours to 2.69 hours (2.67 hr + 0.02 hr). As shown in Table 110, the 
total burden estimate for submitting data on the specified Promoting 
Interoperability objectives and measures is estimated to be 138,930 
hours (51,647 respondents x 2.69 incremental hours for a computer 
analyst's time above and beyond the physician, medical and health 
services manager, and computer system's analyst time required to submit 
quality data) and $13,228,915 (138,930 hr x $95.22/hr)).
[GRAPHIC] [TIFF OMITTED] TR19NO21.138

    As shown in Table 111, with the introduction of subgroup reporting 
in CY 2023 performance period/2025 MIPS payment year, the total burden 
for submitting data on the specified Promoting Interoperability 
objectives and measures is estimated to be 138,984 hours (51,667 
respondents x 2.69 incremental hours for a computer analyst's time 
above and beyond the physician, medical and health services manager, 
and computer system's analyst time required to submit quality data) and 
$13,234,078 (138,984 hr x $95.22/hr)).

[[Page 65600]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.139

    Table 112, using our updated per respondent burden estimate (+0.02 
hr/response), the decrease in number of respondents and SAFER guide 
attestation requirement results in a total adjustment of -4,278 hours 
at a cost of -$407,351 for the CY 2022 performance period/2024 MIPS 
payment year. We are setting forth new burden estimates for the CY 2023 
performance period/2025 MIPS payment year, which results in an increase 
of 138,984 hours (51,667 respondents x 2.69 incremental hours for a 
computer analyst's time above and beyond the physician, medical and 
health services manager, and computer system's analyst time required to 
submit quality data) and $13,234,078 (138,984 hours x $95.22/hour).
[GRAPHIC] [TIFF OMITTED] TR19NO21.140

h. ICRs Regarding the Nomination of Promoting Interoperability (PI) 
Measures
    This rule is not implementing any new or revised collection of 
information requirements or burden related to the nomination of 
Promoting Interoperability measures. The requirements and burden are 
currently approved by OMB under control number 0938-1314 (CMS-10621). 
Consequently, we are not making any changes to the process for 
nomination of Promoting Interoperability measures under that control 
number.
i. ICR Regarding Improvement Activities Submission (Sec. Sec.  
414.1305, 414.1355, 414.1360, and 414.1365)
    The finalized requirements and burden will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621). We refer readers 
to the CY 2017 Quality Payment Program final rule (81 FR 77511 through 
77512), CY 2018 Quality Payment Program final rule (82 FR 53920 through 
53922), CY 2019 PFS final rule (83 FR 60015 through 60017), CY 2020 PFS 
final rule (84 FR 63138 through 63140) and the CY 2021 PFS final rule 
(85 FR 84987 through 84989) for our previously finalized requirements 
and burden for submission of data for the improvement activities 
performance category.
    In section IV.A.3.d.(3) of this rule, we are finalizing to: (1) 
Revise group reporting requirements for the 50 percent threshold to 
address subgroups; (2) add 7 new improvement activities, modify 15 
existing improvement activities, and remove 6 previously adopted 
improvement activities for the CY 2022 performance period/2024 MIPS 
payment year and future years; (3) revise the ``Drug Cost Transparency 
to include requirements for use of real-time benefit tools'' 
improvement activity; and (4) add the COVID-19 ``Clinical Data 
Reporting with or without Clinical Trial'' improvement activity for CY 
2022 performance period/2024 MIPS payment year and future years. 
Additionally, we are finalizing to adjust our currently approved burden 
estimates based on more recent data.
    Specifically, we are finalizing to revise Sec.  414.1360(a)(2) to 
state that, beginning with the CY 2023 performance period/2025 MIPS 
payment year, each improvement activity for which groups and virtual

[[Page 65601]]

groups submit a yes response in accordance with paragraph (a)(1) of 
this section must be performed by at least 50 percent of the NPIs that 
are billing under the group's TIN or virtual group's TINs or that are 
part of the subgroup, as applicable; and the NPIs must perform the same 
activity during any continuous 90-day period within the same 
performance year. In section IV.A.3.d.(3)(b) of this rule, we discussed 
stakeholder requests through the Quality Payment Program help desk to 
apply the 50 percent threshold to a portion of clinicians in a group. 
We anticipate that clinicians will find applicable and meaningful 
activities specific to practice size, specialty, or practice setting. 
Therefore, we assume that the provision to apply the 50 percent minimum 
threshold to clinicians who submit for the improvement activity 
performance category as part of groups, virtual groups, or choose to 
participate as subgroups beginning with the CY 2023 performance period/
2025 MIPS payment year will not present additional complexity or 
burden.
    We do not believe the changes to the improvement activities 
inventory will impact time or financial burden on stakeholders because 
MIPS eligible clinicians are still required to submit the same number 
of activities and the per response time for each activity is uniform. 
Therefore, we are not adjusting the estimated time of 5 minutes (per 
response) currently approved for improvement activities submission.
    As represented in Table 113, based on data from the CY 2019 
performance period/2021 MIPS payment year, we estimate that a total of 
81,562 respondents consisting of 63,845 individual clinicians and 
17,717 groups will submit improvement activities during the CY 2022 
performance period/2024 MIPS payment year. Since our currently approved 
burden sets out 79,927 respondents, this represents an increase of 
1,635 respondents (81,562 respondents-79,927 active respondents). This 
is an increase of 1,242 individuals and 393 groups from the estimates 
of 62,603 individuals and 17,324 groups provided in the CY 2021 PFS 
final rule (85 FR 50362).
    As discussed in sections V.B.8.e. and V.B.8.g.(3) of this final 
rule regarding our estimate of clinicians and groups submitting data 
for the quality and Promoting Interoperability performance categories, 
we are finalizing to update our estimates for the number of clinicians 
and groups that will submit improvement activities data based on 
projections of the number of eligible clinicians that were not QPs or 
participating in an ACO in the CY 2019 performance period/2021 MIPS 
payment year but will be QPs in the CY 2022 performance period/2024 
MIPS payment year, and will therefore not be required to submit 
improvement activities data.
[GRAPHIC] [TIFF OMITTED] TR19NO21.141

    As discussed in section IV.A.3.b.(2)(c)(ii) of this final rule, we 
are finalizing subgroup reporting in the CY 2023 performance period/
2025 MIPS payment year. As we discussed in section V.B.8.e.(7)(a) of 
this final rule, we estimate that there will be 20 subgroup reporters 
in the CY 2023 performance period/2025 MIPS payment year, each of which 
will have burden related to the submission of improvement activities. 
We have included this burden in Table 114.

[[Page 65602]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.142

    Consistent with the CY 2021 PFS final rule, we continue to estimate 
that the per response time required per individual or group is 5 
minutes for a computer system analyst to submit by logging in and 
manually attesting that certain activities were performed in the form 
and manner specified by CMS with a set of authenticated credentials (84 
FR 63140).
    As shown in Table 115, we estimate an annual burden of 6,770 hours 
(81,562 responses x 0.083 hr) at a cost of $644,639 (6,770 hr x $95.22/
hr)) for the CY 2022 performance period/2024 MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TR19NO21.143

    As shown in Table 116, with the introduction of subgroup reporting 
in the CY 2023 performance period/2025 MIPS payment year, we estimate 
an annual burden of 6,771 hours (81,582 responses x 0.083 hr) and 
$644,735 (6,771 hr x $95.22/hr).

[[Page 65603]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.144

    As shown in Table 117, using our unchanged currently approved per 
respondent burden estimate, the increase in the number of respondents 
results in an adjustment of 109 hours at a cost of $10,379 (109 hr x 
$95.22/hr) for the CY 2022 performance period/2024 MIPS payment year. 
We are setting forth new burden estimates for the CY 2023 performance 
period/2025 MIPS payment year, which results in an increase of 6,771 
hours (81,582 responses x 0.083 hr) at a cost of $644,735 (6,771 hr x 
$95.22/hr).
[GRAPHIC] [TIFF OMITTED] TR19NO21.145

j. ICRs Regarding the Nomination of Improvement Activities (Sec.  
414.1360)
    The requirements and burden associated with this rule's data 
submission will be submitted to OMB for approval under control number 
0938-1314 (CMS-10621).
    We refer readers to the CY 2018 Quality Payment Program final rule 
(82 FR 53922), CY 2019 PFS final rule (83 FR 60017 through 60018), CY 
2020 PFS final rule (84 FR 63141) and the CY 2021 PFS final rule (85 FR 
84989 through 85 FR 84990) for our previously finalized requirements 
and information collection burden for the nomination of improvement 
activities.
    In section IV.A.3.d.(3)(c)(i)(B) of this rule, we are finalizing: 
(1) To revise the required criteria for improvement activity 
nominations received through the Annual Call for Activities; (2) 
changes to the timeline for improvement activities nomination during a 
PHE; and (3) to suspend activities that become obsolete or impacted by 
clinical practice guideline changes from the program when this 
occurrence happens outside of the rulemaking process.
    In section IV.A.3.d.(3)(c)(i)(B)(cc) of this rule, we are 
finalizing 2 new criteria that beginning with the CY 2022 Annual Call 
for Activities MIPS improvement activities: (1) Should not duplicate 
other improvement activities in the Inventory; and (2) should drive 
improvements that go beyond purely common clinical practices.
    Additionally, we are finalizing to increase the number of criteria 
stakeholders are required to meet when submitting an activity provision 
from a minimum of 1 to all 8 criteria, which includes the two new 
provision criteria. We believe that this provision will provide clearer 
guidance to stakeholders when submitting a nomination for an 
improvement activity. In the CY 2021 PFS final rule, we estimated that 
it would require 0.6 hours for a medical and health services manager or 
equivalent and 0.4 hours for a physician to link the nominated 
improvement activity to existing and related cost and quality measures 
(85 FR 84989). Given that our current approved estimated time per 
respondent to nominate an improvement activity is 3 hours (1.8 hours 
for a medical and health services manager or equivalent and 1.2 hours 
for a physician), we assume that the new requirement to meet all 8 
criteria will require approximately 1 hour at $114.24/hr for a medical 
and health services manager to identify and submit an activity and 0.4 
hours at a rate of $217.32/hr for a clinician to review each activity. 
Combined with our currently approved burden estimate, we are finalizing 
to revise our estimate to 2.8 hours at $114.24/hr for a medical and 
health services manager or equivalent and 1.6 hours at $217.32/hr for a 
physician to nominate an improvement activity. This represents a change 
of +1

[[Page 65604]]

hours (2.8 hr - 1.8 hr) for a medical and health services manager or 
equivalent and +0.4 hours (2 hr - 1.6 hr) for a physician and an 
overall increase of 1.4 hours. We considered whether we should double 
our estimates for nomination of an improvement activity to 6 hours. 
Since only 2 of the required 8 criteria are new, we assume that 
stakeholders are familiar with the existing criteria and will not need 
additional time to review but will need the additional time to verify 
and confirm if the considered activity meets all the 8 criteria. We 
solicited comment on our estimate to revise the time for nomination of 
an improvement activity to 4.4 hours and if there are additional burden 
implications that we should consider for above provisions to revise the 
criteria.
    We did not receive public comments on the proposed burden estimates 
for this information collection. We are finalizing as proposed. The 
burden estimates have not been updated from the CY 2021 PFS proposed 
rule (86 FR 39514 through 39516).
    In the CY 2021 PFS final rule, we finalized an exception stating 
that during the PHE, stakeholders can nominate improvement activities 
outside of the established Annual Call for Activities timeframe (85 FR 
84989). Instead of only accepting nominations and modifications 
submitted February 1st through July 1 each year, we would accept 
nominations for the duration of the PHE as long as the improvement 
activity is still relevant. No other aspects of the Annual Call for 
Activities process would be affected (for example, criteria for 
nominating improvement activities, considerations for selection of 
improvement activities, or weighting policies would all still apply). 
In section IV.A.3.d.(3)(c)(i)(B)(aa) of this rule, we are finalizing to 
clarify that in order to implement a new improvement activity for a PHE 
during the same year as the nomination, the nomination will need to be 
received no later than January 5th of the nomination year to be 
included in a rule for notice-and-comment rulemaking during that fiscal 
or calendar year, a necessary precursor to implementation if it were to 
be finalized, as described above.
    We believe this provision will not affect our currently approved 
burden estimates since we assume that the number of nominations will 
not change, but it will make an activity available for reporting to 
clinicians in the same performance year it was intended to be 
implemented. Similar to our assumptions in the CY 2021 PFS final rule 
(85 FR 84989), we expect additional nominations may be received as a 
result of this change. However, we do not have any data with which to 
estimate what the additional number may be. As a result, we are not 
making any changes our currently approved burden estimate.
    In section IV.A.3.d.(3)(c)(i)(C)(aa) of this rule, we are 
finalizing that beginning with the CY 2022 performance period/2024 MIPS 
payment year, for each improvement activity that is in the Inventory, 
if applicable, and impacted by significant changes or errors prior to 
the applicable data submission deadline, it will be removed from the 
program as soon as possible. In the CY 2020 PFS final rule (84 FR 62988 
through 62990), we finalized the factors for consideration in removing 
improvement activities. Following the publication of the CY 2021 PFS 
proposed rule, the improvement activities team became aware that 
clinicians could no longer complete the activity from April 1 through 
December 31, 2020, because one of the improvement activities in the 
Inventory had expired on March 31, 2020. We do not anticipate any 
burden for stakeholders because of the above provision as described, 
the policy does not change requirements for the nomination of 
improvement activities. This provision will help avoid stakeholder 
confusion and ensure the accuracy of the available activities in the 
Inventory. Therefore, we are not making any changes to our estimated 
burden due to the above policy.
    Additionally, consistent with our assumptions in the CY 2021 PFS 
final rule (85 FR 84990) we continue to use our currently approved 
assumption that we will receive 31 nominations of new or modified 
activities which will be evaluated for the Improvement Activities Under 
Consideration (IAUC) list for possible inclusion in the CY 2023 
Improvement Activities Inventory as we believe this estimate is more 
realistic than basing our estimate on the number of nominations 
received during the 2021 Annual Call for Activities.
    As shown in Table 118, accounting for the change in burden per 
respondent estimate due to the provision to require all the 8 criteria 
for nomination of an improvement activity as described above in this 
section, we are adjusting our estimated annual information collection 
burden to 136 hours (31 nominations x 4.4 hr/nomination) at a cost of 
$20,695 (31 x [(2.8 hr x $114.24/hr) + (1.6 hr x $217.32/hr)]).
[GRAPHIC] [TIFF OMITTED] TR19NO21.146


[[Page 65605]]


    As shown in Table 119, using our unchanged estimate of the number 
of activities nominated, the increase in the burden per nomination 
results in a change of 43 hours (31 nominations x 1.4 hr/nomination) at 
a cost of $6,492 (31 activities x [(1 hr x $114.24/hr) + (0.4 hr x 
$217.32/hr)]) for the CY 2022 performance period/2024 MIPS payment 
year. We are setting forth new burden estimates for the CY 2023 
performance period/2025 MIPS payment year, which results in an increase 
of 136 hours (31 nominations x 4.4 hr) at a cost of $20,695 (31 x [(2.8 
hr x $114.24/hr) + (1.6 hr x $217.32/hr)]).
[GRAPHIC] [TIFF OMITTED] TR19NO21.147

k. Nomination of MVPs
    This rule is not implementing any new or revised collection of 
information requirements or burden related to the nomination of MVPs 
for inclusion in the Quality Payment Program. The requirements and 
burden are currently approved by OMB under control number 0938-1314 
(CMS-10621). Consequently, we are not making any changes to the MVP 
nomination process 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 to this information collection under that control 
number.
m. ICRs Regarding Partial QP Elections (Sec. Sec.  414.1310(b) and 
414.1430)
    This rule is not implementing any new or revised collection of 
information requirements related to the Partial QP Elections to 
participate in MIPS as a MIPS eligible clinician. However, we are 
finalizing to adjust our currently approved burden estimates based on 
updated projections for the CY 2022 performance period/2024 MIPS 
payment year. The adjusted burden will be submitted to OMB for approval 
under control number 0938-1314 (CMS-10621).
    As shown in Table 120, based on our predictive QP analysis for the 
2022 QP performance period/2024 MIPS payment year, which accounts for 
historical response rates in the CY 2020 performance period/2022 MIPS 
payment year, we are revising our estimate that 150 APM Entities and 
100 eligible clinicians (representing approximately 9,000 Partial QPs) 
will make the election to participate as a Partial QP in MIPS, a total 
of 250 elections which is a decrease of 50 from the 300 elections that 
are currently approved by OMB under the aforementioned control number. 
We continue to estimate it will take the APM Entity representative or 
eligible clinician 15 minutes (0.25 hr) to make this election. In 
aggregate, we are revising our estimated annual burden to 63 hours (250 
respondents x 0.25 hr/election) and $5,999 (63 hr x $95.22/hr).
[GRAPHIC] [TIFF OMITTED] TR19NO21.148


[[Page 65606]]


    As shown in Table 121, using our unchanged currently approved per 
respondent burden estimate (85 FR 84991), the decrease in the number of 
Partial QP elections results in an adjustment of 12.5 hours (-50 
elections x 0.25 hr) at a cost of -$1,191 (-12.5 hr x $95.22/hr) for 
the CY 2022 performance period/2024 MIPS payment year. We are setting 
forth new burden estimates for the CY 2023 performance period/2025 MIPS 
payment year, which results in an increase of 63 hours (250 respondents 
x 0.25 hr/election) at a cost of $5,999 (63 hr x $95.22/hr).
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n. ICRs Regarding Other Payer Advanced APM Determinations: Payer-
Initiated Process (Sec.  414.1445) and Eligible Clinician Initiated 
Process (Sec.  414.1445)
    The following burden will be submitted to OMB for approval under 
control number 0938-1314 (CMS-10621).
(1) Payer Initiated Process (Sec.  414.1445)
    This rule is not implementing any new or revised collection of 
information requirements related to the Payer-Initiated Process. 
However, we are adjusting our currently approved burden estimates based 
on updated projections for the CY 2022 performance period/2024 MIPS 
payment year.
    As shown in Table 122, based on the actual number of requests 
received in the 2020 QP performance period, we are revising our 
estimate that for the 2023 QP performance period, 15 payer-initiated 
requests for Other Payer Advanced APM determinations will be submitted 
(6 Medicaid payers, 6 Medicare Advantage Organizations, and 3 remaining 
other payers), a decrease of 65 from the 80 total requests currently 
approved by OMB under the aforementioned control number. We continue to 
estimate it will take 10 hours for a computer system analyst per 
arrangement submission. We are revising our estimated annual burden to 
150 hours (15 submissions x 10 hr/submission) and $14,283 (150 hr x 
$95.22/hr).
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    As shown in Table 123, using our unchanged currently approved per 
respondent burden estimate (85 FR 84992), the decrease in the number of 
payer-initiated requests from 800 to 150 results in an adjustment of -
650 hours (-65 requests x 10 hr) at a cost of -$61,893 (-650 hr x 
$95.22/hr) for the CY 2022 performance period/2024 MIPS payment year. 
We are setting forth new burden estimates for the CY 2023 performance 
period/2025 MIPS payment year, which results in an increase of 150 
hours (15 requests x 10 hr) at a cost of $14,283 (150 hr x $95.22/hr).

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(2) Eligible Clinician Initiated Process (Sec.  414.1445)
    This rule is not implementing any new or revised collection of 
information requirements or burden related to the Eligible-Clinician 
Initiated Process. As described below, we are adjusting our currently 
approved burden estimates based on updated projections for the CY 2022 
performance period/2024 MIPS payment year. As mentioned above, the new 
and adjusted burden will be submitted to OMB for approval.
    As shown in Table 124, based on the actual number of requests 
received in the 2020 QP performance period, we estimate that in CY 2022 
for the 2023 QP performance period, 15 Eligible-Clinician Initiated 
request for Other Payer Advanced APM determinations will be submitted, 
a decrease of 135 from the 150 total requests currently approved by OMB 
under the aforementioned control number. We continue to estimate it 
will take 10 hours for a computer system analyst per arrangement 
submission. We are adjusting our estimated annual burden to 150 hours 
(15 submissions x 10 hr/submission) and $14,283 (150 hr x $95.22/hr).
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    As shown in Table 125, using our unchanged currently approved per 
respondent burden estimate (85 FR 84993), the decrease in the number of 
eligible clinician-initiated requests from 150 to 15 results in an 
adjustment of -1,350 hours (-135 requests x 10 hr) at a cost of -
$128,547 (-1,350 hr x $95.22/hr) for the CY 2022 performance period/
2024 MIPS payment year. We are setting forth new burden estimates for 
the CY 2023 performance period/2025 MIPS payment year, which results in 
an increase of 150 hours (15 submissions x 10 hr/submission) at a cost 
of $14,283 (150 hr x $95.22/hr).

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(3) Submission of Data for QP Determinations Under the All-Payer 
Combination Option (Sec.  414.1440)
    This rule is not implementing any new or revised collection of 
information requirements related to the Submission of Data for QP 
Determinations under the All-Payer Combination Option. The requirements 
and burden are currently approved by OMB under control number 0938-1314 
(CMS-10621). Consequently, we are not making any changes under that 
control number.
o. ICRs Regarding Voluntary Participants Election To Opt-Out of 
Performance Data Display on Physician Compare (Sec.  414.1395)
    This rule is not implementing any new or revised collection of 
information requirements related to the election by voluntary 
participants to opt-out of public reporting on Physician Compare. As 
described below, we are adjusting our currently approved burden 
estimates based on data from the CY 2019 performance period/2021 MIPS 
payment year. The adjusted burden will be submitted to OMB for approval 
under control number 0938-1314 (CMS-10621).
    We refer readers to the CY 2018 Quality Payment Program final rule 
(82 FR 53924 through 53925), CY 2019 PFS final rule (83 FR 60022), CY 
2020 PFS final rule (84 FR 63145 through 63146) and the CY 2021 PFS 
final rule (85 FR 84993) for our previously finalized requirements and 
burden for voluntary participants to opt-out of public reporting on 
Physician Compare.
    In the CY 2021 PFS final rule (85 FR 84993), we estimated that 10 
percent of the clinicians and groups who voluntarily participate in 
MIPS would opt out of public reporting. Based on the number of opt-out 
eligible clinicians that chose to opt-out of public reporting in the CY 
2019 performance period/2021 MIPS payment year, we are revising our 
estimates. We anticipate that 0.1 percent of the total clinicians and 
groups who will voluntarily participate in the CY 2022 performance 
period/2024 MIPS payment year will also elect not to participate in 
public reporting. This results in a total of 38 (0.001 x 37,934 
voluntary MIPS participants) clinicians and groups, a decrease of 3,448 
from the currently approved estimate of 3,486. Voluntary MIPS 
participants are clinicians that are not QPs and are expected to be 
excluded from MIPS after applying the eligibility requirements set out 
in the CY 2019 PFS final rule but have elected to submit data to MIPS. 
As discussed in the RIA section of the CY 2019 PFS final rule, we 
continue to estimate that 33 percent of clinicians that exceed one (1) 
of the low-volume criteria, but not all three (3), will elect to opt-in 
to MIPS, become MIPS eligible, and no longer be considered a voluntary 
reporter (83 FR 60050).
    Table 126 shows that for these voluntary participants, we continue 
to estimate it will take 0.25 hours for a computer system analyst to 
submit a request to opt-out. In aggregate, we estimate an annual burden 
of 10 hours (38 requests x 0.25 hr/request) and $952 (10 hr x $95.22/
hr).
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[[Page 65609]]


    As shown in Table 127, using our unchanged currently approved per 
respondent burden estimate, the decrease of 3,448 opt outs by voluntary 
participants results in an adjustment of -862 hours (-3,448 requests x 
0.25 hr) at a cost of $-82,079 (-862 hr x $95.22/hr) for the CY 2022 
performance period/2024 MIPS payment year. We are setting forth new 
burden estimates for the CY 2023 performance period/2025 MIPS payment 
year, which results in an increase of 10 hours (38 requests x 0.25 hr/
request) at a cost of $952 (10 hr x $95.22/hr).
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p. Summary of Annual Quality Payment Program Burden Estimates
    Table 128 summarizes this final rule's total burden estimates for 
the Quality Payment Program for the CY 2021, CY 2022 and CY 2023 
performance periods/2023, 2024, and 2025 MIPS payment years.
    As discussed earlier, for this final rule, we are subtracting the 
currently approved burden for the CY 2021 performance period/2023 MIPS 
payment year. As shown in table 128, this represents a decrease in 
burden of 1,479,672 hours and $144,576,960.
    In the CY 2021 PFS final rule, the total estimated burden for the 
CY 2022 MIPS performance period/2024 MIPS payment year was 1,473,741 
hours at a cost of $144,034,968 (85 FR 84994). Accounting for updated 
wage rates and the subset of all Quality Payment Program ICRs discussed 
in this rule compared to the CY 2021 PFS final rule, the total 
estimated annual burden of continuing policies and information set 
forth in the CY 2021 PFS final rule into the CY 2022 performance 
period/2024 MIPS payment year is 1,468,566 hours at a cost of 
$148,078,846. These represent a decrease of 5,175 hours and an increase 
of $4,043,878. 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 
2021 PFS final rule into the CY 2022 performance period/2024 MIPS 
payment year. This burden estimate of 1,424,586 hours at a cost of 
$143,651,994 reflects the availability of more accurate data to account 
for all potential respondents and submissions across all the 
performance categories and more accurately reflect the exclusion of QPs 
from all MIPS performance categories, a decrease of 43,980 hours and 
$4,426,813. This burden estimate is lower than the burden approved for 
information collection related to the CY 2021 PFS final rule due to 
updated data and assumptions. Our total burden estimate for the CY 2022 
performance period/2024 MIPS payment year is 1,428,391 hours and 
$144,014,757, which represents a decrease of 40,175 hours and 
$4,068,418 from the CY 2021 PFS final rule. The difference of +3,805 
hours (43,980 hours-40,175 hours) and +$358,395 ($4,426,813-$4,068,418) 
between this estimate and the total burden shown in Table 128 is the 
increase in burden associated with impacts of the policies for the CY 
2022 performance period/2024 MIPS payment year, which includes the re-
introduction of the CMS Web Interface measures as a collection type/
submission type.
    Table 128 also offers a comparison between the total currently 
approved estimated burden from the CY 2021 PFS final rule and our 
estimated burden for the CY 2023 performance period/2025 MIPS payment 
year. As discussed above, we are setting forth our estimates for the CY 
2023 performance period/2025 MIPS payment year as new burden with no 
currently approved estimate. Our total burden estimate for the CY 2023 
MIPS performance period/2025 MIPS payment year is 1,383,049 hours and 
$139,501,770.
    We have included Table 128 to assist in understanding these 
differences. Note that the difference between the burden estimates for 
the CY 2022 and 2023 MIPS performance periods/2024 and 2025 MIPS 
payment years is entirely due to the policies to introduce MVP and 
subgroup reporting and sunset the CMS Web Interface measures as a 
collection type/submission type beginning in the CY 2023 MIPS 
performance period/2025 MIPS payment year.

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    Table 131 represents averages for the estimated changes in burden 
for the CY 2021, 2022, and 2023 performance periods/2023, 2024, and 
2025 MIPS payment years.
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    Table 132 provides the reasons for changes in the estimated burden 
for information collections in the Quality Payment Program segment of 
this final rule. We have divided the reasons for our change in burden 
into those related to new policies and those related to adjustments in 
burden from continued Quality Payment Program Year 5 policies that 
reflect updated data and revised methods.

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C. Summary of Annual Burden Estimates for Changes

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BILLING CODE 4120-01-C

VI. Regulatory Impact Analysis

A. Statement of Need

    In this final rule, we are finalizing payment and policy changes 
under the Medicare PFS and required statutory changes under the 
Consolidated Appropriations Act, 2021 and sections 2003 and 2005 of the 
SUPPORT for Patients and Communities Act of 2018. We also are 
finalizing changes to payment policy and other related policies for 
Medicare Part B. In addition, this final rule will make modest 
revisions to certain Medicare provider and supplier enrollment 
regulatory provisions and add already existing provider and supplier 
requirements pertaining to prepayment and post-payment review 
activities.
    This final rule is necessary to make policy changes under Medicare 
FFS and to address various provider and supplier enrollment issues. 
Therefore, we included a detailed Regulatory Impact Analysis (RIA) to 
assess all costs and benefits of available regulatory alternatives and 
explain the selection of these regulatory approaches that we believe 
adhere to statutory requirements and, to the extent feasible, maximize 
net benefits

B. Overall Impact

    We examined the impact 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 (February 2, 
2013), 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), Executive Order 13132 on Federalism (August 4, 1999), and the 
Congressional Review Act (5 U.S.C. 804(2)).
    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 (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). An RIA 
must be prepared for major rules with economically significant effects 
($100 million or more in any 1 year). We estimated, as discussed in 
this section, that the PFS provisions included in this final rule will 
redistribute more than $100 million in 1 year. Therefore, we estimate 
that this rulemaking is ``economically significant'' as measured by the 
$100 million threshold, and hence also a major rule under the 
Congressional Review Act. Accordingly, we 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 http://www.sba.gov/content/table-small-business-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.

[[Page 65618]]

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 
final rule is intended to comply with the RFA requirements regarding 
significant impact on a substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 604 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area for Medicare 
payment regulations and has fewer than 100 beds. Medicare does not pay 
rural hospitals for their services under the PFS; rather, 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 final 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 2021, that 
threshold is approximately $158 million. This final 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 final 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 preamble, meets all assessment 
requirements. The analysis explains the rationale for and purposes of 
this final 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 final 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 final rule. We are 
unaware of any relevant Federal rules that duplicate, overlap, or 
conflict with this final rule. The relevant sections of this final rule 
contain a description of significant alternatives 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 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 BN.
    Our estimates of changes in Medicare expenditures for PFS services 
compared payment rates for CY 2021 with payment rates for CY 2022 using 
CY 2020 Medicare utilization. The payment impacts described in this 
final rule reflect averages by specialty based on Medicare utilization. 
The payment impact for an individual practitioner could vary from the 
average and will depend on the mix of services he or she furnishes. The 
average percentage change in total revenues will be less than the 
impact displayed here because practitioners and other entities 
generally furnish services to both Medicare and non-Medicare patients. 
In addition, practitioners and other entities may receive substantial 
Medicare revenues for services under other Medicare payment systems. 
For instance, independent laboratories receive approximately 83 percent 
of their Medicare revenues from clinical laboratory services that are 
paid under the Clinical Laboratory Fee Schedule (CLFS).
    The PFS update adjustment factor for CY 2022, as specified in 
section 1848(d)(19) of the Act, is 0.00 percent before applying other 
adjustments. In addition, section 101 of Division N of the CAA provided 
a 3.75 percent increase in PFS payment amounts for services furnished 
on or after January 1, 2021, and before January 1, 2022 and required 
that the increase shall not be taken into account in determining PFS 
payment rates for subsequent years. The expiration of this 3.75 percent 
increase in payment amounts will result in the CY 2022 conversion 
factor being calculated as though the 3.75 percent increase for the CY 
2021 conversion factor had never been applied.
    To calculate the CY 2022 PFS conversion factor (CF), we took the CY 
2021 conversion factor without the 1-year 3.75 percent increase 
provided by the CAA and multiplied it by the BN adjustment required as 
described in the preceding paragraphs. We estimate the CY 2022 PFS CF 
to be 33.5983 which reflects the BN 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 
expiration of the 3.75 percent increase for services furnished in CY 
2021, as provided in the CAA. We estimate the CY 2022 anesthesia CF to 
be 20.9343 which reflects the same overall PFS adjustments with the 
addition of anesthesia-specific PE and MP adjustments.

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    Table 136 shows the payment impact of the policies contained in 
this final rule on PFS services. To the extent that there are year-to-
year changes in the volume and mix of services provided by 
practitioners, the actual impact on total Medicare revenues will be 
different from those shown in Table 136 (CY 2022 PFS Estimated Impact 
on Total Allowed Charges by Specialty). The following is an explanation 
of the information represented in Table 136.
     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 2020 utilization and CY 
2021 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 2022 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 2022 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 2022 impact on total allowed charges of the changes in the 
MP RVUs.
     Column F (Combined Impact): This column shows the 
estimated CY 2022 combined impact on total allowed charges of all the 
changes in the previous columns. Column F may not equal the sum of 
columns C, D, and E due to rounding.
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BILLING CODE 4120-01-C
2. CY 2021 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 diagnostic testing facilities, portable x-ray, podiatry, hand 
surgery, and geriatrics, reflect increases relative to other physician 
specialties. These increases can be attributed largely to the update to 
clinical labor pricing as the services that these specialties furnish 
involve a higher proportion of clinical labor cost that is reflected in 
their PE RVUs. These increases are also due to increases in value for 
particular services after considering the recommendations from the 
American Medical Association (AMA)'s 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 
interventional radiology, vascular surgery, radiation oncology, and 
cardiology, reflect decreases in payments relative to payment to other 
physician specialties which are largely the result of the 
redistributive effects of the clinical labor pricing update. The 
services furnished by these specialties involve proportionally higher 
supply or equipment item costs, and therefore are affected negatively 
by the updates to clinical labor pricing. Since PE is budget 
neutralized within itself, increased pricing for clinical labor holds a 
corresponding relative decrease for other components of PE such as 
supplies and equipment. These decreases are also due to the revaluation 
of individual procedures based on reviews by the AMA RUC and CMS, 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. 
As a result, the estimated 2 percent decrease for CY 2021 is only 
applicable to approximately 17 percent of the Medicare payment to these 
entities.
    We often receive comments regarding the changes in RVUs displayed 
on the specialty impact table (Table 136), including comments received 
in response to the valuations. We remind stakeholders 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 136 
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 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. 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 2020 utilization data, Total RVUs change between 
-1 percent and 1 percent for more than 90 percent of practitioners, 
representing more than 81 percent of the changes in Total RVUs for all 
practitioners, with variation by specialty. Many specialties, such as 
chiropractic, clinical social worker, family practice, internal 
medicine and emergency medicine, exhibit little variation in changes in 
total RVUs per practitioner. For these specialties, more than 90 
percent of these practitioners will experience a change in Total RVUs 
between -1 percent and 1 percent. Other specialties exhibit more 
variation in changes in total RVUs per practitioner. For example, for 
diagnostic testing facilities, 39 percent of IDTFs will experience a 2 
percent or more decrease in Total RVUs, but these suppliers represent 
only 33 percent of Total RVUs for this specialty. Meanwhile, one 
percent of IDTFs will experience 10 percent or more increases in Total 
RVUs and these suppliers account for 33 percent of Total RVUs for this 
specialty. We also note the code level RVU changes are available in the 
Addendum B public use file that we make available with each rule.
    Many commenters requested that CMS maintain the 3.75 percent 
increase in PFS payment amounts that was specified under section 101 of 
the CAA for services furnished during CY 2021. We remind commenters 
that this increase was provided through a time-limited amendment to the 
statute, which CMS does not have legal authority to alter. The 
expiration of this 3.75 percent increase in payment amounts will result 
in the CY 2022 conversion factor being calculated as though the 3.75 
percent increase for the CY 2021 conversion factor had never been 
applied. Several commenters requested clarification regarding whether 
the specialty impacts displayed in Table 136 reflected the expiration 
of the 3.75 percent CAA provision for CY 2022. We can clarify for the 
commenters that the specialty impacts displayed in Table 136 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 revaluation of E/M codes 
in CY 2021 or the clinical labor

[[Page 65622]]

pricing update in CY 2022) but does not include any changes in spending 
which result from finalized policies outside of BN. The expiration of 
the 3.75 percent CAA provision for CY 2022 is a statutory change that 
takes place outside of BN, and therefore, is not captured in the 
specialty impacts displayed in Table 136.
b. Impact
    Column F of Table 136 displays the estimated CY 2022 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 2022 PFS final rule website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/. 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/PhysisianFeeSched/.

D. Effect of Changes Related to Telehealth Services

    Before the PHE for COVID-19, approximately 15,000 FFS Medicare 
beneficiaries received a Medicare telemedicine service each week. 
According to a report prepared by the Assistant Secretary for Planning 
and Evaluation (ASPE),\267\ in the last week of April 2020, nearly 1.7 
million beneficiaries received telehealth services. By April 2020, 
nearly half of all Medicare primary care visits were telehealth 
encounters, a level consistent with health care encounters more 
broadly. There are approximately 271 services currently included on the 
list of Medicare telehealth services, including more than 165 that were 
added on a temporary basis during the PHE for COVID-19 (including 
service categories such as emergency department visits, initial 
inpatient and nursing facility visits, and discharge day management 
services) that are covered through the end of the PHE. Preliminary data 
show that between mid-March and mid-October 2020, over 24.5 million out 
of 63 million Medicare beneficiaries and enrollees have received a 
Medicare telemedicine service during the PHE. It is important to note 
that preliminary data reflect that the largest increases in services 
furnished via telehealth communications systems, by beneficiary access/
volume, were for services that were already on the Medicare telehealth 
services list before the PHE.
---------------------------------------------------------------------------

    \267\ Medicare Beneficiary Use of Telehealth Visits: Early Data 
from the Start of the Covid-19 Pandemic (hhs.gov).
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    As discussed in section II.D. of this final rule, we are finalizing 
our proposal to amend the regulatory definition of interactive 
telecommunications system for purposes of Medicare telehealth services 
to include audio-only communication technology under certain 
circumstances for mental health services furnished to established 
patients in their homes. We anticipate that this policy will increase 
utilization of Medicare telehealth mental health services relative to 
utilization that will occur without the change. The estimated cost 
impact on overall Medicare services is unclear, though these changes 
will largely maintain current policies and access to the specific 
mental health services that are available to beneficiaries during the 
PHE. By requiring that a modifier be appended to the claim to identify 
that the service was furnished via audio-only communication technology, 
we will be able to closely monitor utilization and address any 
potential concerns regarding overutilization through future rulemaking.
    Comment: Commenters were very supportive of our proposal to allow 
for mental health services to be furnished using audio-only 
communications technology. A few commenters, while supportive of the 
use of audio-only communications technology during the PHE, urged CMS 
to further study and evaluate the safety and effectiveness of the 
audio-only modality for various levels of care and treatments to 
determine appropriateness of continuing payment after the PHE expires. 
Commenters supported the proposal to create a service-level modifier to 
identify mental health telehealth visits ``furnished to a beneficiary 
in their home using audio-only communications technology.''
    Response: We are finalizing creation of a service-level modifier 
that would identify mental health telehealth services furnished to a 
beneficiary in their home using audio-only communications technology. 
We anticipate that our policy of allowing mental health services to be 
furnished using audio-only communications technology this will have a 
positive impact on access to care for mental health services and 
contribute to overall health equity.
    Section 123 of the CAA removed the geographic and site of service 
restrictions for telehealth services furnished for the purpose of 
diagnosis, evaluation, or treatment of a mental health disorder, and 
required as a condition of payment for these telehealth services 
furnished in the patient's home that a physician or practitioner 
furnish an in-person, non-telehealth service to a beneficiary within 6 
months prior to the first time the physician or practitioner furnishes 
a telehealth service to the beneficiary, and thereafter, at intervals 
as specified by the Secretary. Section 125 of the CAA created a new 
Medicare provider type--the rural emergency hospital, effective 
beginning in CY 2023--and added rural emergency hospitals to the list 
of eligible telehealth originating sites at section 1834(m)(4)(C)(ii) 
of the Act. As discussed in section II.D. of this final rule, we will 
require, as a condition of payment for a telehealth service described 
in section 1834(m)(7) of the Act, that the billing physician or 
practitioner must have furnished an in-person, non-telehealth service 
to the beneficiary within the 6-month period before the date of service 
of a telehealth service as specified in section 1834(m)(7)(B)(i) of the 
Act, and proposed in this final rule that an in-person, non-telehealth 
service to the beneficiary must occur at 12-month intervals for 
subsequent care, with the possibility for exceptions that must be 
documented by the practitioner in the medical record.
    We solicited comment on whether the required in-person, non-
telehealth service could also be furnished by another physician or 
practitioner of the same specialty and same subspecialty within the 
same group as the physician or practitioner who furnishes the 
telehealth service, and we are finalizing a policy to allow this. Given 
that the removal of the geographic and site of service restrictions for 
telehealth will expand the availability of mental health services, we 
anticipate that utilization of these mental health services will be 
comparable to observed utilization for mental health services during 
the COVID-19 PHE.
    We received public comments on whether the required in-person, non-
telehealth service could also be furnished by another physician or 
practitioner of the same specialty and same subspecialty within the 
same group as the physician or practitioner who furnishes the 
telehealth service. The following is a summary of the comments we 
received and our responses.
    Comment: Many commenters agreed with the alternative policy we 
considered to allow the required in-

[[Page 65623]]

person, non-telehealth service to be furnished by another physician or 
practitioner of the same specialty and subspecialty in the same group 
as the practitioner who furnishes the mental health telehealth services 
to the beneficiary if the practitioner who furnishes the telehealth 
services is unavailable.
    Response: We are adopting the alternative policy discussed in the 
proposed rule to allow a clinician's colleague in the same subspecialty 
in the same group to furnish the in-person, non-telehealth service to 
the beneficiary if the original practitioner is unavailable. This is 
also consistent with longstanding policy, which defines an established 
patient as an individual who receives professional services from the 
physician/NPP or another physician of the same specialty and 
subspecialty who belongs to the same group within the previous 3 years, 
for purposes of billing for E/M services. While the language in the CAA 
states that the physician or practitioner furnishing the in-person, 
non-telehealth service must be the same person as the practitioner 
furnishing the telehealth service, we believe this policy would be 
consistent with statutory requirements, because we have historically 
treated the billing practitioner and other practitioners of the same 
specialty or subspecialty in the same group as if they were the same 
individual.
    After consideration of public comments, we are finalizing our 
alternative policy that a practitioner in the same subspecialty and the 
same group may furnish the in-person, non-telehealth service to the 
same beneficiary, if the original practitioner is unavailable.
    With regard to our policy to retain all services added to the 
Medicare telehealth services list on a Category 3 basis until the end 
of CY 2023, we believe the establishment of this certain end date will 
provide clarity to the stakeholder community but will have a negligible 
impact on PFS expenditures. For example, services that have already 
been added to the permanent telehealth services list are furnished via 
telehealth, on average, less than 0.1 percent of the time they are 
reported. Further, although data is still being collected, in our 
initial review of the data, we have not noticed an increase in the 
overall utilization trend for these services suggesting that 
practitioners may be furnishing these services via telehealth as 
replacement for in person encounters. The statutory conditions on 
payment for Medicare telehealth services under section 1834(m) of the 
Act, such as the originating site requirements related to geographic 
location and site of service, have limited increases in telehealth 
service utilization outside of the PHE for COVID-19; however, we 
believe there is value in allowing physicians to furnish services added 
to the Medicare telehealth services list on a Category 3 basis, and for 
patients to receive broader access to this care through telehealth, 
through the end of CY 2023 in order to ease the transition from the 
PHE. Additionally, for services added to the Medicare telehealth list 
on a Category 3 basis, outside of the circumstances of the PHE for 
COVID-19, all of the statutory restrictions under section 1834(m) of 
the Act will also apply to these services; therefore, we do not 
anticipate any significant increase in utilization.

E. Effect of Changes Related to Services Furnished in Whole or in Part 
by PTAs and OTAs

    As discussed in section II.H.1., we are finalizing proposed 
revisions to the current de minimis policy for services furnished in 
whole or in part by PTAs/OTAs that we finalized in CY 2020 PFS final 
rule (84 FR 62702 through 62708) under which the CQ or CO modifier 
applies when the PTA or OTA furnished more than 10 percent of a service 
or a 15-minute unit of service. Beginning January 1, 2022, CMS will 
apply a 15 percent reduction to the payment amount for a physical or 
occupational therapy service when the CQ/CO modifier is applied to the 
service. Our revision to the de minimis policy will allow the PT/OT to 
bill without the CQ/CO modifier for the final 15-minute unit (in a 
multi-unit billing scenario) when the PT/OT meets the billing threshold 
of 8 minutes, which is when the minutes are greater than the midpoint 
(7.5 minutes) of the 15-minute unit, regardless of any minutes provided 
by the PTA/OTA for that final unit.
    Under the policy we are finalizing, the PT/OT services will not be 
discounted as the result of any ``left-over'' minutes provided by the 
PTA/OTA when the therapist provides enough minutes on his or her own to 
meet the billing threshold amount. In these scenarios, the PTA's/OTA's 
minutes are considered immaterial for the purposes of billing. For 
example, if the PT/OT provided 23 minutes of a 15-minute service and 
the PTA/OTA provided another 20 minutes of the same service--three 
units of service can be billed for the 43 total minutes (38 minutes 
through 52 minutes). Here, one full 15-minute unit of service is billed 
without the CQ/CO modifier for the PT/OT service with 8 minutes 
remaining, and one full unit of service is billed with the CQ/CO 
modifier for the service provided by the PTA/OTA with 5 minutes 
remaining. Under the policy, the third unit is billed without the CQ/CO 
modifier because the 8 minutes provided by the PT/OT meets the billing 
threshold amount. However, under our current de minimis policy, the 5 
minutes provided by the PTA/OTA is more than 10 percent (it is 38 
percent of the total service-PTA/OTA minutes divided by the total of 
PTA/OTA + PT/OT minutes: 5 divided by 13 = 38 percent) meaning the CQ/
CO modifier is applied to the third and final unit of service.
    Under our current de minimis policy, under which the CQ/CO modifier 
is applied whenever the PTA/OTA provides more than 10 percent of a 
service whether or not the PT/OT furnishes enough of the service to 
bill for it without the portion furnished by the PTA/OTA, stakeholders 
have expressed concern that the PT/OT has a financial incentive not to 
have the PTA/OTA provide any additional minutes, regardless of the 
individual patient's needs, when those minutes of service lead to a 
reduced payment for a unit of a service. There may be a cost 
implication to this policy as fewer billing scenarios may result in 
application of the CQ/CO modifiers and consequent payment reduction. 
However, we believe that basing our policy on a ``midpoint rule'' in 
which the PT/OT provides enough minutes on their own (8 or more 
minutes) to bill for the final unit of a billing scenario could 
eliminate the PT's/OT's financial incentive to not provide appropriate 
therapy to an individual patient when it is furnished by the PTA/OTA. 
On the other hand, if we were to continue with our de minimis standard 
to apply to all billing scenarios for PTA/OTA services that exceed the 
10 percent standard, we are uncertain how to gauge the overall costs of 
this policy because of the possible altered PT/OT behavioral change 
that is due to the financial incentives built into that policy as 
discussed above.

F. Other Provisions of the Regulation

1. Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs)
    In section III.A. of this final rule, we make multiple provisions 
related to RHCs and FQHCs. In terms of estimated impacts to the 
Medicare program, Payment for Attending Physician Services Furnished by 
RHCs or FQHCs to Hospice Patients as required by section 132 of the 
CAA, 2021 and Concurrent Billing for CCM and

[[Page 65624]]

Transitional Care Management TCM Services for RHCs and FQHCs will have 
negligible impact to Medicare spending.
    Section 130 requires that all independent RHCs are now subject to 
the per-visit limit (which is also referred to as ``cap'') and phases 
in an increase in the statutory payment cap over an 8-year period. The 
cap in CY 2021, for services furnished after March 31, is set at $100 
per visit, then at $126 per visit in 2022; at $139 per visit in 2023; 
at $152 per visit in 2024; at $152 per visit in 2025; at $165 per visit 
in 2026; at $178 per visit in 2027; and at $190 per visit in 2028. 
Beyond 2028, the limit is updated by the applicable Medicare Economic 
Index (MEI).
    This provision also controls the annual rate of growth in payments 
to certain provider-based RHCs whose payments are currently higher than 
the payment limit. Each year, but for services provided after March 31 
in 2021, the payment limit shall be set at the greater of: (1) The RHC 
per visit amount from the prior year, increased by the percentage 
increase in the applicable MEI; and (2) the cap limits applicable to 
each year as described above. In order to be eligible for this 
``grandfathering'' policy, the RHC must have been based in a hospital 
with fewer than 50 beds and enrolled in Medicare as of December 31, 
2019.
    Section 2 of Public Law 117-7, enacted on April 14, 2021, made 
technical corrections to section 130. First, for an RHC that is 
hospital-based and whose parent hospital has fewer than 50 beds, the 
date by which the RHC must be Medicare-certified, in order to be 
grandfathered, was changed from December 31, 2019 to December 31, 2020. 
Next, a clinic that is owned by a hospital with fewer than 50 beds and 
that submitted certain applications (received by Medicare) for 
certification as a Medicare RHC prior to the end of 2020 can be 
grandfathered, and its clinic-specific cap is to be set based on its 
2021 cost per visit. Lastly, a grandfathered RHC must continue to be 
owned by a hospital with fewer than 50 beds; if the parent hospital 
exceeds 50 beds, the RHC will lose its grandfathered status.
    Table 137 are the FY estimates (in millions) for the impact of 
section 130, which improves payments to RHCs. These providers are 
currently 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, except for certain provider-based RHCs that 
have an exception to the payment limit. The RHC payment limit per visit 
for CY 2021 is $87.52, which is 1.4 percent higher than the CY 2020 
payment limit of $86.31.
[GRAPHIC] [TIFF OMITTED] TR19NO21.169

    In section III.B. of this final rule, we discuss that we proposed 
to revise 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 to also include 
encounters furnished through interactive, real-time telecommunications 
technology, but only when furnishing services for the purposes of 
diagnosis, evaluation, or treatment of a mental health disorder.
    According to our analysis of Medicare Part B claims data for 
services furnished via Medicare telehealth under the PFS during the 
PHE, use of telehealth for many professional services spiked in 
utilization around April 2020 and diminished over time, but not to pre-
pandemic levels. In contrast, Medicare claims data suggests that for 
mental health services both permanently and temporarily added to the 
Medicare Telehealth list, subsequent to April 2020, the trend is toward 
maintaining a steady state of usage over time. Given the expanded 
availability of mental health services at RHCs and FQHCs, we do 
anticipate that this policy will increase spending; however, we are not 
certain of the magnitude of this increase, since it is not clear at 
this time how or whether trends related to utilization of communication 
technology during the PHE will continue after such a time that the PHE 
were to end. While the estimated cost impact of this provision is 
unclear, the requirement that a modifier be appended to the claim to 
identify that the service was furnished via audio-only communication 
technology will allow us to closely monitor utilization and address any 
potential concerns regarding overutilization through future rulemaking.
2. Requiring Certain Manufacturers To Report Drug Pricing Information 
for Part B (Sec. Sec.  414.802 and 414.806)
    This provision implements new statutory requirements under sections 
1847A and 1927 of the Act, as amended by section 401 of the CAA (for 
the purposes of this section of this final rule, hereinafter is 
referred to as ``section 401''). These new requirements will improve 
the accuracy of reported payment limits and limit the use of WAC-based 
pricing.
    As described in section III.D.1. of this final rule, in considering 
whether to exclude repackagers from the reporting requirements at 
section 1847A(f)(2) of the Act, we conducted two analyses to estimate: 
(1) The proportion of repackaged products in our existing ASP data; (2) 
the number of new ASP submissions we can expect as a result of the new 
reporting requirements under section 401; and (3) the proportion of 
those (new) submissions that involve repackaged products.
    Additionally, while we believe it will impact reporting volume and 
payment limits under section 1847A of the Act for many billing and 
payment codes, we are unable to estimate the magnitude of these effects 
for the following reasons. We estimate: (1) 361 non-reporting 
manufacturers (of either single source or multiple source drugs) will 
now be required to report ASP data under section 1847A(f)(2) of the 
Act; and (2) 6114 products payable under Part B that these non-
reporting manufacturers sell. However, we do not know which Healthcare 
Common Procedure Coding System (HCPCS) code payment limits will be 
impacted by these 6114 products, nor do we know the sales volume of 
these 6114 products. Because this information is used to calculate 
volume-weighted ASP payment limits, we are unable to quantitatively 
estimate the economic impacts of this provision (that is, the likely 
costs or savings) on beneficiaries, the government, and other

[[Page 65625]]

stakeholders. (We note that the economic impacts on manufacturers, as a 
result of the information collection requirements of this provision is 
discussed in section V. of this final rule.)
    For single source drugs, these changes may result in lower payment 
limits because, typically, the WAC-based pricing is higher than ASP 
plus 6 percent. This then translates to cost savings for both the 
government and beneficiaries, who will pay coinsurance on a lesser 
amount. However, for the reason stated previously, we are unable to 
predict the magnitude of this effect.
    Similarly, payment limits for multiple source drugs could increase 
or decrease, and we are unable to predict the direction or magnitude of 
specific or aggregate effects at this time.
    We do not anticipate that this provision of this final rule will 
necessitate the revision of existing Medicaid Drug Rebate Agreements.
    We welcomed comment on (1) the likely costs or savings to 
beneficiaries, the government, and other stakeholders and (2) other 
related impacts of this provision.
    We received public comments on the likely costs or savings to 
beneficiaries, the government, and other stakeholders, and other 
related impacts of this provision. The following is a summary of the 
comments we received and our responses.
    Comment: One commenter suggested that CMS exclude repackagers from 
the proposed ASP reporting requirements. They stated that requiring all 
repackagers to report would likely be duplicative and increase the 
burden on all parties without providing tangible benefit. They 
recommend repackagers who already report ASP data continue to do so, 
but that CMS not require repackagers, as a group, to be subject to the 
reporting requirements at this time.
    Response: We are not persuaded that repackagers should be excluded 
at this time. In order to maintain consistency and integrity of the ASP 
data for those manufacturers with and without Medicaid drug rebate 
agreements, and for operational reasons, we do not believe it is 
appropriate to exclude repackagers from the ASP reporting requirements. 
If warranted, we could revisit this in future rulemaking.
    Comment: One commenter concluded that CMS' analysis and proposal 
not to exclude repackagers without a rebate agreement from reporting 
ASP data is reasonable. The commenter stated given that repackagers 
with a rebate agreement are required to report ASP data, it is 
reasonable not to exclude repackagers without a rebate agreement from 
the requirements of section 401. They added that having ASP data from 
repackagers with and without rebate agreements could also permit future 
analysis of the effect of repackagers' ASP submissions on Medicare Part 
B payment rates.
    Response: We agree it is reasonable not to exclude repackagers 
without a Medicaid drug rebate agreement and thank the commenter for 
their feedback.
    After consideration of public comments, we are finalizing as 
proposed.
3. Determination of ASP for Certain Self-Administered Drug Products
a. Anticipated Effects
    This provision implements new statutory requirements under section 
1847A(g) of the Act, as amended by section 405 of the CAA 2021, (for 
the purposes of this section of this final rule, hereinafter is 
referred to as ``section 405''). As identified by the OIG studies 
discussed in section III.D.2. of this final rule, the CMS payment-limit 
determination under section 1847A of the Act includes all versions of a 
product marketed under a single FDA approval, and consistent with 
section 1847A(b)(5) of the Act, the payment-limit determination does 
not exclude products based on packaging. Thus, the volume-weighted, 
average-ASP determination can include self-administered versions that 
may lead to increased program and beneficiary costs because of 
distorted ASP-based payment limits. In particular, the OIG studies 
identified two billing and payment codes that included self-
administered NDCs. The OIG study determined that as a result of the 
inclusion of these NDCs in the calculation of the ASP payment limit, 
Medicare payment amounts remained inflated in 2017 and 2018, causing 
the program and its beneficiaries to pay an additional $497 million 
during this period. Since 2014, current payment methodology has 
resulted in an additional $173 million in Medicare beneficiary 
coinsurance for these two NDCs. (See OIG's July 2020 report titled, 
``Loophole in Drug Payment Rule Continues To Cost Medicare and 
Beneficiaries Hundreds of Millions of Dollars,'' available at https://oig.hhs.gov/oei/reports/OEI-BL-20-00100.asp.)
    Implementation of the regulatory changes has the potential to 
result in decreased payment limits for identified billing and payment 
codes that could, in turn, substantially reduce Medicare and 
beneficiary expenditures, as described in the OIG study. Since section 
1847A(g)(3) of the Act requires CMS to implement the required payment 
changes beginning on July 1, 2021, these potential savings may be 
observed within the year.
    By adding sections 1847A(g)(1) and (2) of the Act, section 405 also 
directs the OIG to conduct future studies with same or similar 
methodologies to those in the July 2020 report and directs CMS to apply 
the lesser of payment methodology to the applicable billing and payment 
codes. This has the potential to result in additional savings to the 
program and beneficiaries if additional products are identified by 
these periodic OIG studies.
b. Expected Benefits
    Codifying the provisions set forth by section 405 will permit to 
CMS to apply the lesser of payment methodology at section 1847(g)(2) of 
the Act to billing and payment codes identified by future OIG studies 
(described in section III.D.2. of this final rule). This provision 
addresses distorted payment limits for these products and may result in 
payment amounts that are better aligned with versions of these products 
that are payable under Part B (for example, versions that are usually 
not self-administered). Although we are unable to quantify the total 
magnitude of the potential savings, these changes have the potential to 
substantially reduce program expenditures and beneficiary coinsurance.
4. Appropriate Use Criteria
    Section 1834(q)(2) of the Act, as added by section 218(b) of the 
Protecting Access to Medicare Act (PAMA), established a program to 
promote the use of appropriate use criteria (AUC) for applicable 
imaging services furnished in an applicable setting.
    In the CY 2019 PFS final rule (83 FR 59452), we performed an RIA 
for this program. In this final rule, we are finalizing our proposal to 
begin the payment penalty phase of the program on the later of January 
1, 2023 or the January 1 of the year after the year in which the PHE 
for COVID-19 ends. Because, under our provisions, the payment penalty 
phase will be further delayed, we are updating the estimates for 
incremental changes from the RIA from the CY 2019 PFS final rule. Since 
we did not propose new policy requirements nor do we have sufficient 
reason to change any of the assumptions made in the RIA finalized in 
the CY 2019 PFS (83 FR 60034 through 60044), we are only updating the 
analysis to reflect 2019 Medicare claims data (updated from 2014). We 
identify four incremental changes from the CY 2019

[[Page 65626]]

PFS final rule estimates due to updated claims data: (1) Impact of 
required AUC consultations by ordering professionals; (2) impact to 
Medicare beneficiaries; (3) process efficiencies to potentially offset 
the estimated burden on Medicare beneficiaries; and (4) impact on 
transmitting orders for advanced diagnostic imaging services. Each of 
these incremental changes results in a lower estimate.
a. Impact of Required AUC Consultations by Ordering Professionals
    As discussed in detail in the CY 2019 PFS final rule (83 FR 60035 
through 60037), the annual impact estimate of consultations by ordering 
professionals was $70,001,700. In our estimates, we calculated the 
burden for auxiliary personnel to consult AUC under the direction of an 
ordering professional and the burden for ordering professionals to 
perform the consultation directly. We estimated that 90 percent of 
consultations will be performed by a medical assistant (occupation code 
31-9092) and 10 percent of consultations will be performed by a general 
practitioner (occupation code 29-1062). We estimated that 43,181,818, 
2-minute consultations occur annually.
    Using 2019 Medicare claims data as our basis for the analysis, we 
proposed to change the methodology used to determine the volume of 
consultations and proposed to use more granular data that will reduce 
potential double-counting of advanced diagnostic imaging services. For 
example, an imaging service furnished in an outpatient hospital 
department could have two claims associated with that service. There 
could be a claim from the facility and a claim from the physician that 
interprets that imaging service. In the CY 2019 RIA (83 FR 60034 
through 60044) we were concerned that the estimate of 43,181,818 
consultations may be an overestimate because it took into account total 
claims. For this CY 2022 RIA, we proposed to change the method of 
counting the total number of advanced diagnostic imaging services that 
will be furnished under the AUC program which will correspond to the 
total number of consultations.
    Using the Integrated Data Repository we identified Medicare claims 
using the following parameters: (1) 2019 date of service; (2) claim 
lines containing one of the procedure codes identified in CR10481 and 
CR11268 at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R2040OTN.pdf and https://www.cms.gov/files/document/r2404otn.pdf, respectively; and (3) claims types of outpatient 
or practitioner. Claims were then separated based on the setting in 
which the imaging service was furnished and further by claim type. 
Using only services billed on the professional claim type, the total 
number of claim lines containing one of the identified procedure codes 
was included to total 30,359,901 advanced diagnostic imaging services 
estimated to be subject to the AUC program. By using this combination, 
we believe we can reduce the risk of double-counting services to obtain 
a more accurate estimate of total number of diagnostic imaging services 
subject to the AUC program. Therefore, this analysis will use the 
estimate of 30,359,901 AUC consultations.
    Using the May 2020 BLS mean hourly wages, we update our estimates 
for a medical assistant (occupation code 31-9092) with mean hourly wage 
of $17.75 and 100 percent fringe benefits for 90 percent of 
consultations (910,797 hours) to be $30,511,701 (910,797 hours x 
$33.50/hour). The occupation for general practitioner is no longer 
listed on the BLS so, instead, we update our estimate using the 
occupation code for general internal medicine physician (29-1216) with 
mean hourly wage of $101.42 and 100 percent fringe benefits for 10 
percent of consultations (101,200 hours) to be $20,527,408 (101,200 
hours x $202.84/hour). The updated total annual estimated impact of 
consultations is $51,039,109, for an incremental change (reduction) of 
$18,962,591.
b. Impact to Medicare Beneficiaries
    In the CY 2019 PFS final rule, we estimated that the additional 2-
minute consultation would impact the Medicare beneficiary when their 
advanced diagnostic imaging service is ordered by the ordering 
professional by introducing additional time to their office visit. For 
this update, we used the updated number of consultations calculated 
above from claims data, as well as the May 2020 BLS mean hourly wage. 
To estimate this annual cost, we multiplied the annual burden of 
1,011,997 hours by the BLS occupation code that represents all 
occupations in the BLS (00-0000) as mean hourly wage plus 100 percent 
fringe ($54.14/hr) for a total estimate of $54,789,518 per year for an 
incremental change (reduction) of $13,211,482. We also estimated that, 
over time, process efficiencies may be implemented. We assumed that 50 
percent of practices implemented an improvement process that 
streamlined AUC consultation so Medicare beneficiaries spent the same 
amount of time in the physician's office regardless of whether an 
advanced diagnostic imaging service was ordered. The updated estimate 
that such an improvement process could offset the estimated burden on 
Medicare beneficiaries by $27,394,759 annually for an incremental 
change (reduction) of $6,605,741.
c. Impact on Transmitting Orders for Advanced Diagnostic Imaging 
Services
    In the CY 2019 PFS final rule, we estimated that including AUC 
consultation information on the order for an advanced diagnostic 
imaging service to the furnishing professional or facility is estimated 
as the additional 5 minutes spent by a medical secretary (occupation 
code 43-6013). To update this estimate, we use the May 2020 mean hourly 
wage of $18.75 plus 100 percent fringe benefits to transmit the order 
for the advanced diagnostic imaging service. In aggregate, we assumed 
in the CY 2019 PFS final rule that 40,000,000 advanced diagnostic 
imaging services are ordered annually. We proposed to update that 
number to match the total number of AUC consultations proposed earlier 
in this RIA to 30,359,901, so the updated total annual burden to 
communicate additional information in the order is estimated as 
$94,495,192 ($18.75/hr x 2 x 0.083 hr x 30,359,901 orders) for an 
incremental change (reduction) of $20,044,808.
d. Impact on Furnishing Professionals and Facilities
    As described in the CY 2019 PFS final rule, we identified an 
estimated 174,064 furnishing professionals (comprising radiologists, 
ASCs, IDTFs and hospitals) and assumed that every identified furnishing 
professional will choose to update their processes for the purposes of 
the AUC program in the same way by purchasing an automated solution to 
report AUC consultation information which was estimated to cost $10,000 
for each furnishing professional. We update this cost to account for 
inflation and therefore the updated estimated cost is $10,636.07 
($10,000 adjusted for inflation to 2021 dollars) for a total estimated 
one-time update cost of $1,851,356,888.48 (174,064 x $10,636.07).
e. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
    As described in the CY 2019 PFS final rule, we assumed that there 
may be some savings to the Medicare program due to the AUC program 
requirements and potential decreases in inappropriate utilization of 
advanced diagnostic imaging services. This assumption was based on 
literature describing prior

[[Page 65627]]

experiences with clinical decision support in a pilot project conducted 
in Minnesota, a retrospective cohort study on evidence-based clinical 
decision support for lumbar MRI, brain MR and sinus CT and local 
implementation of clinical decision support, and we estimated that 
savings may account for $700,000,000 savings per year.
f. Summary of Delay-Attributable Changes and Discounted Rates
    Table 138 summarizes the substantive changes from the CY 2019 PFS 
final rule to the CY 2022 PFS final rule impact estimates. The effect 
of a 3-year delay is approximated by applying 3 years' worth of 
discounting at 7 percent or 3 percent discount rates (Circular A-4, 
https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/assets/regulatory_matters_pdf/a-4.pdf).
[GRAPHIC] [TIFF OMITTED] TR19NO21.170

5. Removal of Selected National Coverage Determinations (NCDs)
    We proposed to remove two older NCDs that no longer contain 
clinically pertinent and current information or that involve items or 
services that are used infrequently by beneficiaries. Generally, 
proactively removing obsolete or unnecessary NCDs removes barriers to 
innovation and reduces burden for stakeholders and CMS. The two NCDs 
fall into two impact categories. First, eliminating an NCD for items 
and services that were previously covered means that the item or 
service will no longer be automatically covered by Medicare. Instead, 
the coverage determinations for those items and services will be made 
by Medicare Administrative Contractors (MACs). Second, if the previous 
national coverage determination barred coverage for an item or service 
under title XVIII, MACs will now be able to cover the item or service 
if the MAC determines that such action is appropriate under the 
statute. We believe that allowing local contractor flexibility in these 
cases better serves the needs of the Medicare program and its 
beneficiaries since we believe the future utilization for items and 
services within these policies will be limited, each affecting less 
than one percent of the Medicare FFS population.
    For the one NCD where NCD removal changes coverage from limited 
national coverage to MAC discretion, claims data from 2019 shows that 
less than one percent of the Medicare population is affected. 
Specifically, NCD 180.2 Enteral and Parenteral Nutrition Therapy 
provided coverage with limitations. Where in 2019 CMS paid 1,643,739 
Medicare FFS claims for 83,551 unique beneficiaries totaling CMS 
payments of $356,228,606. While we have claims data available for 2020, 
the data shows a decrease in claims, unique beneficiaries and total 
amount paid by CMS. We believe this may be due in part to the COVID-19 
pandemic; however, we do not have any information to be able to say 
that conclusively. The change could be due to other factors not 
examined here. We estimate there will be de minimis change to 2022 
payments, compared to 2019 or 2020 because, as discussed in section 
III.F. of the final rule, local contractors have finalized two LCDs, 
effective for dates of service on or after September 5, 2021 that will 
continue to provide parenteral and enteral nutrition coverage for 
Medicare beneficiaries, after removal of NCD 180.2. Therefore, we 
believe that removing this NCD will not result in significant changes 
to payments.
    For the one non-covered NCD to be eliminated, Positron Emission 
Tomography (PET) Scans under NCD 220.6, we did not expect to find 
historical claims data for the non-oncologic uses of PET at issue. We 
broadly noncover non-oncologic indications of PET, in other words, we 
required that every non-oncologic indication for PET must have its own 
NCD in order to receive coverage. Because this NCD provides for 
noncoverage on non-oncologic indications, we do not have accurate 
claims data to estimate total impact. However, based on the service, we 
expect future claims to affect less than one percent of Medicare FFS 
beneficiaries. As discussed in section III.F. of this final rule, the 
NCD allows coverage for diagnostic PET imaging for oncologic uses not 
already determined by an NCD, to be made at the discretion of local 
MACs. We believe that extending local contractor discretion for non-
oncologic indications of PET provides an immediate avenue to potential 
coverage in appropriate

[[Page 65628]]

candidates and provides a framework that better serves the needs of the 
Medicare program and its beneficiaries. For clarity, we did not propose 
to change any other subsections of 220.6. Thus, the NCDs listed at 
220.6.1 through 220.6.20 will not be changed by this provision.
6. Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive 
Cardiac Rehabilitation
    As discussed in section III.H., Pulmonary Rehabilitation (PR), 
Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR), 
of this final rule, we proposed largely conforming changes throughout 
Sec. Sec.  410.47 (PR) and 410.49 (CR/ICR). These changes are intended 
to ensure consistency and accuracy in terminology, definitions and 
requirements where appropriate across PR and CR/ICR conditions of 
coverage. Specific to PR, we proposed to remove the requirement for 
direct physician-patient contact related to the periodic review of the 
patient's treatment plan because such interaction within the PR program 
is not necessary for all patients and can be specified, as needed, in 
individualized treatment plans (ITPs). We also proposed to add coverage 
of PR for beneficiaries who were hospitalized with a COVID-19 diagnosis 
and experience persistent symptoms, including respiratory dysfunction, 
for at least 4 weeks after hospital discharge. After considering public 
comments and additional clinical evidence, we are finalizing the 
revisions to improve consistency and accuracy across PR and CR/ICR 
conditions of coverage as proposed. We are also finalizing the removal 
of the PR requirement for direct physician-patient contact. We are 
expanding upon our proposal to cover PR for beneficiaries who were 
hospitalized with a COVID-19 diagnosis and experience persistent 
symptoms, including respiratory dysfunction, for at least 4 weeks after 
hospital discharge. We are removing the proposed hospitalization 
requirement and finalizing 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. We did not 
receive public comments on the proposed impact so we use the same 
methodology in estimating the impact of the final expansion of coverage 
for PR below.
    In assessing the impact of these provisions, we note that the 
expansion of PR coverage may increase utilization. Based on the low 
utilization rate discussed below, we do not believe the other revisions 
will significantly impact utilization and the Medicare program.
    To estimate the potential increase from the expansion of coverage 
for PR, we searched the literature for articles that evaluated the 
utilization rate of PR for the currently eligible diagnosis of chronic 
obstructive pulmonary disease (COPD) in order to determine the 
historical utilization trends of this service.
    Nishi et al. (2016) investigated the number of Medicare 
beneficiaries with COPD who received PR from January 1, 2003 to 
December 31, 2012. Their results included both individuals who had 
experienced hospitalizations for COPD and those who were outpatients 
only. The number of unique patients with COPD who initially 
participated in PR during the study period was 2.6 percent in 2003 
(before conditions of coverage at Sec.  410.47 were established) and 
2.88 percent in 2012 (after conditions of coverage at Sec.  410.47 were 
established).\268\ 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.\269\ Using claims data from FFS 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.\270\ Taken together, this data informs us that utilization 
of PR in the Medicare population is very low, and that the majority of 
patients who avail themselves of this service do so, post 
hospitalization.
---------------------------------------------------------------------------

    \268\ 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.
    \269\ 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.
    \270\ 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.
---------------------------------------------------------------------------

    There are limitations to applying this data to identify the 
utilization rate of PR to the conditions of coverage specified at Sec.  
410.47. Most notably, some of these studies included patients whose 
services were billed with non-PR respiratory therapy codes (G0237, 
G0238 and G0239), instead of only patients whose services were billed 
with the PR code (G0424). But the authors also limited patient 
inclusion to those with a principal or secondary COPD diagnosis, so we 
believe this suggests that 3 percent is an upper bound for the 
utilization of PR currently in Medicare beneficiaries. Given that 
participation in PR has remained steady for many years, we do not 
expect this pattern to change. As such, for the purposes of this 
analysis, we assume that 3 percent of eligible beneficiaries under the 
expansion of coverage (beneficiaries who have had confirmed or 
suspected COVID-19 and experience persistent symptoms that include 
respiratory dysfunction for at least 4 weeks) will participate in PR.
    To identify the eligible beneficiaries under our provision, we 
first identify the number of beneficiaries who had COVID-19 using the 
Preliminary Medicare COVID-19 Data Snapshot.\271\ At the time of 
writing, the Snapshot included data from January 1, 2020 to July 24, 
2021, and identified 4,656,553 total COVID-19 cases for Medicare 
beneficiaries. Using Medicare FFS data from February 24, 2020 to 
September 27, 2020 as compared to the same time frame in 2015 through 
2019, Tarazi et al. (2021) found that the COVID-19 related mortality 
rate, defined as death within 60 days of COVID-19 diagnosis, was 17.5 
percent.\272\ To calculate the number of beneficiaries that survive 
COVID-19 to be eligible for PR under our coverage expansion, we reduced 
4,656,553 by 17.5 percent (814,897) to 3,841,656 beneficiaries. A paper 
published by the Tony Blair Institute for Global Change \273\ states 
that the Covid Symptom Study led by King's College London indicated 
that about 10 percent of survey participants reported symptoms 
(including shortness of breath and other symptoms like fatigue, 
headache and loss of smell) beyond a four-week recovery period. Using 
this information, we estimate that the patient population we are 
expanding PR coverage to, those who have had confirmed or suspected 
COVID-19 and experience persistent symptoms that include respiratory 
dysfunction for at least 4 weeks, to be 384,166 beneficiaries 
(3,841,656 x 0.10). Based on our assumption of utilization above, 3 
percent, for the newly covered patient population, we estimate 11,525

[[Page 65629]]

beneficiaries will receive PR (384,166 x 0.03).
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    \271\ https://www.cms.gov/files/document/medicare-covid-19-data-snapshot-fact-sheet.pdf.
    \272\ Tarazi WW, Finegold K, Sheingold SH, et al. COVID-19-
Related Deaths And Excess Deaths Among Medicare Fee-For-Service 
Beneficiaries. Health Affairs 40, No. 6 (2021): 879-885. doi: 
10.1377/hlthaff.2020.02521.
    \273\ Published at https://institute.global/sites/default/files/articles/Long-Covid-Reviewing-the-Science-and-Assessing-the-Risk.pdf 
on October 5 2020.
---------------------------------------------------------------------------

    Medicare covers PR for a maximum of 72 sessions. Using 2018 and 
2019 Medicare claims data from the Chronic Conditions Data Warehouse 
(CCW), beneficiaries on average completed 14 sessions of PR. If we 
assume patients eligible based on our expansion of coverage will 
participate, on average, in the same number of sessions, we estimate 
the expansion of coverage will increase PR utilization by 161,350 
sessions annually (11,525 beneficiaries x 14 average sessions completed 
per beneficiary).
    Claims for PR are submitted using CPT code G0424. Our analysis of 
Medicare claims data indicates that 97.54 percent of PR sessions are 
billed under the Hospital OPPS at $55.66 (national average price) for 
an estimated total of $8,759,815 (161,350 PR sessions x 0.9754 x 
$55.66). The remaining 2.46 percent of PR sessions are billed under the 
PFS, with 2.12 percent of PR sessions furnished in a physician's office 
which has a national average price of $30.36 and 0.34 percent billed by 
a physician when PR was furnished in a HOPD which has a national 
average price of $13.96. Taken together, the estimated total for this 
remaining 2.46 percent of PR sessions is $111,508 ((161,350 PR sessions 
x 0.0212 x $30.36) + (161,350 PR sessions x 0.0034 x $13.96)). We 
estimate the total added cost to the Medicare program of this expansion 
of coverage to be $8,871,323 ($8,759,815 + $111,508) annually during 
and immediately following the PHE for COVID-19. The impact of our final 
rule increases the final estimate by $6,709,876 which reflects the 
larger patient population that will be eligible for PR. Removing the 
proposed hospitalization requirement increased the number of eligible 
beneficiaries by 290,555. As COVID-19 cases decline, we expect the 
annual impact to decrease because eligible patient populations will 
likely decrease; however, we are unable to estimate the longer term 
impact of our provisions due to the unpredictable nature of the PHE and 
the lack of long term data on COVID-19.
7. Medical Nutrition Therapy
    As discussed in section III.I., Medical Nutrition Therapy (MNT), of 
this final rule, we proposed to remove the restriction that patients 
only be referred to MNT by the treating physician and update the 
glomerular filtration rate (GFR) eligibility for patients with chronic 
kidney disease. We do not anticipate any significant increase in 
utilization of MNT services resulting from our revisions. Despite 
various policy changes that could have improved use, such as increasing 
payment via adding work RVUs to MNT codes in 2006, approving MNT for 
telehealth coverage in 2005 and including registered dieticians (RDs) 
and nutrition professionals as telehealth distant site providers, and 
waiving out-of-pocket costs to beneficiaries, MNT participation remains 
under 2 percent of eligible beneficiaries. Based on an analysis of 
Medicare claims data from 2018, 2019, 2020, we identify the utilization 
rate of MNT services among eligible beneficiaries to be between 1.5 and 
1.8 percent.
    Although MNT is covered by many State Medicaid programs and private 
insurers, use is low in the US.274 275 276 The Academy of 
Nutrition and Dietetics recognizes that research specific to the 
underuse of MNT services is scant.\277\ Anecdotal reports and related 
research on diabetes self-management training point to a multitude of 
reasons why utilization of the MNT services benefit have remained low. 
These potential barriers include lack of awareness of MNT by patients 
and clinicians, inconsistent coverage for MNT services by non-Medicare 
payers, patient travel and time issues to receive the services and lack 
of availability of services from RDs who may perceive the process of 
Medicare enrollment/insurance credentialing and billing as being 
burdensome and complex.\278\ Of about 100,000 RDs in the US, only 1,589 
submitted Medicare FFS MNT claims in 2017. One study revealed that less 
than half of RDs providing MNT services in an ambulatory care setting 
indicated they were not Medicare providers due to reasons such as 
perceived low reimbursement rates, not providing MNT to Medicare 
eligible patients, not knowing how to become a Medicare provider, and 
providing MNT to Medicare patients for diagnoses not covered by 
Medicare.\279\
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    \274\ https://www.eatrightpro.org/payment/nutrition-services/medicaid/medicaid-and-rdns.
    \275\ Kramer, H., Jimenez, E.Y., Brommage, D., Vassalotti, J., 
Montgomery, E., Steiber, A., & Schofield, M. (2018). Medical 
nutrition therapy for patients with non-dialysis-dependent chronic 
kidney disease: barriers and solutions. Journal of the Academy of 
Nutrition and Dietetics, 118(10), 1958-1965.
    \276\ Jimenez, E.Y., Kelley, K., Schofield, M., Brommage, D., 
Steiber, A., Abram, J.K., & Kramer, H. (2021). Medical nutrition 
therapy access in CKD: A cross-sectional survey of patients and 
providers. Kidney medicine, 3(1), 31-41.
    \277\ Kramer, H., Jimenez, E.Y., Brommage, D., Vassalotti, J., 
Montgomery, E., Steiber, A., & Schofield, M. (2018). Medical 
nutrition therapy for patients with non-dialysis-dependent chronic 
kidney disease: Barriers and solutions. Journal of the Academy of 
Nutrition and Dietetics, 118(10), 1958-1965.
    \278\ Ibid.
    \279\ Parrott JS, White JV, Schofield M, Hand RK, Gregoire MB, 
Ayoob KT, Pavlinac J, Lewis JL, Smith K. Current coding practices 
and patterns of code use of registered dietitian nutritionists: The 
Academy of Nutrition and Dietetics 2013 coding survey. J Acad Nutr 
Diet. 2014;114(10):1619-1629.
---------------------------------------------------------------------------

    Our revisions may increase beneficiary access to the MNT benefit 
and reduce primary care physician burden since we proposed that 
referrals can come from other physicians and not only from the 
physician treating the patient for their diabetes or kidney disease; 
although, as discussed above, we do not expect the changes to make a 
significant impact on the Medicare program. We do not anticipate 
increased administrative burden as documentation in the medical record 
of any referred service is already a part of discharge planning in the 
hospital setting. The changes to the GFR requirements are to conform 
our regulation to updated clinical standards and also do not pose a 
significant change.
8. Medicare Shared Savings Program
a. Modifications to the Shared Savings Program Quality Reporting 
Requirements Under the APP and the Quality Performance Standard
    In section IV.A.3.d.(1)(d) of this final rule, we are extending the 
use of the CMS Web Interface as a collection type for the Quality 
Payment Program for performance years 2022, 2023, and 2024 for Shared 
Savings Program ACOs reporting under the APP. In section III.J.1.c. of 
this final rule, we are finalizing that in order for ACOs to meet the 
quality reporting requirements under the Shared Savings Program for 
performance year 2022 and subsequent performance years, ACOs must meet 
the following requirements:
    For performance years 2022, 2023, and 2024: An ACO must report on 
either:
    (a) The ten CMS Web Interface measures and administer a CAHPS for 
MIPS survey and CMS will calculate the two claims-based measures 
included under the APP, or
    (b) The three eCQMs/MIPS CQMs and administer a CAHPS for MIPS 
survey and CMS will calculate the two claims-based measures included 
under the APP.
    If an ACO chooses to report the three eCQMs/MIPS CQMs, its 
performance on all three eCQMs/MIPS CQMs will be used for purposes of 
MIPS scoring under the APP. If an ACO decides to report both the ten 
CMS Web Interface measures and the three eCQMs/MIPS CQMs, it will 
receive the higher of the

[[Page 65630]]

two quality scores for purposes of the MIPS Quality performance 
category. For performance year 2025 and subsequent years: The ACO must 
report the three eCQMs/MIPS CQMs and administer a CAHPS for MIPS survey 
and CMS will calculate the two claims-based measures included under the 
APP.
    Absent the related provision analyzed below to reduce the quality 
performance standard for PY 2023 to the 30th percentile MIPS Quality 
performance category score, the changes to the quality reporting 
requirements, including the accommodation to continue the availability 
of the CMS Web Interface as a reporting mechanism under the APP will 
likely provide an easier path for a meaningful subset of ACOs that 
would otherwise have faced difficulty meeting the quality performance 
threshold previously established in rulemaking for PY 2023. However, we 
estimate that nearly all such ACOs would already have met the lower 
30th percentile performance standard in PY 2023 without the additional 
reporting flexibility. Of the relatively few, remaining ACOs that we 
estimate would have failed to meet the lower 30th percentile 
performance standard without the additional reporting flexibility, we 
estimate that about half (on average) will meet the quality performance 
standard as a result of the quality reporting flexibility adopted in 
this final rule, and thereby further increase shared savings payments 
to ACOs by about $20 million in PY 2023.
    In section III.J.1.d. of this final rule, we are finalizing, with 
modifications, the proposal to freeze the quality performance standard 
at the 30th percentile across all MIPS Quality performance category 
scores for performance year 2023, and to establish incentives to 
encourage ACOs to begin the transition to eCQM/MIPS CQM reporting in 
performance year 2022 and performance year 2023. The quality 
performance standard will increase to the 40th percentile across all 
MIPS Quality performance category scores for performance years 2024 and 
subsequent performance years. The quality performance standard is the 
minimum performance level ACOs must achieve in order to share in any 
savings earned, avoid maximum shared losses under certain payment 
tracks, and avoid quality-related compliance actions.
    We are finalizing that, with the exception of an ACO in the first 
performance year of its first agreement period, an ACO will meet the 
quality performance standard under the Shared Savings Program by 
reporting quality data via the APP established under Sec.  414.1367 
according the method of submission established by CMS and for:
     Performance years 2022 and 2023:
    ++ Achieving a quality performance score that is equivalent to or 
higher than the 30th percentile across all MIPS Quality performance 
category scores, excluding entities/providers eligible for facility-
based scoring, or
    ++ If the ACO reports the three eCQMs/MIPS CQMs, meeting the data 
completeness requirement at Sec.  414.1340 and the case minimum 
requirement at Sec.  414.1380 for all three measures, and achieves a 
quality performance score equivalent to or higher than the 10th 
percentile of the performance benchmark on at least 1 of the 4 outcome 
measures in the APP measure set and a quality performance score 
equivalent to or higher than the 30th percentile of the performance 
benchmark on at least 1 of the 5 remaining measures in the APP measure 
set. Consequently, the ACO would be required to meet the performance 
benchmark on either 2 outcome measures (one measure at the 10th 
percentile and the other at the 30th percentile), or 1 outcome measure 
at the 10th percentile and any other measure in the APP measure set at 
the 30th percentile.
    If the ACO (1) does not report any of the 10 CMS Web Interface 
measures or any of the three eCQMs/MIPS CQMs and (2) does not 
administer a CAHPS for MIPS survey, the ACO would not meet the quality 
performance standard.
     Performance year 2024 and subsequent performance years:
    Achieving a 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.
    If the ACO (1) does not report any of the 10 CMS Web Interface 
measures or any of the three eCQMs/MIPS CQMs and (2) does not 
administer a CAHPS for MIPS survey, the ACO would not meet the quality 
performance standard.
    Our analysis of quality performance data reported by ACOs for 
performance years starting during 2019 indicates that about 20 percent 
of ACOs would have failed a quality performance standard defined as the 
40th percentile across all MIPS Quality performance category scores. 
There is significant uncertainty whether PY 2023 will play out 
similarly to the baseline data. The fraction of ACOs that would 
ultimately fail to meet a higher standard in PY 2023 could change 
significantly if the universe of MIPS Quality performance category 
scores improves relative to ACOs' quality performance scores, or 
alternatively if ACOs, particularly ACOs at risk of failing, respond to 
the increased quality performance standard by boosting their 
performance. Utilizing a Monte Carlo approach, assuming that the 
simulated poor performing ACOs have a 50 percent chance of improving 
their quality performance beyond the 40th percentile, if CMS kept the 
quality performance standard at the 40th percentile, then the cost of 
reducing to the 30th percentile in 2023 will be $190 million (range $10 
million to $370 million). There is a wide range because slight changes 
in quality scoring at the low end of the distribution could render the 
40th percentile more or less of an effective point of discrimination 
among ACOs earning shared savings.
b. Modifications to Other Shared Savings Program Requirements
    We do not anticipate a material aggregate impact for the other 
changes we are finalizing as proposed related to the Shared Savings 
Program, specifically: Revisions to the definition of primary care 
services used in the Shared Savings Program's beneficiary assignment 
methodology (section III.J.2. of this final rule); revisions to the 
repayment mechanism arrangement policy, including changes to the 
calculation and recalculation of repayment mechanism amounts (section 
III.J.3. of this final rule); revision of the requirements concerning 
disclosure of prior participation in the Shared Savings Program by the 
ACO, ACO participants, and ACO providers/suppliers, and revisions to 
Shared Savings Program requirements to reduce the frequency and 
circumstances under which ACOs submit sample ACO participant agreements 
and executed ACO participant agreements to CMS (section III.J.4. of 
this final rule); and revisions to the beneficiary notification 
requirement as it applies to ACOs under prospective assignment and ACOs 
under preliminary prospective assignment with retrospective 
reconciliation (section III.J.5. of this final rule).
    However, as we note in section III.J.3. of this final rule, lower 
required repayment mechanism amounts could reduce costs for ACOs in 
fees charged by financial institutions for letters of credit and by 
insurance companies for surety bonds. We estimate that such relief, in 
total for all participating ACOs, could be worth $2 to $4 million 
annually under the approach we are finalizing (assuming a reduction of 
approximately $196 million in repayment mechanism amounts, in 
aggregate).

[[Page 65631]]

    We also note that the revisions we are finalizing to the definition 
of primary care services used in the assignment methodology may have 
differing effects on a subset of participating ACOs, for example, by 
leading a beneficiary to be assigned to a competing ACO, for a small 
subset of beneficiaries. We do not anticipate such ACO-level changes 
will result in a net impact on program spending overall.
9. Medicare Ground Ambulance Data Collection System
    In section III.K. of this final rule, we finalized our proposed 
changes to the Medicare Ground Ambulance Data Collection System 
including the proposed change to the data collection period and data 
reporting period for selected ground ambulance organizations in year 3, 
proposed revisions to the timeline for when the payment reduction for 
failure to report will begin and when the data will be publicly 
available, and proposed revisions to the Medicare Ground Ambulance Data 
Collection Instrument.
    We stated in the proposed rule that while we believed that these 
changes and clarifications will be well received by the ground 
ambulance stakeholders, we did not believe that these changes will have 
any substantive impact on the cost or time associated with completing 
the Medicare Ground Ambulance Data Collection Instrument. We also noted 
in the proposed rule that the overall length of the Medicare Ground 
Ambulance Data Collection Instrument would be the same as previously 
finalized (84 FR 62888) with these changes. Additionally, some of the 
instructions which we proposed to add were intended to improve clarity 
and may therefore reduce the time the ground ambulance organizations 
spend addressing the questions. We did not receive any public comments 
on our estimated impact on the cost or time associated with completing 
the Medicare Ground Ambulance Data Collection Instrument. As we 
discussed in section III.K of this final rule, we are finalizing our 
proposed changes to the Medicare Ground Ambulance Data Collection 
System.
10. Medicare Diabetes Prevention Program Expanded Model
a. Effects of Provisions Relating to the Medicare Diabetes Prevention 
Program Expanded Model
(1) Effects on Beneficiaries
    We proposed to modify certain Medicare Diabetes Prevention Program 
(MDPP) expanded model policies to: (1) Allow CMS to remove the ongoing 
maintenance phase (months 13-24) of the MDPP set of services for those 
beneficiaries who started their first core session on or after January 
1, 2022; (2) update the performance payments for the MDPP set of 
services in the core and core maintenance performance periods; and (3) 
waive the Medicare provider enrollment application fee for all 
organizations enrolling as MDPP suppliers on a prospective basis. These 
changes will have a positive impact on beneficiaries' health by 
increasing the capacity of MDPP eligible organizations to enroll in 
Medicare as MDPP suppliers and increasing access to the MDPP set of 
services for beneficiaries. Eligible beneficiaries receive these 
services as preventive services, which require no copays or cost 
sharing. These changes address MDPP supplier and beneficiary needs 
based upon all available monitoring and evaluation data. The changes 
are also responsive respond to stakeholder comments.
(2) Effects on the Market
    Currently, more than 1,000 organizations nationally are eligible to 
become MDPP suppliers based on their preliminary or full CDC Diabetes 
Prevention Recognition Program (DPRP) status. However, only 27 percent 
of eligible organizations are participating in MDPP. We anticipate that 
the removal of the second year of the MDPP set of services will make 
MDPP attractive and feasible to more MDPP eligible organizations. Not 
only does a 12-month MDPP services period align with that of the CDC's 
National DPP and the DPP model test, our data show that only 10 percent 
of enrolled MDPP participants continue with the Ongoing Maintenance 
phase sessions (Year 2), and the majority are reaching their weight 
loss milestone within the first 6 months of the set of MDPP services. 
Stakeholders report that the second year of MDPP, or the ongoing 
maintenance phase, is cost prohibitive due to the costs to retain 
beneficiaries in year 2 of the expanded model as well as the costs to 
deliver an additional year of the expanded model that is not supported 
by the CDC National DPP curriculum. The CDC's National DPP curriculum 
supports a 1-year program and suppliers have found it difficult to 
extrapolate the curriculum to a second year. Additionally, MDPP 
suppliers commented that they have an increasingly difficult time 
making the business case for MDPP given the costs associated with the 
ongoing maintenance phase and the low performance payments associated 
with the second year. Given the low volume of participants continuing 
in the second year of MDPP, delivering the MDPP ongoing maintenance 
period creates an undue burden to MDPP suppliers. The cost to offer and 
deliver the sessions to a small cohort of individuals outweigh the 
maximum payments available from Medicare.
    Stakeholders have consistently commented that CMS should shorten 
the MDPP expanded model to 1 year, with payment levels at least 
equivalent to the levels provided in the DPP model test. For example, 
during the DPP model test, suppliers were paid an average of $462 per 
beneficiary for the 1-year model test. The second year has made 
delivering MDPP both financially unattractive and unstainable for many 
of the current and eligible MDPP suppliers. Suppliers have reported 
that it is very difficult to engage and retain beneficiaries in a 
second year, and the reimbursement levels for a second year are 
inadequate to cover supplier costs. We proposed to shorten the MDPP 
service period to 1 year and increase the performance payments in the 
first year. These changes respond to stakeholder feedback and may 
alleviate some of the difficulty retaining MDPP participants during the 
core maintenance phase of the expanded model.
(3) Burden Related to Information Collection Requirements--No impact
(a) Supplier Standards
    MDPP suppliers may encounter the Medicare enrollment fee during the 
following Medicare provider enrollment transactions: initial 
enrollment; revalidation (every 5 years for MDPP); or the addition of a 
new practice location. The provider/supplier enrollment fee for 
Calendar Year 2021 is $599. Although MDPP suppliers may submit a 
written request to CMS for a hardship exception to the application fee 
in accordance with Sec.  424.514, many will not qualify and the 
hardship application process will simply add more burden on the 
organization. We have heard from the CDC as well as other stakeholders 
that the enrollment fee is a potential barrier to eligible MDPP 
suppliers who will not otherwise enroll in Medicare except for MDPP. 
Approximately 39 percent of our current suppliers are non-traditional 
suppliers that serve their local communities and play a critical role 
in enrolling more diverse, equitable, and inclusive cohorts of Medicare 
beneficiaries to MDPP. These non-traditional suppliers include, but are 
not limited to YMCAs, county health departments, community health 
centers, and non-profit organizations that focus on health education, 
and otherwise will neither enroll nor be able

[[Page 65632]]

to enroll as a Medicare supplier at all if it were not for MDPP. They 
often serve as trusted sources of health information for their 
communities. However, they also represent a large number of eligible 
organizations who have not enrolled in Medicare as MDPP suppliers. We 
anticipate that waiving the enrollment fee on a prospective basis along 
with the other programmatic adjustments are likely to result in more 
MDPP suppliers, increased beneficiary access to MDPP services, and an 
ongoing reduction of the incidence of diabetes in eligible Medicare 
beneficiaries, in both urban and rural communities.
    In April 2020, CMS waived all provider enrollment application fees 
as part of the COVID-19 Emergency Declaration Blanket Waivers for 
Health Care Providers. As a result, we saw an increase in MDPP supplier 
enrollment. We believe that granting a waiver of the fee for MDPP 
suppliers to extend beyond the COVID-19 Emergency Declaration Blanket 
Waiver, along with the other change to MDPP, may stimulate MDPP 
supplier enrollment and enhance the MDPP evaluation. We proposed 
waiving the Medicare provider enrollment fee beyond COVID-19 Emergency 
Declaration Blanket Waivers for Health Care Providers because the 
enrollment fee creates a potential barrier to MDPP supplier enrollment, 
beneficiary access to the program, and subsequently, our ability to 
evaluate MDPP. Specifically, we proposed, to waive the enrollment fee 
as described in section 1866(j)(2)(C)(i) and (ii) of the Act during the 
MDPP expanded model test phase.
(b) Payment for MDPP Services
    Our regulations at Sec.  414.84 specify the payments MDPP suppliers 
may be eligible to receive, payments for furnishing MDPP services, and 
meeting performance targets related to beneficiary weight loss and/or 
attendance. MDPP suppliers are paid by CMS by submitting claims for 
MDPP beneficiaries using claim form CMS-1500 (https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS1500.pdf). As a condition for 
payment, claims submitted by MDPP suppliers must be for services 
furnished to eligible beneficiaries in accordance with Sec.  414.84(b) 
and (c). We have streamlined the performance payments so that they are 
easier to understand and suppliers receive larger payments for 
participants reaching attendance and weight loss performance-based 
milestones. For example, the attendance-based performance payments are 
based on a standardized per-session rate, paid after the 1st, 4th, and 
9th sessions attended during the core sessions interval, and after 
attending the two (2) sessions during each of the core maintenance 
intervals. We have redistributed all the Year 2 ongoing maintenance 
sessions phase performance payments to certain core and core 
maintenance session performance payments in Year 1. As finalized, the 
maximum payment of $705 over a 1-year service period is $1 more than 
the current maximum payment of $704 under the original 2-year payment 
structure. We believe eliminating the second year and its associated 
payments while increasing the first-year payments will result in a more 
financially sustainable expanded model.
    Increasing the first year MDPP payment amounts should not 
negatively affect a supplier's performance (for example, participants' 
weight loss). As finalized, we increased the per session payments to 
$35, with suppliers receiving $53 more per beneficiary who attends the 
4th core session compared to current payments and $27 more than 
proposed. We increased the attendance-based payments in response to 
stakeholder comments and maintained the 5 percent weight loss payments. 
Although some of the largest payments to suppliers are still driven by 
weight loss achievement, the maximum payment for attendance only is 
finalized at $455 compared to $338 proposed and $205 current. Further, 
in order to maintain CDC Diabetes Prevention Recognition Program (DPRP) 
recognition status, which is required to be an MDPP supplier, certain 
levels of performance metrics (for example, weight loss) must be 
satisfied. There is no evidence that eliminating the second-year 
maintenance sessions, shortening the MDPP services period to 1 year, 
will have any negative effects on performance of the expanded model.
(4) Effects on the Medicare Program
(a) Estimated 10-Year Impact of MDPP
    Table 140 shows an updated estimate (in millions) for the impact on 
Medicare spending of two changes to the Medicare Diabetes Prevention 
Program (MDPP) to be implemented in 2022, with corrected assumptions:
     Waiving the Medicare enrollment fee for all new MDPP 
suppliers; and
     Shortening the MDPP services period to 1 year and shifting 
all of the Ongoing Maintenance reimbursement amounts to year one.
[GRAPHIC] [TIFF OMITTED] TR19NO21.171

    These estimates by the CMS Office of the Actuary do not consider 
waiving the Medicare enrollment fee as a direct cost and assume there 
will be an additional 500 beneficiaries per year participating in MDPP. 
The average payment for an MDPP participant will increase by $150. 
While the maximum payment available to an MDPP supplier is only 
slightly greater than the maximum payment available under the original 
2-year payment structure, the second year set of MDPP services have 
historically been far less utilized than the first year set of 
services. Therefore, eliminating the second-year payments has a minimal 
negative effect to the assumed costs of the expanded model. In the most 
recent year prior to the PHE, 747 Medicare FFS beneficiaries entered 
MDPP. Increasing the first-year payment amounts to suppliers and 
waiving the Medicare enrollment fee should increase access to MDPP, 
resulting in more utilization of the MDPP set of services. Starting in 
2022, we can assume that 750 beneficiaries will have entered the 
expanded model each year without including the finalized changes. After 
including these changes, we will now

[[Page 65633]]

assume 1,250 beneficiaries will enter the expanded model each year. 
This assumption has a high level of uncertainty and we revisit it in 
the Sensitivity Analysis section.
    Increasing the first year MDPP payment amounts should not 
negatively affect a supplier's performance (for example, participants' 
weight loss). Almost all of the increases to the payment amounts are 
applied after the 4th core session. Even though most of the payment 
increases are not tied to weight loss achievement, in order to maintain 
CDC Diabetes Prevention Recognition Program recognition status, which 
is required to be an MDPP supplier, certain levels of performance 
metrics (for example, weight loss) must be satisfied.
    There is no evidence that eliminating the second-year maintenance 
sessions, shortening the MDPP services period to one year, will have 
any negative effects on performance of the expanded model.
(b) Sensitivity Analysis
    Since the cost to suppliers for delivering the MDPP set of services 
is generally unknown, how utilization of the expanded model will be 
affected by the changes is highly uncertain. Table 141 shows the 10-
year impact estimates (in millions) for different levels of additional 
beneficiary participation as a result of the changes:
[GRAPHIC] [TIFF OMITTED] TR19NO21.172

    Finally, higher projected savings are associated with increases in 
beneficiary participation, while no additional beneficiaries will 
result in an estimated cost.
    The financial impacts we provided for the previously proposed 
payment schedule changes included errors that impacted our estimates: 
additional costs resulting from payment increases were not applied to 
the baseline participants; the count of 1,742 participants used to 
estimate future baseline participation included Medicare Advantage 
beneficiaries, which should have been excluded; and since there were 
only 747 new FFS participants in the most recent year prior to the 
start of the PHE, our best estimate would have assumed 250 additional 
FFS participants per year resulting from the previously proposed 
changes.
[GRAPHIC] [TIFF OMITTED] TR19NO21.173

b. Alternatives Considered
    No alternatives were considered. The 2-year MDPP service period has 
depressed interest in MDPP among would-be MDPP suppliers. These actions 
address stakeholder comments on the barriers to MDPP expanded model 
success. If we do not take action, we will not be able to scale MDPP as 
intended, impacting Medicare beneficiary access to this expanded model. 
Reducing the MDPP from a 24-to a 12-month services period, increasing 
the year 1 performance payments, and waiving the Medicare provider 
enrollment application fee not only better aligns the expanded model 
with the evidence that helped certify the DPP model test initially, but 
it will encourage eligible organizations to enroll as MDPP suppliers.
c. Impact on Beneficiaries
    This change will have a positive impact on eligible MDPP 
beneficiaries, as it better aligns with the CDC's National DPP, giving 
both the participants and the coaches similar messaging regarding this 
expanded model, regardless of payer. MDPP suppliers often offer the 
MDPP set of services to mixed cohorts, or classes with participants who 
are not eligible for MDPP, but who are enrolled in a National DPP 
cohort. Since MDPP generally follows the CDC's National DPP and aligns 
its expanded model with the CDC's DPRP Standards, it is confusing to 
participants, coaches, and staff when talking about a 2-year set of 
services to its eligible Medicare participants when the non-Medicare 
participants have a 1-year program. Finally, reducing the MDPP service 
period from 2 years to 1 year allows more cohorts to start and finish 
MDPP during the expanded model initial period of performance, which is 
expected to end in March 2023.
d. Estimating Regulatory Familiarization Costs
    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

[[Page 65634]]

have started the MDPP expanded model or are interested in MDPP.
11. Vaccine Administration Services
    In section II.J.1. of this final rule, we are finalizing that 
effective January 1, 2022, CMS will pay $30 per dose for the 
administration of the influenza, pneumococcal and hepatitis B virus 
vaccines. In addition, CMS will maintain the current payment rate of 
$40 per dose for the administration of the COVID-19 vaccines through 
the end of the calendar year in which the ongoing PHE ends. Effective 
January 1 of the year following the year in which the PHE ends, the 
payment rate for COVID-19 vaccine administration will be set at a rate 
to align with the payment rate for the administration of other Part B 
preventive vaccines.
    We estimate that the policy to increase the administration cost for 
influenza/pneumococcal/HBV vaccine services to $30 in 2022 will 
increase Medicare spending by roughly $250 million in CY 2022. This 
estimate doesn't reflect the impact of induced utilization of the 
vaccine, or any offsetting savings resulting from averted 
hospitalizations for those who would now get the vaccine. This policy 
may encourage more health care providers to offer these services or 
encourage those that already offer these services to proactively 
identify and vaccinate more beneficiaries compared to what they might 
under the lower rates, which would result in further additional vaccine 
costs. However, if more beneficiaries were vaccinated then Medicare 
costs associated with the treatment of influenza, pneumonia, and 
hepatitis B could be reduced. In order to offset the costs associated 
with this policy roughly 10-11K influenza-related hospitalizations 
would have to be averted.
12. Medicare Provider and Supplier Enrollment Changes--Provider 
Enrollment
    As explained in section III.N. of this final rule, we proposed 
changes to three of our existing revocation reasons:
     We proposed to expand Sec.  424.535(a)(2) to permit 
revocation based on the OIG exclusion of administrative or management 
services personnel furnishing services payable by a Federal health care 
program, such as a billing specialist, accountant, or human resources 
specialist.
     We proposed to expand Sec.  424.535(a)(13) to permit 
revocation of a physician's or other eligible professional's enrollment 
if he or she surrenders his/her Drug Enforcement Administration (DEA) 
certificate of registration in response to an order to show cause.
     We proposed to revise the factors in Sec.  
424.535(a)(8)(ii) (which permits revocation based on a pattern or 
practice of submitting non-compliant claims) to better enable CMS to 
target shorter periods of non-compliant billing.
    We believe that all three of these changes will result in an 
increase in the number of revocations that CMS imposes. However, we 
believe this number will be rather small. We currently impose only a 
limited number of revocations under Sec. Sec.  424.535(a)(2), (a)(13), 
and (a)(8)(ii). Accordingly, since our expansion of these three 
revocation reasons will be fairly modest, we do not foresee more than a 
very slight increase in revocations.
    Table 143 outlines the number of revocations we estimate will ensue 
under our revocation expansions. These numbers only account for 
additional revocations stemming from our changes:
[GRAPHIC] [TIFF OMITTED] TR19NO21.174

Internal CMS data indicates that the average provider/supplier that 
will be affected by these regulatory expansions receives roughly 
$50,000 in Medicare payments each year. (We used a similar $50,000 
annual payment estimate for our provider enrollment provisions in the 
CY 2020 PFS final rule) (84 FR 62568)). Providers/suppliers revoked 
under our revocation expansions will thus not receive these payments. 
Hence, multiplying our $50,000 estimate by the revocation totals in 
Table 143 results in a projected transfer from these providers/
suppliers to the Federal Government of $750,000 ($50,000 x 15 
revocations).
    We did not receive public comments on these estimates and are 
therefore finalizing them as proposed.
13. Provider/Supplier Medical Review Requirements--Prepayment and Post-
Payment Reviews
    In section III.N.2. of this final rule, we proposed to: (1) Define 
key terms including ``additional documentation,'' ``additional 
documentation request,'' ``post-payment medical review,'' and 
``prepayment medical review;'' (2) codify contractors' authority to 
request additional documentation for prepayment and post-payment review 
within established timeframes; (3) codify timeframes for response to 
requests for documentation; and (4) codify result of a failure to 
comply with prepayment or post-payment documentation request(s) by a 
provider or supplier, specifically denial of payment. We do not believe 
these provisions involve any additional impact or burden on providers, 
suppliers, or States; however, we welcomed feedback from stakeholders 
regarding the potential costs of these provisions.
    The regulations will incorporate already established key terms and 
definitions as well as processing requirements pertaining to prepayment 
and post-payment medical review into regulation. Placing this 
information in regulation will improve provider and supplier 
understanding of the medical review process and their responsibilities 
in complying with our review contractor's requests. Further, the 
regulations represent no change to medical review requirements. As 
such, we did not anticipate any change in the number of prepayment 
medical reviews, post-payment medical reviews or the number of 
additional documentation requests made by contractors.
    We did not receive public comments on this provision, and 
therefore, we are finalizing as proposed.

[[Page 65635]]

14. Effect of Modifications to Medicare Coverage for Opioid Use 
Disorder (OUD) Treatment Services Furnished by Opioid Treatment 
Programs (OTPs)
    As discussed in section III.O of this final rule, we are finalizing 
our proposal to allow OTPs to continue to furnish the therapy and 
counseling portions of the weekly bundles, as well as any additional 
counseling or therapy that is billed using the add-on code, using 
audio-only telephone calls rather than via two-way interactive audio-
video communication technology in cases where audio/video communication 
is not available to the beneficiary after the conclusion of the PHE for 
COVID-19, provided all other applicable requirements are met. We 
believe this change will facilitate broader access to these services 
for beneficiaries. We are also finalizing our proposal to require that 
when these services are furnished using audio-only technology, 
practitioners certify that they had the capacity to furnish the 
services using two-way audio/video communication technology, but 
instead, used audio-only technology because audio/video communication 
technology was not available to the beneficiary.
    We believe the Part B cost impact of these final policies will be 
minimal, since payment for therapy and counseling is included in the 
bundled payment regardless of the modality used to deliver it and we do 
not expect that this provision will increase the frequency at which 
medically necessary counseling and therapy services are billed using 
the counseling and therapy add-on code (HCPCS code G2080).
    Additionally, as discussed in section III.O. of this final rule, 
the FDA recently announced the approval of a new, higher dose naloxone 
hydrochloride nasal spray product used to treat opioid overdose and 
that the newly approved product delivers 8mg of naloxone. In the CY 
2021 PFS final rule (85 FR 84683 through 84685), we finalized payment 
for HCPCS code G2215 (Take-home supply of nasal naloxone (provision of 
the services by a Medicare-enrolled Opioid Treatment Program); List 
separately in addition to code for primary procedure). HCPCS code G2215 
was priced based on an assumption of a typical case in which the 
beneficiary will be provided with a box of two 4mg nasal spray 
products. At the time of drafting the proposed rule, we did not yet 
have any available pricing information for this newly approved product. 
However, in order to be able to make payment to OTPs under Medicare for 
this product, we proposed to create a new G-code describing a take-home 
supply of this higher dose naloxone hydrochloride nasal spray product. 
After considering the comments received, we are finalizing our proposal 
to establish a new code for a higher-dose of naloxone hydrochloride 
nasal spray. We will price this code as proposed; the drug component is 
based on the methodology at Sec.  410.67(d)(2)(i) and the amount of the 
non-drug component of the code is based on the CY 2020 Medicare payment 
rate for CPT code 96161, as updated by the MEI. Based on utilization of 
the existing naloxone codes under the OTP benefit, we believe that the 
cost impact of finalizing this new code will be minimal.
15. Physician Self-Referral Update
    The physician self-referral law provisions are discussed in section 
III.P. of this final rule.
    As discussed in section III.P.2. of this final rule, we are 
amending the provisions of Sec.  411.354(c)(2) identifying unbroken 
chains of financial relationships that constitute ``indirect 
compensation arrangements'' to ensure that a longstanding prohibition 
on certain per unit of service-based compensation formulas for 
determining charges for the rental of office space and equipment 
remains within the ambit of the law. This provision, which was 
inadvertently omitted when the definition of ``indirect compensation 
arrangement'' was revised in the December 2, 2020 final rule entitled 
``Modernizing and Clarifying the Physician Self-Referral Regulations'' 
(85 FR 77492), is necessary to protect against potential abuses such as 
overutilization and anti-competitive behavior. We believe that most 
parties have continued to comply with the regulatory provisions on per 
unit of service-based compensation formulas for the rental (or lease) 
of office space and equipment as they have done since the requirements 
became effective on October 1, 2009. We are also adding provisions to 
assist stakeholders in identifying the individual unit to be analyzed 
under the provisions of Sec.  411.354(c)(2)(ii)(A)(2)(i) through (iv). 
We believe that the clarity provided by these provisions will 
facilitate compliance without adding burden.
    As discussed in section III.P.3. of this final rule, we are 
finalizing our proposal to permit the use of the exception for 
preventive screening tests and vaccines at Sec.  411.355(h) for COVID-
19 vaccines during such period as the vaccines are not subject to CMS-
mandated frequency limits, provided that all other requirements of the 
exception are satisfied. We believe that this provision will ensure 
that the physician self-referral law will not impede the availability 
of critically important COVID-19 vaccines for Medicare and other 
patients.
    As discussed in section III.P.4. of this final rule, we are 
finalizing our proposal to publish the Code List for Certain Designated 
Health Services (Code List) solely on the CMS website. Commencing after 
the publication of the January 1, 2022 Code List in this final rule, 
the Code List will be updated annually and published on the CMS website 
at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes. No less than 30 consecutive calendar days prior to the 
effective date of a Code List update, we will provide advance notice of 
the updated Code List on the CMS website. We will also provide for a 
30-day public comment period for each update using www.regulations.gov, 
and publish instructions for submitting comments on the CMS website. We 
will address all public comments that we receive through this process 
on the CMS website. Finally, we are revising the definition of ``List 
of CPT/HCPCS Codes'' at Sec.  411.351 by updating the URL that 
indicates where the Code List is published on the CMS website. We 
believe that these provisions will facilitate compliance with the 
physician self-referral law and allow easier access to the most up-to-
date Code List.
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 addition to the cost reflected in the Collection of Information 
section of this final rule, we expect that there will be an additional 
burden for CMS to award and work with a CMS contractor to develop a 
process for reviewing the PDE data to assess prescriber compliance with 
the regulatory provision and review and process prescriber 
attestations. Based on similar contracts, and conversations with the 
industry, in the CY 2022 PFS proposed rule, we estimated the costs of 
(A) development of operational strategy for the new program, (B) 
reviewing PDE data, and (C) prescriber case work. We solicited 
stakeholder feedback on our estimate and all our assumptions.
    (A) Development of policy: We estimated that it would take our 
contractor a week of work, 40 hours, to develop the strategy for how 
the contractor will process the prescriber attestations. We estimated 
that it would take an operations manager and compliance officer working 
together at a combined hourly wage of $193.60/hr

[[Page 65636]]

($120.90/hr + $72.70/hr) a full 40-hour work week to operationalize 
this aspect of it. Therefore, we estimated the aggregate cost to be 
$7,744 (40hr * $193.60/hr).
    (B) Since systems already exist to collect the appropriate PDE 
data, in our proposed rule, we stated that our contractor would only 
have to review the data for compliance with the EPCS mandate. 
Therefore, we estimated that it would take 2 computer systems analysts 
each working at $95.22/hr, a week and a half of work, 60 hours. 
Therefore, the aggregate cost would be $5,713.20 (60 hr * $95.22/hr).
    (C) We estimated that it would take 4 administrative support 
workers each working at $36.82/hr, 60 hours to generate the letters and 
disseminate them to the appropriate prescriber, which means that it 
would cost our contractor $2,209.20/year (60 hr * $36.82/hr) in 
administrative support costs. We estimated that it would be the full-
time job of a customer service representative working at $37.02/hr to 
field prescriber inquiries about the disseminated letters. Thus, we 
estimated that our contractor would spend $77,001.60 ($37.02/hr * 40 * 
52) on the salary of the customer service representative for this task.
    The aggregate impact for our contractor is 200 hours at a cost of 
$92,668. We solicited comment on the accuracy of this burden estimate 
and on any measures that CMS can take to decrease the impact of this 
provision, while maintaining its utility and implementing the statutory 
mandate. We did not receive public comments on the burden estimates for 
this provision, and therefore, we are finalizing as proposed.
17. Open Payments
a. Payment Context Field for Teaching Hospitals
    This provision is for a mandatory freeform text context field. We 
have created this provision at the request of stakeholders, 
particularly after conversations with teaching hospitals. The teaching 
hospitals confirmed that the majority of their disputes arise because 
of a lack of information within the record and an inability to 
associate the payment to the correct area within their large 
organization, not the inaccuracy of the record itself. The benefit of 
this field is to give better context to the records attributed to 
teaching hospitals and thereby reduce the number of disputes. For this 
reason, we also believe it will increase goodwill between the program's 
stakeholders. The cost is that reporting entities will need to collect 
an additional piece of information, which will increase burden. We do 
not believe this burden will be great because the volume of reported 
teaching hospital payments is much lower than the volume of physician 
covered recipient payments. In addition, we have created flexibility 
with this field so that the reporting entity can choose which piece of 
information is most appropriate and can be something that they already 
collect, such as a check number or name of the department in the 
hospital.
b. Optional Annual Recertification
    The optional annual recertification is at the request of reporting 
entities and will increase the availability of communication to CMS. 
The burden associated with this action is low because it will be a low-
effort process only completed by the entities who choose to do so.
c. Defining a Physician-Owned Distributorship
    Since the program began in 2013, we have heard feedback that 
physician-owned distributorship (PODs) should be better represented in 
the data because the conflict of interest potentially created by PODs 
is at the heart of the program. We created this new definition due to 
the lack of an existing POD definition that would be appropriate for 
the program's needs. Although this is a new definition, it will only be 
a subset of the existing definitions of applicable manufacturer and 
applicable group purchasing organization. ``Applicable manufacturer--
POD'' and ``Group purchasing organization--POD'' are already ``business 
type'' choices when registering in the Open Payments system. Therefore, 
this definition will not alter existing regulations beyond requiring 
PODs to identify themselves as such.
d. Disallowing Record Deletion Without Reason
    We believe there is not currently language to prevent an applicable 
manufacturer or applicable group purchasing organization from 
submitting and attesting to records, then deleting the records to 
prevent publication. This action would be contrary to the spirit of 
transparency of the program. To help ensure compliance with this 
requirement, we are also adding a new field that will allow entities to 
communicate the reason for the deletion to CMS. Since the entities will 
have attested to the accuracy and completeness of these records, we 
believe it is appropriate to confirm the reason for the deletion. We 
have not perceived the behavior of inappropriate deletions within the 
data and do not believe it will increase burden beyond the additional 
field when deleting a record. We are preemptively closing a potential 
loophole.
e. Disallow Publication Delays of General Payments
    The statute requires that delays are ``made pursuant to product 
research or development agreements and clinical investigations'' 
(1128G(c)(1)(E) of the Act). A small number of general payments are 
delayed annually, which we are unable to verify meet this requirement. 
Research payments contain the appropriate fields to ensure that the 
statutory provisions are being met. We do not believe that it will be a 
burden for the small number of general payments to either be reported 
as research payments or not delayed.
f. Short-Term Loans
    Short-term loans are not required to be reported, but they must be 
shorter than 91 days to meet the exception. This provision does not 
create burden because it only clarifies that those 90 days must be the 
cumulative total for a year, which is already outlined in subregulatory 
guidance. We do not anticipate that this will change reporting behavior 
but want to explain the exception more clearly within the text of the 
final rule.
g. Remove General Ownership Records
    Ownership records have special rules for reporting outlined in the 
statute (section 1128G(a)(2) of the Act), which are not included in the 
format for general records. However, there is currently a general 
record for reporting ownership and investment interest (Nature of 
Payment = 11). We anticipate a small burden for the approximately 92 
reporting entities who have previously used the general nature of 
payment category in order to fill out the different fields in the 
ownership record. This burden will allow the records to meet statutory 
mandates.
h. Updated Contact Information
    Open Payments conducts regular compliance-related outreaches to 
reporting entities when it encounters data that may not meet program 
requirements. We have found that the two contacts provided by 
applicable manufacturers and group purchasing organizations often 
become obsolete, especially if a company has not updated its contact 
information during the recertification process. It is crucial for the 
integrity of the data that we have the ability to contact entities in 
the case of

[[Page 65637]]

irregularities. Additionally, we believe that ensuring informal 
communications from CMS will reduce burden since it may prevent more 
formal compliance actions if the entity is unresponsive due to outdated 
contact information. However, we do not believe this is an issue for 
the majority of reporting entities, nor do we believe that keeping the 
contact information updated will create a large burden.
18. Updates to the Quality Payment Program
    In section IV.A. of this final rule, we include our finalized 
policies for the Quality Payment Program. In this section, we first 
present the overall and incremental impacts to the number of expected 
QPs and associated APM Incentive Payments. In the following sections, 
we estimate the overall and incremental impacts to the total MIPS 
eligible population and the payment impacts by practice size for the CY 
2022 performance period/2024 MIPS payment year based on various 
finalized policies, including policies to modify MIPS eligibility, the 
MIPS final score and the performance threshold and additional 
performance threshold as discussed in sections IV.A.3.a., IV.A.3.d., 
IV.A.3.e., and IV.A.3.f. of this final rule.
    For the MIPS payment adjustment, we ran two RIA models: A baseline 
and a final policies model. The aim of the baseline model is to model 
the status of our population of clinicians for the CY 2022 performance 
period/2024 MIPS payment year if this final rule does not take effect. 
It therefore reflects previously finalized policies for the CY 2022 
performance period/2024 MIPS payment year. Select examples of the 
baseline policies scheduled to start in the CY 2022 performance period/
2024 MIPS payment year include the removal of the Web Interface as a 
collection type and the change in the performance category weights. 
There was no defined performance threshold or additional performance 
threshold, so our baseline model assumed the performance threshold and 
additional performance threshold used for the previous period (CY 2021 
performance period/2023 MIPS payment year).
    The aim of the final policies model is to estimate the incremental 
effect of the final policies for the CY 2022 performance period/2024 
MIPS payment year on MIPS eligibility, MIPS final scores, and payment 
adjustments. In other words, by comparing the difference between our 
baseline model and our final policies model we can estimate the 
incremental impact of finalizing the policies contained in this final 
rule. Select examples of the finalized policies include, the inclusion 
of new MIPS eligible clinician types, the inclusion of the Web 
Interface as a collection type, the change in performance threshold and 
additional performance threshold, and the changes to the complex 
patient bonus. Refer to section VI.F.18.e.(2) of this final rule for 
the detailed methods on how we integrated the policies into the 
baseline and final policies models.
a. Assessing Use of 2020 Data for Estimating Future MIPS Performance
    In the 2022 PFS proposed rule (86 FR 39546), we stated that the RIA 
used the 2019 MIPS performance period data because the data for the 
2020 MIPS performance period were not available in time to incorporate 
into the proposed rule model. We noted we would evaluate whether it is 
appropriate to use the 2020 performance period data to predict 
performance in CY 2022 for the final rule and whether adjustments would 
need to be made if CY 2020 performance period data are used. We have 
already acknowledged some data from the CY 2020 performance period is 
not usable. For example, we have stated that based on our analysis of 
the 2020 performance period data, we could not reliably calculate 
scores for the cost measures that would adequately capture and reflect 
the performance of MIPS eligible clinicians. As a result, we reweighted 
the cost performance category for all MIPS eligible clinicians for the 
CY 2020 MIPS performance period.\280\ Additionally, in section 
IV.A.3.f.(2) of this final rule, we noted we have final score data for 
the CY 2020 performance period/2022 MIPS payment year available to use 
in our assessment of whether to use the mean or median for the 
performance threshold, but the data for the CY 2020 performance period/
2022 MIPS payment year may be subject to change as a result of the 
targeted review process. However, we have also indicated that for 
certain purposes 2020 performance period data could be beneficial too. 
As discussed in section IV.A.3.e.(1)(c)(ii) of this final rule, we 
believe 2020 performance period data is appropriate to use for historic 
benchmarks in part because it is the most recent available dataset and 
it reflects a performance period in which clinicians were facing the 
PHE.
---------------------------------------------------------------------------

    \280\ https://qpp.cms.gov/mips/cost?py=2020. Last accessed 
October 20, 2021.
---------------------------------------------------------------------------

    To evaluate whether the 2020 MIPS performance period data is 
appropriate to use to predict future performance, we considered whether 
the extreme and uncontrollable circumstances policy impacted 
submissions and data, and whether the COVID-19 PHE impacted services 
provided (for example, quality measures, the number of MIPS eligible 
clinicians, claims). For the 2020 performance year, we applied the MIPS 
automatic extreme and uncontrollable circumstances policy to all 
individual MIPS eligible clinicians and allowed for extreme and 
uncontrollable applications due to the COVID-19 PHE (https://qpp.cms.gov/resources/covid19?py=2020). Due to these extreme and 
uncontrollable circumstances policies, not all clinicians or groups may 
have submitted data for the 2020 MIPS performance period.
    When we evaluated whether the 2020 MIPS performance period data is 
appropriate to use to estimate 2022 MIPS performance period performance 
for MIPS eligible clinicians, we compared the 2020 MIPS performance 
period data to the 2019 MIPS performance period data on key metrics. 
Overall, we observed a decrease in the number of MIPS eligible 
clinicians at the individual level who exceed the low-volume threshold. 
We also observed a decline in data submitted by individual and group. 
Finally, when examining actual scores and payment information for the 
2020 performance period/2022 MIPS payment year compared to the 2019 
performance period/2021 MIPS payment year, we found an increase in the 
number of MIPS eligible clinicians receiving a neutral score. However, 
our initial findings suggest the extreme and uncontrollable 
circumstances policy combined with the COVID-19 PHE limit the data 
needed to simulate future MIPS eligible population and associated 
performance. Therefore, this RIA uses the 2019 MIPS performance period 
submissions which were used for the CY 2021 PFS final rule RIA (85 FR 
85011 through 85023) and CY 2022 PFS proposed rule RIA (86 FR 39545 
through 39556). We note that the findings are specific for purposes of 
estimating future performance for the entire population of MIPS 
eligible clinicians.
b. Estimated APM Incentive Payments to QPs in Advanced APMs and Other 
Payer Advanced APMs
    For payment years 2019 through 2024, through the Medicare Option, 
eligible clinicians with a sufficient percentage of Medicare Part B 
payments for covered professional services or Medicare patients through 
Advanced APMs will be QPs in the applicable QP performance period for a 
year. These QPs will receive a lump-sum APM Incentive Payment equal to 
5 percent of

[[Page 65638]]

their estimated aggregate paid amounts for Medicare covered 
professional services furnished during the calendar year immediately 
preceding the payment year. 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 does not meet any other exemption category, the eligible 
clinician will be subject to MIPS, will report to MIPS, 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. In addition, MIPS eligible clinicians will receive 
positive, neutral, or negative MIPS payment adjustments to payment for 
their Part B PFS services in a payment year based on performance during 
a prior performance period. Although the statute establishes overall 
payment rate and procedure parameters until 2026 and beyond, this 
impact analysis covers only the 2024 MIPS payment year of the Quality 
Payment Program.
    Overall, we estimate that for the 2022 QP Performance Period 
between 225,000 and 290,000 eligible clinicians will become QPs. 
Therefore, they will be excluded them from MIPS and will qualify for 
the lump sum APM incentive payment in Payment Year 2024 based on 5 
percent of their Part B paid amounts for covered professional services 
in the preceding year. These paid amounts for QPs are estimated to be 
between approximately $12,000 million and $15,000 million in total for 
the 2022 performance year. The analysis for this final rule used the 
2020 third snapshot participation file. We based APM Incentive Payment 
Amounts on paid amounts with service dates of January 1, through 
September 30, 2020. We multiplied the calculated amounts by 1.5 to 
approximate payment amounts for the full calendar year. We estimate 
that the total lump sum APM Incentive Payments will be approximately 
$600-750 million for the 2024 Quality Payment Program payment year.
    In section VI.F.18.a. of this final 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 2022 QP Performance Period as well as some Advanced APMs 
anticipated to be operational during the 2022 QP Performance Period. 
The projections also reflect an estimated number of eligible clinicians 
that will attain QP status through the All-Payer Combination Option. We 
note that the Kidney Care Choices Model and the Radiation Oncology 
model have been included in our analysis as we anticipate that the 
model will be Advanced APMs in 2022. Additionally, we anticipate that 
the Maryland Primary Care Program will not be an Advanced APMs in 2022. 
The following APMs are expected to be Advanced APMs for the 2022 QP 
Performance Period:
     Bundled Payments for Care Improvement Advanced Model;
     Comprehensive Care for Joint Replacement Payment Model 
(CEHRT Track);
     Global and Professional Direct Contracting Model;
     Kidney Care Choices Model (Kidney Care First; Professional 
Option and Global Option);
     Maryland Total Cost of Care Model (Care Redesign Program);
     Medicare Shared Savings Program (Basic Track Level E, and 
the ENHANCED Track);
     Oncology Care Model (Two-Sided Risk Arrangements);
     Primary Care First (PCF) Model;
     Radiation Oncology model; and,
     Vermont All-Payer ACO Model (Vermont Medicare ACO 
Initiative).
    We used the Participation Lists and Affiliated Practitioner Lists, 
as applicable, (see 81 FR 77444 through 77445 for information on the 
APM Participant Lists and QP determinations) on the 2020 third snapshot 
participation file 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 2022 QP Performance Period. We examined 
the extent to which Advanced APM participants will meet the QP 
Thresholds of having at least 50 percent of their Part B covered 
professional services or at least 35 percent of their Medicare 
beneficiaries furnished Part B covered professional services through 
the APM Entity.
c. Impact for the CY 2021 Performance Period/2023 MIPS Payment Year
    In section IV.A.3.e.(2)(a)(ii) of this final rule, we finalize our 
proposal to double the complex patient bonus, and to increase its cap 
to 10 points for the CY 2021 Performance Period/2023 MIPS Payment Year. 
We expect this policy to result in an increase of 3 points in the 
median bonus thus increasing MIPS final scores at the median by 3 
points. We do not know the effects of the PHE for COVID-19 and its 
effect on MIPS performance in 2021, so we did not recreate the analysis 
and payment distributions with the updated bonus for the CY 2021 
performance period/2023 MIPS payment year (85 FR 85012 through 85019). 
The increase in complex patient bonus points will result in smaller 
payment adjustments for three reasons. First, the resulting increase in 
final scores will reduce the budget neutral pool. Second, the increase 
in complex patient bonus points will increase the number of clinicians 
with scores above the performance threshold or additional performance 
threshold, meaning more clinicians will share in the budget neutral 
pool and additional $500 million for exceptional performance and 
potentially lower the scaling factor that is applied to the MIPS 
payment adjustment and additional payment adjustment. Third, the 
average scores of those receiving a positive or additional adjustment 
will be higher, which means the adjustment rates for clinicians that 
have scores above the performance threshold or additional performance 
threshold will be lower.
d. Estimated Number of Clinicians Eligible for MIPS Eligibility for the 
CY 2022 Performance Period/2024 MIPS Payment Year
(1) Methodology To Assess MIPS Eligibility
(a) Clinicians Included in the Model Prior To Applying the Low-Volume 
Threshold Exclusion
    To estimate the number of MIPS eligible clinicians for the CY 2022 
performance period/2024 MIPS payment year and the effect of the final

[[Page 65639]]

policies in this final rule, we ran two models as described in section 
VI.F.18., a baseline model and final policies model.
    For the baseline and final policies models, we used the same 
eligibility files and approach described in the CY 2021 PFS final rule 
(85 FR 85013) which resulted in the inclusion of 1.6 million clinicians 
who had PFS claims from October 1, 2018 to September 30, 2019, as well 
as additional clinicians associated with a group who had at least one 
PFS claim from October 1, 2019, through December 31, 2019. We used the 
same exclusion criteria to exclude clinicians from our MIPS eligibility 
assessment as described in the CY 2021 PFS final rule RIA (85 FR 85013) 
with the following model updates:
    (1) In both the baseline and final policies models, we excluded 
practitioners in Next Generation ACOs because the Next Generation ACO 
model ends in the CY 2021 MIPS performance period.
    (2) In both the baseline and final policies models, to determine 
which clinicians in the initial population of 1.6 million should be 
excluded as QPs, we used Advanced APM payment and patient percentages 
from the APM Participant List for the final snapshot date for the 2019 
QP performance period. We elected to use this data source because the 
APM participant list for the 2019 final snapshot can reliably be used 
for RIA projections. From this data, we calculated the QP and Partial 
QP determinations as described in section of IV.A.4.c.(1)(b) of this 
final rule for the 2022 QP performance period for both models.
    (3) In the final policies model, we included in our estimated MIPS 
eligible population for the CY 2022 performance period/2024 MIPS 
payment year clinical social workers and CNMs as finalized in section 
IV.A.3.a.(1) of this final rule.
    (4) In the final policies model, we are integrating the provision 
that starting with the CY 2022 MIPS performance period/2024 MIPS 
payment year, small practices, excluding virtual groups, must submit 
data as a group in any performance category to indicate that they wish 
to be scored as a group for Medicare Part B claims. This affects 
eligibility because previously a single Medicare Part B claims 
submission, without any other submission, started a group score. Once a 
group score is created, a clinician who was individually excluded from 
MIPS for being under the low-volume threshold, may now be eligible if 
the group exceeds the low-volume threshold. This policy is described at 
section IV.A.3.a.(3) of this rule.
(b) Assumptions Related To Applying the Low-Volume Threshold Exclusion
    The low-volume threshold policy may be applied at the individual 
(TIN/NPI) or group (TIN) levels based on how data are submitted 
including under the APM Entity level if the clinician is part of an APM 
Entity in a MIPS APM (hereafter, a MIPS APM Entity) that elects to 
submit to MIPS. 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 
getting measured on performance and receiving a MIPS payment 
adjustment.
    For the final policies model, we describe below the estimated MIPS 
eligibility status and the associated PFS allowed charges of clinicians 
in the initial population of 1.6 million clinicians. We present in 
section VI.F.18.d.(1)(c) the incremental impact of the final policies 
from the baseline model for the CY 2022 performance period/2024 MIPS 
payment year on the MIPS eligible clinician population and their 
associated PFS allowed charges. We applied the same assumptions 
presented in the CY 2021 PFS final rule RIA to apply the low-volume 
threshold and to understand whether clinicians participate as a group, 
virtual group, APM entity, or as individuals (85 FR 85013 through 
85016), except for three modifications. We assumed only individuals or 
APM TINs that exceeded the low-volume threshold will receive an APM 
Performance Pathway (APP) score consistent with the policy as finalized 
in the CY 2021 PFS final rule (85 FR 84897).\281\ We assumed APM TINs 
that qualified for opt-in and submitted data as a TIN will also be 
eligible. Finally, we did not consider clinicians in groups as MIPS 
eligible clinicians nor start a group score for clinicians in small 
practices with only Medicare Part B claims submissions to reflect the 
policy finalized at section IV.A.3.a.(3) of this rule.
---------------------------------------------------------------------------

    \281\ Under the policy, APM TINs must submit data, but as that 
was not a requirement for 2019 Shared Saving Program participants, 
we assumed all TINs that exceed the low-volume threshold would 
submit data.
---------------------------------------------------------------------------

    Table 144 summarizes our eligibility estimates for the final 
policies model. We identify approximately 212,000 clinicians \282\ as 
having ``required eligibility'' in Table 144. These clinicians will be 
MIPS eligible because they exceed the low volume threshold as 
individuals and are not otherwise excluded. These clinicians may 
ultimately choose to participate in MIPS as an individual, group, 
virtual group or APM entity or to not participate. Regardless of how 
they participate they will be considered MIPS eligible. We estimate 
approximately 595,000 additional MIPS eligible clinicians will be 
eligible as ``group eligibility'' in Table 144. These clinicians belong 
to an APM entity, group or virtual group that meets the low-volume 
threshold and submits to MIPS. If they were not associated with the 
group submission, these clinicians would not be eligible for MIPS. 
Finally, we estimate about 3,000 clinicians will be eligible through 
``opt-in eligibility'' through the ``opt-in'' policy for a total MIPS 
eligible clinician population of approximately 810,000. This leads to 
an associated $67 billion allowed PFS charges estimated to be included 
in the CY 2022 performance period/2024 MIPS payment year.
---------------------------------------------------------------------------

    \282\ The count of 212,000 MIPS eligible clinicians for required 
eligibility is rounded and includes those who participated in MIPS 
(approximately 186,000 MIPS eligible clinicians), as well as those 
who did not participate (approximately 26,000 MIPS eligible 
clinicians).
---------------------------------------------------------------------------

BILLING CODE 4120-01-P

[[Page 65640]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.175

    Furthermore, we estimate there will be approximately 412,000 
clinicians as ``Potentially MIPS eligible'' in Table 144. These 
clinicians are not MIPS eligible but could be if their practice decides 
to participate or they elect to opt-in. These clinicians will 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. This assumption is important because it quantifies 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 1.2 million clinicians. Finally, we estimate approximately 
101,000 clinicians will not be MIPS eligible because they and their 
group are below the low-volume threshold on all three criteria and 
another approximately 304,000 will not be MIPS eligible because they 
are categorically excluded regardless of volume or submission activity.
    Eligibility among many clinicians is contingent on submission to 
MIPS as a

[[Page 65641]]

group, virtual 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 2022 MIPS performance period is closed. For this final 
policies model analysis, we use the estimated population of 809,593 
MIPS eligible clinicians described above.
(c) Estimated Impact of the Final Policies on MIPS Eligibility and PFS 
Allowed Charges
    We illustrate in Table 145 how the final policies to add clinical 
social workers and CNMs as MIPS eligible clinician types and the policy 
to require small practices to submit data as a group for a group 
quality performance category score as finalized in sections 
IV.A.3.a.(1) and IV.A.3.a.(3) of this final rule affects the estimated 
number of MIPS eligible clinicians. The amended regulation text that we 
finalized in section IV.A.3.a.(2) of this final rule does not make 
modify how we assess eligibility in MIPS in our final policies model.
    The first row in Table 145 presents the estimates from the RIA 
baseline model with the number of individuals that will be MIPS 
eligible clinicians for the 2022 performance period/2024 MIPS payment 
year if this rule does not take effect. The second row presents 
estimates from the RIA final policies model with the incremental impact 
of adding the two new MIPS eligible clinician types on the number of 
MIPS eligible clinicians for the CY 2022 performance period/2024 MIPS 
payment year. As shown in Table 145, the final policies lead to a small 
increase in the number of MIPS eligible clinicians (1.1 percent 
increase) and a minimal increase in the PFS allowed charges (0.1 
percent increase) for the CY 2022 performance period/2024 MIPS payment 
year.
[GRAPHIC] [TIFF OMITTED] TR19NO21.176

BILLING CODE 4120-01-C
e. Estimated Impacts on Payments to MIPS Eligible Clinicians for the CY 
2022 Performance Period/2024 MIPS Payment Year
(1) Summary of Approach
    In sections IV.A.3.d., IV.A.3.e. and IV.A.3.f. of this final rule, 
we present several provisions which impact the measures and activities 
that impact the performance category scores, final score calculation, 
and the MIPS payment adjustment. We discuss these changes in more 
detail in section VI.F.18.e.(2). of this RIA as we describe our 
methodology to estimate MIPS payments for the CY 2022 performance 
period/2024 MIPS payment year. We then present the impact of the 
overall final policies on the CY 2022 performance period/2024 MIPS 
payment year and then compare select metrics to the baseline model, 
which only incorporates previously finalized policies for the CY 2022 
performance period/2024 MIPS payment year. By comparing the baseline 
model to the final policies model, we can estimate the incremental 
impact of this rule's policies to the CY 2022 performance period/2024 
MIPS payment year.
    The payment impact for a MIPS eligible clinician is based on the 
clinician's final score, and MIPS eligible clinicians can participate 
as an individual, group, virtual group, or APM Entity in the four MIPS 
performance categories: Quality, cost, improvement activities, and 
Promoting Interoperability. As discussed in section VI.F.18. of this 
final rule, we generally used data submitted for the 2019 performance 
period. For the cost performance category, we used the same data as the 
CY 2020 PFS final rule (84 FR 63169), which is primarily testing data 
for the cost measures.
    The estimated payment impacts presented in this final rule are 
averages by practice size weighted by Medicare utilization. The payment 
impact for a MIPS eligible clinician will vary from the average and 
will depend on the measure submissions, scores and their performance.
(2) Methodology To Assess Impact
    To estimate participation in MIPS for the CY 2022 performance 
period/2024 MIPS payment year for this final rule, we generally used 
2019 MIPS performance period data for both the baseline and final 
policies models. Our baseline and final policies scoring models 
included the 801,013 and 809,593 estimated MIPS eligible clinicians, 
respectively, as described in section VI.F.18.d.(1) of this RIA.
    To estimate the impact of MIPS policies on MIPS eligible 
clinicians, we generally used the 2019 MIPS performance period 
submissions data, including data submitted for the quality, improvement 
activities, and Promoting Interoperability performance categories. We 
supplemented this information with 2019 data available for CAHPS for 
MIPS and CAHPS for ACOs, testing data for the revised total per capita 
cost measure and Medicare Spending Per Beneficiary (MSPB) clinician 
measures which were finalized in the CY 2020 PFS final rule (84 FR 
62969 through 62977), testing data for the new episode cost measures, 
administrative claims data for the new quality performance category 
measures, and other data sets.\283\ We calculated a hypothetical final 
score for the 2022 performance period/2024 MIPS

[[Page 65642]]

payment year for the baseline and final 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 
subsections.
---------------------------------------------------------------------------

    \283\ Data submitted to MIPS for the 2018 MIPS performance 
period data was used for the improvement score for the quality 
performance category. We also incorporated some additional data 
sources when available to represent more current data.
---------------------------------------------------------------------------

(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 2021 PFS final rule (85 FR 
85016 through 85017) for baseline and final policy RIA models for the 
CY 2022 performance period/2024 MIPS payment year.
    For the baseline policies RIA model, which does not reflect the 
final policies for CY 2022 performance period/2024 MIPS payment year 
from this final rule, we made the following modifications to reflect 
the previously finalized policies for the CY 2022 performance period/
2024 MIPS payment year for the quality performance category:
     As previously finalized in the CY 2021 PFS final rule (85 
FR 84870 and 85 FR 84843), we removed the Web Interface as a collection 
type in MIPS and through the APP for the CY 2022 performance period/
2024 MIPS payment year. Although the Web Interface is to be reinstated 
for groups for the CY 2022 performance period/2024 MIPS payment year 
and ACOs for CY 2022 performance period/2024 MIPS payment year through 
CY 2024 performance period/2026 MIPS payment year as discussed in 
sections IV.A.3.d.(1)(d) and IV.A.3.c.(2)(a), respectively, the 
baseline model is attempting to capture the CY 2022 performance period/
2024 MIPS payment year as if this provision did not exist. Therefore, 
the baseline model does not incorporate the Web Interface as a 
collection type for groups and ACOs. To estimate a quality performance 
category score for clinicians in groups who previously used the Web 
Interface as a collection type in 2019, we assumed these groups will 
use the other two other collection types (MIPS CQMs and eCQMs) 
available in the 2022 performance period/2024 MIPS payment year. We 
then applied the same methodology described in the CY 2021 PFS proposed 
rule when the removal of Web Interface as a collection type was 
previously proposed (85 FR 50387 through 50388) using 2019 MIPS 
submissions data. To estimate a quality performance category score for 
ACOs, we used the same methodology described in the CY 2021 PFS 
proposed rule when the Web Interface was not included in the APP (85 FR 
50388).
     We used the published 2021 MIPS historical quality 
benchmarks file to identify measures subject to the topped out scoring 
cap that was finalized (82 FR 53721 through 53727).\284\
---------------------------------------------------------------------------

    \284\ Data downloaded on April 9, 2021 from https://qpp.cms.gov/resources/resource-library.
---------------------------------------------------------------------------

    For the final policies model, we made the following modifications 
to the baseline model to reflect the new final policies for the 2022 
performance period/2024 MIPS payment year for the quality performance 
category:
     As discussed in section IV.A.3.d.(1)(e) of this final 
rule, we finalized one new administrative claims measure for those for 
whom it is applicable: Clinician and Clinician Group Risk-standardized 
Hospital Admission Rates for Patients with Multiple Chronic Conditions. 
To implement this policy in our final policies RIA model for the CY 
2022 performance period/2024 MIPS payment year, we used testing data 
for this new administrative claims measure.
     As discussed in section IV.A.3.d.(1)(c) of this final 
rule, we are finalizing our proposals with modification to maintain the 
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 for QCDR measures, MIPS CQMs, or eCQMs. This is not 
a change from our baseline model assumptions.
     As discussed in section IV.A.3.d.(1)(e) of this final 
rule, we are finalizing our proposal to establish measure substantive 
change criteria. We did not make modifications to the final policies 
model for this policy. We scored measures using the benchmarks 
described below.
     In section IV.A.3.d.(1)(g) of this final rule, we are 
finalizing several changes to the CAHPS for MIPS survey. We did not 
incorporate these changes into our model due to the lack of data.
     In Appendix 1 of this final rule, we added 4 new quality 
measures, removed 13 measures, and finalized 87 substantially modified 
measures. Consistent with prior rules, (83 FR 50053), our RIA estimates 
assume that clinicians who reported Medicare Part B claims, eCQM, MIPS 
CQM and QCDR measures that are removed would find alternate measures; 
therefore, we assign points to the measures that and included them in 
our scoring model.
     As discussed in section IV.A.3.e.(1)(c)(ii) of this final 
rule, we did not finalize our proposal to use performance period 
benchmarks for the CY 2022 performance period in accordance with Sec.  
414.1380(b)(1)(ii) as opposed to a historical benchmark. For the final 
policies model, we utilized the most recent benchmark file: the 2021 
MIPS performance period historic benchmarks.\285\ However, the 2019 
performance data we are using to estimate future performance includes 
data on measures that do not have a benchmark in the 2021 MIPS 
benchmark file (either because the measure was removed or because there 
were significant changes). If a benchmark was not available in the 2021 
MIPS performance period historic benchmark file, then we supplemented 
the 2021 MIPS benchmark file with the benchmarks used for the CY 2019 
performance period/2021 MIPS payment year.
---------------------------------------------------------------------------

    \285\ Data downloaded on September 1, 2021 from https://qpp.cms.gov/resources/resource-library.
---------------------------------------------------------------------------

     As discussed in section IV.A.3.e.(1)(c)(iii)(A) of this 
final rule, we are delaying our proposal to remove the 3-point floor 
for each measure that can be reliably scored against the benchmark and 
score the measure from 1 to 10 points until the CY 2023 performance 
period/2025 MIPS payment year. Similarly, we are delaying our proposal 
in section IV.A.3.e.(1)(c)(iii)(B) of this final rule to remove the 
special scoring policy of scoring 3 points for class 2 measures, except 
for clinicians in small practices until the CY 2023 performance period/
2025 MIPS payment year. Therefore, our RIA for the CY 2022 performance 
period/2024 MIPS payment year re-established the 3-point floor for 
class 1 measures and 3 points for class 2 measures.
     As discussed in section IV.A.3.e.(1)(c)(iii)(B), we are 
finalizing our proposed policies for scoring new measures with 
modifications. For measures in their first two performance periods that 
meet data completeness and can be reliably scored against a benchmark 
(class 4a measures), we will assign a floor of 7 points for measures in 
their first year and a floor of 5 points for measures in their second 
year. For new measures in their first two performance periods that meet 
data completeness, but cannot be reliably scored against a benchmark 
because they lack a benchmark or do not meet case minimum in the 
program (class 4b measures), we will assign 7 points for measures in 
their first year and 5 points for measures in their second year. We 
incorporated these scoring changes into our final policies model. 
Because we are using 2019 MIPS performance period

[[Page 65643]]

data, we assume that measures new to MIPS in 2019 are in their first 
year and measures new to MIPS in 2018 are in their second year.
     As discussed in sections IV.A.3.e.(1)(c)(vii) and 
IV.A.3.e.(1)(c)(viii) of this final rule, we finalized our proposal to 
remove measure bonus points for reporting high priority measures and 
for submitting with end-to-end electronic reporting beginning in the 
2022 MIPS performance period. We incorporated these scoring changes 
into our final rule model for all MIPS collection types.
     As discussed in section IV.A.3.d.(1)(d), we are extending 
the Web Interface measures for the CY 2022 performance period/2024 MIPS 
payment year for groups and virtual groups using the existing 10 CMS 
Web Interface measures. To estimate the impact of this policy, we used 
the same methodology described in the CY 2021 PFS final rule (85 FR 
85016 through 85017) using 2019 MIPS submissions data.
     Finally, we will extend the CMS Web Interface as a means 
of reporting quality under the APM Performance Pathway for Shared 
Savings Program ACOs for the 2022 performance period/2024 MIPS payment 
year through the 2024 performance period/2026 MIPS payment years as 
described in section IV.A.3.c.(2)(a) of this final rule. Under the 
provision, Web Interface reporting will work in the same manner as for 
performance year 2021, where ACOs will have the option of reporting 
either the CMS Web Interface, the APP eCQM/MIPS CQM measure set, or 
both. To estimate the impact of this policy, we used the same 
methodology described in the CY 2021 PFS final rule RIA (85 FR 85016 
through 85017) when Web Interface was retained for the APP.
(b) Methodology To Estimate the Cost Performance Category Score
    We estimated the cost performance category score using a similar 
methodology described in the CY 2020 PFS final rule (84 FR 63169) with 
the modifications to the baseline and the final policies RIA model 
described in this section.
    In the baseline model, we refined our methodology for developing 
benchmarks to better reflect the previously finalized policy in CY 2017 
Quality Payment Program final rule (81 FR 77308 through 77309). We did 
not estimate cost improvement scoring that starts in the 2022 
performance period/2024 MIPS payment year as previously finalized at 
Sec.  414.1380(a)(1)(ii) and in the CY 2019 PFS final rule (83 FR 
58956) since we did not have sufficient data to conduct improvement 
scoring, which requires 2 years of cost data to model.
    In the final policies model, we modified the baseline model to 
incorporate the provision to add five new episode-based cost 
performance category measures in the CY 2022 performance period/2024 
MIPS payment year as described in section IV.A.3.d.(2) of this final 
rule, by using claims data from January 1, 2019 to December 31, 2019. 
Cost measures were scored if the clinicians or groups met or exceeded 
the case volume: 10 episodes for Melanoma Resection to align with the 
reporting case minimum for procedural cost measures currently in use in 
MIPS, 20 episodes for Sepsis to align with the reporting case minimum 
for acute inpatient condition cost measures currently in use in MIPS, 
20 episodes for Diabetes and Asthma/COPD as used in field testing for 
these chronic measures, and 20 episodes for Colon Resection. These new 
cost episode-based measures were calculated for both the TIN/NPI and 
the TIN.
(c) Methodology To Estimate the Facility-Based Measurement Scoring
    For the baseline model, we estimated the facility-based score using 
the scoring policies finalized in the CY 2018 Quality Payment Program 
final rule (82 FR 53763) and the methodology described in the CY 2020 
PFS final rule (84 FR 63169). For the final policies model, we used the 
methodology for the CY 2022 performance period/2024 MIPS payment year 
as discussed in section IV.A.3.e.(2)(b)(v)(B) of this final rule. We 
proposed at Sec.  414.1380(e)(vi) that beginning with the CY 2022 MIPS 
performance period/CY 2024 MIPS payment year, the MIPS quality and cost 
performance category scores will be based on the facility-based 
measurement scoring methodology unless a clinician or group receives a 
higher MIPS final score through another MIPS submission. Therefore, if 
a MIPS eligible clinician or a group is eligible for facility-based 
measurement, but they participate in MIPS as an individual or group, we 
used the higher final score between the facility-based scoring and MIPS 
submission-based scoring.
(d) Methodology To Estimate the Promoting Interoperability Performance 
Category Score
    For the baseline model, we used the CY 2019 MIPS Promoting 
Interoperability performance period data submissions data to estimate 
CY 2022 MIPS performance for the Promoting Interoperability performance 
category. We made the following two modifications to the 2019 
performance period scoring to reflect the previously finalized policy 
changes between the CY 2019 and CY 2021 performance periods: (1) We 
doubled the bonus points for clinicians who submitted the PDMP measure 
as described in section IV.A.3.d.(4)(c)(i) of this final rule; and (2) 
we did not incorporate the Verify Opioid Treatment Agreement measure 
data, a measure that was finalized in the CY 2019 performance period 
(83 FR 59807) but removed in the CY 2020 performance period (84 FR 
62994). We retained the PDMP bonus for the baseline model for 
continuity between the CY 2021 and 2022 performance periods and for 
consistency since bonuses for the quality performance category were 
retained for the baseline as well. Because we lacked data on who would 
adopt the finalized Health Information Exchange bi-directional exchange 
measure for the CY 2021 performance period we only used past reporting 
on the two existing Health Information Exchange Objective measures to 
estimate CY 2022 Promoting Interoperability performance.
    For the final policies model, we considered the following policy 
provisions as potential modifications to the baseline model:
     In section IV.A.3.d.(4)(c)(i) of this final rule, we 
finalized our proposal for the PDMP measure to remain optional and at 
10 points. Modifications were not made to reflect this policy in the 
final policies model since the baseline model already incorporated this 
policy.
     In section IV.A.3.d.(4)(c)(ii) of this final rule, we did 
not finalize our proposed modifications to the Provide Patients 
Electronic Access to Their Health Information measure. For this model, 
we did not make any modifications and continued to use the Provide 
Patients Electronic Access to Their Health Information measure that was 
submitted for the 2019 MIPS performance period.
     In section IV.A.3.d.(4)(c)(iii) of this final rule, we 
finalized to require two of the measures associated with the Public 
Health and Clinical Data Exchange Objective, beginning with the CY 2022 
performance period: Immunization Registry Reporting; and Electronic 
Case Reporting. We also finalized in section IV.A.3.d.(4)(c)(iii) of 
this final rule to retain the Public Health Registry Reporting, 
Clinical Data Registry Reporting, and Syndromic Surveillance Reporting 
measures, and to make them optional and available for bonus points 
beginning with the CY 2022 performance period/2024 MIPS payment year. 
We did not model these policy changes because the Promoting

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Interoperability data we used for this analysis is based on the CY 2019 
performance period when a clinician was only required to report two of 
the possible 5 measures for the Public Health and Clinical Data 
Exchange Objective. We believe incorporating this policy might 
artificially lower scores for the Public Health and Clinical Data 
Exchange Objective because there was no requirement to specifically 
report the Immunization Registry Reporting and Electronic Case 
Reporting measures in 2019.
     In section IV.A.3.d.(4)(d) of this final rule, we 
finalized the additional requirement that eligible clinicians must 
attest to conducting an annual assessment of the High Priority Guide of 
the SAFER Guides beginning with the 2022 performance period. This 
policy was not implemented in the final policies model as it does not 
affect eligibility or payment. We included this policy in our burden 
calculations in section V.B.8.g.(3) of this rule.
     In section IV.A.3.d.(4)(g) of this final rule, we 
finalized changes to the attestation statements for information 
blocking. We did not include this policy in our model due to lack of 
information.
     In section IV.A.3.d.(4)(h)(i) of this final rule, we 
finalized beginning with the CY 2022 performance period/2024 MIPS 
payment year, we will no longer require an application for clinicians 
and small practices seeking to qualify for the small practice hardship 
exception and reweighting. We will assign a weight of zero only in the 
event a small practice did not submit any data for any of the measures 
specified for the Promoting Interoperability performance category. This 
policy was implemented in the final policies model.
     In section IV.A.3.d.(4)(h)(ii) and IV.A.3.d.(4)(h)(iii) of 
this final rule, we finalized our proposal to continue the existing 
policy to reweight the Promoting Interoperability performance category 
for NPs, PAs, CRNAs, CNSs, physical therapists, occupational 
therapists, qualified speech-language pathologist, qualified 
audiologists, clinical psychologists, and registered dieticians or 
nutrition professionals for the CY 2022 performance period/2024 MIPS 
payment year. The baseline model already incorporated this policy.
     In section IV.A.3.d.(4)(h)(iv), we finalized that we will 
apply the same Promoting Interoperability reweighting policy we adopted 
previously for NPs, PAs, CNSs, CRNAs, and other types of MIPS eligible 
clinicians to clinical social workers. This policy was implemented in 
the final policies model.
(e) Methodology To Estimate the Improvement Activities Performance 
Category Score
    For the baseline model, we modeled the improvement activities 
performance category score based on CY 2019 performance period data and 
APM participation identified in section VI.F.18.d.(1) of this final 
rule. For clinicians and groups not participating in a MIPS APM, we 
used the CY 2019 submissions improvement activities score. We did not 
model the policy finalized for the CY 2020 performance period (84 FR 
62980) to require a minimum threshold of 50 percent of clinicians in a 
group to complete an improvement activity for the group to receive 
credit since we did not have data to determine the proportion of 
clinicians in a group that completed the improvement activity. We 
continued to apply the methodology described in the CY 2020 PFS final 
rule (84 FR 63170) to assign an improvement activities performance 
category score. For the APM participants identified in section 
VI.F.18.d.(1) of this final rule, we assigned an improvement activity 
performance category score of 100 percent.
    For the final policies model, we did not make modifications to the 
baseline model for the improvement activities changes finalized in 
section IV.A.3.d.(3) of this final rule. The final policies are (1) 
revise group reporting requirements for the 50 percent threshold to 
address subgroups; (2) revise the timeframe for improvement activities 
nominated during a PHE; (3) revise the required criteria for 
improvement activity nominations received through the Annual Call for 
Activities; (4) suspend activities that raise possible safety concerns 
or become obsolete from the program when this occurrence happens 
outside of the rulemaking process; (5) add 7 new improvement 
activities, modify 15 existing improvement activities, and remove 6 
previously adopted improvement activities; (6) revise the ``Drug Cost 
Transparency to include requirements for use of real-time benefit 
tools'' improvement activity; and (7) add the COVID-19 ``Clinical Data 
Reporting with or without Clinical Trial'' improvement activity. For 
policy 1, we lacked data to model the impact on improvement activities 
performance category. Policies 2 and 3 are related to the call for 
improvement activities which does not affect the improvement activities 
performance category scores. Policies 4 through 7 address changes to 
specific improvement activities or the improvement activity inventory. 
We anticipate most clinicians performing improvement activities will 
continue to identify and report similar improvement activities from the 
inventory in future years. Please see section VI.F.18.g.(2)(f) of this 
final rule for additional details on the impact of these policy 
changes.
(f) Methodology To Estimate the Complex Patient Bonus Points
    In section IV.A.3.e.(2)(a)(iii)(B) of this final rule, we will 
continue to apply the complex patient bonus, with updates, for the CY 
2022 performance period/2024 MIPS payment year. For the baseline model, 
we used the complex patient bonus information calculated for the 2019 
performance period data for the CY 2022 performance period/2024 MIPS 
payment year, as was previously done in the CY 2021 PFS final rule (85 
FR 85017).
    For the final policies model, we calculated the complex patient 
bonus using the calculation in section IV.A.3.e.(2)(a)(iii)(B) of this 
final rule for the CY 2022 performance period/2024 payment year. We 
finalized updates to the complex patient bonus for the CY 2022 
performance period/2024 MIPS payment year and future MIPS performance 
periods/payment years to account for social and medical complexity, 
while still using our current established indicators of dual proportion 
and HCC risk scores, respectively. Consistent with the policy for the 
2022 performance period, our final policies RIA model calculated and 
applied the separate risk indicator complex patient bonus components 
methodology with a single overall cap.
(g) Methodology To Estimate the Final Score
    We did not make changes for how we calculated the MIPS final score. 
Our baseline and final policies 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 model, we applied the performance category weights 
and redistribution weights finalized in the CY 2021 PFS final rule (85 
FR 84913 through 84916).
    For the final policies model, we modified the redistribution policy 
for small practices as described in section IV.A.3.e.(2)(b)(iii)(A) of 
this final rule.
    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

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MIPS eligible clinicians who were assigned a weight of zero percent for 
any performance category, we redistributed the weights according to 
section IV.A.3.e.(2)(b)(ii) of this final rule.
(h) Methodology To Estimate the MIPS Payment Adjustment
    For the baseline model, we applied the hierarchy as finalized in 
the CY 2021 PFS final rule (85 FR 84917 through 84919) 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. 
For the final policies model, we applied the scoring hierarchy 
finalized in section IV.A.3.f.(5) of this final rule. We then 
calculated the parameters of an exchange function in accordance with 
the statutory requirements related to the linear sliding scale, budget 
neutrality, minimum and maximum adjustment percentages, and additional 
payment adjustment for exceptional performance (Sec.  414.1405).
    For the baseline model, we applied the performance threshold and 
additional performance thresholds finalized for the CY 2021 performance 
period/2023 payment year (85 FR 84923), of 60 and 85, respectively. For 
the final policies model, we used the performance threshold of 75 
points in section IV.A.3.f.(2) and the additional performance threshold 
of 89 points in section IV.A.3.f.(3). We used these resulting 
parameters to estimate the positive or negative MIPS payment adjustment 
based on the estimated final score and the paid amount for covered 
professional services furnished by the MIPS eligible clinician. As 
discussed in the CY 2021 PFS final rule RIA (85 FR 85013), we adjusted 
the paid amount of non-engaged clinicians to equal their proportion of 
paid amount prior to the PHE for COVID-19 for the baseline and final 
policies models.
(3) Impact of Payments by Practice Size
    As we shift from previous MIPS transition policies by removing 
bonuses from the quality performance category and increasing the 
performance threshold and the additional performance threshold, we 
observe large changes between the baseline model and final policies 
model.
    First, we observe an increase in the funds available for 
redistribution due to the increase in clinicians with final scores 
below the performance threshold. The baseline model estimates $428 
million will be redistributed through BN and that $500 million will be 
distributed to MIPS eligible clinicians for exceptional performance. 
The mean and median final scores for the baseline model are 78.13 and 
82.59, respectively. Our final policies model estimates that $603 
million will be redistributed through BN. For clinicians who meet or 
exceed the additional performance threshold, an additional $360 million 
was estimated to be distributed. The mean and median final scores for 
the final policies model are 75.21 and 79.59, respectively.
    In the final policies model, the estimated bonus for exceptional 
performance is less than the $500 million of available funding because 
the maximum additional payment adjustment for clinicians with 
exceptional performance reached 10 percent. As finalized in the 2017 
QPP final rule (81 FR 77339 through 77340), we stated the maximum 
additional payment adjustment would be 10 percent, which is established 
by the statute, and that it would be multiplied by a scaling factor 
that cannot exceed 1.0. We reached the maximum additional payment 
adjustment allowed of 10 percent because the additional performance 
threshold is higher, and fewer clinicians performed above this higher 
additional performance threshold while a greater percentage of 
clinicians performed below the additional performance threshold. As a 
result, fewer clinicians are estimated to share the funds available 
through the additional bonus for exceptional performance.
    Second, we observe an increase in the maximum positive payment 
adjustment. The baseline model estimates the maximum positive MIPS 
payment adjustment based on the budget neutral pool at 1.5 percent and 
the maximum positive MIPS additional payment adjustment for exceptional 
performance at 5.1 percent, for a combined maximum payment adjustment 
of 6.6 percent. The final policies model estimates the maximum MIPS 
positive payment adjustment based on the budget neutral pool is 4.4 
percent and the maximum positive additional MIPS payment adjustment for 
exceptional performance bonus at 10.0 percent for a combined maximum 
payment adjustment of 14.4 percent.
    Finally, we see narrower differences in performance across practice 
sizes due to the shift from MIPS transition policies. Table 146 shows 
the overall impact of the payment adjustments by practice size and 
based on whether clinicians are expected to submit data to MIPS for the 
final policies model. In Table 147, we present the overall impact of 
the baseline and the final policies models among clinicians who submit 
data to assess the incremental impact of the final policies. The 
overall proportion of clinicians receiving a positive or neutral 
payment adjustment decreases from 91.7 percent to 66.8 percent with the 
implementation of the final policies that shift away from MIPS 
transition policies. In addition, we no longer observe a 
disproportionate number of clinicians in small practices receiving a 
negative payment adjustment when implementing the final policies.
    For the CY 2022 performance period/2024 payment year, we have 
policies targeted towards small practices including special scoring 
policies to minimize burden and facilitate small practice participation 
in MIPS or APMs, which we describe in section VI.F.18.g.(2)(e) of this 
final rule. The intention of the final policies is to provide a more 
equitable participation process and reduce the disparity in performance 
between clinicians in large and small practices. These findings and 
final policies reflect movement away from the transition policies 
implemented during the early years of MIPS and how MIPS has shifted its 
focus to value rather than primarily on engagement. However, non-
engagement by not submitting data to MIPS among clinicians in small 
practices is still a concern. Among those who we estimate will not 
submit data to MIPS, 86 percent are in small practices (22,475 out of 
26,180 clinicians who do not submit data). We intend to continue 
working with stakeholders to improve engagement in MIPS among 
clinicians in small practices.
    We want to highlight we are using 2019 MIPS performance period 
submissions data to simulate a 2022 MIPS performance period final 
score, and it is likely that there will be changes that we cannot 
account for at this time, including services and payments disrupted by 
the PHE for COVID-19 or clinicians changing behavior in response to the 
performance thresholds increased for the CY 2022 performance period/
2024 MIPS payment year to avoid a negative payment adjustment. 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 2022 performance period/2024 MIPS payment year. This is 
because the PHE for COVID-19 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 
COVID-19 for the 2019 MIPS performance period. Therefore, engagement 
levels in MIPS

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for the CY 2022 performance period/2024 MIPS payment year may differ 
from these reported estimates. We also note this participation data is 
generally based off participation for the 2019 performance period, 
which is associated with the CY 2019 performance period/2021 MIPS 
payment year and had a performance threshold of 30 points, and that 
participation may change for the CY 2022 performance period/2024 MIPS 
payment year when the performance threshold is 75 points.
    Finally, the combined impact of negative and positive adjustments 
and the additional positive adjustments for exceptional performance as 
a percent of paid amount among those that do not submit data to MIPS on 
average was negative 8.5 percent. It was not the maximum negative 
payment adjustment of 9 percent because some MIPS eligible clinicians 
that do not submit data to MIPS can still receive a MIPS final score 
that is greater than \1/4\ of the performance threshold (and avoid the 
maximum negative adjustment as stipulated by section 
1848(q)(6)(A)(iv)(II) of the Act \286\) if they have sufficient claims 
volume to measure performance for cost measures or quality 
administrative claim measure, which utilizes administrative claims data 
and does not require separate data submission to MIPS.
---------------------------------------------------------------------------

    \286\ Section 1848(q)(6)(A)(iv)(II) of the Act stipulates that 
MIPS eligible professionals with MIPS final scores that are equal to 
or greater than 0, but not greater than \1/4\ of the performance 
threshold, receive a negative payment adjustment factor that is 
equal to the negative of the applicable percent which is 9 percent 
for the CY 2022 performance period/2024 MIPS payment year.
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f. Estimated Impacts on Payments to MIPS Eligible Clinicians for the CY 
2023 Performance Period/2025 MIPS Payment Year
    We proposed for the CY 2023 MIPS Performance Period to begin 
transitioning to MIPS Value Pathways (MVPs) and introduce subgroup 
reporting in the CY 2023 MIPS performance period/2025 payment year. As 
described in section IV.A.3.b.(2)(c) of this final rule, the first step 
in the transition plan for MVPs and subgroup reporting is to be 
voluntary, where eventually MVPs and subgroups will become required. 
Additionally, subgroups, if applicable, will have the option to report 
an APP. Since MVP and subgroup reporting will only begin in the CY 2023 
performance period/2025 MIPS payment year, we do not have the data to 
report who will select MVPs and who will report through subgroups in 
the first year and how these clinicians will score. As discussed in 
section IV.A.3.b.(5) of this final rule, for MVP scoring policies, we 
evaluated all traditional MIPS scoring policies and maintained those 
that are required under section 1848(q)(2) of the Act such as 
requirements to measure achievement and improvement of the quality and 
cost of care. We noted MVPs offer incentives in terms of requiring 
fewer measures and activities tied to a specialty or medical condition 
which can offer clinicians a more cohesive experience and that we would 
continue to evaluating additional incentives that align with our 
scoring policies and the goals of MVPs in future rulemaking. For this 
RIAs, we assume clinicians who elect to use MVPs and subgroups for 
reporting to MIPS will perform similarly to how they performed through 
traditional MIPS because the scoring policies are similar. We will 
revisit this assumption in future rulemaking as needed. As discussed in 
section V.B.8.e.(7)(a) of this final rule, for the purposes of 
estimating burden associated with the provision to implement MVP and 
subgroup reporting, we assume that 10 percent of MIPS eligible 
clinicians in the CY 2022 performance period/2024 MIPS payment year 
will report as MVP participants in the CY 2023 performance period/2025 
MIPS payment year. In addition, we assume that there will be 20 
subgroup reporters in the CY 2023 performance period/2025 MIPS payment 
year. We anticipate a per respondent reduction of 3 hours and $412 
dollars per CQM/QCDR quality submission, 3 hours and $336 per eCQM 
quality submission, and 5 hours and $717 per claims quality submission. 
Overall, we estimate a net reduction in burden of $7,463,145 in the 
quality performance category ICRs due to the introduction of MVP and 
subgroup reporting in the CY 2023 performance period/2025 MIPS payment 
year. We refer readers to section V.B.8.e.(7)(a)(iii) of this final 
rule for further discussion of our burden associated with MVPs and 
subgroups including the number of respondents.
g. Additional Impacts From Outside Payment Adjustments
(1) Burden Overall
    In addition to policies affecting the payment adjustments, we 
proposed several policies that have an impact on burden in the CY 2022 
and CY 2023 performance periods/2024 and 2025 MIPS payment years. In 
section V.B.8 of

[[Page 65648]]

this final rule, we outline estimates of the costs of data collection 
that includes both the effect of policy updates and adjustments due to 
the use of updated data sources. For each provision included in this 
regulation which impacts our estimate of collection burden, the 
incremental burden for each is summarized in Table 148. We also provide 
additional burden discussions that we are not able to quantify.
    As discussed in the section V.B.8 of this final rule, we are 
setting forth our estimates for the CY 2023 performance period/2025 
MIPS payment year as new burden with no currently approved estimate. To 
provide the reader a better sense of the differences in burden between 
our CY 2022 and CY 2023 performance period/2024 and 2025 MIPS payment 
year estimates due to changes in policy, we are presenting our CY 2023 
performance period/2025 MIPS payment year estimates in Table 148 in 
comparison to the CY 2022 performance period/2024 MIPS payment year 
estimate found in the CY 2021 PFS final rule. In Table 148, we are only 
including our CY 2023 performance period/2025 MIPS payment year 
estimates for the ICRs where our estimate is different from our CY 2022 
performance period/2024 MIPS payment year estimate.

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(2) Additional Impacts to Clinicians
(a) Web Interface
    As discussed in section IV.A.3.d.(1)(d) of this final rule, we 
finalized the proposal to continue the use of the CMS Web Interface 
measures as a collection type for groups and virtual groups with 25 or 
more eligible clinicians for the CY 2022 performance period/2024 MIPS 
payment year. We are also sunsetting the CMS Web Interface measures as 
a collection type for groups and virtual groups with 25 or more 
eligible clinicians starting with the CY 2023 performance period/2025 
MIPS payment year. As discussed in section IV.A.3.c.(2)(a), we are also 
extending the CMS Web Interface as a means of reporting quality under 
the APP for Shared Savings Program ACOs for the CY 2022 performance 
period/2024 MIPS payment year through the CY 2024 performance period/
2025 MIPS payment year.
    We refer readers to sections V.B.8.e.(8) and V.B.8.e.(10) of this 
final rule for our discussion on the estimated burden associated with 
the extension of the CMS Web Interface collection type in CY 2022 
performance period/2024 MIPS payment year and the sunset of the CMS Web 
Interface collection type in the CY 2023 performance period/2025 MIPS 
payment year (for those not using the APP). Additionally, we assume 
that the impacts associated with the sunset of CMS Web Interface 
measures as a collection type for groups and virtual groups with 25 or 
more eligible clinicians will remain the same as our discussion in the 
CY 2021 PFS final rule (85 FR 85020 through 85021).
(b) Administrative Claims Measure
    As discussed in section IV.A.3.d.(1)(e), we are adding one new 
administrative claims measures beginning in the CY 2022 performance 
period/2024 MIPS payment year and for future performance periods: 
Clinician and Clinician Group Risk-standardized Hospital Admission 
Rates for Patients with Multiple Chronic Conditions. We acknowledge 
there are administrative burdens and related financial costs associated 
with each administrative claims measure that clinicians, groups, and 
organizations may choose to monitor. However, because these costs can 
vary significantly due to organizational size, number of administrative 
claims measures being reported, volume of clinicians reporting each 
measure, and the specific methods employed to improve performance, we 
are unable to provide an estimate of the financial impact each 
clinician, group, or organization may experience. In summary, we are 
acknowledging that while there are no data submission requirements per 
Sec.  414.1325(a)(2)(i) for administrative claim measures, there may be 
associated costs for clinicians and group practices to monitor new 
administrative claim measures; however, we are unable to quantify that 
impact.
(c) Modifications to the Improvement Activities Inventory
    As discussed in section IV.A.3.d.(3)(c)(ii) of this final rule, we 
finalized the proposals to remove 7 previously adopted improvement 
activities, modify 15 existing improvement activities, and adopt 5 new 
improvement activities. We refer readers to Appendix 2 of this final 
rule for further details. We do not believe these changes to the 
inventory will impact time or financial burden on stakeholders because 
MIPS eligible clinicians are still required to submit the same number 
of activities and the per response time for each activity is uniform. 
We do not expect these changes to the inventory to affect our currently 
approved information collection burden estimates in terms of neither 
the number of estimated respondents nor the burden per response. We 
anticipate most clinicians performing improvement activities, to comply 
with existing MIPS policies, will continue to perform the same 
activities under the policies in this final rule because previously 
finalized improvement activities continue to apply for the current and 
future years unless otherwise modified per rulemaking (82 FR 54175). 
Most of the improvement activities in the Inventory remain unchanged 
for the CY 2022 performance period/2024 MIPS payment year.
(d) Stakeholders Nominating Improvement Activities
    In section IV.A.3.d.(3)(c)(i)(B) of this rule, we finalized these 
proposals: (1) To revise the required criteria for improvement activity 
nominations received through the Annual Call for Activities; (2) 
changes to the timeline for improvement activities nomination during a 
PHE; and (3) to suspend

[[Page 65651]]

activities that become obsolete or impacted by clinical practice 
guideline changes from the program when this occurrence happens outside 
of the rulemaking process.
    Regarding the provision to clarify the timeline for an improvement 
activity nominated during the PHE, we believe this provision will not 
affect our currently approved burden estimates since we believe that 
the number of nominations will not change, but it would make an 
activity available for reporting to clinicians in the same performance 
year it was intended to be implemented. In section 
IV.A.3.d.(3)(c)(i)(B)(aa) of this rule, we finalized the proposal that 
in order to implement a new improvement activity for a PHE during the 
same year as the nomination, the nomination will need to be received no 
later than January 5th of the nomination year to be included in a rule 
for notice-and-comment rulemaking during that fiscal or calendar year, 
a necessary precursor to implementation if it were to be finalized. As 
described in section V.B.8.j of this rule, we expect additional 
nominations may be received as a result of this provision, but we do 
not have any data with which to estimate what the additional number may 
be. As a result, we did not make any revisions to our currently 
approved burden estimate.
    Regarding the provision to suspend activities that become obsolete 
or impacted by clinical practice guideline changes from the program 
when this occurrence happens outside of the rulemaking process, we do 
not anticipate additional burden for stakeholders because of the 
provision described above as the policy does not change requirements 
for the nomination of improvement activities.
    As described in section IV.A.3.d.(3)(c)(i)(B) of this rule, due to 
the provisions to add two new criteria and to increase the number of 
criteria stakeholders are required to meet when submitting an activity 
provision from a minimum of 1 to all 8 criteria, which includes the two 
new criteria, we proposed to revise our estimated annual information 
collection burden for nomination of improvement activities to 136 hours 
(31 nominations x 4.4 hr/nomination) at a cost of $20,355 (31 x [(2.8 
hr x $114.24/hr) + (1.6 hr x $210.44/hr)]).
(e) Impact on Small Practices
    As described in section VI.F.18.e.(3) of this final rule RIA, we 
found 85 percent of clinicians who did not submit data to MIPS were in 
small practices. However, the estimated number of MIPS eligible 
clinicians who do not submit data, including those in small practices, 
may be smaller in the CY 2022 performance period/2024 MIPS payment year 
since the submission window for the 2019 performance period was 
impacted by the start of the PHE for COVID-19. CMS is committed to 
identifying flexibilities and options to help clinicians in small 
practices participate meaningfully and successfully in MIPS. 
Specifically, CMS finalized several policies to support clinicians in 
small practices once they engage with MIPS in the quality, improvement 
activities and Promoting Interoperability performance categories for 
the CY 2022 performance period/2024 MIPS payment year. Based on our RIA 
model findings described in section VI.F.18.e.(3) of this final rule, 
the final policies for the CY 2022 performance period/2024 payment year 
led to clinicians in small practices no longer disproportionately 
receiving negative payment adjustments compared to clinicians in larger 
sized practices. Therefore, the combination of the special scoring 
policies for clinicians in small practices is expected to positively 
affect this group of clinicians and will hopefully encourage and 
improve future engagement in MIPS among clinicians in small practices.
(f) Impact on Third Party Intermediaries
    In section IV.A.3.h. of this rule, we finalized multiple changes to 
the third-party intermediary regulations at Sec.  414.1400. 
Specifically, we finalized: (1) Reorganization and consolidation of 
Sec.  414.1400 generally; (2) an expansion of the general participation 
requirements of third-party intermediaries to third party 
intermediaries reporting to MIPS on behalf of APM Entities in order to 
align reporting requirements for all participants in MIPS; (3) a 
requirement 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. Health IT vendors must support MVPs that are applicable to 
the MVP participants on whose behalf they submit MIPS data; (4) to 
require QCDRs, qualified registries, health IT vendors, and CAHPS for 
MIPS survey vendors to support subgroup reporting, beginning with the 
CY 2023 performance period/2025 MIPS payment year; (5) to require QCDRs 
and qualified registries that have never submitted data since the 
inception of MIPS (CY 2017 performance period/2019 MIPS payment year) 
through the 2020 performance period/2022 MIPS payment year, to submit a 
participation plan as part of their self-nomination for CY 2023; (6) a 
requirement that, beginning with the 2024 performance period/2026 MIPS 
payment year, a QCDR or qualified registry that was approved but did 
not submit any MIPS data for either of the 2 years preceding the 
applicable self-nomination period must submit a participation plan for 
CMS' approval; (7) a requirement that, beginning with the CY 2023 
performance period/2025 MIPS payment year, the QCDR or qualified 
registry must submit a data validation plan annually, at the time of 
self-nomination, for CMS' approval, and may not change the plan once 
approved, without the prior approval of the agency; and (8) to add a 
rejection criterion to state that a QCDR does not have permission to 
use a QCDR measure owned by another QCDR for the applicable performance 
period. Additionally, to provide further clarification of our current 
policy (84 FR 63070 through 63073), we finalized the proposal to state 
that if a QCDR measure owner is not approved during a given self-
nomination period, any associated QCDR measures with that QCDR would 
also not be approved.
    With regard to the reorganization and consolidation of Sec.  
414.1400 generally, we do not anticipate this to require any additional 
effort for affected entities as the provision is to allow CMS to 
reorganize the existing information.
    For the requirements related to expanding the general participation 
requirements of third-party intermediaries to third party 
intermediaries reporting to MIPS on behalf of APM Entities in order to 
align reporting requirements for all participants in MIPS, we did not 
propose to revise our burden estimates as this requirement is not 
different from how third-party intermediaries currently submit data for 
the quality, improvement activities and Promoting Interoperability 
performance categories in MIPS on behalf of individual eligible 
clinicians and groups.
    As previously discussed in section IV.A.3.h.(2)(b)(ii) of this 
rule, we finalized the proposal to require QCDRs, qualified registries, 
health IT vendors, and CAHPS for MIPS survey vendors to support 
subgroup reporting, beginning with the CY 2023 performance period/2025 
MIPS payment year. During the MVP Town Hall held in January 2021 (85 FR 
74729), we heard from third-party intermediaries that they are 
confident that they can make the necessary updates to allow for 
subgroup reporting, if they have enough time. A few vendors suggested 
that we add

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subgroup reporting to the existing CEHRT requirements. Given our 
provision described in section IV.A.3.b.(2)(d) of this rule to delay 
the implementation of subgroup reporting option to the CY 2023 
performance period/2025 MIPS payment year, we assume that the delay 
will give these entities adequate time to make the necessary updates. 
We assume that there will be no additional burden that third-party 
intermediaries will incur to implement the subgroup reporting option. 
We anticipate that there may be administrative burden associated with 
changes in workflows to their existing systems for submission of 
subgroup data for the CY 2023 performance period/2025 MIPS payment 
year. However, given that each of these entities and their information 
technology systems are unique, we are unable to quantify the burden for 
these entities to capture and submit data on behalf of clinicians who 
may choose to participate as subgroups.
    We do not anticipate a significant impact to QCDRs and qualified 
registries resulting from the finalized provision to require QCDRs and 
qualified registries to conduct an annual data validation audit and if 
one or more deficiencies or data errors are identified also conduct 
targeted audits. First, we are not revising our burden estimates 
because the finalized data validation requirements are like existing 
expectations which we have already accounted for the associated burden 
as stated in the CY 2017 Quality Payment Program final rule (81 FR 
77383 through 77384) and the CY 2019 PFS final rule (83 FR 59998 
through 59999). Second, we believe that the requirements for conduct of 
the data validation audits are aligned with methods and procedures 
which stakeholders currently utilize.
    As discussed in section IV.A.3.h.(3)(a)(i) of this rule, due to the 
provision to require QCDRs and qualified registries that have never 
submitted data since the inception of MIPS (CY 2017 performance period/
2019 MIPS payment year) through the CY 2020 performance period/2022 
MIPS payment year to submit a participation plan as part of their self-
nomination for CY 2023 performance period/2025 MIPS payment year, we 
refer readers to section V.B.8.c.(2) of this rule for details on the 
adjusted burden.
    As discussed in section V.B.8.c.(2) of this rule, we are not 
adjusting our burden estimates due to the provision related to two new 
rejection criteria for QCDR measures.
(g) Assumptions & Limitations
    We note several limitations to our estimates of clinicians' MIPS 
eligibility and participation, negative MIPS payment adjustments, and 
positive payment adjustments for the CY 2022 performance year/2024 MIPS 
payment year. Due to the PHE for COVID-19, we are aware that there may 
be changes in health care delivery and billing patterns that will 
impact results for the CY 2022 performance year/2024 MIPS payment year 
that we are not able to model with our historic data sources. The 
scoring model results presented in this final rule assume that CY 2019 
Quality Payment Program data submissions and performance are 
representative of CY 2022 Quality Payment Program data submissions and 
performance. The estimated performance for the CY 2022 performance 
year/2024 MIPS payment year using CY 2019 Quality Payment Program data 
may be underestimated because the performance threshold to avoid a 
negative payment adjustment for the 2019 MIPS performance period/2021 
MIPS payment year was significantly lower (30 out of 100 points) than 
the performance threshold for the 2022 performance year/2024 payment 
year (75 out of 100). We anticipate clinicians may participate more 
robustly by submitting more performance categories to meet the higher 
performance threshold to avoid a negative payment adjustment.
    In our MIPS eligible clinician assumptions, we assumed that 
clinicians who elected to opt-in in the CY 2019 Quality Payment Program 
and submitted data would continue to elect to opt-in in the CY 2022 
performance year/2024 MIPS payment year. It is difficult to predict, 
based on 2019 data, whether clinicians will elect to opt-in to 
participate in MIPS with the CY 2022 performance year/2024 payment year 
finalized policies.
    In addition to the limitations described throughout the methodology 
sections, there are additional limitations to our estimates including: 
(1) 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 144; and (2) due to updates in 
measure specifications and new measures, our cost performance is 
modeled using test data that does not always overlap with CY 2019 so we 
may not be capturing performance for clinicians or groups that change 
practices or TINs between when the testing data and the 2019 
performance period. Due to the limitations described, there is 
considerable uncertainty around our estimates that is difficult to 
quantify.

G. Alternatives Considered

    This final rule contains a range of policies, including some 
provisions related to specific statutory provisions. The preceding 
preamble provides descriptions of the statutory provisions that are 
addressed, identifies those policies when discretion has been 
exercised, presents rationale for our policies and, where relevant, 
alternatives that were considered. For purposes of the payment impact 
on PFS services of the policies contained in this final rule, we 
presented the estimated impact on total allowed charges by specialty.
1. Alternatives Considered for Utilization Data in PFS Ratesetting
    As discussed earlier in this section II.C.1 (Changes in Relative 
Value Unit (RVU) Impacts), our estimates of changes in Medicare 
expenditures for PFS services compared payment rates for CY 2021 with 
payment rates for CY 2022 using CY 2020 Medicare utilization. As an 
alternative to using CY 2020 data, we considered using CY 2019 
utilization data for the purposes of determining the CY 2022 RVUs, as 
well as in determining the CY 2022 BN adjustment and conversion factor. 
We considered using CY 2019 data due to the PHE for COVID-19, which has 
impacted the delivery of health care services over the past 18 months. 
Increases in remote delivery of services to reduce risk of exposure to 
both practitioner and patients, as well as postponement of elective 
procedures have resulted in a change to service utilization patterns 
across Medicare FFS payment systems. Specific to the PFS, overall 
service utilization decreased by approximately 20 percent in CY 2020 
compared to CY 2019, which caused us to question whether CY 2020 data 
is the best available data to use for CY 2022 ratesetting.
    In order to determine if lower overall utilization in CY 2020 would 
result in differential impacts on specialties and practitioners, we 
modeled the PFS ratesetting process using CY 2019 utilization data. We 
found that the use of CY 2020 as opposed to CY 2019 data in 
establishing payment rates had relatively little differential impacts 
on payment, despite the approximately 20 percent decrease in overall 
service utilization. Table 149 illustrates specialty-specific impacts 
for the proposed rule using CY 2019 data.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TR19NO21.181


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[GRAPHIC] [TIFF OMITTED] TR19NO21.182

BILLING CODE 4120-01-C
    The majority of specialties experienced shifts of less than a 
percent when we used CY 2019 data, as opposed to CY 2020 data, as 
displayed in Table 136, as the basis for setting rates. Several 
specialties shifted by approximately one percent. We did not detect a 
pattern of specialties that were notably affected by the choice of 
claims data, either positively or negatively. While Pediatrics shifted 
from a 1 percent impact when we used CY 2020 claims data to a 5-payment 
impact when we used CY 2019 claims data, this shift is likely due to 
the smaller amount of allowed charges associated with the Pediatrics 
specialty.
    We analyzed the percentage change in total RVUs per practitioner. 
Using CY 2019 utilization data, Total RVUs change between -1 percent 
and 1 percent for 53 percent of practitioners, representing more than 
48 percent of the changes in Total RUs for all practitioners, similar 
to the results we found when using CY 2020 claims that we discussed in 
section II.C.1. Variations by specialty were also similar to the 
results we found using CY 2020 claims and are contained in the public 
use file that describes the percentage change in total RVUs per 
practitioner.
    Similar to the process described in section II.C.1. of this final 
rule, we used CY 2019 claims data to estimate the CY 2021 PFS CF to be 
33.6184 which reflects a BN adjustment under section 
1848(c)(2)(B)(ii)(II) of the Act, which we estimated to be -0.04 using 
CY 2019 data, the 0.00 percent update adjustment factor specified under 
section 1848(d)(19) of the Act, and the expiration of the 3.75 percent 
fee schedule payment increase for CY 2021 provided by the CAA. The 
anesthesia CF, which reflects the same overall PFS adjustments with the 
addition of anesthesia-specific PE and MP adjustments, would shift by a 
similar magnitude as the PFS CF. Thus, the estimated PFS CF and 
anesthesia CF using CY 2019 data is slightly higher compared to using 
claims data for CY 2020 with an estimated difference of 0.0336 (a 
little less than three and half cents). We note that the BN adjustment 
will be recalculated for the CY 2022 PFS final rule and the use of CY 
2019 claims may or may not be higher than the use of CY 2020 claims 
based on which policies are ultimately finalized.
    Comment: We received few comments on our Alternatives Considered 
for Utilization Data in PFS Ratesetting. One commenter stated that they 
supported the use of the alternate CY 2019 claims data because it 
resulted in a slight improvement (approximately 1 percent) in the 
impact of changes in RVUs for their specialty. A different commenter 
stated that practice patterns in CY 2020 were atypical as a result of 
the COVID-19 pandemic and they believed that the use of 2019 claims 
data would be likely to more closely approximate overall PFS service 
utilization and costs in 2022.
    Response: We continued to believe that the use of CY 2020 as 
opposed to CY 2019 data in establishing payment rates had relatively 
little differential impacts on payment, despite the approximately 20 
percent decrease in overall service utilization. We found that the use 
of CY 2020 as opposed to CY 2019 data in establishing payment rates had 
little differential impact on payment at the specialty, service 
categories, and individual services levels. We also did not detect a 
pattern of specialties who were notably affected by the choice of 
claims data, either positively or negatively. We received few comments 
on this alternative considered which we believe indicates support for 
our use of CY 2020 claims data from the majority of commenters.
    After consideration of the comments, we are finalizing our 
continued use of CY 2020 claims data instead of the potential 
alternative to use CY 2019 claims data for the purposes of determining 
the CY 2022 RVUs as well as in determining the CY 2022 BN adjustment 
and conversion factor.
2. Alternatives Considered for Split (or Shared) Visits
    In section II.F of this final rule, we codify our current policy 
allowing billing of certain ``split'' or ``shared'' E/M visits by a 
physician, when the visit is performed in part by both a physician and 
an NPP, who are in the same group and the physician performs a 
substantive portion of the visit. We will codify in our regulations a 
definition of a split (or shared) visit as an E/M visit in the facility 
setting that is performed in part by both a physician and NPP who are 
in the same group, in accordance with applicable laws and regulations, 
such that the E/M visit could be billed by either the physician or the 
NPP if it were furnished independently by only one of them in the 
facility setting (rather than as a split (or shared) visit). The 
physician or NPP who performs the substantive portion of the split (or 
shared) visit will bill for the visit. We are also finalizing our 
proposed definition of substantive portion as more than half of the 
total time spent by the physician and NPP.
    We considered several alternative approaches. First, we considered 
the option of disallowing split (or shared) visit billing beginning in 
CY 2022. Under this alternative, in settings where payment for 
``incident to'' services is prohibited, physicians and NPPs would only 
be able to bill for visits they furnish in their entirety under their 
own NPI. Such a policy would be administratively simple, and reduce the 
likelihood of paying significantly more than the actual resource costs 
incurred. When physicians and practitioners furnish services in 
facility settings, they do not ordinarily incur the cost of clinical 
staff or other PE costs involved in furnishing the services. When the 
physician bills for an E/M visit, in accordance with section 
1833(a)(1)(N) of the Act, the Medicare Part B payment is equal to 80 
percent of the payment basis under the PFS which, under section 
1848(a)(1) of the Act, is the lesser of the actual charge or the full 
fee schedule

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amount for the service. In contrast, if the NPP bills for it, in 
accordance with section 1833(a)(1)(O) of the Act, the Medicare Part B 
payment is equal to 80 percent of the lesser of the actual charge or 85 
percent of the fee schedule rate. Because of this payment differential 
and the lower resource costs associated with E/M visits performed 
partly by a physician and partly by an NPP, it could be argued that the 
physician should not be able to bill for such a visit and be paid at 
the higher fee schedule amount. Our proposal was informed by our belief 
that longstanding clinical practice relies substantially upon shared 
visits between physicians and NPPs in facility settings. To avoid the 
potential disruption in this common medical practice approach, we did 
not propose to disallow billing for split (or shared) visits.
    Comment: We received public comments confirming that it would be 
disruptive of current practice patterns to disallow split (or shared) 
visit billing. We did not receive public data indicating specifically 
how often split (or shared) visits occur.
    Response: After consideration of the public comments, we are 
finalizing a policy to continue allowing billing of split (or shared) 
visits under specified conditions. We will require a modifier on claims 
for these types of visits, as proposed, to help inform future policy in 
this area.
    We also considered several alternatives for how to define the 
substantive portion of a split (or shared) visit. We considered 
defining ``substantive portion'' as any face-to-face portion of the 
split (or shared) visit, consistent with our current definition. We did 
not believe it would be appropriate to consider just any portion of the 
visit--with or without direct patient contact-- as a substantive 
portion. For instance, we did not believe it would be appropriate to 
consider a brief or trivial interaction, with or without direct patient 
contact, such as where the physician merely ``pokes their head'' into 
the room, to be a substantive portion of the visit. We did not believe 
it would be appropriate to permit a physician to bill for a visit if 
they do not substantially participate in the visit, given that 
physicians are paid under the PFS at a higher rate than NPPs. 
Therefore, we proposed to define ``substantive portion'' as more than 
half of the total time spent by the physician or NPP.
    Another alternative we considered, but did not propose, was to 
utilize the medical decision making (MDM) to define substantive 
portion. We did not propose this approach because MDM is not easily 
attributed to a single physician or NPP when the work is shared, 
because MDM is not necessarily quantifiable and can depend on patient 
characteristics. We believed that time is a more precise factor than 
MDM to use as a basis for deciding which practitioner performs the 
substantive portion of the visit. We believed that using the time spent 
by each practitioner furnishing the split (or shared) visit would 
provide a more precise metric than potentially finding a way to parse 
MDM between the physician and the NPP.
    We also considered defining substantive portion as performance of 
the history and/or physical exam, which are key components of certain 
E/M visits. Given recent changes in the CPT E/M Guidelines, history and 
physical exam are no longer necessarily included in all E/M visits, 
because for office/outpatient E/M visits, the visit level can now be 
selected based on either MDM or time, and history and exam are 
performed only as medically appropriate. Also, the CPT Editorial Panel 
is considering removing history and physical exam as key visit 
components for institutional visits, similar to the changes already 
made for office/outpatient E/M visits. Accordingly, defining 
``substantive portion'' as any key component including history or exam 
did not seem to be a viable approach.
    Lastly, we considered not defining substantive portion and instead 
leaving determinations regarding the substantive portion to MAC and/or 
medical review discretion. However, this approach would impose a 
significant burden on MACs to assess individual cases and could lead to 
too much regional variation in payment. We solicited public comment to 
help inform what we consider to be the ``substantive portion'' of a 
split (or shared) visit in institutional settings and assist us in 
consideration of our definition of ``substantive portion''.
    We received public comments to help inform what we consider to be 
the ``substantive portion'' of a split (or shared) visit in 
institutional settings and assist us in consideration of our definition 
of ``substantive portion.'' We refer readers to section II.F. of this 
final rule with comment period for a complete discussion of the public 
comments on this topic and our responses, summarized below.
    Comment: The commenters agreed that the individual who performs the 
substantive portion should bill for the visit. Approximately half of 
the commenters supported our proposal, believing that it was 
appropriate and would provide a clear rule. However, approximately half 
of the public comments recommended alternative definitions of 
substantive portion, including:
     A lower percentage of time (25 to 30 percent of the total 
time) (several comments).
     MDM (several comments).
     Some portion of MDM (several comments).
     Choice of MDM or time, for example, based on whichever is 
used to select visit level (several comments).
     One of the three key components of history, exam, or MDM, 
at least until the AMA completes changes for E/M visit coding and the 
CPT E/M Guidelines that the commenters expect for 2023 (several 
comments).
     Some combination of the above, for example, more than half 
of the MDM or more than half of total time (several comments).
     Working with the CPT Editorial Panel to develop a policy 
(several comments).

These commenters were concerned about a perceived devaluation of the 
medical decision-making portion of visits, disruptions to current 
practice patterns, and administrative burdens associated with timing 
each of the practitioner's contribution to the visit.
    Response: Regarding recommendations to consider the substantive 
portion to be a lower percentage of time, having reviewed our current 
policy, we do not believe that the higher physician payment rate under 
the PFS should be made when a physician performs less than half of the 
visit, such as a quarter or a third of the total time or less than half 
of the MDM. We do not think that MDM is necessarily the most critical 
or central component of E/M visits, and it is not the only service 
component being paid for. PFS payment rates incorporate and assume a 
certain amount of physician time per visit, reflected in the assigned 
RVUs and reflected annually in our physician time files. PFS payment 
rates reflect the typical amount of time spent on visits, and the Act 
requires us to reflect both time and intensity of work (physician and 
practitioner) in our payment rates. We do not believe this in any way 
devalues the unique education, training, experience, or expertise of 
physicians, but rather that both time and expertise are important and 
included in payment under the PFS. We continue to believe that MDM 
cannot be readily attributed to only the physician or the NPP, or 
definitively divided between them.
    We believe the commenters overestimate the administrative burden

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of tracking and attributing time, given the advent of EHRs and new E/M 
visit coding structures. However, we understand that an adjustment 
period may be needed to establish systems to track and attribute time 
for split (or shared) visits, especially since the coding for E/M 
visits in many facility settings will not use MDM or time to 
distinguish visit levels until 2023. Therefore, we are finalizing our 
definition of substantive portion for split (or shared) visits as 
proposed (more than half of the total time spent by the physician and 
NPP performing the split (or shared) visit) beginning January 1, 2023. 
However, we are modifying our proposed policy for one transitional 
year. For CY 2022, except for critical care visits, the substantive 
portion will be defined as 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). In other 
words, for CY 2022, the practitioner who spends more than half of the 
total time, or performs the history, exam, or MDM can be considered to 
have performed the substantive portion and can bill for the split (or 
shared) E/M visit. We wish to be clear that practitioners can still use 
MDM to select visit level for the E/M split (or shared) visit, as 
proposed. We also are clarifying that when one of the three key 
components is used as the substantive portion in CY 2022, the 
practitioner who bills the visit must perform that component in its 
entirety in order to bill (see section II.F.1.c.1. of this final rule 
for a more detailed discussion).
    For visits that are already timed (that is, critical care 
services), the choice to use more than half of the total time, or 
performance of the history, exam, or MDM will not apply. For critical 
care visits, starting in CY 2022, the substantive portion will be more 
than half of the total time, as proposed. We will continue to review 
and consider any future changes by the AMA/CPT Editorial Panel to the 
CPT E/M Guidelines for split (or shared) visits. We also intend to 
monitor the claims data for split (or shared) visits, to better 
understand how frequently practitioners use or rely upon this billing 
construct.
    We considered disallowing split (or shared) billing in critical 
care, SNF and nursing facility (NF) visits, as well as new patient and 
initial patient visits. We require certain SNF/NF visits to be provided 
entirely by a physician, but we believed we should allow split (or 
shared) visit billing for other visits that can be split (or shared) in 
these settings. (We refer readers to our Conditions of Participation in 
42 CFR 483.30 for information regarding the SNF/NF visits that are 
required to be performed in their entirety by a physician. That 
regulation requires that certain SNF/NF visits must be furnished 
directly and solely by a physician). However, we believed current 
clinical practice generally allows sharing of critical care visits by 
appropriately trained and qualified practitioners, and we solicited 
comment on this belief and this alternative considered. We proposed to 
allow split (or shared) visit billing in critical care because we 
believe the practice of medicine has evolved towards a more team-based 
approach to care, and greater integration in the practice of physicians 
and NPPs, particularly when care is furnished by clinicians in the same 
group in the facility setting. Given this evolution in medical 
practice, the concerns that may have been present when we issued 
current policy may no longer be as relevant. We understand that there 
have been changes in the practice of medicine over the past several 
years, some facilitated by the advent of EHRs and other systems, toward 
a more team-based approach to care. There has also been an increase in 
alternative payment models that employ a more team-based approach to 
care.
    Comment: We received many comments on our proposals for allowed 
settings of care, all in support of those proposals.
    Response: We thank the commenters for their support. After 
consideration of the public comments, we are finalizing as proposed.
    We proposed to allow split (or shared) visits for both new and 
established patients as well as initial and subsequent visits. After 
conducting an internal review, including consulting our medical 
officers, we believed that the practice of medicine has evolved toward 
a more team-based approach to care, and greater integration in the 
practice of physicians and NPPs, particularly when care is furnished by 
practitioners in the same group in the facility setting. Given this 
evolution in medical practice, the concerns that may have been present 
when we issued the manual instructions may no longer be as relevant. We 
understand that there have been changes in the practice of medicine 
over the past several years, some facilitated by the advent of EHRs and 
other systems, toward a more team-based approach to care. There has 
also been an increase in alternative payment models that employ a more 
team-based approach to care. In considering and reevaluating our 
policy, we saw no reason to preclude the physician or NPP from billing 
for split (or shared) visits for a new patient, in addition to an 
established patient, or for initial and subsequent split (or shared) 
visits. Therefore, we proposed to permit the physician or NPP to bill 
for split (or shared) visits for both new and established patients, as 
well as for initial and subsequent visits. We believed this approach is 
also consistent with the CPT E/M Guidelines for split (or shared) 
visits, which does not exclude these types of visits from being billed 
when furnished as split (or shared) services.
    Comment: We received many comments on this proposal, all in support 
of it.
    Response: We thank the commenters for their support. After 
consideration of public comments, we are finalizing as proposed.
3. Alternatives Considered for Requiring Certain Manufacturers To 
Report Drug Pricing Information for Part B (Sec. Sec.  414.802, 
414.806)
    This provision implements new statutory requirements under sections 
1847A and 1927 of the Act, as amended by section 401 of the CAA (for 
the purposes of this section of this final rule, hereinafter is 
referred to as ``section 401''). These new requirements will improve 
the accuracy of reported prices and limit the use of WAC-based pricing.
    As discussed in section III.D.1. of this final rule, section 
1847A(c)(6)(A) of the Act incorporates the definition of manufacturer 
at section 1927(k)(5) of the Act, but permits the Secretary to exempt 
repackagers from the definition of manufacturer, as determined 
appropriate, for purposes of section 1847A(f)(2) of the Act.
    We considered whether to implement the flexibility afforded by the 
statute. However, implementing the flexibility afforded by the statute 
could potentially lead to a gap in the ASP reporting requirements, 
meaning that ASPs could be distorted to the extent that certain sales 
are carved out of the reporting requirement through the use of 
repackagers.
    As discussed previously in this RIA, we are unable to 
quantitatively estimate the impacts of this provision. We welcomed 
comments on our approach, and on the alternative relative to: (1) The 
likely costs or savings (to manufacturers, beneficiaries, the 
government, and other stakeholders); and (2) any other related impacts 
of this provision.

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4. Alternatives Considered for the MDPP Expanded Model Emergency Policy
    For the MDPP Expanded Model Emergency Policy, no alternatives were 
considered. The 2-year MDPP service period has depressed interest in 
MDPP among would-be MDPP suppliers. These actions address stakeholder 
comments on the barriers to MDPP expanded model success. If we do not 
take action, we will not be able to scale MDPP as intended, impacting 
Medicare beneficiary access to this program. Reducing the MDPP from a 
24- to a 12-month services period, increasing the year 1 performance 
payments, and waiving the Medicare provider enrollment application fee 
not only better aligns the model with the evidence that helped certify 
the DPP model test initially, but it will encourage eligible 
organizations to enroll as MDPP suppliers.
5. Alternatives Considered for the Quality Payment Program
    We view the performance threshold as a critical factor affecting 
the distribution of payment adjustments in the Quality Payment Program. 
We ran a separate final policies RIA model based on the actual mean for 
the CY 2019 performance period/2021 MIPS payment year with a 
performance threshold of 86 and an additional performance threshold of 
92 points, which are potential values that may be used for the CY 2022 
performance period/2024 MIPS payment year. The model with a performance 
threshold of 86 and additional performance threshold of 92 has the same 
mean and median final score as our policies RIA model since the 
performance threshold does not change the final score. We estimate that 
$ 907 million will be redistributed through BN. For clinicians who meet 
or exceed the additional performance threshold, an additional $241 
million was distributed. The maximum positive payment adjustment will 
be 18.2 percent prior to the maximum additional payment adjustment and 
28.2 percent after considering the MIPS maximum positive payment 
adjustment and the additional MIPS payment adjustment for exceptional 
performance. In addition, 74.0 percent of MIPS eligible clinicians will 
receive a negative payment adjustment among those that submit data.
    We report the findings for the baseline model which describes the 
impact for the CY 2022 performance period/2024 MIPS payment year if 
this regulation did not exist. The baseline model has a final score 
mean of 78.13 and median of 82.59. We estimate that $428 million will 
be redistributed through BN. There will be a maximum payment adjustment 
of 6.6 percent after considering the MIPS payment adjustment and the 
additional MIPS payment adjustment for exceptional performance. In 
addition, 8.3 percent of MIPS eligible clinicians will receive a 
negative payment adjustment among those that submit data.

H. Impact on Beneficiaries

    We do not believe these provisions will have a negative impact on 
beneficiaries given overall PFS BN.
1. Requiring Certain Manufacturers To Report Drug Pricing Information 
for Part B (Sec. Sec.  414.802, 414.806)
    Section 1927(b)(3)(A)(iii) of the Act requires manufacturers with a 
Medicaid drug rebate agreement to report ASP data consistent with the 
information required for such reporting at section 1847A of the Act. 
Some manufacturers without Medicaid drug rebate agreements voluntarily 
submit ASP data for their single source drugs or biologicals that are 
payable under Part B, however other manufacturers without Medicaid drug 
rebate agreements do not voluntarily submit such data. Without 
manufacturer reported ASP data, CMS cannot calculate the ASP payment 
limit, and consequently, payment is typically based on Wholesale 
Acquisition Cost (WAC).
    Consistent with section 1847A(c)(3) of the Act and our regulations 
at Sec.  414.804(a)(2), the ASP is net of price concessions. However, 
consistent with the definition of WAC at section 1847A(c)(6)(B) of the 
Act, the WAC is not net of price concessions and is thus nearly always, 
and sometimes significantly, higher than ASP. Drugs with payment 
allowances based on WAC may have greater ``spreads'' between 
acquisition costs and payment than drugs for which there is an ASP-
based payment allowance, which, in turn, may: (1) Incent the use of the 
drug based on its spread rather than on purely clinical considerations; 
(2) result in increased payments under Medicare Part B; and (3) result 
in increased beneficiary cost sharing. This provision implements new 
statutory requirements under sections 1847A and 1927 of the Act, as 
amended by section 401 of Division CC, Title IV of the CAA, 2021. These 
new requirements will improve the accuracy of reported payment limits 
and limit the use of WAC-based pricing.
    For single source drugs, these changes may result in lower payment 
limits because, typically, the WAC plus 3 percent is higher than ASP 
plus 6 percent. This then translates to cost savings for both the 
government and beneficiaries, who will pay coinsurance on a lesser 
amount. However, for the reason stated earlier in this RIA (see section 
VI.G.4. of this final rule), we are unable to predict the magnitude of 
this effect.
    Similarly, payment limits for multiple source drugs could increase 
or decrease, and we are unable to predict the direction or magnitude of 
specific or aggregate effects at this time.
2. Determination of ASP for Certain Self-Administered Drug Products
    Although we are unable to quantify the total magnitude of the 
potential savings, these changes have the potential to substantially 
reduce program expenditures and beneficiary coinsurance. The OIG's July 
2020 report (discussed in section III.D.2. of this final rule) 
determined that the inclusion of self-administered versions of 
certolizumab and abatacept in their respective volume-weighted, average 
ASPs, alone, has resulted in $173 million in additional Medicare 
beneficiary coinsurance between 2014 and 2018.
    The regulatory changes have the potential to result in decreased 
payment limits for identified billing and payment codes and could, in 
turn, substantially reduce beneficiary coinsurance. Since section 405 
of Division CC, Title IV of the CAA, 2021 directs CMS to implement the 
statutory changes at section 1847A(g)(3) of the Act beginning on July 
1, 2021, these potential savings may be observed within the year.
3. Medicare Diabetes Prevention Program Expanded Model Emergency Policy
    This change will have a positive impact on eligible MDPP 
beneficiaries, as it better aligns with the CDC's National DPP, giving 
both the participants and the coaches similar messaging around this 
program, regardless of payer. MDPP suppliers often offer the MDPP set 
of services to mixed cohorts, or classes with participants who are not 
eligible for MDPP, but who are enrolled in a National DPP cohort. Since 
MDPP generally follows the CDC's National DPP and aligns its program 
with the CDC's DPRP Standards, it is confusing to participants, 
coaches, and staff when talking about a 2-year program to its eligible 
Medicare participants when the non-Medicare participants have a 1-year 
program. Finally, reducing the MDPP service period from 2 years to one 
(1) year allows more cohorts to start and finish MDPP during the 
expanded

[[Page 65658]]

model initial period of performance, which ends in March 2023.
4. Quality Payment Program
    There are several changes in this 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, will lead to 
more meaningful and relevant data being available to beneficiaries on 
the type and scope of care provided by clinicians on the compare tool. 
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 this will improve the quality and value of care provided to 
Medicare beneficiaries. For example, several of the new 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.

K. 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 rule will be the number of reviewers of last 
year's 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 rule in detail, and it is also 
possible that some reviewers will choose not to comment on the rule. 
For these reasons we thought that the number of commenters will be a 
fair estimate of the number of reviewers of last year's 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 $114.24 per hour, including overhead and fringe benefits 
https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average 
reading speed, we estimate that it will 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 $913.92 (8.0 hours x $114.24). 
Therefore, we estimated that the total cost of reviewing this 
regulation is $32,380,186 ($885.92 x 35,430 reviewers on this year's 
proposed rule).

J. Accounting Statement

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Tables 150 and 151 
(Accounting Statements), we have prepared an accounting statement. This 
estimate includes growth in incurred benefits from CY 2021 to CY 2022 
based on the FY 2022 President's Budget baseline.
[GRAPHIC] [TIFF OMITTED] TR19NO21.183

[GRAPHIC] [TIFF OMITTED] TR19NO21.184

K. Conclusion

    The analysis in the previous sections, together with the remainder 
of this preamble, provided an initial Regulatory Flexibility Analysis. 
The previous analysis, together with the preceding portion of this 
preamble, provides an RIA. In accordance with the provisions of 
Executive Order 12866, this regulation was reviewed by the Office of 
Management and Budget.

    Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & 
Medicaid Services, approved this document on October 28, 2021.

List of Subjects

42 CFR Part 403

    Grant programs--health, Health insurance, Hospitals, 
Intergovernmental relations, Medicare, Reporting and recordkeeping 
requirements.

[[Page 65659]]

42 CFR Part 405

    Administrative practice and procedure, Diseases, Health facilities, 
Health insurance, Health professions, Medical devices, Medicare, 
Reporting and recordkeeping requirements, Rural areas, X-rays.

42 CFR Part 410

    Diseases, Health facilities, Health professions, Laboratories, 
Medicare, Reporting and recordkeeping requirements, Rural areas, X-
rays.

42 CFR Part 411

    Diseases, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 414

    Administrative practice and procedure, Biologics, Diseases, Drugs, 
Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 415

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 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

    Emergency medical services, 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.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 403--SPECIAL PROGRAMS AND PROJECTS

0
1. The authority citation for part 403 continues to read as follows:

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


0
2. In Sec.  403.902--
0
a. Amend the definition of ``Ownership or investment interest'' by 
adding paragraphs (3)(vi) and (vii);
0
b. Add a definition for ``Physician-owned distributorship'' in 
alphabetical order; and
0
c. Revise the definition of ``Short term medical supply or device 
loan''.
    The additions and revision read as follows:


Sec.  403.902  Definitions.

* * * * *
    Ownership or investment interest * * *
    (3) * * *
    (vi) A titular ownership or investment interest that excludes the 
ability or right to receive the financial benefits of ownership or 
investment, including, but not limited to, the distribution of profits, 
dividends, proceeds of sale, or similar returns on investment; or
    (vii) An interest in an entity that arises from an employee stock 
ownership plan (ESOP) that is qualified under section 401(a) of the 
Internal Revenue Code of 1986.
* * * * *
    Physician-owned distributorship, for the purposes of determining 
the existence of a reportable ownership or investment interest under 
this subpart, means an entity that:
    (1) Meets the definition of an applicable manufacturer or 
applicable group purchasing organization as defined in this section, 
and
    (2) Meets at least one of the following two conditions:
    (i) Has a minimum of 5 percent direct or indirect ownership or 
investment interest in the applicable manufacturer or applicable group 
purchasing organization held by a physician or a physician's immediate 
family member, or
    (ii) A physician or a physician's immediate family member receives 
compensation from the applicable manufacturer or group purchasing 
organization in the form of a commission, return on investment, profit 
sharing, profit distribution, or other remuneration directly or 
indirectly derived from the sale or distribution of devices by the 
applicable manufacturer or group purchasing organization in which the 
physician or physician's immediate family member has ownership.
    (3) This physician owned distributor definition does not apply for 
purposes of any other laws or regulations, including, but not limited 
to, section 1877 of the Act, the regulations at 42 CFR part 411, 
subpart J, section 1128B of the Act, or the regulations at 42 CFR 
1001.952.
* * * * *
    Short term medical supply or device loan means the loan of a 
covered device or a device under development, or the provision of a 
limited quantity of medical supplies for a short-term trial period, not 
to exceed a loan period of 90 cumulative days per calendar year or a 
quantity of 90 cumulative days of average daily use per calendar year, 
to permit evaluation of the device or medical supply by the covered 
recipient.
* * * * *

0
3. Amend Sec.  403.904 by adding paragraph (a)(3) to read as follows:


Sec.  403.904  Reports of payments or other transfers of value to 
covered recipients.

    (a) * * *
    (3) An applicable manufacturer or applicable group purchasing 
organization that has reported payments or transfers of value under the 
scope of this section may not remove, delete, or alter any record/(s) 
unless an error is discovered in the information that had been 
furnished, or the record is otherwise believed to meet exceptions for 
reporting.
* * * * *

0
4. Amend Sec.  403.908 by revising paragraph (c)(3) and adding 
paragraph (c)(4) to read as follows:


Sec.  403.908  Procedures for electronic submission of reports.

* * * * *
    (c) * * *
    (3) During registration, applicable manufacturers and applicable 
group purchasing organizations must name two points of contact with 
appropriate contact information. These points of contact must be 
updated for 2 years following record submission.
    (4) An applicable manufacturer or applicable group purchasing 
organization that meets the definition of physician-owned 
distributorship as defined in Sec.  403.902 must identify its status as 
a physician-owned distributorship when registering or recertifying.
* * * * *

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

0
5. 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
6. Amend Sec.  405.902 by adding definitions for ``Additional 
documentation'', ``Additional documentation request (ADR)'', ``Post-
payment medical review'', and ``Prepayment medical review'' in 
alphabetical order to read as follows:

[[Page 65660]]

Sec.  405.902  Definitions.

* * * * *
    Additional documentation means any information requested by a 
contractor when conducting a prepayment review or post-payment review.
    Additional documentation request (ADR) means a contractor's initial 
documentation request in reviewing claims selected for prepayment 
review or post-payment review.
* * * * *
    Post-payment medical review (or post-payment review) means a review 
that occurs after payment is made on the selected claim to determine 
whether the initial determination for payment was appropriate.
    Prepayment medical review (or prepayment review) means a review 
that occurs before an initial determination for payment is made on the 
selected claim to determine whether payment should be made.
* * * * *

0
7. Add Sec.  405.903 to read as follows:


Sec.  405.903  Prepayment review.

    (a) A contractor may select a claim(s) for prepayment review.
    (b) In conducting a prepayment review, a contractor may issue 
additional documentation requests to a provider or supplier.
    (1) A provider or supplier will be provided 45 calendar days to 
submit additional documentation in response to a contractor's request, 
except as stated in paragraph (b)(2) and (c) of this section.
    (2) A contractor may accept documentation received after 45-
calendar days for good cause. Good cause means situations such as 
natural disasters, interruptions in business practices, or other 
extenuating circumstances that the contractor deems good cause in 
accepting the documentation.
    (c) A provider or supplier will be provided 30 calendar days to 
submit additional documentation in response to a UPIC's request for 
additional documentation. A UPIC may accept documentation received 
after the 30 calendar days for good cause. Good cause means situations 
such as natural disasters, interruptions in business practices, or 
other extenuating circumstances that the UPIC deems good cause in 
accepting the documentation.
    (d) A contractor's prepayment review will result in an initial 
determination under Sec.  405.920.

0
8. Add Sec. Sec.  405.929 and 405.930 under the undesignated ceneter 
heading ``Initial Determinations'' in subpart I to read as follows:


Sec.  405.929  Post-payment review.

    (a) A contractor may select a claim(s) for post-payment review, 
which is conducted under the reopening authority in Sec.  405.980.
    (b) In conducting a post-payment review, a contractor may issue an 
additional documentation request to a provider or supplier.
    (1) A provider or supplier will be provided 45 calendar days to 
submit additional documentation in response to a contractor's request, 
except as stated in paragraph (b)(2) and (c) of this section.
    (2) A contractor may accept documentation received after 45 
calendar days for good cause. Good cause means situations such as 
natural disasters, interruptions in business practices, or other 
extenuating circumstances that the contractor deems good cause in 
accepting the documentation.
    (c) A provider or supplier will be provided 30 calendar days to 
submit additional documentation in response to a UPIC's request for 
additional documentation. A UPIC may accept documentation received 
after 30 calendar days for good cause. Good cause means situations such 
as natural disasters, interruptions in business practices, or other 
extenuating circumstances that the UPIC deems good cause in accepting 
the documentation.
    (d) The outcome of a contractor's review will result in either no 
change to the initial determination or a revised determination under 
Sec.  405.984.


Sec.  405.930  Failure to respond to additional documentation request.

    If a contractor gives a provider or supplier notice and time to 
respond to an additional documentation request and the provider or 
supplier does not provide the additional documentation in a timely 
manner, the contractor has authority to deny the claim.

0
9. Amend Sec.  405.986 by revising the paragraph (a) subject heading to 
read as follows:


Sec.  405.986  Good cause for reopening.

    (a) Establishing good cause for reopening. * * *
* * * * *

0
10. Amend Sec.  405.2411 by--
0
a. Revising paragraph (b)(2);
0
b. Redesignating paragraph (b)(3) as (b)(4); and
0
c. Adding a new paragraph (b)(3).
    The revision and addition read as follows:


Sec.  405.2411  Scope of benefits.

* * * * *
    (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 or clinical psychologist 
employed or under contract with the RHC or FQHC at the time the 
services are furnished;
    (3) Inclusive of hospice attending physician services, and are 
covered when furnished during a patient's hospice election only when 
provided by an RHC/FQHC physician, nurse practitioner, or physician 
assistant designated by the patient as his or her attending physician 
and employed or under contract with the RHC or FQHC at the time the 
services are furnished; and
* * * * *

0
11. Amend Sec.  405.2446 by revising paragraph (c) to read as follows:


Sec.  405.2446  Scope of services.

* * * * *
    (c) FQHC services are covered when provided in outpatient settings 
only, including a patient's place of residence, which may be a skilled 
nursing facility or a nursing facility, other institution used as a 
patient's home, or are hospice attending physician services furnished 
during a hospice election.
* * * * *

0
12. Amend Sec.  405.2462--
0
a. By revising paragraphs (a) and (b);
0
b. By redesignating paragraphs (c) through (g) as paragraphs (e) 
through (i), respectively;
0
c. By adding new paragraphs (c) and (d); and
0
d. In newly redesignated paragraph (e) introductory text, by removing 
the reference ``paragraph (d)'' and adding in its place ``paragraph 
(f)''.
    The revisions and additions read as follows:


Sec.  405.2462  Payment for RHC and FQHC services.

    (a) Payment to independent RHCs that are authorized to bill under 
the reasonable cost system. (1) RHCs that are authorized to bill under 
the reasonable cost system are paid on the basis of an all-inclusive 
rate, subject to a payment limit per visit determined in paragraph (b) 
of this section, for each beneficiary visit for covered services. This 
rate is determined by the Medicare Administration Contractor (MAC), in 
accordance with this subpart and general instructions issued by CMS.
    (2) The amount payable by the MAC for a visit is determined in 
accordance with paragraphs (i)(1) and (2) of this section.

[[Page 65661]]

    (b) RHC payment limit per visit. (1) In establishing limits on 
payment for rural health clinic services provided by rural health 
clinics the limit for services provided prior to April 1, 2021:
    (i) In 1988, after March 31, at $46 per visit; and
    (ii) In a subsequent year (before April 1, 2021), at the limit 
established for the previous year increased by the percentage increase 
in the Medicare Economic Index (MEI) (as defined in section 1842(i)(3) 
of the Act) applicable to primary care services (as defined in section 
1842(i)(4) of the Act) furnished as of the first day of that year.
    (2) In establishing limits on payment for rural health services 
furnished on or after April 1, 2021, by rural health clinics or any 
rural health clinic that is enrolled on or after January 1, 2021 under 
section 1866(j) of the Act), the limit for services provided:
    (i) In 2021, after March 31, at $100 per visit;
    (ii) In 2022, at $113 per visit;
    (iii) In 2023, at $126 per visit;
    (iv) In 2024, at $139 per visit;
    (v) In 2025, at $152 per visit;
    (vi) In 2026, at $165 per visit;
    (vii) In 2027, at $178 per visit; and
    (viii) In 2028, at $190 per visit.
    (ix) In a subsequent year, at the limit established for the 
previous year increased by the percentage increase in MEI applicable to 
primary care services furnished as of the first day of such year.
    (3) In establishing limits on payment for rural health services 
furnished on or after April 1, 2021, by provider-based rural health 
clinics as described in section (c)(4) of this part, the limit for 
services provided:
    (i) In 2021, after March 31, at an amount equal to the greater of:
    (A) For rural health clinics that had an all-inclusive rate 
established for services furnished in 2020--
    (1) The all-inclusive rate applicable to the rural health clinic 
for services furnished in 2020, increased by the percentage increase in 
the MEI applicable to primary care services furnished as of the first 
day of 2021, or
    (2) The payment limit per visit applicable in paragraph (b)(2) of 
this section.
    (B) For rural health clinics that did not have an all-inclusive 
rate established for services furnished in 2020--
    (1) The all-inclusive rate applicable to the rural health clinic 
for services furnished in 2021, or
    (2) The payment limit per visit applicable in paragraph (b)(2) of 
this section.
    (ii) In a subsequent year, at an amount equal to the greater of:
    (A) The amount established under paragraph (b)(3)(i)(A) or (B) of 
this section, as applicable for the previous year, increased by the 
percentage increase in MEI applicable to primary care services 
furnished as of the first day of such subsequent year, or
    (B) The payment limit per visit applicable under paragraph (b)(2) 
of this section for such subsequent year.
    (c) Payment to provider-based RHCs that are authorized to bill 
under the reasonable cost system. (1) An RHC that is authorized to bill 
under the reasonable cost system is paid in accordance with parts 405 
and 413 of this subchapter, as applicable, if the RHC is--
    (i) An integral and subordinate part of a hospital, skilled nursing 
facility or home health agency participating in Medicare (that is, a 
provider of services); and
    (ii) Operated with other departments of the provider under common 
licensure, governance and professional supervision.
    (2) An RHC, described in paragraph (c)(1) of this section, is paid 
on the basis of an all-inclusive rate, subject to a payment limit per 
visit, described in paragraphs (b)(1) and (2) of this section, for each 
beneficiary visit for covered services when in a hospital with greater 
than 50 beds as determined in Sec.  412.105(b) of this subchapter. This 
all-inclusive rate is determined by the MAC, in accordance with this 
subpart and general instructions issued by CMS. The amount payable by 
the MAC for a visit is determined in accordance with paragraphs (i)(1) 
and (2) of this section.
    (3) Prior to April 1, 2021, an RHC, described in paragraph (c)(1) 
of this section, is paid on the basis of an all-inclusive rate and is 
not subject to a payment limit per visit described in paragraphs (b)(1) 
and (2) of this section for each beneficiary visit for covered services 
when in a hospital with less than 50 beds as determined in Sec.  
412.105(b) of this subchapter. This all-inclusive rate is determined by 
the MAC, in accordance with this subpart and general instructions 
issued by CMS. The amount payable by the MAC for a visit is determined 
in accordance with paragraphs (i)(1) and (2) of this section.
    (4) On or after April 1, 2021, an RHC, described in paragraph 
(c)(1) of this section, is paid on the basis of an all-inclusive rate, 
subject to a payment limit per visit, described in paragraph (b)(3) of 
this section, for each beneficiary visit for covered services when it 
meets the specified qualifications in paragraph(d) of this section. 
This all-inclusive rate is determined by the MAC, in accordance with 
this subpart and general instructions issued by CMS. The amount payable 
by the MAC for a visit is determined in accordance with paragraphs 
(i)(1) and (2) of this section.
    (d) Specified qualifications. A provider-based rural health clinic 
must meet the following qualifications to have a payment limit per 
visit established in accordance with paragraph (b)(3) of this section.
    (1) As of December 31, 2020, was in a hospital with less than 50 
beds (as determined in Sec.  412.105(b) of this subchapter) and after 
December 31, 2020, in a hospital that continues to have less than 50 
beds (not taking into account any increase in the number of beds 
pursuant to a waiver during the COVID-19 Public Health Emergency 
(PHE)); and one of the following circumstances:
    (i) As of December 31, 2020, was enrolled under section 1866(j) of 
the Act (including temporary enrollment during the COVID-19 PHE); or
    (ii) Submitted an application for enrollment under section 1866(j) 
of the Act (or a request for temporary enrollment during the COVID-19 
PHE) that was received not later than December 31, 2020.
    (2) [Reserved]
* * * * *

0
13. Amend Sec.  405.2463 by revising paragraphs (a)(1)(i) introductory 
text and (b)(3) introductory text to read as follows:


Sec.  405.2463  What constitutes a visit.

    (a) * * *
    (1) * * *
    (i) Face-to-face encounter (or, for mental health disorders only, 
an encounter that meets the requirements under paragraph (b)(3) of this 
section) between an RHC patient and one of the following:
* * * * *
    (b) * * *
    (3) Visit--Mental health. A mental health visit is a face-to-face 
encounter or an encounter furnished using interactive, real-time, audio 
and video telecommunications technology or audio-only interactions in 
cases where the patient is not capable of, or does not consent to, the 
use of video technology for the purposes of diagnosis, evaluation or 
treatment of a mental health disorder, including an in-person mental 
health service 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

[[Page 65662]]

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:
* * * * *

0
14. Amend Sec.  405.2466 by revising paragraph (b)(1)(iv) to read as 
follows:


Sec.  405.2466  Annual reconciliation.

* * * * *
    (b) * * *
    (1) * * *
    (iv) For RHCs and FQHCs, payment for pneumococcal, influenza, and 
COVID-19 vaccine and their administration is 100 percent of Medicare 
reasonable cost.
* * * * *

0
15. Amend Sec.  405.2469 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, there must be an in-person mental health 
service furnished within 6 months prior to the furnishing of the 
telecommunications service and that an in-person mental health service 
(without the use of telecommunications technology) must be provided at 
least every 12 months while the beneficiary is receiving services 
furnished via telecommunications technology for diagnosis, evaluation, 
or treatment of mental health disorders, unless, for a particular 12-
month period, the physician or practitioner and patient agree that the 
risks and burdens outweigh the benefits associated with furnishing the 
in-person item or service, and the practitioner documents the reasons 
for this decision in the patient's medical record.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
16. The authority citation for part 410 continues to read as follows:

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


0
17. Amend Sec.  410.33 by--
0
a. Revising paragraphs (c) and (g)(6)(i) and (ii);
0
b. Redesignating paragraphs (g)(8)(i) through (iii) as paragraphs 
(g)(8)(i)(A) through (C), respectively; and
0
c. Adding paragraphs (g)(8)(i) introductory text and (g)(8)(ii); and
0
d. Revising paragraph (g)(9).
    The revisions and additions read as follows:


Sec.  410.33  Independent diagnostic testing facility.

* * * * *
    (c) Nonphysician personnel. (1) Except as otherwise stated in 
paragraph (c)(2) of this section, any nonphysician personnel used by 
the IDTF to perform tests must demonstrate the basic qualifications to 
perform the tests in question and have training and proficiency as 
evidenced by licensure or certification by the appropriate State health 
or education department. In the absence of a State licensing board, the 
technician must be certified by an appropriate national credentialing 
body. The IDTF must maintain documentation available for review that 
these requirements are met.
    (2) For services that do not require direct or in-person 
beneficiary interaction, treatment, or testing, any nonphysician 
personnel used by the IDTF to perform the tests must meet all 
applicable State licensure requirements for doing so. If there are any 
applicable State licensure requirements, the IDTF must maintain 
documentation available for review that these requirements are met.
* * * * *
    (g) * * *
    (6) * * *
    (i) Except as otherwise stated in paragraph (g)(6)(ii) of this 
section, have a comprehensive liability insurance policy of at least 
$300,000 per location that covers both the place of business and all 
customers and employees of the IDTF. The policy must be carried by a 
nonrelative-owned company. Failure to maintain required insurance at 
all times will result in revocation of the IDTF's billing privileges 
retroactive to the date the insurance lapsed. IDTF suppliers are 
responsible for providing the contact information for the issuing 
insurance agent and the underwriter. In addition, the IDTF must--
    (A) Ensure that the insurance policy must remain in force at all 
times and provide coverage of at least $300,000 per incident; and
    (B) Notify the CMS designated contractor in writing of any policy 
changes or cancellations.
    (ii) Paragraph (g)(6)(i) of this section does not apply to IDTFs 
that only perform services that do not require direct or in-person 
beneficiary interaction, treatment, or testing.
* * * * *
    (8) * * *
    (i) Except as otherwise stated in paragraph (g)(8)(ii) of this 
section, answer, document, and maintain documentation of a 
beneficiary's written clinical complaint at the physical site of the 
IDTF. (For mobile IDTFs, this documentation would be stored at their 
home office.) This includes, but is not limited to, the following:
* * * * *
    (ii) Paragraph (g)(8)(i) of this section does not apply to IDTFs 
that only perform services that do not require direct or in-person 
beneficiary interaction, treatment, or testing.
    (9) Openly post these standards for review by patients and the 
public. (This requirement does not apply to IDTFs that only perform 
services that do not require direct or in-person beneficiary 
interaction, treatment, or testing.)
* * * * *

0
18. Amend Sec.  410.37 by adding paragraph (j) to read as follows:


Sec.  410.37  Colorectal cancer screening tests: Conditions for and 
limitations on coverage.

* * * * *
    (j) Expansion of coverage of colorectal cancer screening tests. 
Effective January 1, 2022, colorectal cancer screening tests include a 
planned screening flexible sigmoidoscopy or screening colonoscopy that 
involves the removal of tissue or other matter or other procedure 
furnished in connection with, as a result of, and in the same clinical 
encounter as the screening test.

0
19. Amend Sec.  410.47--
0
a. In paragraph (a), by revising the definitions of ``Individualized 
treatment plan'', ``Medical director'', Outcomes assessment'', 
``Physician prescribed exercise'', ``Psychosocial assessment'', and 
``Supervising physician'';
0
b. By revising paragraphs (b) through (e);
0
c. By removing paragraph (f); and
0
d. By redesignating paragraph (g) as paragraph (f).
    The revisions read as follows:

[[Page 65663]]

Sec.  410.47  Pulmonary rehabilitation program: Conditions of coverage.

    (a) * * *
    Individualized treatment plan means a written plan tailored to each 
individual patient that includes all of the following:
    (i) A description of the individual's diagnosis.
    (ii) The type, amount, frequency, and duration of the items and 
services furnished under the plan.
    (iii) The goals set for the individual under the plan.
    Medical director means the physician who oversees the pulmonary 
rehabilitation program at a particular site.
    Outcomes assessment means an evaluation of progress as it relates 
to the individual's rehabilitation which includes the following:
    (i) Evaluations, based on patient-centered outcomes, which must be 
measured by the physician or program staff at the beginning and end of 
the program. Evaluations measured by program staff must be considered 
by the physician in developing and/or reviewing individualized 
treatment plans.
    (ii) Objective clinical measures of exercise performance and self-
reported measures of shortness of breath and behavior.
* * * * *
    Physician-prescribed exercise means aerobic exercise combined with 
other types of exercise (such as conditioning, breathing retraining, 
step, and strengthening) as determined to be appropriate for individual 
patients by a physician.
    Psychosocial assessment means an evaluation of an individual's 
mental and emotional functioning as it relates to the individual's 
rehabilitation or respiratory condition which includes an assessment of 
those aspects of an individual's family and home situation that affects 
the individual's rehabilitation treatment, and psychosocial evaluation 
of the individual's response to and rate of progress under the 
treatment plan.
* * * * *
    Supervising physician means a physician 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) General rule--(1) Covered conditions. Medicare Part B covers 
pulmonary rehabilitation for beneficiaries:
    (i) With moderate to very severe COPD (defined as GOLD 
classification II, III and IV), when referred by the physician treating 
the chronic respiratory disease;
    (ii) Who have had confirmed or suspected COVID-19 and experience 
persistent symptoms that include respiratory dysfunction for at least 
four weeks;
    (iii) Additional medical indications for coverage for pulmonary 
rehabilitation may be established through a national coverage 
determination (NCD).
    (2) Components. Pulmonary rehabilitation must include all of the 
following:
    (i) Physician-prescribed exercise during each pulmonary 
rehabilitation session.
    (ii) Education or training that is closely and clearly related to 
the individual's care and treatment which is tailored to the 
individual's needs and assists in achievement of goals toward 
independence in activities of daily living, adaptation to limitations 
and improved quality of life. Education must include information on 
respiratory problem management and, if appropriate, brief smoking 
cessation counseling.
    (iii) Psychosocial assessment.
    (iv) Outcomes assessment.
    (v) An individualized treatment plan detailing how components are 
utilized for each patient. The individualized treatment plan must be 
established, reviewed, and signed by a physician every 30 days.
    (3) Settings. (i) Medicare Part B pays for pulmonary rehabilitation 
in the following settings:
    (A) A physician's office.
    (B) A hospital outpatient setting.
    (ii) All settings must have the following:
    (A) A physician 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 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.
    (B) The necessary cardio-pulmonary, emergency, diagnostic, and 
therapeutic life-saving equipment accepted by the medical community as 
medically necessary (for example, oxygen, cardiopulmonary resuscitation 
equipment, and defibrillator) to treat chronic respiratory disease.
    (c) Medical director standards. The physician responsible for a 
pulmonary rehabilitation program is identified as the medical director. 
The medical director, in consultation with staff, is involved in 
directing the progress of individuals in the program and must possess 
all of the following:
    (1) Expertise in the management of individuals with respiratory 
pathophysiology.
    (2) Cardiopulmonary training in basic life support or advanced 
cardiac life support.
    (3) Be licensed to practice medicine in the State in which the 
pulmonary rehabilitation program is offered.
    (d) Supervising physician standards. Physicians acting as the 
supervising physician must possess all of the following:
    (1) Expertise in the management of individuals with respiratory 
pathophysiology.
    (2) Cardiopulmonary training in basic life support or advanced 
cardiac life support.
    (3) Be licensed to practice medicine in the State in which the 
pulmonary rehabilitation program is offered.
    (e) Limitations on coverage: The number of pulmonary rehabilitation 
sessions are limited to a maximum of 2 1-hour sessions per day for up 
to 36 sessions over up to 36 weeks with the option for an additional 36 
sessions over an extended period of time if approved by the Medicare 
Administrative Contractor.
* * * * *

0
20. Amend Sec.  410.49--
0
a. In paragraph (a), by revising the definition of ``Medical 
director'', revising paragraph (i) in the definition of ``Outcomes 
assessment'', and revising the definition of ``Physician-prescribed 
exercise''; and
0
b. By revising paragraphs (b)(1) introductory text, (b)(2) introductory 
text, (b)(2)(ii), (b)(3)(i) introductory text, (d) introductory text, 
(e) introductory text, and (f).
    The revisions read as follows:


Sec.  410.49  Cardiac rehabilitation program and intensive cardiac 
rehabilitation program: Conditions of coverage.

    (a) * * *
    Medical director means the physician who oversees the cardiac 
rehabilitation or intensive cardiac rehabilitation program at a 
particular site.
    Outcomes assessment * * *
    (i) Evaluations, based on patient-centered outcomes, which must be 
measured by the physician or program staff at the beginning and end of 
the program. Evaluations measured by program staff must be considered 
by the physician in developing and/or reviewing individualized 
treatment plans.
* * * * *

[[Page 65664]]

    Physician-prescribed exercise means aerobic exercise combined with 
other types of exercise (such as strengthening and stretching) as 
determined to be appropriate for individual patients by a physician.
* * * * *
    (b) * * *
    (1) Covered conditions. Medicare Part B covers cardiac 
rehabilitation and intensive cardiac rehabilitation for beneficiaries 
who have experienced one or more of the following:
* * * * *
    (2) Components. Cardiac rehabilitation and intensive cardiac 
rehabilitation must include all of the following:
* * * * *
    (ii) Cardiac risk factor modification, including education, 
counseling, and behavioral intervention, tailored to the individual's 
needs.
* * * * *
    (3) * * *
    (i) Medicare Part B pays for cardiac rehabilitation and intensive 
cardiac rehabilitation in the following settings:
* * * * *
    (d) Medical director standards. The physician responsible for a 
cardiac rehabilitation program or intensive cardiac rehabilitation 
program is identified as the medical director. The medical director, in 
consultation with staff, is involved in directing the progress of 
individuals in the program and must possess all of the following:
* * * * *
    (e) Supervising physician standards. Physicians acting as the 
supervising physician must possess all of the following:
* * * * *
    (f) Limitations on coverage--(1) Cardiac rehabilitation. The number 
of cardiac rehabilitation sessions are limited to a maximum of 2 1-hour 
sessions per day for up to 36 sessions over up to 36 weeks with the 
option for an additional 36 sessions over an extended period of time if 
approved by the Medicare Administrative Contractor.
    (2) Intensive cardiac rehabilitation. Intensive cardiac 
rehabilitation sessions are limited to 72 1-hour sessions (as defined 
in section 1848(b)(5) of the Act), up to 6 sessions per day, over a 
period of up to 18 weeks.

0
21. Amend Sec.  410.59 by revising paragraph (a)(4)(iii)(B) and adding 
paragraphs (a)(4)(iv) and (v) to read as follows:


Sec.  410.59  Outpatient occupational therapy services: Conditions.

    (a) * * *
    (4) * * *
    (iii) * * *
    (B) Except as provided in paragraph (a)(4)(iv) of this section, 
furnishes a portion of a service, or in the case of a 15-minute (or 
other time interval) timed code, a portion of a unit of service 
separately from the part furnished by the occupational therapist such 
that the minutes for that portion of a service (or unit of a service) 
furnished by the occupational therapist assistant exceed 10 percent of 
the total minutes for that service (or unit of a service).
    (iv) Paragraph (a)(4)(iii)(B) of this section does not apply when 
determining whether the prescribed modifier applies to the last 15-
minute unit of a service billed for a patient on a treatment day when 
the occupational therapist provides more than the midpoint of a 15-
minute timed code, that is, 8 or more minutes, regardless of any 
minutes for the same service furnished by the occupational therapy 
assistant.
    (v) Where there are two remaining 15-minute units to bill of the 
same service, and the occupational therapist and occupational therapy 
assistant each provided between 9 and 14 minutes of the service with a 
total time of at least 23 minutes and no more than 28 minutes, one unit 
of the service is billed with the prescribed modifier for the minutes 
furnished by the occupational therapy assistant and one unit is billed 
without the prescribed modifier for the service provided by the 
occupational therapist.
* * * * *

0
22. Amend Sec.  410.60 by revising paragraph (a)(4)(iii)(B) and adding 
paragraphs (a)(4)(iv) and (v) to read as follows:


Sec.  410.60  Outpatient physical therapy services: Conditions.

    (a) * * *
    (4) * * *
    (iii) * * *
    (B) Except as provided in paragraph (a)(4)(iv) of this section, 
furnishes a portion of a service, or in the case of a 15-minute (or 
other time interval) timed code, a portion of a unit of service 
separately from the part furnished by the physical therapist such that 
the minutes for that portion of a service (or unit of a service) 
furnished by the physical therapist assistant exceed 10 percent of the 
total minutes for that service (or unit of a service).
    (iv) Paragraph (a)(4)(iii)(B) of this section does not apply when 
determining whether the prescribed modifier applies to the last 15-
minute unit of a service billed for a patient on a treatment day, when 
the physical therapist provides more than the midpoint of a 15-minute 
timed code, that is, 8 or more minutes, regardless of any minutes for 
the same service furnished by the physical therapist assistant.
    (v) Where there are two remaining 15-minute units to bill of the 
same service, and the physical therapist and physical therapist 
assistant each provided between 9 and 14 minutes of the service with a 
total time of at least 23 minutes, one unit of the service is billed 
with the prescribed modifier for the minutes furnished by the physical 
therapist assistant and one unit is billed without the prescribed 
modifier for the service provided by the physical therapist.
* * * * *

0
23. Amend Sec.  410.67--
0
a. In paragraph (b), by revising paragraphs (3) and (4) in the 
definition of ``Opioid use disorder treatment service'';
0
b. By revising paragraphs (d)(4)(ii) and (iii) and (d)(5); and
0
c. By adding paragraph (d)(6).
    The revisions and addition read as follows:


Sec.  410.67  Medicare coverage and payment of Opioid use disorder 
treatment services furnished by Opioid treatment programs.

* * * * *
    (b) * * *
    Opioid use disorder treatment service * * *
    (3) Substance use counseling by a professional to the extent 
authorized under State law to furnish such services including services 
furnished via two-way interactive audio-video communication technology, 
as clinically appropriate, and in compliance with all applicable 
requirements. During a Public Health Emergency, as defined in Sec.  
400.200 of this chapter, or for services furnished after the end of 
such emergency, in cases where audio/video communication technology is 
not available to the beneficiary, the counseling services may be 
furnished using audio-only telephone calls if all other applicable 
requirements are met.
    (4) Individual and group therapy with a physician or psychologist 
(or other mental health professional to the extent authorized under 
State law), including services furnished via two-way interactive audio-
video communication technology, as clinically appropriate, and in 
compliance with all applicable requirements. During a Public Health 
Emergency, as defined in Sec.  400.200 of this chapter, or for services 
furnished after the end of such emergency, in cases where audio/video 
communication technology is not available to the beneficiary, the 
therapy

[[Page 65665]]

services may be furnished using audio-only telephone calls if all other 
applicable requirements are met.
* * * * *
    (d) * * *
    (4) * * *
    (ii) The payment amounts for the non-drug component of the bundled 
payment for an episode of care, the adjustments for counseling or 
therapy, intake activities, periodic assessments, and the non-drug 
component of the adjustment for take-home supplies of opioid antagonist 
medications will be geographically adjusted using the Geographic 
Adjustment Factor described in Sec.  414.26 of this subchapter.
    (iii) The payment amounts for the non-drug component of the bundled 
payment for an episode of care, the adjustments for counseling or 
therapy, intake activities, periodic assessments, and the non-drug 
component of the adjustment for take-home supplies of opioid antagonist 
medications will be updated annually using the Medicare Economic Index 
described in Sec.  405.504(d) of this subchapter.
    (5) Payment for medications delivered, administered or dispensed to 
a beneficiary as part of the bundled payment or an adjustment to the 
bundled payment under paragraph (d)(4)(i) of this section is considered 
a duplicative payment if a claim for delivery, administration or 
dispensing of the same medications for the same beneficiary on the same 
date of service was also separately paid under Medicare Part B or Part 
D. CMS will recoup the duplicative payment made to the opioid treatment 
program.
    (6) For purposes of the adjustment to the bundled payment under 
paragraph (d)(4)(i)(A) of this section, after the end of the Public 
Health Emergency as defined in Sec.  400.200 of this chapter, when 
services are furnished using audio-only technology the practitioner 
must certify, in a form and manner specified by CMS, that they had the 
capacity to furnish the services using two-way, audio/video 
communication technology, but used audio-only technology because audio/
video communication technology was not available to the beneficiary.
* * * * *

0
24. Add Sec.  410.72 to read as follows:


Sec.  410.72  Registered dietitians' and nutrition professionals' 
services.

    (a) Definition: Registered dietitians and nutrition professionals. 
Meet the qualifications at Sec.  410.134.
    (b) Covered registered dietitian and nutrition professional 
services. Medicare Part B covers:
    (1) Coverage condition. Medical nutrition therapy (MNT) services as 
defined at Sec.  410.130 under the conditions of coverage at Sec.  
410.132.
    (2) Other services. Registered dietitians and nutrition 
professionals may also provide diabetes self-management (DSMT) services 
if they are or represent an accredited DSMT entity and have an order 
from a physician or qualified nonphysician practitioner who is treating 
the patient's diabetic condition.
    (3) Limits on MNT and DSMT. (i) DSMT and MNT cannot be furnished to 
a patient on the same date of service, and
    (ii) MNT and DSMT services cannot be furnished incident to the 
professional services of a physician or nonphysician practitioner 
service.
    (c) Limitations. The following services are not registered 
dietitian or nutrition professional services for purposes of billing 
Medicare Part B:
    (1) Services furnished by a registered dietitian or nutrition 
professional to an inpatient of a Medicare-participating hospital.
    (2) Services furnished by a registered dietitian or nutrition 
professional to an inpatient of a Medicare-participating SNF.
    (3) Services furnished by a registered dietitian or nutrition 
professional to a patient in a Medicare-participating ESRD facility in 
accordance with the limitation on coverage of MNT service listed at 
Sec.  410.132(b)(1).
    (d) Professional services. Registered dietitians and nutrition 
professionals can be paid for professional services only when the 
services have been directly performed by them.
    (e) Telehealth services. MNT and DSMT services may be provided as 
telehealth services (meeting the requirements in Sec.  410.78) when 
registered dietitians or nutrition professionals act as distant site 
practitioners.
    (f) Restrictions. The services of a registered dietitian or 
nutrition professional are provided on an assignment-related basis, and 
a registered dietitian or nutrition professional may not charge a 
beneficiary in excess of the amounts permitted under 42 CFR 424.55. If 
a beneficiary has made payment for a service in excess of these limits, 
the registered dietitian or nutrition professional must refund the full 
amount of the impermissible charge to the beneficiary.

0
25. Amend Sec.  410.74 by revising paragraphs (a)(2)(v) and (d)(2) to 
read as follows:


Sec.  410.74  Physician assistants' services.

    (a) * * *
    (2) * * *
    (v) Prior to January 1, 2022, furnishes services that are billed by 
the employer of a physician assistant; and
* * * * *
    (d) * * *
    (2) The services of a physician assistant are provided on an 
assignment-related basis, and the physician assistant may not charge a 
beneficiary in excess of the amounts permitted under 42 CFR 424.55. If 
a beneficiary has made payment for a service in excess of these limits, 
the physician assistant must refund the full amount of the 
impermissible charge to the beneficiary.
* * * * *

0
26. Amend Sec.  410.75 by revising paragraph (e)(2) to read as follows:


Sec.  410.75  Nurse practitioners' services.

* * * * *
    (e) * * *
    (2) The services of a nurse practitioner are provided on an 
assignment-related basis, and the nurse practitioner may not charge a 
beneficiary in excess of the amounts permitted under 42 CFR 424.55. If 
a beneficiary has made payment for a service in excess of these limits, 
the nurse practitioner must refund the full amount of the impermissible 
charge to the beneficiary.
* * * * *

0
27. Amend Sec.  410.76 by revising paragraph (e)(2) to read as follows:


Sec.  410.76  Clinical nurse specialists' services.

* * * * *
    (e) * * *
    (2) The services of a clinical nurse specialist are provided on an 
assignment-related basis, and the clinical nurse specialist may not 
charge a beneficiary in excess of the amounts permitted under 42 CFR 
424.55. If a beneficiary has made payment for a service in excess of 
these limits, the clinical nurse specialist must refund the full amount 
of the impermissible charge to the beneficiary.
* * * * *

0
28. Amend Sec.  410.77 by revising paragraph (d)(2) to read as follows:


Sec.  410.77  Certified nurse-midwives' services: Qualifications and 
conditions.

* * * * *
    (d) * * *
    (2) The services of a certified nurse-midwife are provided on an 
assignment-related basis, and the certified nurse-midwife may not 
charge a beneficiary in excess of the amounts permitted under 42 CFR 
424.55. If a beneficiary has made

[[Page 65666]]

payment for a service in excess of these limits, the certified nurse-
midwife must refund the full amount of the impermissible charge to the 
beneficiary.
* * * * *

0
29. Amend 410.78 by revising paragraph (a)(3) and adding paragraphs 
(b)(3)(xiii) and (xiv) and (b)(4)(iv)(D) to read as follows:


Sec.  410.78  Telehealth services.

    (a) * * *
    (3) Interactive telecommunications system means, except as 
otherwise provided in this paragraph, multimedia communications 
equipment that includes, at a minimum, audio and video equipment 
permitting two-way, real-time interactive communication between the 
patient and distant site physician or practitioner. For services 
furnished for purposes of diagnosis, evaluation, or treatment of a 
mental health disorder to a patient in their home, interactive 
telecommunications may include two-way, real-time audio-only 
communication technology if the distant site physician or practitioner 
is technically capable to use an interactive telecommunications system 
as defined in the previous sentence, but the patient is not capable of, 
or does not consent to, the use of video technology. A modifier 
designated by CMS must be appended to the claim for services described 
in this paragraph to verify that these conditions have been met.
* * * * *
    (b) * * *
    (3) * * *
    (xiii) A rural emergency hospital (as defined in section 
1861(kkk)(2) of the Act), for services furnished on or after January 1, 
2023.
    (xiv) The home of a beneficiary for the purposes of diagnosis, 
evaluation, and/or treatment of a mental health disorder for services 
furnished on or after the first day after the end of the PHE as defined 
in our regulation at Sec.  400.200 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:
    (A) 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;
    (B) The physician or practitioner has furnished an item or service 
in-person, without the use of telehealth, at least once within 12 
months of each subsequent telehealth service described in this 
paragraph, unless, for a particular 12-month period, the physician or 
practitioner and patient agree that the risks and burdens associated 
with an in-person service outweigh the benefits associated with 
furnishing the in-person item or service, and the practitioner 
documents the reason(s) for this decision in the patient's medical 
record.
    (C) The requirements of paragraphs (b)(3)(xiv)(A) and (B) may be 
met by another physician or practitioner of the same specialty and 
subspecialty in the same group as the physician or practitioner who 
furnishes the telehealth service, if the physician or practitioner who 
furnishes the telehealth service described under this paragraph is not 
available.
    (4) * * *
    (iv) * * *
    (D) Services furnished on or after the first day after the end of 
the PHE as defined in our regulation at Sec.  400.200 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.
* * * * *

0
30. Amend Sec.  410.79 by revising paragraphs (c)(1)(ii) and 
(e)(3)(v)(C) to read as follows:


Sec.  410.79  Medicare Diabetes Prevention Program expanded model: 
Conditions of coverage.

* * * * *
    (c) * * *
    (1) * * *
    (ii) An MDPP beneficiary is eligible for the first ongoing 
maintenance session interval only if the beneficiary:
    (A) Starts his or her first core session on or before December 31, 
2021;
    (B) Attends at least one in-person core maintenance session during 
the final core maintenance session interval; and
    (C) Achieves or maintains the required minimum weight loss at a 
minimum of one in-person core maintenance session during the final core 
maintenance session interval.
* * * * *
    (e) * * *
    (3) * * *
    (v) * * *
    (C) Beneficiaries who began the set of MDPP services between 
January 1, 2021 and December 31, 2021 and who are in the second year of 
the set of MDPP services as of the start of an applicable 1135 waiver 
event, whose in-person sessions are suspended due to the applicable 
1135 waiver event, and who elect not to continue with MDPP services 
virtually can elect to attend ongoing maintenance sessions; and may 
restart the ongoing maintenance session interval in which they were 
participating at the start of the applicable 1135 waiver event or may 
resume with the most recent attendance session of record.
* * * * *

0
31. Amend Sec.  410.105 by revising paragraph (d)(3)(ii) and adding 
paragraphs (d)(3)(iii) and (iv) to read as follows:


Sec.  410.105  Requirements for coverage of CORF services.

* * * * *
    (d) * * *
    (3) * * *
    (ii) Except as provided in paragraph (d)(3)(iii) of this section, 
furnishes a portion of a service, or in the case of a 15-minute (or 
other time interval) timed code, a portion of a unit of service, 
separately from the part furnished by the physical or occupational 
therapist such that the minutes for that portion of a service (or unit 
of a service) exceed 10 percent of the total time for that service (or 
unit of a service).
    (iii) Paragraph (d)(3)(ii) of this section does not apply when 
determining whether the prescribed modifier applies to the last 15-
minute unit of a service billed for a patient on a treatment day when 
the physical or occupational therapist provides more than the midpoint 
of a 15-minute timed code, that is, 8 or more minutes, regardless of 
any minutes for the same service furnished by the physical therapist 
assistant or occupational therapy assistant.
    (iv) Where there are two remaining 15-minute units to bill of the 
same service and the physical therapist and the physical therapist 
assistant or the occupational therapist and the occupational therapy 
assistant, as applicable, each provided between 9 and 14 minutes, with 
a total time of at least 23 minutes, one unit of the service is billed 
with the prescribed modifier for the minutes furnished by the physical 
therapist assistant or occupational therapy assistant and one unit is 
billed without the prescribed modifier for the service provided by the

[[Page 65667]]

physical therapist or occupational therapist.

0
32. Amend Sec.  410.130 by revising the definition of ``Chronic renal 
insufficiency'' and removing the definition of ``Treating physician''.
    The revision reads as follows:


Sec.  410.130  Definitions.

* * * * *
    Chronic renal insufficiency means the stage of renal disease 
associated with a reduction in renal function not severe enough to 
require dialysis or transplantation (glomerular filtration rate [GFR] 
15-59 ml/min/1.73m \2\).
* * * * *

0
33. Amend Sec.  410.132 by revising paragraphs (a), (b)(5), and (c) to 
read as follows:


Sec.  410.132  Medical nutrition therapy.

    (a) Conditions for coverage of MNT services. Medicare Part B pays 
for MNT services provided by a registered dietitian or nutrition 
professional as defined in Sec.  410.134 when the beneficiary is 
referred for the service by a physician.
    (b) * * *
    (5) An exception to the maximum number of hours in paragraphs 
(b)(2), (3), and (4) of this section may be made when a physician 
determines that there is a change of diagnosis, medical condition, or 
treatment regimen related to diabetes or renal disease that requires a 
change in MNT during an episode of care.
    (c) Referrals. Referral may only be made by a physician when the 
beneficiary has been diagnosed with diabetes or renal disease as 
defined in this subpart with documentation noted by a referring 
physician in the beneficiary's medical record.

0
34. Amend Sec.  410.150 by revising paragraph (b)(15) to read as 
follows:


Sec.  410.150  To whom payment is made.

* * * * *
    (b) * * *
    (15)(i) Prior to January 1, 2022, to the qualified employer of a 
physician assistant for professional services furnished by the 
physician assistant and for services and supplies provided incident to 
his or her services. Payment is made to the employer of a physician 
assistant regardless of whether the physician assistant furnishes 
services under a W-2, employer-employee employment relationship, or 
whether the physician assistant is an independent contractor who 
receives a 1099 reflecting the relationship. Both types of 
relationships must conform to the appropriate guidelines provided by 
the Internal Revenue Service. A qualified employer is not a group of 
physician assistants that incorporate to bill for their services. 
Payment is made only if no facility or other provider charges or is 
paid any amount for services furnished by a physician assistant.
    (ii) Effective on or after January 1, 2022, payment is made to a 
physician assistant for professional services furnished by a physician 
assistant in all settings in both rural and nonrural areas and for 
services and supplies furnished incident to those services. Payment is 
made only if no facility or other provider charges, or is paid, any 
amount for the furnishing of professional services of the physician 
assistant.
* * * * *

0
35. Amend Sec.  410.152 by revising paragraphs (l) introductory text 
and (l)(5) to read as follows:


Sec.  410.152  Amounts of payment.

* * * * *
    (l) Amount of payment: Preventive services. Except as provided 
otherwise in this paragraph, Medicare Part B pays 100 percent of the 
Medicare payment amount established under the applicable payment 
methodology for the service furnished by a provider or supplier for the 
following preventive services:
* * * * *
    (5) Colorectal cancer screening tests (excluding barium enemas).
    (i) For the colorectal cancer screening tests described in Sec.  
410.37(j), Medicare Part B pays at the specified percentage as follows:
    (A) 80 percent for CY 2022.
    (B) 85 percent for CY 2023 through 2026.
    (C) 90 percent for 2027 through 2029.
    (D) 100 percent beginning January 1, 2030.
    (ii) [Reserved]
* * * * *

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. Amend Sec.  411.351 by revising the definition of ``List of CPT/
HCPCS Codes'' to read as follows:


Sec.  411.351  Definitions.

* * * * *
    List of CPT/HCPCS Codes means the list of CPT and HCPCS codes that 
identifies those items and services that are DHS under section 1877 of 
the Act or that may qualify for certain exceptions under section 1877 
of the Act. It is updated annually and posted on the CMS website at 
https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.
* * * * *

0
38. Amend Sec.  411.354 by revising paragraphs (c)(2)(ii)(A) through 
(C) to read as follows:


Sec.  411.354  Financial relationship, compensation, and ownership or 
investment interest.

* * * * *
    (c) * * *
    (2)* * *
    (ii) * * *
    (A)(1) The referring physician (or immediate family member) 
receives aggregate compensation from the person or entity in the chain 
with which the physician (or immediate family member) has a direct 
financial relationship that varies with the volume or value of 
referrals or other business generated by the referring physician for 
the entity furnishing the DHS; and
    (2) The amount of compensation that the physician (or immediate 
family member) receives per individual unit--
    (i) Is not fair market value for items or services actually 
provided;
    (ii) Could increase as the number or value of the physician's 
referrals to the entity furnishing DHS increases, or could decrease as 
the number or value of the physician's referrals to the entity 
decreases;
    (iii) Could increase as the amount or value of the other business 
generated by the physician for the entity furnishing DHS increases, or 
could decrease as the amount or value of the other business generated 
by the physician for the entity furnishing DHS decreases; or
    (iv) Is payment for the lease of office space or equipment or for 
the use of premises or equipment.
    (B) For purposes of applying paragraph (c)(2)(ii)(A)(2) of this 
section, the individual unit is:
    (1) Item, if the physician (or immediately family member) is 
compensated solely per item provided.
    (2) Service, if the physician (or immediate family member) is 
compensated solely per service provided, which includes arrangements 
where the ``service'' provided includes both items and services.
    (3) Time, if the conditions of paragraph (c)(2)(ii)(B)(1) or (2) of 
this section are not met.
    (C) If the financial relationship between the physician (or 
immediate family member) and the person or entity

[[Page 65668]]

in the chain with which the referring physician (or immediate family 
member) has a direct financial relationship is an ownership or 
investment interest, the nonownership or noninvestment interest closest 
to the referring physician (or immediate family member) is used to 
determine whether the aggregate compensation varies with the volume or 
value of referrals or other business generated by the referring 
physician for the entity furnishing the DHS and whether the amount of 
compensation that the physician (or immediate family member) receives 
per individual unit meets the conditions in paragraph (c)(2)(ii)(A)(2) 
of this section. (For example, if a referring physician has an 
ownership interest in company A, which owns company B, which has a 
compensation arrangement with company C, which has a compensation 
arrangement with entity D that furnishes DHS, we would look to the 
aggregate compensation between company B and company C for purposes of 
this paragraph (c)(2)(ii).
* * * * *

0
39. Amend Sec.  411.355 by revising paragraph (h) to read as follows:


Sec.  411.355  General exceptions to the referral prohibition related 
to both ownership/investment and compensation.

* * * * *
    (h) Preventive screening tests and vaccines. (1) Preventive 
screening tests and vaccines that meet the following conditions:
    (i) The preventive screening test or vaccine is listed on the List 
of CPT/HCPCS Codes as a code to which the exception in this paragraph 
is applicable.
    (ii) The preventive screening test or vaccine is covered by 
Medicare.
    (iii) The preventive screening test or vaccine is subject to a CMS-
mandated frequency limit.
    (2) During such period as the vaccine is not subject to a CMS-
mandated frequency limit, paragraph (h)(1)(iii) of this section does 
not apply to a COVID-19 vaccine identified on the List of CPT/HCPCS 
Codes as a code to which the exception in this paragraph is applicable.
* * * * *

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

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

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


0
41. Amend Sec.  414.64 by revising paragraph (a) to read as follows:


Sec.  414.64  Payment for medical nutrition therapy.

    (a) Payment under the physician fee schedule. Medicare payment for 
medical nutrition therapy is made under the physician fee schedule in 
accordance with subpart B of this part. Payment to nonphysician 
professionals, as specified in paragraph (b) of this section, is 80 
percent (or 100 percent if such services are recommended with a grade 
of A or B by the United States Preventive Services Task Force for any 
indication or population and are appropriate for the individual) of the 
lesser of the actual charges or 85 percent of the physician fee 
schedule amount.
* * * * *

0
42. Amend Sec.  414.84--
0
a. By revising paragraphs (b)(1)(i);
0
b. In paragraph (b)(1)(ii), by removing the reference ``CY 2018'' and 
adding in its place the reference ``CY 2022'';
0
c. By revising paragraph (b)(2)(i);
0
d. In paragraph (b)(2)(ii), by removing the reference CY 2018'' and 
adding in its place the reference ``CY 2022'';
0
e. By revising paragraph (b)(3)(i);
0
f. In paragraph (b)(3)(ii), by removing the reference ``CY 2018'' and 
adding in its place the reference ``CY 2022'';
0
g. By revising paragraph (b)(4)(i)(A);
0
h. In paragraph (b)(4)(i)(B), by removing the reference ``CY 2018'' and 
adding in its place the reference ``CY 2022'';
0
i. By revising paragraph (b)(4)(ii)(A);
0
h. In paragraph (b)(4)(ii)(B), by removing the reference ``CY 2018'' 
and adding in its place the reference ``CY 2022''; and
0
j. By revising paragraphs (b)(5), (b)(6)(i), (b)(7)(i) and (ii), and 
(c).
    The revisions read as follows:


Sec.  414.84  Payment for MDPP Services.

* * * * *
    (b) * * *
    (1) * * *
    (i) For a first core session furnished January 1, 2022, through 
December 31, 2022 the amount is $35.
* * * * *
    (2) * * *
    (i) For the fourth core session furnished January 1, 2022, through 
December 31, 2022 the amount is $105.
* * * * *
    (3) * * *
    (i) For the ninth core session furnished January 1, 2022, through 
December 31, 2022 the amount is $175.
* * * * *
    (4) * * *
    (i) * * *
    (A) For a second core maintenance session January 1, 2022, through 
December 31, 2022 the amount is $93.
* * * * *
    (ii) * * *
    (A) For a second core maintenance session January 1, 2022, through 
December 31, 2022 the amount is $75.
* * * * *
    (5) Performance Goal 5: Attends two ongoing maintenance sessions 
and maintains the required minimum weight loss during an ongoing 
maintenance session interval. For an MDPP beneficiary who attends his 
or her first core session on or before December 31, 2021, CMS makes a 
performance payment to an MDPP supplier if an MDPP beneficiary attends 
two ongoing maintenance sessions during an ongoing maintenance session 
interval, achieves attendance at that second ongoing maintenance 
session upon attendance at an ongoing maintenance session furnished by 
that supplier, and achieves or maintains the required minimum weight 
loss as measured in-person during an ongoing maintenance session 
furnished during the applicable ongoing maintenance session interval. 
CMS makes this performance payment to an MDPP supplier only once per 
MDPP beneficiary per ongoing maintenance session interval. The amount 
of this performance payment is determined as follows:
    (i) For a second ongoing maintenance session furnished in interval 
1 (months 13-15 of the MDPP services period), January 1, 2022, through 
December 31, 2022, the amount is $52.
    (ii) For a second ongoing maintenance session furnished in interval 
2 (months 16-18 of the MDPP services period), January 1, 2022, through 
December 31, 2022, the amount is $52.
    (iii) For a second ongoing maintenance session furnished in 
interval 3 (months 19-21 of the MDPP services period), January 1, 2022, 
through December 31, 2022, the amount is $53.
    (iv) For a second ongoing maintenance session furnished in interval 
4 (months 22-24 of the MDPP services period), January 1, 2022, through 
December 31, 2022 the amount is $53.
    (v) For a second ongoing maintenance session furnished during a 
subsequent year. The performance payment amount specified in this 
paragraph, adjusted as specified in paragraph (d) of this section.
    (6) * * *
    (i) For a core session or core maintenance session, as applicable, 
furnished January 1, 2022, through December 31, 2022, the amount is 
$169.
* * * * *
    (7) * * *
    (i) For a core session or core maintenance session, as applicable,

[[Page 65669]]

furnished January 1, 2022, through December 31, 2022, the amount is 
$35.
    (ii) For a core session or core maintenance session, as applicable, 
furnished during a calendar year subsequent to CY 2018. The performance 
payment amount specified in this paragraph, adjusted as specified in 
paragraph (d) of this section.
    (c) Bridge payment. CMS makes a bridge payment to an MDPP supplier 
only for a core session or core maintenance session furnished to an 
MDPP beneficiary who has previously received MDPP services from a 
different MDPP supplier. An MDPP supplier that has previously been paid 
either a bridge payment or a performance payment for an MDPP 
beneficiary is not eligible to be paid a bridge payment for that 
beneficiary. A bridge payment is made only on an assignment-related 
basis in accordance with Sec.  424.55 of this subchapter, 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 bridge payment only to an MDPP supplier that complies with all 
applicable enrollment and program requirements, and only for MDPP 
services 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 amount of the bridge payment is determined as 
follows:
    (1) For core session or core maintenance session, as applicable, 
furnished January 1, 2022, through December 31, 2022, the amount is 
$35.
    (2) For core session and core maintenance session, as applicable, 
furnished during a calendar year subsequent to CY 2022. The bridge 
payment amount specified in this paragraph, adjusted as specified in 
paragraph (d) of this section.
* * * * *

0
43. Amend Sec.  414.626 by revising paragraphs (b)(1) and (f) to read 
as follows:


Sec.  414.626  Data reporting by ground ambulance organizations.

* * * * *
    (b) * * *
    (1) Within 30 days of the date that CMS notifies a ground ambulance 
organization under paragraph (c)(3) of this section that it has 
selected the ground ambulance organization to report data under this 
section, the ground ambulance organization must select a data 
collection period that corresponds with its annual accounting period 
and provide the start date of that data collection period to CMS or its 
contractor.
* * * * *
    (f) Public availability of data. Beginning in 2024, and at least 
once every 2 years thereafter, CMS will post on its website data that 
it collected under this section, including but not limited to summary 
statistics and ground ambulance organization characteristics.
* * * * *


0
44. Amend Sec.  414.802 by revising the definition of ``Drug'' to read 
as follows:


Sec.  414.802  Definitions.

* * * * *
    Drug means a drug or a biological, and for purposes of applying 
section 1847A(f) of the Act, includes an item, service, supply, or 
product that is payable under Medicare Part B as a drug or biological.
* * * * *


0
45. Section 414.806 is revised to read as follows:


Sec.  414.806  Penalties associated with misrepresentation and the 
failure to submit timely and accurate ASP data.

    (a) Misrepresentation. Section 1847A(d)(4)(A) of the Act specifies 
the penalties associated with misrepresentations in the reporting of 
the manufacturer's average sales price for a drug as defined at Sec.  
414.802.
    (b) Failure to provide timely information or the submission of 
false information. (1) For a manufacturer that has entered into and has 
in effect a rebate agreement under section 1927 of the Act, section 
1927(b)(3)(C) of the Act specifies the penalties associated with a 
manufacturer's failure to submit timely information or the submission 
of false information.
    (2) For a manufacturer that has not entered into and does not have 
in effect a rebate agreement under section 1927 of the Act, sections 
1847A(d)(4)(B) and (C) of the Act specify the penalties associated with 
a manufacturer's failure to submit timely information or the submission 
of false information.


0
46. Amend Sec.  414.904 by adding paragraph (d)(4) to read as follows:


Sec.  414.904  Average sales price as the basis for payment.

* * * * *
    (d) * * *
    (4) Payment adjustment for certain drugs for which there is a self-
administered version--(i) In general. Except as provided in paragraphs 
(d)(4)(ii) and (iii) of this section, if the Inspector General 
identifies a drug or biological product in a study described in section 
1847A(g)(1) of the Act, the Secretary must apply the payment limit for 
the applicable billing and payment code as specified in paragraph 
(d)(4)(iv) of this section, beginning with the first day of the second 
quarter after such study is publicly available. The methodology 
described in this paragraph will be recalculated each quarter 
thereafter, except when conditions described in paragraph (d)(4)(ii) 
are met.
    (ii) Exception. The adjustment described in paragraph (d)(4)(i) of 
this section does not apply to the payment limit for a billing and 
payment code for a quarter if, at the time that ASP calculations are 
finalized for such quarter, the drug in the dosage form described by 
the billing and payment code is included by the FDA on the drug 
shortage list in effect under section 506E of the Federal Food, Drug, 
and Cosmetic Act.
    (iii) Special rule for certain billing and payment codes. Effective 
July 1, 2021, for a billing and payment code described under section 
1847A(g)(3) of the Act, the payment limit for the applicable billing 
and payment code must be determined as described in paragraph 
(d)(4)(iv) of this section, and the exception specified at paragraph 
(d)(4)(ii) of this section does not apply.
    (iv) Lesser-of methodology. For purposes of this section, the 
payment limit is the lesser of:
    (A) The payment limit determined under section 1847A of the Act for 
such billing and payment code if each National Drug Code for such 
product so identified under section 1847A(g)(1) of the Act were 
excluded from such determination; and
    (B) The payment limit otherwise determined under section 1847A of 
the Act for such billing and payment code without application of 
section 1847A(g) of the Act.
    (v) NDC changes. For an Inspector General-identified National Drug 
Code, as described under section 1847A(g)(1) or (3) of the Act, for 
which the manufacturer has redesignated the National Drug Code (without 
changes to the dosage form), the application of the lesser-of 
methodology described in this paragraph must use manufacturer-reported 
ASP data associated with the redesignated National Drug Code in the 
same manner as the one originally identified by the Inspector General.
* * * * *


0
 47. Amend Sec.  414.1300 by revising paragraphs (a)(2) and (3) to read 
as follows:

[[Page 65670]]

Sec.  414.1300  Basis and scope.

    (a) * * *
    (2) Section 1848(k)--Quality Reporting System.
    (3) Section 1848(m)--Incentive Payments for Quality Reporting.
* * * * *

0
48. Amend Sec.  414.1305--
0
a. By revising the definitions of ``Collection type'' and ``Meaningful 
EHR user for MIPS'';
0
b. In the definition of ``MIPS determination period'', by revising 
paragraph (2);
0
c. In the definition of ``MIPS eligible clinician'', by revising the 
introductory text, paragraph (2) introductory text, and adding 
paragraph (3);
0
d. By adding the definitions of ``Multispecialty group'', ``MVP 
participant'', ``Population health measure'', ``QCDR measure'', 
``Single specialty group'', ``Special status'' and ``Subgroup'' in 
alphabetical order; and
0
e. By revising the definition of ``Submission type''.
    The revisions and additions read as follows:


Sec.  414.1305  Definitions.

* * * * *
    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; and administrative claims measures.
    (1) For the CY 2021 through CY 2024 performance periods/2023 
through 2026 MIPS payment years, collection types include CMS Web 
Interface measures for APM Entities reporting through the APM 
Performance Pathway in accordance with Sec.  414.1367.
    (2) [Reserved]
* * * * *
    Meaningful EHR user for MIPS means a MIPS eligible clinician who 
possesses CEHRT, uses the functionality of CEHRT, reports on applicable 
objectives and measures specified for the Promoting Interoperability 
performance category for a performance period in the form and manner 
specified by CMS, does not knowingly and willfully take action (such as 
to disable functionality) to limit or restrict the compatibility or 
interoperability of CEHRT, and engages in activities related to 
supporting providers with the performance of CEHRT.
* * * * *
    MIPS determination period means: * * *
    (2) Subject to Sec.  414.1310(b)(1)(iii), an individual eligible 
clinician, group, or APM Entity group that is identified as not 
exceeding the low-volume threshold or as having special status, as 
applicable, during the first segment of the MIPS determination period 
will be identified as such for the applicable MIPS payment year 
regardless of the results of the second segment of the MIPS 
determination period. An individual eligible clinician, group, or APM 
Entity group for which the unique billing TIN and NPI combination is 
established during the second segment of the MIPS determination period 
will be assessed based solely on the results of such segment.
    MIPS eligible clinician as identified by a unique billing TIN and 
NPI combination used to assess performance, means any of the following 
(except as excluded under Sec.  414.1310(b)):
* * * * *
    (2) For the 2021 through 2023 MIPS payment years:
* * * * *
    (3) For the 2024 MIPS payment year and future years:
    (i) A clinician described in paragraph (2) of this definition;
    (ii) A clinical social worker (as defined in section 1861(hh)(1) of 
the Act);
    (ii) A certified nurse midwife (as defined in section 1861(gg)(2) 
of the Act); and
    (vii) A group that includes such clinicians.
* * * * *
    Multispecialty group means a group that consists of two or more 
specialty types.
    MVP participant means an individual MIPS eligible clinician, 
multispecialty group, single-specialty group, subgroup, or APM Entity 
that is assessed on an MVP in accordance with Sec.  414.1365 for all 
MIPS performance categories. For the CY 2026 performance period/2028 
MIPS payment year and future years, MVP Participant means an individual 
MIPS eligible clinician, single-specialty group, subgroup, or APM 
Entity that is assessed on an MVP in accordance with Sec.  414.1365 for 
all MIPS performance categories.
* * * * *
    Population health measure means a quality measure that indicates 
the quality of a population or cohort's overall health and well-being, 
such as access to care, clinical outcomes, coordination of care and 
community services, health behaviors, preventive care and screening, 
health equity, or utilization of health services.
* * * * *
    QCDR measure means a quality measure that is submitted by a QCDR 
and approved by CMS under Sec.  414.1400. QCDR measures consist of:
    (1) Measures that are not included in the MIPS final list of 
quality measures described in Sec.  414.1330(a)(1) for the applicable 
MIPS payment year; and
    (2) Measures that are included in the MIPS final list of quality 
measures described in Sec.  414.1330(a)(1) for the applicable MIPS 
payment year, but have undergone substantive changes, as determined by 
CMS.
* * * * *
    Single specialty group means a group that consists of one specialty 
type.
* * * * *
    Special status means that a MIPS eligible clinician:
    (1) Meets the definition of an ASC-based MIPS eligible clinician, 
facility-based MIPS eligible clinician, hospital-based MIPS eligible 
clinician, non-patient facing MIPS eligible clinician, or is in a small 
practice; or
    (2) Is located in an HPSA or rural area.
    Subgroup means a subset of a group which contains at least one MIPS 
eligible clinician and is identified by a combination of the group TIN, 
subgroup identifier, and each eligible clinician's NPI.
    Submission type means the mechanism by which the submitter type 
submits data to CMS, including, but not limited to:
    (1) Direct;
    (2) Log in and upload;
    (3) Log in and attest;
    (4) Medicare Part B claims; and
    (5) CMS Web Interface (except as provided in paragraph (5)(i) of 
this definition, for the CY 2017 through CY 2022 performance periods/
2019 through 2024 MIPS payment years).
    (i) For the CY 2021 through CY 2024 performance periods/2023 
through 2026 MIPS payment years, submission types include the CMS Web 
Interface for APM Entities reporting through the APM Performance 
Pathway in accordance with Sec.  414.1367.
    (ii) [Reserved]
* * * * *


0
49. Amend Sec.  414.1310 by revising paragraph (e)(1) to read as 
follows:


Sec.  414.1310  Applicability.

* * * * *
    (e) * * *

[[Page 65671]]

    (1) Except as provided under Sec. Sec.  414.1315(a)(2), 
414.1317(b), 414.1318(b), and 414.1370(f)(2) each MIPS eligible 
clinician in the group receives a final score based on the group's 
combined performance assessment.
* * * * *


0
50. Amend Sec.  414.1317 by revising paragraph (b)(2) to read as 
follows:


Sec.  414.1317  APM Entity groups.

* * * * *
    (b) * * *
    (2) Performance category weights. The cost performance category 
weight is zero percent of the final score for an APM Entity. The 
performance category reweighting scenarios under Sec.  414.1380(c)(2) 
apply to an APM Entity.
* * * * *


0
51. Section 414.1318 is added to subpart O to read as follows:


Sec.  414.1318  Subgroups.

    (a) Eligibility and special status--(1) General. Except as provided 
under paragraph (a)(2) of this section, for a MIPS payment year, 
determinations of meeting the low-volume threshold criteria and special 
status for subgroups are determined at the group level in accordance 
with Sec. Sec.  414.1305 and 414.1310.
    (2) Exclusions. An individual eligible clinician or group that 
elects to participate in MIPS as a MIPS eligible clinician in 
accordance with Sec.  414.1310(b)(1)(iii)(A) or (b)(2) is not eligible 
to participate in a subgroup.
    (b) Final score. Except as provided under Sec.  414.1317(b), each 
MIPS eligible clinician in the subgroup receives a final score based on 
the subgroup's combined performance assessment.
    (c) Subgroup reporting requirements. For individual eligible 
clinicians to participate in MIPS as a subgroup, all of the following 
requirements must be met:
    (1) Individual eligible clinicians that elect to participate in 
MIPS as a subgroup must aggregate their quality and improvement 
activities performance data across the subgroup's identifier.
    (2) Individual eligible clinicians that elect to participate in 
MIPS as a subgroup will have their performance assessed at the subgroup 
level across all the MIPS performance categories based on an MVP in 
accordance with Sec.  414.1365 and on the APM Performance Pathway in 
accordance with Sec.  414.1367, as applicable. Subgroups that are MVP 
Participants must adhere to an election process described in Sec.  
414.1365(b).


0
52. Amend Sec.  414.1320 by--
0
a. Redesignating paragraphs (d) through (g) as paragraphs (e) through 
(h), respectively; and
0
b. Adding a new paragraph (d).
    The addition reads as follows:


Sec.  414.1320  MIPS performance period.

* * * * *
    (d) For purposes of the CY 2020 performance period/2022 MIPS 
payment year, the performance period for:
    (1) The quality and cost performance categories are the full 
calendar year (January 1 through December 31) that occurs 2 years prior 
to the applicable MIPS payment year.
    (2) The improvement activities performance categories are a minimum 
of a 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.
* * * * *


0
53. Amend Sec.  414.1325 by revising paragraph (c)(1) to read follows:


Sec.  414.1325  Data submission requirements.

* * * * *
    (c) * * *
    (1) For the quality performance category, the direct; login and 
upload; Medicare Part B claims (beginning with the CY 2019 MIPS 
performance period/2021 MIPS payment year, for small practices only); 
and CMS Web Interface (for groups consisting of 25 or more eligible 
clinicians, a third party intermediary submitting on behalf of a group) 
submission type.
* * * * *

0
54. Amend Sec.  414.1340 revising paragraphs (a)(3) and (b)(3) to read 
as follows:


Sec.  414.1340  Data completeness criteria for the quality performance 
category.

    (a) * * *
    (3) At least 70 percent of the MIPS eligible clinician or group's 
patients that meet the measure's denominator criteria, regardless of 
payer for MIPS payment years 2022, 2023, 2024, and 2025.
* * * * *
    (b) * * *
    (3) At least 70 percent of the applicable Medicare Part B patients 
seen during the performance period to which the measure applies for 
MIPS payment years 2022, 2023, 2024, and 2025.
* * * * *


0
55. Amend Sec.  414.1350 by revising paragraph (c)(4) and adding 
paragraph (c)(6) to read as follows:


Sec.  [thinsp]414.1350  Cost performance category.

* * * * *
    (c) * * *
    (4) For the procedural episode-based measures specified beginning 
with 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.
* * * * *
    (6) For the chronic condition episode-based measures specified 
beginning with the CY 2022 performance period/2024 MIPS payment year, 
the case minimum is 20.
* * * * *


0
56. Amend Sec.  414.1360 by revising paragraph (a)(2) to read as 
follows:


Sec.  [thinsp]414.1360  Data submission criteria for the improvement 
activities performance category.

    (a) * * *
    (2) Groups and virtual groups. Beginning with the 2022 performance 
year, each improvement activity for which groups and virtual groups 
submit a yes response in accordance with paragraph (a)(1) of this 
section must be performed by at least 50 percent of the NPIs that are 
billing under the group's TIN or virtual group's TINs or that are part 
of the subgroup, as applicable; and the NPIs must perform the same 
activity during any continuous 90-day period within the same 
performance year.
* * * * *


0
57. Section 414.1365 is added to subpart O to read as follows:


Sec.  414.1365  MIPS Value Pathways.

    (a) General. (1) Beginning with the CY 2023 MIPS performance 
period/2025 MIPS payment year, CMS uses MVPs included in the MIPS final 
inventory of MVPs established by CMS through rulemaking to assess 
performance for the quality, cost, improvement activities, and 
Promoting Interoperability performance categories.
    (2) [Reserved]
    (b) MVP/Subgroup registration. (1) To report an MVP, an MVP 
Participant must register for the MVP, and if applicable, as a subgroup 
during a period that begins on April 1 and ends on November 30 of the 
applicable CY performance period or a later date specified by CMS. To 
report the CAHPS for MIPS survey associated with an MVP, a group, 
subgroup or APM Entity must complete their registration by June 30 of 
such performance period or a later date specified by CMS.

[[Page 65672]]

    (2) At the time of registration, the MVP Participant must submit 
the following information, as applicable:
    (i) Each MVP Participant must select an MVP, 1 population health 
measure included in the MVP, and any outcomes-based administrative 
claims measure on which the MVP Participant intends to be scored.
    (ii) Each subgroup must submit a list of each TIN/NPI associated 
with the subgroup and a plain language name for the subgroup.
    (c) MVP reporting requirements--(1) Quality. Except as provided in 
paragraph (c)(1)(i) of this section, an MVP Participant must select and 
report, if applicable, 4 quality measures, including 1 outcome measure 
(or, if an outcome measure is not available, 1 high priority measure), 
included in the MVP, excluding the population health measure required 
under paragraph (c)(4)(ii) of this section.
    (i) Paragraph (c)(1) introductory text of this section does not 
apply to a small practice that reports on an MVP that includes fewer 
than 4 Medicare Part B claims measures, provided that the small 
practice reports each such measure that is applicable.
    (ii) [Reserved]
    (2) Cost. An MVP Participant is scored on the cost measures 
included in the MVP that they select and report.
    (3) Improvement activities. An MVP Participant who reports an MVP, 
must report one of the following:
    (i) Two medium-weighted improvement activities;
    (ii) One high-weighted improvement activity;
    (iii) Participation in a certified or recognized patient-centered 
medical home (PCMH) or comparable specialty practice, as described at 
Sec.  414.1380(b)(3)(ii).
    (4) Foundational layer--(i) Promoting interoperability. An MVP 
Participant is required to meet the Promoting Interoperability 
performance category reporting requirements described at Sec.  
414.1375(b).
    (A) For the CY 2023 and 2024 performance periods/2025 and 2026 MIPS 
payment years, an MVP Participant that is a subgroup is required to 
submit its affiliated group's data for the Promoting Interoperability 
performance category.
    (B) [Reserved]
    (ii) Population health measures. Each MVP Participant is scored on 
1 population health measure in accordance with paragraph (d)(1) of this 
section.
    (d) MVP scoring--(1) General. An MVP Participant that is not an APM 
Entity is scored on measures and activities included in the MVP in 
accordance with paragraphs (d)(1) through (3) of this section. An MVP 
Participant that is an APM Entity is scored on measures and activities 
included in the MVP in accordance with Sec.  414.1317(b).
    (2) Performance standards. Unless otherwise indicated in this 
paragraph (d), the performance standards described at Sec.  
414.1380(a)(1)(i) through (iv) apply to the measures and activities 
included in the MVP.
    (3) Performance categories. An MVP Participant is scored under MIPS 
in four performance categories.
    (i) Quality performance category. Except as provided in paragraphs 
(d)(3)(i)(A)(1) and (d)(3)(i)(B) of this section, the quality 
performance category score for MVP Participants is calculated in 
accordance with Sec.  414.1380(b)(1) based on measures included in the 
MVP.
    (A) Population health measures. Except as provided in paragraph 
(d)(3)(i)(A)(1) of this section, each selected population health 
measure that does not have a benchmark or meet the case minimum 
requirement is excluded from the MVP participant's total measure 
achievement points and total available measure achievement points.
    (1) Subgroups are scored on each selected population health measure 
that does not have a benchmark or meet the case minimum requirement 
based on their affiliated group score, if available. If the subgroup's 
affiliated group score is not available, each such measure is excluded 
from the subgroup's total measure achievement points and total 
available measure achievement points.
    (2) [Reserved]
    (B) Outcomes-based administrative claims measures. MVP Participants 
receive zero measure achievement points for each selected outcomes-
based administrative claims measure that does not have a benchmark or 
meet the case minimum requirement.
    (ii) Cost performance category. The cost performance category score 
is calculated for an MVP Participant using the methodology at Sec.  
414.1380(b)(2)(i) through (v) and the cost measures included in the MVP 
that they select and report.
    (iii) Improvement activities performance category. The improvement 
activities performance category score is calculated based on the 
submission of high- and medium-weighted improvement activities. MVP 
Participants will receive 20 points for each medium-weighted 
improvement activity and 40 points for each high-weighted improvement 
activity required under Sec.  414.1360 on which data is submitted in 
accordance with Sec.  414.1325 or for participation in a certified or 
recognized patient-centered medical home (PCMH) or comparable specialty 
practice, as described at Sec.  414.1380(b)(3)(ii).
    (iv) Promoting interoperability performance category. The Promoting 
Interoperability performance category score is calculated for an MVP 
Participant using the methodology at Sec.  414.1380(b)(4), except as 
provided in paragraph (d)(3)(iv)(A) of this section.
    (A) If a subgroup does not submit its affiliated group's data for 
the Promoting Interoperability performance category, the subgroup will 
receive a score of zero for the Promoting Interoperability performance 
category.
    (B) [Reserved]
    (e) Final score calculation. The final score is calculated for an 
MVP Participant using the methodology at Sec.  414.1380(c), unless 
otherwise indicated in this paragraph (e).
    (1) MVP performance category weights. For an MVP Participant that 
is not an APM Entity, the final score is calculated using the 
performance category weights described at Sec.  414.1380(c)(1). For an 
MVP Participant that is an APM Entity, the final score is calculated 
using the performance category weights described at Sec.  414.1317(b).
    (2) Reweighting MVP performance categories--(i) General 
reweighting. For an MVP Participant that is not an APM Entity, in 
accordance with paragraph (e)(2)(iii) of this section, a scoring weight 
different from the weights described at Sec.  414.1380(c)(1) will be 
assigned to a performance category, and its weight as described at 
Sec.  414.1380(c)(1) will be redistributed to another performance 
category or categories, in the circumstances described at Sec.  
414.1380(c)(2)(i)(A)(2) through (9) and Sec.  414.1380(c)(2)(i)(C). For 
an MVP Participant that is an APM Entity, the performance category 
weights will be redistributed in accordance with Sec.  414.1317(b).
    (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, if reweighting is not applied to the affiliated 
group, the subgroup may receive reweighting in the following 
circumstances independent of the affiliated group:
    (A) A subgroup may submit an application to CMS demonstrating that 
it was subject to extreme and uncontrollable circumstances and receive 
reweighting in accordance with Sec.  414.1380(c)(2)(i)(A)(6) and 
(c)(2)(i)(C)(2). In the event that a

[[Page 65673]]

subgroup submits data for a performance category, the scoring weight 
described at Sec.  414.1380(c)(1) would be applied and its weight would 
not be redistributed.
    (B) A subgroup will receive reweighting if CMS determines, based on 
information known to the agency prior to the beginning of the relevant 
MIPS payment year, that data for the subgroup are inaccurate, unusable 
or otherwise compromised due to circumstances outside of the control of 
the subgroup and its agents, in accordance with Sec.  
414.1380(c)(2)(i)(A)(9) and (c)(2)(i)(C)(10).
    (iii) Reweighting scenarios. For an MVP Participant that is not an 
APM Entity, a scoring weight different from the weights described at 
Sec.  414.1380(c)(1) will be assigned to a performance category, and 
its weight as described at Sec.  414.1380(c)(1) will be redistributed 
to another performance category or categories, in accordance with Sec.  
414.1380(c)(2)(ii). For an MVP Participant that is an APM Entity, the 
performance category weights will be redistributed in accordance with 
Sec.  414.1317(b).
    (3) Facility-based scoring. If an MVP Participant, that is not an 
APM Entity, is eligible for facility-based scoring, a facility-based 
score also will be calculated in accordance with Sec.  414.1380(e).
    (4) Complex patient bonus. A complex patient bonus will be added to 
the final score for an MVP Participant in accordance with Sec.  
414.1380(c)(3).

0
58. Amend Sec.  414.1375--
0
a. By revising paragraph (b)(2)(ii);
0
b. By revising the paragraph (b)(3) subject heading;
0
c. By revising paragraph (b)(3)(ii) introductory text; and
0
c. Adding paragraph (b)(3)(iii).
    The revisions and addition read as follows:


Sec.  414.1375  Promoting Interoperability (PI) performance category.

* * * * *
    (b) * * *
    (2) * * *
    (ii) Beginning with the 2021 MIPS payment year:
    (A) Report that the MIPS eligible clinician completed the actions 
included in the Security Risk Analysis measure during the year in which 
the performance period occurs;
    (B) For each required measure, as applicable, report the numerator 
(of at least one) and denominator, or yes/no statement, or an exclusion 
for each measure that includes an option for an exclusion; and
    (C) Beginning with the 2024 MIPS payment year, report that the MIPS 
eligible clinician completed the actions included in the SAFER Guides 
measure during the year in which the performance period occurs.
    (3) Engaging in activities related to supporting providers with the 
performance of CEHRT; support for health information exchange and the 
prevention of information blocking; actions to limit or restrict the 
compatibility or interoperability of CEHRT. * * *
* * * * *
    (ii) Support for health information exchange and the prevention of 
information blocking. For the 2019, 2020, 2021, 2022, and 2023 MIPS 
payment years, the MIPS eligible clinician must attest to CMS that he 
or she--
* * * * *
    (iii) Actions to limit or restrict the compatibility or 
interoperability of CEHRT. Beginning with the 2024 MIPS payment year, 
the MIPS eligible clinician must attest to CMS that he or she--
    (A) Did not knowingly and willfully take action (such as to disable 
functionality) to limit or restrict the compatibility or 
interoperability of certified EHR technology.
    (B) [Reserved]

0
59. Amend Sec.  414.1380 by--
0
a. Revising paragraphs (b)(1)(i) introductory text and(b)(1)(i)(A)(1);
0
b. Adding paragraphs (b)(1)(i)(A)(3) and (b)(1)(i)(C);
0
c. Revising paragraphs (b)(1)(iii), (b)(1)(v)(A) introductory text, and 
(b)(1)(v)(B) introductory text;
0
d. Adding paragraph (b)(1)(v)(B)(1)(iii);
0
e. Revising paragraphs (b)(1)(vi)(C) introductory text, 
(b)(1)(vi)(C)(4), (b)(1)(vi)(E), (b)(1)(vii) introductory text, 
(b)(1)(vii)(A), (b)(2)(iii) introductory text, and (b)(2)(v) 
introductory text;
0
f. Adding paragraphs (b)(2)(v)(A) and (B);
0
g. Revising paragraph (b)(4)(ii) introductory text and (b)(4)(ii)(C);
0
h. Revising the table in paragraph (c) introductory text;
0
i. Revising paragraph (c)(2)(i)(A)(4);
0
j. Removing and reserving paragraph (c)(2)(i)(A)(5);
0
k. Revising paragraphs (c)(2)(i)(C)(9), (c)(2)(ii)(A), and 
(c)(2)(ii)(F);
0
l. Adding paragraph (c)(2)(ii)(G); and
0
m. Revising paragraphs (c)(3) and (e)(6)(iv) through (vi).
    The revisions and additions read as follows:


Sec.  414.1380  Scoring.

* * * * *
    (b) * * *
    (1) * * *
    (i) Measure achievement points. For the CY 2017 through 2021 
performance periods/2019 through 2023 MIPS payment years, MIPS eligible 
clinicians receive between 3 and 10 measure achievement points 
(including partial points) for each measure required under Sec.  
414.1335 on which data is submitted in accordance with Sec.  414.1325 
that has a benchmark at paragraph (b)(1)(ii) of this section, meets the 
case minimum requirement at paragraph (b)(1)(iii) of this section, and 
meets the data completeness requirement at Sec.  414.1340 and for each 
administrative claims-based measure that has a benchmark at paragraph 
(b)(1)(ii) of this section and meets the case minimum requirement at 
paragraph (b)(1)(iii) of this section. Except as provided under 
paragraph (b)(1)(i)(C) of this section, beginning with the CY 2023 
performance period/2025 MIPS payment year, MIPS eligible clinicians 
receive between 1 and 10 measure achievement points (including partial 
points) for each such measure. The number of measure achievement points 
received for each such measure is determined based on the applicable 
benchmark decile category and the percentile distribution. MIPS 
eligible clinicians receive zero measure achievement points for each 
measure required under Sec.  414.1335 on which no data is submitted in 
accordance with Sec.  414.1325. MIPS eligible clinicians that submit 
data in accordance with Sec.  414.1325 on a greater number of measures 
than required under Sec.  414.1335 are scored only on the required 
measures with the greatest number of measure achievement points. 
Beginning with the CY 2019 performance period/2021 MIPS payment year, 
MIPS eligible clinicians that submit data in accordance with Sec.  
414.1325 on a single measure via multiple collection types are scored 
only on the data submission with the greatest number of measure 
achievement points.
    (A) * * *
    (1) Except as provided in paragraphs (b)(1)(i)(A)(2) and (3) of 
this section, for the CY 2017 through 2021 MIPS performance periods/
2019 through 2023 MIPS payment years, MIPS eligible clinicians receive 
3 measure achievement points for each submitted measure that meets the 
data completeness requirement, but does not have a benchmark or meet 
the case minimum requirement. Beginning with the CY 2022 performance 
period/2024 MIPS payment year, MIPS eligible clinicians other than 
small practices receive 0 measure achievement points

[[Page 65674]]

for each such measure, and small practices receive 3 measure 
achievement points for each such measure.
* * * * *
    (3) Beginning with the CY 2023 performance period/2025 MIPS payment 
year, MIPS eligible clinicians receive 7 measure achievement points for 
each submitted measure in its first year in MIPS and 5 measure 
achievement points for each submitted measure in its second year in 
MIPS that meets the data completeness requirement, but does not have a 
benchmark or meet the case minimum requirement.
* * * * *
    (C) New measures. Beginning with the CY 2023 performance period/
2025 MIPS payment year, for each measure required under Sec.  414.1335 
on which data is submitted in accordance with Sec.  414.1325 that has a 
benchmark at paragraph (b)(1)(ii) of this section, meets the case 
minimum requirement at paragraph (b)(1)(iii) of this section, and meets 
the data completeness requirement at Sec.  414.1340, a MIPS eligible 
clinician receives between 7 and 10 measure achievement points 
(including partial points) for each such measure in its first year in 
MIPS and between 5 and 10 measure achievement points for each such 
measure in its second year in MIPS.
* * * * *
    (iii) Minimum case requirements. Except as otherwise specified in 
the MIPS final list of quality measures described in Sec.  
414.1330(a)(1), the minimum case requirement is 20 cases.
    (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 with the 2021 MIPS payment year, MIPS eligible clinicians do 
not receive such measure bonus points for CMS Web Interface measures.
* * * * *
    (B) End-to-end electronic reporting. Subject to paragraph 
(b)(1)(v)(B)(1) of this section, for the CY 2017 through 2021 MIPS 
performance periods/2019 through 2023 MIPS payment years, MIPS eligible 
clinicians receive 1 measure bonus point for each measure (except 
claims-based measures) submitted with end-to-end electronic reporting 
for a quality measure under certain criteria determined by the 
Secretary.
    (1) * * *
    (iii) Beginning in the 2024 MIPS payment year, MIPS eligible 
clinicians will no longer receive measure bonus for submitting using 
end-to-end electronic reporting.
* * * * *
    (vi) * * *
    (C) The improvement percent score is assessed at the performance 
category level for the quality performance category and included in the 
calculation of the quality performance category score as described in 
paragraph (b)(1)(vii) of this section.
* * * * *
    (4) Beginning with the CY 2018 performance period/2020 MIPS payment 
year, we will assume a quality performance category achievement percent 
score of 30 percent if a MIPS eligible clinician earned a quality 
performance category score less than or equal to 30 percent in the 
previous year.
* * * * *
    (E) For the purpose of improvement scoring methodology, the term 
``improvement percent score'' means the score that represents 
improvement for the purposes of calculating the quality performance 
category score as described in paragraph (b)(1)(vii) of this section.
* * * * *
    (vii) Quality performance category score. A MIPS eligible 
clinician's quality performance category score is the sum of all the 
measure achievement points assigned for the measures required for the 
quality performance category criteria plus the measure bonus points in 
paragraph (b)(1)(v) of this section. The sum is divided by the sum of 
total available measure achievement points. The improvement percent 
score in paragraph (b)(1)(vi) of this section is added to that result. 
The quality performance category score cannot exceed 100 percentage 
points.
    (A) For each measure that is submitted, if applicable, and impacted 
by significant changes or errors prior to the applicable data 
submission deadline at Sec.  414.1325(e), performance is based on data 
for 9 consecutive months of the applicable CY performance period. If 
such data are not available or CMS determines that they 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. For purposes of this paragraph 
(b)(1)(vii)(A), ``significant changes or errors'' means changes to or 
errors in a measure that are outside the control of the clinician and 
its agents and that CMS determines may result in patient harm or 
misleading results. Significant changes or errors include, but are not 
limited to, changes to codes (such as ICD-10, CPT, or HCPCS codes) or 
the active status of codes, the inadvertent omission of codes or 
inclusion of inactive or inaccurate codes, or changes to clinical 
guidelines or measure specifications. CMS will publish on the CMS 
website a list of all measures scored under this paragraph 
(b)(1)(vii)(A) as soon as technically feasible, but by no later than 
the data submission deadline at Sec.  414.1325(e)(1).
* * * * *
    (2) * * *
    (iii) The cost performance category score is the sum of the 
following, not to exceed 100 percent:
* * * * *
    (v) A cost performance category score is not calculated if a MIPS 
eligible clinician or group is not attributed any cost measures for the 
performance period because the clinician or group has not met the 
minimum case volume specified by CMS for any of the cost measures or a 
benchmark has not been created for any of the cost measures that would 
otherwise be attributed to the clinician or group.
    (A) Beginning with the 2024 MIPS payment year, if data used to 
calculate a score for a cost measure are impacted by significant 
changes during the performance period, such that calculating the cost 
measure score would lead to misleading or inaccurate results, then the 
affected cost measure is excluded from the MIPS eligible clinician's or 
group's cost performance category score. For purposes of this paragraph 
(b)(2)(v)(A), ``significant changes'' are changes external to the care 
provided, and that CMS determines may lead to misleading or inaccurate 
results. Significant changes include, but are not limited to, rapid or 
unprecedented changes to service utilization, and will be empirically 
assessed by CMS to determine the extent to which the changes impact the 
calculation of a cost measure score that reflects clinician 
performance.
    (B) [Reserved]
* * * * *
    (4) * * *
    (ii) Beginning with the 2019 performance period/2021 MIPS payment 
year, a MIPS eligible clinician's Promoting Interoperability 
performance category score equals the sum of the scores for each of the 
required measures and any applicable bonus scores, not to exceed 100 
points.
* * * * *

[[Page 65675]]

    (C) Each optional measure is worth five or ten bonus points, as 
specified by CMS.
* * * * *
    (c) * * *

               Table 1 to Paragraph (c) Introductory Text
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
For the 2019 MIPS payment year:
    Final score = [(quality performance category score x quality
     performance category weight) + (cost performance category score x
     cost performance category weight) + (improvement activities
     performance category score x improvement activities performance
     category weight) + (Promoting Interoperability performance category
     score x Promoting Interoperability performance category weight)],
     not to exceed 100 points.
For the 2020 MIPS payment year:
    Final score = [(quality performance category score x quality
     performance category weight) + (cost performance category score x
     cost performance category weight) + (improvement activities
     performance category score x improvement activities performance
     category weight) + (Promoting Interoperability performance category
     score x Promoting Interoperability performance category weight)] x
     100 + [the complex patient bonus + the small practice bonus], not
     to exceed 100 points.
Beginning with the 2021 MIPS payment year:
    Final score = [(quality performance category score x quality
     performance category weight) + (cost performance category score x
     cost performance category weight) + (improvement activities
     performance category score x improvement activities performance
     category weight) + (Promoting Interoperability performance category
     score x Promoting Interoperability performance category weight)] x
     100 + the complex patient bonus, not to exceed 100 points.
------------------------------------------------------------------------

* * * * *
    (2) * * *
    (i) * * *
    (A) * * *
    (4) For the Promoting Interoperability performance category: (i) 
For the 2021 through 2024 MIPS payment years, the MIPS eligible 
clinician is a physical therapist, occupational therapist, clinical 
psychologist, qualified audiologist, qualified speech-language 
pathologist, or a registered dietitian or nutrition professional. 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 redistributed.
    (ii) For the 2019 through 2024 MIPS payment years, the MIPS 
eligible clinician is a nurse practitioner, physician assistant, 
clinical nurse specialist, or certified registered nurse anesthetist. 
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 redistributed.
    (iii) For the 2024 MIPS payment year, 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 redistributed.
* * * * *
    (C) * * *
    (9) For the 2020 MIPS payment year through the 2023 MIPS payment 
year the MIPS eligible clinician demonstrates through an application 
submitted to CMS that they are in a small practice as defined in Sec.  
414.1305, and overwhelming barriers prevent them from complying with 
the requirements for the Promoting Interoperability performance 
category. Beginning with the 2024 MIPS payment year the MIPS eligible 
clinician is in a small practice as defined in Sec.  414.1305.
* * * * *
    (ii) * * *
    (A) For the 2019 MIPS payment year:

                                       Table 2 to Paragraph (c)(2)(ii)(A)
----------------------------------------------------------------------------------------------------------------
                                                        Reweight scenario
                                                         if no promoting   Reweight scenario   Reweight scenario
                                     Weighting for the   interoperability    if no quality     if no improvement
      Performance category (%)       2019 MIPS payment     performance        performance         activities
                                          year (%)        category score     category score       performance
                                                               (%)                (%)         category score (%)
----------------------------------------------------------------------------------------------------------------
Quality............................                 60                 85                  0                  75
Cost...............................                  0                  0                  0                   0
Improvement Activities.............                 15                 15                 50                   0
Promoting Interoperability.........                 25                  0                 50                  25
----------------------------------------------------------------------------------------------------------------

* * * * *
    (F) Except as provided in paragraph (c)(2)(ii)(G) of this section, 
beginning with the 2024 MIPS payment year:

                                       Table 7 to Paragraph (c)(2)(ii)(F)
----------------------------------------------------------------------------------------------------------------
                                                                                                   Promoting
               Reweighting scenario                 Quality (%)    Cost (%)     Improvement    interoperability
                                                                              activities (%)          (%)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
    Scores for all four performance categories....           30           30              15                  25
    No Cost.......................................           55            0              15                  30

[[Page 65676]]

 
    No Promoting Interoperability.................           55           30              15                   0
    No Quality....................................            0           30              15                  55
    No Improvement Activities.....................           45           30               0                  25
    No Cost and no Promoting Interoperability.....           85            0              15                   0
    No Cost and no Quality........................            0            0              15                  85
    No Cost and no Improvement Activities.........           70            0               0                  30
    No Promoting Interoperability and no Quality..            0           50              50                   0
    No Promoting Interoperability and no                     70           30               0                   0
     Improvement Activities.......................
    No Quality and no Improvement Activities......            0           30               0                  70
----------------------------------------------------------------------------------------------------------------

    (G) For small practices beginning with the 2024 MIPS payment year:

                                       Table 8 to Paragraph (c)(2)(ii)(G)
----------------------------------------------------------------------------------------------------------------
                                                                                                    Promoting
                Reweighting scenario                  Quality (%)    Cost (%)     Improvement   interoperability
                                                                                activities (%)         (%)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
    Scores for all four performance categories......           30           30              15               25
    No Cost.........................................           55            0              15               30
    No Promoting Interoperability...................           40           30              30                0
    No Quality......................................            0           30              15               55
    No Improvement Activities.......................           45           30               0               25
    No Cost and no Promoting Interoperability.......           50            0              50                0
    No Cost and no Quality..........................            0            0              15               85
    No Cost and no Improvement Activities...........           70            0               0               30
    No Promoting Interoperability and no Quality....            0           50              50                0
    No Promoting Interoperability and no Improvement           70           30               0                0
     Activities.....................................
    No Quality and no Improvement Activities........            0           30               0               70
----------------------------------------------------------------------------------------------------------------

* * * * *
    (3) Complex patient bonus. For the CY 2020, 2021, 2022, and 2023 
MIPS payment years and associated performance periods, provided that a 
MIPS eligible clinician, group, virtual group or APM Entity submits 
data for at least one MIPS performance category for the applicable 
performance period for the MIPS payment year, a complex patient bonus 
will be added to the final score for the MIPS payment year, as stated 
in paragraphs (c)(3)(i) through (iv) of this section. Beginning with 
the CY 2022 MIPS performance period/CY 2024 MIPS payment year, provided 
that a MIPS eligible clinician, group, subgroup, virtual group or APM 
Entity submits data for at least one MIPS performance category for the 
applicable performance period for the MIPS payment year, a complex 
patient bonus will be added to the final score for the MIPS payment 
year, if applicable, as described in paragraphs (c)(3)(v) through 
(viii) of this section.
    (i) For the CY 2020, 2021, 2022, and 2023 MIPS payment years and 
associated performance periods, for MIPS eligible clinicians and 
groups, the complex patient bonus is calculated as follows: [The 
average HCC risk score assigned to beneficiaries (pursuant to the HCC 
risk adjustment model established by CMS pursuant to section 1853(a)(1) 
of the Act) seen by the MIPS eligible clinician or seen by clinicians 
in a group] + [the dual eligible ratio x 5].
    (ii) For the CY 2020, 2021, 2022, and 2023 MIPS payment years and 
associated performance periods, for APM Entities and virtual groups, 
the complex patient bonus is calculated as follows: [The beneficiary 
weighted average HCC risk score for all MIPS eligible clinicians, and 
if technically feasible, TINs for models and virtual groups which rely 
on complete TIN participation within the APM Entity or virtual group, 
respectively] + [the average dual eligible ratio for all MIPS eligible 
clinicians, and if technically feasible, TINs for models and virtual 
groups which rely on complete TIN participation, within the APM Entity 
or virtual group, respectively, x 5].
    (iii) For the 2020, 2021, 2022, and 2023 MIPS payment years and 
associated performance periods, the complex patient bonus cannot exceed 
5.0 except as provided in paragraph (c)(3)(iv) of this section.
    (iv) For the 2022 and 2023 MIPS payment years and associated 
performance periods, the complex patient bonus is calculated pursuant 
to paragraphs (c)(3)(i) and (ii) of this section, and the resulting 
numerical value is then multiplied by 2.0. The complex patient bonus 
cannot exceed 10.0.
    (v) Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS 
payment year, the complex patient bonus is limited to MIPS eligible 
clinicians, groups, subgroups, APM Entities, and virtual groups with a 
risk indicator at or above the risk indicator calculated median. To 
determine the median for the respective risk indicator (HCC and dual 
proportion), risk indicators associated with the final score assigned 
to a clinician from the most recent prior performance period, for all 
those who have submitted data for at least one MIPS performance 
category or are facility-based, are used.
    (vi) Beginning with the CY 2022 MIPS performance period/CY 2024 
MIPS payment year, for MIPS eligible clinicians, groups, and subgroups, 
the complex patient bonus components are calculated as follows for the 
specific

[[Page 65677]]

risk indicators: Medical complex patient bonus component = 1.5 + 4 * 
associated HCC standardized score calculated with the average HCC risk 
score assigned to beneficiaries (pursuant to the HCC risk adjustment 
model established by CMS pursuant to section 1853(a)(1) of the Act) 
seen by the MIPS eligible clinician or seen by clinicians in a group or 
subgroup; social complex patient bonus component = 1.5 + 4 * associated 
dual proportion standardized score. The components are added together 
to calculate one overall complex patient bonus. A standardized score 
for each risk indicator is determined based on the mean and standard 
deviation of the raw risk indicator score and provides a standardized 
measurement of how far each risk score is from the mean: (raw risk 
indicator score-risk indicator mean)/risk indicator standard deviation.
    (vii) Beginning with the CY 2022 MIPS performance period/CY 2024 
MIPS payment year, for APM Entities and virtual groups, the complex 
patient bonus components are calculated as follows for the specific 
risk indicators: Medical complex patient bonus component = 1.5 + 4 * 
the beneficiary weighted average HCC risk standardized score for all 
MIPS eligible clinicians, and if technically feasible, TINs for models 
and virtual groups which rely on complete TIN participation within the 
APM Entity or virtual group, respectively; social complex patient bonus 
component = 1.5 + 4 * the average dual proportion standardized score 
for all MIPS eligible clinicians, and if technically feasible, TINs for 
models and virtual groups which rely on complete TIN participation, 
within the APM Entity or virtual group, respectively. The components 
are added together to calculate one overall complex patient bonus. A 
standardized score for each risk indicator is determined based on the 
mean and standard deviation of the raw risk indicator score and 
provides a standardized measurement of how far each risk score is from 
the mean: (raw risk indicator score-risk indicator mean)/risk indicator 
standard deviation.
    (viii) Beginning with the CY 2022 MIPS performance period/CY 2024 
MIPS payment year, the complex patient bonus cannot exceed 10.0 and 
cannot be below 0.0.
* * * * *
    (e) * * *
    (6) * * *
    (iv) Quality. The quality performance category score is established 
by determining the percentile performance of the facility in the value-
based purchasing program for the specified year as described in 
paragraph (e)(1) of this section and awarding a score associated with 
that same percentile performance in the MIPS quality performance 
category score for those MIPS-eligible clinicians who are not eligible 
to be scored using facility-based measurement for the MIPS payment 
year. A clinician or group receiving a facility-based performance score 
will not earn improvement points based on prior performance in the MIPS 
quality performance category
    (v) Cost. The cost performance category score is established by 
determining the percentile performance of the facility in the value-
based purchasing program for the specified year as described in 
paragraph (e)(1) of this section and awarding a score associated with 
that same percentile performance in the MIPS cost performance category 
score for those MIPS eligible clinicians who are not eligible to be 
scored using facility-based measurement for the MIPS payment year. A 
clinician or group receiving a facility-based performance score will 
not earn improvement points based on prior performance in the MIPS cost 
performance category.
    (A) Other cost measures. MIPS eligible clinicians who are scored 
under facility-based measurement are not scored on cost measures 
described in paragraph (b)(2) of this section.
    (B) [Reserved]
    (vi) Use of score from facility-based measurement. The MIPS quality 
and cost performance category scores will be based on the facility-
based measurement scoring methodology described in paragraph (e)(6) of 
this section unless:
    (A) For the CY 2019 MIPS performance period/2021 MIPS payment year, 
through the CY 2021 MIPS performance period/2023 MIPS payment year, a 
clinician or group receives a higher combined MIPS quality and cost 
performance category score through another MIPS submission.
    (B) Beginning with the CY 2022 MIPS performance period/2024 MIPS 
payment year, a clinician or group receives a higher MIPS final score 
through another MIPS submission.

0
60. Amend Sec.  414.1395 by revising paragraph (c) to read as follows:


Sec.  414.1395  Public reporting.

* * * * *
    (c) New measures and activities. (1) CMS does not publicly report 
any data on new quality or cost measure for the first 2 years in which 
it is in the program, after which CMS evaluates the measure to 
determine whether it is suitable for public reporting under paragraph 
(b) of this section.
    (2) CMS does not publicly report any MVP data on new improvement 
activity or Promoting Interoperability measure, objective, or activity 
included in an MVP for the first year in which it is included in the 
MVP.
* * * * *

0
61. Revise Sec.  414.1400 to read as follows:


Sec.  414.1400  Third party intermediaries.

    (a) General. (1) MIPS data may be submitted on behalf of a MIPS 
eligible clinician, group, virtual group, subgroup, or APM Entity by 
any of the following third party intermediaries:
    (i) QCDR;
    (ii) Qualified registry;
    (iii) Health IT vendor; or
    (iv) CMS-approved survey vendor.
    (2) Third party intermediary approval criteria--
    (i) To be approved as a third party intermediary, an entity must 
agree to meet the applicable requirements of this section, including, 
but not limited to, the following:
    (A) A third party intermediary's principle place of business and 
retention of any data must be based in the U.S.
    (B) If the data is derived from CEHRT, a QCDR, qualified registry, 
or health IT vendor must be able to indicate its data source.
    (C) All data must be submitted in the form and manner specified by 
CMS.
    (D) If the clinician chooses to opt-in in accordance with Sec.  
414.1310, the third party intermediary must be able to transmit that 
decision to CMS.
    (E) The third party intermediary must provide services throughout 
the entire performance period and applicable data submission period.
    (F) 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.
    (ii) The determination of whether to approve an entity as a third 
party intermediary for a MIPS payment year may take into account:
    (A) Whether the entity failed to comply with the requirements of 
this section for any prior MIPS payment year for which it was approved 
as third party intermediary; and
    (B) Whether the entity provided inaccurate information regarding 
the

[[Page 65678]]

requirements of this subpart to any eligible clinician.
    (iii) 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.
    (3) 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.
    (b) Additional requirements for QCDRs and qualified registries--(1) 
General. (i) Beginning with the CY 2021 performance period/2023 MIPS 
payment year, QCDRs and qualified registries must be able to submit 
data for all of the following MIPS performance categories:
    (A) Quality, except:
    (1) The CAHPS for MIPS survey; and
    (2) For qualified registries, QCDR measures;
    (B) Improvement activities; and
    (C) Promoting Interoperability, if the eligible clinician, group, 
virtual group, or subgroup is using CEHRT, unless the third party 
intermediary's MIPS eligible clinicians, groups, virtual groups, or 
subgroups fall under the reweighting policies at Sec.  
414.1380(c)(2)(i)(A)(4)(i) through (iii) or (c)(2)(i)(C)(1) through (7) 
or (c)(2)(i)(C)(9).
    (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.
    (2) Self-nomination. For the CY 2018 and 2019 performance periods/
2020 and 2021 MIPS payment years, entities seeking to qualify as a QCDR 
or qualified registry must self-nominate September 1 until November 1 
of the CY preceding the applicable performance period. For the CY 2020 
performance period/2022 MIPS payment year and future years, entities 
seeking to qualify as a QCDR or qualified registry must self-nominate 
during a 60-day period during the CY preceding the applicable 
performance period (beginning no earlier than July 1 and ending no 
later than September 1). Entities seeking to qualify as a QCDR or 
qualified registry for a performance period must provide all 
information required by CMS at the time of self-nomination and must 
provide any additional information requested by CMS during the review 
process. 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.
    (3) Conditions for approval. (i) Beginning with the CY 2020 
performance period/2022 MIPS payment year, the QCDR or qualified 
registry must have at least 25 participants by January 1 of the year 
prior to the applicable performance period.
    (ii) If an entity seeking to qualify as a QCDR or qualified 
registry uses an external organization for purposes of data collection, 
calculation, or transmission, it must have a signed, written agreement 
with the external organization that specifically details the 
responsibilities of the entity and the external organization. The 
written agreement must be effective as of September 1 of the year 
preceding the applicable performance period.
    (iii) Beginning with the CY 2021 performance period/2023 MIPS 
payment year, the QCDR or qualified registry must provide performance 
feedback to their clinicians and groups at least 4 times a year, and 
provide specific feedback to their clinicians and groups on how they 
compare to other clinicians who have submitted data on a given measure 
within the QCDR or qualified registry. Exceptions to this requirement 
may occur if the QCDR or qualified registry submits notification to CMS 
within the performance period promptly within the month of realization 
of the impending deficiency and provides sufficient rationale as to why 
they do not believe they would be able to meet this requirement (for 
example, if the QCDR does not receive the data from their clinician 
until the end of the performance period).
    (iv) Beginning with the CY 2023 performance period/2025 MIPS 
payment year, the QCDR or qualified registry must submit a data 
validation plan annually, at the time of self-nomination for CMS' 
approval and may not change the plan once approved without the prior 
approval of the agency.
    (v) Beginning with the CY 2021 performance period/2023 MIPS payment 
year, the QCDR or qualified registry must conduct annual data 
validation audits in accordance with this paragraph (b)(3)(v).
    (A) The QCDR or qualified registry must conduct data validation for 
the payment year prior to submitting any data for that payment year to 
CMS for purposes of the MIPS program.
    (B) The QCDR or qualified registry must conduct data validation on 
data for each performance category for which it will submit data, 
including if applicable the Quality, Improvement Activities, and 
Promoting Interoperability performance categories.
    (C) The QCDR or qualified registry must conduct data validation on 
data for each submitter type for which it will submit data, including 
MIPS eligible clinicians, groups, virtual groups, subgroups, APM 
entities, voluntary participants, and opt-in participants, if 
applicable.
    (D) The QCDR or qualified registry must use clinical documentation 
(provided by the clinicians they are submitting data for) to validate 
that the action or outcome measured actually occurred or was performed.
    (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.
    (F) Each QCDR or qualified registry data validation audit must 
include the following:
    (1) Verification of the eligibility status of each eligible 
clinician, group, virtual group, subgroup, opt-in participant, and 
voluntary participant.
    (2) Verification of the accuracy of TINs and NPIs.
    (3) Calculation of reporting and performance rates.
    (4) Verification that only the MIPS quality measures and QCDR 
measures, as applicable, that are relevant to the performance period 
will be used for MIPS submission.
    (G) In a form and manner and by a deadline specified by CMS, the 
QCDR or qualified registry must report the results of each data 
validation audit, including the overall data deficiencies or data error 
rate, the types of deficiencies or data errors discovered, the 
percentage of clinicians impacted by any deficiency or

[[Page 65679]]

error, and, how and when each deficiency or data error type was 
corrected.
    (1) QCDRs and qualified registries must conduct validation on the 
data they intend to submit for the MIPS performance period and provide 
the results of the executed data validation plan by May 31st of the 
year following the performance period.
    (2) [Reserved]
    (vi) Beginning with the CY 2021 performance period/2023 MIPS 
payment year, the QCDR or qualified registry must conduct targeted 
audits in accordance with this paragraph (b)(3)(vi).
    (A) If a data validation audit under paragraph (b)(3)(v) of this 
section identifies one or more deficiency or data error, the QCDR or 
qualified registry must conduct a targeted audit into the impact and 
root cause of each such deficiency or data error for that MIPS payment 
year.
    (B) The QCDR or qualified registry must conduct any required 
targeted audits for the MIPS payment year and correct any deficiencies 
or data errors identified through such audit prior to the submission of 
data for that MIPS payment year.
    (C) The QCDR or qualified registry must conduct the targeted audit 
using the sampling methodology that meets the requirements described in 
paragraph (b)(3)(iv)(E) of this section. The sample for the targeted 
audit must not include data from the sample used for the data 
validation audit in which the deficiency or data error was identified.
    (D) In a form and manner and by a deadline specified by CMS, the 
QCDR or qualified registry must report the results of each targeted 
audit, including the overall deficiency or data error rate, the types 
of deficiencies or data errors discovered, the percentage of clinicians 
impacted by each deficiency or data error, and how and when each 
deficiency or data error type was corrected.
    (vii) For the CY 2023 performance period/2025 MIPS payment year, a 
QCDR or qualified registry that was approved but did not submit any 
MIPS data for any of the 2019 through 2023 MIPS payment years must 
submit a participation plan for CMS' approval. The participation plan 
must include the QCDR and/or qualified registry's detailed plans about 
how the QCDR or qualified registry intends to encourage clinicians to 
submit MIPS data to CMS through the QCDR or qualified registry.
    (viii) Beginning with the CY 2024 performance period/2026 MIPS 
payment year, a QCDR or qualified registry that was approved but did 
not submit any MIPS data for either of the 2 years preceding the 
applicable self-nomination period must submit a participation plan for 
CMS' approval. This participation plan must include the QCDR's and/or 
qualified registry's detailed plans about how the QCDR or qualified 
registry intends to encourage clinicians to submit MIPS data to CMS 
through the QCDR or qualified registry.
    (4) QCDR measures for the quality performance category--(i) QCDR 
measure self-nomination requirements. For the CY 2018 performance 
period/2020 MIPS payment year and future years, at the time of self-
nomination an entity seeking to become a QCDR must submit the following 
information for any measure it intends to submit for the payment year.
    (A) For MIPS quality measures, the entity must submit 
specifications including the MIPS measure IDs and specialty-specific 
measure sets, as applicable.
    (B) For QCDR measures, the entity must submit for CMS-approval 
measure specifications including: Name/title of measures, NQF number 
(if NQF- endorsed), 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 approval of any QCDR measure 
specifications, the entity must publicly post the measure 
specifications for that QCDR measure (including the CMS- assigned QCDR 
measure ID) and provide CMS with a link to where this information is 
posted.
    (ii) QCDR measure submission requirements. A QCDR must include the 
CMS-assigned QCDR measure ID when submitting data on any QCDR measure 
to CMS.
    (iii) QCDR measure approval criteria. (A) QCDR measure requirements 
for approval are:
    (1) QCDR measures that are beyond the measure concept phase of 
development.
    (2) QCDR measures that address significant variation in 
performance.
    (3) Beginning with the CY 2022 performance period/2024 MIPS payment 
year, all QCDR measures must meet face validity. To be approved for the 
CY 2023 performance period/2025 MIPS payment year, all QCDR measures 
must meet face validity for the initial MIPS payment year for which it 
is approved. For subsequent years after being initially approved, all 
QCDR measures must be fully developed and tested, with complete testing 
results at the clinician level, prior to submitting the QCDR measure at 
the time of self-nomination.
    (i) To be included in an MVP for the CY 2022 performance period/
2024 MIPS payment year and future years, a QCDR measure must be fully 
tested.
    (ii) [Reserved]
    (4) Beginning with the CY 2022 performance period/2023 MIPS payment 
year, QCDRs are required to collect data on a QCDR measure, appropriate 
to the measure type, prior to submitting the QCDR measure for CMS 
consideration during the self-nomination period.
    (5) Beginning with the CY 2020 performance period/2022 MIPS payment 
year, CMS may provisionally approve the individual QCDR measures for 1 
year with the condition that QCDRs address certain areas of duplication 
with other approved QCDR measures or MIPS quality measures in order to 
be considered for the program in subsequent years. If such areas of 
duplication are not addressed, CMS may reject the duplicative QCDR 
measure.
    (B) QCDR measure considerations for approval include, but are not 
limited to:
    (1) Measures that are outcome-based rather than clinical process 
measures.
    (2) Measures that address patient safety and adverse events.
    (3) Measures that identify appropriate use of diagnosis and 
therapeutics.
    (4) Measures that address the domain of care coordination.
    (5) Measures that address the domain for patient and caregiver 
experience.
    (6) Measures that address efficiency, cost, and resource use.
    (7) Beginning with the CY 2021 performance period/2023 MIPS payment 
year -
    (i) That QCDRs link their QCDR measures as feasible to at least one 
cost measure, improvement activity, or an MVP at the time of self-
nomination.
    (ii) In cases where a QCDR measure does not have a clear link to a 
cost measure, improvement activity, or an MVP, CMS would consider 
exceptions if the potential QCDR measure otherwise meets the QCDR 
measure requirements and considerations.
    (8) Beginning with the CY 2020 performance period/2022 MIPS payment 
year CMS may consider the extent to which a QCDR measure is available 
to MIPS eligible clinicians reporting through QCDRs other than the QCDR 
measure owner for purposes of MIPS. If CMS determines that a QCDR 
measure is not available to MIPS eligible clinicians, groups, and 
virtual groups reporting through other QCDRs, CMS may not approve the 
measure.
    (9) Greater consideration is given to measures for which QCDRs:

[[Page 65680]]

    (i) Conducted an environmental scan of existing QCDR measures; MIPS 
quality measures; quality measures retired from the legacy Physician 
Quality Reporting System (PQRS) program; and
    (ii) Utilized the CMS Quality Measure Development Plan Annual 
Report and the Blueprint in the CMS Measures Management System to 
identify measurement gaps prior to measure development.
    (10) Beginning with the CY 2020 performance period/2022 MIPS 
payment year, CMS places greater preference on QCDR measures that meet 
case minimum and reporting volumes required for benchmarking after 
being in the program for 2 consecutive CY performance periods. Those 
that do not, may not continue to be approved.
    (i) Beginning with the CY 2020 performance period/2022 MIPS payment 
year, in instances where a QCDR believes the low-reported QCDR measure 
that did not meet benchmarking thresholds is still important and 
relevant to a specialist's practice, that the QCDR may develop and 
submit a QCDR measure participation plan for our consideration. This 
QCDR measure participation plan must include the QCDR's detailed plans 
and changes to encourage eligible clinicians and groups to submit data 
on the low-reported QCDR measure for purposes of the MIPS program.
    (ii) [Reserved]
    (C) Beginning with the CY 2021 performance period/2023 MIPS payment 
year, QCDR measures may be approved for 2 years, at CMS discretion by 
attaining approval status by meeting QCDR measure considerations and 
requirements. Upon annual review, CMS may revoke a QCDR measure's 
second year approval, if the QCDR measure is found to be: Topped out; 
duplicative of a more robust measure; reflects an outdated clinical 
guideline; or if the QCDR self-nominating the QCDR measure is no longer 
in good standing.
    (iv) QCDR measure rejection criteria. Beginning with the CY 2020 
performance period/2022 MIPS payment year, QCDR measure rejection 
considerations include, but are not limited to:
    (A) QCDR measures that are duplicative or identical to other QCDR 
measures or MIPS quality measures that are currently in the program.
    (B) QCDR measures that are duplicative or identical to MIPS quality 
measures that have been removed from MIPS through rulemaking.
    (C) QCDR measures that are duplicative or identical to quality 
measures used under the legacy Physician Quality Reporting System 
(PQRS) program, which have been retired.
    (D) QCDR measures that meet the topped out definition as described 
at Sec.  414.1305.
    (E) QCDR measures that are process-based, with consideration to 
whether the removal of the process measure impacts the number of 
measures available for a specific specialty.
    (F) Whether the QCDR measure has potential unintended consequences 
to a patient's care.
    (G) Considerations and evaluation of the measure's performance 
data, to determine whether performance variance exists.
    (H) QCDR measures that split a single clinical practice or action 
into several QCDR measures.
    (I) QCDR measures that are ``check-box'' with no actionable quality 
action.
    (J) QCDR measures that do not meet the case minimum and reporting 
volumes required for benchmarking after being in the program for 2 
consecutive years.
    (K) QCDR measures with clinician attribution issues, where the 
quality action is not under the direct control of the reporting 
clinician.
    (L) QCDR measures that focus on rare events or ``never events'' in 
the measurement period.
    (M) QCDR does not have permission to use a QCDR measure owned by 
another QCDR for the applicable performance period.
    (N) If a QCDR measure owner is not approved or is not in good 
standing, any associated QCDR measures will not be approved.
    (c) Additional requirements for Health IT vendors. (1) Beginning 
with the CY 2021 performance period/2023 MIPS payment year, health IT 
vendors must be able to submit data for the MIPS performance categories 
as follows:
    (i) Health IT vendors that support MVPs must be able to submit data 
for all of the MIPS performance categories:
    (A) Quality, except:
    (1) The CAHPS for MIPS survey; and
    (2) QCDR measures;
    (B) Improvement activities; and
    (C) Promoting Interoperability, if the eligible clinician, group, 
virtual group, or subgroup is using CEHRT, unless:
    (1) The third party intermediary's MIPS eligible clinicians, 
groups, virtual groups, or subgroups fall under the reweighting 
policies at Sec.  414.1380(c)(2)(i)(A)(4)(i) through (iii) or 
(c)(2)(i)(C)(1) through (7) or (c)(2)(i)(C)(9).
    (2) [Reserved]
    (ii) Health IT vendors that do not support MVPs must be able to 
submit data for at least one of the MIPS performance categories 
described in paragraphs (c)(1)(i) of this section.
    (iii) Beginning with the CY 2023 performance period/2025 MIPS 
payment year, Health IT vendors must support MVPs that are applicable 
to the MVP participant on whose behalf they submit MIPS data. Health IT 
vendors may also support the APP.
    (2) [Reserved]
    (d) Additional requirements for CMS-approved survey vendors. (1) 
CMS-approved survey vendors may submit data on the CAHPS for MIPS 
survey for the MIPS quality performance category.
    (2) Entities seeking to be a CMS-approved survey vendor for any 
MIPS performance period must submit a survey vendor application to CMS 
in a form and manner specified by CMS for each MIPS performance period 
for which it wishes to transmit such data. The application and any 
supplemental information requested by CMS must be submitted by 
deadlines specified by CMS. For an entity to be a CMS-approved survey 
vendor, it must meet the following criteria:
    (3) The entity must have sufficient experience, capability, and 
capacity to accurately report CAHPS data, including:
    (i) At least 3 years of experience administering mixed-mode surveys 
(that is, surveys that employ multiple modes to collect date), 
including mail survey administration followed by survey administration 
via Computer Assisted Telephone Interview (CATI);
    (ii) At least 3 years of experience administering surveys to a 
Medicare population;
    (iii) At least 3 years of experience administering CAHPS surveys 
within the past 5 years;
    (iv) Experience administering surveys in English and at least one 
other language for which a translation of the CAHPS for MIPS survey is 
available;
    (v) Use equipment, software, computer programs, systems, and 
facilities that can verify addresses and phone numbers of sampled 
beneficiaries, monitor interviewers, collect data via CATI, 
electronically administer the survey and schedule call-backs to 
beneficiaries at varying times of the day and week, track fielded 
surveys, assign final disposition codes to reflect the outcome of data 
collection of each sampled case, and track cases from mail surveys 
through telephone follow-up activities; and
    (vi) Employment of a program manager, information systems 
specialist, call center supervisor and mail center supervisor to 
administer the survey.

[[Page 65681]]

    (4) The entity has certified that it has the ability to maintain 
and transmit quality data in a manner that preserves the security and 
integrity of the data.
    (5) The entity has successfully completed, and has required its 
subcontractors to successfully complete, vendor training(s) 
administered by CMS or its contractors.
    (6) The entity has submitted a quality assurance plan and other 
materials relevant to survey administration, as determined by CMS, 
including cover letters, questionnaires and telephone scripts.
    (7) The entity has agreed to participate and cooperate, and has 
required its subcontractors to participate and cooperate, in all 
oversight activities related to survey administration conducted by CMS 
or its contractors.
    (8) The entity has sent an interim survey data file to CMS that 
establishes the entity's ability to accurately report CAHPS data.
    (e) Remedial action and termination of third party intermediaries. 
(1) If CMS determines that a third party intermediary has ceased to 
meet one or more of the applicable criteria for approval, 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) Require the third party intermediary to submit a corrective 
action plan (CAP) by a date specified by CMS. The CAP must address the 
following issues, unless different or additional information is 
specified by CMS:
    (A) The issues that contributed to the non-compliance.
    (B) The impact to individual clinicians, groups, or virtual groups, 
regardless of whether they are participating in the program because 
they are MIPS eligible, voluntary 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.
    (D) The detailed timeline for achieving compliance with the 
applicable requirements.
    (ii) Publicly disclose the entity's data error rate on the CMS 
website until the data error rate falls below 3 percent.
    (2) CMS may immediately or with advance notice terminate the 
ability of a third party intermediary to submit MIPS data on behalf of 
a MIPS eligible clinician, group, or virtual group for one or more of 
the following reasons:
    (i) CMS has grounds to impose remedial action;
    (ii) CMS has not received a CAP within the specified time-period or 
the CAP is not accepted by CMS; or
    (iii) The third party intermediary fails to correct the 
deficiencies or data errors by the date specified by CMS.
    (3) Contains data inaccuracies affecting the third party 
intermediary's total 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, 
including but not limited to, if the submitted data:
    (i) Includes, without limitation, TIN/NPI mismatches, formatting 
issues, calculation errors, or data audit discrepancies.
    (ii) [Reserved]
    (f) Auditing of entities submitting MIPS data. Any third party 
intermediary must comply with the following procedures as a condition 
of its qualification and approval to participate in MIPS as a third 
party intermediary.
    (1) The entity must make available to CMS the contact information 
of each MIPS eligible clinician or group on behalf of whom it submits 
data. The contact information must include, at a minimum, the MIPS 
eligible clinician or group's practice phone number, address, and, if 
available, email.
    (2) The entity must retain all data submitted to CMS for purposes 
of MIPS for 6 years from the end of the MIPS performance period.
    (3) For the purposes of auditing, CMS may request any records or 
data retained for the purposes of MIPS for up to 6 years from the end 
of the MIPS performance period.

0
62. Amend Sec.  414.1405 by adding paragraphs (b)(9), (d)(7), and (g) 
to read as follows:


Sec.  414.1405  Payment.

* * * * *
    (b) * * *
    (9) Pursuant to the methodology established at paragraph (g) of 
this section, the performance threshold for the 2024 MIPS payment year 
is 75 points. The prior period used to determine the performance 
threshold is the 2019 MIPS payment year.
* * * * *
    (d) * * *
    (7) The additional performance threshold for the 2024 MIPS payment 
year is 89 points.
* * * * *
    (g) Performance threshold methodology. 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.

0
63. Amend Sec.  414.1430 by--
0
a. Revising paragraph (a)(1)(iii);
0
b. Adding paragraphs (a)(1)(iv);
0
c. Removing the second occurrence of paragraph (a)(2)(ii);
0
d. Adding paragraphs (a)(2)(iii) and (iv); and
0
e. Revising paragraphs (b)(1)(i)(A) and (B) and (b)(2)(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) * * *
    (iii) 2023 and 2024: 50 percent.
    (iv) 2025 and later: 75 percent.
    (2) * * *
    (iii) 2023 and 2024: 50 percent.
    (iv) 2025 and later: 75 percent.
* * * * *
    (b) * * *
    (1) * * *
    (i) * * *
    (A) 2021 through 2024: 50 percent.
    (B) 2025 and later: 75 percent.
* * * * *
    (2) * * *
    (i) * * *
    (A) 2021 through 2024: 35 percent.
    (B) 2025 and later: 50 percent.
* * * * *

0
64. Amend Sec.  414.1450 by revising paragraph (c) introductory text to 
read as follows:


Sec.  414.1450  APM incentive payment.

* * * * *
    (c) APM Incentive Payment recipient. CMS will pay the APM Incentive 
Payment amount for a payment year to a solvent TIN or TINs associated 
with the QP, identified based on Medicare Part B claims submitted for 
covered professional services during the base period or payment year, 
according to this section. If no TIN or TINs with which the QP has an 
association can be identified at a step, CMS will move to the next and 
successive steps listed in paragraphs (c)(1) through (8) of this 
section until CMS identifies a TIN or TINs with which the QP is 
associated, and to which CMS will make the APM

[[Page 65682]]

Incentive Payment. If more than one TIN is identified at a step, the 
payment will be proportionately divided among the TINs according to the 
relative total paid amounts for Part B covered professional services 
paid to each TIN for services provided during the base year.
* * * * *

PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS, 
SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN 
CERTAIN SETTINGS

0
65. The authority citation for part 415 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.


0
66. Section 415.140 is added to subpart D to read as follows:


Sec.  415.140  Conditions for payment: Split (or shared) visits.

    (a) Definitions. For purposes of this section, the following 
definitions apply:
    Facility setting for purposes of this section means institutional 
settings in which payment for services and supplies furnished incident 
to a physician or practitioner's professional services is prohibited 
under Sec.  410.26(b)(1) of this subchapter.
    Split (or shared) visit means an evaluation and management (E/M) 
visit in the facility setting that is performed in part by both a 
physician and a nonphysician practitioner who are in the same group, in 
accordance with applicable law and regulations such that the service 
could be could be billed by either the physician or nonphysician 
practitioner if furnished independently by only one of them.
    Substantive portion means more than half of the total time spent by 
the physician and nonphysician practitioner performing the split (or 
shared) visit, except as otherwise provided in this paragraph. For 
visits other than critical care visits furnished in calendar year 2022, 
substantive portion means one of the three key components (history, 
exam or medical decision-making) or more than half of the total time 
spent by the physician and nonphysician practitioner performing the 
split (or shared) visit.
    (b) Conditions of payment. For purposes of this section, the 
following conditions of payment apply:
    (1) Substantive portion of split (or shared) visit. In general, 
payment is made to the physician or nonphysician practitioner who 
performs the substantive portion of the split (or shared) visit.
    (2) Medical record documentation. Documentation in the medical 
record must identify the physician and nonphysician practitioner who 
performed the visit. The individual who performed the substantive 
portion of the visit (and therefore bills for the visit) must sign and 
date the medical record.
    (3) Claim modifier. The designated modifier must be included on the 
claim to identify that the service was a split (or shared) visit.

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

0
67. 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
68. Amend Sec.  423.160 by revising paragraph (a)(5) to 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 (iv) 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. 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:
    (i) Prescriber and dispensing pharmacy are the same entity.
    (ii) Prescriber issues 100 or fewer controlled substance 
prescriptions for Part D drugs per calendar year as determined using 
CMS claims data as of December 31st of the preceding year.
    (iii) Prescriber has an NCPDP database address in the geographic 
area of an emergency or disaster declared by a Federal, State, or local 
government entity.
    (iv) Prescriber has received a CMS-approved waiver because the 
prescriber is unable to conduct electronic prescribing of controlled 
substances (EPCS) due to circumstances beyond the prescriber's control.
* * * * *

PART 424--CONDITIONS FOR MEDICARE PAYMENT

0
69. The authority for part 424 continues to read as follows:

    Authority: 42 U.S.C. 1302 and 1395hh.


0
70. Amend Sec.  424.205 by redesignating paragraphs (b)(5) and (6) as 
paragraphs (b)(6) and (7), respectively, and adding new paragraph 
(b)(5).
    The addition reads as follows:


Sec.  424.205  Requirements for Medicare Diabetes Prevention Program 
suppliers.

* * * * *
    (b) * * *
    (5) The Medicare provider enrollment application fee does not apply 
to all Medicare Diabetes Prevention Program (MDPP) suppliers that 
submit an enrollment application on or after January 1, 2022.
* * * * *

0
71. Amend Sec.  424.502 by revising the definition of ``Institutional 
provider'' to read as follows:


Sec.  424.502  Definitions.

* * * * *
    Institutional provider means any provider or supplier that submits 
a paper Medicare enrollment application using the CMS-855A, CMS-855B 
(not including physician and nonphysician practitioner organizations), 
CMS-855S, or an associated internet-based PECOS enrollment application.
* * * * *

0
72. Amend Sec.  424.530 by revising paragraphs (a)(2) introductory text 
and (a)(11)(i) to read as follows:


Sec.  424.530  Denial of enrollment in the Medicare program.

    (a) * * *
    (2) Provider or supplier conduct. The provider or supplier, or any 
owner, managing employee, 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, of the provider or supplier is--
* * * * *
    (11) * * *
    (i) A physician or other eligible professional's Drug Enforcement 
Administration (DEA) Certificate of Registration to dispense a 
controlled substance is currently suspended or revoked or is 
surrendered in response to an order to show cause;
* * * * *

0
 73. Amend Sec.  424.535 by revising paragraphs (a)(2) introductory 
text,

[[Page 65683]]

(a)(8)(ii), (a)(13)(i), and (e) to read as follows:


Sec.  424.535  Revocation of enrollment in the Medicare program.

    (a) * * *
    (2) Provider or supplier conduct. The provider or supplier, or any 
owner, managing employee, 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, of the provider or supplier is--
* * * * *
    (8) * * *
    (ii) 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:
    (A) The percentage of submitted claims that were denied during the 
period under consideration.
    (B) Whether the provider or supplier has any history of final 
adverse actions and the nature of any such actions.
    (C) The type of billing non-compliance and the specific facts 
surrounding said non-compliance (to the extent this can be determined).
    (D) Any other information regarding the provider or supplier's 
specific circumstances that CMS deems relevant to its determination.
* * * * *
    (13) * * *
    (i) A physician or other eligible professional's Drug Enforcement 
Administration (DEA) Certificate of Registration to dispense a 
controlled substance is currently suspended or revoked or is 
surrendered in response to an order to show cause;
* * * * *
    (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, 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 individual within 
30 days of the revocation notification.
* * * * *


Sec.  424.545  [Amended]

0
74. Amend Sec.  424.545 in paragraph (b) by removing the reference 
``Sec.  405.374'' and adding in its place the reference ``Sec.  
424.546''.

0
75. Add Sec.  424.546 to read as follows:


Sec.  424.546  Deactivation rebuttals.

    (a) Rebuttal submittal period. (1) If a provider or supplier 
receives written notice from CMS or its contractor that the provider's 
or supplier's billing privileges are to be or have been deactivated 
under Sec.  424.540, the provider or supplier has 15 calendar days from 
the date of the written notice to submit a rebuttal to CMS as permitted 
under Sec.  424.545(b).
    (2) CMS may, at its discretion, extend the 15-day time-period 
referenced in paragraph (a)(1) of this section.
    (b) Rebuttal requirements. A rebuttal submitted pursuant to this 
section and Sec.  424.545(b) must:
    (1) Be in writing.
    (2) Specify the facts or issues about which the provider or 
supplier disagrees with the deactivation's imposition and/or the 
effective date, and the reasons for disagreement.
    (3) Submit all documentation the provider or supplier wants CMS to 
consider in its review of the deactivation.
    (4) 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.
    (c) Waiver of rebuttal rights. The provider's or supplier's failure 
to submit a rebuttal that is both timely under paragraph (a) of this 
section and fully compliant with all of the requirements of paragraph 
(b) of this section constitutes a waiver of all rebuttal rights under 
this section and Sec.  424.545(b).
    (d) CMS review. Upon receipt of a timely and compliant deactivation 
rebuttal, CMS reviews the rebuttal to determine whether the imposition 
of the deactivation and/or the designated effective date are correct.
    (e) Imposition. Nothing in this section or in Sec.  424.545(b) 
requires CMS to delay the imposition of a deactivation pending the 
completion of the review described in paragraph (d) of this section.
    (f) Initial determination. A determination made under this section 
is not an initial determination under Sec.  498.3(b) of this chapter 
and therefore not appealable.

PART 425--MEDICARE SHARED SAVINGS PROGRAM

0
76. The authority citation for part 425 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.

0
77. Amend Sec.  425.116 by revising paragraph (c) to read as follows:


Sec.  425.116  Agreements with ACO participants and ACO providers/
suppliers.

* * * * *
    (c) Submission of agreements. The ACO must submit an executed ACO 
participant agreement for each ACO participant that it requests to add 
to its list of ACO participants in accordance with Sec.  425.118. The 
agreements may be submitted in the form and manner set forth in Sec.  
425.204(c)(6) or as otherwise specified by CMS.

0
78. Amend Sec.  425.204 by revising paragraphs (b), (c)(6), 
(f)(4)(ii)(A) and (B), (f)(4)(iii) introductory text, and 
(f)(4)(iii)(A) and adding paragraph (f)(4)(v) to read as follows:


Sec.  425.204  Content of the application.

* * * * *
    (b) Prior participation. Upon request by CMS during the application 
cycle, the ACO must submit information regarding prior participation in 
the Medicare Shared Savings Program by the ACO, its ACO participants, 
or its ACO providers/suppliers, including such information as may be 
necessary for CMS to determine whether to approve an ACO's application 
in accordance with Sec.  425.224(b).
    (c) * * *
    (6) Upon request by CMS during the application cycle or at any 
point during an agreement period, the ACO must submit documents 
demonstrating that its ACO participants, ACO providers/suppliers, and 
other individuals or entities performing functions or services related 
to ACO activities are required to comply with the requirements of the 
Shared Savings Program. Upon such a request, the evidence to be 
submitted must include, without limitation, sample or form agreements 
and, in the case of ACO participant agreements, the first and signature 
page(s) of each executed ACO participant agreement.

[[Page 65684]]

CMS may request all pages of an executed ACO participant agreement to 
confirm that it conforms to the sample form agreement submitted by the 
ACO. The ACO must certify that all of its ACO participant agreements 
comply with the requirements of this part.
* * * * *
    (f) * * *
    (4) * * *
    (ii) * * *
    (A) One-half percent of the total per capita Medicare Parts A and B 
fee-for-service expenditures for the ACO's assigned beneficiaries, 
based on expenditures and the number of assigned beneficiaries for the 
most recent calendar year for which 12 months of data are available.
    (B) One percent of the total Medicare Parts A and B fee-for-service 
revenue of its ACO participants, based on revenue for the most recent 
calendar year for which 12 months of data are available, and based on 
the ACO's number of assigned beneficiaries for the most recent calendar 
year for which 12 months of data are available.
    (iii) CMS recalculates the ACO's repayment mechanism amount for the 
second and each subsequent performance year in the agreement period in 
accordance with paragraph (f)(4)(ii) of this section based on the 
certified ACO participant list for the relevant performance year, 
except that the number of assigned beneficiaries used in the 
calculations is the number of beneficiaries assigned to the ACO at the 
beginning of the relevant performance year under Sec.  425.400(a)(2)(i) 
(for ACOs under preliminary prospective assignment with retrospective 
reconciliation) or Sec.  425.400(a)(3)(i) (for ACOs under prospective 
assignment).
    (A) If the recalculated repayment mechanism amount exceeds the 
existing repayment mechanism amount by at least $1,000,000, CMS 
notifies the ACO in writing that the amount of its repayment mechanism 
must be increased to the recalculated repayment mechanism amount.
* * * * *
    (v)(A) An ACO that established a repayment mechanism to support its 
participation in a two-sided model beginning on July 1, 2019, January 
1, 2020, or January 1, 2021, may elect to decrease the amount of its 
repayment mechanism if the repayment mechanism amount for performance 
year 2022, as recalculated pursuant to paragraph (f)(4)(iii) of this 
section, is less than the existing repayment mechanism amount.
    (B) CMS will notify the ACO in writing if the ACO may elect to 
decrease the amount of its repayment mechanism pursuant to this 
paragraph (f)(4)(v). The ACO must submit such election, and revised 
repayment mechanism documentation, in a form and manner and by a 
deadline specified by CMS. CMS will review the revised repayment 
mechanism documentation and may reject the election if the repayment 
mechanism documentation does not comply with the requirements of this 
paragraph (f).
* * * * *

0
79. Amend Sec.  425.312 by revising paragraph (a)(2)(ii) and adding 
paragraph (a)(2)(iii) to read as follows:


Sec.  425.312  Beneficiary notifications.

    (a) * * *
    (2) * * *
    (ii) In the case of an ACO that has selected preliminary 
prospective assignment with retrospective reconciliation, by the ACO or 
ACO participant providing each fee-for-service beneficiary with a 
standardized written notice prior to or at the first primary care visit 
of the performance year in the form and manner specified by CMS.
    (iii) In the case of an ACO that has selected prospective 
assignment, by the ACO or ACO participant providing each prospectively 
assigned beneficiary with a standardized written notice prior to or at 
the first primary care visit of the performance year in the form and 
manner specified by CMS.
* * * * *

0
80. Amend Sec.  425.400 by--
0
a. Revising paragraph (c)(1)(v) introductory text;
0
b. Adding paragraph (c)(1)(vi); and
0
c. Revising paragraphs (c)(2)(i) introductory text, (c)(2)(i)(A)(2), 
and (c)(2)(ii).
    The revisions and addition read as follows:


Sec.  425.400  General.

* * * * *
    (c) * * *
    (1) * * *
    (v) For the performance year starting on January 1, 2021:
* * * * *
    (vi) For the performance year starting on January 1, 2022, and 
subsequent performance years as follows:
    (A) CPT codes:
    (1) 96160 and 96161 (codes for administration of health risk 
assessment).
    (2) 99201 through 99215 (codes for office or other outpatient visit 
for the evaluation and management of a patient).
    (3) 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).
    (4) 99319 through 99340 (codes for patient domiciliary, rest home, 
or custodial care visit).
    (5) 99341 through 99350 (codes for evaluation and management 
services furnished in a patient's home for claims identified by place 
of service modifier 12).
    (6) 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)).
    (7) 99421, 99422, and 99423 (codes for online digital evaluation 
and management).
    (8) 99424, 99425, 99426, and 99427 (codes for principal care 
management services).
    (9) 99437, 99487, 99489, 99490 and 99491 (codes for chronic care 
management).
    (10) 99439 (code for non-complex chronic care management).
    (11) 99483 (code for assessment of and care planning for patients 
with cognitive impairment).
    (12) 99484, 99492, 99493 and 99494 (codes for behavioral health 
integration services).
    (13) 99495 and 99496 (codes for transitional care management 
services).
    (14) 99497 and 99498 (codes for advance care planning; services 
identified by these codes furnished in an inpatient setting are 
excluded).
    (B) HCPCS codes:
    (1) G0402 (code for the Welcome to Medicare visit).
    (2) G0438 and G0439 (codes for the annual wellness visits).
    (3) G0442 (code for alcohol misuse screening service).
    (4) G0443 (code for alcohol misuse counseling service).
    (5) G0444 (code for annual depression screening service).
    (6) G0463 (code for services furnished in ETA hospitals).
    (7) G0506 (code for chronic care management).
    (8) G2010 (code for the remote evaluation of patient video/images).
    (9) G2012 and G2252 (codes for virtual check-in).
    (10) G2058 (code for non-complex chronic care management).
    (11) G2064 and G2065 (codes for principal care management 
services).
    (12) G2212 (code for prolonged office or other outpatient visit for 
the evaluation and management of a patient).

[[Page 65685]]

    (13) G2214 (code for psychiatric collaborative care model).
    (C) 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 this section or a HCPCS code specified in paragraph 
(c)(1)(vi)(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 (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:
    (A) * * *
    (2) 99441, 99442, and 99443 (codes for telephone evaluation and 
management services). These codes are used in determining beneficiary 
assignment as specified in paragraphs (c)(2)(i) and (ii) of this 
section and until they are no longer payable under Medicare fee-for-
service payment policies as specified under section 1834(m) of the Act 
and Sec. Sec.  410.78 and 414.65 of this subchapter.
* * * * *
    (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 (as defined in Sec.  425.20), when the assignment 
window includes any month(s) during the COVID-19 Public Health 
Emergency defined in Sec.  400.200 of this chapter.

0
81. Amend Sec.  425.512 by--
0
a. Revising paragraphs (a)(2) and (3);
0
b. Redesignating paragraph (a)(4) as paragraph (a)(5);
0
c. Adding a new paragraph (a)(4);
0
d. Revising newly redesignated paragraph (a)(5); and
0
e. Revising paragraphs (b)(2)(i) and (ii) and (b)(3)(i) and (ii).
    The revisions and addition 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. 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 measures specified in this paragraph (a)(2) 
for the applicable performance year, the ACO will meet the quality 
performance standard.
    (i) For performance years 2022, 2023, and 2024. The ten CMS Web 
Interface measures or the three eCQMs/MIPS CQMs, and the CAHPS for MIPS 
survey.
    (ii) For performance year 2025 and subsequent performance years. 
The three eCQMs/MIPS CQMs and the CAHPS for MIPS survey.
    (3) For performance year 2021. (i) Except as specified in paragraph 
(a)(2) of this section, CMS designates the quality performance standard 
as the ACO reporting quality data via the APP established under Sec.  
414.1367 of this subchapter, according to the method of submission 
established by CMS and achieving a quality performance score that is 
equivalent to or higher than the 30th percentile across all MIPS 
Quality performance category scores, excluding entities/providers 
eligible for facility-based scoring.
    (ii) If an ACO does not report any of the ten CMS Web Interface 
measures or any of the three eCQMs/MIPS CQMs and does not administer a 
CAHPS for MIPS survey under the APP, the ACO will not meet the quality 
performance standard.
    (4) For performance years 2022 and 2023. (i) Except as specified in 
paragraph (a)(2) of this section, CMS designates the quality 
performance standard as the ACO reporting quality data via the APP 
established under Sec.  414.1367 of this subchapter according to the 
method of submission established by CMS and either:
    (A) Achieving a quality performance score that is equivalent to or 
higher than the 30th percentile across all MIPS Quality performance 
category scores, excluding entities/providers eligible for facility-
based scoring, or
    (B) 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 and the case minimum requirement at Sec.  414.1380 of 
this subchapter for all three eCQMs/MIPS CQMs, 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 30th percentile of the performance benchmark on at 
least one of the remaining five measures in the APP measure set.
    (ii) If an ACO does not report any of the ten CMS Web Interface 
measures or any of the three eCQMs/MIPS CQMs and does not administer a 
CAHPS for MIPS survey under the APP, the ACO will not meet the quality 
performance standard.
    (5) For performance year 2024 and subsequent performance years. (i) 
Except as specified in paragraph (a)(2) of this section, CMS designates 
the quality performance standard as the ACO reporting quality data via 
the APP established under Sec.  414.1367 of this subchapter, according 
to the method of submission established by CMS and achieving a 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.
    (ii) If an ACO does not report any of the three eCQMs/MIPS CQMs and 
does not administer a CAHPS for MIPS survey under the APP, the ACO will 
not meet the quality performance standard.
    (b) * * *
    (2) * * *
    (i) For performance years 2021, 2022, and 2023, the ACO's minimum 
quality performance score is set to 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 2024 and subsequent performance years, 
the ACO's minimum quality performance score is set to 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.
    (3) * * *
    (i) For performance years 2021, 2022, and 2023, CMS will use the 
higher of the ACO's quality performance score or the equivalent of the 
30th percentile MIPS Quality performance category score across all MIPS 
Quality performance category scores, excluding entities/providers 
eligible for facility-based scoring, for the relevant performance year.
    (ii) For performance year 2024 and subsequent performance years, 
CMS will use the higher of the ACO's quality performance score or the 
equivalent of the 40th percentile MIPS Quality performance category 
score across all MIPS Quality performance category

[[Page 65686]]

scores, excluding entities/providers eligible for facility-based 
scoring, for the relevant performance year.
* * * * *

Xavier Becerra,
Secretary, Department of Health and Human Services.

    Note:  The following appendices will not appear in the Code of 
Federal Regulations.

BILLING CODE 4120-01-P

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[FR Doc. 2021-23972 Filed 11-2-21; 8:45 am]
BILLING CODE 4120-01-P