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; Provider and Supplier Prepayment and Post-Payment Medical Review Requirements., 39104-39907 [2021-14973]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Proposed Rules]
[Pages 39104-39907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14973]



[[Page 39103]]

Vol. 86

Friday,

No. 139

July 23, 2021

Part II

Book 2 of 2 Books

Pages 39103-39938





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Parts 403, 405, 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; 
Provider and Supplier Prepayment and Post-Payment Medical Review 
Requirements; Proposed Rule

Federal Register / Vol. 86 , No. 139 / Friday, July 23, 2021 / 
Proposed Rules

[[Page 39104]]


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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-P]
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; Provider and Supplier Prepayment and Post-Payment Medical 
Review Requirements.

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

ACTION: Proposed rule.

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SUMMARY: This major proposed rule addresses: Changes to the physician 
fee schedule (PFS); other changes to Medicare Part B payment policies 
to ensure that payment systems are updated to reflect changes in 
medical practice, relative value of services, and changes in the 
statute; 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: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on September 13, 
2021.

ADDRESSES: In commenting, please refer to file code CMS-1751-P. 
Comments, including mass comment submissions, must be submitted in one 
of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to https://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1751-P, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1751-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

FOR FURTHER INFORMATION CONTACT: 
    [email protected], for any issues not 
identified below.
    Michael Soracoe, (410) 786-6312, 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.
    Donta Henson, (410) 786-1947, 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, for issues related to split (or 
shared) services.
    Christiane LaBonte, (410) 786-7237, for issues related to indirect 
practice expense, PFS payment for critical care services, and PFS 
payment for teaching physician services.
    [email protected], 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.
    Pamela West, (410) 786-2302, for issues related to PFS payment for 
therapy services, medical nutrition therapy services, and services of 
registered dieticians and nutrition professionals.
    Liane Grayson, (410) 786-6583, and Donta Henson, (410) 786-1947, 
for issues related to coinsurance for certain colorectal cancer 
screening services.
    Lisa Parker, (410) 786-4949, 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 select 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.
    Fiona Larbi, (410) 786-7224, for issues related to the Medicare 
Shared Savings Program (Shared Savings Program) Quality performance 
standard and quality reporting requirements.
    Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518, 
or [email protected], for issues related to Shared 
Savings Program beneficiary assignment, 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.
    Thomas J. Kessler, (410) 786-1991, 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.

[[Page 39105]]

    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: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that website to 
view public comments. CMS will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the individual will take actions to harm the individual. CMS 
continues to encourage individuals not to submit duplicative comments. 
We will post acceptable comments from multiple unique commenters even 
if the content is identical or nearly identical to other comments.
    Addenda Available Only Through the Internet on the CMS Website: The 
PFS Addenda along with other supporting documents and tables referenced 
in this proposed rule are available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. 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 proposed rule, refer to item CMS-1751-P. Readers with 
questions related to accessing any of the Addenda or other supporting 
documents referenced in this proposed rule and posted on the CMS 
website identified above should contact 
[email protected].
    CPT (Current Procedural Terminology) Copyright Notice: Throughout 
this proposed rule, we use CPT codes and descriptions to refer to a 
variety of services. We note that CPT codes and descriptions are 
copyright 2020 American Medical Association. All Rights Reserved. CPT 
is a registered trademark of the American Medical Association (AMA). 
Applicable Federal Acquisition Regulations (FAR) and Defense Federal 
Acquisition Regulations (DFAR) apply.

I. Executive Summary

    This major proposed rule proposes to revise payment polices under 
the Medicare PFS and makes other policy changes, including proposals to 
implement certain provisions of the Consolidated Appropriations Act, 
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 (SUPPORT) for Patients and Communities Act (the SUPPORT 
Act) (Pub. L. 115-271, October 24, 2018), related to Medicare Part B 
payment. In addition, this major proposed rule includes proposals 
regarding other Medicare payment policies described in sections III. 
and IV.

A. 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 proposed rule, we are proposing to establish 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 proposed rule also includes 
discussions and provisions regarding several other Medicare Part B 
payment policies.
    Specifically, this proposed 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 Select 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.)
     Response to Comments (section VI.)
     Regulatory Impact Analysis (section VII.)

[[Page 39106]]

3. Summary of Costs and Benefits
    We have determined that this proposed rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VII., Regulatory Impact Analysis, of this proposed rule.

II. Provisions of the Proposed Rule for the PFS

A. Background

    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 relative value 
units (RVUs) into payment rates. The concepts and methodology 
underlying the PFS were enacted as part of the Omnibus Budget 
Reconciliation Act of 1989 (OBRA '89) (Pub. L. 101-239, December 19, 
1989), and the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) 
(Pub. L. 101-508, November 5, 1990). The final rule published in the 
November 25, 1991 Federal Register (56 FR 59502) set forth the first 
fee schedule used for payment for physicians' services.
    We note that throughout this proposed rule, unless otherwise noted, 
the term ``practitioner'' is used to describe both physicians and 
nonphysician practitioners (NPPs) who are permitted to bill Medicare 
under the PFS for the services they furnish to Medicare beneficiaries.
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 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

[[Page 39107]]

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 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 Budget Neutrality to Adjustments of RVUs
    As described in section VII. of this proposed 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 will 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,

[[Page 39108]]

nationally representative, PE survey of both physicians and NPPs paid 
under the PFS using a survey instrument and methods highly consistent 
with those used for the SMS and the supplemental surveys. The PPIS 
gathered information from 3,656 respondents across 51 physician 
specialty and health care professional groups. We believe the PPIS is 
the most comprehensive source of PE survey information available. We 
used the PPIS data to update the PE/HR data for the CY 2010 PFS for 
almost all of the Medicare-recognized specialties that participated in 
the survey.
    When we began using the PPIS data in CY 2010, we did not change the 
PE RVU methodology itself or the manner in which the PE/HR data are 
used in that methodology. We only updated the PE/HR data based on the 
new survey. Furthermore, as we explained in the CY 2010 PFS final rule 
with comment period (74 FR 61751), because of the magnitude of payment 
reductions for some specialties resulting from the use of the PPIS 
data, we transitioned its use over a 4-year period from the previous PE 
RVUs to the PE RVUs developed using the new PPIS data. As provided in 
the CY 2010 PFS final rule with comment period (74 FR 61751), the 
transition to the PPIS data was complete for CY 2013. Therefore, PE 
RVUs from CY 2013 forward are developed based entirely on the PPIS 
data, except as noted in this section.
    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical 
oncology supplemental survey data submitted in 2003 for oncology drug 
administration services. Therefore, the PE/HR for medical oncology, 
hematology, and hematology/oncology reflects the continued use of these 
supplemental survey data.
    Supplemental survey data on independent labs from the College of 
American Pathologists were implemented for payments beginning in CY 
2005. Supplemental survey data from the National Coalition of Quality 
Diagnostic Imaging Services (NCQDIS), representing independent 
diagnostic testing facilities (IDTFs), were blended with supplementary 
survey data from the American College of Radiology (ACR) and 
implemented for payments beginning in CY 2007. Neither IDTFs, nor 
independent labs, participated in the PPIS. Therefore, we continue to 
use the PE/HR that was developed from their supplemental survey data.
    Consistent with our past practice, the previous indirect PE/HR 
values from the supplemental surveys for these specialties were updated 
to CY 2006 using the Medicare Economic Index (MEI) to put them on a 
comparable basis with the PPIS data.
    We also do not use the PPIS data for reproductive endocrinology and 
spine surgery since these specialties currently are not separately 
recognized by Medicare, nor do we have a method to blend the PPIS data 
with Medicare-recognized specialty data.
    Previously, we established PE/HR values for various specialties 
without SMS or supplemental survey data by crosswalking them to other 
similar specialties to estimate a proxy PE/HR. For specialties that 
were part of the PPIS for which we previously used a crosswalked PE/HR, 
we instead used the PPIS-based PE/HR. We use crosswalks for specialties 
that did not participate in the PPIS. These crosswalks have been 
generally established through notice and comment rulemaking and are 
available in the file titled ``CY 2022 PFS proposed rule PE/HR'' on the 
CMS website under downloads for the CY 2022 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/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 are 
proposing 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 proposed rule PE/
HR'' file available on the CMS website under the supporting data files 
for the CY 2022 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Allocation of PE to Services
    To establish PE RVUs for specific services, it is necessary to 
establish the direct and indirect PE associated with each service.
(1) Direct Costs
    The relative relationship between the direct cost portions of the 
PE RVUs for any two services is determined by the relative relationship 
between the sum of the direct cost resources (that is, the clinical 
staff, medical supplies, and medical equipment) typically involved with 
furnishing each of the services. The costs of these resources are 
calculated from the refined direct PE inputs in our PE database. For 
example, if one service has a direct cost sum of $400 from our PE 
database and another service has a direct cost sum of $200, the direct 
portion of the PE RVUs of the first service would be twice as much as 
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
    We allocate the indirect costs at the code level based on the 
direct costs specifically associated with a code and the greater of 
either the clinical labor costs or the work RVUs. We also incorporate 
the survey data described earlier in the PE/HR discussion. The general 
approach to developing the indirect portion of the PE RVUs is as 
follows:
     For a given service, we use the direct portion of the PE 
RVUs calculated as previously described and the average percentage that 
direct costs represent of total costs (based on survey data) across the 
specialties that furnish the service to determine an initial indirect 
allocator. That is, the initial indirect allocator is calculated so 
that the direct costs equal the average percentage of direct costs of 
those specialties furnishing the service. For example, if the direct 
portion of the PE RVUs for a given service is 2.00 and direct costs, on 
average, represent 25 percent of total costs for the specialties that 
furnish the service, the initial indirect allocator would be calculated 
so that it equals 75 percent of the total PE RVUs. Thus, in this 
example, the initial indirect allocator would equal 6.00, resulting in 
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 
percent of 8.00).
     Next, we add the greater of the work RVUs or clinical 
labor portion of the direct portion of the PE RVUs to this initial 
indirect allocator. In our example, if this service had a work RVU of 
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we 
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 
clinical labor portion) to the initial indirect allocator of 6.00 to 
get an indirect allocator of 10.00. In the absence of any further use 
of the survey data, the relative relationship between the indirect cost 
portions of the PE RVUs for any two services would be determined by the 
relative relationship between these indirect cost allocators. For 
example, if one service had an indirect cost allocator of 10.00 and 
another service had an indirect cost allocator of 5.00,

[[Page 39109]]

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 proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file 
contains a table that illustrates the calculation of PE RVUs as 
described in this proposed rule for individual codes.
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty-specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service.
    Step 2: Calculate the aggregate pool of direct PE costs for the 
current year. We set the aggregate pool of PE costs equal to the 
product of the ratio of the current aggregate PE RVUs to current 
aggregate work RVUs and the projected aggregate work RVUs.
    Step 3: Calculate the aggregate pool of direct PE costs for use in 
ratesetting. This is the product of the aggregate direct costs for all 
services from Step 1 and the utilization data for that service.
    Step 4: Using the results of Step 2 and Step 3, use the CF to 
calculate a direct PE scaling adjustment to ensure that the aggregate 
pool of direct PE costs calculated in Step 3 does not vary from the 
aggregate pool of direct PE costs for the current year. Apply the 
scaling adjustment to the direct costs for each service (as calculated 
in Step 1).
    Step 5: Convert the results of Step 4 to a 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 59283) a 
policy to apply these service-level overrides for both PE and MP, 
rather than one or the other category.
    Step 8: Calculate the service level allocators for the indirect PEs 
based on the percentages calculated in Step 7. The indirect PEs are 
allocated based on the three components: the direct PE RVUs; the 
clinical labor PE RVUs; and the work RVUs.
    For most services the indirect allocator is: Indirect PE percentage 
* (direct PE RVUs/direct percentage) + work RVUs.
    There are two situations where this formula is modified:
     If the service is a global service (that is, a service 
with global, professional, and technical components), then the indirect 
PE allocator is: Indirect percentage (direct PE RVUs/direct percentage) 
+ clinical labor PE RVUs + work RVUs.
     If the clinical labor PE RVUs exceed the work RVUs (and 
the service is not a global service), then the indirect

[[Page 39110]]

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 
budget neutrality. (See ``Specialties excluded from ratesetting 
calculation'' later in this final rule.)
    Step 19: Apply the phase-in of significant RVU reductions and its 
associated adjustment. Section 1848(c)(7) of the Act specifies that for 
services that are not new or revised codes, if the total RVUs for a 
service for a year would otherwise be decreased by an estimated 20 
percent or more as compared to the total RVUs for the previous year, 
the applicable adjustments in work, PE, and MP RVUs shall be phased in 
over a 2-year period. In implementing the phase-in, we consider a 19 
percent reduction as the maximum 1-year reduction for any service not 
described by a new or revised code. This approach limits the year one 
reduction for the service to the maximum allowed amount (that is, 19 
percent), and then phases in the remainder of the reduction. To comply 
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure 
that the total RVUs for all services that are not new or revised codes 
decrease by no more than 19 percent, and then apply a relativity 
adjustment to ensure that the total pool of aggregate PE RVUs remains 
relative to the pool of work and MP RVUs. For a more detailed 
description of the methodology for the phase-in of significant RVU 
changes, we refer readers to the CY 2016 PFS final rule with comment 
period (80 FR 70927 through 70931).
(e) Setup File Information
     Specialties excluded from ratesetting calculation: For the 
purposes of calculating the PE and MP RVUs, we exclude certain 
specialties, such as certain NPPs paid at a percentage of the PFS and 
low-volume specialties, from the calculation. These specialties are 
included for the purposes of calculating the BN adjustment. They are 
displayed in Table 1.
BILLING CODE 4120-01-P

[[Page 39111]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.000

     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 2 details the manner in which the 
modifiers are applied.

[[Page 39112]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.001

BILLING CODE 4120-01-C
    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 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)[and] life of equipment)))) + maintenance)

Where:

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

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

[[Page 39113]]

    In the CY 2021 PFS final rule, we finalized a proposal to treat 
equipment life durations of less than 1 year as having a duration of 1 
year for the purpose of our equipment price per minute formula. In the 
rare cases where items are replaced every few months, we noted that we 
believe it is more accurate to treat these items as disposable supplies 
with a fractional supply quantity as opposed to equipment items with 
very short equipment life durations. For a more detailed discussion of 
the methodology associated with very short equipment life durations, we 
refer readers to the CY 2021 PFS final rule (85 FR 84482 through 
84483).
     Maintenance: We finalized the 5 percent factor for annual 
maintenance in the CY 1998 PFS final rule with comment period (62 FR 
33164). As we previously stated in the CY 2016 PFS final rule with 
comment period (80 FR 70897), we do not believe the annual maintenance 
factor for all equipment is precisely 5 percent, and we concur that the 
current rate likely understates the true cost of maintaining some 
equipment. We also noted that we believe it likely overstates the 
maintenance costs for other equipment. When we solicited comments 
regarding sources of data containing equipment maintenance rates, 
commenters were unable to identify an auditable, robust data source 
that could be used by CMS on a wide scale. We noted that we did not 
believe voluntary submissions regarding the maintenance costs of 
individual equipment items would be an appropriate methodology for 
determining costs. As a result, in the absence of publicly available 
datasets regarding equipment maintenance costs or another systematic 
data collection methodology for determining a different maintenance 
factor, we did not propose a variable maintenance factor for equipment 
cost per minute pricing as we did not believe that we have sufficient 
information at present. We noted that we would continue to investigate 
potential avenues for determining equipment maintenance costs across a 
broad range of equipment items.
     Interest Rate: In the CY 2013 PFS final rule with comment 
period (77 FR 68902), we updated the interest rates used in developing 
an equipment cost per minute calculation (see 77 FR 68902 for a 
thorough discussion of this issue). The interest rate was based on the 
Small Business Administration (SBA) maximum interest rates for 
different categories of loan size (equipment cost) and maturity (useful 
life). The Interest rates are listed in Table 3.
[GRAPHIC] [TIFF OMITTED] TP23JY21.002

    We are not proposing 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 
proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
    As we noted in the CY 2015 PFS final rule with comment period (79 
FR 67640 through 67641), we continue to make improvements to the direct 
PE input database to provide the number of clinical labor minutes 
assigned for each task for every code in the database instead of only 
including the number of clinical labor minutes for the preservice, 
service, and post service periods for each code. In addition to 
increasing the transparency of the information used to set PE RVUs, 
this level of detail would allow us to compare clinical labor times for 
activities associated with services across the PFS, which we believe is 
important to maintaining the relativity of the direct PE inputs. This 
information would facilitate the identification of the usual numbers of 
minutes for clinical labor tasks and the identification of exceptions 
to the usual values. It would also allow for greater transparency and 
consistency in the assignment of equipment minutes based on clinical 
labor times. Finally, we believe that the detailed information can be 
useful in maintaining standard times for particular clinical labor 
tasks that can be applied consistently to many codes as they are valued 
over several years, similar in principle to the use of physician 
preservice time packages. We believe that setting and maintaining such 
standards would provide greater consistency among codes that share the 
same clinical labor tasks and could improve relativity of values among 
codes. For example, as medical practice and technologies change over 
time, changes in the standards could be updated simultaneously for all 
codes with the applicable clinical labor tasks, instead of waiting for 
individual codes to be reviewed.
    In the CY 2016 PFS final rule with comment period (80 FR 70901), we 
solicited comments on the appropriate standard minutes for the clinical 
labor tasks associated with services that use digital technology. After 
consideration of comments received, we finalized standard times for 
clinical labor tasks associated with digital imaging at 2 minutes for 
``Availability of prior images confirmed'', 2 minutes for ``Patient 
clinical information and questionnaire reviewed by technologist, order 
from physician confirmed and exam protocoled by radiologist'', 2 
minutes for ``Review examination with interpreting MD'', and 1 minute 
for ``Exam documents scanned into PACS'' and ``Exam completed in RIS 
system to generate billing process and to populate images into 
Radiologist work queue.'' In the CY 2017 PFS final rule (81 FR 80184 
through 80186), we finalized a policy to establish a range of 
appropriate standard minutes for the clinical labor activity, 
``Technologist QCs images in PACS, checking for all images, reformats, 
and dose page.'' These standard minutes will be applied to new and 
revised

[[Page 39114]]

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, a 
commenter expressed concern with the published list of common 
refinements to equipment time. The commenter stated that these 
refinements were the formulaic result of the applying refinements to 
the clinical labor time and did not constitute separate refinements; 
the commenter requested that CMS no longer include these refinements in 
the table published each year. In the CY 2020 PFS final rule, we agreed 
with the commenter that these equipment time refinements did not 
reflect errors in the equipment recommendations or policy discrepancies 
with the RUC's equipment time recommendations. However, we believed 
that it was important to publish the specific equipment times that we 
were proposing (or finalizing in the case of the final rule) when they 
differed from the recommended values due to the effect that these 
changes can have on the direct costs associated with equipment time. 
Therefore, we finalized the separation of the equipment time 
refinements associated with changes in clinical labor into a separate 
table of refinements. For additional details, we direct readers to the 
discussion in the CY 2020 PFS final rule (84 FR 62584).
    Historically, the RUC has submitted a ``PE worksheet'' that details 
the recommended direct PE inputs for our use in developing PE RVUs. The 
format of the PE worksheet has varied over time and among the medical 
specialties developing the recommendations. These variations have made 
it difficult for both the RUC's development and our review of code 
values for individual codes. Beginning with its recommendations for CY 
2019, the RUC has mandated the use of a new PE worksheet for purposes 
of their recommendation development process that standardizes the 
clinical labor tasks and assigns them a clinical labor activity code. 
We believe the RUC's use of the new PE worksheet in developing and 
submitting recommendations will help us to simplify and standardize the 
hundreds of different clinical labor tasks currently listed in our 
direct PE database. As we did in previous calendar years, to facilitate 
rulemaking for CY 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 proposed rule at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
b. Technical Corrections to Direct PE Input Database and Supporting 
Files
    For CY 2022, we are proposing 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

[[Page 39115]]

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 are addressing this issue for CY 2022 by proposing to assign all 
claims data associated with CPT codes 97165-97167 to the occupational 
therapy specialty. This should ensure that CPT codes 97165-97167 would 
always receive the same indirect PE allocation as well as preventing 
any fluctuations to the indirect practice cost index for the wider 
occupational therapy specialty. This proposal 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 are soliciting public comments 
regarding this proposal, and specifically on what commenters suggest as 
the most appropriate method of assigning indirect PE allocation for 
these services.
     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 their concern 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 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 are proposing to maintain the currently assigned 
physician specialty for indirect PE allocation for HCPCS codes G2082 
and G2083. We are proposing 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 are soliciting 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 request 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.
     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 are 
proposing to update the intraservice work time to 90 minutes to match 
the survey results.

[[Page 39116]]

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 are proposing 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 16: 
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 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/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 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-

[[Page 39117]]

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 4.
[GRAPHIC] [TIFF OMITTED] TP23JY21.003

    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 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 a 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

[[Page 39118]]

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 are proposing to update the prices of six supply 
items listed in the valuation of specific codes section of the preamble 
under Table 16: 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 16 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 are proposing 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 proposed price of 
$0.051 would 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 are not proposing to update the price. We believe that the 
submitted invoices confirm that the current pricing of $625.00 is 
typical for the SD343 supply.
(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 proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/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 are proposing 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 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 are soliciting any additional information 
that commenters can supply that CMS should consider to establish 
national payment for HCPCS code G0460.
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

[[Page 39119]]

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 are proposing 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 are proposing 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 5 lists our proposed 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 
5.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TP23JY21.004

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

[[Page 39121]]

would 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 are also 
proposing 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 are soliciting comments on the proposed updated clinical labor 
pricing. We are 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 appreciate any additional information 
that commenters can 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:
BILLING CODE 4120-01-P

[[Page 39122]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.005


[[Page 39123]]


[GRAPHIC] [TIFF OMITTED] TP23JY21.006

BILLING CODE 4120-01-C
    The potential effects of the clinical labor pricing update on 
specialty payment impacts are 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 has 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 have 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 are 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 emphasize that these are not the projected impacts by 
specialty of all the policies we are proposing in this 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 VII.I) of this rule.
e. Proposal To Establish 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 public health 
emergency (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. The following 
section will discuss proposed policies to establish RVUs for CPT code 
92229, solicit 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 solicit 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

[[Page 39124]]

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 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 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 are proposing 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 are proposing 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 are 
proposing 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 are also soliciting 
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 proposed rule, we are proposing to use our crosswalk approach for 
CPT code 77X01 (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 77X03 
(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 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

[[Page 39125]]

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 
hospital outpatient department setting under the Outpatient Prospective 
Payment System (OPPS) in CY 2018 (82 FR 59284). For the PFS, we 
typically assign contractor pricing for Category III codes since they 
are temporary codes assigned to emerging technology and services. 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/PhysicianFeeSched/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 hospital 
outpatient departments 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 technical component because CPT code 0503T is a technical 
component-only service, and that have similar total costs to CPT code 
0503T. We identified the following potential crosswalks, and seek 
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 are also seeking comment on whether other codes would 
provide a more appropriate crosswalk in terms of resource costs.
    We are also more broadly soliciting 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. Specifically, we are requesting commenters consider 
the following questions:
     To what extent are services involving innovative 
technologies such as software algorithms and/or AI substitutes and/or 
supplements for physician work? To what extent do these services 
involving innovative technology inform, augment, or replace physician 
work? For example, CPT code 92229 is a PE-only code in which the 
software algorithm may be substituting for some work of an 
ophthalmologist to diagnose/detect diabetic retinopathy. CPT code 77X01 
is a service in which the trabecular bone score software may be 
supplementing physician work to predict and detect fracture risk. CPT 
code 0503T may be both substituting for, and supplementing physician 
work to detect coronary artery disease.
     How has innovative technology such as software algorithms 
and/or AI affected physician work time and intensity of furnishing 
services involving the use of such technology to Medicare 
beneficiaries? For example, if a new software algorithm or AI 
technology for a diagnostic test results in a reduction in the amount 
of time that a practitioner spends reviewing and interpreting the 
results of a diagnostic test that previously did not involve such 
software algorithm or AI technology, and if the software algorithm or 
AI could be considered in part a substitute for at least some physician 
work, it may follow that the intensity of the service decreases. It is 
also possible that a software algorithm for a diagnostic test that is 
supplementing other tests to establish a diagnosis or treatment pathway 
for a particular condition could result in an increase in the amount of 
time that a practitioner spends explaining the test to a patient and 
then reviewing the results.
     How is innovative technology such as software algorithms 
and/or AI changing cost structures in the physician office setting? As 
discussed previously, the PPIS data that underlie the PE methodology 
were last collected in 2007 and 2008, which was prior to the widespread 
adoption of electronic health records and services that involve care 
management, non-face-to-face and/or asynchronous remote care; the need 
to use electronic clinical quality measure data to support quality 
improvement, disparity identification and resolution, and value based 
payment; and the emergence of software algorithms and/or AI and other 
technologies that use data to inform, augment, or replace physician 
work in the delivery of health care. Do costs for innovative technology 
such as software algorithms and/or AI to furnish services to patients 
involve a one-time investment and/or recurring costs? How should CMS 
consider costs for software algorithms and/or AI that use patient data 
that were previously collected as part of another service? As 
technology adoption grows, do these costs decrease over time?
     How is innovative technology affecting beneficiary access 
to Medicare-covered services? How are services involving software 
algorithms and/or AI being furnished to Medicare beneficiaries and what 
is important for

[[Page 39126]]

CMS to understand as it considers how to accurately pay for services 
involving software algorithms and/or AI? For example, it is possible 
that services that involve software algorithms and/or AI may allow a 
practitioner to more efficiently furnish care to more Medicare 
beneficiaries, potentially increasing access to care. Additionally, to 
what extent have services that involve innovative technology such as 
software algorithms and/or AI affected access to Medicare-covered 
services in rural and/or underserved areas, or for beneficiaries that 
may face barriers (homelessness, lack of access to transportation, 
lower levels of health literacy, lower rates of internet access, mental 
illness, having a high number of chronic conditions/frailty, etc.) in 
obtaining health care?
     Compared to other services paid under the PFS, are 
services that are driven by or supported by innovative technology such 
as software algorithms and/or AI at greater risk of overutilization or 
more subject to fraud, waste, and abuse? As we are considering 
appropriate payment for services enabled by new technologies, there are 
considerations for program integrity. For example, section 218(b) of 
the PAMA required that we establish an Appropriate Use Criteria Program 
to promote appropriate use of advanced diagnostic imaging services 
provided to Medicare beneficiaries.\1\ To what extent do services 
involving innovative technology require mechanisms such as appropriate 
use criteria to guard against overutilization, fraud, waste, or abuse?
---------------------------------------------------------------------------

    \1\ Appropriate Use Criteria Program. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program.
---------------------------------------------------------------------------

     Compared to other services paid under the PFS, are 
services driven by or supported by innovative technology such as 
software algorithms and/or AI associated with improvements in the 
quality of care or improvements in health equity? For example, 
increased access to services to detect diabetic retinopathy such as the 
service described by CPT code 92229 could eventually lead to fewer 
beneficiaries losing their vision. Because CPT code 92229 can be 
furnished in a primary care practice's office and may not require the 
specialized services of an ophthalmologist, more beneficiaries could 
have access to a test, including those who live in areas with fewer 
ophthalmologists. Additionally, taking into consideration that a 
software algorithm and/or AI may introduce bias into clinical decision 
making that could influence outcomes for racial and ethnic minorities 
and people who are socioeconomically disadvantaged, are there 
guardrails, such as removing the source of bias in a software algorithm 
and/or AI, that Medicare should require as part of considering payment 
amounts for services enabled by software algorithm and/or AI?
     Our proposals to use crosswalks to set values for codes 
describing diabetic retinopathy and trabecular bone score would allow 
us to account for overall resource costs involved in furnishing the 
services. The possible crosswalks for FFRCT may also account for 
overall resource costs involved in furnishing the service. We also 
believe it is important to accurately account for resource costs for 
innovative and emerging technologies such as ongoing service-specific 
software costs and, as explained above, such costs are not well 
accounted for in the PE methodology. We continue to be interested in 
potentially refining the PE methodology and updating the underlying 
data, including the PPIS data that are the data source that underpins 
the indirect PE allocation. How might CMS consider updating such data 
to reflect ongoing advances in technology so that we could establish 
appropriate relative values without resorting to crosswalks? The RAND 
Corporation laid out a number of issues for CMS to consider in two 
reports. We refer readers to RAND's first phase of research, available 
at https://www.rand.org/pubs/research_reports/RR2166.html, and RAND's 
second phase of research, available at https://www.rand.org/pubs/research_reports/RR3248.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 proposed 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), the Medicare Payment Advisory Commission 
(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 (https://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

[[Page 39127]]

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 (https://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since 
MedPAC made the initial recommendations, CMS and the RUC have taken 
several steps to improve the review process. Also, section 
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the 
Secretary to specifically examine, as determined appropriate, 
potentially misvalued services in the following categories:
     Codes that have experienced the fastest growth.
     Codes that have experienced substantial changes in PE.
     Codes that describe new technologies or services within an 
appropriate time-period (such as 3 years) after the relative values are 
initially established for such codes.
     Codes which are multiple codes that are frequently billed 
in conjunction with furnishing a single service.
     Codes with low relative values, particularly those that 
are often billed multiple times for a single treatment.
     Codes that have not been subject to review since 
implementation of the fee schedule.
     Codes that account for the majority of spending under the 
PFS.
     Codes for services that have experienced a substantial 
change in the hospital length of stay or procedure time.
     Codes for which there may be a change in the typical site 
of service since the code was last valued.
     Codes for which there is a significant difference in 
payment for the same service between different sites of service.
     Codes for which there may be anomalies in relative values 
within a family of codes.
     Codes for services where there may be efficiencies when a 
service is furnished at the same time as other services.
     Codes with high intraservice work per unit of time.
     Codes with high PE RVUs.
     Codes with high cost supplies.
     Codes as determined appropriate by the Secretary.
    Section 1848(c)(2)(K)(iii) of the Act also specifies that the 
Secretary may use existing processes to receive recommendations on the 
review and appropriate adjustment of potentially misvalued services. In 
addition, the Secretary may conduct surveys, other data collection 
activities, studies, or other analyses, as the Secretary determines to 
be appropriate, to facilitate the review and appropriate adjustment of 
potentially misvalued services. This section also authorizes the use of 
analytic contractors to identify and analyze potentially misvalued 
codes, conduct surveys or collect data, and make recommendations on the 
review and appropriate adjustment of potentially misvalued services. 
Additionally, this section provides that the Secretary may coordinate 
the review and adjustment of any RVU with the periodic review described 
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of 
the Act specifies that the Secretary may make appropriate coding 
revisions (including using existing processes for consideration of 
coding changes) that may include consolidation of individual services 
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
    To fulfill our statutory mandate, we have identified and reviewed 
numerous potentially misvalued codes as specified in section 
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work 
examining potentially misvalued codes in these areas over the upcoming 
years. As part of our current process, we identify potentially 
misvalued codes for review, and request recommendations from the RUC 
and other public commenters on revised work RVUs and direct PE inputs 
for those codes. The RUC, through its own processes, also identifies 
potentially misvalued codes for review. Through our public nomination 
process for potentially misvalued codes established in the CY 2012 PFS 
final rule with comment period, 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

[[Page 39128]]

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.
     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 this proposed rule, we are soliciting comments regarding the 
potentially misvalued codes nominated by the public to inform our 
decision on whether to establish the codes as potentially misvalued in 
the CY 2022 PFS final rule. We received public nominations for 
potentially misvalued codes by February 10th. We display these public 
nominations on our public website, including the submitter's name and 
their associated organization to provide full transparency. Among the 
public nominations that we received this year, one was a request for 
CMS to review a PE-related input for a code. We refer readers to 
section II.B. of this proposed rule, Determination of PE RVUs, for 
further discussion on the PE-related submission. The summary of this 
year's submissions under the potentially misvalued code initiative are 
discussed below.
    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

[[Page 39129]]

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 that any of the 
codes identified as common related services are misvalued. Therefore, 
we are not inclined to propose this code as potentially misvalued. 
However, we welcome additional 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 ambulatory surgical center (ASC) setting. We are not inclined 
to propose this code as potentially misvalued; however, we welcome 
additional 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. There is no case presented here 
that constitutes a misvaluation of CPT code 55880, and therefore, we 
are not inclined to put this code forward as potentially misvalued for 
CY 2022; however, we welcome additional 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 now submits 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 
welcome additional 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 proposed rule (we refer readers to section II.E. of this proposed 
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

[[Page 39130]]

(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. 
There is no case presented here that constitutes a misvaluation of CPT 
codes 66982 to 66986, and therefore, we are not inclined to put this 
code family forward as potentially misvalued for CY 2022; however, we 
welcome additional 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.
[GRAPHIC] [TIFF OMITTED] TP23JY21.007

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. Proposed 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 would 
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 would 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

[[Page 39131]]

when furnished via telehealth. We considered the following factors:
    ++ Whether, outside of the circumstances of the PHE for COVID-19, 
there are concerns for patient safety if the service is furnished as a 
telehealth service.
    ++ Whether, outside of the circumstances of the PHE for COVID-19, 
there are concerns about whether the provision of the service via 
telehealth is likely to jeopardize quality of care.
    ++ Whether all elements of the service could fully and effectively 
be performed by a remotely located clinician using two-way, audio/video 
telecommunications technology.
    In the CY 2021 PFS final rule (85 FR 84507), we also temporarily 
added several services to the Medicare telehealth services list using 
the Category 3 criteria described above. In this proposed rule, we are 
considering additional requests to add services to the Medicare 
telehealth services list on a Category 3 basis using the previously 
described Category 3 criteria.
    The Medicare telehealth services list, including the additions 
described later in this section, is available on the CMS website at 
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/.
    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/.
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 8.
BILLING CODE 4120-01-P

[[Page 39132]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.008


[[Page 39133]]


[GRAPHIC] [TIFF OMITTED] TP23JY21.009

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 would include acquisition of the 
uroflowmetric

[[Page 39134]]

information, would meet the criterion to 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 
communication technology to the degree that would 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 
would 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 would 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 
are not proposing 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 
would 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 are not

[[Page 39135]]

proposing to add these services to the Medicare telehealth services 
list. We 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 9, 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 would 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 would 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 are not proposing to add them to the Medicare list of 
telehealth services.
[GRAPHIC] [TIFF OMITTED] TP23JY21.010

    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 10). 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 
are not proposing to add these services to the Medicare telehealth list 
of services on a Category 3 basis at this time.

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[GRAPHIC] [TIFF OMITTED] TP23JY21.011

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 would 
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 would 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. Services that were 
temporarily added on an interim basis during the PHE for COVID-19 would 
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

[[Page 39137]]

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 are proposing 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 
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 propose to retain all services added to the Medicare telehealth 
services list on a Category 3 basis until the end of CY 2023. This will 
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.
    See Table 11 for a list of services that were added to the Medicare 
telehealth services list on an interim basis to respond to the PHE for 
COVID-19, but were not extended on a temporary Category 3 basis in the 
CY 2021 PFS final rule. Under our current policy, these services will 
be removed from the Medicare telehealth services list as of the date 
that the PHE for COVID-19 ends. We recognize that, during the time 
between the publication of the CY 2021 PFS final rule and this proposed 
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 would likely meet the category 1 or 
category 2 criteria if provided with more time. We are soliciting 
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.
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BILLING CODE 4120-01-C
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.\2\
---------------------------------------------------------------------------

    \2\ 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 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 are seeking comment on whether we

[[Page 39146]]

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 are also seeking 
comment on whether a clarification should be added to the regulation at 
Sec.  410.78 as follows (which would take into account the other 
amendments we are proposing 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 
(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 propose 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 are also seeking 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. 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 would 
bill for a subsequent critical care service rather than an initial 
critical care visit. As we explain in in section II.F.2 of this 
proposed 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 proposed rule for further discussion of our current and proposed 
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 would 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.\3\
---------------------------------------------------------------------------

    \3\ American Medical Association. (2020). CPT 2021 professional 
edition. Chicago, Ill.: American Medical Association.
---------------------------------------------------------------------------

    We are interested in 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 to beneficiaries who are unable to see the same 
practitioner who furnished the prerequisite in-person services due to 
the practitioner's unavailability, we are seeking 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 times as the 
Secretary determines appropriate. We are proposing 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 mental 
health disorders by the same practitioner, other than for

[[Page 39147]]

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 
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 proposed 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 are seeking comment 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. However, we note 
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 proposed rule, ``e. 
Payment for Medicare Telehealth Services Furnished Using Audio-Only 
Communication Technology,'' we are proposing 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 are also seeking comment 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 propose 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 are proposing 
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 are also proposing 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 are also proposing 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 propose 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.
e. Payment for Medicare Telehealth Services Furnished Using Audio-Only 
Communication 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 communication 
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 communication 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

[[Page 39148]]

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 
communication 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/sites/default/files/bureau-health-workforce/data-research/technical-documentation-health-workforce-simulation-model.pdf), 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 
communication 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 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 other 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 would 
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 communication technology for mental health care would 
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 suggest 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 would 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 are proposing 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 are 
proposing 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 proposed 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 are also proposing 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 
an instance 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 
communication 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 or 
preferences. In the interests of monitoring utilization and program 
integrity concerns for audio-only telehealth services furnished under 
the terms of this proposed exception, we are proposing 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 would 
also serve to certify that the audio-only telehealth service meets the 
requirements for the exception specified in proposed on 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 communication technology, but instead used audio-
only

[[Page 39149]]

technology under the conditions specified in the regulation.
    We are proposing 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 are seeking comment 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 are also seeking 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 are seeking 
comment on whether the full scope of service elements for these codes 
could be performed via audio-only communication technology. However, we 
also note that maintaining the availability of these services through 
audio-only communication 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 
communication technology.
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 
communication 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 note 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 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 continue to seek 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 are seeking comment 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 are 
seeking comment 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 are soliciting 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 seek 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

[[Page 39150]]

supervision without physical presence for some services, due to 
potential concerns over patient safety if the practitioner is not 
immediately available in-person. We are also seeking comment on, were 
this policy to be made permanent, if a service level modifier should be 
required to identify when the requirements for direct supervision were 
met using two-way, audio/video communications technology.
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 would 
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 would be expedient to establish additional 
coding and payment for an extended virtual check-in, which could be 
furnished using any form of synchronous communication 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 communication 
technology, which can include audio-only communication. 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 would 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 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 are proposing to permanently adopt coding and payment 
for CY 2022, HCPCS code G2252 as described in the CY 2021 PFS final 
rule.

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 and CY 2015. Under the 5-year 
review process, revisions in RVUs were proposed and finalized via 
rulemaking. In addition to the 5-year reviews, beginning with CY 2009, 
CMS and the RUC identified a number of potentially misvalued codes each 
year using various identification screens, as discussed in section 
II.C. of this proposed rule, Potentially Misvalued Services under the 
PFS. Historically, when we received RUC recommendations, our process 
had been to establish interim final RVUs for the potentially misvalued 
codes, new codes, and any other codes for which there were coding 
changes in the final rule with comment period for a year. Then, during 
the 60-day period following the publication of the final rule with 
comment period, we accepted public comment about those valuations. For 
services furnished during the calendar year following the publication 
of interim final rates, we paid for services based upon the interim 
final values established in the final rule. In the final rule with 
comment period for the subsequent year, we considered and responded to 
public comments received on the interim final values, and typically 
made any appropriate adjustments and finalized those values.
    In the CY 2015 PFS final rule with comment period (79 FR 67547), we 
finalized a new process for establishing values for new, revised and 
potentially misvalued codes. Under the new process, we include proposed 
values for these services in the proposed rule, rather than 
establishing them as interim final in the final rule with comment 
period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the 
new process was applicable to all codes, except for new codes that 
describe truly new services. For CY 2017, we proposed new values in the 
CY 2017 PFS proposed rule for the vast majority of new, revised, and 
potentially misvalued codes for which we received complete RUC 
recommendations by February 10, 2016. To complete the transition to 
this new process, for codes for which we established interim final 
values in the CY 2016 PFS final rule with comment period (81 FR 80170), 
we reviewed the comments received during the 60-day public comment 
period following release of the CY 2016 PFS final rule with comment 
period (80 FR 70886), and re-proposed values for those codes in the CY 
2017 PFS proposed rule.
    We considered public comments received during the 60-day public 
comment period for the proposed rule before establishing final values 
in the CY 2017 PFS final rule. As part of our established process, we 
will adopt interim final values only in the case of wholly new services 
for which there are no predecessor codes or values and for which we do 
not receive recommendations in time to propose values.
    As part of our obligation to establish RVUs for the PFS, we 
thoroughly review and consider available information including 
recommendations and supporting information from the RUC, the Health 
Care Professionals Advisory Committee (HCPAC), public commenters, 
medical literature, Medicare claims data, comparative databases, 
comparison with other codes within the PFS, as well as consultation 
with other physicians and healthcare professionals within CMS and the

[[Page 39151]]

federal government as part of our process for establishing valuations. 
Where we concur that the RUC's recommendations, or recommendations from 
other commenters, are reasonable and appropriate and are consistent 
with the time and intensity paradigm of physician work, we proposed 
those values as recommended. Additionally, we continually engage with 
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

[[Page 39152]]

RVUs to account for significant changes in time, we have started by 
looking at the change in the time in the context of the RUC-recommended 
work RVU. When the recommended work RVUs do not appear to account for 
significant changes in time, we have employed the different approaches 
to identify potential values that reconcile the recommended work RVUs 
with the recommended time values. Many of these methodologies, such as 
survey data, building block, crosswalks to key reference or similar 
codes, and magnitude estimation have long been used in developing work 
RVUs under the PFS. In addition to these, we sometimes use the 
relationship between the old time values and the new time values for 
particular services to identify alternative work RVUs based on changes 
in time components.
    In so doing, rather than ignoring the RUC-recommended value, we 
have used the recommended values as a starting reference and then 
applied one of these several methodologies to account for the 
reductions in time that we believe were not otherwise reflected in the 
RUC-recommended value. If we believe that such changes in time are 
already accounted for in the RUC's recommendation, then we do not make 
such adjustments. Likewise, we do not arbitrarily apply time ratios to 
current work RVUs to calculate proposed work RVUs. We use the ratios to 
identify potential work RVUs and consider these work RVUs as potential 
options relative to the values developed through other options.
    We do not imply that the decrease in time as reflected in survey 
values should always equate to a one-to-one or linear decrease in newly 
valued work RVUs. Instead, we believe that, since the two components of 
work are time and intensity, absent an obvious or explicitly stated 
rationale for why the relative intensity of a given procedure has 
increased, significant decreases in time should be reflected in 
decreases to work RVUs. If the RUC's recommendation has appeared to 
disregard or dismiss the changes in time, without a persuasive 
explanation of why such a change should not be accounted for in the 
overall work of the service, then we have generally used one of the 
aforementioned methodologies to identify potential work RVUs, including 
the methodologies intended to account for the changes in the resources 
involved in furnishing the procedure.
    Several 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.
    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 13 contains a list of codes and 
descriptors for which we are proposing work RVUs; this includes all 
codes for which we received RUC recommendations by February 10, 2021. 
The proposed 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 proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/).
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 14 details 
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this proposed rule, Determination 
of Practice Expense Relative Value Units (PE RVUs), we addressed 
certain refinements that would 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

[[Page 39153]]

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. We also noted that many of the refinements 
listed in Table 14 result in changes under the $0.35 threshold and are 
unlikely to result in a change to the RVUs.
    We also noted 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 proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs 
displayed there have been used in developing the CY 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 
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 would 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 note that we believe these same assumptions would 
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 would be available if the 
room is not being occupied by a particular patient. For additional 
information, we refer readers to our discussion of these issues in the 
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
    In general, the preservice, intraservice, and postservice clinical 
labor minutes associated with clinical labor inputs in the direct PE 
input database reflect the sum of particular tasks described in the 
information that accompanies the RUC-recommended direct PE inputs, 
commonly called the ``PE worksheets.'' For most of these described 
tasks, there is a standardized number of minutes, depending on the type 
of procedure, its typical setting, its global period, and the other 
procedures with which it is typically reported. The RUC sometimes 
recommends a number of minutes either greater than or less than the 
time typically allotted for certain tasks. In those cases, we review 
the deviations from the standards and any rationale provided for the 
deviations. When we do not accept the RUC-recommended exceptions, we 
refine the proposed direct PE inputs to conform to the standard times 
for those tasks. In addition, in cases when a service is typically 
billed with an E/M service, we remove the preservice clinical labor 
tasks to avoid duplicative inputs and to reflect the resource costs of 
furnishing the typical service.
    We refer readers to section II.B. of this proposed rule, 
Determination of Practice Expense Relative Value Units (PE RVUs), for 
more information regarding the collaborative work of CMS and the RUC in 
improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
    In some cases, the PE worksheets included with the RUC's 
recommendations include items that are not clinical labor, disposable 
supplies, or medical equipment or that cannot be allocated to 
individual services or patients. We addressed these kinds of 
recommendations in previous rulemaking (78 FR 74242), and we do not use 
items included in these recommendations as direct PE inputs in the 
calculation of PE RVUs.
(5) New Supply and Equipment Items
    The RUC generally recommends the use of supply and equipment items 
that already exist in the direct PE input database for new, revised, 
and potentially misvalued codes. However, some recommendations include 
supply or equipment items that are not currently in the direct PE input 
database. In these cases, the RUC has historically recommended that a 
new item be created and has facilitated our pricing of that item by 
working with the specialty societies to provide us copies of sales 
invoices. For CY 2022 we received invoices for several new supply and 
equipment items. Tables 16 and 17 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of this proposed rule, Determination of Practice Expense Relative 
Value Units, we encourage 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.

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    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 16 and 17 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 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 proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. 
For more information regarding the history of the MPPR policy, we refer 
readers to the CY 2014 PFS final rule with comment period (78 FR 74261 
through 74263).
    Effective January 1, 2007, section 5102(b)(1) of the Deficit 
Reduction Act of 2005 (Pub. L. 109-171) (DRA) amended section 
1848(b)(4) of the Act to require that, for imaging services, if--(i) 
The technical component (including the technical component 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 hospital outpatient department 
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 technical 
component for such year. As required by the section 1848(b)(4)(A) of 
the statute, 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 are proposing 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 (e.g., fat, iron, water content), 
including multiparametric data acquisition, data preparation and 
transmission, interpretation and report, obtained without diagnostic 
MRI examination of the same anatomy (e.g., organ, gland, tissue, target 
structure) during the same session), 0649T (Quantitative magnetic 
resonance for analysis of tissue composition (e.g., fat, iron, water 
content), including multiparametric data acquisition, data preparation 
and transmission, interpretation and report, obtained with diagnostic 
MRI examination of the same anatomy (e.g., organ, gland, tissue, target 
structure) (List separately in addition to code for primary 
procedure)), 77X01 (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), 77X02

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(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), 77X03 (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), 77X04 (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), 9111X (Gastrointestinal tract imaging, 
intraluminal (e.g., capsule endoscopy), colon, with interpretation and 
report), and 933X0 (3D echocardiographic imaging and postprocessing 
during transesophageal echocardiography or transthoracic 
echocardiography for congenital cardiac anomalies for the assessment of 
cardiac structure(s) (e.g., cardiac chambers and valves, left atrial 
appendage, intraterial septum, interventricular septum) and function, 
when performed). We believe 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.
4. Proposed 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 
are proposing 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 are proposing the RUC-recommended direct PE inputs for CPT code 
00537.
(2) Anesthesia Services for Image-Guided Spinal Procedures (CPT Codes 
01XX2, 01XX3, 01XX4, 01XX5, 01XX6, and 01XX7)
    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 01XX2 (Anesthesia for percutaneous image-guided injection, 
drainage or aspiration procedures on the spine or spinal cord; cervical 
or thoracic), 01XX3 (Anesthesia for percutaneous image guided 
injection, drainage or aspiration procedures on the spine or spinal 
cord; lumbar or sacral), 01XX4 (Anesthesia for percutaneous image 
guided destruction procedures by neurolytic agent on the spine or 
spinal cord; cervical or thoracic), 01XX5 (Anesthesia for percutaneous 
image guided destruction procedures by neurolytic agent on the spine or 
spinal cord; lumbar or sacral), 01XX6 (Anesthesia for percutaneous 
image guided neuromodulation or intravertebral procedures (e.g., 
Kyphoplasty, vertebroplasty) on the spine or spinal cord; cervical or 
thoracic) and 01XX7 (Anesthesia for percutaneous image guided 
neuromodulation or intravertebral procedures (e.g., Kyphoplasty, 
vertebroplasty) on the spine or spinal cord; lumbar or sacral).
    We are proposing the RUC-recommended valuation of 4 base units for 
CPT codes 01XX2, 01XX3, 01XX4, and 01XX5.
    We disagree with the RUC-recommend valuation of 6 base units for 
CPT codes 01XX6 and 01XX7. 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 01XX6 and 01XX7 
appears to be a high valuation. We are proposing 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 notes that CPT codes 01XX6 and 01XX7 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 supports 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 01XX6 and 01XX7 have a total time 
of 58 minutes and a PIPPA time of 20 minutes. We agree 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 
disagree with the use of

[[Page 39156]]

this crosswalk code to support a valuation of 6 base units and instead 
propose a valuation of 5 base units supported by reference CPT code 
00813, which has higher times and the same base unit valuation.
    We are proposing the RUC-recommended direct PE inputs for all six 
codes in the family.
(3) Closed Treatment of Nasal Bone Fracture (CPT Codes 21315 and 21320)
    We agree 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 disagree 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 are proposing 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 are proposing 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 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 23215. 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 are seeking 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, given the potentially flawed methodology used to 
arrive at the current valuations for CPT codes 21315 and 21320 that are 
used in the total time ratios.
    We are also proposing the RUC-recommended direct PE inputs without 
refinements and the surveyed physician times for CPT codes 21315 and 
21320.
(4) Insertion of Interlaminar/Interspinous Device (CPT Code 22867)
    We are proposing 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 is 
not recommending changes to the current

[[Page 39157]]

PE inputs, and CMS is not proposing any changes to the current PE 
inputs.
(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 are proposing 
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 are proposing a work RVU of 2.79 for CPT code 
28002 and we are proposing 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 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 are 
proposing 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

[[Page 39158]]

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 are proposing all of the PE refinements as recommended 
by the RUC for these codes, which can be found in section II.B. of this 
proposed rule, under the Determination of Practice Expense RVUs.
(6) Percutaneous Cerebral Embolic Protection (CPT Codes 33XXX)
    CPT code 33XXX (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 33XXX.
    We are proposing the RUC-recommended work RVU of 2.50 for CPT code 
33XXX. This is a facility-based add-on code with no direct PE inputs.
(7) Exclusion of Left Atrial Appendage (CPT Codes 33XX3, 33XX4, and 
33XX5)
    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 33XX3 
(Exclusion of left atrial appendage, open, any method (e.g., excision, 
isolation via stapling, oversewing, ligation, plication, clip), CPT 
code 33XX4 (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 33XX5 (Exclusion of left atrial appendage, thoracoscopic, any 
method (e.g., excision, isolation via stapling, oversewing, ligation, 
plication, clip). CPT codes 33XX3 and 33XX5 are 090-day global codes 
while CPT code 33XX4 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 33XX3, 2.50 work RVUs for CPT code 33XX4, and 14.31 
work RVUs for CPT code 33XX5.
    We are proposing the RUC-recommended work RVUs for the three new 
codes. We are also proposing the RUC-recommended direct PE inputs for 
CPT codes 33XX3 and 33XX5. We note that CPT code 33XX4 has no direct PE 
inputs.
(8) Endovascular Repair of Aortic Coarctation (CPT Codes 338X1, 338X2, 
and 338X0)
    In October 2020, the CPT Editorial Panel created CPT codes 338X1 
(Endovascular stent repair of coarctation of the ascending, transverse, 
or descending thoracic or abdominal aorta, involving stent placement; 
across major side branches) and 338X2 (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 338X0 (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 338X1, a work RVU 17.97 
for CPT code 338X2, and a work RVU 14.00 for CPT code 338X0.
    We disagree with the RUC-recommended work RVUs for the CPT code 
family of 338X1, 338X2, and 338X0. We found that the recommended work 
RVUs for these CPT codes were high when compared to other codes with 
similar time values. Therefore, we are proposing the RUC survey 25th 
percentile of 18.27 as the work RVU for 338X1, we are proposing a work 
RVU of 14.54 for 338X2, and we are proposing a work RVU of 10.81 for 
338X0.
    When we reviewed CPT code 338X1, 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 338X1 with intra service time similar to 
the 134 minutes of intra service time for CPT code 338X1; 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 338X2 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 
338X2, we concur that the relative difference in work between CPT codes 
338X1 and 338X2 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 are proposing a work 
RVU of 14.54 for CPT code 338X2, based on the RUC-recommended interval 
of 3.73 RVUs below our proposed work RVU of 18.27 for CPT code 338X1.
    The RUC-recommended work RVU of 14.00 for CPT code 338X0 was higher 
than other codes with the same 90 minutes of intra service time and 
similar total time and we believe it would 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 338X0, we propose a work 
RVU of 10.81 which also continues the 3.73 incremental difference used 
between CPT codes 338X1 and 338X2, instead of the RUC incremental 
difference of 3.97 between CPT codes 338X2 and 338X0. Although

[[Page 39159]]

the work RVU of 10.81 we are proposing for CPT code 338X0 is lower than 
the RUC recommendation, the 3.73 incremental difference between CPT 
codes 338X2 and 338X0 we are proposing is more generous than the RUC 
incremental difference of 3.97 between CPT codes 338X2 and 338X0.
    We are proposing no direct PE inputs for the CPT code family of 
338X1, 338X2, and 338X0, as recommended by the RUC. These services are 
provided exclusively in the facility setting.
(9) Harvest of Upper Extremity Artery (CPT Codes 35XX0 and 35600)
    In May 2020, the CPT Editorial Panel created CPT code 35XX0 
(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 35XX0 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 35XX0 and 
a work RVU of 4.00 for CPT code 35600.
    We disagree with the RUC-recommended RVUs for the CPT code family 
of 35XX0 and 35600. We found that the recommended work RVUs for these 
CPT codes were high when compared to other codes with similar time 
values. Therefore, we are proposing 3.34 as the work RVU for 35XX0 and 
we are proposing a work RVU of 3.59 for 35600.
    We disagree with the RUC-recommended work RVU for CPT code 35XX0 
and are proposing 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 35XX0 with the same 35 minutes of intra service time and 35 
minutes of total time as CPT code 35XX0; 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 
35XX0 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 are proposing 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 35XX0.
    We are proposing no direct PE inputs for the CPT code family of 
35XX0 and 35600 as recommended by the RUC. These services are provided 
exclusively in the facility setting.
    The RUC acknowledged that CPT codes 35XX0 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 35XX0 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 35XX0 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 35XX0 and 35600, and we are 
proposing to assign the ZZZ-day global period to CPT codes 35XX0 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 are compelled to understand more about the billing 
circumstances presented by the RUC and stakeholders that have presented 
this approach for CPT codes 35XX0 and 35600 to CMS for consideration. 
We are seeking comments and requesting information that may inform why 
CPT codes 35XX0 and 35600 should have an XXX-day global period instead 
of the ZZZ-day global period that is customary for add-on codes.
(10) Needle Biopsy of Lymph Nodes (CPT Code 38505)
    CPT code 38505 (Biopsy or excision of lymph node(s); by needle, 
superficial (e.g., 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 are proposing the RUC-recommended work RVU of 1.59 for CPT code 
38505. We are also proposing the RUC-recommended direct PE inputs for 
this code.
(11) Drug Induced Sleep Endoscopy (CPT Codes 42XXX)
    CPT code 42XXX (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 are proposing CPT 
code 31575 (Diagnostic laryngoscopy) as the endoscopic base code for 
CPT code 42XXX 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 42XXX 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 are proposing the RUC-recommended work RVU of 1.90 for

[[Page 39160]]

CPT code 42XXX. We are also proposing the RUC-recommended direct PE 
inputs for this code.
(12) Per-Oral Endoscopic Myotomy (POEM) (CPT Codes 434XX)
    In May 2020, the CPT Editorial Panel created a new CPT code 434XX 
(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 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 
434XX.
    We disagree with the RUC-recommended work RVU for CPT code 434XX 
and are proposing 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 434XX, and has 283 minutes of 
total time, which is 2 minutes more than the 281 minutes of total time 
than for 434XX. 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 
434XX. 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 434XX. Therefore, we believe 
the proposed work RVU of 13.29 for CPT code 434XX 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 are proposing the RUC-recommended direct PE inputs for CPT code 
434XX 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 are proposing 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, 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 are proposing the following standard clinical labor times for 
extensive use of clinical staff for a 000-day global code:
     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 are also proposing 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

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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 are proposing the following standard clinical labor times 
for use of clinical staff in the non-facility setting. We are also 
proposing 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 are also proposing 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.
(14) Periurethral Balloon Continence Device Procedures (CPT Codes 
53XX1, 53XX2, 53XX3, and 53XX4)
    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 are proposing contractor pricing for all four 
codes in the family, CPT codes 53XX1 (Periurethral transperineal 
adjustable balloon continence device; bilateral insertion, including 
cystourethroscopy and imaging guidance), 53XX2 (Periurethral 
transperineal adjustable balloon continence device; unilateral 
insertion, including cystourethroscopy and imaging guidance), 53XX3 
(Periurethral transperineal adjustable balloon continence device; 
removal, each balloon) and 53XX4 (Periurethral transperineal adjustable 
balloon continence device; percutaneous adjustment of balloon(s) fluid 
volume).
(15) Intracranial Laser Interstitial Thermal Therapy (LITT) (CPT Codes 
617X1 and 617X2)
    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 617X1 (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 617X1 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 617X1, 
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 671X1, 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, 617X1 would have a work RVU of 
19.06.
    The steps are as follows:
     Step (1): CPT code 617X1 does not have a hospital 
discharge day management service; therefore, we would 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 are proposing a work RVU of 19.06 for CPT 
code 671X1.
    In reviewing the RUC-recommended direct PE inputs for 671X1 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 are proposing 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 617X2 (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 would be appropriate 
to apply the 23-hr policy to CPT code 617X2 as well.

[[Page 39162]]

    The steps are as follows:
     Step (1): CPT code 617X2 does not have a hospital 
discharge day management service. Therefore, we would skip this step.
     Step (2): 24 - 2** = 22
     Step (3): 22 + (30 minutes x 0.0224)*** = 22.67 RVUs
    * Value associated with 1/2 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 a proposing a work RVU of 
22.67 and 70 minutes of immediate postservice time for CPT code 617X2.
    For the direct PE, the RUC proposed identical preservice times for 
CPT codes 617X1 and 617X2. For the reasons stated above concerning the 
direct PE inputs for CPT code 671X1, we are proposing the standard 
clinical labor times associated with a 000-day extensive for CPT code 
617X2 for CY 2022.
(16) Arthrodesis Decompression (CPT Codes 630XX and 630X1)
    For CPT codes 630XX (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; single vertebral 
segment (List separately in addition to code for primary procedure)) 
and 630X1 (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 (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 are proposing a work RVU of 
3.08 for CPT code 630XX and a work RVU of 2.31 for CPT code 630X1.
    CPT codes 630XX and 630X1 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 
630XX is based on an intraservice time ratio between the proposed 40 
minutes of intraservice time for CPT code 630XX 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], [eg, 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 believe that CPT code 63048 is a stronger 
reference code for CPT code 630XX 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 630XX and 63048. The intraservice time ratio between CPT codes 
63048 and 630XX equals a work RVU of 3.08 for CPT code 630XX ((40 
minutes/45 minutes) * 3.47 = 3.08). Therefore, we are proposing a work 
RVU of 3.08 for CPT code 630XX. The intraservice time ratio between CPT 
codes 63048 and 630XX was selected to value CPT code 630XX because of 
the similarities in the descriptions of intraservice work provided in 
the RUC's summary of recommendations for CPT code 630XX and the RUC 
Database for CPT code 63048. We are proposing a work RVU of 2.31 for 
CPT code 630X1 based on an intraservice time ratio between the proposed 
30 minutes of intraservice time for CPT code 630X1 and the proposed 40 
minutes of intraservice time for CPT code 630XX ((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 
630X1 compared to CPT code 630XX. 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 630XX 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 630XX. The proposed work RVU for CPT 
code 630X1 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 630X1. 
When we compared the RUC-recommended work RVU of 5.55 for CPT code 
630XX and 4.44 for CPT code 630X1 to other spinal add-on codes in the 
63000 CPT code series in the RUC database, we found that CPT code 630XX 
would have the highest work RVU and the second shortest intraservice 
time (with CPT code 630X1 having the shortest intraservice time), and 
CPT code 630X1 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 that have longer 
intraservice times. We believe that our proposed work RVUs of 3.08 for 
CPT code 630XX and 2.31 for CPT code 630X1 better serve the interests 
of relativity. We note that the specialty societies did not survey the 
two new add-on codes with the base codes, which is a standard to 
provide assurance that the respondents followed instruction to only 
consider the work of the add-on codes. CPT codes 630XX and 630X1 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

[[Page 39163]]

were approved by the CPT Editorial Panel for CY 2022.
    The RUC did not recommend any direct PE inputs for these codes and 
we are not proposing any direct PE inputs.
(17) Hypoglossal Nerve Stimulator Services (CPT Codes 645X1, 645X2, and 
645X3)
    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 (eg, vagus 
nerve) neurostimulator electrode array and pulse generator), 64569 
(Revision or replacement of cranial nerve (eg, vagus nerve) 
neurostimulator electrode array, including connection to existing pulse 
generator) and 64570 (Removal of cranial nerve (eg, vagus nerve) 
neurostimulator electrode array and pulse generator).
    CPT code 645X1 (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 are not proposing the RUC-
recommendation to use the survey median work RVU of 16.00 for CPT code 
645X1. We are proposing 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 645X1. CPT code 64568 has a work RVU of 
9.00, intraservice time of 90 minutes and total time of 275 minutes. 
CPT code 645X1 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 645X1, we found that the RUC-recommended work RVU 
was higher than other global 90-day codes with similar time values. We 
do 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 are not proposing the RUC-recommended work value of 16.50 for 
CPT code 645X2 (Revision or replacement of hypoglossal nerve 
neruostimulator array and distal respiratory sensor electrode or 
electrode array, including connection to an existing pulse generator), 
rather we are proposing 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 645X1 and 645X2 is equivalent to the recommended 
increment of 0.50 RVUs. Therefore, we are proposing a work RVU of 14.50 
for CPT code 645X2 based on the recommended increment of 0.50 
additional RVUs above our proposed work RVU of 14.00 for CPT code 
645X1. 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 645X2 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 are not proposing the RUC-recommended work value of 14.00 for 
CPT code 645X3 (Removal of hypoglossal nerve neruostimulator array, 
pulse generator, and distal respiratory sensor electrode or electrode 
array), rather we are proposing 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 645X1 and 645X3 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 are proposing a work RVU of 12.00 for CPT 
code 645X3 based on the recommended increment of 2.0 RVUs below our 
proposed work RVU of 14.00 for CPT code 645X1. Additionally, we note 
that the proposed work RVU of 12.00 is also the RUC 25th percentile 
survey value for CPT code 645X3.
    We are proposing the RUC-recommended direct PE inputs without 
refinements for CPT codes 645X1, 645X2 and 645X3.
(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 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 are proposing 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 are not proposing 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 would 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.

[[Page 39164]]

    We are proposing the RUC-recommended direct PE inputs without 
refinement.
(19) Destruction of Intraosseous Basivertebral Nerve (CPT Codes 646X0 
and 646X1)
    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 are not proposing the RUC-recommended work value of 8.25 for CPT 
code 646X0 (Thermal destruction of intraosseous basivertebral nerve, 
inclusive of all imaging guidance; first two vertebral bodies, lumbar 
or sacral). When we reviewed CPT code 646X0, 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 646X0 at the 90th 
percentile of comparable 10-day globals and we do not agree that it 
would be typical to value this code so much higher than services with 
similar work time values. We believe 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 646X0.
    We also are not proposing the RUC-recommended work value of 4.87 
for CPT code 646X1 (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 646X0 and 
646X1 is equivalent to the recommended increment of -3.38 RVUs. 
However, since the recommended work RVU of code 646X0 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 646X1 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 are proposing a work RVU of 3.77 for CPT code 646X1 based 
on the recommended increment of 3.38 RVUs below our proposed work RVU 
of 7.15 for CPT code 646X0.
    We are proposing the RUC-recommended direct PE inputs without 
refinements for CPT code 646X0. CPT code 646X1 is an add-on code and 
does not have any direct PE inputs.
(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 are not proposing the RUC-recommended work RVUs of 8.53 for CPT 
code 66174 and 10.25 for CPT code 66175 (Transluminal dilation of 
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 would rank these codes among the highest 
valued 090-day global period codes of similar time values. We are 
proposing 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 (eg, 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 are proposing the RUC-recommended PE inputs without refinement.
(21) Cataract Removal With Drainage Device Insertion (CPT Codes 669X1, 
669X2, 66982, 66984, 66987, 66988, and 0X12T)
    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 669X1 
and 669X2, 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 669X1 
(Extracapsular cataract removal with insertion of intraocular lens 
prosthesis (1-stage procedure), manual or mechanical technique (eg, 
irrigation and aspiration or phacoemulsification), complex, requiring 
devices or techniques not generally used in routine cataract surgery 
(eg, 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 (eg, 
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 669X1 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

[[Page 39165]]

or mechanical technique (eg, irrigation and aspiration or 
phacoemulsification), complex, requiring devices or techniques not 
generally used in routine cataract surgery (eg, 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 669X1 would 
be lower than the intraservice time for CPT code 66982, as CPT code 
669X1 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 would 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 in line for both CPT codes 669X1 and 
669X2.
    CPT code 69982 has a work RVU of 10.25, 125 minutes of total time 
and 30 minutes of intraservice time. CPT code 669X1 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 669X1, are almost identical in 
time and intensity. However, we disagree with the RUC-recommended work 
RVU of 12.13 for CPT code 669X1 noting that CPT code 66982 has a work 
RUV of 10.25. We are proposing 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 669X1.
    For CPT code 669X2, 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 669X1 and the current 
RUC-reviewed work RVU value for CPT code 66982 to build a work RVU 
recommendation for CPT code 669X2. The RUC determined that the 
increment between the 25th percentile work RVU value for CPT code 669X1 
(work RVU = 12.13) and the current RUC-reviewed work RVU value for CPT 
code 66982 (work RVU = 10.25) would 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 669X2. We are proposing 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 669X1.
    We are proposing the RUC-recommended indirect PE values for CPT 
codes 669X1 and 669X2.
    We are not proposing any new valuations but reaffirming 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 
(eg, irrigation and aspiration or phacoemulsification), complex, 
requiring devices or techniques not generally used in routine cataract 
surgery (eg, 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 (eg, 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 (eg, irrigation and aspiration or phacoemulsification), 
complex, requiring devices or techniques not generally used in routine 
cataract surgery (eg, 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 (eg, irrigation and aspiration or 
phacoemulsification); with endoscopic cyclophotocoagulation) we 
continue to believe these services should be contractor priced.
(22) Retinal Detachment Prophylaxis (CPT Codes 67141 and 67145)
    CPT code 67145 (Prophylaxis of retinal detachment (eg, 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 (eg, 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 are proposing the RUC-recommended work RVU of 2.53 
for CPT codes 67141 and 67145. We are also proposing the RUC-
recommended direct PE inputs without refinements.
(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 are proposing 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

[[Page 39166]]

(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 are also proposing 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 (eg, 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 (eg, prior ocular injury, strabismus or retinal 
detachment surgery) or restrictive myopathy (eg, 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 are proposing the RUC-recommended direct PE inputs for this code 
family without refinements.
(24) Lacrimal Canaliculus Drug Eluding Implant Insertion (CPT Codes 
68XXX)
    CPT code 68XXX (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 are proposing the RUC-recommended work RVU 
of 0.49 for CPT code 68XXX.
    For the direct PE inputs, we are proposing 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 68XXX. 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 68XXX was reviewed. The recommended materials 
for CPT code 68XXX state the standard equipment time formula would be 
typical for this service, which would be 5 minutes in this case (the 
CA013 and CA024 equipment times are included but not the CA035 
equipment time). We are proposing 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 are seeking 
additional comment 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 68XXX to require an additional 4 minutes of 
equipment time totaling 9 minutes.
(25) Transcutaneous Passive Implant-Temporal Bone (CPT Codes 69714, 
69717, 69X50, 69X51, 69X52, and 69X53)
    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 are proposing the RUC-recommended work RVU for all six of the 
codes in this family. We are proposing 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 69X50 (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 69X51 (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 69X52 (Removal, osseointegrated implant, skull; with percutaneous 
attachment to external speech processor), and a work RVU of 7.13 for 
CPT code 69X53 (Removal, osseointegrated implant, skull; with magnetic 
transcutaneous attachment to external speech processor).
    For the direct PE inputs, we are proposing 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 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 are also proposing 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.
(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 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 are proposing the RUC-recommended work RVU of 0.21 for

[[Page 39167]]

CPT code 74301. This is an add-on code with no direct PE inputs.
(27) Trabecular Bone Score (TBS) (CPT Codes 77X01, 77X02, 77X03, and 
77X04)
    We are proposing the RUC-recommended work RVUs of 0.20 for CPT 
codes 77X01 (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 77X04 (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 77X02 (Trabecular bone score 
(TBS), structural condition of the bone microarchitecture; technical 
preparation and transmission of data for analysis to be performed 
elsewhere) and 77X03 (Trabecular bone score (TBS), structural condition 
of the bone microarchitecture; technical calculation only) are PE only 
codes; the RUC did not recommend and we are not proposing a work RVU 
for these codes.
    The RUC PE recommendations for CPT codes 77X01 and 77X03 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 section II.B. of this proposed rule 
(the PE section), 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 77X01 
and 77X03 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.
    We are therefore proposing to value the PE for CPT codes 77X01 and 
77X03 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 are proposing that the PE RVU for CPT code 77X03 
equals the PE RVU from code 77X01 minus the PE RVU from codes 77X02 and 
77X04 so that the three codes sum to the valuation of code 77X01. (CPT 
code 77X01 is the global code in this family and CPT codes 77X02, 
77X03, and 77X04 must sum together to equal the value of 77X01.) CPT 
code 71101 is another type of bone imaging procedure that we believe 
reflects codes 77X01 and 77X03 similar direct PE resource costs as CPT 
codes 77X01 and 77X03. We recognize that the services being performed 
in this crosswalk code are not the same as the services in CPT codes 
77X01 and 77X03, however we believe that the direct resource costs 
would 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 77X01 and 77X03 which would not typically be 
considered direct PE under our current methodology. We are soliciting 
comments, both on the specific proposal for the Trabecular Bone Score 
codes as well as our broader discussion of this topic in section II.B. 
of this proposed rule.
(28) Pathology Clinical Consult (CPT Codes 80XX0, 80XX1, 80XX2, and 
80XX3)
    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 80XX0 (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)), 80XX1 (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), 80XX2 (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 80XX3 (prolonged service, each additional 30 minutes (List 
separately in addition to code for primary procedure) (Use 80XX3 in 
conjunction with 80XX2) (Do not report 80XX0, 80XX1, 80XX2, 80XX3 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 80XX0 based on 
the 25th percentile of the survey. The RUC-recommended 15 minutes of 
intraservice and total times for CPT code 80XX0 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 are proposing 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 80XX0 (0.15) 
applied to the current value of CPT code 80500 (0.37 x 0.15 = 0.43).
    We are proposing the RUC-recommended work RVU of 0.91 without 
refinements for CPT code 80XX1.
    The RUC recommended a work RVU of 1.80 for CPT code 80XX2 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 80XX2 are 54 minutes. Similar to the scenario described above 
for CPT code 80XX0, the intraservice and total times for CPT code 80XX2 
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

[[Page 39168]]

decrease in the work RVU. Therefore, for CPT code 80XX2 we are 
proposing 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 
80XX2.
    We are proposing the RUC-recommended work RVU of 0.80 for CPT code 
80XX3 without refinement.
    For the direct PE inputs of CPT codes 80XX0, 80XX1, and 80XX2, we 
are proposing 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 80XX0, 80XX1, 80XX2, and 
80XX3, 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 EHR and therefore we are proposing to 
remove the equipment time associated with EP024 (microscope, compound) 
from CPT codes 80XX0, 80XX1, 80XX2, and 80XX3.
    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 CMS would 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 are also 
seeking comment on how these replacement codes would most typically be 
billed relative to use of existing pathology coding. Such information 
would 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 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 are proposing 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 are also seeking 
comment on our proposal to increase the value of CPT code 90954.
(30) Colon Capsule Endoscopy (CPT Codes 91110, 91111, and 9111X)
    In October 2020, the CPT Editorial Panel replaced Category III code 
0355T (Gastrointestinal tract imaging, intraluminal (eg, capsule 
endoscopy), colon, with interpretation and report) with a new Category 
I code 9111X (Gastrointestinal tract imaging, intraluminal (eg, capsule 
endoscopy), colon, with interpretation and report) to report 
gastrointestinal tract imaging. CPT codes 91110 (Gastrointestinal tract 
imaging, intraluminal (eg, capsule endoscopy), esophagus through ileum, 
with interpretation and report) and 91111 (Gastrointestinal tract 
imaging, intraluminal (eg, capsule endoscopy), esophagus with 
interpretation and report) were added as part of the family and 
surveyed for the January 2021 RUC meeting.
    We are proposing the RUC-recommended work RVU for two of the codes 
in this family. We are proposing a work RVU of 2.24 for CPT code 91110 
and a work RVU of 2.41 for CPT code 9111X 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 are proposing 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 would be more accurate to propose a 
work RVU of 0.90 based on a crosswalk

[[Page 39169]]

to CPT code 95923 to account for these decreases in the surveyed work 
time.
    For the direct PE inputs, we are proposing 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 
9111X 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 would 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 are also proposing 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.
(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 disagree with the RUC-recommended work 
RVU of 0.52, and we are proposing a 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 are recommending 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 are proposing 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 are seeking public comment about the typicality of a second senior 
technician. We are requesting 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 are also seeking 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 are proposing 0 minutes for Clinical Activity 
Code CA021, Line 67 on the RUC-recommended PE Spreadsheet, unless 
commenters can provide compelling information that a second, senior 
technician typically performs quality assurance measures. Otherwise, we 
agree with the RUC-recommended direct PE inputs and are proposing the 
refinements as recommended.
    In addition to the proposed work RVU and direct PE input 
refinements, we are requesting 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 are seeking public comment on the manufacturing costs and 
other information to help update the equipment item for CY 2022. 
Second, we are requesting additional information about the useful 
lifetime of EQ340. CMS currently assigns 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 are seeking public comment to help update the useful life of 
EQ340, as it has not been updated since 2008, and the device has 
experienced significant technological changes.
(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

[[Page 39170]]

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 (eg, 
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 are proposing 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 are not proposing 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 would 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 are proposing 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

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value of 19.75. We are proposing 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 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 are proposing the RUC-
recommended 60 minutes of intraservice and total time, but instead 
propose 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 are proposing 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 are proposing 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.
(34) 3D Imaging of Cardiac Structures (CPT Codes 933X0)
    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

[[Page 39172]]

structure(s). The 3D imaging could be performed as a follow-up to a 2D 
transthoracic echocardiogram.
    We are proposing the RUC-recommended work RVU of 0.50 for CPT code 
93XX0 (3D echocardiographic imaging and postprocessing during 
transesophageal echocardiography, or during transthoracic 
echocardiography for congenital cardiac anomalies, for the assessment 
of cardiac structure(s) (eg, 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 are proposing no refinements to the direct PE inputs, we 
are requesting 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 are seeking additional information 
to know if this equipment item reflected both the 3D probe and the base 
echocardiography machine or only the probe.
(35) Cardiac Catheterization for Congenital Defects (CPT Codes 93X1X, 
93X2X, 93X3X, 93X4X, 93X5X, and 93X6X)
    In May 2020, the CPT Editorial Panel replaced a family of four 
cardiac catheterization codes with five new codes (CPT codes 93X1X-
93X5X) 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 93X6X) to report 
cardiac output measurement(s), performed during cardiac catheterization 
for congenital cardiac defects.
    We are proposing the RUC-recommended work RVU for two of the codes 
in this family. We are proposing a work RVU of 3.99 for CPT code 93X1X 
(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 93X2X (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 93X3X (Left heart catheterization for congenital heart 
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 are instead proposing a work RVU of 5.50 based on a crosswalk to CPT 
code 32607 (Thoracoscopy; with diagnostic biopsy(ies) of lung 
infiltrate(s) (eg, wedge, incisional), unilateral). CPT code 32607 is a 
thorascopy procedure with three fewer minutes of intraservice work time 
(45 minutes) than CPT code 93X3X but a higher total work time of 178 
minutes. CPT code 93X3X has similar surveyed work time to CPT code 
93X1X 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 93X3X. While we agree that 
CPT code 93X3X 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 would 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 93X3X remains higher 
than the first two codes in the family at the proposed work RVU of 
5.50.
    For CPT code 93X4X (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 are instead proposing 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) (eg, 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 93X4X and a higher total work time of 195 minutes. In the same 
fashion as the previous code, CPT code 93X4X has similar surveyed work 
time to CPT code 93X2X 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 93X4X. 
While we agree that CPT code 93X4X 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 would 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 
93X4X 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 93X3X and 93X4X better preserve relativity both within the 
family and also with other services on the PFS.
    For CPT code 93X5X (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 are instead proposing 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 93X5X that sits within 0.01 RVUs 
of the survey 75th percentile. The survey for CPT code 93X5X 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 93X5X 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. We are therefore proposing a work RVU of 8.88 for CPT code 
93X5X 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 93X6X (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 are instead 
proposing a work RVU of 1.44 based on a crosswalk

[[Page 39173]]

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 93X6X and has 1 additional minute of immediate postservice 
time. We note that the intensity of CPT code 93X6X as recommended by 
the RUC at a work RVU of 1.75 would be the second-highest in the 
family, higher than CPT code 93X5X 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 93X5X.
    We also note that the recommended work RVU for CPT code 93X6X 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 would be lower than the RUC's recommendation of 1.75 for CPT 
code 93X6X. The RUC's recommendation suggests that there would be no 
efficiencies gained or savings created in the process of creating CPT 
code 93X6X; 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 93X6X 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. We therefore believe that it would be more 
accurate to propose 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 are not proposing any direct PE inputs.
(36) Outpatient Pulmonary Rehabilitation Services (CPT Codes 946X1 and 
946X2)
    CPT code 946X1 (Physician or other qualified health care 
professional services for outpatient pulmonary rehabilitation; without 
continuous oximetry monitoring (per session)) and CPT code 946X2 
(Physician or other qualified health care professional services for 
outpatient pulmonary rehabilitation; with continuous oximetry 
monitoring (per session) (Do not report 946X1, 946X2 in conjunction 
with 94760, 94761)) are two new codes created by the CPT Editorial 
Panel to take the place of the HCPCS G-code G0424 (Pulmonary 
rehabilitation, including exercise (includes monitoring), one hour, per 
session, up to two sessions per day) which was created in 2010. The RUC 
recommended work RVUs for CPT codes 946X1 and 946X2 of 0.55 and 0.69 
respectively. We disagree with the RUC-recommended work RVUs for both 
CPT code 946X1 and 946X2. Although the pulmonary rehab service as 
described by these new codes have not changed, the RUC recommendation 
included an increase in intraservice and total time for the services. 
As the survey time increased for the pulmonary rehabilitation codes, an 
increase in work value may be appropriate.
    Based on a comparison of intraservice time for the current code 
relative the recommended values, we are proposing a work RVU of 0.36 
for CPT code 946X1 and a work RVU of 0.56 for CPT code 946X2, which is 
an increase to the work RVU from the HCPCS G-code G0424 that these two 
codes are replacing and reflects a commensurate increase in work 
relative to the increase in intraservice time.
    For the direct PE inputs, we are proposing 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 946X1 and 946X2. The recommended materials for this code family 
state that the 15 minutes for the CA011 activity are used for education 
which is an integral component of pulmonary rehabilitation programs. 
There is education provided at each separate session following a 
curriculum outlined in the guideline and covers both educational topics 
concerning self-management and educational topics concerning advance 
care planning which is different at every session.
    We do not agree that it would be typical for CPT codes 946X1 and 
946X2 to require an additional 13 minutes for education and consent 
given the patient is seen two to three times a week for pulmonary 
rehabilitation and the education can be covered during those sessions. 
We are refining the clinical labor time to 2 minutes for both CPT codes 
946X1 and 946X2 to maintain relativity, particularly in light of the 
clinical similarities between these services. The education would be 
done during the ``Perform procedure/service--NOT directly related to 
physician work time'' (CA021), as stated above, as the patient is seen 
two to three times a week for pulmonary rehabilitation.
    We are also proposing to refine the equipment time and lower 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 this change in clinical labor 
time for CPT codes 946X1 and 946X2.
    Additionally, we are proposing to revise the utilization that we 
would use to set rates for CPT code 946X2 to reflect our understanding 
that pulmonary rehabilitation is always done with pulse oximetry. Thus, 
we are proposing 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 946X2. We believe that it is unlikely that these 
services would typically be billed using CPT code 946X1 since it is our 
understanding that pulmonary rehabilitation is typically provided with 
pulse oximetry, and therefore, we expect little to no utilization for 
CPT code 946X1. We are seeking comment from stakeholders on our 
understanding and proposal to revise the utilization as stated.
(37) Remote Therapeutic Monitoring (CPT Codes 989X1, 989X2, 989X3, 
989X4, and 989X5)
    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 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

[[Page 39174]]

physician work, although the specific equipment used is different.
    While there are notable similarities between the two sets of code 
descriptors, there are two primary differences. One difference is that 
according to RUC documents, primary billers of RTM codes are projected 
to be nurses 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 look similar to those 
of RPM. RPM services are considered to be E/M services and physical 
therapists, for example, are practitioners who cannot bill E/M 
services. The RTM codes, instead, are general medicine codes.
    In our review of the new codes, we identified an issue that 
disallows physical therapists and other practitioners, who are not 
physicians or NPPs, to bill the RTM codes. By modeling the new RTM 
codes on the RPM codes, ``incident to'' services became part of the 
three direct practice expense-only (PE-only) codes (that is, CPT codes 
989X1, 989X2, and 989X3) as well as the two professional work codes 
(that is, CPT codes 989X4 and 989X5). As a result, the RTM codes as 
constructed currently cannot be billed by, for example, physical 
therapists. We describe ``incident to'' services in the CMS Medicare 
Benefit Policy Manual, Chapter 15, beginning at section 60 and note 
that only physicians and certain other practitioners are authorized to 
furnish and bill ``incident to'' services. Incident to services are:
     An integral, although incidental, part of the physician's 
professional service (see Sec.  60.1);
     Commonly rendered without charge or included in the 
physician's bill (see Sec.  60.1A);
     Of a type that are commonly furnished in physician's 
offices or clinics (see Sec.  60.1A); and
     Furnished by the physician or by auxiliary personnel under 
the physician's direct supervision (see Sec.  60.1B).
    Additionally, we designated the treatment management RPM codes 
(that is, CPT codes 99457 and 99458) as care management services (84 FR 
62697 through 62698), which allow general supervision rather than 
direct supervision for incident to services. The treatment management 
RTM codes (CPT codes 989X4 and 989X5), because they are not E/M codes, 
cannot be designated as care management services. As a result, we are 
seeking 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 the RTM codes.
    The second primary difference between the RTM and RPM codes is the 
nature of the data to be collected and how it is collected. According 
to the code descriptors, RTM codes monitor health conditions, including 
musculoskeletal system status, respiratory system status, therapy 
(medication) adherence, and therapy (medication) response, and as such, 
allow non-physiologic data to be collected. Reportedly, data also can 
be self-reported as well as digitally uploaded. 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 medical 
device as described in section 201(h) of the Federal Food, Drug and 
Cosmetic Act (FFDCA). We are seeking 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 (for 
example, respiratory system status, musculoskeletal status, medication 
adherence, pain) for the RTM services.
    For CY 2022, we are proposing the RUC-recommended work RVU of 0.62 
for CPT code 989X4 (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 
989X5 (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 also 
are proposing the RUC-recommended direct PE inputs for the two 
treatment management codes, CPT codes 989X4 and 989X5, without 
refinement.
    We are proposing to refine the direct PE inputs for the three PE-
only codes: CPT code 989X1 (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 989X2 (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 989X3 (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 are proposing to value the PE for CPT code 989X1 by 
crosswalking to the PE RVU for RPM code 99453 upon which the new RTM 
code was based. We also are proposing to value the PE for CPT codes 
989X2 and 989X3 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 note that the only input to CPT code 
989X2 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 proposed rule (the PE section), 
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.
(38) Principal Care Management and Chronic Care Management (CPT Codes 
99490, 99439, 99491, 99X21, 99487, 99489, 99X22, 99X23, 99X24, and 
99X25)
    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

[[Page 39175]]

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 (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; 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 (Chronic care management 
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 (Chronic care management 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 
Complex Chronic Care Management (CCCM) and Principal Care Management 
(PCM), and added five new CPT codes: 99X21 (Chronic care management 
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)), 99X22 (Principal care 
management services for a single high-risk disease 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 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), 99X24 (Principal care management services, 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 99X25 (Principal care management 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 (see Table 12).
    We reviewed the RUC-recommended values for the 10 codes in the CCM 
family and are proposing to accept the recommended work values for the 
codes. We are proposing the RUC-recommended direct PE inputs without 
refinements. We believe that proposing to accept these updated values 
is 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 are seeking comment, 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 are 
interested in understanding more about the standard practice used by 
practitioners to obtain beneficiary consent for these services. We have 
received questions from stakeholders regarding the consent requirements 
for CCM services. We believe that these questions have arisen because 
of the many flexibilities allowed in response to the PHE for COVID-19. 
In particular, during the PHE for COVID-19, we allowed 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. As we consider what policies implemented during the PHE for COVID-
19 should remain in effect beyond the PHE, we are interested in 
understanding how billing practitioners furnishing CCM at different 
service sites (for example, physician office settings, RHCs, FQHCs) 
have been obtaining beneficiary consent over the past year and how 
different levels of supervision impact this activity. We welcome public 
comment on the issue, specifically on what levels of supervision are 
necessary to obtain beneficiary consent when furnishing CCM services 
and will

[[Page 39176]]

consider such comments in future rulemaking.
    We also are proposing to adopt CPT codes 99X22 (PCM First 30 
minutes provided personally by a physician or other qualified health 
care professional, per calendar month) and 99X24 (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] TP23JY21.020

(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 disagree 
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

[[Page 39177]]

2017 PFS final rule (81 FR 80339 through 80349).
    Although we are not proposing a change in the work time for HCPCS 
code G0500, we are soliciting comments on this issue in the interest of 
gaining additional information about the typical use of this procedure.
(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 at section 361 of the Public 
Health Service (PHS) Act for human cells, tissues, and cellular and 
tissue-based products (HCT/Ps). We want to 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 are proposing to create 
eight 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 believe that 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 are proposing to 
consider these products as incident to supplies in the office setting.
    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 are proposing 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 are also seeking 
comment and documentation regarding the appropriate values for these 
services for consideration of national pricing in future rulemaking.
    Though we are proposing contractor pricing in the interim, 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 limited data 
exists 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 hospital outpatient 
department costs for graft synthetic skin substitute products averaged 
$1,500. 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

[[Page 39178]]

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 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 regards 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 $1,500. 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, 
for the purposes of the work RVUs, MP RVUs, and facility PE RVUs, we 
believe 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 realize 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 welcome 
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 are also seeking 
comment on the alternative approach that we considered (using 
crosswalks to value these services in the physician office setting). 
Additionally, we are seeking 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.
(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 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

[[Page 39179]]

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 are once again seeking 
public comment 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, would 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 are proposing to maintain contractor 
pricing for these services.
(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. CMS is 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 are 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 are 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.
(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.\4\ In the United States, 42.6 percent 
of adults report having pain on some days in the past 6 months,\5\ and 
chronic pain and high-impact chronic pain are experienced by 20.4 
percent and 8 percent of adults, respectively.\6\ 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.\7\
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Medical care. 2013 Oct;51(10).
    \5\ Erratum: Vol. 66, No. 29. MMWR Morb Mortal Wkly Rep 
2017;66:1238. DOI: https://dx.doi.org/10.15585/mmwr.mm6644a10external 
icon.
    \6\ 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: 
https://dx.doi.org/10.15585/mmwr.mm6736a2.
    \7\ 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.\8\ 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 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.\9\ 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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    \8\ https://www.nap.edu/catalog/13172/relieving-pain-in-america-a-blueprint-for-transforming-prevention-care.
    \9\ https://www.iprcc.nih.gov/national-pain-strategy-overview/national-pain-strategy-report.
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    This work was followed by HHS's 2019 release of its Pain Management 
Best Practices Inter-Agency Task Force Report: Updates, Gaps, 
Inconsistencies, and Recommendations (PMTF Report).\10\ 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

[[Page 39180]]

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 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 Public Health Emergency 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.
---------------------------------------------------------------------------

    \10\ https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf.
---------------------------------------------------------------------------

    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.\11\ 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).\12\
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    \11\ https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
    \12\ 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.\13\ 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.\14\ 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 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.\15\
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    \13\ https://www.hhs.gov/opioids/sites/default/files/2019-10/Dosage_Reduction_Discontinuation.pdf.
    \14\ https://www.cdc.gov/drugoverdose/pdf/assessing_benefits_harms_of_opioid_therapy-a.pdf.
    \15\ 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.\16\
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    \16\ 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

[[Page 39181]]

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 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's 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 would 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.'' \17\ 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.\18\ 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,\19\ which integrates functional status, and then aim to 
optimize physical function and mental function in the beneficiary with 
chronic pain.
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    \17\ https://www.qualityforum.org/Home.aspx.
    \18\ https://www.qualityforum.org/ProjectMaterials.aspx?projectID=89422.
    \19\ 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.\20\
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    \20\ 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 \21\ on dually eligible beneficiaries using ``high dose'' opioids 
to treat pain between 2006 through 2015

[[Page 39182]]

indicated that the common conditions in beneficiaries studied were 
chronic pain, migraine, rheumatoid arthritis, osteoporosis, HIV/AIDS, 
viral hepatitis, and SUD.\22\
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    \21\ https://www.macpac.gov/wp-content/uploads/2020/06/Chapter-1-Integrating-Care-for-Dually-Eligible-Beneficiaries-Background-and-Context.pdf.
    \22\ 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 are soliciting 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 are interested in feedback regarding whether the resource costs 
involved in furnishing these activities would 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 seek information on which healthcare settings and stages in 
treatment these transitions from opioid dependence are occurring, as 
well as what types of practitioners furnish these services. We are 
soliciting 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 
also seek comment 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.
BILLING CODE 4120-01-P

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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 are proposing a number of refinements to our 
current policies. The following section will discuss proposed policies 
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 a 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 39204]]

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/PhysicianFeeSched/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.'' \23\ In this section of our proposed rule, 
we use the term ``CPT E/M Guidelines'' to refer to this material.
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    \23\ 2021 CPT Codebook, p. 5.
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    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).'' \24\
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    \24\ 2021 CPT Codebook, p. 7.
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    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 this proposed rule, we are making 
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.
b. Definition of Split (or Shared) Visits
    We are proposing 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 propose to add this definition to a 
new section of our regulations at Sec.  415.140.
    Additionally, we propose 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 are proposing to revise our regulations at Sec.  415.140 to 
codify this definition.
    We believe 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, will 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 do 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 for the visit, rather than billing under the 
NPP's own provider number.
    We are also proposing 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 are proposing 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

[[Page 39205]]

the evolving role of NPPs as part of the medical team.
c. Definition of Substantive Portion
(1) More Than Half of the Total Time
    As stated earlier, only the physician or NPP who performs the 
substantive portion of the split (or shared) visit would bill for the 
visit. We are proposing to define ``substantive portion'' as more than 
half of the total time spent by the physician and non-physician 
practitioner performing the visit. We note 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 medical decision-making (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 believe 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 do 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 do 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 are proposing 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 are proposing to revise our 
regulation at Sec.  415.140 to codify this definition.
    We recognize 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 propose to base the definition of substantive portion on 
the amount of time spent by the physician and NPP providing the visit. 
We recognize that this policy would necessitate the practitioners' 
tracking and documenting the time they spent for these visits. However, 
we believe 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 do not believe this would comprise a substantial new 
burden.
(2) Distinct Time
    We propose 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).
---------------------------------------------------------------------------

    \25\ 2021 CPT Codebook (Evaluation and Management (E/M) Services 
Guidelines), p.7.
---------------------------------------------------------------------------

(3) Qualifying Time
    Drawing on the CPT E/M Guidelines, we are proposing 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 are proposing the same listing of activities that can 
count when time is used to select 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\
---------------------------------------------------------------------------

    \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 are proposing a 
different listing of qualifying activities, discussed in our section 
below on split (or shared) critical care services. Additionally, we are 
seeking public comment 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 visits, 
since those visits also have a unique construct.
(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/

[[Page 39206]]

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 believe 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 are proposing 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 note 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.
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, we believe 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 electronic health records 
(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 see 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 are proposing 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 
believe 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.
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 are proposing to allow billing of split (or 
shared) visits, including critical care visits, when they are performed 
in any institutional setting and are proposing 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. of this proposed 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 propose to define 
split (or shared) visits to be limited to services furnished in 
institutional settings, as discussed above. As discussed below, we do 
not see any reason to preclude billing for split (or shared) visits for 
critical care services, although we are seeking 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 
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 are less 
concerned about potential disruptions in continuity of care than we 
might once have been. Rather, we believe 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 do 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. If finalized, 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 propose that those visits could be furnished and 
billed as split (or shared) visits.
f. Same Group
    In accordance with the current policy outlined in the withdrawn 
manual provisions, we are proposing 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 believe 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

[[Page 39207]]

and NPP to bill independently, and only for the services they 
specifically and fully furnish. Further, consistent with our withdrawn 
manual guidance, we note 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 furnish 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 are seeking public comment on whether we should further define 
``group'' for purposes of split (or shared) visit billing. While we are 
not proposing a definition in this proposed rule, we have 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.\27\ We are 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 
as being in the same group. We are 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 note 
that some of these approaches may not align with the definition of 
``group'' used for purposes of Medicare enrollment.
---------------------------------------------------------------------------

    \27\ 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.''
---------------------------------------------------------------------------

g. Medical Record Documentation
    To ensure program integrity and quality of care, we are proposing 
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 are proposing to 
revise our regulation at Sec.  415.140 to reflect the conditions of 
payment for split (or shared) visits as discussed in this section.
h. Claim Identification
    We are proposing to create a modifier to describe split (or shared) 
visits, and we are proposing 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 believe 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 below for additional 
information). The proposed modifier, if finalized, 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 are proposing 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 are proposing 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 are also 
considering whether it is necessary to amend our regulations to 
explicitly state that Medicare does not pay for partial E/M visits and 
are interested in public comments on this issue.
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 
are proposing a number of refinements to other E/M code sets. 
Historically, our policy for billing critical care services was 
reflected in several provisions of the Medicare Claims Processing 
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 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, 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 accompanying enforcement instruction issued on May 26, 
2021, available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Evaluation-and-Management-Visits. In those documents, we indicated that we intend to 
address split (or shared) visits (addressed above) 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. Therefore, in this section of the proposed rule, we are 
proposing 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.
    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 are proposing to adopt the CPT 
prefatory language for critical care services as currently described in 
the CPT Codebook, except as otherwise specified in this section of the 
proposed rule. Should CPT make changes to the guidance for critical 
care services in a

[[Page 39208]]

subsequent edition of the CPT Codebook, we could revisit these policies 
in future rulemaking.
    We are also proposing to clarify our definition of critical care 
visits, and the requirements governing how critical care visits are 
reported when more than one practitioner or specialty is involved in 
furnishing critical care services to a patient. Further, we are 
proposing to prohibit a practitioner that reports critical care 
services furnished to a patient from also reporting any other E/M visit 
for that same patient on the same calendar day that the critical care 
services are furnished to that patient, and vice versa. Additionally, 
we are proposing to prohibit practitioners from reporting critical care 
visits during the same time-period as a procedure with a global 
surgical period.
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). As 
stated above, the 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, and that definition tracked 
closely with the CPT prefatory language regarding critical care 
services. To improve transparency and clarity, we are proposing to 
adopt the CPT prefatory language as the definition of critical care 
services. 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.\28\ It involves high 
complexity decision-making to treat single or multiple vital organ 
system failure and/or to prevent further life-threatening deterioration 
of the patient's condition. We continue to believe 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 are 
proposing to adopt the CPT prefatory language as the definition of 
critical care services, and refer readers to the CPT Codebook for 
additional details.
---------------------------------------------------------------------------

    \28\ 2021 CPT Codebook, p. 31.
---------------------------------------------------------------------------

    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 are proposing that critical care services may be reported by a 
physician or NPP who is a QHP as explained above.
    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 are proposing to adopt this CPT prefatory 
language to improve transparency and clarity of our policy for this 
service for Medicare billing purposes.
    CPT prefatory language and billing and coding 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 are proposing to adopt CPT's 
listing of bundled services that are part of critical care visits to 
improve transparency and clarity of our policy for this service. 
Therefore, we are proposing that the following services would be 
bundled into critical care visits: Interpretation of cardiac output 
measurements (93561, 93562), chest X rays (71045, 71046), pulse 
oximetry (94760, 94761, 94762), blood gases, and collection and 
interpretation of physiologic data (for example, ECGs, blood pressures, 
hematologic data); gastric intubation (43752, 43753); temporary 
transcutaneous pacing (92953); ventilator management (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 are also proposing 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.
b. Critical Care by a Single Physician or NPP
    Our withdrawn manual provisions and the prefatory language in the 
CPT Codebook cited above 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 for this 
service, we are proposing 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. Thereafter, they would report CPT code 99292 for 
additional 30-minute time increments provided to the same patient. We 
refer readers to the CPT Codebook for examples of the total duration of 
critical care visits.\29\ 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 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. 
The CPT Codebook indicates that CPT code 99291 is used to report the 
first 30-74 minutes of critical care on a given date, and that the code 
should be used only once per date even if the time spent by the 
practitioner is not continuous on that date. We are proposing to adopt 
this rule for critical care services furnished by a single physician or 
NPP. We note that the prefatory language does not indicate how 
practitioners should report critical care when a service lasts beyond 
midnight. We are seeking comment about how practitioners should report 
CPT codes 99291 and 99292 when a service extends beyond midnight to the 
following calendar day.
---------------------------------------------------------------------------

    \29\ CPT Codebook, p. 32.
---------------------------------------------------------------------------

c. Critical Care Services Furnished Concurrently by Different 
Specialties
    The CPT Codebook does not provide any special instructions 
regarding how to report critical care furnished 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

[[Page 39209]]

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 
overlap. Consistent with our current policy, and to improve 
transparency and clarity of our policy for critical care services, we 
are proposing that concurrent care occurs where more than one physician 
or qualified NPP furnishes services to the same patient on the same 
day. In general, concurrent care is covered when the services of each 
practitioner are medically necessary, and not duplicative. For example, 
concurrent care may be medically necessary because of the existence of 
more than one medical condition requiring diverse specialized medical 
services, that is, more than one specialty (which can include a 
qualified NPP as a specialty). 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 are proposing 
that critical care services may be furnished as concurrent care (or 
concurrently) to the same patient on the same day 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. However, as for 
most Medicare-covered services, these critical care services 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 are seeking comment on this 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.
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 that we generally 
acknowledge, a practitioner who furnishes a timed service such as 
critical care would typically need to report the primary service or 
procedure code before reporting an add-on code. However, we are 
proposing 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 day, 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. Because practitioners in the same 
specialty and same group cover for one another to provide concurrent 
critical care 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. 
The practitioner furnishing the initial critical care service would 
report CPT code 99291, and the practitioner(s) reporting subsequent 
critical care service time would report CPT code 99292.
    Under our current policy, the initial critical care service must be 
performed by a single physician or qualified NPP. In considering and 
reevaluating this policy, we believe it would better reflect current 
medical practice to allow critical care service time spent by more than 
one practitioner in the same group with the same specialty to be added 
together for the purposes of meeting the time requirement to bill for 
the initial critical care service using CPT code 99291. We are 
proposing this policy for two main reasons. First, we believe this 
proposal would appropriately recognize that multiple practitioners in 
the same specialty and group can concurrently furnish critical care 
services to a patient on a single day. Second, this proposal would 
conform our policy for the initial critical care service with our 
proposal described above for multiple practitioners in the same 
specialty and same group to report CPT code 99292 for their cumulative 
critical care service time. Thus, we are proposing that where one 
practitioner begins furnishing the initial critical care service but 
does not meet the time required to report CPT code 99291, and another 
practitioner in the same specialty and group continues to deliver 
critical care to the same patient on the same day, the time spent by 
those practitioners could be aggregated to meet the time requirement to 
bill CPT code 99291. Under our proposal, once the cumulative required 
critical care service time is met to report CPT code 99291, CPT code 
99292 would not be reported by the practitioner or another 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 (114 total minutes). Finally, consistent with our current 
policy, we are proposing 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. We are seeking 
comment on this 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

[[Page 39210]]

critical care services to a patient on a single day.
e. Split (or Shared) Critical Care Services
    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 proposed 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 believe 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 
are proposing that critical care visits may be furnished as split (or 
shared) visits. The proposals described in section II.F.1. of this 
proposed rule for split (or shared) visits would apply (with one 
exception 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 are proposing 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).
    In section II.F.1. of this proposed rule, drawing on the CPT E/M 
Guidelines, we proposed a list of activities that could count toward 
total time for purposes of determining the substantive portion. We 
stated that since critical care services can include additional 
activities that are bundled into the critical care visits code(s), we 
are proposing 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 CPT Codebook. Thus, when 
critical care services are furnished as a split (or shared) visit, we 
are proposing 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. Additionally, the billing practitioner would 
first report CPT code 99291 and, if 75 or more cumulative total minutes 
were spent providing critical care, 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 we are proposing that the 
documentation and other rules proposed in section II.F.1. of this 
proposed rule for split (or shared) visits would apply to split 
critical care services. We note that, in contrast to our proposals 
regarding concurrent critical care services above, we are proposing 
that 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 may be counted only once for 
purposes of reporting the split (or shared) critical care visit. This 
proposed policy accords with our proposed policy for all split (or 
shared) visits. It also accords 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).\32\
---------------------------------------------------------------------------

    \32\ 2021 CPT Codebook (Evaluation and Management (E/M) Services 
Guidelines), p.7.
---------------------------------------------------------------------------

    We are seeking comment on these proposals to ensure they reflect a 
clinically appropriate approach, and intend to assess whether we should 
instead require that an individual physician or NPP directly perform 
the entirety of each critical care visit. We are seeking comment on 
this 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 to a patient.
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.\33\ 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.'' \34\ With respect to hospital visits, hospital ED visits, 
and critical care services furnished on the same day, 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 the same date as 
critical care services when provided by the same physician to the same 
patient.'' \35\
---------------------------------------------------------------------------

    \33\ Medicare Claims Processing Manual (Pub. 100-02), Chapter 
12, Section 30.6.5, Physicians In Group Practice.
    \34\ 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.
    \35\ 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 are concerned that adopting the CPT rule that critical care and 
other E/M visits may be furnished to the same patient on the same date 
by the same practitioner could have unintended consequences for the 
Medicare program. We have previously expressed concerns that 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). It is 
possible that adopting the CPT rule allowing billing for critical care 
and other E/M

[[Page 39211]]

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 are proposing 
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.
    There are possible alternative approaches to address 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 have previously considered a 
Multiple Procedure Payment Reduction (MPPR) for standalone office/
outpatient E/M visits that occur on the same day as a procedure to 
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 use documentation requirements 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 also recognize 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, 
may be appropriate only in certain clinical situations. For example, it 
may be possible that a patient would 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 may also be possible that the 
practitioner who furnished the ED visit later provided critical care 
services to the same patient on the same calendar date. Thus, we are 
seeking comment on this proposal to better understand clinical practice 
for critical care, whether and how CMS could pay for E/M services 
furnished on the same date as critical care services when provided by 
the same practitioner, or practitioners in the same specialty within a 
group, while also reducing the potential for duplicative payment.
g. Critical Care Visits and Global Surgery
    Critical care services may be needed on the on the same calendar 
date as a procedure code with a global surgical 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 the challenges of 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. We finalized a policy to change all 
global periods to 0-day global periods, and 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 will 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 the 
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 are proposing to bundle critical 
care visits with procedure codes that have a global surgical period. We 
note that this proposal contrasts with the 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.\36\ As we have made clear in previous rulemaking, we are 
continuing to assess values for global surgery procedures (84 FR 2452), 
including in particular the number and level of preoperative and 
postoperative visits, which can include critical care services. Because 
this work is still ongoing, we are proposing to bundle critical care 
visits with procedure codes that have a global surgical period.
---------------------------------------------------------------------------

    \36\ Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, 
Section 40.2.9, available on the CMS website.
---------------------------------------------------------------------------

h. Documentation Requirements
    Because critical care is a time-based service, we are proposing 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). The documentation 
would also 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, 
services would need to be sufficiently documented to allow a medical 
reviewer to determine the role each practitioner played in the 
patient's care (that is, the condition or conditions for which the 
practitioner treated the patient). To support coverage and payment 
determinations regarding split (or shared) critical care services, the 
documentation requirements proposed above for all split (or shared) E/M 
visits would also apply to critical care visits (see section II.F. of 
this proposed rule).
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

[[Page 39212]]

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 are proposing 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 
resident's 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 note 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 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.
b. Primary Care Exception Policy
    The regulation at Sec.  [thinsp]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 are proposing 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.  [thinsp]415.174 is 
that E/M visits of lower and mid-level complexity furnished by 
residents are simple enough to permit a teaching 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 would 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 are proposing 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 are seeking comment 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 
are also seeking comment 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.

[[Page 39213]]

G. Billing for Physician Assistant (PA) Services

    Under the respective Medicare statutory benefit categories for 
services of Physician assistants (PAs), nurse practitioners (NPs), and 
clinical nurse specialists (CNSs), these practitioners 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 furnished incident to the practitioners' 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 the Act, is equal to 80 percent of the lesser of the 
practitioner'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), amends 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 
neither changed 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 did 
it change the statutory payment percentage applicable to PA services 
specified in section 1833(a)(1)(O) of the Act.
    We are proposing to amend pertinent sections of our regulations to 
reflect the amendment made by section 403 of the CAA. Specifically, we 
are proposing 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 January 1, 2022. We are also proposing to amend Sec.  410.150(b) 
to redesignate the current requirements in paragraph (b)(15) as Sec.  
410.150(b)(15)(i), and to amend that paragraph 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 propose 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 furnished incident to their services. We would 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 proposed new 
paragraph at Sec.  410.150(b)(15)(ii) would provide that payment will 
be 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 also intend to update our program manual 
instructions to reflect the statutory change made by section 403 of the 
CAA and the changes to our regulations.

H. Therapy Services

    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 physical therapist assistants (PTAs) 
and occupational therapy assistants (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

[[Page 39214]]

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 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 
are proposing 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 proposed 
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

[[Page 39215]]

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 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

[[Page 39216]]

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 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 propose 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 19, this proposal would require 
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.

[[Page 39217]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.042

    Under this proposed 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 
proposed ``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 20.
[GRAPHIC] [TIFF OMITTED] TP23JY21.043

    With these proposed 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 19) 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 propose 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.

[[Page 39218]]

    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 are proposing 
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 
propose that one unit of the service would be billed with the CQ/CO 
modifier and the other unit of the service would be billed without the 
assistant modifier. We are proposing 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 Comprehensive 
Outpatient Rehabilitation Facility (CORF) services.
    As noted above, 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 are proposing 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 
are proposing 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 an MLN 
article once the CR is released, after the CY 2022 PFS final rule is 
issued.
    We are seeking comment on all of our proposals.

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

    Section 122 of the Consolidated Appropriations Act (CAA) of 2021, 
Waiving Medicare Coinsurance for

[[Page 39219]]

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 enemas, which are not recommended by the USPSTF with a grade of 
A or B).\37\
---------------------------------------------------------------------------

    \37\ We refer readers to the CY 2022 OPPS proposed 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;

[[Page 39220]]

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 are 
proposing 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 note 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 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 are proposing to make two modifications to current 
regulations.
    At Sec.  410.37, we propose 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 propose to modify our regulation. 
Here we describe payment for colorectal cancer screening tests. 
Effective January 1, 2022, we propose 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 propose 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 in CY 2030 and will remain at zero percent for these 
services furnished beginning in CY 2030 and thereafter.

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

    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 
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 April 15, 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 
proposed 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

[[Page 39221]]

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 this section, we are 
seeking 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
    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 hospital outpatient department, rural health 
clinic (RHC), or federally qualified health center (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 note 
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. To implement this section, we issued 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 note 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 this proposed rule.
    We note that the vaccine administration services described under 
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 note 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 note that these 
payments 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 noted in Table 21, the national 
payment rate for administering these preventive vaccines has declined 
more than 30 percent since 2015.

[[Page 39222]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.044

    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 payment rates for vaccine 
administration services at a rate that is approximately the same as the 
CY 2017 rate (as noted in Table 21) 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. Section 3713 of the CARES Act allows us to implement 
the amendments made by that section through ``program instruction or 
otherwise.'' In the November 4th COVID-19 IFC (85 FR 71147) 
implementing section 3713 of the CARES Act, we indicated that we would 
establish specific coding and payment rates for the COVID-19 vaccine 
and vaccine administration through technical direction to Medicare 
Administrative Contractors (MACs) and information posted publicly on 
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 39223]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.045

    As discussed above, payment rates for suppliers such as physicians, 
NPPs, and mass immunizers for administering the Part B covered 
preventive vaccines have generally been based on a direct crosswalk to 
CPT code 96372 (Therapeutic, prophylactic, or diagnostic injection 
(specify substance or drug); subcutaneous or intramuscular). 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 an ambulatory payment 
classification (APC) to each service 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.
    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 note 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 are requesting 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 are interested in detailed feedback on the following 
questions, which we believe would 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 note 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.) We are also interested in whether 
different providers and suppliers furnish different aspects of the 
vaccine administration for the same beneficiary.
     What are the differences in incurred costs of furnishing 
flu, pneumonia 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? We are interested in specific information on 
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 are also interested in 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, how, and what would be the 
primary factors driving the change)?
     As described previously, Medicare has generally relied on 
the PFS methodology for setting payment rates for HCPCS codes G0008, 
G0009 and

[[Page 39224]]

G0010. 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, 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 hospital 
outpatient departments 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 beneficiary's 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 are also interested in feedback on specific rates used by 
other insurers.
2. Payment for COVID-19 Vaccine Administration in the Home
    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 
beneficiary's home.\38\ Under this new policy, providers and suppliers 
that administer a COVID-19 vaccine in a beneficiary's 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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    \38\ 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 beneficiary's 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 beneficiary's 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. We are clarifying 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, as well as most nursing 
facilities under Medicaid.\39\
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    \39\ 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, the COVID-19 vaccine administration service must be 
furnished inside an individual's home. 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

[[Page 39225]]

home) are 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 can 
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 is 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 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.
    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''.\40\ We are using this proposed rule as a way to 
collect feedback on these policies and potential future changes.
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    \40\ https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
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     We are interested in 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. We are interested in detailed feedback on the costs 
associated with furnishing COVID-19 vaccines in the home, and how 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?
    We note that this add-on payment of $35.50 only applies when 
providers or suppliers furnish the COVID-19 vaccine in the 
beneficiary's home, and is not billable when providers and suppliers 
furnish a different preventive vaccine (influenza, pneumonia, HBV) in 
the home. 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 are interested in 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

[[Page 39226]]

circumstances, and whether the costs to furnish other preventive 
vaccines in the beneficiary's home would be consistent with the costs 
to furnish the COVID-19 vaccine.
3. Monoclonal Antibodies Used To Treat COVID-19
    On November 10, 2020, the FDA issued an Emergency Use Authorization 
(EUA) for bamlanivimab monotherapy.\41\ On November 21, 2020 the FDA 
issued an EUA for casirivimab and imdevimab, which are administered 
together.\42\ On February 9, 2021, the FDA issued an EUA for 
bamlanivimab and etesevimab, which are also administered together.\43\ 
On April 16, 2021, the FDA revoked the EUA for bamlanivimab 
monotherapy.\44\ On May 26, 2021, the FDA issued an EUA for sotrovimab 
monotherapy.\45\ On June 3, 2021, the FDA revised the EUA for 
casirivimab and imdevimab, which revised the dosing regimen from 2400mg 
(1200 mg of casirivimab and 1200 mg of imdevimab) to 1200mg (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.\46\ On June 24, 2021, the FDA issued an 
EUA for tocilizumab monotherapy.\47\ Under the EUAs, for all of these 
products except for tocilizumab, they can 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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    \41\ https://www.fda.gov/media/143602/download.
    \42\ https://www.fda.gov/media/143891/download.
    \43\ https://www.fda.gov/media/145801/download.
    \44\ https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab.
    \45\ https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-monoclonal-antibody-treatment-covid-19.
    \46\ https://www.regeneron.com/downloads/treatment-covid19-eua-fda-letter.pdf.
    \47\ https://www.fda.gov/media/150319/download.
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    When these products were authorized 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''.\48\
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    \48\ 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 note 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, the sotrovimab monotherapy, 
and the tocilizumab monotherapy. All four products may be administered 
through intravenous (IV) infusion, and casirivimab and imdevimab may be 
administered via subcutanoues 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 note 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 note 
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 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.\49\
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    \49\ https://www.cms.gov/newsroom/press-releases/cms-increases-medicare-payment-covid-19-monoclonal-antibody-infusions.
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    The decision to cover and pay for monoclonal antibody products used 
to treat COVID-19 under the COVID-19 vaccine benefit prioritized access 
to 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 note 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 note 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, 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), the 
sotrovimab monotherapy has been authorized and the tocilizumab 
monotherapy has been authorized. It is also becoming clear that, as 
more products enter the market, the federal government may not purchase 
them for distribution to providers and suppliers for free, as is the 
case with sotrovimab monotherapy and tocilizumab monotherapy. Given 
these fast-moving changes, we are seeking feedback on our approach to 
coverage and payment for COVID-19 monoclonal antibody products under 
the COVID-19 vaccine benefit. 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 
believe that 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

[[Page 39227]]

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 note 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 how it applies to other drugs and biologics that are 
not paid for under a preventive vaccine benefit.
    We also note that tocilizumab--typically sold under the brand name 
Actemra--was previously approved by the FDA for several 
indications.\50\ 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 are interested in feedback on these issues.
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    \50\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125472s044lbl.pdf.
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    We are also interested in 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 are 
interested in 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.
4. Summary
    We have taken several steps to promote timely access to COVID-19 
vaccines including monoclonal antibody products during the PHE for 
COVID-19. As explained above, we increased the payment rates we 
initially established for services to administer a COVID-19 injected 
vaccine and a COVID-19 infused or injected monoclonal antibody product. 
We also developed specific payment rates when these products are 
administered in the beneficiary's home. Taken together, these efforts 
signal our understanding of the importance of COVID-19 vaccines for the 
health of the individual beneficiary and the public. We also believe 
these efforts, and the PHE broadly, provide an opportunity to consider 
a more rational payment framework for the other preventive vaccines 
covered under Medicare Part B. We are encouraged by stakeholder 
engagement on these important issues and continue to seek information 
that reflects the resource costs that we should consider for vaccine 
administration services. We are interested in detailed feedback and 
verifiable data from the public to help inform whether we should 
consider making changes to payments for administering preventive 
vaccines, or develop separate payments for vaccine administration in 
the home.
    We appreciate feedback from the public on these important issues 
regarding preventive vaccine administration, vaccine administration in 
the home, and monoclonal antibodies used to treat COVID-19.

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 benefits 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 services that are furnished by a 
registered dietitian or nutrition professionals. 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 is discussed in this proposed rule at section III.H. More 
recently, stakeholders who are 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 proposal to address 
them are discussed elsewhere in this rule (see section III.H.), 
including proposals to remove the requirement that the MNT referral be 
made by the ``treating physician'' and update the glomerular filtration 
rate (GFR) to reflect current medical practice. And, some factors are 
being considered here. First, stakeholders recommend 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 recommend 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.

[[Page 39228]]

    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 
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).
    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 references 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 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 are now proposing to modify to the 
requirement at Sec.  414.64(a) for payment of MNT services to reflect 
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.
    Because the registered dietitian and nutrition professional are the 
only practitioners 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 are 
proposing to create a new section at Sec.  410.72 to reflect these 
policies. We are proposing 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 are proposing 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 personally 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 are proposing 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 propose 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 propose 
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 are proposing 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 are also proposing 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 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

[[Page 39229]]

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 are adding 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.
    As such, we are proposing to add at 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 in the CY 2002 PFS final rule (66 
FR 55331). In addition, in the CY 2002 PFS final rule, we established a 
regulation at Sec.  410.132(a) that requires registered dietitians and 
nutrition professionals to provide MNT services and that those services 
consist of face-to-face nutritional assessments and interventions in 
accordance with nationally accepted dietary or nutritional protocols. 
Both of these provisions were codified in our regulations at Sec. Sec.  
410.132(a) and 410.134.
    In 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 payment for MNT services would not 
be made when beneficiaries are inpatients in Part A stays in hospitals 
and skilled nursing facilities (SNFs) (66 FR 55279). We explained that 
our payment to hospitals and SNFs includes payment for MNT services. We 
established these regulations at Sec.  414.64(c). We are proposing to 
add these rules to our regulation at Sec.  410.72(c)(1) and (2), as on 
payment for services of registered dietitians and nutrition 
professionals when beneficiaries are inpatients of hospitals and SNFs. 
Also, in the CY 2001 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. This was 
codified at Sec.  410.132(b). We are proposing to add this non-covered 
service to our regulation at Sec.  410.72(c)(3) and note its 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 are proposing 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 note that the proposed regulatory text for Sec.  410.72(f) 
is consistent with the text in existing Sec. Sec.  410.74(d)(2), 
410.75(e)(2), 410.76(e)(2) and 410.77(d)(2). We are also considering 
whether alternate regulatory text that cross-refers to the assignment 
requirements in Sec.  424.55 would provide additional clarity. 
Specifically, we are considering whether to specify restrictions at 
Sec.  410.72(f) to specify 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 42 CFR 424.55. In 
addition, 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, 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 seek public comments on the clearest 
language to describe the assignment requirements.
    We are seeking comment on our proposals.

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, nurse practitioners (NPs), physician assistants (PA), 
certified nurse midwives (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 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. 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, 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

[[Page 39230]]

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 
proposed 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 \51\), 
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), 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 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 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,\52\ 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,\53\ 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 \54\ (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

[[Page 39231]]

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) \55\ (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
    Section 130 of the Consolidated Appropriations Act, 2021 (CAA 2021) 
(Pub. L. 116-260, December 27, 2020) updated section 1833(f) of the Act 
by restructuring the payment limits for RHCs beginning April 1, 2021. 
We note that section 2 of H.R. 1868 (Pub. L. 117-7), enacted April 14, 
2021, provided a technical correction to 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).
    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.
    Beginning April 1, 2021, provider-based RHCs that meet 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, are 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. The details of the most recent MEI 
rebasing and revising is 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. We note that the MEI percentage increase for CY 
2021 is 1.4 percent, which reflects historical MEI data through the 2nd 
quarter 2020 and historical multifactor productivity (MFP) data through 
2019. 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/.
    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. The proposed CY 2022 MEI update is 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 are

[[Page 39232]]

proposing that if more recent data become available after the 
publication of this proposed rule and before the publication of the 
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.
    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.
    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.
    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
    As we stated above, RHCs began to receive an increase in the 
national statutory payment limit over an 8-year period, with a 
prescribed amount for each year from 2021 through 2028. Prior to this 
legislation, the CY 2020 national statutory payment limit for RHCs was 
$86.31. Then for calendar year 2021, there are two sets of payment 
rules for RHCs. 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.\56\ 
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. 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 
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 note, 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 note 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 this proposed 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 will review each 
provider-based RHC using the existing bed count review process, as 
described above, to determine if this criterion is met. In addition, 
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 continuing 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 will 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 specifies that for the duration 
of the PHE, we will use the number of beds from the cost reporting 
period prior to the start of the PHE as the official hospital bed 
count. We note that the criteria specified in section 1833(f)(3)(B)(i) 
of the Act specifies ``in a hospital with less than 50 beds'' 
therefore, beginning April 1, 2021, we will apply the bed definition at 
Sec.  412.105(b) exclusively.
    Section 1833(f)(3)(B)(ii) of the Act, as added by section 2 of 
Public Law 117-7, requires that these specified provider-based RHCs as 
of December 31, 2020 are ``enrolled under 1866(j) (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 propose 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 propose to use the date an application or request was 
received to determine if the RHC met the qualification. 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 above 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 propose, 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

[[Page 39233]]

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 stated above, 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.
    We interpret the ``per visit payment amount'' to align with the 
interim rate process the MACs use in determining an RHC's AIR 
(discussed above in section III.A.2. of this proposed rule). 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 interpret 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, we understand that certain RHCs file consolidated cost 
reports, as described above. 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. 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, 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 statutory 
payment limit for RHCs. Therefore, beginning with RHCs enrolled in 
Medicare as of January 1, 2021, we will no longer allow new RHCs to 
file consolidated cost reports.
ii. All Other RHCs
    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. While there may be new RHCs that are ``in a hospital with less 
than 50 beds'' and ``enrolled under section 1866(j)'', 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.
    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. However, the payment limit that is established will 
be the maximum amount that an RHC will be paid by Medicare per visit. 
As discussed above, 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 will collect any 
overpayment for that visit. To implement this provision beginning April 
1, 2021, CMS instructed the MACs to increase the payment limits to $100 
per visit.
    Although the payment limit per-visit as set forth in section 
1833(f) of the Act has already been implemented in administrative 
instructions issued to the MACs in Change Request 12185, we are 
proposing revisions to Sec.  405.2462 to reflect the provisions set 
forth in section 1833(f)(2) and (3) of the Act. We solicit comment on 
these revisions and on our proposals regarding the implementation of 
section 130 of the CAA 2021.
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,\57\ 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

[[Page 39234]]

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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    \57\ 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 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.\58\
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    \58\ 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
    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 technical component, 
the provider furnishing the technical component 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 propose 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.
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), Medicare 
payment for TCM services furnished by an RHC or FQHC practitioner was 
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 
are 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 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 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

[[Page 39235]]

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 \59\ and on the CMS RHC \60\ and FQHC \61\ web 
pages.
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    \59\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.
    \60\ https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html.
    \61\ 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
    In the CY 2020 PFS final rule (84 FR 62687), we finalized a policy 
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, for CY 2022, we are proposing 
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 believe 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 note that 
under this proposal, time and effort could not be counted more than 
once.
4. Proposed 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, consistent with the changes described above, we are 
proposing 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 are proposing 
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.

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 professional component 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

[[Page 39236]]

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 FQHC market basket.
    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 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 permanent authority provided under section 
1834(m)(4)(C)(ii) of the Act, RHCs and FQHCs, like hospitals, physician 
offices, and other sites, are 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 when 
RHCs and FQHCs serve as the distant site 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,\62\ 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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    \62\ https://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,

[[Page 39237]]

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.\63\
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    \63\ 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
    We believe beneficiaries receiving mental health services from 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 also 
believe 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 believe 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 can access services furnished by RHCs and 
FQHCs in a manner similar to mental health services under the PFS after 
the PHE, we believe it is 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 are proposing 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 proposals for mental 
health services furnished under the PFS, as described in section II.D. 
of this proposed 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 are proposing 
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 note 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 prefer a hybrid whereby some mental 
health services are in person, but other times they are done using 
telecommunications technology. We believe that this decision should be 
based on the clinical judgment of the practitioner, in consideration of 
patient needs and preferences.
    This proposed 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 proposed 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 proposed 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 proposed 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 are proposing 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

[[Page 39238]]

service level modifier in cases where the service was furnished audio-
only.
    Additionally, we note 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 are seeking 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. If 
we were to establish a similar requirement for RHC and FQHC mental 
health services, we could consider the proposal for Medicare telehealth 
services described in section II.D. of this proposed 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.
d. Regulatory Changes
    We are proposing 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 are 
proposing 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 are also 
proposing 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.

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,\64\ 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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    \64\ 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 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. There are many FQHCs operated by IHS and 
tribes. 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

[[Page 39239]]

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. 
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.
    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 FQHC PPS 
market basket, 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
    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. The American 
Recovery and Reinvestment Act of 2009 section 5006(e)(1), 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.
    The TTAG has requested \65\ that CMS amend its Medicare regulations 
to make all IHS and tribally-operated outpatient

[[Page 39240]]

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, Ambulatory Surgical Centers are paid 
differently than hospital outpatient departments; which are paid 
differently whether they're under the under the outpatient prospective 
payments system or a located in a critical access hospital.
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    \65\ 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 note 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. Comment Solicitation
    We appreciate 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. However, we have insufficient information necessary 
to evaluate the costs and benefits of potential changes to these 
policies. Therefore, we would like to solicit comment 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 seek 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 seek 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 seek 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 seek 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.
    While, we have information on grandfathered tribal FQHCs and the 
outpatient hospital cost reports, we do 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 Fund, we are also seeking comment on the magnitude of that 
payment change and whether any program integrity concerns would be 
present with the increased payment. We also request 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 above, having a full 
picture of the costs of providing care is important so that CMS can be 
sure that payments are adequate. Are these services included in the 
IHS/AIR?
    We are also seeking 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, we could 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, we could 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. We seek comment 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.

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

[[Page 39241]]

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 \66\ from the definition of ``manufacturer'' for purposes 
of the ASP reporting requirement in section 1847A(f)(2) of the Act, if 
the Secretary determines appropriate.
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    \66\ 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.
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    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.
    We are proposing 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 42 
CFR part 414, 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 42 CFR part 414 
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 do not believe 
it is 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 seeks 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 propose 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.
    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 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.
    To confirm the Medicare Payment Advisory Commission's (MedPAC's) 
assertion in their June 2017 report (available at https://medpac.gov/docs/default-source/reports/jun17_ch2.pdf) that many repackagers 
currently do not report ASP data, and thus 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, we 
conducted an analysis to estimate the proportion of repackaged products 
in our existing ASP data. If our existing ASP data do not contain an 
appreciable

[[Page 39242]]

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).\67\ We also obtained a list of labeler codes for 
which the manufacturers have Medicaid drug rebate agreements.\68\ 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:
---------------------------------------------------------------------------

    \67\ https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory. We note that this list only included 
prescription drugs approved under a New Drug Application (NDA) or 
Abbreviated NDA (ANDA) and did not include biological products 
approved under a Biologics License Application (BLA) or devices.
    \68\ 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 estimate that, of all 6319 products for which we currently 
receive ASP data submissions (the sum of categories (1)-(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.\69\ 
We supplemented this crosswalk by adding HCPCS codes with NDCs that are 
payable under Part B, but not already reflected in the crosswalk.\70\ 
We then identified \71\ 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 estimate there 
will be 6994 total products for which manufacturers will now be 
required to submit ASP data. We then compared this number to the FDA's 
list of repackaged products in the previous analysis, and found that of 
the 6994 products for which manufacturers will be required to submit 
ASP data, 223 (3.19 percent) are repackaged products. Further, we 
estimate 6114 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.
---------------------------------------------------------------------------

    \69\ https://www.dmepdac.com/palmetto/PDACv2.nsf/DID/FFYLYC1WVL 
Accessed April 12, 2021, using the April 2021 files.
    \70\ We note that such products were spread across the second 
and fourth categories in the prior analysis.
    \71\ 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 do not persuade us that it is 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, CMS reviews 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 are 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 do not believe it is 
appropriate to exclude repackagers from the requirements of section 401 
at this time. However, we may propose to exempt repackagers in the 
future, if warranted.
    We solicit comment on this approach.
    In summary, we propose 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 are not proposing to exclude 
repackagers from the definition of manufacturer for purposes of the 
reporting requirements at section 1847A(f)(2) of the Act.
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),

[[Page 39243]]

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 Medicare Prescription Drug, Improvement, and Modernization Act 
(MMA) of 2003 (Pub. L. 108-173, December 8, 2003), as specifying the 
penalties associated with a manufacturer's failure to submit timely 
information or the submission of false information.
    We propose 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 propose 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 welcome comments on these proposals.
e. Summary of all Proposals
    In summary, to implement the new reporting requirements for 
manufacturers without Medicaid drug rebate agreements, we are proposing 
to modify:
     The definition of drug at Sec.  414.802; and
     The regulations describing civil money penalties at Sec.  
414.806.
    We welcome comments on these proposals.
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 Average Sales Price (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 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 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 \72\ \73\ 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.
---------------------------------------------------------------------------

    \72\ https://www.oig.hhs.gov/oei/reports/oei-12-17-00260.pdf, 
accessed March 15, 2021.
    \73\ 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, amended 
section 1847A of the Act by redesignating

[[Page 39244]]

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.
    We propose to codify the new requirements of section 1847A(g) of 
the Act at Sec.  414.904. Our proposals described in the next section 
specify when the application of the lesser-of methodology would be 
appropriate, describe how we will 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 
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. We 
propose that when the OIG conducts a periodic study, OIG informs us at 
the time the study becomes are publicly available. CMS will obtain the 
NDCs identified by the OIG study described in section 1847A(g)(1) of 
the Act. However, if the specific NDCs are not available in the OIG 
study report, we will request OIG provide documentation of the 
identified NDCs to CMS.
    To allow operational time for assessment and application of the 
lesser-of methodology, we believe it is 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 becomes 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 other words, the July ASP 
pricing file) and each quarter thereafter.
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 this section, we describe how we propose to apply the lesser-of 
methodology. We propose to codify this methodology, which we currently 
use for the billing and payment codes that describe certolizumab pegol 
and abatacept, and which we propose 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 average sales prices 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 average sales price 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 propose 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

[[Page 39245]]

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 will be used as the payment limit 
for the applicable billing and payment code for that quarter's ASP 
pricing files. We propose 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 does 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. We plan to 
incorporate methodology in the current operational process that is 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 (2017-2018) if such a 
methodology had been in place.
d. Exceptions
    We further propose that the application of the lesser-of 
methodology is 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.\74\ As stated in the OIG's July 
2020 report, CMS expressed concern about potential impact on 
beneficiary access if certain versions identified to be self-
administered were excluded from the ASP payment limit calculation. 
Because of potential for drug shortages that may affect patient care, 
beneficiary and provider access, and drug prices for providers, we 
would consider it not appropriate to apply the lesser-of methodology 
when a product 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 propose to add 
Sec.  414.904(d)(4)(ii) to specify that we will not apply the lesser-of 
methodology (that is, we will 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) at the time that ASP payment limits are 
being finalized for the next quarter. However, we propose 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 recognize that NDCs identified by 
an OIG study described in section 1847A(g)(1) or (g)(3) of the Act may 
change, for example, because of a manufacturer change. In the event 
that the manufacturer of an OIG-identified product simply redesignates 
the NDC for its product, we believe the new NDC also would meet the 
same criteria defined in the OIG study. In this circumstance, we expect 
that the product labeling would not contain substantial changes 
regarding the redesignated NDC. Therefore, we propose 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 will be used in the lesser-of methodology in the 
same way as the original OIG-identified NDC.
---------------------------------------------------------------------------

    \74\ 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 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.
e. Summary
    In summary, to implement new section 1847A(g) of the Act, we are 
proposing 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 welcome comments on these proposals.

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
    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 
Average Sales Price (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.

[[Page 39246]]

    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.\75\ 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.)
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    \75\ 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.
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    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 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.
    Based on these observed data points, we are planning an 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 3 of this 
preamble.
2. CY 2021 Proposal
    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,76 77 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

[[Page 39247]]

detail about the decision framework and the determination process.
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    \76\ 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.
    \77\ 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.
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    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 recognize that 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. The framework 
discussed in the next section 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.
    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. As part of our further 
consideration, we are soliciting 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.
    The framework described in the next section 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. We are not proposing to adopt the framework at this 
time. Rather, we are seeking comment on the framework to inform future 
policy making.
3. The Framework
    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.\78\ 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.
---------------------------------------------------------------------------

    \78\ 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/PhysicianFeeSched/PFS-Federal-Regulation-Notices.
    We are soliciting comment on:
     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.

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 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

[[Page 39248]]

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 
electronic health records (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 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.

[[Page 39249]]

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 hospital 
outpatient department services under section 1833(t) of the Act; and 
(3) the ambulatory surgical center 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 hospital outpatient department (including an 
emergency department), an ambulatory surgical center, 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 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,

[[Page 39250]]

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. Proposals for Continuing Implementation
a. Proposed 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. 
These BPM sections 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 propose 
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 instructions state 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.
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

[[Page 39251]]

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).
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 are soliciting comments on whether additional 
scenarios require our consideration, and whether the proposed solutions 
adequately address issues raised by stakeholders. We are soliciting 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. Therefore, we need to find 
workable solutions that allow the AUC program to accurately pay and 
deny claims using the information available on Medicare claims, while 
working within the limitations of the Medicare claims processing 
system. 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, hospital outpatient departments 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 hospital outpatient departments 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) \79\ to support the educational and 
operations testing period. We established HCPCS Level III G-codes for 
furnishing professionals to report which CDSM was consulted. 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 corresponding G-code. Both G-codes and 
modifiers are applicable to practitioner and institutional claims. We 
established additional HCPCS modifiers for furnishing professionals to 
report situations in which the ordering professional is not required to 
consult AUC. These modifiers are reported on the same claim line as the 
code for the advanced diagnostic imaging procedure since a G-code would 
not be reported. 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, which means that 90-91 percent of claims would not be 
considered compliant with AUC program 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.
---------------------------------------------------------------------------

    \79\ 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.
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 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

[[Page 39252]]

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 professional component (PC) of the service and on the 
provider's or supplier's claim for the facility portion or technical 
component (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 propose 
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 would 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 propose 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.
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 ambulatory surgical center 
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 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 appreciate that this has been brought to our attention and we seek 
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.
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

[[Page 39253]]

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 propose to allow 
institutional claims with condition code 44 to bypass AUC claims 
processing edits. We make 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 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.
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 are requesting comments to help us better 
understand which path would be most appropriate once we fully implement 
the AUC program claims edits. Additionally, we are requesting 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.
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 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 propose 
to exclude claims that identify Medicare as the secondary payer from 
application of the AUC consultation and reporting requirements. 
Specifically, we propose 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 propose 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 
proposed rule to indicate that the claim is not subject to the AUC 
claims processing edits.
viii. HCPCS Modifiers
    We established two primary sets of HCPCS modifiers for this 
program. One set is to be included on the same claim line as the G-code 
identifying the CDSM that was consulted, and reports whether the 
imaging service adheres to the AUC (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). 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 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 data was provided 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 
propose to redefine modifier MH to describe situations in which the

[[Page 39254]]

ordering professional is not required to consult AUC and the claim is 
not required to report AUC consultation information. For example, we 
would 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 proposed rule as those scenarios would fall outside the 
scope of the AUC program requirements.
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 hospital outpatient 
department (including an emergency department), and ambulatory surgical 
center 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 propose to limit AUC program claims processing 
edits to apply only to type of bill 13x (hospital outpatient). This 
claim type code encompasses the hospital outpatient department and the 
emergency department which represent all applicable settings under the 
program that would bill Medicare using institutional claims. For 
practitioner claims, we propose 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.
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 request feedback on 
whether additional scenarios require consideration and whether the 
proposed claims processing solutions will adequately address the issues 
raised. We also request 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 request 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 have 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 
would 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 are proposing 
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 seek public comment on this 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 seek 
information from the public on the state of readiness of practitioners, 
facilities, and EHR and CDSM vendors.
5. Summary
    In summary, we are providing 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 are also proposing several claims processing solutions to 
ensure accurate identification of claims that are and are not subject 
to the AUC program requirements. These proposals address special 
circumstances related to: Services furnished by a CAH, services paid 
under the Maryland Total Cost of

[[Page 39255]]

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 discuss 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 are also proposing 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 invite the 
public to submit comments on these clarifications and proposals.
    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/.

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 evolves 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 
(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:
     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 23, we list the NCDs that we propose 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 are proposing 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 believe the other five NCDs should be 
retained.
    We solicit comment on the two NCDs discussed in Table 23, as well 
as comments recommending other NCDs for CMS to consider for removal in 
a future rulemaking or through the NCD process.
[GRAPHIC] [TIFF OMITTED] TP23JY21.046

    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/

[[Page 39256]]

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 
Medicare administrative contractors (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 are 
proposing 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 are not proposing to change any other 
subsections of 220.6. Thus, the NCDs listed at 220.6.1 through 220.6.20 
would not be changed by this proposal.
    In summary, we solicit comment on the proposal to remove the two 
NCDs, as well as comments recommending other NCDs for CMS to consider 
for future removal. We request commenters include a rationale to 
support their comments. We will 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.

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 are proposing 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 are proposing 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),\80\ 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.\81\ 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.
---------------------------------------------------------------------------

    \80\ Fleg J.L., Keteyian S.J., Peterson P.N., Benzo R., 
Finkelstein J., Forman D.E., Gaalema D.E., Cooper L.S., 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.
    \81\ https://millionhearts.hhs.gov/tools-protocols/action-guides/cardiac-change-package/.
---------------------------------------------------------------------------

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) 
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)

[[Page 39257]]

(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.\82\ 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 
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.
---------------------------------------------------------------------------

    \82\ 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 evaluation and management (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. Proposed 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 are proposing 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 are also proposing to 
adjust the regulatory structure of Sec.  410.47 to align with Sec.  
410.49. The proposed revisions will also enable stakeholders with 
interest in both PR and CR/ICR programs to more easily compare 
requirements and implement programs.

[[Page 39258]]

a. Definitions
    We are proposing 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 are proposed for the CR/ICR definition of 
physician-prescribed exercise. We are proposing 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 are proposing conforming changes to the 
CR/ICR definition of medical director. Proposed revisions to the PR and 
CR/ICR definitions of outcomes assessment remove and revise redundant 
and unnecessary language. Also, we are proposing 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 proposed 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 aim to improve 
program efficiency in implementing the conditions of coverage.
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 \83\ 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.\84\ 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.85 86 We are proposing 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.
---------------------------------------------------------------------------

    \83\ Centers for Disease Control and Prevention. Post-COVID 
Conditions: Information for Healthcare Providers. Updated Apr. 8, 
2021. Accessed 4/30/2021 at https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/post-covid-conditions.html.
    \84\ 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.
    \85\ Post-COVID Conditions updated 4/8/2021 accessed 4/13/2021 
at https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects.html.
    \86\ 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.
---------------------------------------------------------------------------

    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-19.87 88 We are 
soliciting 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.
---------------------------------------------------------------------------

    \87\ 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.
    \88\ Barker-Davies R.M., 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.
---------------------------------------------------------------------------

c. Components
    We are proposing revisions to the description of each of the five 
PR components under Sec.  410.47(b)(2) (previously Sec.  410.47(c)). 
Proposed 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. Proposed revisions to the education or training component 
more concisely explain, but do not change, the existing requirements 
for meeting this component. Proposed 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 align 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.
d. Settings
    We are proposing 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.
e. Physician Standards
    We are proposing revisions to align regulatory text regarding the 
standards for the PR medical director and the supervising physician 
found at

[[Page 39259]]

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 
are proposing 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 are 
proposing 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 are proposing to remove the requirement 
for direct physician-patient contact within the PR program every 30 
days. We are requesting 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 proposed 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 proposed 
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.
f. Limitations
    We are proposing conforming changes to Sec.  410.47(e) (previously 
Sec.  410.47(f)) and Sec.  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.
4. Summary
    To improve consistency and accuracy across PR and CR/ICR conditions 
of coverage, we are proposing largely conforming changes throughout 
Sec. Sec.  410.47 and 410.49. We are also proposing 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. We believe 
these proposals result in clearer and more streamlined regulatory text 
and better assist stakeholders in understanding and implementing PR, CR 
and ICR programs. We look forward to public comments on our proposals, 
in particular our proposals to remove the PR direct physician-patient 
contact requirement and 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.

I. Medical Nutrition Therapy

    Medical nutrition therapy became a distinct Medicare benefit under 
section 1861(s)(2) of the Act pursuant to 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 \89\ 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.
---------------------------------------------------------------------------

    \89\ https://www.kidney.org/sites/default/files/Nutrition_GL%2BSubmission_101719_Public_Review_Copy.pdf.
---------------------------------------------------------------------------

    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

[[Page 39260]]

National Kidney Foundation, less than 1 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 this proposed rule, we provide background on the MNT 
services, discuss the MNT regulation revisions, and make proposals to 
implement these modifications. We are proposing 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 42 CFR 410.130 (definitions), Sec.  410.132 (MNT), and 
Sec.  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 
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 are proposing 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 proposed 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).

[[Page 39261]]

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 are proposing 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.  
410.130 and Sec.  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 are proposing to delete 
the term treating and the definition of treating physician, as there is 
a separate definition for physician within this provision. Therefore, 
we are not proposing 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 are proposing 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.'' \90\ The definitions and staging of chronic kidney 
disease have evolved since the release of the report and stakeholders 
have noted that our definition does not reflect current medical 
practice. Therefore, we are proposing to update the GFR eligibility 
criteria so that it aligns with up to date accepted standards for CKD 
stage III through stage V, specifically GFR 15-59 mL/min/
1.73m2. The accepted CKD staging system separates stage III 
into two parts: Stage III-a; and Stage III-b. Stage III-a is GFR 45-59. 
The existing regulatory upper limit of 50 is mid stage III-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.91 92
---------------------------------------------------------------------------

    \90\ IOM (2000). The Role of Nutrition in Maintaining Health in 
the Nation's Elderly: Evaluating Coverage of Nutrition Services for 
the Medicare. Retrieved from https://www.nap.edu/catalog/9741.html.
    \91\ 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.
    \92\ National Kidney Foundation (2021). eGFR. Retrieved from 
https://www.kidney.org/atoz/content/gfr.
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3. Proposed Regulatory Text Changes
    We are proposing 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 propose 
to revise Sec.  410.130 (definitions) and Sec.  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 propose 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 propose 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 are proposing 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 are also proposing to strike the term, ``maintained,'' and replace 
it with the term, ``noted.''
4. Summary
    The MNT services may help reduce illnesses and improve quality of 
life for people with diabetes or renal disease. We believe the proposed 
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 CMS 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. We look forward to receiving 
public comment on these proposals.

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 fee-
for-service (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

[[Page 39262]]

amended section 1899 of the Act to provide for the following: Expanded 
use of telehealth services by physicians or practitioners participating 
in an applicable ACO to furnish services to prospectively assigned 
beneficiaries, greater flexibility in the assignment of Medicare FFS 
beneficiaries to ACOs by allowing ACOs in tracks under retrospective 
beneficiary assignment a choice of prospective assignment for the 
agreement period; permitting Medicare FFS beneficiaries to voluntarily 
identify an ACO professional as their primary care provider and 
requiring that such beneficiaries be notified of the ability to make 
and change such identification, and mandating that any such voluntary 
identification will supersede claims-based assignment; and allowing 
ACOs under certain two-sided models to establish CMS-approved 
beneficiary incentive programs.
    The Shared Savings Program regulations are codified at 42 CFR part 
425. The final rule establishing the Shared Savings Program appeared in 
the November 2, 2011 Federal Register (Medicare Program; Medicare 
Shared Savings Program: Accountable Care Organizations; final rule (76 
FR 67802) (hereinafter referred to as the ``November 2011 final 
rule'')). A subsequent major update to the program rules appeared in 
the June 9, 2015 Federal Register (Medicare Program; Medicare Shared 
Savings Program: Accountable Care Organizations; final rule (80 FR 
32692) (hereinafter referred to as the ``June 2015 final rule'')). The 
final rule entitled, ``Medicare Program; Medicare Shared Savings 
Program; Accountable Care Organizations--Revised Benchmark Rebasing 
Methodology, Facilitating Transition to Performance-Based Risk, and 
Administrative Finality of Financial Calculations,'' which addressed 
changes related to the program's financial benchmark methodology, 
appeared in the June 10, 2016 Federal Register (81 FR 37950) 
(hereinafter referred to as the ``June 2016 final rule''). A final 
rule, ``Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2019; 
Medicare Shared Savings Program Requirements; Quality Payment Program; 
Medicaid Promoting Interoperability Program; Quality Payment Program--
Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS 
Payment Year; Provisions From the Medicare Shared Savings Program--
Accountable Care Organizations--Pathways to Success; and Expanding the 
Use of Telehealth Services for the Treatment of Opioid Use Disorder 
Under the Substance Use-Disorder Prevention That Promotes Opioid 
Recovery and Treatment (SUPPORT) for Patients and Communities Act'', 
appeared in the November 23, 2018 Federal Register (83 FR 59452) 
(hereinafter referred to as the ``November 2018 final rule'' or the 
``CY 2019 PFS final rule''). In the November 2018 final rule, we 
finalized a voluntary 6-month extension for existing ACOs whose 
participation agreements would otherwise expire on December 31, 2018; 
allowed beneficiaries greater flexibility in designating their primary 
care provider and in the use of that designation for purposes of 
assigning the beneficiary to an ACO if the clinician they align with is 
participating in an ACO; revised the definition of primary care 
services used in beneficiary assignment; provided relief for ACOs and 
their clinicians impacted by extreme and uncontrollable circumstances 
in performance year 2018 and subsequent years; established a new 
Certified Electronic Health Record Technology (CEHRT) use threshold 
requirement; and reduced the Shared Savings Program quality measure set 
from 31 to 23 measures (83 FR 59940 through 59990 and 59707 through 
59715).
    A final rule redesigning the Shared Savings Program appeared in the 
December 31, 2018 Federal Register (Medicare Program: Medicare Shared 
Savings Program; Accountable Care Organizations--Pathways to Success 
and Uncontrollable Circumstances Policies for Performance Year 2017; 
final rule) (83 FR 67816) (hereinafter referred to as the ``December 
2018 final rule''). In the December 2018 final rule, we finalized a 
number of policies for the Shared Savings Program, including a redesign 
of the participation options available under the program to encourage 
ACOs to transition to two-sided models; new tools to support 
coordination of care across settings and strengthen beneficiary 
engagement; and revisions to ensure rigorous benchmarking.
    In the interim final rule with comment period (IFC) entitled 
``Medicare and Medicaid Programs; Policy and Regulatory Revisions in 
Response to the COVID-19 Public Health Emergency'', which was effective 
on the March 31, 2020 date of display and appeared in the April 6, 2020 
Federal Register (85 FR 19230) (hereinafter referred to as the ``March 
31, 2020 COVID-19 IFC''), we removed the restriction 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 
Public Health Emergency (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 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

[[Page 39263]]

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.
    As a general summary, in this proposed rule, we are proposing to:
     Clarify the Application of the CAHPS for MIPS Survey 
sampling policies, including the CAHPS for MIPS minimum sampling 
thresholds, for Shared Savings Program ACOs.
     Amend the reporting requirements under the APM Performance 
Pathway (APP) for performance year 2022 and performance year 2023.
    ++ Solicit comments on addressing health disparities and promoting 
health equity.
    ++ Solicit comments on the feasibility of TIN level reporting and 
sampling for eCQMs/MIPS CQMs.
    ++ Solicit comments on reporting options for specialist providers 
within an ACO.
    ++ 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.
    ++ Solicit comments on publicly displaying prior year performance 
scores that equate to the 30th or 40th percentile MIPS Quality 
performance category scores.
     Revise the extreme and uncontrollable circumstances policy 
to align with the proposal 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.
     Solicit comments on considerations related to the use of 
regional FFS expenditures in the Shared Savings Program's benchmarking 
methodology.
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

[[Page 39264]]

requirements and quality performance standard for PY 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 (PY) 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 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, we want to clarify that they do apply for 
performance year 2021 and subsequent years. As explained in the CY 2021 
PFS final rule, under the APP we are replacing the CAHPS for ACOs that 
was previously used in the Shared Savings Program with the CAHPS for 
MIPS. Because our intent in including the CAHPS for MIPS in the APP was 
to align reporting requirements under the Shared Savings Program with 
MIPS, we believe that the discussion surrounding 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 
note that we 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. 
From the feedback received, we determined that it was necessary to 
clarify that the minimum sampling threshold will apply.
    As discussed previously in this section, 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. In addition, 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. 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 believe applying the 
CAHPS for MIPS minimum

[[Page 39265]]

sampling thresholds does not negatively impact Shared Savings Program 
ACOs because, as discussed below, only a few ACOs would potentially be 
impacted by these minimum sampling thresholds.
    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 estimate 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, one large-sized ACO would not 
have been able to administer the CAHPS survey for PY 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 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 note that in both cases, these ACOs would 
have been eligible for CAHPS sampling based on their counts of 
assigned, quality-eligible \93\ beneficiaries with 2 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.
---------------------------------------------------------------------------

    \93\ 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.
---------------------------------------------------------------------------

    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 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 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 
PY 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 seek comment on this clarification that the CAHPS for MIPS 
Minimum Sampling Thresholds also apply to Shared Savings Program ACOs.
    In section IV.A.3.d. of this proposed rule, we discuss proposals 
related to the CAHPS for MIPS survey. In section IV.A.3.d, 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, 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 Table 40 of the CY 2021 
PFS final rule (85 FR 84733) for a list of the measures included in the 
final APP measure set for performance year 2021.
    Under the policies adopted in the CY 2021 PFS final rule:
     For performance year 2021, ACOs are required to report 
quality data via the APP, and can choose to actively report either the 
10 measures under the CMS Web Interface or the 3 eCQM/MIPS CQM 
measures. In addition, ACOs are required to field the CAHPS for MIPS 
survey, and CMS will calculate 2 measures using administrative claims 
data.
     For performance year 2022 and subsequent performance 
years, ACOs are required to actively report quality data on the 3 eCQM/
MIPS CQM measures via the APP. In addition, ACOs are required to field 
the CAHPS for MIPS survey, and CMS will calculate two measures using 
administrative claims data. All 6 measures will be included in the 
calculation of the ACO's quality performance score for purposes of the 
Shared Savings Program.
    Our initial proposal in the CY 2021 PFS proposed rule included the 
removal of the CMS Web Interface collection type and a requirement that 
ACOs report quality data via the eCQM/MIPS CQM collection type starting 
in PY 2021. Public comments on our proposal expressed concerns about 
moving ACOs away from a collection type under which they report quality 
data on a sample of their assigned Medicare beneficiary population to a 
collection type that requires ACOs to report quality data on a broader, 
all-payer population.
    For example, we received public comments expressing concerns about 
the increased burden of reporting eCQM/MIPS CQM measures, as ACOs would 
be responsible for aggregating the data across multiple ACO participant 
Taxpayer Identification Numbers (TINs) and submitting this data to CMS. 
In

[[Page 39266]]

addition, commenters expressed concerns about the increased cost of 
modifying existing electronic health record (EHR) technology, obtaining 
new EHR interfaces and aggregation tools, and updating performance 
dashboards. Also, there was concern that vendors and developers would 
need additional lead time to update and test systems, train staff and 
configure tools and measurement algorithms to aggregate data at an ACO 
level, in order to handle the wave of new entities reporting using 
eCQM/MIPS CQM measures.
    In the CY 2021 PFS final rule (85 FR 84730), we noted that while 
the three eCQM/MIPS CQM measures are based on all payer data, we 
believe they are appropriate for assessing the quality of care 
furnished by ACOs, as required by section 1899(b)(3) of the Act. These 
measures focus on the management of chronic health conditions that are 
a high priority and have high prevalence among Medicare beneficiaries. 
To the extent that these conditions are also prevalent among other 
populations of patients that receive services from the eligible 
clinicians participating in an ACO, we believe it is relevant to 
consider the quality of care that is furnished by ACO participants 
across all of their patients as part of assessing the overall quality 
of care furnished by the ACO. We also noted that measuring care 
delivery to all patients is appropriate because improving care 
processes and practices is expected to improve care for all patients 
(for example, improvements to an electronic health record would be 
expected to improve care for all patients, not just Medicare patients). 
Additionally, we explained that CMS would not want ACOs participating 
in the Shared Savings Program to improve care for Medicare 
beneficiaries by reducing care quality for non-Medicare beneficiaries. 
Thus, looking at the overall quality of care furnished to all patients 
is consistent with the goal of improving care furnished by ACOs, by 
ensuring that care delivery is improving across all patients, rather 
than encouraging ACOs to focus disproportionately on improving measure 
performance for Medicare beneficiaries.
    However, in light of the concerns raised during the public comment 
period for the CY 2021 PFS proposed rule, in the CY 2021 PFS final 
rule, we decided to extend the use of the CMS Web Interface as a 
collection type under the APP for performance year 2021. We believed 
that this additional year would allow ACOs the time needed to make the 
necessary changes to begin reporting quality data via eCQMs/MIPS CQMs.
    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 note 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, ACOs 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 the 
threshold established under Sec.  414.1415(a)(1)(i).
    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.
    According to a recent National Association of Accountable Care 
Organizations (NAACOS) survey \94\ regarding the readiness of ACOs to 
report eCQM/MIPS CQM data, NAACOS noted that 77 percent of respondents 
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, stakeholders have 
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 focus on perceived HIPAA Privacy Rule limitations on sharing 
protected health information (PHI) for non-Medicare beneficiaries with 
an ACO.
---------------------------------------------------------------------------

    \94\ https://www.naacos.com/assets/docs/pdf/2021/NAACOS-QualityhandoutCCSQmeeting03222021.pdf pdf.
---------------------------------------------------------------------------

    Furthermore, we have heard concerns from ACOs that are acting 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 have indicated that current agreements may only address 
sharing the PHI of Medicare beneficiaries. Therefore, they have 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).
    To report eCQMs successfully, health care providers must adhere to 
the requirements identified by the CMS quality program in which they 
intend to participate. 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, we believe 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.'' 
\95\ 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 note that the HIPAA Privacy Rule minimum necessary

[[Page 39267]]

standard does not apply to uses or disclosures that are required by 
law.\96\
---------------------------------------------------------------------------

    \95\ See 45 CFR 164.512(a).
    \96\ See 45 CFR 164.502(b)(2)(v).
---------------------------------------------------------------------------

    Furthermore, 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. 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 believe that 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 eCQM/MIPS CQM measures consistent with the MIPS reporting 
requirements.
    In addition, we want to correct 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, 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 want to clarify 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.
    Based on the feedback we received, we are convinced that ACOs and 
their ACO participants, Health IT vendors, and developers need 
additional time to prepare for reporting all-payer eCQM/MIPS CQM 
measures. We believe the updates we are proposing to the reporting 
requirements under the APP are responsive to stakeholder requests to 
delay the requirement that ACOs report all-payer eCQM/MIPS CQM 
measures, while still providing incentives for ACOs that are ready 
report to eCQM/MIPS CQM measures. As discussed in section 
IV.A.3.d.(1)(d) of this proposed rule, we are proposing 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 are proposing that the 
CMS Web Interface would be a collection type under the APP only for 
Shared Savings Program ACOs. Accordingly, we are proposing to modify 
the quality measure set that must be reported by Shared Savings Program 
ACOs under the APP, as discussed in this section and section 
IV.A.3.c.(2)(a) of this 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 electronic health record (EHR) technology, 
while also providing incentives for ACOs to take the steps necessary to 
report all-payer measures, we are proposing that:
     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 CQM measures 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 eCQM/MIPS CQM 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, 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. We 
believe that allowing ACOs that report eCQM/MIPS CQM measures 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 eCQM/MIPS CQM measures, while allowing them time to gauge 
their performance on the eCQM/MIPS CQM measures before full reporting 
of these measures is required beginning in PY 2024. If an ACO chooses 
this option, its performance on all three eCQM/MIPS CQM measures would 
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 eCQM/
MIPS CQM measures, it will receive the higher of the two quality scores 
for purposes of the MIPS Quality performance category.
    Please note, as indicated in Tables 25 and 40, 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# 
236)) 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.
    If an ACO does not report any of the ten CMS Web Interface measures 
or any of the three eCQM/MIPS CQM measures and does not administer a 
CAHPS for MIPS survey under the APP, the ACO will not meet the quality 
performance standard.
     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 
measure, 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 CQM measures 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 eCQM/MIPS CQM 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

[[Page 39268]]

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 eCQM/MIPS CQM 
measures would 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 eCQM/MIPS CQM measures, it will receive the higher of the two 
quality scores for purposes of the MIPS Quality performance category.
    If an ACO does not report at least one eCQM/MIPS CQM measure 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 eCQM/MIPS CQM 
measures 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 eCQM/MIPS CQM measures 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 are proposing 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 eCQM/MIPS CQM measures 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 eCQM/MIPS CQM measures, and administers a CAHPS for MIPS 
survey under the APP.
     For performance year 2024 and subsequent performance 
years. The ACO reports on the three eCQM/MIPS CQM measures and 
administers a CAHPS for MIPS survey under the APP.
    The proposed changes are summarized in Table 24. We are proposing 
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 note that as part of these proposed changes, we are also 
proposing to update the provision at Sec.  425.512(a)(2), which applies 
to new ACOs that are in the first performance year of their first 
agreement under the Shared Savings Program and are able to meet the 
quality performance standard under the Shared Savings if they 
completely and accurately report all required measures via the APP, to 
reflect the proposed changes to the quality reporting requirements for 
performance years 2022 and 2023.
BILLING CODE 4120-01-P

[[Page 39269]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.047

BILLING CODE 4120-01-C
    We seek comment on these proposed updates to the reporting 
requirements under the APP for performance year 2022 and subsequent 
years. In addition, we are seeking comment on whether we should extend 
the CMS Web Interface collection type for more than the 2 years 
proposed above. We believe 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 are 
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.
(1) Solicitation of Comments on Addressing Health Disparities and 
Promoting Health Equity
    We note that we continue to believe the move to eCQM/MIPS CQM 
measures is the appropriate next step for ACO quality measurement. For 
many years, ACOs have only reported on a sample of their assigned 
Medicare beneficiary population, as the CMS Web Interface

[[Page 39270]]

only requires that ACOs report on 248 consecutively ranked 
beneficiaries for each measure in the CMS Web Interface measure set. As 
we move forward with reporting under the APP and increasing the quality 
performance standard as described above, we believe that looking at the 
overall quality of care furnished to all patients is consistent with 
the goal of improving care furnished by ACOs by ensuring that care 
delivery is improving across all patients, rather than encouraging ACOs 
to focus disproportionately on improving measure performance for 
Medicare beneficiaries. We also believe that assessing Shared Savings 
Program ACO quality performance on a broader population can have a 
positive impact on the quality of care for all groups, including 
Medicare beneficiaries. We also expect the transition to all-payer 
eCQM/MIPS CQM measures will help to address health disparities and 
promote health equity by promoting a single standard of care across all 
patients receiving care from practices participating in Shared Savings 
Program ACOs regardless of location or racial/ethnic group. However, we 
are seeking 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 are also seeking 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 measure benchmarks to 
take into account ACOs serving vulnerable populations.
(2) Solicitation of Comments on Feasibility of TIN Level Reporting and 
Sampling for eCQMs/MIPS CQMs
    To assist ACOs in reporting eCQM/MIPS CQM measures and to address 
concerns regarding data aggregation across multiple TINs with multiple 
different EHR systems, we are seeking comment on allowing ACO 
providers/suppliers to submit eCQMs/MIPS CQM measures to CMS at the ACO 
participant TIN level. CMS would then calculate/aggregate the TIN level 
quality data to create an ACO level score. For example, CMS could 
calculate the average of the decile scores for each measure for each 
TIN within the ACO to create an aggregate measure level score for the 
ACO. Alternatively, CMS could calculate an ACO-level numerator for each 
measure (sum of performance met across TINs within the ACO) and an ACO-
level denominator (sum of the met and performance not met across TINs 
within the ACO), then divide the two--numerator/denominator x 100--to 
obtain the ACO-level performance rate. We seek comment on these two 
potential approaches as well as any other suggested approaches to the 
aggregation of ACO participant TIN level quality data at the ACO level.
    While we continue to believe that reporting on all-payer data is 
important to improve the quality of care furnished to all patients, 
including Medicare beneficiaries, we have heard from stakeholders that 
CMS should allow ACOs to report the eCQM/MIPS CQM measures for a 
smaller, more defined beneficiary population rather than the all-payer 
population, to serve as an intermediary step to reporting on all 
patients. Thus, while we believe that the move to all-payer measures is 
the next step in quality reporting, we acknowledge that the denominator 
of patients for a given quality measure for an ACO may be significantly 
higher, depending on ACO size and composition, than for MIPS groups. 
Therefore, we seek comment on how stakeholders would envision CMS 
determining an appropriate beneficiary population. For example, should 
ACOs report on a small sample size similar to the sample size for the 
CMS Web Interface? Should CMS broaden the beneficiary sample to include 
all assigned beneficiaries that meet the denominator for a given 
measure? Should CMS provide ACOs with a bigger sample size, larger than 
the size that has historically been used for CMS Web Interface but 
smaller than all the assigned beneficiaries that meet the denominator 
for a given measure? Or should CMS develop ACO-level eCQM/MIPS CQM 
measure sampling specifications? We seek 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.
(3) Comment Solicitation for Reporting Options for Specialist Providers 
Within an ACO
    We have also heard from stakeholders that the population health/
primary care focused measures in the APP are not applicable for 
specialist providers within an ACO. In order to address measure 
applicability for specialist providers, we are seeking comment on 
allowing ACO participant TINs to report either the eCQM/MIPS CQM 
measures 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 seek input on the role 
specialists play in ACOs and what specialty measures in the current 
eCQM or MIPS CQM measure set should be considered for inclusion in the 
Shared Savings Program quality measure set in future performance years. 
Alternatively, how could the existing APP measure set be used or 
modified to reinforce the role of specialists in ACO population health 
strategies?
(4) Updates to the APM Performance Pathway (APP) Measure Set
    In section IV.A.3.(c) of this proposed rule, we are proposing 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. 
We are proposing 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. 
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). For a 
detailed description of this proposal refer to section IV.A.3.(c) of 
this proposed rule.
    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 
calculated as part of the APP looks at an ACO's all Medicare population 
rather than just the ACO's assigned beneficiary population, we believe 
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. Further 
details on the specifications for the MCC

[[Page 39271]]

for MIPS measure can be found in Table A-5 in Appendix A of this 
proposed rule.
    Please see Table 25 for the proposed APP measure set that would be 
reported by Shared Savings Program ACOs for PY 2022 and subsequent 
performance years.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP23JY21.048

BILLING CODE 4120-01-C
d. Shared Savings Program Quality Performance Standard
(1) Proposal To Freeze 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:

[[Page 39272]]

     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 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 PY 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 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 eCQM or MIPS CQM measures, 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 2021 PFS final rule, we indicated that we would continue 
to monitor emerging performance to determine the impact of a measured 
increase to the quality performance standard. We stated that we might 
revisit the policy in future rulemaking in order to promote an 
attainable standard and degree of improvement based on initial 
performance under the new methodology (85 FR 85008). If our proposal to 
extend the availability of the CMS Web Interface as a reporting 
mechanism under the APP is finalized, performance year 2024 would be 
the first year that all ACOs would be required to report all three 
eCQM/MIPS CQM measures and would have no option to report data via the 
CMS Web Interface, with data submission beginning in 2025. However, we 
have heard from some ACOs that they are beginning to update their 
systems and workflows to further develop their capacity for reporting 
on the eCQM/MIPS CQM measure set in performance year 2022. These ACOs 
are gearing up for all-payer reporting and are performing self-tests in 
order to understand their performance on the 3 eCQM/MIPS CQM measures. 
It is also important to note that some ACOs will likely report on eCQM/
MIPS CQM measures beginning with the 2021 performance year. Therefore, 
there is an opportunity for ACOs to gain some familiarity with meeting 
the requirements for these measures starting in performance year 2021. 
Even with all of these contingencies in place and our proposals to 
phase-in reporting of the eCQM/MIPS CQM measures, we still recognize 
that transitioning to eCQM/MIPS CQM quality data reporting and 
aggregation may come with unforeseen data collection and/or system 
operational issues. Therefore, we have concluded that it would be 
appropriate to freeze the quality performance at the 30th percentile 
MIPS Quality performance category score for an additional year; and to 
raise the quality performance standard in conjunction with the 
transition to reporting of the three eCQM/MIPS CQMs measures by all 
ACOs in PY 2024. Although this increase in the quality performance 
standard to the 40th percentile would coincide with the first full year 
of eCQM/MIPS CQM quality reporting, we believe our proposal to extend 
the CMS Web Interface for an additional 2 years and to allow for a 
gradual phase in of reporting the three eCQMs/MIPS CQMs is responsive 
to stakeholder concerns related to the transition to eCQM/MIPS CQM 
measures 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 proposed rule, as part of this gradual 
phase-in to full reporting of eCQMs/MIPS CQMs, we are proposing to 
include incentives to encourage 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 eCQM/MIPS CQM 
measures, for performance year 2023 we would require an ACO to report 
at least one eCQM/MIPS CQM measure (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 are also proposing for both performance year 2022 and 
performance year 2023 that ACOs that elect to report all three eCQM/
MIPS CQM measures 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.
    We believe that our proposal to freeze the quality performance 
standard at the 30th percentile for an additional year, is consistent 
with the requirement in the statute that CMS increase the quality 
performance standard overtime. There are two ways to increase the 
quality performance standard: (1) By increasing the threshold for the 
quality performance standard, and (2) by moving to all payer measure 
populations that ACOs are required to report for purposes of Shared 
Savings Program quality. In this proposed rule, we are proposing 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 propose to freeze the quality performance standard at 
the 30th percentile MIPS Quality performance category score for PY 
2023, and to establish incentives to encourage ACOs to begin the 
transition to eCQM/MIPS CQM measure reporting in PY 2022 and PY 2022. 
This would mean that for all Shared Savings Program ACOs, CMS would 
designate the quality performance standard as the ACO reporting via the 
APP established under Sec.  414.1367 of this chapter and for:
     Performance year 2022, if an ACO reports:

[[Page 39273]]

    ++ 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 eCQM/MIPS CQM measures, meeting the data completeness 
requirement at Sec.  414.1340 of this chapter and case minimum 
requirement at Sec.  414.1380 of this chapter 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 eCQM/MIPS CQM measures 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 eCQM/MIPS CQM measures, meeting the data completeness 
requirement at Sec.  414.1340 of this chapter and case minimum 
requirement at Sec.  414.1380 of this chapter 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.
    Our proposal to extend the CMS Web Interface collection type and 
phase-in the reporting of the eCQMs/MIPS CQMs provides the transition 
time that stakeholders have requested in order to be ready to submit 
aggregated data on eCQMs/MIPS CQMs. We believe that the transition to 
the all-payer eCQM/MIPS CQM measures is the future of Shared Savings 
Program quality performance assessment and that ACOs are well-
positioned to impact the quality of care across an all-payer population 
not just the Medicare population given their redesigned care processes 
and quality improvement activities. Ultimately, we believe that the 
transition time afforded ACOs by extending the availability of the CMS 
Web Interface as a collection type, in conjunction with the incentives 
to encourage early adoption of eCQM/MIPS CQM reporting, should allow 
ACOs to prepare for full reporting of eCQMs/MIPS CQMs as well as the 
incremental increase in the quality performance standard to the 40th 
percentile of MIPS Quality performance category score in PY 2024. 
Accordingly, we are proposing that for PY 2024 and all subsequent 
performance years, CMS 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 
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 propose to revise the 
regulation at Sec.  425.512 to reflect the extended phase-in of the ACO 
quality performance standard.
    As we explained in the CY 2021 PFS final rule, this approach to 
phasing in the new, higher quality performance standard is consistent 
with the statutory requirement in section 1899(b)(3)(C) of the Act, 
which requires the Secretary to establish quality performance standards 
to assess the quality of care furnished by ACOs and to seek to improve 
the quality of care furnished by ACOs over time by specifying higher 
standards, new measures or both for purposes of assessing such quality 
of care. We believe that even though we are proposing to freeze the 
quality performance standard at the 30th percentile MIPS Quality 
performance category score for an additional year, we will still be 
holding ACOs to a higher standard than the previous quality standard, 
which merely required ACOs to achieve the 30th percentile relative to 
national benchmarks on one measure in each domain. We recognize the 
change from the CMS Web Interface collection type to the eCQM or MIPS 
CQM collection type, coupled with this higher quality performance 
standard, adds 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 believe that with this proposal to delay 
the increase in the quality performance standard, coupled with the 
proposal to extend the CMS Web Interface through PY2023, with 
incentives for e early adoption of eCQM/MIPS CQM reporting, ACOs will 
have ample time to prepare for the transition to full eCQM/MIPS CQM 
reporting in PY 2024 and the incremental increase in the quality 
performance standard to the 40th percentile MIPS Quality performance 
category score. We also believe this 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.
    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. 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 eCQM/MIPS CQM measures 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. 
However, for the reasons described previously, we believe the timeline 
we are proposing for phasing in the new quality reporting and quality 
performance requirements will provide ample time for ACOs to prepare to 
meet these new requirements while also satisfying the statutory 
requirement that we seek to improve the quality of care furnished by 
ACOs over time.
    We seek 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 PY 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 PY 2024. In addition, 
we seek comment on the alternative of freezing the Shared Savings 
Program quality performance standard at the 30th percentile across all 
MIPS Quality

[[Page 39274]]

performance category scores, excluding entities/providers eligible for 
facility-based scoring for PYs 2023 and 2024.
(2) Comment Solicitation on Publicly Displaying Prior Year Performance 
Scores That Equate to the 30th or 40th Percentile Across MIPS Quality 
Performance Category Scores
    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. These 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, there is no information that can be provided prior to or 
during the performance year. However, we note 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 seek 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 seek 
comment on other ways we could address these concerns.
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:
     PY 2021 and PY 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.
     PY 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).
    As discussed in section III.J.1.d. of this proposed rule, we are 
proposing to make changes to the quality performance standard for 
Shared Savings Program ACOs by freezing the quality performance 
standard at the 30th percentile for PY 2023. Therefore, we are also 
proposing to update the extreme and uncontrollable circumstances policy 
under the Shared Savings Program consistent with the proposal in 
section III.J.1.d. of this proposed rule. Specifically, we propose 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.
    For performance years 2021 and 2022, 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 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 
would apply the 30th percentile MIPS Quality performance category 
score.
    For performance year 2023, if the ACO is able to report quality 
data via the APP, including at least one eCQM/MIPS CQM measure, and 
meets data completeness and case minimum requirements, CMS will use the 
higher of the ACO's quality performance score or the equivalent of the 
30th percentile MIPS Quality performance category score. 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 would apply the 30th percentile MIPS 
Quality performance category score.
    Similarly, we propose 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. 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 would apply the 40th percentile MIPS Quality performance category 
score. We believe these proposed updates are appropriate to align with 
the proposed changes to the quality performance standard in section 
III.J.1.d. of this proposed rule, and would also allow impacted ACOs to 
be

[[Page 39275]]

eligible to share in savings at their maximum sharing rate or to avoid 
maximum shared losses, if applicable. We also propose 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 seek comment on these proposed revisions to the extreme and 
uncontrollable circumstances policy.
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 or after January 1, 2019, the Secretary shall assign 
beneficiaries to an ACO based on their utilization of primary care 
services provided by a physician who is an ACO professional and all 
services furnished by Rural Health Clinics (RHCs) and Federally 
Qualified Health Centers (FQHCs). However, the statute does not specify 
a list of services considered to be primary care services for purposes 
of beneficiary assignment.
    In the November 2011 final rule (76 FR 67853), we established the 
initial list of services, identified by Current Procedural Terminology 
(CPT) and Healthcare Common Procedure Coding System (HCPCS) codes, that 
we considered to be primary care services. In that final rule, we 
indicated that we intended to monitor CPT and HCPCS codes and would 
consider making changes to the definition of primary care services to 
add or delete codes used to identify primary care services, if there 
were sufficient evidence that revisions were warranted. We have updated 
the list of primary care service codes in subsequent rulemaking 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 
skilled nursing facility (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).

[[Page 39276]]

    (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).
    (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. Proposed Revisions
(1) HCPCS and CPT Codes Used in Assignment
    Based on feedback from ACOs and our further review of the HCPCS and 
CPT codes currently recognized for payment under the PFS, we believe it 
would be appropriate to amend the definition of primary care services 
used in the Shared Savings Program assignment methodology to include 
certain additional codes and 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 propose 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 are proposing 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 nonphysician practitioner (NPP) 
who can bill E/M services, and CCM services personally furnished by a 
physician or NPP. Elsewhere in this proposed rule, we propose 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).
    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.
    The CCM services that will be furnished under the new CPT code 
99X21 are similar to the CCM services that are billed under the exiting 
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 believe it would be appropriate to 
include HCPCS code 99X21, if 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.
     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).

[[Page 39277]]

    ++ 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 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).
    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, we believe it would be appropriate to propose 
to include CPT code 99X22, 99X23, 99X24, and 99X25, if 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, the Shared Savings Program will 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 evaluation 
and management (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 99205 and 
99215 (codes for office or other outpatient visit for the evaluation 
and management 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 believe it would be appropriate to propose 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). Elsewhere in this proposed rule, 
we are proposing to pay for this service on a permanent basis starting 
January 1, 2022.
    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), we believe 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

[[Page 39278]]

primary care services. Accordingly, we propose 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, if payment for the code is made permanent through 
the CY 2022 PFS rulemaking.
    We propose to specify a revised definition of primary care services 
in a 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 proposed 
additional CPT codes 99X21, 99X22, 99X23, 99X24, and 99X25, and HCPCS 
codes G2212 and G2252, if finalized through the CY 2022 PFS rulemaking, 
as applicable. We propose 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 propose 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 COVID-19 PHE
    As previously described in this section III.J.2.a. of this proposed 
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 COVID-
19 PHE. 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 COVID-19 PHE 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.  [thinsp]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 section II.D. of this proposed rule, we are proposing 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.
    In order to remain consistent with Medicare FFS payment policies, 
we propose 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 propose 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 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 have assigned CPT codes. Thus, the CPT Editorial 
Panel may also create new CPT

[[Page 39279]]

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, we are proposing 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 its having a substantially similar code 
description or the relevant discussion in CMS rulemaking establishing 
payment for the replacement code. This proposed 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 propose 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. 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. 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.
    We anticipate 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.
    As discussed in section III.J.2.b.(1) of this proposed rule, we 
propose 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 propose 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 seek comment on these proposed changes to the definition of 
primary care services used for assigning beneficiaries to Shared 
Savings Program ACOs for the performance year starting on January 1, 
2022, and subsequent performance years. We also welcome comments on any 
other existing HCPCS or CPT codes, and new HCPCS or CPT codes proposed 
elsewhere in this proposed rule, that we should consider adding to the 
definition of primary care services for purposes of assignment in 
future rulemaking.
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.\97\ We 
established the repayment mechanism requirements through earlier 
rulemaking,\98\ 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).
---------------------------------------------------------------------------

    \97\ 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).
    \98\ 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

[[Page 39280]]

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. 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),\99\ 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.
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    \99\ 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 proposed 
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.
---------------------------------------------------------------------------

    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 mechanism amounts, we believe it is appropriate to modify the 
approach to calculating repayment mechanism amounts. 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 this section of this proposed rule, we discuss 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.
b. Proposed Revisions
(1) Repayment Mechanism Amount Calculations
    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. We also considered the 
magnitude of potential decreases in the repayment mechanism amounts 
under each option. We propose the first option, to reduce the 
percentages used in the existing repayment mechanism amount 
calculations, but we are seeking comment on the second, alternative 
option we considered. We propose to lower the repayment mechanism

[[Page 39281]]

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 propose 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.
    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 PY 2021, the mean repayment mechanism savings would 
be $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 26.
[GRAPHIC] [TIFF OMITTED] TP23JY21.049

    Under this second, alternative option, we considered using separate 
per beneficiary dollar amounts, for low revenue ACOs and high revenue 
ACOs. We believe 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 believe 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 26). 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 PY 
2021,the mean repayment mechanism savings would be $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.
    We believe there are a number of advantages to the option under 
which we would calculate repayment

[[Page 39282]]

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 believe this is 
appropriate considering the previously described factors: The lower 
potential loss liability for low revenue ACOs; historically, low 
revenue ACOs have incurred shared losses less often and have had lower 
per beneficiary shared losses compared to high revenue ACOs; and 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, that 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 have 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 required amounts determined 
under the existing repayment mechanism amount calculation methodology, 
we believe 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 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 26. 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.
    Both our proposal and the second, alternative option would lower 
repayment mechanism amounts and would reduce the amount available to 
CMS to support repayment of shared losses. However, we believe this 
risk to CMS is mitigated for a number of reasons. As noted previously 
in this section of this 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), 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

[[Page 39283]]

including, but not limited to, non-compliance with requirements in 42 
CFR part 425 (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. ACOs will continue to have the 
option to secure a repayment mechanism at an amount greater than the 
CMS required amount, if they feel that is appropriate to prepare their 
ACO to repay all shared losses.
    Furthermore, we believe 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 from $10,000 or $20,000 in reduced fees for the ACO. 
We estimate 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 propose to revise the 
regulations in 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 propose 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 propose 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 proposed 
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 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 seek comment 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 seek 
comment on applying different per beneficiary dollar amounts for low 
revenue ACOs and high revenue ACOs under this alternative approach. We 
welcome 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. We also seek comment 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 note 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 welcome comments 
on these considerations.
    We propose that these modifications would be effective and 
applicable on January 1, 2022. We note 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 
proposed rule). If the proposed modifications to the repayment 
mechanism amount calculation methodology described in this section of 
this proposed rule are finalized, and 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 are 
committed to ensuring that ACOs do not overfund their repayment 
mechanism arrangements according to the existing methodology if we 
finalize the proposed revisions to reduce repayment mechanism amounts.
(2) Population of Assigned Beneficiaries Used in Calculating and 
Recalculating Repayment Mechanism Amounts
    We propose 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, we first 
describe our current approach for calculating repayment mechanism 
amounts under 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 fee-for-service 
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 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 
(hereinafter referred to as a revenue-based amount).

[[Page 39284]]

    Currently, 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.
     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 (currently 1 percent).
    We currently 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; \100\ and multiplying the resulting number by a dollar 
trend factor to account for expected growth in Medicare FFS revenue.
---------------------------------------------------------------------------

    \100\ 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.
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     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 (currently 2 percent).
    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.
    We believe there are several important reasons for using 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. Currently, in recalculating ACOs' repayment 
mechanism amounts we use the same approach to calculating the 
expenditure-based amount and revenue-based amount in accordance with 
Sec.  425.204(f)(4)(ii), as previously described in this section. 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.
    We propose to modify the methodology for the annual repayment 
mechanism amount recalculation. Specifically, we propose 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 
propose 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 that uses more recent

[[Page 39285]]

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 believe 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.
    Under this proposed approach, we anticipate performing the annual 
recalculation of the repayment mechanism amounts shortly before or 
shortly after the start of the new performance year. CMS will 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 note that under the 
existing 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 this 
proposed approach, we would follow the previously described steps for 
calculating the expenditure-based amount and revenue-based amount, with 
the exception of the number of beneficiaries used as a multiplier in 
step 3 of the calculations. 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).
    Several examples illustrate the calculation and recalculation of 
the repayment mechanism amounts under the proposals. First, for an ACO 
applying to enter a two-sided model for an agreement period beginning 
on January 1, 2022, we will 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. As described in 
this illustration, 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 is consistent with our 
current operational approach.
    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 PY 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.\101\ We would multiply the number of such beneficiaries by an 
assignment growth factor.
---------------------------------------------------------------------------

    \101\ 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 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 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. Currently, that is 1 percent under the expenditure-based 
amount calculation, and 2 percent under the revenue-based amount 
calculation. Under the proposals described in section III.J.3.b.(1) of 
this proposed rule, the applicable percentages would be one-half 
percent under the expenditure-based amount calculation, and 1 percent 
under the revenue-based amount calculation.
    Our second example illustrates how we would perform the annual 
recalculation of the repayment mechanism amount for performance year 
(PY) 2022.
    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 PY 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.
    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, using the ACO's certified ACO 
participant list for PY 2022. We would determine the estimated per 
capita FFS expenditures, and the estimated per capita FFS revenues of 
ACO participants, by

[[Page 39286]]

dividing the CY 2020 dollar amounts by the number of assigned 
beneficiaries for CY 2020 (determined in accordance with step 1).
    In step 3, we would identify the total number of assigned 
beneficiaries specified within the ACO's initial assignment list report 
for PY 2022. This population of assigned beneficiaries would be 
specified in the ACO's initial assignment list report for PY 2022, and 
would be the population identified based on the assignment window from 
October 1, 2019 through September 30, 2020, and which would be the 
basis for determining prospective assignment for PY 2022. Assignment 
would be determined based on the ACO's certified ACO participant list 
for PY 2022. In step 3 of the expenditure-based amount calculation, the 
number of assigned beneficiaries for PY 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 PY 2022 would be 
multiplied by the estimated per capita FFS revenues determined for CY 
2020 in accordance with step 2.
    In step 4, we would recalculate the repayment mechanism amount by 
multiplying the amount determined in step 3 by the applicable 
percentage. Currently, that is 1 percent under the expenditure-based 
amount calculation, and 2 percent under the revenue-based amount 
calculation. Under the proposals described in section III.J.3.b.(1) of 
this proposed rule, the applicable percentages would be one-half 
percent under the expenditure-based amount calculation, and 1 percent 
under the revenue-based amount calculation.
    We propose 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 fee-
for-service 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 propose to amend paragraph (f)(4)(ii)(A) to 
refer to a specified percentage of 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'' (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 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.'' We propose to amend paragraph 
(f)(4)(ii)(B) to refer to a specified percentage of 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'' (emphasis added to reflect revised text).
    We also propose 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 
propose to revise the introductory text for clarity to specify that CMS 
would 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 propose 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 propose that these modifications would be effective and 
applicable on January 1, 2022. If finalized as proposed, these policies 
would be used 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, and in determining 
recalculated repayment mechanism amounts for performance year 2022 and 
subsequent performance years, as well as the determination that 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 
this proposed rule.
(3) Optional One-Time Repayment Mechanism Decrease for Eligible ACOs
    In connection with the proposal for lowering the repayment 
mechanism amounts, described in section III.J.3.b.(1) of this proposed 
rule, we are proposing to allow certain ACOs a one-time opportunity to 
decrease the amount of their repayment mechanisms. 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 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.
    As discussed in section III.J.3.b.(1) of this proposed rule, if the 
proposed modifications to the repayment mechanism amount calculation 
methodology are finalized, and effective and applicable on January 1, 
2022, we would ensure that the revised methodology would be used in 
determining repayment mechanism amounts for ACOs establishing a 
repayment mechanism to support their participation in a two-sided model 
beginning with performance 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 established repayment mechanism amounts determined according to 
the proposed amount calculation methodology, if finalized. Therefore, 
we would not consider such ACOs 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

[[Page 39287]]

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 propose 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 to the 
recalculation methodology which would be effective and applicable 
January 1, 2022, as discussed in this proposed rule). 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 propose that CMS would notify the ACO in writing that the ACO 
may elect to decrease the amount of its repayment mechanism. If this 
proposal is finalized, we anticipate that we would notify an ACO of its 
opportunity to reduce its repayment mechanism amount after the start of 
performance year 2022. We also propose 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 expect 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 
recognize 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 propose 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.
(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.
    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.
    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. 
Further, based on our operational experience and input from ACOs and 
other program stakeholders, modifications to repayment mechanism 
arrangements to revise the amount are burdensome for ACOs. 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 believe the burden 
for these ACOs to increase their repayment mechanism amounts is 
disproportional to the benefit to CMS in the availability of additional 
repayment mechanism arrangement funds to support repayment of losses.
    Further, we believe it is timely to revisit the amount increase 
thresholds under the repayment mechanism amount recalculation policy in 
light of our proposal described in section III.J.3.b.(1) of this 
proposed rule to reduce the amounts required for repayment mechanism 
arrangements. If we finalize our proposal to reduce by one-half the 
repayment mechanism amounts, the 50 percent threshold of the amount 
recalculation provision would be proportionally lower, and the burden 
for these ACOs to increase their repayment mechanism amounts would be 
even more disproportional to the benefit to CMS.
    We believe 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 propose 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, CMS would notify the ACO in 
writing that the amount of its repayment mechanism must be increased to 
the recalculated repayment mechanism amount. We anticipate 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.

[[Page 39288]]

    We propose that this modification would be effective and applicable 
on January 1, 2022. If finalized as proposed, the revised threshold 
would be used in determining required repayment mechanism increases for 
performance year 2022, and subsequent performance years.
4. Reducing Shared Savings Program Application Burden
a. Background
    In order to participate in the Shared Savings Program, a 
prospective ACO must submit an application and certify that it 
satisfies 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. The ACO must 
also disclose in the application whether the related participation 
agreement was terminated (voluntarily or involuntarily), the cause for 
prior termination, and what safeguards are in place to enable the ACO, 
ACO participant, or ACO provider/supplier to participate in the program 
for the full term of the participation agreement. We refer to both of 
these disclosure requirements as the ``prior participation disclosure 
requirement.''
    Our application evaluation criteria for renewing ACOs and re-
entering ACOs are designed to prevent ACOs with a history of poor 
performance or a history of 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.
    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. Such documents must include sample or form 
agreements and the first and signature pages of each executed ACO 
participant agreement. 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.
    Under Sec.  425.116(c), we also require an ACO to submit an 
executed ACO participant agreement for each 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.
b. Proposed Revisions
    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 the 
eligibility requirements for participation. We therefore propose to 
revise Sec. Sec.  425.204(b) and (c)(6), and Sec.  425.116(c) to reduce 
applicant burden.
    First, we propose 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. Under this 
proposal, we would continue review of an ACO's history of compliance 
with the Shared Savings Program regulations and the ACO's quality and 
financial performance results in accordance with Sec.  425.224(b), at 
CMS' request.
    Second, we propose 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 still certify that the all of its ACO participant agreements 
comply with the regulatory requirements of the Shared Savings Program. 
CMS would retain the discretion to request ACO participant agreement 
documentation at any time during an agreement period.
    Third, we propose 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 would retain the 
requirement that an ACO must submit an executed ACO participant 
agreement for each ACO participant that it requests to add to its list 
of ACO participants. We believe these three proposals will collectively 
reduce the administrative and programmatic burden for ACOs 
significantly without sacrificing program integrity and reinforce that 
ACOs are responsible for ensuring their ACO participant agreements meet 
Shared Savings Program requirements.
(1) Prior Participation Requirement (Sec.  425.204(b))
    We propose 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, CMS already determines 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 rigorous screening process during the application cycle (and 
throughout the agreement period, if approved to participate in the 
program) to ensure

[[Page 39289]]

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 
provides necessary information about ACOs and individual ACO 
participants.
    We propose 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). Under this 
proposal, and 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. Thus, 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 ACO providers/suppliers, 
we believe we 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.
(2) Submission of Sample Agreements (Sec.  425.204(c)(6))
    We propose 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. 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 have concerns that CMS review of sample participant 
agreements gave the incorrect impression that CMS had determined that 
an agreement met all regulatory requirements.
    We believe 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 would retain the ability to request ACO sample participant 
agreements during the application cycle and at any point during an 
agreement period. Although we would not expect to routinely request 
during the application cycle that an ACO submit copies of ACO 
participant agreement documentation, it could be particularly useful in 
the case of ACOs that have a history of noncompliance with Sec.  
425.116 or other program requirements.
    We would retain 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 believe this 
modification to Sec.  425.204(c)(6) more clearly prescribes that the 
ACO is ultimately responsible for compliance with all program 
requirements.
(3) Submission of Executed Participant Agreements (Sec.  425.116(c))
    Lastly, we propose 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. The submission of 
agreements at the time of initial application will be governed by Sec.  
425.204(c)(6) and does not need to be addressed in Sec.  425.116(c). 
Moreover, 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. In our experience, neither 
ACOs nor their ACO participants have frequently raised concerns about 
continuing participation with an ACO into a new agreement period, nor 
notified CMS of changes to ACO participant agreements. An ACO must 
notify CMS within 30 days after the termination of an ACO participant 
agreement in accordance with Sec.  425.118(b)(2).
    We would retain the remainder of Sec.  425.116(c), which requires 
ACOs to submit ACO participant agreements when requesting additions to 
their ACO participant lists 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 note 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 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. Should CMS need 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 
proposed Sec.  425.206(c)(6) or under its audit authority in accordance 
with Sec.  425.314.
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

[[Page 39290]]

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.
    In the December 2018 final rule, we finalized requirements to 
further strengthen the beneficiary notification requirements. 
Specifically, we made changes to permit an ACO (not just its ACO 
participants) to disseminate the beneficiary information notice to 
beneficiaries, to require the notice to be provided prior to or at the 
first primary care visit of each performance year, and to permit the 
distribution of the notice through electronic transmission (such as 
email) or mail. 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. Proposed Revisions
    In considering the several different iterations of the beneficiary 
notice requirement over the history of the program,\102\ 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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    \102\ 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 earlier, the intention of the beneficiary notification is 
to empower beneficiaries, encourage beneficiary engagement, and improve 
transparency. For an ACO participating under the prospective assignment 
methodology, 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 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 at the beginning of a performance year. Therefore, we 
believe that it would cause 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 should receive the notice. This ensures that all 
beneficiaries ultimately assigned to the ACO would be informed of their 
right to decline data sharing.
    We propose 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 propose at Sec.  
425.312(a)(2)(ii) to provide that, in the case of an ACO that has 
selected preliminary prospective assignment, the ACO or ACO participant 
must provide the standardized written beneficiary notice to each fee-
for-service beneficiary prior to or at the first primary care visit of 
the performance year. We propose 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.
    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 seek 
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 expect that ACOs would be 
required to provide the notice to their FFS beneficiaries, based on 
assignment methodology, including any beneficiaries who seek care from 
ACO providers/suppliers throughout the agreement period. ACOs would 
also be responsible for issuing the beneficiary information notice 
during subsequent agreement periods, reminding assigned beneficiaries 
of their participation in the Shared Savings Program. Beneficiaries 
would continue to be able to modify their decision on whether to allow 
data sharing at any point. While we have received feedback from program 
stakeholders regarding the current annual requirement being too 
frequent, potentially confusing beneficiaries, and increasing burden on 
ACOs, reducing the frequency to once per agreement period may 
ultimately be too infrequent, given the many changes a beneficiary may 
experience with their health and life in general in that span of time. 
It is our goal to provide the notifications in a way that will continue 
to empower and inform beneficiaries without overwhelming or confusing 
them with

[[Page 39291]]

information. We encourage stakeholders to provide feedback on this 
suggestion, as well as other suggestions they may have in the spirit of 
burden reduction with regard to the beneficiary notification 
requirement as well as transparency and beneficiary engagement.
6. Seeking Comment on Considerations Related to the Use of Regional FFS 
Expenditures 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 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 the following discussion, we summarize select aspects of the 
Shared Savings Program's benchmarking methodology and related concerns 
that have been expressed by ACOs and other stakeholders. We specify 
some considerations based on our initial analyses of these issues, and 
seek comment on considerations that may inform future policy 
developments. However, we note 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 are also monitoring the impact of any 
anomalies in Medicare FFS expenditures and healthcare utilization by 
Medicare FFS beneficiaries resulting from the COVID-19 Public Health 
Emergency, 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).
b. Request for Comment on Calculation of the Regional Adjustment and 
Blended National-Regional Growth Rates for Trending and Updating the 
Benchmark
    In calculating the historical benchmark, CMS uses 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), CMS adjusts 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 
(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

[[Page 39292]]

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.\103\ \104\ 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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    \103\ 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).
    \104\ 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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    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.\105\ 
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.\106\ As another example, Aledade 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.\107\ 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.\108\ 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.\109\ 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.\110\ 
\111\ We appreciate ACOs and other program stakeholders bringing their 
concerns, and suggested alternatives, to our attention. We have begun 
to analyze these concerns about the use of factors based on regional 
FFS expenditures in 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 note that any such modifications would need to be adopted 
through notice and comment rulemaking.
---------------------------------------------------------------------------

    \105\ 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 COVID-19 PHE, although we noted these 
comments went beyond the modifications to the program's established 
in that IFC (85 FR 84783 through 84785).
    \106\ See NAACOS, Fixing the Rural Glitch, available at https://www.naacos.com/assets/docs/pdf/2021/RuralGlitchExplainer.pdf.
    \107\ 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.
    \108\ 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.
    \109\ 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.
    \110\ 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.
    \111\ 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 (text had not been 
received as of 07/05/21).
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    In this section of this proposed rule we discuss some of our 
considerations based on our initial analyses of stakeholders' concerns. 
We continue to investigate these concerns and perform additional 
simulations. We seek comment on these considerations and other related 
issues, as well as suggested approaches to modifying the program's 
benchmarking methodology, which could inform future rulemaking.
    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. 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

[[Page 39293]]

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 \112\ and the weight on (c) is one minus the ACO's 
regional market share. Shown as an equation this is:
---------------------------------------------------------------------------

    \112\ 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 seek comment on the approach we have outlined, or 
alternative approaches to calculating regional FFS expenditures without 
an ACO's assigned beneficiaries. In particular, we seek 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.
    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 PY 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 note 
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, to include ACOs that did not participate in a 6-month 
performance year from July 1, 2019, through December 31, 2019. We seek 
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 considering alternative benchmarking methodologies to address 
ACOs' penetration in their regional service areas, we believe it is 
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 PY 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 seek 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 seek comment on approaches that 
could strike a balance between adjusting program policies to address 
impacts on 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.
    We seek 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 seek 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

[[Page 39294]]

regional FFS expenditure trends used in benchmark calculations?
    Additionally, we seek 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.
    We also seek comment on using other approaches to calculating 
benchmarks under the Shared Savings Program. In particular, we seek 
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 seek 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 seek 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.
    We also note that 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 consideration of these issues.
c. Request for Comment on the Shared Savings Program's Risk Adjustment 
Methodology
    CMS takes 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, CMS 
adjusts expenditures for changes in severity and case mix using 
prospective HCC risk scores. Pursuant to Sec.  425.601(a)(10), CMS 
further adjusts the ACO's historical benchmark at the time of 
reconciliation for a performance year to account for changes in 
severity and case mix for the ACO's assigned beneficiary population 
between BY3 and the performance year (refer to Sec.  425.601(a)(10); 
Sec.  425.605(a)(1), (a)(2); Sec.  425.610(a)(2), (a)(3)). In making 
this risk adjustment, CMS makes 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). CMS uses 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.\113\
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    \113\ 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.\114\ 
\115\ In earlier rulemaking, commenters expressed that the 3 percent 
cap on risk score increases was especially problematic for ACOs whose 
regional service area includes a population of beneficiaries whose risk 
scores rise more than the cap. One 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).
---------------------------------------------------------------------------

    \114\ 85 FR 84783 through 84785.
    \115\ 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.
---------------------------------------------------------------------------

    We seek comment on--
     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 
raises 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

[[Page 39295]]

beneficiaries from the assignable beneficiary population used to 
calculate regional FFS expenditures and growth rates (described 
elsewhere in this section of this proposed rule), and policies 
addressing regional risk score growth.

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 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. We refer 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. Proposed 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 27 includes a high-level summary of the 13 
sections of the Medicare Ground Ambulance Data Collection Instrument.

[[Page 39296]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.050

    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 
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, we are proposing the following changes and 
clarifications to the Medicare Ground Ambulance Data Collection 
Instrument. The proposed changes and clarifications aim to reduce 
burden on respondents, improve data quality, or both.
a. Proposed 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 asks 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.''

[[Page 39297]]

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.
    We propose 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 
change clarifies that the intent of Section 2, Question 9 is to collect 
information on services or operations provided by the sampled 
organization. We invite comments on our proposal regarding reporting 
shared services.
b. Proposed 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.
    We are proposing 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 would be clearer to respondents and would 
result in higher-quality reported data. We invite comments on our 
proposal to change the definition of the average trip time.
c. Proposed 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. We propose 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 invite comments on our proposal to 
revise the secondary service area instructions.
d. Proposed Change to the 90th Percentile Emergency Response Time
    Section 4 (Emergency Response Time), Question 3 asks ground 
ambulance organizations to report the

[[Page 39298]]

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 asking ground ambulance organizations to provide 90th 
percentile response time rather than or in addition to the average 
response time. They believed 90th percentile response time is a more 
accurate indicator of ambulance services capabilities and quality. They 
stated that the average time has too wide a range for error, since 
roughly half of responses are quicker/slower than average. They 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 asking 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, we propose to revise the question to ask: ``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 would 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 would be different, the reported information would 
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 invite 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.
e. Proposed 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 propose 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 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 are proposing 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 invite comments on our proposal to revise reporting paid ground 
ambulance transports.
f. Proposed 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 asks 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

[[Page 39299]]

public safety responsibilities. The rationale for asking for 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 asking 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.
    We propose to change the instructions in Section 7 to ask 
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 would 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 propose to ask 
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 would 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 propose to ask 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 would 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 invite comments on our proposal to revise the 
labor hours.
g. Proposed 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 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 asked 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 asking 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 
would 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 would increase burden for respondents, potentially 
significantly for organizations that do not currently calculate 
depreciation, it would result in the most standardized information 
being submitted to CMS and the fewest changes to the layout of the 
instrument. Another option would 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, we propose to add screening 
questions to the instrument asking individually

[[Page 39300]]

whether the organization depreciates facilities, vehicles, and 
equipment. We believe this would 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 propose to add an additional 
column for clarity, but note that if the screening questions are added 
as described above not all columns would 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 
asks 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 would involve the least change to the 
instrument, we would 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 ask 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 propose to ask 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 would preserve our and MedPAC's ability to separately 
analyze these expenses. We invite comment on these alternatives to 
address instructions related to facility, vehicle, and equipment 
expenses.
h. Proposed 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.'' We propose 
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 are also proposing 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 are proposing 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 asks 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/

[[Page 39301]]

Supplies). Without these questions, total reported costs may be biased 
downward for NPIs that are part of broader parent organizations. We 
propose to add questions like the one reproduced above to the end of 
these four sections for completeness. The text would 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 propose 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 invite comments 
on our proposal to address questions related to NPIs under broader 
parent organizations.
i. Other Clarifications to the Medicare Ground Ambulance Data 
Collection Instrument
    We propose 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 propose 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 propose 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 propose 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 asks 
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 propose 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 propose 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 propose 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 these staff follows the current instruction.
    vii. Sections 7.1 and 7.2 Instruction Clarification: We propose 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 propose 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 propose 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 propose 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 recommend 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 invite 
comments on these proposed clarifications and updates to the 
instrument.
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 four 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

[[Page 39302]]

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 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 would 
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 public health emergency (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 would collect and report data in four 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, we are proposing 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 would align with the data collection period 
and data reporting period requirements for selected ground ambulance 
organizations in year 4. As a result, there would 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 COVID-19 PHE, we examined the 
possibility of extending the data reporting to encompass 4 years as 
planned instead of 2 years. We concluded that it would not be feasible 
to extend the data reporting period over 4 years. Extending the data 
reporting to encompass four years would 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 would be collected in 2023 as there 
would 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 two years for comparison by MedPAC. We invite comments on our 
proposal to revise the data collection period and data reporting period 
for

[[Page 39303]]

ground ambulance organizations selected in year 3.
5. Proposed 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.
    We propose 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 would not 
preclude CMS from including the MACs in the notification process. We 
also propose 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 invite comments on our technical 
revisions to the citation at Sec.  414.626(b)(1).
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 beginning in 2020. Due to the delay caused by 
the COVID-19 PHE, 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-May 31, 2023. We would 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 would 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 -February 28, 2024, we would 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 would 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.
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, 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.
    Due to the COVID-19 delay, we are proposing 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 invite comments on our 
proposal to revise the timeline when the public availability of data 
will begin.

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 propose to amend our regulation at Sec.  410.79 to preclude the 
provision of ongoing maintenance sessions unless

[[Page 39304]]

the MDPP beneficiary has started his or her first core session on or 
before December 31, 2021. In addition, we propose 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 the proposal herein. 
We propose that this change apply to all MDPP beneficiaries starting 
the MDPP set of services on or after January 1, 2022. Additionally, we 
propose 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 propose 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 proposed changes would impact our 
ability to complete an evaluation of the MDPP expanded model, but the 
evaluation would consider these proposed changes if enacted. The 
evaluation would continue to use beneficiary-level Diabetes Prevention 
Recognition Program (DPRP) encounter data and program data furnished by 
the 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 would 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 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.
1. Proposed Changes to Sec.  410.79(b), (c), and (e)
    We are proposing 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.
    CMS 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. The 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 these proposed changes would 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 would improve CMS's 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; \116\ 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 would make MDPP attractive to more MDPP 
eligible organizations and beneficiaries.
---------------------------------------------------------------------------

    \116\ 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.
---------------------------------------------------------------------------

    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.\117\ 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

[[Page 39305]]

sessions phase. To be eligible to 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.
---------------------------------------------------------------------------

    \117\ CDC DPRP Standards (March 1, 2021) https://nationaldppcsc.cdc.gov/s/article/DPRP-Standards-and-Operating-Procedures.
---------------------------------------------------------------------------

    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 fee-
for-service 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 are proposing 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 propose 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. If adopted, this 
change would effectively make the MDPP timeframe consistent with the 
National DPP for MDPP service periods that begin on or after January 1, 
2022. In addition, if finalized, this policy would 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 would 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 are 
proposing 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. We propose 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. Although 
the proposed maximum payment of $661.00 over a 1-year service period is 
less than the current maximum payment of $704.00 under the original 2-
year payment structure, we believe the proposed payment structure would 
have a net positive effect on the MDPP suppliers. Additionally, the 
maximum proposed payment is more than the 2021 National Average 
Facility Medicare Payment of $528.00 for the face-to-face intensive 
behavioral counseling for obesity (IBT-Obesity) for individuals.\118\ 
The IBT-Obesity, a Medicare preventive service benefit whose goal is to 
promote sustained weight loss among Medicare beneficiaries with a BMI 
of 30 kg/m2 and higher, pays a similar per session rate as what we are 
proposing for MDPP, including a maximum of 22 IBT-Obesity sessions in a 
primary care setting over a 12-month period. Our Office of the Actuary 
estimated that that the average payment for an MDPP supplier would 
increase by $100 with the elimination of the second year of MDPP. While 
the proposed maximum payment available to an MDPP supplier would 
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 would have minimal negative impact on the expanded model's 
costs. Table 28 shows the

[[Page 39306]]

current 2021 non-cumulative performance payments and the proposed 
performance payments for those MDPP beneficiaries who started their 
first core service on or after January 1, 2022. We are not proposing to 
change the payment rates for ongoing maintenance sessions in cases 
where a beneficiary remains eligible for them (that is, because they 
started receiving the MDPP set of services on or before December 31, 
2021 and achieve 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] TP23JY21.051

    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 proposed changes to the payment structure, which would 
pay a total of $61 more per beneficiary who attends at least 9 session 
than what is currently paid, would 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, increasing the number of locations beneficiaries 
may access the MDPP set of services. We expect the proposed changes to 
the MDPP payment structure would not affect MDPP's qualification for 
expansion. We would 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 
estimates that these proposed changes would reduce Medicare spending 
over 10 years, with potential savings starting in 2026. 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 are proposing a change to our emergency policy at Sec.  
410.79(e)(3)(v)(C) to account for the proposed 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.
    As noted above, we propose 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

[[Page 39307]]

set of services on or before December 31, 2021 would be able to 
continue with the ongoing maintenance phase if they meet the 
eligibility requirements described in Sec.  410.79(c)(3). Table 29 
summarizes our proposal for the MDPP services period based on 
beneficiary start date.
[GRAPHIC] [TIFF OMITTED] TP23JY21.052

    Additionally, we propose 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 are proposing to amend our regulation at Sec.  410.79(b), (c), 
and (e). We seek comment on these proposals and ways to simplify the 
proposed policies.
2. Proposed Changes to Sec.  414.84(b) and (c)
    We propose 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 the proposal herein. We propose 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 propose 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 are proposing to amend our regulation at Sec.  414.84(b) and 
(c). We seek comment on these proposals.
3. Proposed 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, skilled nursing facilities, 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 
would 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.

[[Page 39308]]

    In an effort to minimize the impact of this potential barrier and 
allow for a more robust expanded model evaluation, we are proposing 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 are proposing to amend our regulation at 
Sec.  424.205 (b) to reflect this waiver.
    We seek comment on these proposals.
4. Proposed Changes to Sec.  424.502
    We propose 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 are proposing to reverse 
this policy by amending Sec.  424.502 to remove the reference to the 
CMS-20134 thereby removing MDPP suppliers from the list of 
institutional providers required to pay the Medicare enrollment fee 
under Sec.  424.514. As proposed, Sec.  424.514 would no longer be 
applicable to organizations enrolling in Medicare as an MDPP supplier.
    We seek comment on this proposal.

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

1. Background on the Clinical Laboratory Fee Schedule
    Prior to January 1, 2018, Medicare paid for clinical diagnostic 
laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule 
(CLFS), with certain exceptions, under sections 1833(a), (b), and (h) 
of the Act. Under the previous payment system, CDLTs were paid based on 
the lesser of: (1) The amount billed; (2) the local fee schedule amount 
established by the Medicare Administrative Contractor (MAC); or (3) a 
national limitation amount (NLA), which is a percentage of the median 
of all the local fee schedule amounts (or 100 percent of the median for 
new tests furnished on or after January 1, 2001). In practice, most 
tests were paid at the NLA. Under the previous payment system, the CLFS 
amounts were updated for inflation based on the percentage change in 
the Consumer Price Index for All Urban Consumers (CPI-U), and reduced 
by a productivity adjustment and other statutory adjustments, but were 
not otherwise updated or changed. Coinsurance and deductibles generally 
do not apply to CDLTs paid under the CLFS.
    Section 1834A of the Act, as established by section 216(a) of the 
Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93, April 
1, 2014), required significant changes to how Medicare pays for CDLTs 
under the CLFS. In the June 23, 2016 Federal Register (81 FR 41036), we 
published a final rule entitled ``Medicare Clinical Diagnostic 
Laboratory Tests Payment System'' (CLFS final rule), that implemented 
section 1834A of the Act at 42 CFR part 414, subpart G.
2. Payment for Laboratory Specimen Collection and Travel Allowance for 
COVID-19 Clinical Diagnostic Laboratory Tests
    In general, section 1833(h)(3) of the Act requires the Secretary to 
provide for and establish a nominal fee for specimen collection for 
laboratory testing and a fee to cover transportation and personnel 
expenses for trained personnel to collect specimens from homebound 
patients and inpatients (not in a hospital), in addition to the amounts 
provided under the Medicare CLFS. Section 1833(h)(3)(A) of the Act 
provides that the Secretary must establish a nominal fee to cover the 
appropriate costs in collecting the sample on which a CDLT was 
performed and for which payment is made under Medicare Part B, except 
that not more than one such fee may be provided with respect to samples 
collected in the same encounter. The HCPCS codes for the nominal 
specimen fees currently listed on the CLFS (HCPCS codes 36415, P9612, 
and P9615) have a payment rate of $3. Section 216(a) of PAMA added 
section 1834A(b)(5) to the Act, which increases by $2 the nominal fee 
that would otherwise apply under section 1833(h)(3)(A) of the Act for a 
sample collected from an individual in a skilled nursing facility (SNF) 
or by a laboratory on behalf of a home health agency (HHA). Therefore, 
effective April 1, 2014, the nominal fee that would otherwise apply for 
a sample collected from an individual in a SNF or by a laboratory on 
behalf of a HHA is $5 (see Sec.  414.507(f)), and the relevant HCPCS 
code is G0471.
    In addition, section 1833(h)(3)(B) of the Act requires the 
Secretary to provide for and establish a fee to cover the 
transportation and personnel expenses for trained personnel to travel 
to the location of an individual to collect the sample, except that 
such a fee may be provided only with respect to an individual who is 
homebound or an inpatient in an inpatient facility (other than a 
hospital). In accordance with this provision, Medicare established a 
travel allowance for a laboratory technician to draw a specimen from 
homebound patients and non-hospital inpatients. Under current guidance, 
the travel allowance is intended to cover the estimated travel costs of 
collecting a specimen from a Medicare beneficiary and to reflect the 
technician's salary and travel costs. It is paid only when the nominal 
specimen collection is also payable and is not available if the 
technician is merely performing a messenger service to pick a specimen 
drawn by a physician or nursing home personnel. The methodology for 
determining the travel allowance varies depending on the round trip 
mileage to patients' homes. For instance, a per mile travel allowance 
methodology applies when the round trip to patients' homes is greater 
than 20 miles and a flat rate travel allowance methodology applies when 
the round trip to patients' homes is less than 20 miles. Medicare Part 
B MACs calculate the travel allowance for each claim. Stakeholders have 
reported that, in some cases, the MACs require them to maintain paper 
logs of miles traveled to receive the travel allowance.
    Our general policies for payment of the nominal specimen collection 
fee and the fee to cover transportation and expenses for trained 
personnel to collect specimens from homebound patients and non-hospital 
inpatients are set forth in Pub. 100-04, Medicare Claims Processing 
Manual, chapter 16, section 60. We also implemented the increased 
nominal specimen collection fee under section 1834A(b)(5) of the Act in 
our regulations at Sec.  414.507(f). The manual instructions regarding 
payment of these fees are available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c16.pdf. Neither the annual cash deductible nor the 20 percent 
coinsurance for Medicare apply to the specimen collection fees or 
travel allowance for laboratory tests.
    In the interim final rule with comment period titled, ``Medicare 
and Medicaid Programs; Policy and Regulatory Revisions in Response to 
the COVID-19 Public Health Emergency'' (March 2020 COVID-19 IFC), which 
displayed and became effective on

[[Page 39309]]

March 31, 2020, and appeared in the April 6, 2020 Federal Register (85 
FR 19230), we established that Medicare will pay a nominal specimen 
collection fee and associated travel allowance to independent 
laboratories for the collection of specimens for COVID-19 clinical 
diagnostic laboratory testing for homebound and non-hospital inpatients 
(85 FR 19256 through 19258). This policy provides independent 
laboratories with additional resources to provide COVID-19 testing and 
helps with efforts to limit patients' exposure to the general 
population and alleviate patients' unease with leaving the home 
specifically for the duration of the public health emergency (PHE) for 
the COVID-19 pandemic. To identify specimen collection for COVID-19 
testing specifically, we established two new level II HCPCS codes: 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.
    We stated in the March 2020 COVID-19 IFC (85 FR 19258) that, in 
establishing a nominal fee for COVID-19 specimen collection, we 
considered the type of trained laboratory personnel required to collect 
the specimen and the resources COVID-19 specimen collection could 
require, and we recognized that the existing specimen collection fees 
were not intended to address additional resources needed during the PHE 
for the COVID-19 pandemic. Absent concrete information regarding the 
costs associated with independent laboratories collecting such 
specimens for COVID-19 tests in the context of the PHE, we looked to 
similar services in other settings of care as a potential benchmark. We 
identified the PFS as the best source for a potential payment amount 
since physicians and other practitioners often bill for services that 
involve specimen collection by trained, non-institutional staff.
    We described how under the PFS, a Level 1 office visit (CPT[supreg] 
code 99211) typically does not require the presence of a physician or 
other qualified health care professional and the usual presenting 
problem(s) are minimal. This code is what is typically reported by 
physician practices when the patient only sees clinical office staff 
for services like acquiring a routine specimen sample. CPT[supreg] code 
99211 describes an: Office visit for E/M of an established patient that 
may be performed by clinical staff under supervision (may not require a 
physician's presence). Usually the presenting problem(s) are minimal 
and typically, 5 minutes are spent supervising or performing the 
service.
    We stated in the March 2020 COVID-19 IFC that, in the case of 
collecting a specimen for COVID-19 testing, we believe that in the 
context of and for the duration of the PHE for the COVID-19 pandemic, 
collecting specimens using nasopharyngeal and oropharyngeal swabs or 
collection of sputum will require a trained laboratory professional, as 
well as additional precautions that must be taken to minimize exposure 
risks in handling specimens that are suspected or confirmed for COVID-
19. Thus, we believe that collecting a specimen for COVID-19 testing 
may incur higher costs than similar specimen collection services, which 
require a trained laboratory professional, but not additional 
precautions, to minimize exposure risk.
    We indicated in the March 2020 COVID-19 IFC that this specimen 
collection fee policy was established for the duration of the PHE for 
COVID-19 (85 FR 19256) and will end once the PHE for the COVID-19 
pandemic has ended.
    In the CY 2021 PFS proposed rule, we requested comments on whether 
we should delete HCPCS codes G2023 and G2024 once the PHE for COVID-19 
ends (85 FR 50211). Specifically, we sought public input on why these 
codes, and their corresponding payment amounts, which are higher than 
the nominal specimen collection fees for other conditions, would be 
necessary or useful outside of the context of the PHE for COVID-19. We 
stated that we were particularly interested in why separate, increased 
payment for specimen collection, specifically for COVID-19 tests, in 
contrast to other tests, may be needed following the end of the PHE. We 
noted that comments received may inform a future proposal.
    We received public comments on the laboratory specimen collection 
fees for COVID-19 CDLTs. Commenters expressed support for permanently 
extending payment for specimen collection for COVID-19 CDLTs after the 
PHE ends, as commenters expect the COVID-19 virus to be present into CY 
2021, thus making it appropriate for CMS to continue to pay 
laboratories for specimen collection using HCPCS codes G2023 and G2024. 
Commenters recommended that we expand and permanently authorize the 
specimen collection fees under HCPCS codes G2023 and G2024 to apply to 
all CDLTs to compensate for the supplies, equipment, and sterilization 
protocols required for safe and uncontaminated specimen collection and 
handling in the presence of COVID-19. Commenters noted that COVID-19 
will continue to spread and may become an ongoing and/or seasonal 
infectious disease event, and because of this possibility, they expect 
that the heightened safety precautions, the need for personal 
protective equipment (PPE), and the requirement for special training 
for specimen collection will persist beyond the immediate PHE. In the 
CY 2021 PFS final rule (85 FR 84695), we noted that we planned to take 
this feedback into consideration for possible future rulemaking or 
guidance regarding the nominal specimen collection fees and associated 
travel allowance to independent laboratories for the collection of 
specimens for COVID-19 clinical diagnostic laboratory testing.
    After considering these comments, 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). 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. 
As described above, 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. Given the advances in the types of COVID-19 
CDLTs available to the public and the reduced need for specimen 
collection by trained laboratory professionals, we believe that the 
increased laboratory professional resources needed for COVID-19 
specimen collection will no longer be necessary after the PHE for the 
COVID-19 pandemic ends. Additionally, 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, PPE, and heightened sterilization and 
safety

[[Page 39310]]

protocols for laboratory specimen collection and handling will be at a 
more manageable level. Likewise, 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. Furthermore, we 
anticipate that widespread vaccination of both medical professionals as 
well as the general population will likely reduce the need for 
intensive PPE.
3. Comment Solicitation on Specimen Collection Fee and Travel Allowance 
for Clinical Diagnostic Laboratory Tests
    Although we expect the increased specimen collection fees for 
COVID-19 CDLTs will end at the termination of the PHE for the COVID-19 
pandemic, we are taking this opportunity to seek broad comment on our 
policies for specimen collection fees and the travel allowance as we 
consider updating these policies in the future through notice and 
comment rulemaking. Therefore, in this proposed rule, we are requesting 
comments regarding the nominal specimen collection fees for trained 
personnel to collect specimens from homebound patients and inpatients 
(not in a hospital). We are also seeking comments related to the 
calculation of costs for transportation and personnel expenses for 
trained personnel to collect specimens from such patients.
    We are seeking additional public input regarding considerations for 
the nominal fees for laboratory specimen collection for COVID-19 
testing beyond the PHE. We are particularly interested in what 
additional resources might be needed for specimen collection for COVID-
19 CDLTs and other tests after the PHE ends. For example, laboratories 
may see a benefit to using more PPE for laboratory staff than they did 
before the onset of the PHE as way to improve safety for personnel and 
patients. We expect there will be ongoing interest in minimizing 
outbreaks of diseases such as influenza in various settings, including 
SNFs, where beneficiaries may not be able to travel to a laboratory for 
testing. We seek feedback from stakeholders regarding how their 
specimen collection practices may have changed as a result of, or from 
insight gained during, the PHE for the COVID-19 pandemic, specifically 
in terms of changes to supplies and staffing resources as well as 
related costs. We recognize that the COVID-19 pandemic may have changed 
the approaches to specimen collection for laboratory testing from 
homebound patients and inpatients (not in a hospital) in ways that will 
persist beyond the termination of the PHE for the COVID-19 pandemic, 
and we want to understand these changes to inform potential 
modifications to our laboratory specimen collection policies in the 
future.
    We also seek comments on the methodology for calculating the travel 
allowance, including calculation of mileage specific to per mile or 
flat rate and proration when there are multiple patients or specimens.
    Comments received may inform a future proposal.
4. Medicare Clinical Laboratory Fee Schedule: Electronic Travel Logs
    In addition to insights we have gained, and are seeking to gain, 
from the COVID-19 CDLT laboratory specimen collection fees policies we 
implemented for the duration of the COVID-19 PHE, we have also had the 
opportunity to gain insight about other CLFS policies established for 
the purposes of the PHE for COVID-19.
    As described in the March 2020 COVID-19 IFC (85 FR 19256), and 
noted above, section 1833(h)(3)(B) of the Act requires the Secretary to 
provide for and establish a fee to cover the transportation and 
personnel expenses for trained personnel to travel to the location of 
an individual to collect the sample, except that such a fee may be 
provided only with respect to an individual who is homebound or an 
inpatient in an inpatient facility (other than a hospital). In 
accordance with this provision, Medicare established a travel allowance 
for a laboratory technician to draw a specimen from homebound patients 
and non-hospital inpatients. The travel allowance is intended to cover 
the estimated travel costs of collecting a specimen from a Medicare 
beneficiary and reflect the technician's salary and travel costs. It is 
paid only when the nominal specimen collection is also payable and is 
not available if the technician is merely performing a messenger 
service to obtain a specimen drawn by a physician or nursing home 
personnel. The methodology for determining the travel allowance varies 
depending on the round trip mileage to patients' homes. For instance, a 
per mile travel allowance methodology applies when the round trip to a 
patients' home is greater than 20 miles and a flat rate travel 
allowance methodology applies when the round trip is less than 20 
miles.
    We stated in the March 2020 COVID-19 IFC (85 FR 19258) that 
Medicare payment for transportation and expenses for trained personnel 
to collect specimens from homebound patients and inpatients (not in a 
hospital) for purposes of COVID-19 testing would be made in accordance 
with existing instructions found in the Medicare Claims Processing 
Manual. Our policies for payment of the fee to cover transportation and 
expenses for trained personnel to collect specimens from homebound 
patients and non-hospital inpatients are set forth in Pub. 100-04, 
Medicare Claims Processing Manual, chapter 16, section 60.
    Medicare Part B MACs calculate the travel allowance for each claim, 
and we understand from stakeholders that, in some cases, the MACs have 
required laboratories to maintain paper logs of miles traveled to 
receive the travel allowance. In the March 2020 COVID-19 IFC (85 FR 
19258), we noted that stakeholders reported to us that maintaining 
paper logs of miles is burdensome, whereas maintaining electronic logs 
is less burdensome, especially with the development of GPS systems and 
various applications for cellular phones in recent years that can track 
miles traveled. We indicated that, for the duration of the PHE for the 
COVID-19 pandemic, paper documentation of miles traveled would not be 
required and that laboratories could maintain electronic logs if they 
preferred. However, we indicated that laboratories would need to be 
able to produce these electronic logs in a form and manner that could 
be shared with MACs, and that the MACs may provide more information on 
acceptable formats.
    We understand that laboratories have benefited from the operational 
guidance we announced in the March 2020 COVID-19 IFC to permit them to 
use electronic rather than paper logs of miles traveled. Using 
electronic logs reduces administrative burden for laboratories and 
their staffs, as we understand from stakeholders that paper logs are 
extremely time- and resource-intensive and they have requested that CMS 
provide flexibilities for the use of electronic logs. Paper logs 
require storage, which can be a burden to laboratories. Additionally, 
manipulation of paper logs is time- and labor-intensive, which could 
increase laboratory costs. Therefore, 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. To be clear, this option for laboratories to 
maintain electronic logs is not limited to COVID-19 specimen 
collection, but

[[Page 39311]]

rather, applies to specimen collection for any CDLT. We are announcing 
electronic logs as a permanent option in this proposed rule, and 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.

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 
II.N. of this proposed rule, we propose several changes to our existing 
provider enrollment regulations.
b. Legal Authorities
    There are two principal categories of legal authorities for our 
proposed 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. Proposed 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 
propose several changes related to these authorities.
    First, we propose 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.\119\ Such 
individuals can impact a provider's or supplier's operations in a 
manner harmful to the interests of the Medicare program; for example, 
an individual in a lower-level administrative position could undertake 
fraudulent activity to the same extent (and with consequences as 
severe) as a high-ranking officer. For program integrity purposes, the 
central issue is not the specific individual who engaged in the abusive 
conduct, but the conduct itself. Accordingly, we believe this 
regulatory revision is necessary to protect Medicare and its 
beneficiaries.
---------------------------------------------------------------------------

    \119\ 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.'' (Section 424.535(a)(2) 
does not contain the entirety of this clause.) To conform to our change 
described in the previous paragraph, we propose to replace this 
language with ``other health care or administrative or management 
services personnel furnishing services payable by a federal health care 
program.'' This would ensure consistency with the previously referenced 
OIG guidance, which, we note, is not restricted to services: (1) Only 
reimbursable by Medicare; or (2) furnished by individuals listed on a 
Medicare enrollment application. We would also 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 propose 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.''

[[Page 39312]]

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 propose 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 proposed change is warranted.
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.\120\ To reactivate one's billing 
privileges, current regulations state that the deactivated provider or 
supplier must recertify that their enrollment information on file with 
Medicare is correct and must furnish any missing information as 
appropriate (or submit a complete Form CMS-855 application if required 
by CMS).
---------------------------------------------------------------------------

    \120\ We are proposing 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 Proposed 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).
---------------------------------------------------------------------------

    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 propose 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. This would streamline and 
clarify the deactivation rebuttal process, promote transparency, and 
enable the provider community to submit feedback on our proposal.
    The specific changes we propose are as follows:
     At Sec.  424.545(b), we propose 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 are proposing to create a new Sec.  424.546 to 
address the deactivation rebuttal process. This would enable us to 
tailor our procedures to the unique facts and circumstances of 
deactivation rebuttals, which are different from payment suspensions.
     At new Sec.  424.546(a)(1), we propose 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. We believe that a 15-day period strikes an ideal balance 
between the need to expeditiously take measures to safeguard program 
integrity and the importance of ensuring that the provider or supplier 
has a reasonable time-period in which to submit a rebuttal.
     At new Sec.  424.546(a)(2), we propose that CMS may, at 
its discretion, extend the 15-day time-period referenced in Sec.  
424.546(a)(1). This would permit CMS to account for special situations, 
such as the following: (1) A particularly and unusually complex 
deactivation case that perhaps warrants giving the provider or supplier 
more time to prepare its rebuttal; or (2) circumstances beyond the 
provider's or supplier's control prevents or would likely prevent the 
timely submission of its rebuttal.
     At new Sec.  424.546(b)(1) through (4), we propose 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 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 proposed 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 would 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.
    We believe that the requirements of proposed Sec.  424.546(b)(1) 
through (4) are necessary to ensure: (1) A uniform and standard process 
for submitting deactivation rebuttals; (2) that there is written 
documentation of the provider's or supplier's contentions; (3) that CMS 
has sufficient information to perform its review; and (4) that the 
provider or supplier authorized the rebuttal submission.
     At new Sec.  424.546(c), we propose 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). This provision would not only specify the 
consequences of an untimely or non-compliant rebuttal but also help 
encourage the provider or supplier to abide by paragraphs (a) and (b) 
should it choose to rebut a deactivation.
     At new Sec.  424.546(d), we propose that upon receipt of a 
timely and compliant deactivation rebuttal, CMS

[[Page 39313]]

reviews the latter to determine whether the imposition of the 
deactivation and/or the designated effective date are correct. We 
believe this provision would adequately notify the public of the scope 
of CMS' review.
     At new Sec.  424.546(e), we propose that nothing in Sec.  
424.546 or in Sec.  424.545(b) would require CMS to delay the 
imposition of a deactivation pending the completion of the CMS review 
described in paragraph (d). That is, the filing of a rebuttal and the 
review period associated therewith does not suspend or postpone the 
deactivation's implementation. This provision, which mirrors our 
existing subregulatory policy on the matter, is needed so that CMS can 
expeditiously enforce the program integrity protections that a 
deactivation affords, all the while recognizing the provider's or 
supplier's ability to challenge the deactivation via the rebuttal 
process. If CMS determines under paragraph (d) that the deactivation 
was erroneous, it would be reversed.
     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 would not be an initial 
determination under Sec.  498.3(b) and, therefore, would not be 
appealable. This would clarify for providers and suppliers that a 
rebuttal is the only administrative remedy available for a 
deactivation.
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. 
This includes requirements for supervising physicians (Sec.  
410.33(b)), nonphysician personnel (Sec.  410.33(c)), and the ordering 
of tests (Sec.  410.33(d)). In addition, Sec.  410.33(g) contains 
various certification 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 
compliance with enrollment requirements.
    IDTFs generally perform diagnostic tests on beneficiaries in, for 
instance, a health care facility, physician's office, or mobile 
setting. Indeed, the IDTF standards at Sec.  410.33(g) (as well as 
other provisions at Sec.  410.33) were designed for traditional IDTF 
suppliers that engage in direct or in-person beneficiary interaction, 
treatment, and/or testing. Yet, some health care entities have 
developed or utilize diagnostic tests that do not require this form of 
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 
propose that IDTFs that have no beneficiary interaction, treatment, or 
testing at their practice location would 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 that the IDTF 
uses to perform diagnostic tests to demonstrate the basic 
qualifications to perform these tests as evidenced by state licensure 
or state certification. In the absence of a state licensing board, the 
technician must be certified by an appropriate national credentialing 
body. (The IDTF must also maintain documentation available for review 
that these requirements have been met.) However, the indirect tests in 
question often 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 
would reduce 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 propose to divide current Sec.  410.33(c) into two 
paragraphs. New paragraph (c)(1) would contain the existing 
requirements of Sec.  410.33(c) except as stated in new paragraph 
(c)(2). We propose 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 there are such 
state licensure requirements, the IDTF must maintain documentation 
available for review that these requirements have been met.
    While we believe that personnel performing the tests described in 
proposed paragraph (c)(2) should meet whatever state requirements exist 
for those services, paragraph (c)(2) would not include any reference to 
national credentialing bodies. Further, we recognize 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 propose that the following IDTF certification standards in 
Sec.  410.33(g) would not apply to the aforementioned 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)). (For mobile IDTFs, this documentation 
would be stored at their home office.)

[[Page 39314]]

     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), we note that 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 would revise 
paragraph (g)(8) in this vein. We propose a similar approach with Sec.  
410.33(g)(9); neither beneficiaries whose tests are sent to the 
exempted IDTF nor the public in general will visit its physical 
location, therefore negating the need for a posting of standards.
    As previously mentioned, we also propose that Sec.  410.33(g)(6) 
would not apply to exempted IDTFs. 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. Nevertheless, we recognize that 
a chain of liability could involve an exempted IDTF if a computer 
malfunction or other error arose in the IDTF's diagnostic services. To 
illustrate, a software problem could lead to inaccurate test results, 
which in turn might result in an incorrect interpretation by a 
beneficiary's physician and ultimately harm the beneficiary. There 
could be other instances, too, where the performance of a particular 
test raises questions of possible liability. Consequently, we are 
soliciting 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) 
if Sec.  410.33(g)(6) remains an exception, whether a liability amount 
of less than $300,000 is warranted 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.
    In short, we believe that applying the foregoing exemptions to 
IDTFs that have developed innovative proprietary software for 
diagnostic testing where no patient interaction is involved would 
benefit the Medicare program and its beneficiaries by encouraging new 
IDTF technologies and services. We welcome comments on our proposed 
exemptions, and we specifically request comment on whether to retain 
and modify the IDTF standards in Sec.  410.33(g)(6), (8), and (9) for 
the aforementioned exempted IDTFs, rather than waive those requirements 
for them.
e. Proposed 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. The purpose of this provision is to place 
providers and suppliers on notice that they are legally obligated to 
always submit correct and accurate claims and that failing to do so 
could lead to the revocation of their enrollment; indeed, the 
submission of non-compliant claims places the Trust Funds at risk due 
to the potential for erroneous payments. 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 believe we must 
revise Sec.  424.535(a)(8)(ii)(A) through (F) as follows:
     In paragraph (a)(8)(ii)(A), we propose 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. As 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 timeframe. For example, assume Provider X 
enrolled in Medicare on February 1. Although only a small percentage of 
its claims were denied through June 30, the denial rate was very high 
between July 1 and July 31. Under our proposed change, our period of 
review could be limited to July. This reflects our view that even a 
comparatively short timeframe of improper billing can threaten the 
Trust Funds, as evidenced by the aforementioned cases we have seen. We 
reiterate that the submission of non-compliant claims generates a risk 
of improper payments, which could lead to thousands or even millions of 
Medicare dollars being paid pursuant to either a lengthy or brief 
billing period.
     For reasons similar to our proposed revision of Sec.  
424.535(a)(8)(ii)(A), we propose 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 believe that eliminating paragraph 
(a)(8)(ii)(D) would strengthen our program integrity efforts.
     We also propose to remove Sec.  424.535(a)(8)(ii)(E), 
which addresses the length of the provider's or supplier's enrollment. 
We consider this factor to be largely immaterial to the issue of 
whether a pattern of improper billing exists. More importantly, it can 
hinder our ability to utilize Sec.  424.535(a)(8)(ii) as a whole. We 
have encountered fraud schemes where providers and suppliers enroll in 
Medicare, bill inappropriately, and then leave the program after a 
brief timeframe. We believe the enrollment length in these and other 
cases of non-compliant billing 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 propose 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

[[Page 39315]]

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 
this 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 propose to add new paragraph (a)(8)(ii)(C) 
by which we would consider the type of billing non-compliance and the 
specific facts surrounding said non-compliance (to the extent this can 
be determined). We believe this paragraph would provide greater 
specificity than the broader, catch-all factor at Sec.  
424.535(a)(8)(ii)(F) (which we would 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.
    Given the foregoing, 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 recognize that these revisions would represent a reduction in 
the number of factors we would consider. However, we believe the 
remaining criteria would still give the provider or supplier fair 
consideration in our determinations while permitting us to address a 
wider range of non-compliant billing periods in order to protect the 
Medicare program.
2. Provider/Supplier Medical Review Requirements
a. Background
    CMS identifies improper payments in the Medicare Fee-for-Service 
(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 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. Proposal for 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 proposed rule, we are proposing key terms and 
definitions associated with these two review types; language codifying 
a contractors' authority to request additional documentation within 
established timeframes; and 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. We believe that adding 
these provisions in regulation will enhance provider and supplier 
understanding of our review processes, as well as, improve consistency 
among our contractors.
c. Proposed Key Terms and Definitions
    To ensure consistency across prepayment and post-payment reviews 
and establish clear requirements, we propose adding the following key 
terms and their definitions to Sec.  405.902: ``Additional 
documentation'' means the 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 would be consistent with longstanding 
manual language and common use of these terms by our contractors.
d. Prepayment and Post-Payment Medical Review
    We are proposing to add new Sec.  405.903 to outline the prepayment 
medical review provisions.
     At paragraph (a), we are proposing 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 are proposing language detailing our 
contractors' authority to request additional documentation while 
conducting a prepayment review.
     At paragraph (b)(1), we are proposing 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 are proposing that a contractor 
may accept documentation received after 45

[[Page 39316]]

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 are proposing 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 proposed 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 propose to specify 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 are also proposing similar provisions at new Sec.  405.929 
regarding post-payment medical reviews.
     At paragraph (a), we are proposing language outlining our 
contractors' authority to select claims and conduct post-payment 
medical reviews.
     At paragraph (b), we are proposing language that specifies 
our contractors' authority to request additional documentation.
     At paragraph (b)(1), we are proposing 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 propose 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 are proposing 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.
     At paragraph (d), we propose 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 
proposed 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 are also proposing 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 proposed 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 are also proposing 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 are adopting the 
criteria set forth in Sec. Sec.  405.903 and 405.929, and we are not 
utilizing 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.

[[Page 39317]]

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 are proposing 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 current 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 the CY 2022 PFS final rule.
3. Proposed 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 payment 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 those 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).
    As noted previously, 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 believe the same considerations regarding varying costs 
based on geographic locality and the need for annual updates apply. 
Accordingly, we are proposing 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 are 
also proposing 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.
    Additionally, in the CY 2021 PFS final rule (85 FR 84688), we 
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 are also 
proposing to revise Sec.  410.67(d)(5) to state explicitly that 
payments for medications that are delivered, administered or dispensed 
to

[[Page 39318]]

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. 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 note 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 seek comment on these proposed changes.
4. Proposed OTP Coding and Payment for New Nasal Naloxone Product
    We are aware that 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.\121\ 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. At the time of drafting this proposed 
rule, we do 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 are proposing to create a new 
G-code describing a take-home supply of this higher dose naloxone 
hydrochloride nasal spray product.
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    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 would 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 welcome comment on this proposal.
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 Public 
Health Emergency (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 
could 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 were 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.
    We have continued to evaluate whether this flexibility would 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.\122\ Additionally, public comments received 
in response to the CY 2021 PFS proposed rule (85 FR 84691) encouraged 
us to reconsider our position on coverage of audio-only services 
following the conclusion of PHE for COVID-19 and commenters suggested 
that CMS consider permanently allowing OTPs to furnish certain OUD 
treatment services using audio-only telephone calls. Commenters stated 
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, commenters 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. 
Other commenters stated that the use of communication technology has 
reduced stress and stigma for those who require OUD treatment services 
and the allowance of

[[Page 39319]]

audio-only services has greatly expanded access for beneficiaries who 
may not be able to use interactive video. Another commenter 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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    After further consideration, we are persuaded by the public 
comments and other stakeholder feedback 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 are proposing 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 
following the end of the PHE for COVID-19 in cases where audio/video 
communication technology is not available to the beneficiary, provided 
all other applicable requirements are met. Accordingly, we are 
proposing 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 note 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.
    Additionally, we are proposing 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 
are not proposing 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 recognize 
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 are limiting our proposal regarding the use 
of modifier 95 to claim lines for the counseling and therapy add-on 
code (HCPCS code G2080). We are also proposing 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 are proposing 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 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. 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, these proposed 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 counselling 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 are proposing 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 Sec.  400.200 of this chapter, 
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 
counselling and therapy services, the practitioner must also 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 communications technology. 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 are seeking 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 have access to the most appropriate form of care.

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

[[Page 39320]]

(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.
    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).
    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 are proposing to revise the regulation at Sec.  411.354(c)(2) 
that sets forth the conditions for the existence of an indirect 
compensation arrangement. First, we are proposing to revise 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 are proposing 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 include arrangements for the rental 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 the requirements of another applicable exception). 
Second, following the publication of the MCR final rule, we received 
inquiries from stakeholders requesting clarification on the term 
``unit'' in Sec.  411.354(c)(2)(ii)(A). We are proposing to define the 
term ``unit'' for purposes of applying the regulation. We are also 
proposing 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

[[Page 39321]]

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 
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 relative value unit 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 (88 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 must satisfy the requirements 
of an applicable exception in order to avoid the prohibitions of 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 55739 through 55747). 
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 an important program integrity 
requirement that previously applied when determining satisfaction of 
the requirements of the

[[Page 39322]]

exception at Sec.  411.357(p) for indirect compensation arrangements. 
As a result, 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 of office space 
or equipment.
    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 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 office space 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 (D.C. Cir. 
2015), we explained our rationale for the restrictions as they apply to 
arrangements for the lease or use of office space 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).
    Our position on the inherent risks presented by unit of service-
based compensation formulas in the context of the rental of space or 
equipment has not changed since the 2017 PFS final rule. 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, making it applicable to the rental 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 a similar restriction 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 rental of office space or equipment, whether 
direct or indirect, may pose a significant risk of program abuse, and 
are proposing revisions to Sec.  411.354(c)(2)(ii) that would ensure 
that the prohibition on certain unit of service-based compensation 
formulas for the rental of office space 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 rental of office 
space or equipment would be an indirect compensation arrangement if all 
other conditions of Sec.  411.354(c)(2)(i) through (iii) are met. If

[[Page 39323]]

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 rental or 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.
    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 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.
    To better align with our view regarding the reduced risk of program 
or patient abuse where compensation to a physician (or an immediate 
family member of a physician) is solely for services that he or she 
personally performs, the proposed revisions to Sec.  411.354(c)(2)(ii) 
would require 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, as noted above, arrangements for the rental 
of office space or equipment. Specifically, we are proposing 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 are also proposing 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 of the amount of compensation per 
unit. As proposed, the condition at Sec.  411.354(c)(ii)(A) would state 
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), we would consider 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) not to be personally performed by the physician. We are 
proposing to codify this policy at Sec.  411.354(c)(2)(ii)(B)(3).
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 Sec.  411.354(c)(2)(ii)(A)(1) through (3), the 
unbroken chain of financial relationships does not constitute an 
indirect compensation arrangement. Since the publication of the MCR 
final rule, we have 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 are 
proposing 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) and 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.

[[Page 39324]]

Compensation formulas that incorporate a percentage of a variable are 
also unit-based. For example, if a physician is 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 time-period 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 would be a month, and the formula for 
determining the compensation per month would be ($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 would 
be 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 would be a calendar year, and the formula for 
determining the compensation per year would be $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 arrangement, we are proposing 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 
is: (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 seek comment on the proposals discussed above and whether 
additional guidance is needed with respect to the determination of 
whether an indirect compensation arrangement exists.
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,\123\ 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) would apply to the referral and billing of COVID-19 vaccines.
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    \123\ See https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies.
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    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

[[Page 39325]]

and in annual PFS Updates. In Phase II, we removed the requirement that 
the preventive screening test, immunization, or vaccine is reimbursed 
based on a fee schedule, in recognition that some of the vaccines 
eligible for the exception may be paid by Medicare using different 
reimbursement methods (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 would 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 would 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 List of CPT/HCPCS Codes as codes to which the exception at Sec.  
411.355(h) is applicable, they would 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 are 
proposing 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 are proposing to revise and renumber 
the regulation at Sec.  411.355(h). Revised Sec.  411.355(h)(1) would 
include the conditions that must be met to avoid the physician self-
referral law's referral and billing prohibitions, and revised Sec.  
411.355(h)(2) would state 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 would pose a risk of program or patient 
abuse. We seek comment on our approach and whether we should limit 
relief from the requirement at proposed Sec.  411.355(h)(1)(iii) to the 
period during which the current public health emergency is in effect, 
until such time as CMS-mandated frequency limits apply for COVID-19 
vaccines, or some other period of time.
    In the alternative, we are proposing to remove the CMS-mandated 
frequency limit requirement for all vaccines. We seek comment on 
whether it would then be necessary to include alternative program 
integrity requirements in the exception at Sec.  411.355(h). We are 
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.
    We are not proposing to remove the CMS-mandated frequency limit 
requirement with respect to preventive screening tests. We remain 
concerned that a physician's ability to refer frequently for preventive 
screening tests could lead to program or patient abuse, and do not 
believe that the current COVID-19 pandemic or any other circumstances 
necessitate the removal of this important program integrity protection 
with respect to preventive screening tests.
    We are also proposing to revise the terminology used in the 
exception at Sec.  411.355(h) for clarity and consistency. 
Specifically, we are proposing to remove the terms ``immunization'' and 
``immunizations'' throughout Sec.  411.355(h) and the headers used in 
the Code List. The Centers for Disease Control and Prevention (CDC) 
defines immunization as a process by which a person becomes protected 
against a disease through vaccination. This term is often used 
interchangeably with vaccination or inoculation. Vaccine is defined as 
a product that stimulates a person's immune system to produce immunity 
to a specific disease, protecting the person from that disease.\124\ 
All of 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.''
---------------------------------------------------------------------------

    \124\ https://www.cdc.gov/vaccines/vac-gen/imz-basics.htm.
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    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 in Sec.  411.351) and 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

[[Page 39326]]

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 are proposing to improve the accuracy of the 
terminology at this time to prevent any possible confusion in the 
future. The proposed revisions to Sec.  411.355(h), if finalized, would 
not affect whether we consider a code to be a designated health 
service.
4. List of CPT/HCPCS Codes (Sec.  411.351)
    As described in section III.P.1. of this proposed 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. 
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 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 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 https://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).\125\
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    \125\ https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.
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    Coding changes have become more frequent since we initially began 
publishing the Code List. Currently, CPT codes are updated annually and 
effective for use on January 1 of each year, with some exceptions for 
Category I, II, and III codes, which are published more frequently. CMS 
has updated its HCPCS Level II coding procedures to enable shorter and 
more frequent HCPCS coding cycles. For example, we have implemented 
quarterly HCPCS code application opportunities for drugs and 
biologicals; and bi-annual application opportunities for Durable 
Medical Equipment (DME) and Orthotics, Prosthetics (O&P), and Supplies, 
as part of our comprehensive initiative to foster innovation and 
expedite adoption of and patient access to new medical technologies. 
(See https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo.)
    In order to make available the most recent updates in a timelier 
manner for purposes of the physician self-referral law, we are 
proposing to update the Code List on a more frequent basis. 
Specifically, we are proposing to update the Code List each calendar 
quarter, and provide public notification in advance of Code List 
updates. 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 are also proposing a 30-day public 
comment period following the posting of each advance notification of 
the upcoming quarterly Code List update. Under this proposal, 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 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, a longer 
timeframe may be necessary to address complex comments or those that 
require coordination with external parties. This new process and 
schedule would begin with the update effective April 1, 2022. The Code 
List that is effective January 1, 2022 would be included in the CY 2022 
PFS final rule. We believe that predetermined dates for the updates 
will provide clarity and transparency for stakeholders regarding any 
revisions to the Code List.
    In addition, we are proposing to publish the Code List solely on 
the CMS website (commencing after the publication of the January 1, 
2022 Code List in the CY 2022 PFS final rule, as proposed above). We 
believe that publication via the CMS website would facilitate 
compliance with the physician self-referral law and allow access to the 
most up-to-date Code List. Further, this approach would provide a more 
comprehensive list of codes identifying designated health services for 
purposes of the physician self-referral law that better aligns with the 
current coding cycles for CPT and HCPCS codes.
    Finally, we are proposing corresponding revisions to the definition 
of List of CPT/HCPCS Codes at Sec.  411.351 to update the URL that 
indicates where the Code List is published on the CMS website. 
Specifically, we are proposing to revise the definition of List of CPT/
HCPCS Codes at Sec.  411.351 to state ``List of CPT/HCPCS Codes means 
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 each calendar quarter and posted on the CMS 
website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.''
    We seek comment on our proposals and whether more or less frequent 
Code List updates would be appropriate.

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

[[Page 39327]]

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 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 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 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 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 of 
the most effective 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 
between 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

[[Page 39328]]

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 observe 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 ePrescribing software can support EPCS and 
meets 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 individual prescribers (those prescribers not 
prescribing under an institutional practitioner's DEA registration), 
the individuals managing logical access controls must verify that their 
DEA registration is valid. This step is required even if they are 
already prescribing controlled substances on paper. After being granted 
access, practitioners 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 is 
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,\126\ 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 in the DOJ 
requirements should allow prescribers to start conducting EPCS with 
greater ease.
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    \126\ https://www.reginfo.gov/public/do/eAgendaMain.
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    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. In CY 2021, EPCS increased to 70 percent of all prescription 
drug events (PDEs) for controlled substances as compared to 38 percent 
in CY 2019.\127\ 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 vulnerable persons 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.
---------------------------------------------------------------------------

    \127\ Based on Prescription Drug Event data processed through 
April 6, 2021.

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[[Page 39329]]

4. Proposed 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 crafting this policy, we also examined 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, even though we 
declined to take compliance actions until 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 controlled 
substances to vulnerable populations, including Part D beneficiaries 
who need pain treatment or who have 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 we are proposing to revise Sec.  
423.160(a)(5) to change the EPCS compliance date from January 1, 2022 
to January 1, 2023. We welcome comments on this proposal, including 
whether commenters believe that we should maintain the January 1, 2022 
compliance date, given the benefits of EPCS, and the feasibility for 
prescribers to adopt EPCS for Part D prescriptions by January 1, 2023.
    We propose to extend the compliance deadline for Part D controlled 
substance prescriptions written for beneficiaries in long-term care 
(LTC) facilities, excluding beneficiaries who are residents of nursing 
facilities and whose care is provided under Part A of the benefit, from 
January 1, 2022 to January 1, 2025. The intent of this extension 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.
    After considering the comments in response to our August 2020 RFI 
and CY 2021 PFS proposed rule, in addition to our conversations with 
stakeholders, we believe that LTC facilities face additional barriers 
to EPCS adoption that most prescribers do not face. 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 specific guidance for LTC 
facilities within the SCRIPT 2017071 standard, which would 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 NCPDP may be able to adopt these changes 
and integrate them into the LTC workflow by January 1, 2023.
    We also 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,\128\ 
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 
pandemic decreases, LTCs should be able to more easily conduct EPCS.
---------------------------------------------------------------------------

    \128\ 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 propose to revise Sec.  423.160(a)(5) to clarify 
that compliance actions for prescriptions written for beneficiaries in 
an LTC facility will not begin until January 1, 2025. We do not propose 
a specific LTC waiver or exception to the EPCS requirement, and we do 
not anticipate extending the compliance deadline beyond January 1, 
2025. We solicit comments on the benefits, burdens, and challenges of 
this approach.
5. Proposed 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, however, 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.

[[Page 39330]]

    We note that the 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. Based on our 
review of the current NCPDP standard, all opioids have risk evaluation 
and mitigation strategies and as a result, would fall into the 
exception if there were one, which would frustrate the purpose of this 
statute.\129\ As a result, we decline to propose to adopt this 
suggested exception. However, we seek comment on this decision.
---------------------------------------------------------------------------

    \129\ National Council for Prescription Drug Programs, 
``Implementation Guide'' January 2020.
---------------------------------------------------------------------------

    We do believe that other reasons 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 are not 
proposing 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 propose 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 are proposing 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 would 
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 
seek 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.
6. Proposed 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 seek comment on this 
assumption.
    As stated in our current regulation at Sec.  423.160(a)(3)(iii), we 
currently allow Part D plans to use either HL7 messages or the NCPDP 
SCRIPT standard to transmit prescriptions or prescription-related 
information internally when the sender and the beneficiary are part of 
the same legal entity. This allowance stands in contrast to our 
overarching requirement at Sec.  423.160(a)(1) and (3), for prescribers 
to use the NCPDP SCRIPT standard for most external transactions. We 
believe that allowing Part D plans to continue to have more discretion 
over their internal transactions is consistent with our current policy. 
Therefore, we propose 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 seek comment on this proposal.
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 (which CMS will define in subsequent rulemaking), 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 circumstances 
for a waiver of 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 propose 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 would 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

[[Page 39331]]

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 seek comment on this assumption. Although we 
understand that prescribers will be required to purchase third party 
applications with additional identity and security measures so that 
EHRs meet DEA requirements, we have not included this cost in our 
calculation, due to the wide variability of these costs for which there 
is a dearth of information. We seek stakeholder feedback on the costs 
of these third-party applications.
    We believe that requiring prescribers who prescribe 100 or fewer 
Part D controlled substance prescriptions per year to purchase and 
construct EPCS hardware and software may be financially burdensome for 
these prescribers compared to the benefits of EPCS, since any reduced 
costs from EPCS transactions may not be enough to justify the initial 
start-up costs for purchasing and installation of EPCS hardware and 
software. We also believe that the cost of any future CMS compliance 
actions may be too great to justify when 100 or fewer Part D controlled 
substance prescriptions per year are at issue. Although we considered 
using a lower threshold (such as 50) or a higher threshold (such as 
200), we believe that 100 Part D controlled substance prescriptions per 
year strikes the right balance between helping ensure that we implement 
section 2003 of the SUPPORT Act's EPCS mandate and that prescribers can 
use resources appropriately.
    In order to implement this exception using the data that we have 
available, we are proposing 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 would protect these 
small prescribers, should they change their place of employment or if 
their place of employment does not offer support for implementing EPCS. 
We seek comment on this proposal.
    Based on our examination of PDE data and conversations with 
stakeholders, we believe that prescribers working under most research 
protocols would fall under the proposed exception for small 
prescribers. However, we seek comment on this assumption. Although we 
have not proposed to adopt the suggested exception listed in section 
1860D-4(e)(7)(B)(v) of the Act, which describes an exemption for 
prescribers working under a research protocol, we believe that in most 
cases prescribers who would fall within this category would be included 
in the exception for small prescribers or in the exception for cases 
where the prescriber and dispenser are the same entity. We decline to 
propose to specifically create an exception for prescribers working 
under a research protocol in the regulations, since we believe that so 
few prescribers would 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 EHR companies will set up the appropriate EHR equipment, 
provided around 100 Part D controlled substance prescriptions are 
transmitted per year. We propose 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 seek comment on such an assumption. We believe that, to the 
extent this is an accurate assumption, such donations further decrease 
the burden for prescribers working under a research protocol. It is for 
these additional reasons that we have declined to propose an exception 
for those working under a research protocol. We seek comment on this 
decision.
    We propose 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 CMS claims data as of December 31st 
of the preceding year, so that these prescribers will not be required 
to meet the EPCS requirement. We seek 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.
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 seek 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 are proposing two exceptions to the EPCS requirement. 
The first exception, at proposed 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.

[[Page 39332]]

As a result, we are proposing to exempt prescribers who are issuing 
prescriptions in areas that are affected by such circumstances. To 
qualify for this exception, this circumstance would have to arise from 
an emergency or disaster declared by a federal, state, or local 
government entity. We would 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.
    The second exception, at proposed Sec.  423.160(a)(5)(iv), is for 
prescribers who request and receive from CMS a waiver, which CMS would 
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 define ``extraordinary circumstance'' 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 proposed Sec.  423.160(a)(5)(iii), 
prior to imposing any compliance actions on a prescriber, we would 
ascertain whether there is an emergency or disaster declared by a 
federal, state, or local government entity for the geographic area 
associated with the prescriber's address in the NCPDP database.
    For purposes of the proposed exception at proposed Sec.  
423.160(a)(5)(iv), we are proposing that prescribers will 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 would prevent the prescriber from conducting EPCS. 
This waiver could be for any circumstance outside of the prescriber's 
control and does not require an official declaration by a 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.
    We have proposed the first part of the waiver process below and 
will include more information about it in subsequent rulemaking. We 
welcome stakeholder comments on a potential waiver process.
    To implement this proposal, we propose 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. Section 423.160(a)(5)(iv) would clarify 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. 
In order to receive a CMS-approved waiver, the prescriber would have to 
submit an attestation using a form, which would 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 would be required on the 
attestation:
     Prescriber's first and last name;
     Prescriber's NPI;
     Prescriber's taxpayer identification number (TIN) or TIN 
associated with his or medical practice, when applicable;
     Prescriber's contact information, including name, 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 the attestation using the contact information 
submitted via the portal. Under the proposed policy, the prescriber 
would submit their attestation about the circumstance and receive a 
waiver based on such an attestation. We welcome comments on the 
different aspects of this proposal.
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 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 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.\130\ The OIG 
has found that these categories of drugs should generally be paid under 
the hospice benefit.\131\ 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 would 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 would 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 would 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 the EPCS

[[Page 39333]]

requirement would not apply to any prescriptions for Part A or Part B 
controlled substances in any event.
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    \130\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/Downloads/2014-PartD-Hospice-Guidance-Revised-Memo.pdf.
    \131\ 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 would be required). We believe 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 decline to propose an exemption for prescribers 
issuing prescriptions for individuals enrolled in hospice. However, we 
seek comment on this decision.
    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 decline to propose an exemption for prescribers issuing 
prescriptions for individuals who are residents of a nursing facility 
and eligible for Medicare and Medicaid benefits. However, we seek 
comment on this issue.
7. Fraud and Abuse Laws
    We are aware that Prescription Drug Plans (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 would 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 proposed 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.
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 propose 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 seek 
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.

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, physician 
assistants (PAs), nurse practitioners (NPs), clinical nurse specialists 
(CNSs), certified registered

[[Page 39334]]

nurse anesthetists (CRNAs) & anesthesiologist assistants (AAs), and 
certified nurse-midwives (CNMs).
    Payments or other transfers of value that must be reported include 
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, with two bases for reporting: 
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 aggregate threshold and therefore 
must be reported, 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 to 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 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 this rule, we propose to clarify existing Open Payments 
requirements, as well as add provisions that program stakeholders have 
requested and we agree would improve the quality of the data. We 
propose 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 disclose relationships they have with 
other companies for the purposes of transparent reporting; (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

[[Page 39335]]

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 believe these changes will increase the 
usability of the data, address concerns we have heard from 
stakeholders, and give reporting entities sufficient time to prepare 
for changes to their data collection and reporting procedures.
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 Proposed 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 yields 
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 are proposing a mandatory context 
field for payments or transfers of value attributed to teaching 
hospitals, which would contain information to better identify the 
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.
(2) Optional Annual Recertification
    Over the course of the program, we have received feedback from 
several companies that they would like the ability to attest that they 
do not have any reportable records for that year. At this time, any 
entity that does not have any reportable payments or transfers of value 
does not need to recertify in Open Payments, but also does not have a 
way to communicate to CMS that it believes it is still compliant even 
though it has not reported.
    We propose to make it optional for a company that does not have 
reportable payments or transfers of value for the program year to 
recertify their registration in Open Payments and attest that it does 
not have any records to submit, which would give peace of mind to 
reporting entities which are correctly not reporting records. We 
believe this optional recertification for entities without reporting 
requirements would be low burden to reporting entities, but would be 
invaluable to ensuring the integrity of the data. We propose 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.''
(3) Defining a Physician-Owned Distributorship
    The preamble of 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 propose 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 are also proposing 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 are including the exceptions for 
titular ownership and employee stock ownership programs (ESOPs) that 
are qualified under IRS regulations for consistency in application.
    In addition, we emphasize 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 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

[[Page 39336]]

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 would 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 would have to choose its business type as 
``Applicable Manufacturer--Physician Owned Distributorship.''
     We believe 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.
(4) Disallowing Record Deletion Without Reason
    While we have not seen evidence of the following behavior, 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 propose to 
prevent reporting followed by deletion by adding language at Sec.  
403.904(a)(3) that would 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 would add a dialogue box in the system for 
reporting entities to provide a reason for record deletion. We note 
that deletions will continue to undergo additional scrutiny to ensure 
the integrity of the data.
(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 a company's research activities. 
According to Sec.  403.910, only payments that are made in connection 
with (1) Research or on 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'' are allowed to be 
delayed from publication. 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 
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 propose 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 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.
(6) Short Term Loans
    The 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 were 
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 propose 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.
g. 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 propose 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 proposal would create a cleaner and more consistent 
data set.
(7) 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. It is important for the 
integrity of the data that the program is able to contact the reporting 
entities in case of perceived irregularities or potential 
noncompliance. We propose to make it mandatory for a company that has 
had reportable payments or transfers of

[[Page 39337]]

value within the past 2 calendar years to keep its contact information 
current 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 
propose to include this requirement at Sec.  403.908(c)(3).

IV. Summary of the Quality Payment Program Proposed Provisions

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 2022 MIPS 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 
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 rose in the third 
year. We saw 99.99 percent of eligible clinicians participate in MIPS 
in 2019 with 954,614 MIPS eligible clinicians receiving a payment 
adjustment, which exceeded our 2018 participation rates. In addition, 
97.6 percent of eligible clinicians participating in MIPS received a 
positive payment adjustment for 2021 based on 2019 performance year 
results. Regarding performance in Advanced APMs, for the 2019 QP 
Performance Period, 195,564 eligible clinicians earned Qualifying APM 
Participant (QP) status while another 27,995 eligible clinicians earned 
partial QP status. \132\ We note that due to the Public Health 
Emergency (PHE) for COVID-19, 65,237 (or about 6.83 percent of 954,614) 
MIPS eligible clinicians received reweighting for performance year 2019 
of one or more MIPS performance categories due to our MIPS extreme and 
uncontrollable circumstances policy.
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    \132\ 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 
would 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 are proposing to begin transitioning to MVPs in the 2023 
MIPS performance 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's 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

[[Page 39338]]

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 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 
would 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 are proposing to 
establish voluntary subgroup reporting to help provide patients and 
clinicians information that is clinically meaningful at a more granular 
level.
    We are additionally issuing 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 are also issuing an RFI to address Closing the Health 
Equity Gap in CMS Clinician Quality Programs 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 propose 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)--Quality Reporting System. At Sec.  
414.1400(a)(3), we also propose to add new language to state section 
1848(m)--Incentive Payments for Quality Reporting.
(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 proposed rule, for MIPS 
Value Pathways (MVPs) we propose:
     To define who can report MVPs, through the term MVP 
Participant.
     A delay to the CY 2023 MIPS performance period/CY 2025 
MIPS payment year: MVP implementation and subgroup reporting timelines. 
Beginning in the CY 2025 MIPS performance period/CY 2027 MIPS payment 
year, multispecialty groups would be required to form subgroups in 
order to report MVPs.
     An introductory set of 7 MVPs to be available beginning 
with the 2023 performance period.
     MVP reporting requirements that account for the four MIPS 
performance categories.
     During the CY 2023 and CY 2024 performance periods, 
voluntary subgroup reporting within MIPS limited to reporting through 
MVPs or the APP. For the MIPS program, eligibility, special status 
determination, and QP determination would 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.
     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 proposed rule, future 
considerations and goals of the MIPS program:
     We request 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 proposed rule, for the 
APM Performance Pathway, to create stability within the APP, we are not 
proposing any major changes to the APP.
(c) Other MIPS and APM Policies
    We are proposing the following provisions for MIPS beginning with 
the 2022 performance period:
     As discussed in section IV.A.3.d. of this proposed rule, 
for the MIPS Performance Measures and Activities, we propose:
    ++ In section IV.A.3.d.(1) of this proposed rule, for the quality 
performance category, to maintain the data completeness criteria 
threshold at 70 percent for the 2021 and 2022 MIPS performance periods 
(2023 and 2024 MIPS payment years); establish the data completeness 
criteria threshold at 80 percent for the 2023 MIPS performance period 
(2025 MIPS payment year); extend the availability of the CMS Web 
Interface as a collection and submission type for the 2022 MIPS 
performance period; establish a set of 195 MIPS quality measures; and 
seek public comment 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 proposed rule, for the cost 
performance category, to establish 5 new cost measures for 
implementation into MIPS, which adds to the 2 global or population-
based measures and 18 episode-based measures.
    In section IV.A.3.e.(2) of this proposed rule, in regard to 
calculating the final score, we propose 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 propose

[[Page 39339]]

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 proposed 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 proposing to 
establish the performance threshold using the mean and the 2017 
performance period/2019 MIPS payment year data, which would result in a 
performance threshold of 75 points. In addition, for the 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 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 
proposing to establish an additional performance threshold of 89 
points. This is the 25th percentile of actual final scores from the 
2017 performance period/2019 MIPS payment year at or above 75 points.
     As discussed in section IV.A.3.h. of this proposed rule, 
for Third Party Intermediaries, we are proposing to modify third party 
intermediary requirements, remedial actions and termination policies. 
Specifically, beginning with the 2023 MIPS 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 propose to require QCDRs, 
qualified registries, health IT vendors, and CMS-approved survey 
vendors to support subgroup reporting beginning with the 2023 MIPS 
performance period/2025 MIPS payment year.
     As discussed in section IV.A.3.i. of this proposed rule, 
for Public Reporting on Compare Tools hosted by the U.S. Department of 
Health and Human Services (Compare Tools), we are proposing to publicly 
report clinician affiliations to certain types of facilities (for 
example, LTCHs, IRFs, etc.). We also seek comment 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 proposing 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 are also 
proposing 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 section IV.A.4.b. and IV.A.4.c. of this 
rule, we are proposing a change to the APM Incentive Payment payee 
hierarchy to include payment to TINs associated with QPs 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 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.\133\ 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.\134\ 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

[[Page 39340]]

achieving full digital quality measurement across our quality reporting 
programs may vary.
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    \133\ https://www.cms.gov/files/document/2021-cms-quality-conference-cms-quality-measurement-action-plan-march-2021.pdf.
    \134\ 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).\135\ 
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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    \135\ 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).\136\ 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.\137\ 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).\138\
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    \136\ 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.
    \137\ https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
    \138\ 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 Fee-for-Service 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 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.\139\ 
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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    \139\ 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

[[Page 39341]]

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 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 seek 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.
    We discuss one potential approach to developing dQM software in 
section IV.A.1.c of this proposed rule. In this section, we are seeking 
comment on the potential definition of dQMs in this RFI.
    We also seek 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.\140\ 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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    \140\ 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] (https://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 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

[[Page 39342]]

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 are requesting 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 are seeking feedback on the goal of aligning data needed for 
quality measurement with interoperability requirements and the 
strengths and limitations of this approach. We are also seeking 
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--
    ++ 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

[[Page 39343]]

improvement and clinical tools through, for example, the use of open-
source core architecture.
    We seek comment 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 \141\ at section IV.A.3.g. of this proposed rule and can also 
support measure reporting.
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    \141\ 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 seek feedback on aggregation of data from multiple sources to 
inform measurement and potential policy considerations. We also seek 
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 seek feedback on initial priority areas for the dQM portfolio 
given evolving interoperability requirements (for example, measurement 
areas, measure requirements, tools, and data standards). 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 seek input on the future development of the 
following:
(a) Definition of Digital Quality Measures
    We are seeking feedback on the following as described in section 
IV.A.1.c. of this proposed 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 are seeking feedback on the following as described in section 
IV.A.1.c. of this proposed 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)?

[[Page 39344]]

     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 are seeking feedback on the following as described in 
section IV.A.1.c. of this proposed 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 are seeking feedback on the following as described in 
section IV.A.1.c. of this proposed 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 seek feedback on the following as described in section 
IV.A.1.c. of this proposed 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 seek feedback on the following as described in section 
IVA.1.c. of this proposed 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 would be addressed through separate and future 
notice-and-comment rulemaking, as necessary.
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.\142\ 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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    \142\ 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.143 144 145 146 147 148 149 150 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 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.151 152 153 154 155 156
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    \143\ Joynt K.E., Orav E., Jha A.K. Thirty-Day Readmission Rates 
for Medicare Beneficiaries by Race and Site of Care. JAMA. 
2011;305(7):675-681.
    \144\ Lindenauer P.K., Lagu T., Rothberg M.B., et al. Income 
Inequality and 30 Day Outcomes After Acute Myocardial Infarction, 
Heart Failure, and Pneumonia: Retrospective Cohort Study. British 
Medical Journal. 2013;346.
    \145\ Trivedi A.N., 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.
    \146\ 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.
    \147\ Rural Health Research Gateway. Rural Communities: Age, 
Income, and Health Status. Rural Health Research Recap. November 
2018.
    \148\ https://www.minorityhealth.hhs.gov/assets/PDF/Update_HHS_Disparities_Dept-FY2020.pdf.
    \149\ www.cdc.gov/mmwr/volumes/70/wr/mm7005a1.htm.
    \150\ Poteat T.C., Reisner S.L., Miller M., Wirtz A.L. 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.
    \151\ Martino, S.C., Elliott, M.N., Dembosky, J.W., 
Hambarsoomian, K., Burkhart, Q., Klein, D.J., Gildner, J., and 
Haviland, A.M. Racial, Ethnic, and Gender Disparities in Health Care 
in Medicare Advantage. Baltimore, MD: CMS Office of Minority Health. 
2020.
    \152\ 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.
    \153\ Singh J.A., Lu X., Rosenthal G.E., 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.
    \154\ Rivera-Hernandez M., Rahman M., Mor V., Trivedi A.N. 
Racial Disparities in Readmission Rates among Patients Discharged to 
Skilled Nursing Facilities. J Am Geriatr Soc. 2019 Aug;67(8):1672-
1679.
    \155\ Joynt K.E., Orav E., Jha A.K. Thirty-Day Readmission Rates 
for Medicare Beneficiaries by Race and Site of Care. JAMA. 
2011;305(7):675-681.
    \156\ Tsai T.C., Orav E.J., Joynt K.E. 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.\157\ 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

[[Page 39345]]

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.'' \158\ 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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    \157\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
    \158\ 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. \159\ 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.\160\ The CMS Quality Strategy \161\ and Meaningful 
Measures Framework \162\ 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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    \159\ 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.
    \160\ 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.
    \161\ 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.
    \162\ 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.\163\
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    \163\ 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.\164\
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    \164\ 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.\165\
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    \165\ 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.\166\
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    \166\ 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) \167\ and the Office of the 
Assistant Secretary for Planning and Evaluation (ASPE) \168\ which have 
examined the influence of social risk factors on several of our quality 
programs. In this RFI, we discuss initiatives specific to further 
bridging the health equity gap within the MIPS track of the Quality 
Payment Program.
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    \167\ 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.
    \168\ 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 proposed rule, we 
discuss a proposed 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 propose 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 section IV.A.3.e.(2) of this proposed rule, we are 
proposing 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.\169\ 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-

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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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    \169\ 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 proposed 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 propose 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 propose 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.\170\ 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 are seeking public 
comment 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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    \170\ 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.\171\ 
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.\172\ Another example, the ``Race & Ethnicity--CDC'' code 
system in PHIN Vocabulary Access and Distribution System (VADS) \173\ 
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 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.\174\ 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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    \171\ 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.
    \172\ https://www.census.gov/topics/population/hispanic-origin/about.html.
    \173\ https://phinvads.cdc.gov/vads/ViewValueSet.action?id=67D34BBC-617F-DD11-B38D-00188B398520.
    \174\ 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.\175\ In recent decades, 
to address these data quality

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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.176 177 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.\178\ 
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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    \175\ Zaslavasky A.M., Ayanian J.Z., Zaborski L.B. The validity 
of racial and ethnic codes in enrollment data for Medicare 
beneficiaries. Health Services Research, 2012 Jun (47) (3 Pt 2): 
1300-21.
    \176\ Filice C.E., Joynt K.E. Examining Race and Ethnicity 
Information in Medicare Administrative Data. Med Care. 2017; 
55(12):e170-e176. doi:10.1097/MLR.0000000000000608.
    \177\ Eicheldinger, C., & Bonito, A. (2008). More accurate 
racial and ethnic codes for Medicare administrative data. Health 
Care Financing Review, 29(3), 27-42.
    \178\ Zaslavsky A.M., Ayanian J.Z., Zaborski L.B. 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 
\179\ 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.\180\ 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.\181\
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    \179\ 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.
    \180\ 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 M.N., 
Dembosky J.W., 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.
    \181\ 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.\182\ 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.\183\
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    \182\ IOM. 2009. Race, Ethnicity, and Language Data: 
Standardization for Health Care Quality Improvement. Washington, DC: 
The National Academies Press.
    \183\ 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 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.\184\ 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.\185\
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    \184\ Bonito A.J., 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.
    \185\ 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 A.J., 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

[[Page 39348]]

ethnicity.\186\ 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 2.1187 188 The 
algorithms under consideration are considerably less accurate for 
individuals who self-identify as American Indian/Alaskan Native or 
multiracial.\189\ 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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    \186\ 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.
    \187\ 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.
    \188\ 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.
    \189\ Haas, A., Elliott, M.N., Dembosky, J.W., 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 feel 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 soliciting 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.\190\ 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.\191\ 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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    \190\ 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.
    \191\ 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 collection, 
we understand challenges and barriers exist in using the technologies 
with these capabilities.
    We are interested in learning about, and are soliciting 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 
\192\) 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 \193\). 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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    \192\ https://minorityhealth.hhs.gov/assets/pdf/checked/1/Fact_Sheet_Section_4302.pdf.
    \193\ 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 
seek 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

[[Page 39349]]

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.
2. Definitions
    At Sec.  414.1305, we are proposing 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 proposed 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 certified registered nurse anesthetist (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 proposed rule, we are proposing 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 (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); certified nurse-midwives (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, CNS (as such terms are defined 
in section 1861(aa)(5) of the Act); a certified registered nurse 
anesthetist (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 requested 
comments on specifying qualified speech-language pathologists, 
qualified audiologists, certified nurse-midwives, 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 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, CNS (as such terms are defined 
in section 1861(aa)(5) of the Act); a certified registered nurse 
anesthetist (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 this proposed rule, we are proposing 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 (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, CNS (as such terms 
are defined in section 1861(aa)(5) of the Act); a certified registered 
nurse anesthetist (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, certified nurse-midwives (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.

[[Page 39350]]

    In order to assess whether these additional eligible clinicians 
(certified nurse-midwives 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 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 will 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 and available measures available. We refer 
readers to section IV.A.3.d.(4)(h) of this proposed rule, where we are 
proposing a policy to automatically assign a zero percent weighting for 
the Promoting Interoperability performance category for the clinical 
social workers. However, for the certified nurse-midwives we do believe 
they would have sufficient and available measures as many of them have 
participated in the Medicaid EHR Incentive Program and have experience 
with the adoption or use of CEHRT (81 FR 77243). Therefore, the 
certified nurse-midwives score would not be reweighted for the 
Promoting Interoperability performance category. However, it should be 
noted that if a clinician believes they are under undue hardship they 
may apply for a Hardship Application. 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 certified nurse-midwives 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 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 certified 
nurse-midwives we believe there are 7 quality measures which includes 2 
outcome measures and 5 high priority measures available for reporting 
in performance year 2022. In Appendix 1, Table Group BA of this 
proposed rule, we are proposing 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 certified nurse-midwives would 
align with Sec.  414.1305 definition of an eligible clinician utilized 
by MIPS APMs for eligibility determinations.
    We request comments on 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, or CNS (as such terms 
are defined in section 1861(aa)(5) of the Act); a certified registered 
nurse anesthetist (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 
certified nurse-midwives (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 would 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 would 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 would 
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 would be contrary to the public interest. We believe that 
failure to reinstate the inadvertently deleted language retroactively 
would be contrary to the public interest because the performance period 
establishes the timespan for the

[[Page 39351]]

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 would be unable to operate the 
MIPS program as required by statute. Therefore, we are requesting 
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 would 
state, 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. Lastly, 
we propose to redesignate 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 
would 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 would 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 would 
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 are proposing that starting with the 
CY2022 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. This 
means a group would 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 would 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 would 
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 would 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 request public comments on our proposal.
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

[[Page 39352]]

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 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.
    Further, MVPs will provide multispecialty groups a way to report 
performance information which is meaningful to various specialties and 
teams within the group through the proposed future subgroup reporting 
option discussed in section IV.A.3.b.(3) of this proposed rule. 
Multispecialty groups, especially those groups with many specialties 
and clinicians, often provide an array of services that may not be 
captured in a single set of measures or in a single MVP. Subgroup 
reporting would allow increased comprehensiveness of multispecialty 
group performance data as more services, including specialty services, 
can be represented since a group and subgroup may be able to report 
more than one MVP. The subgroup performance data would provide more 
detailed and clinically relevant information than the group reporting 
option available under traditional MIPS. The subgroup performance data 
would also assist patients in selecting clinicians because the data 
would be more relevant and specific to the care provided by clinicians 
in the subgroup. We refer readers to section IV.A.3.b.(3) of this 
proposed rule for our proposals on MVP subgroup reporting.
    Under traditional MIPS, we understand clinicians and their 
administrative staff spend time and resources sifting through large 
inventories of measures and activities and depending upon how their 
practice decides to participate, may ultimately submit unrelated 
measures and activities. While we have attempted to streamline this 
process through the development of quality specialty sets and user-
friendly tools on our website (see measure selection tool at https://qpp.cms.gov/mips/explore-measures?tab=qualityMeasures&py=2020#measures), we still hear concerns 
from stakeholders about not having relevant measures and activities 
(January 7, 2021 Town Hall (85 FR 74729 through 74730) feedback). MVPs 
are being developed to focus on a given specialty, condition, and/or 
episode of care (85 FR 84851). As more MVPs become available, we intend 
to continue to offer tools to clinicians that meet the real needs of 
the users, based on human-centered design considerations \194\ that 
will be helpful as they select and submit MVPs, such as including MVPs 
in the MIPS shopping cart. MVPs would also bring the opportunity for 
clinicians to participate as subgroups, which would address the issue 
that exists under traditional MIPS of limited multispecialty group 
performance reporting. Subgroups formed within a multispecialty group 
would be able to submit performance measures and activities that are 
specific to their services and the associated patient conditions or 
health priorities. Additionally, clinician performance data, which is 
more meaningful to the services provided by subgroup participants, will 
be more readily available to be used by clinicians to improve quality 
and value of their services. 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.
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    \194\ https://qpp.cms.gov/about/hcd-research.
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    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 propose MVP implementation policies, we are considering the 
critical factors that will contribute to and demonstrate MVP success 
and the characteristics of the 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
    As discussed in the 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 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 note 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 inventory.
(a) MVP Transition
    Stakeholders have urged us to allow sufficient transition time for 
MVP implementation (85 FR 84859). We recognize that the complete 
transition to MVPs should account for clinicians' readiness for change, 
the current state of measure development, CMS's operational 
limitations, and stakeholder capacity for developing and implementing 
MVPs. We refer readers to our 2022 PFS Proposed Rule Timeline: 
Transition from Traditional MIPS to MVPs graphic at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1501/2022%20PFS%20Proposed%20Rule_MVP%20Timeline%20Graphic.pdf and section 
IV.A.3.b.(2)(d) of this proposed rule for discussion of our MVP 
transition timeline which outlines our response to stakeholder concerns 
about adequate transition time and our plans for a gradual incremental 
transition to MVPs.
    Stakeholders have largely supported our MVP goals, but a few have 
voiced 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 have received comments 
stating MVPs should utilize more innovative approaches (85 FR

[[Page 39353]]

84850). Regarding utilization of innovative approaches, we note that 
the statutory requirements at section 1848 of the Act may constrain our 
ability to adopt certain changes. 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, the portfolio of MVPs will be developed with a focus on 
our end goals while adhering to statutory requirements.
    We request public comment on innovative ideas that can help achieve 
our desired MVP results. 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.
    Additional performance measures that support targeted MVP clinical 
areas may be needed to develop MVPs for all clinicians and to ensure 
they have meaningful measures, which include the patient perspective, 
care outcomes, and to support linkages between cost and quality. In 
section IV.A.3.d.(2)(c) of this proposed rule, we seek comment on 
challenges that stakeholders may encounter, and ways to ensure that 
stakeholder-developed cost measures meet certain standards and are 
consistent with the goals of MIPS and MVPs. Additionally, in section 
IV.A.1.(d) of this proposed rule, we discuss our request for 
information on closing the health equity gap in CMS clinician quality 
programs, potential future stratification of quality measures, and 
request comments on other efforts we can take within the MIPS program 
to further bridge the health equity gap.
    While we aim to shift towards the ideal MVP state, we have data 
submission limitations slowing our ability to reach our objective of 
reporting burden reduction. Ultimately, we envision that the future 
goal of the Quality Payment Program, particularly with MIPS and MVPs, 
is to ensure there is more granular data available for patients, 
clinicians, and other stakeholders. We envision an end state where 
technology will allow for the submission of discrete data elements. CMS 
will be able to calculate measure performance for clinicians, 
subgroups, and groups, rather than having measure performance 
aggregated and calculated at a group or subgroup level prior to 
reporting. We anticipate more granular data will be available for 
patients, clinicians, and other stakeholders through an approach of 
future mandatory subgroup reporting (as discussed in section 
IV.A.3.b.(3)(h) of this proposed rule). We also look forward to broad 
use of standards-based APIs that leverage the FHIR standard within EHRs 
(as discussed in section IV.A.3.d.(4)(j)(i) of this proposed rule) and 
the creation and use of dQMs (as discussed in section IV.A.1.c.(5) of 
this proposed rule). See section IV.A.1.c. of this proposed rule for 
our Advancing to Digital Quality Measurement and the Use of Fast 
Healthcare Interoperability Resources (FHIR[supreg]) in Physician 
Quality Programs RFI, which addresses: (1) A refined definition of 
digital quality measures, (2) the use of FHIR[supreg] for eCQMs, and 
(3) changes under consideration to advance digital quality measurement 
with the intent of transitioning to digital quality measures by 2025.
    We held a Town Hall meeting on January 7, 2021(recording available 
at https://www.youtube.com/watch?v=7CjQeuD3eFE&feature=youtu.be) to 
obtain stakeholder feedback on MVP considerations for MVP design and 
implementation (85 FR 74729 through 74730). We have received commenter 
concerns from previous MVP rulemaking and MIPS MVP Town Hall about 
fragmented care under specialty focused MVPs with a few commenters 
voicing support for a care-coordination focus. We do not want to 
restrict MVP development to only the concepts already presented. For 
example, we envision that some MVPs would be reported primarily by a 
single specialty and other MVPs would include measures and activities 
relevant to a broad range of clinicians. We are interested in MVPs that 
target a focused episode of care, as well as MVPs that measure the 
patient journey and care experience longitudinally. We would like to 
explore how MVPs could best measure the value of multi-disciplinary 
team-based care. See section IV.A.3.b.(4)(b)(i)(A) of this proposed 
rule, for discussion of MVP development areas and broad and team-based 
holistic MVP approaches.
    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. We seek stakeholder feedback on the types of MVPs and 
quality and cost measures required to meet those objectives.
    We request public comment on the concepts outlined above.
(b) MVP Guiding Principles
(i) Overview of the Guiding Principles
    In the CY 2021 PFS final rule (85 FR 84845 through 84849), we 
updated the MVP guiding principles from the CY 2020 PFS proposed rule 
(84 FR 40734) to incorporate RFI comments and the evolution of the MVP 
framework.
    The guiding principles for MVPs are as follows:
    1. MVPs should consist of limited, connected complementary sets of 
measures and activities that are meaningful to clinicians. This will 
reduce clinician burden, align scoring, and lead to sufficient 
comparative data.
    2. MVPs should include measures and activities that result in 
providing comparative performance data, which is valuable to patients 
and caregivers in evaluating 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.
    3. MVPs should include measures selected using the Meaningful 
Measures approach and, wherever possible, the patient voice must be 
included, to encourage performance improvements in high priority areas.
    4. MVPs should reduce barriers to APM participation by including 
measures that are part of APMs where feasible, and by linking cost and 
quality measurement.
    5. MVPs should support the transition to digital quality measures.
(ii) Implementation of MVP Guiding Principles and Practical 
Considerations
    The MVP guiding principles will help move us towards our goals of 
transforming healthcare. Stakeholders have supported the guiding 
principles and have indicated their interest in further understanding 
how we intend to implement the MVP Guiding Principles (85 FR 84845). As 
we introduce MVPs and address operational policies, we are focused on 
the guiding principles and the concrete steps needed to implement the 
principles at both the individual MVP level and the MVP portfolio 
level. We acknowledge certain tensions between our intent to simplify 
MIPS through increased performance measurement standardization versus 
clinician's desire for flexibility and choice of performance measure 
and

[[Page 39354]]

activities. We also acknowledge tensions between our intent to obtain 
comparable clinician performance data and include meaningful measures 
for all clinician types and specialties while minimizing burden. We 
want to provide patients with valuable and comparable clinician 
performance data to assist patients and caregivers when selecting a 
clinician or group. At the same time, we must consider clinician burden 
and performance measurement aspects such as measure reliability and 
attribution methodologies. The availability of the subgroup reporting 
option, proposed in section IV.A.3.b.(3) of this proposed rule, would 
move in the direction of facilitating more comprehensive performance 
data for multidisciplinary groups.
    We want to connect cost measures to quality measures and 
improvement activities in newly developed MVPs as stated in guiding 
principle 1 (85 FR 84849 through 84854). However, as we look to develop 
MVPs for all MIPS eligible clinicians, we are hampered by the limited 
availability of cost measures. Also, the siloed cost measures and 
quality measures development processes can present a degree of 
challenge in forming cohesive measure sets in MVPs as cost and quality 
measures are often developed independently of one another, addressing 
different patient populations and care conditions. Because improving 
value requires the ability to measure quality and cost of care, we are 
concerned with the limited number of cost measures currently available. 
We are proposing five cost measures for implementation into MIPS in 
section IV.A.3.d.(2)(b) of this proposed rule. We also want to expand 
our ability to have cost measures available for MVPs. We refer readers 
to section IV.A.3.d.(2)(c) of this proposed rule, which discusses our 
proposal for external cost measure development by stakeholders.
    Given these tensions and challenges, we plan to continue balancing 
the MVP framework approaches and our incremental MVP introduction while 
focusing on our overarching goals and considerations of current and 
future developments to help us implement the MVP guiding principles.
(iii) Implementing MVP Guiding Principles
    In this rule we propose several policies that begin to implement 
the MVP guiding principles. We also outline several challenges to 
implementing the guiding principles and, in multiple sections of this 
rule, request public comment to guide us in future rulemaking.
    We are proposing seven initial MVPs in section IV.A.3.b.(4)(c) of 
this proposed rule for implementation in CY 2023 performance period. 
The proposed MVPs contain related cost and quality measures and 
improvement activities. The proposed MVPs also limit the number of 
quality measures and improvement activities from which clinicians would 
choose to report and require fewer reported quality measures than in 
traditional MIPS. Both cost and population health measures are 
calculated from claims data and do not have to be submitted by 
clinicians. The proposed MVPs represent concrete progress toward 
implementing the guiding principles.
    For example:
     Requiring the submission of fewer quality measures and a 
lessened measure selection effort reduces clinician burden.
     Hearing from stakeholders ensures that measures are 
relevant to clinicians.
     The limited numbers of cost and quality measures in an MVP 
will support greater numbers of clinicians being scored on the same 
measures, leading to improved comparative data.
     The MVPs address a Meaningful Measure domain and contain 
measures that are clinically appropriate to the clinicians and care 
settings for whom the MVP is focused.
    In section IV.A.3.b.(5) of this proposed rule, we implement the 
guiding principle 1 concept to ``align scoring'' by proposing MVP 
scoring policies that mirror traditional MIPS scoring in MVPs while 
moving away from earlier transitional policies that may have masked 
performance differences or inflated performance scores. Our scoring 
policies aim to spur improvements, drive higher value care, and promote 
fairness. We propose to maintain scoring policies finalized in 
traditional MIPS for MVPs to leverage meaningful scoring policies and 
retain stable scoring for APM Participants.
    The subgroup reporting option outlined in section IV.A.3.b.(3) of 
this proposed rule operationalizes guiding principle 2 and, as noted 
above, will increase the number of clinicians reporting and better 
serve specialty clinicians who want to be scored on performance 
measures relevant to their specialty and services provided. Public 
reporting of MVP and subgroup information as proposed in section 
IV.A.3.b.(3)(g) of this rule will further guiding principle 2 goal of 
providing comparative information that is valuable to patients and 
caregivers.
    We request public comment on innovative approaches to measuring 
value that might include APM performance measurement approaches and 
using a single patient population both for MVP cost and quality 
measures in the future.
    We have also discussed our intent to provide more robust clinician 
performance data feedback for MVP submissions (84 FR 40733 through 
40734). Receiving more meaningful feedback through MVPs would help 
prepare clinicians to meet APM goals for managing patient populations. 
While clinicians support more robust data feedback, the current timing 
of data submission after the performance year ends is a barrier to 
providing more timely data feedback to clinicians during the 
performance year. As we move to dQMs and utilization of standards-based 
APIs to retrieve data from provider data sources, earlier, more 
frequent reporting, and more granular data (as in subgroup reporting) 
may be possible without additional clinician burden, allowing us to 
provide more timely clinician performance data feedback. See section 
IV.A.3.b.(5)(d) of this proposed rule for discussion of MVP clinician 
data feedback.
    During our January 7, 2021, MVP Town Hall meeting we sought 
feedback on how to best coordinate and align MVPs and APMs (85 FR 74729 
through 74730). A few Town Hall commenters suggested that MVPs serve as 
a long-term performance-based option to improve physicians' experience 
in MIPS and as an on-ramp for clinicians from MIPS to APMs. A few 
commenters supported the development of MVPs for areas where APMs are 
absent, with a few stakeholders supporting an initial focus on 
developing MVPs around existing specialty measures sets before 
transitioning the MVP into a bridge for clinicians who do not have an 
applicable APM. We also received a comment that there may be scenarios 
in which it may be challenging to use the same measures in an MVP as an 
APM, as the commenter stated APM participants have more legal 
flexibility and APM models often use Innovation Center waiver authority 
(section 1115A of the Act). We continue to explore the ideal MVP 
relationship with APMs, and how to best drive value and align 
performance measurement given differences in payment, performance 
measurement methods (such as prospective and retrospective measure 
attribution), patient population (all payer versus fee-for-service), 
and data submission.
    While the proposals in this proposed rule referenced above 
demonstrate important progress toward realizing the MVP guiding 
principles, challenges remain for CMS and stakeholders in

[[Page 39355]]

developing a portfolio of MVPs that fully implement the guiding 
principles and achieve our vision for MVPs. As we propose to introduce 
MVPs and implement our guiding principles, we continue to strive to 
fully implement MVPs and the overall portfolio to drive value, obtain 
comparative performance data, and elevate the patient voice while 
reducing clinician burden.
(c) 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 are not 
proposing to change these definitions, and are using these existing 
terms, we seek to clarify who can participate in MVPs. We are proposing 
a new opportunity for clinicians to participate in MVPs, as a subgroup. 
We refer readers to section IV.A.3.b.(3) and Sec.  414.1305 of this 
proposed rule, where we propose the definition for 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) and Sec.  
414.1305 of this proposed rule, where we propose definitions for 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 are proposing 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)(d)(ii) of this 
proposed rule for discussion of subgroup implementation, including 
multispecialty groups forming subgroups to report MVPs beginning with 
the CY 2025 MIPS performance period/2027 MIPS payment year. Table 30 
serves to summarize our proposals, specifically which MVP Participants 
can report an MVP in the future:
[GRAPHIC] [TIFF OMITTED] TP23JY21.053

    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, in section 
IV.A.3.b.(5)(b)(iv) of this proposed rule, we propose 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 request public comment on the proposal.
(ii) Opt-In Participants, Voluntary Participants, and Virtual Groups
    As discussed above, we are proposing 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)(d)(iv)(C) of this proposed rule for 
discussion of the participation rates of opt-in and voluntary 
participants. Similar to our request for comments on whether Opt-In and 
voluntary participants should be allowed to join subgroup reporting in 
a future state, we also request comment on whether opt-in participants, 
voluntary participants, and virtual groups should be allowed to report 
MVPs as MVP Participants in a future state.
(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 39356]]

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 proposed MVPs, described in 
Appendix 3: MVP Inventory of this proposed rule until the 2023 
performance period/2025 MIPS payment year, of the MIPS program. We 
propose 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.
    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 request public comment 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 \195\) the importance in continuing this shift to 
value through MVPs, and doing so by providing as much transparency as 
possible. We agree, and believe that providing transparency with our 
thinking (in terms of a transition timeline) and seeking public comment 
will serve to provide stakeholders with important 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.
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    \195\ ``Medicare Should Transform MIPS, Not Scrap It,'' Health 
Affairs Blog, March 2, 2021. DOI: 10.1377/hblog20210226.949893.
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    As such, we outline a timeline in which MVP implementation could 
occur. As stated above, we are proposing at Sec.  414.1365(a) that the 
first year MVP reporting be available is the CY 2023 MIPS performance 
period/2025 MIPS payment year. Based on the discussion above, we are 
proposing for the CY 2023 MIPS performance period/2025 MIPS payment 
year, MVP reporting is voluntary. We request comments on this proposal.
    Through the remainder of the timeline outlined in Table 31, we seek 
to lay out our thinking for the future of the MIPS program, for 
purposes of transparency, and to request public comment. 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 are considering 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] TP23JY21.054

    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 would like to note that 
we are not proposing 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 request 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 stakeholders 
readiness to sunset traditional MIPS and transition to MVPs? We 
understand that some clinicians who participate in MIPS practice in 
highly specialized clinical

[[Page 39357]]

areas and subspecialties, where they may believe there is not an MVP 
applicable to their highly specialized practice. Therefore, we also 
request comment on what should happen in instances where highly 
specialized clinicians cannot identify an applicable and relevant MVP.
    We request public comments on this approach.
(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 
proposed rule for detailed discussion of subgroup proposals; and to 
section IV.A.3.b.(3)(c) of this proposed 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 information on primary care measures when searching for a 
specialist is not helpful. 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. We anticipate that multispecialty groups would need some 
time to familiarize and prepare themselves for subgroup reporting.
    We refer readers to section IV.A.3.b.(2)(c)(i) of this proposed 
rule, where we discuss the proposed MVP Participant definition. Through 
the proposed 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 and CY 2024 performance 
period/2025 and 2026 MIPS payment year. We believe that the delayed 
implementation of subgroups for 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.
    In addition, beginning with the CY 2025 MIPS performance period/
2027 MIPS payment year, we propose through the MVP Participant 
definition to no longer allow multispecialty groups to report MVPs. 
This would mean that if a multispecialty group would like to report 
MVPs, beginning with the CY 2025 MIPS performance period/2027 MIPS 
payment year, they could only do so if they form subgroups. We believe 
this 2-year span of time would give multispecialty groups time to 
familiarize themselves and prepare for subgroup reporting. We strongly 
encourage multispecialty groups to monitor the implementation of MVPs 
to determine when to adopt subgroup reporting and transition to MVPs 
prior to the CY 2025 MIPS performance period/2027 MIPS payment year. 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 would 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 proposed rule, that MVPs may be developed 
to reflect the team-based care approach used during an episode of care. 
A proposed timeline to implement subgroup reporting is outlined in 
Table 32.

[[Page 39358]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.055

    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 proposed 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 would 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 proposed 
rule for a detailed discussion of subgroup proposals and MVP reporting 
requirement proposals.
(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 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 
this rule, 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 proposed 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) 
of this proposed rule, we propose 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.
    Proposing 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.
(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

[[Page 39359]]

section IV.A.3.i. of this proposed rule for discussion of public 
reporting proposals related to MVP data and subgroup reporting.
(3) Subgroup Composition
(a) Overview
    In the CY 2021 PFS final rule, we finalized updates to MVP guiding 
principles (85 FR 84844 through 84849), including the addition of 
subgroup reporting to enhance comparative performance data, and MVP 
development criteria and process (85 FR 84845 through 84849) that guide 
MVP implementation. Through this proposed rule, we are proposing to 
establish subgroup reporting as an option for MVP Participants and for 
those individuals and entities who choose to report the APP. In this 
section, we propose: (1) Definitions for subgroup reporting, single 
specialty group, multispecialty group, and special status designation; 
(2) subgroup eligibility requirements; and (3) application of low-
volume threshold and special status designations for subgroups. In this 
section, we also have a request for information on the future direction 
of subgroup reporting. Additionally, we refer readers to section 
IV.A.3.b.(4) of this proposed rule, where we detail our proposals on: 
(1) Subgroup reporting requirements; (2) subgroup election process; and 
(3) subgroup identification. In section IV.A.3.b.(5) of this proposed 
rule, we detail our proposals on subgroup scoring.
(b) Background
    Section 1848(q)(1)(D)(i) of the Act requires that the Secretary 
establish and apply a process that includes features of the provisions 
of section 1848(m)(3)(C) of the Act for group practice reporting for 
the quality performance category and provides that the Secretary may 
establish such a process for the other MIPS performance categories. At 
Sec.  414.1305, a group is defined 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. In the CY 2021 PFS final rule, we finalized 
updates to MVP guiding principles (85 FR 84844 through 84849), 
including the addition of subgroup reporting to enhance comparative 
performance data, and MVP development criteria and process (85 FR 84849 
through 84853) that guide MVP implementation. In section 
IV.A.3.b.(2)(d)(ii) of this proposed rule, we propose to allow 
voluntary MVP reporting beginning with the CY 2023 MIPS performance 
period/2025 MIPS payment year and are considering mandatory MVP 
reporting to coincide with the sunset of traditional MIPS beginning 
with the CY 2028 MIPS performance period/2030 MIPS payment year. We 
believe one important element of transitioning to MVPs is allowing 
clinicians the ability to report and be assessed on measures and 
activities which are meaningful to their practice. Currently, within 
the MIPS program, we offer clinicians many opportunities to 
participate, including as an individual and as a group; we have found 
most clinicians choose the group reporting option. We anticipate some 
groups may consist of clinicians who all practice under a single-
specialty or clinical focus and are able to successfully select an MVP 
whose measures and activities are applicable and meaningful to all or a 
significant majority of their patients or practice. On the other hand, 
some groups encompass 20 or more different specialties, contain many 
clinicians, and often provide an array of services that may not be 
captured in a single set of measures or in a single MVP. For instance, 
we estimated in the CY 2021 PFS final rule RIA that among the 863,627 
clinicians who submitted data, 510,057 were in practices with more than 
100 clinicians (85 FR 85019). This represents 59 percent of the total 
MIPS eligible clinician population estimated for the CY 2023 payment 
year using 2019 submissions data (85 FR 85019).
    In the 2017 Quality Payment Program final rule (81 FR 77058), 
commenters had noted interest in CMS providing additional flexibility 
to allow clinicians to submit information that would represent 
reporting for some portion, but not the entirety, of a group or TIN. In 
the CY 2018 Quality Payment Program final rule (82 FR 53593), we stated 
that in future rulemaking we intend to explore the feasibility of 
establishing group-related policies which would permit participation in 
MIPS at a subgroup level and create such functionality through a new 
identifier. Prior to the introduction of MVPs, in the CY 2019 PFS 
proposed rule (83 FR 35891), we again acknowledged the overarching 
themes from stakeholders that we should make an option available to 
groups which would allow a portion of a group to report as a separate 
subgroup on measures and activities which are more applicable to the 
subgroup and be assessed and scored accordingly based on the 
performance of the subgroup. We solicited comment on specific options 
and questions for implementation of subgroup level reporting in future 
years. However, as we noted in the CY 2019 PFS final rule (83 FR 
59742), because there are numerous operational challenges with 
implementing a subgroup option, we did not propose any changes to our 
established reporting policies regarding the use of a subgroup 
identifier.
    In the CY 2020 PFS proposed rule (84 FR 40740 through 40741), we 
sought comment on MVP policies for multispecialty practices. Overall, 
we heard from commenters that subgroup reporting should be offered as 
an additional reporting option where subgroup reporting would provide 
more specific information for patients and clinicians rather than 
having multispecialty groups report on multiple MVPs at the group 
level. We also sought comment in the CY 2020 PFS proposed rule (84 FR 
40740 through 40741) on whether we should use an approach in which 
groups submitted data on multiple MVPs reflecting their diverse 
specialties as an alternative to subgroup reporting to more 
comprehensively capture the range of items and services furnished by a 
group practice. Several commenters voiced concerns related to tradeoffs 
between the burden of reporting multiple MVPs and having more 
comprehensive performance data. Many commenters urged CMS to allow for 
subgroups and did not see reporting on multiple MVPs by the entire 
group as an alternative to subgroup reporting. Some commenters 
recommended allowing subgroup reporting in lieu of MVPs, while others 
recommended subgroup reporting for either the traditional MIPS program 
rules or for MVPs. A few commenters recommended steps we could take to 
identify subgroups, including creating a subgroup identifier and 
allowing the formation of subgroups through an election process at the 
Quality Payment Program website (qpp.cms.gov) that would function 
similarly to CMS Web Interface or CAHPS for MIPS registration. A few 
commenters suggested that allowing subgroup reporting may be necessary 
to implement MVPs and help groups, particularly multispecialty 
practices, meet data completeness criteria.
    Additionally, in response to our request for comment on whether we 
could use the MVP approach as an alternative to subgroup reporting to 
more comprehensively capture the range of items and services furnished 
by a group practice, we heard concerns that subgroup reporting may 
deter group practices from utilizing a team approach to patient care, 
may make departments more competitive, may not improve care for 
patients, and may increase errors,

[[Page 39360]]

costs, stress, and administrative burdens to implementation across 
various departments. In considering these concerns, we have continued 
to work towards meaningful subgroup reporting that balances the hurdles 
of a new reporting option with the benefits of more comprehensive and 
granular data available for patients and clinicians.
    We held the MVP Town Hall on January 7, 2021 (85 FR 74729) and 
publicly shared the MVP Town Hall Preparation Guide (https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1233/MVP%20Town%20Hall%20Preparation%20Guide.pdf) to aid MVP Town Hall 
participants in understanding the direction we may take with MVPs and 
subgroups. We sought public comment on the MVP Town Hall topics and the 
approaches outlined in the MVP Town Hall Preparation Guide (recording 
available at https://www.youtube.com/watch?v=7CjQeuD3eFE&feature=youtu.be). Overall, several commenters 
supported the option of voluntary subgroup reporting and recognized the 
value for patient care and research. Several commenters suggested CMS 
to allow sufficient time for CMS and stakeholders to make software 
changes (that include coding, development, testing, production, 
training, and education tasks) to support subgroup reporting, 
ultimately recommending CMS to slow down implementation. Additionally, 
we have solicited comment from stakeholders beginning in the CY 2018 
PFS proposed rule (82 FR 30027) through the MVP Town Hall (85 FR 74729) 
on the ways in which participation in MIPS at the subgroup level could 
be established. In considering stakeholder feedback--in conjunction 
with the introduction of MVPs, technical innovations, and working 
through operational issues within CMS--we are ready to propose subgroup 
reporting. We acknowledge some clinicians in multispecialty groups are 
currently not able to report as a team for the measures that are 
meaningful to them because the group reports on behalf of all 
clinicians within the practice. Even with the introduction of MVP 
reporting, we anticipate this problem could persist if subgroup 
reporting is not offered as a reporting option for MIPS. Therefore, 
subgroup reporting would provide an avenue for clinical teams within a 
larger group to be able to submit MVPs that are clinically relevant to 
them. It would also be a first step in allowing for more granular 
clinician information to be made available to patients.
    We thank commenters for their feedback. After considering the 
feedback, in section IV.A.3.b.(2)(d)(ii) of this rule, we propose 
voluntary subgroup reporting in MIPS beginning with the CY 2023 MIPS 
performance period/2025 MIPS payment year for MIPS eligible clinicians 
and groups who participate in MIPS through MVP reporting. As discussed 
in section IV.A.3.b.(3)(d)(iv)(B) of this proposed rule, APM Entities 
can report to MIPS through MVPs but may not break out into subgroups. 
As discussed in section IV.A.3.b.(2)(d)(ii) of this proposed rule, we 
are proposing that beginning in the CY 2025 MIPS performance period/
2027 MIPS payment year, multispecialty groups would be required to form 
subgroups in order to report MVPs.
(c) 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)(d) of this proposed rule, we are proposing to use certain 
characteristics of the group to determine eligibility and special 
status of the clinicians in the subgroup. To provide clarity, we are 
proposing definitions for single specialty groups, multispecialty 
groups, subgroups, and special status.
(i) Proposed Single Specialty and Multispecialty Groups Definitions
    We propose 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/). We believe 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.\196\ We refer readers 
to our comment solicitation in section IV.A.3.b.(3)(h)(iv) of this 
proposed rule, where we request information on the threshold that 
subgroups would have to meet in order to be defined as a single 
specialty (such as having at least 75 percent of clinicians sharing the 
same specialty in a subgroup).
---------------------------------------------------------------------------

    \196\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/About-Physician-Compare-An-Overview.
---------------------------------------------------------------------------

    We also propose 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). We refer readers to our comment solicitation in section 
IV.A.3.b.(3)(h)(iv) of this proposed rule, where we request information 
on setting the threshold that subgroups would have to meet in order to 
be defined as a multispecialty group. Beginning in the CY 2025 MIPS 
performance period/CY 2027 MIPS payment year and discussed in section 
IV.A.3.b.(2)(d)(ii) of this proposed rule, multispecialty groups would 
be required to form subgroups in order to report MVPs.
    Additionally, we recognize that individual eligible clinicians may 
practice or be a part of multiple specialties as a part of their scope 
of practice and that eligible clinicians may have more than one 
specialty designation in PECOS. These clinicians could participate in 
multiple subgroups and report on multiple MVPs or clinicians could join 
a subgroup that is most applicable to their scope of practice and 
report on one MVP. We anticipate that at a future time when subgroup 
reporting is mandatory, that there will need to be criteria to 
determine which specialty is a primary specialty of clinicians. At this 
time, we do not have limitations on which specialty will be considered 
the primary specialty. However, we refer readers to section 
IV.A.3.b.(3)(h)(iv) of this proposed rule, where we request information 
on the identification of a primary specialty in scenarios where an 
eligible clinician may have more than one.
    We request public comment on these proposals.
(ii) Proposed Subgroup Definition
    We propose 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 propose 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 propose to 
amend Sec.  414.1310(e)(1) to state that except as provided under 
Sec. Sec.  414.1315(a)(2), 414.1317(b),

[[Page 39361]]

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.
    We note that in these proposed additions to and amendments of the 
regulation text, we refer to the final score instead of the MIPS 
payment adjustment factor (or additional MIPS payment adjustment 
factor) because we believe this phrasing is more precise. It is 
possible that more than one final score could be associated with a TIN/
NPI for a performance period, and in those situations, we apply a final 
score hierarchy for purposes of determining the MIPS payment adjustment 
for that TIN/NPI (see, for example, the discussion in the CY 2021 PFS 
final rule (85 FR 84917 through 84919)). We believe allowing and, 
beginning with the CY 2025 MIPS performance period/CY 2027 MIPS payment 
year, requiring subgroup reporting for MVPs would offer clinicians the 
opportunity to participate in MIPS more meaningfully and would allow 
patients to have more granular and meaningful information when 
selecting an eligible clinician.
    Measuring performance at the subgroup level would still allow for 
groups to practice team-based care, with groups having the ability to 
self-define which clinicians participate in which subgroups. 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.'' \197\ As discussed in section 
IV.A.3.b.(3)(d)(iii) of this proposed rule, we request comments on how 
to establish criteria around the composition of subgroups; criteria may 
include clinical relevance, scope of care, and patient population.
---------------------------------------------------------------------------

    \197\ 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, D.C. 
https://doi.org/10.31478/201210c.
---------------------------------------------------------------------------

    As discussed in section IV.A.3.b.(2)(d)(ii) of this proposed rule, 
MIPS eligible clinicians in groups who do not have an MVP available and 
applicable to their practice would participate in 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 
through the CY 2024 MIPS performance period/CY 2026 MIPS payment year, 
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.(2)(d)(i) of 
this proposed rule.
    We request public comment on this proposal.
(iii) Proposed Special Status Definition
    In the CY 2018 Quality Payment Program final rule, we finalized 
definitions for special status 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 
propose 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.
    We request public comment on this proposal.
(d) Subgroup Eligibility
    As described in section IV.A.3.b.(3)(c)(ii) of this proposed rule, 
we are proposing voluntary subgroup reporting for clinicians beginning 
with the CY 2023 MIPS performance period/CY 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 MVP Town Hall held in January 2021 (85 FR 74729 to 
74730), stakeholders expressed concern about creating separate 
eligibility criteria and associated policies which would lead to 
confusion and additional burden for clinicians in subgroups and 
associated groups. These stakeholders recommended that eligibility for 
subgroup reporting be based on group eligibility. Additionally, 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. Therefore, in this proposed rule, we are proposing: (1) 
Application of a low-volume threshold; (2) application of special 
status designation; and (3) subgroup inclusions and exclusions. 
Additionally, we seek comment on subgroup composition and limitations.
(i) Proposed 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 propose 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 request public comment on this proposal. As MVPs continue to 
evolve, we anticipate increased opportunities for clinician 
participation in subgroups,

[[Page 39362]]

and we also request feedback from stakeholders if we should reevaluate, 
in the future, MIPS eligibility for clinician participation in 
subgroups at the subgroup level.
(ii) Proposed 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)(c)(iii) of this proposed rule, are determined at 
the time of eligibility determinations.
    We propose 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)(c)(iii) of this 
proposed 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.
    Additionally, at this time, we are not planning to establish limits 
on the number of subgroups that a clinician can be part of. For 
example, a primary care clinician who is part of a multispecialty group 
may choose to participate in a subgroup. This subgroup may choose to 
report through two MVPs because they believe both were relevant to the 
scope of care provided by the clinicians in their subgroup and under 
this example, the subgroup would be allowed to report and be assessed 
on both MVPs if they choose to do so. While we acknowledge the 
potential for clinicians to participate in multiple subgroups for 
reporting MVPs, we also recognize the burden for groups to submit data 
for an unlimited number of subgroups for each clinician, but we 
anticipate this will be an uncommon scenario. For instance, we do not 
anticipate that a group of 20 specialties would want to form 100 
subgroups and be assessed on all the applicable MVPs. We believe 
clinician participation in subgroup reporting will be based on the 
scope of clinical care provided or a relevant specialty type and 
clinicians would not use subgroup reporting to game the MIPS program. 
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.
    We request public comments on this proposal.
(iii) Subgroup Composition Limitations
    We are not proposing to require any criteria for the composition of 
subgroups at this time; however, as discussed in section 
IV.A.3.b.(3)(h) of this proposed rule, we are seeking comment on 
criteria that we could consider in the future, such as in the CY 2023 
PFS rulemaking cycle. In developing the voluntary subgroup reporting 
proposal, we also considered whether we should limit the opportunity 
for clinicians to participate as a subgroup based on certain 
characteristics for the first year of voluntary subgroup reporting and 
in the future under mandatory subgroup reporting. As we have noted in 
this section of the rule, many stakeholders requested that we create an 
opportunity to participate via subgroups and suggested that 
participation in subgroups would allow clinicians across different 
specialties within a practice to report.
    We considered whether we should limit the composition of a subgroup 
to clinicians of the same specialty or a related specialty. We are also 
aware clinicians providing patient care as part of a clinical team may 
practice in different locations under the same group (TIN) and may be 
interested in reporting through different subgroups. These clinicians 
may practice in specific clinical settings, such as dialysis centers or 
urgent care settings, and may use different third-party intermediaries, 
such as different EHR vendors or qualified registries. Alternatively, 
we considered if we should establish limits on the size of a subgroup, 
such as setting minimum and maximum thresholds for the number of 
clinicians that could participate as a subgroup. Similarly, we 
considered establishing a threshold where 75 percent of the eligible 
clinicians in a group or subgroup would have to be of the same 
specialty or a related specialty to report a given MVP, and thus form a 
subgroup. We also considered if we should establish criteria based on 
the number of clinicians practicing in a group, specialty mix assessed 
through analyzing previous billing patterns within a group, practice 
location, type of clinical setting, patient population, or scope of 
care provided. Additionally, we also considered establishing 
restrictions on the type of clinicians who can report a given MVP. In 
considering these potential restrictions, we are concerned we would be 
unable to anticipate the different methods by which groups may wish to 
utilize subgroup reporting without seeking public comment on the best 
approach.
    As MVPs evolve and subgroup reporting becomes mandatory in the 
future, we plan to explore the options for establishing criteria for 
composition of subgroups. We recognize that MVPs will continue to be 
developed by the time subgroup reporting is mandatory for MVP reporting 
by multispecialty groups and that there will be clinicians in 
multispecialty groups who do not have an available MVP, and thus, would 
be unable to form subgroups. We believe it is valuable for 
multispecialty group practices to gain experience with subgroup 
reporting while MVPs continue to be developed. We also note that as 
described below in this section, APM Entities cannot be broken down 
into subgroups because APM Entities are often composed of multiple 
TINs. We refer readers to section IV.A.3.b.(4)(d) of this proposed rule 
for additional details on MVP and subgroup reporting requirements for 
APM Entities.
    Therefore, we request comment from stakeholders on the options for 
multispecialty groups to participate as subgroups for reporting MVPs 
for the first year of voluntary subgroup reporting, beginning in the CY 
2023 MIPS performance period/2025 MIPS payment year. We also request 
feedback from stakeholders on whether restrictions should be applied in 
the future for the composition of subgroups and any associated criteria 
that need to be established without needlessly limiting flexibility for 
clinicians involved in team-based care. We request public comment on 
the criteria which should be used to define what types of groups are 
required to report more than one MVP.
(iv) Proposed Subgroup Inclusions and Exclusions
(aa) Background
    We recognize MIPS eligible clinicians participating in subgroups 
may be part of a group that has a portion of its

[[Page 39363]]

clinicians participating in MIPS as part of a virtual group, MIPS APM, 
or clinicians that do not attain QP or Partial QP status in an Advanced 
APM. Eligible clinicians may participate in MIPS if they meet at least 
one of the low-volume threshold criteria and choose to opt-in to MIPS 
reporting (83 FR 59740). Eligible clinicians (as defined at Sec.  
414.1305) who are not MIPS eligible, have the option to voluntarily 
report on applicable measures and activities for MIPS and these 
clinicians will not be subject to MIPS payment adjustment (81 FR 
77041). Additionally, Partial QPs in Advanced APMs will have the option 
to elect whether or not to report under MIPS, which determines whether 
or not they will be subject to MIPS payment adjustments (81 FR 77062). 
We believe eligible clinicians in MIPS APMs, clinicians that do not 
attain QP or Partial QP status in Advanced APMs, or who are opt-in 
eligible may desire to participate as subgroups for reporting MVPs and 
may meet the proposed criteria for definition of a subgroup as 
described in section IV.A.3.b.(3)(c)(ii) of this proposed rule.
(bb) Proposed Subgroup Eligibility--Participants in MIPS APMs
    In the CY 2021 PFS final rule (85 FR 84860), we finalized a policy 
to allow groups and APM Entities to report through the APP on behalf of 
their constituent MIPS eligible clinicians. We believe that an APM 
Entity should not be eligible to form subgroups for reporting MVPs or 
the APP because APM Entities are often composed of multiple TINs and 
may use multiple EHR systems. We believe that the definition of a 
subgroup consisting of one TIN, as proposed in section 
IV.A.3.b.(3)(c)(ii) of this rule, would not include APM Entities 
comprised of more than one TIN, which would result in exclusion of APM 
Entities from forming subgroups for reporting MVPs or the APP. We 
anticipate that eligible clinicians in APM Entities comprised of 
multiple TINs could choose to form subgroups through their affiliated 
TIN. We refer readers to section IV.A.3.b.(4)(d)(vi)(B) of this rule 
where we seek comment on whether there are strategies that CMS should 
consider to allow the formation of subgroups for clinicians in APM 
Entities comprised of multiple billing TINs. We also note that, in 
cases where an APM Entity is itself comprised of a single TIN, the 
single TIN could form subgroups under the TIN, rather than under the 
APM Entity ID.
(cc) Proposed 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 for 
reporting MVPs. Additionally, we believe that the definition of a 
subgroup consisting of one TIN, as proposed in section 
IV.A.3.b.(3)(c)(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 MIPS performance period/2025 
MIPS payment year, we are proposing 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 seek 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.
    We seek public comment on this proposal.
(e) Subgroup Examples
    In Appendix 3: MVP Inventory of this proposed rule, we are 
proposing seven MVPs for implementation in the CY 2023 MIPS 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 33 illustrates an example of subgroup reporting 
for a group consisting of anesthesiologists, orthopedic surgeons, and 
certified registered nurse anesthetists (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 
MIPS Performance Period/2025 MIPS Payment Year of Appendix 3: MVP 
Inventory of this proposed 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

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[GRAPHIC] [TIFF OMITTED] TP23JY21.056

BILLING CODE 4120-01-C
(f) Third-Party Intermediaries for Subgroup Reporting
    As described in section IV.A.3.h.(2)(b) of this proposed rule, we 
are proposing 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 MIPS performance period/CY 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 proposed rule for

[[Page 39365]]

additional details on requirements for third-party intermediaries 
supporting MVPs and subgroups.
(g) Public Reporting of Subgroup Performance Information
    As described in section IV.A.3.i.(1) of this proposed rule, we 
propose to delay public reporting of subgroup performance information 
by an additional year. Our proposal would result in the public 
reporting of subgroup performance information beginning with the CY 
2024 MIPS 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 proposed rule for additional details on 
the proposed policies related to public reporting of subgroup 
performance information on the compare tool.
(h) Future Vision of Subgroups
(i) Overview
    Given the delay of subgroup and MVP implementation until the CY 
2023 MIPS performance period/2025 MIPS payment year, we recognize there 
are additional policy nuances which need to be worked through during 
future rulemaking, and we would like to share our vision and request 
information to help us craft policy solutions. We believe team-based 
care is an essential element to providing high-quality care to patients 
and acknowledge some of the subgroup policies may be construed to 
create competition within groups. It is not our intention to create 
this competition, rather, we believe as MVPs continue to be created and 
evolve, this will also include MVPs that are focused on team-based care 
for some specialties. We share this vision below along with a request 
for information on the future of subgroup reporting. We welcome 
feedback and potential alternatives ideas we could consider ensuring 
the success of subgroup and MVP reporting.
(ii) Vision for Data Granularity
    Ultimately, we envision that a future goal of the Quality Payment 
Program, particularly with MIPS and MVPs, is to ensure there is more 
granular data available for patients, clinicians, and other 
stakeholders. We envision an end state where technology will allow for 
the submission of discrete data elements and allow us to calculate 
measure performance for clinicians, subgroups, groups, and APM 
Entities, rather than having measure performance aggregated and 
calculated at a group or subgroup level prior to reporting. We 
anticipate more granular data will 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 within EHRs (as discussed in section 
IV.A.1.c.(4)(a) of this proposed rule), and the creation and use of 
dQMs (as discussed in section IV.A.1.c.(2) of this proposed rule). We 
believe this would give patients specific and meaningful information 
which can better inform their choices when selecting a clinician and 
offer more targeted feedback to clinicians. We request information on 
the vision for data granularity.
(iii) Sunsetting Traditional MIPS
    Given our goals for increasing the level of data that is available 
to clinicians and patients, we envision a future state where all 
multispecialty groups would participate in MIPS through subgroup 
reporting. As additional MVPs are developed and eligible clinicians are 
given the opportunity to report on MVPs, including reporting via 
subgroups, we believe that clinicians will have even more meaningful 
ways to participate in MIPS at a more discrete level. As discussed in 
section IV.A.3.b.(2)(d) of this proposed rule, we are considering 
retiring traditional MIPS, where it would no longer be available by the 
CY 2028 MIPS performance period/2030 MIPS payment year but would make 
any proposal to do so in a future rulemaking.
    If we sunset traditional MIPS beginning in the 2028 MIPS 
performance period/2030 MIPS payment year, we anticipate that groups, 
particularly large multispecialty groups, would have had the 
opportunity to gradually ramp up their reporting on MVPs, gaining a few 
years of experience reporting on more than one MVP. This allows for 
clinicians to be assessed on information that is clinically meaningful 
to their scope of practice and to publicly report that information. At 
a high-level, if we finalize the proposal as described in section 
IV.A.3.b.(2)(d)(ii) of this rule, we anticipate that multispecialty 
groups would report more than 1 MVP beginning in the CY 2025 MIPS 
performance period/2027 MIPS payment year. We believe that clinicians 
in multispecialty groups should be assessed on measures and activities 
that are related to the scope of care that they provide. We believe 
that in order to meet the goals of MVPs and provide enhanced 
performance feedback to clinicians and to ensure more granular 
information is publicly available for patients, multispecialty groups 
must form subgroups to report additional information. Additionally, we 
do not believe that there will be an MVP that will be applicable to all 
types of clinicians within multispecialty groups. We refer readers to 
section IV.A.3.b.(2)(d) of this rule for additional details on the 
proposed timeline for MVPs and subgroup implementation.
(iv) Limiting Subgroup Composition to Single-Specialty
    We are also considering placing limits around how clinicians can 
participate and be assessed as subgroups, particularly if clinician 
participation in subgroups must be restricted to a single specialty. As 
a central part of the MVP goals, we believe that the value of subgroup 
reporting would be for clinicians to be assessed and scored on measures 
and activities that are applicable to their scope of care while also 
allowing patients to have greater access to clinician information. We 
are concerned that we if do not place limitations on how subgroups can 
be constructed, subgroups could be formed in a way that would result in 
different types of clinicians assessed on measures that are only 
applicable to a small subset. We believe that without establishing 
limitations to subgroup composition prior to implementation, we would 
not meet the desired programmatic goals of MVPs and in many ways would 
replicate our concerns with the current state with traditional MIPS. 
One approach we could consider would be to limit clinicians in 
multispecialty groups to participate through single-specialty 
subgroups. Under this approach, we would determine specialty 
designation as defined by PECOS and are considering if it is feasible 
for this to be determined at the time of MIPS eligibility 
determination. We recognize many clinicians have more than one 
specialty designation in PECOS and may even have multiple PECOS 
profiles, which contain different specialty designations. We also 
recognize for many clinician types, the primary specialty designation 
is related to their clinical degree and not to the type of care they 
provide (such as PAs, NPs, etc.). To account for differences in care, 
we could set a threshold to be met in order for a subgroup to be 
considered a single-specialty subgroup. To align with other thresholds 
in the Quality Payment Program, such as the requirements for facility-
based and hospital-based clinicians, we are considering requiring that 
75 percent of clinicians in a subgroup have the same PECOS primary 
specialty designation or specialty codes on Medicare Part-B claims. 
This would mean that 75 percent of clinicians in subgroup would need to 
have the same

[[Page 39366]]

primary specialty designation. We believe that this would offer 
simplicity for clinicians and help assure that clinicians are being 
assessed with like clinicians within their subgroup on the same 
measures and activities.
    For instance, if anesthesiologists are a part of multispecialty 
group, we anticipate a future state where the anesthesiologists would 
form a subgroup and report the Patient Safety and Support of Positive 
Experiences with Anesthesia MVP if it is finalized (detailed in this 
proposed rule under Table G: Proposed Patient Safety and Support of 
Positive Experiences with Anesthesia MVP Beginning with the CY 2023 
MIPS Performance Period/2025 MIPS Payment Year in Appendix 3: MVP 
Inventory). Under this scenario, the scope of applicable measures in 
the MVP is narrow and we anticipate that this MVP would be appropriate 
for limited clinician types, thus a single-specialty subgroup. In 
another example, if the Optimizing Chronic Disease Management MVP 
(detailed in Appendix 3: MVP Inventory of this proposed rule) is 
finalized, we could anticipate that a group that included family 
physicians and cardiologists could form two subgroups, one single-
specialty subgroup each for the family physicians and cardiologists, 
with each subgroup reporting the Optimizing Chronic Disease Management 
MVP. In this scenario, the family physician subgroup and cardiology 
subgroup would both be reporting on the same MVP, but they could be 
selecting different measures/activities from within the MVP as 
applicable to their scope of practice, as the Optimizing Chronic 
Disease Management MVP is more broadly applicable to a wider range of 
clinicians.
    We do recognize that there may be issues that need to be resolved 
with this approach. We have concerns about some of the limitations of 
PECOS, especially for clinician types such as PAs and NPs, whose 
specialty in PECOS is not related to the scope of care they provide but 
rather the degree received. We believe that all clinician types are 
essential to team-based care and request comment on ways to 
comprehensively categorize clinician specialty. We believe setting a 
high but not absolute threshold would allow additional flexibilities 
for subgroups to accurately reflect the care they provide. We do have 
concerns that this may leave gaps in data because it would not require 
everyone under a given specialty to report together, may exclude 
clinicians given the limitations intrinsic to the PECOS system and 
Medicare Part-B claims data, and could result in clinicians being 
unable to report in a subgroup based on their specialty designation. 
For future consideration, we seek comment on setting a threshold for 
single-specialty subgroups and ways to overcome our concerns. We would 
also like to consider potential approaches to validating and auditing 
specialty information. Specialty information could be validated at the 
time of eligibility determination, during subgroup and MVP 
registration, or even through attestation. We seek comment on ways we 
can validate specialty information in a low burden, streamlined manner 
for future consideration.
    Alternatively, we are considering whether subgroup composition 
could be determined by a different data source. We are interested in 
ways that we could provide guardrails for subgroups that do not use 
PECOS or use PECOS information to categorize specialties into specialty 
families or teams of clinicians who practice in relevant specialties 
for a given MVP. For ease of readability, we will refer to this concept 
as specialty families for the remainder of this discussion. Under this 
alternative, we anticipate that during the subgroup and MVP 
registration period, a practice administrator or the clinicians in a 
particular subgroup would attest that the clinicians in a subgroup 
practice similar scopes of care. We welcome feedback on how specialty 
families could be identified and what criteria would need to be 
established for us to set requirements on subgroup formation. For 
example, specialty families could be constructed similarly to how the 
Aligned Other Payer Medical Home Model \198\ defines primary care focus 
through identifying multiple specialties to include the following 
Physician Specialty Codes: 01 General Practice; 08 Family Medicine; 11 
Internal Medicine; 16 Obstetrics and Gynecology; 37 Pediatric Medicine; 
38 Geriatric Medicine; 50 Nurse Practitioner; 89 Clinical Nurse 
Specialist; and 97 Physician Assistant. As a third alternative, we have 
also considered whether we should analyze claims data to identify the 
primary clinician specialty based on their billing patterns. We believe 
that this could be a way to help validate subgroup composition for 
clinicians who practice in more than one specialty. We request comment 
on these three approaches to setting limitations around the composition 
of subgroups for future consideration.
---------------------------------------------------------------------------

    \198\ Sec.  414.1305.
---------------------------------------------------------------------------

    As an alternative to establishing limits on how subgroups could be 
formed, we are also considering adding to the MVP specifications an 
approved list of specialties and clinician types permitted to report 
each MVP. Instead of directly limiting the composition of the subgroup, 
this would limit who can report a given MVP. We believe this option 
offers additional benefit of not being specific to subgroup reporting 
but possibly standardizing MVP reporting and impacting clinicians and 
groups as well. We believe this approach may also promote team-based 
care and further ensure that MVPs are relevant to those who report 
them. However, we do have concerns this could have unforeseen 
consequences in that certain MVPs may be appropriate for specialties 
not on the designated list, and we would not want to inadvertently 
place artificial limitations on how clinicians provide care and report 
to MIPS. We also request comment on this approach for our future 
consideration.
(v) Request for Information on the Future Vision of Subgroup Reporting
    As we look towards future rulemaking, we also request feedback on:
     If the determination of specialty composition should be 
made during the MVP registration process, as discussed in section 
IV.A.3.b.(4)(f) of this proposed rule.
     Additional approaches we should consider to incentivize 
team-based care as we move towards MVP and subgroup implementation.
     If there are other approaches or data sets, in addition to 
PECOS, that should be considered to classify the scope of care 
clinicians provide.
     If individual clinicians or groups should attest to their 
specialty during MVP and subgroup registration.
     If there may be ways to group clinicians in like 
specialties who may provide similar care and would be interested in 
reporting the same measures and activities under a given MVP.
     If we should establish criteria or set a threshold for 
groups to be deemed multispecialty.
     If there are concepts other than specialty that could 
demonstrate that a subgroup is composed of clinicians who provide care 
relevant to the MVP the subgroup intends to report.
    Overall, we request public comments on how subgroups should be 
structured, assessed, and scored in a future state as clinicians gain 
familiarity with the program, more MVPs are developed, and 
technological advancements allow for low-burden reporting.

[[Page 39367]]

(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. Through this proposed rule, 
we are proposing to establish additional MVP related policies to 
support the implementation and availability of MVPs. In this section, 
we propose: (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
    From the time the CY 2021 PFS final rule 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.'' 
\199\ Other clinicians may be specialized in a manner where they focus 
on a limited number of procedures.
---------------------------------------------------------------------------

    \199\ 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 a 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.
    In section IV.A.3.b.(4)(b)(ii) of this proposed 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 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). Through this rulemaking cycle, we are 
proposing reporting requirements for MVPs, and discuss the allowance of 
clinician choice in selecting which quality measures and improvement 
activities to report, as described in detail below in section 
IV.3.b.(4)(d) of this proposed 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.
    Generally, 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 
section IV.3.b.(4)(d) of this proposed 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, in Appendix 3: MVP Inventory, we are proposing 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
    In section IV.3.b.(4)(d)(ii) of this proposed rule, we propose 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) Proposed Outcomes Measures Requirement
    Therefore, we propose 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

[[Page 39368]]

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.3.b.(4)(b)(i)(B)(AA) of this proposed 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 Payment Systems (MIPS) outcome-based 
administrative claims measure. In addition, in Appendix 1: MIPS Quality 
Measures of this proposed rule, we propose at Table A.4. the Risk-
Standardized Acute Unplanned Cardiovascular-Related Admission Rates for 
Patients with Heart Failure for the Merit-based Incentive Payment 
System, which is also an outcome-based administrative claims measure. 
We propose 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 proposed rule. We request comments on these 
proposals.
(BB) Proposed 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.
    Therefore, we propose 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.3.b.(4)(b)(i)(A) of this proposed 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 request comments on these 
proposals.
(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.
    We clarify that we are not proposing 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 \200\ 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.'' We request comment on whether there are other aspects of 
patient measurement that should be considered as a part of the patient-
centered measures definition.
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    \200\ 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.
(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. Through this proposed rule, we seek to clarify 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

[[Page 39369]]

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 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. Through this proposed rule, we propose: (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 this proposed rule, we propose 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 request 
comments on this proposal.
(BB) Population Health Measures Inventory
    In the CY 2021 PFS final rule (85 FR 84856 through 84857), we 
finalized the inclusion of the Hospital-Wide, 30-day, All-Cause 
Unplanned Readmission (HWR) Rate for the Merit-Based Incentive Payment 
System Program (MIPS) Eligible Clinician Groups as a part of the 
population health measures within the foundational layer of MVPs.
    As described in Appendix 1: MIPS Quality Measure Inventory of this 
proposed rule, we are proposing to include the Clinician and Clinician 
Group Risk-standardized Hospital Admission Rates for Patients with 
Multiple Chronic Conditions in the MIPS program. This measure is 
calculated from administrative claims and measures the annual risk-
standardized rate of acute, unplanned hospital admissions among 
Medicare FFS patients aged 65 years and older with multiple chronic 
conditions (MCCs). We refer readers to Appendix 1: MIPS Quality Measure 
Inventory of this proposed rule for additional details on this measure. 
If finalized, this measure would be an additional population health 
measure for MVP reporters to submit as part of the Foundational Layer. 
We have heard from stakeholders the need for more specialty relevant 
population health measures. We encourage stakeholders to utilize the 
aforementioned 2020 CMS Quality Measure Development Plan--2020 
Population Health Environmental Scan and Gap Analysis Report as a 
resource to explore population health measure development. Furthermore, 
we continue to encourage stakeholders to utilize our established Call 
for Measures process, described in the CY 2020 PFS final rule (84 FR 
62953 through 62955) to submit fully developed population health 
measures for our consideration.
(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 proposed rule where we discuss Promoting 
Interoperability performance category proposed policies and updates.
(D) Health Equity Measures in MVPs--Request for Information (RFI)
    In section IV.A.1.c.(5)(d) of this proposed rule, we discuss our 
request for information on closing the health equity gap in CMS 
clinician quality programs, describing our current efforts as an 
agency, and asking specifically what other efforts can we take within 
the MIPS program to further bridge the equity gap. We believe there is 
potential to address health equity specifically through MVPs. As 
described in Appendix 3: The MVP Inventory, we are proposing 
improvement activities related to health equity in all 7 proposed MVPs. 
We also believe there is value in including quality measures that 
capture health equity in each MVP. However, in evaluating our current 
measure inventory, we acknowledge that we lack the availability of 
health equity measures. We intend on prioritizing the development of 
health equity measures through future cycles of measure development, 
and would also encourage stakeholders to do the same by utilizing our 
established processes, such as the Call for Measures: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rulemaking, to develop health equity 
measures for consideration of the MIPS program and potential inclusion 
in an MVP. Health equity continues to be a high priority for the agency 
and for the MIPS program. We envision a future state where health 
equity measures would be included in all MVPs. We request information 
on the following:
     Should health equity measures be developed in a manner to 
be broadly

[[Page 39370]]

applicable to the various specialties and subspecialties that 
participate in MIPS?
     Is there value in the development of more specialty 
specific health equity measures?
     Considering MIPS and MVPs includes several specialties and 
subspecialties, what factors should be considered when developing a 
health equity measure?
     Should we include a health equity measure in the 
foundational layer of all MVPs, as a required measure, in the future? 
If not, why not?
(ii) Proposed Maintenance Process for MVPs
    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 propose an annual maintenance process for 
finalized MVPs. In order to ensure that various stakeholder 
perspectives are also considered, we propose 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 would 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. 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. However, CMS would consult with the stakeholders 
who originally nominated the MVP about any publicly recommended changes 
to that MVP. We would be unable to communicate with a stakeholder 
whether or not their recommendations would be accepted ahead of 
rulemaking and CMS would ultimately decide whether updates to the 
established MVPs should be made. 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 request comments on these proposals.
(c) Establishing a Portfolio of MVPs
    In this proposed rule, we are proposing 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 for a 
full description of each MVP, proposal rationale, and where we are 
soliciting comments.
    We anticipate that the portfolio of MVPs would 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 and intend to address this 
concern through this proposed rule. We also refer readers to section 
IV.A.3.d.(2)(c) of this proposed rule, for our proposal on Cost measure 
development by stakeholders, where we discuss a potential strategy to 
mitigate the issue of a limited inventory of cost measures that would 
potentially remove barriers for MVP implementation.
(d) Proposed 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) Proposed Quality Reporting Requirements in MVPs
    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 propose 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)(aa)(AA) of this proposed 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

[[Page 39371]]

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 propose 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 request comments on these proposals. We refer readers to section 
IV.A.3.b.(5)(b)(i) of this proposed rule for details on the MVP quality 
scoring proposals.
(iii) Proposed Cost Reporting Requirements in MVPs
    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 propose 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 request comments on this proposal.
    In addition, we refer readers to section IV.A.3.b.(5)(b)(ii) of 
this proposed rule for details on the MVP cost scoring proposals.
(iv) Proposed 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, at Sec.  414.1365(c)(3), we propose 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 request 
comments on this proposal and refer readers to section 
IV.A.3.b.(5)(b)(iii) of this proposed rule for proposals related to MVP 
improvement activities scoring and discussion of why improvement 
activities are double-weighted under MVP reporting.
(v) Proposed Reporting Requirements for the Foundational Layer
(A) Promoting Interoperability
(aa) Proposed 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, we propose 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 request comments on this proposal and refer readers to 
section IV.A.3.b.(5)(b)(iv) of this proposed rule for details on the 
proposals for MVP Promoting Interoperability scoring and reweighting.
(bb) Subgroup Limitations
    As noted in section IV.A.3.b.(3) of this proposed rule, 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 propose 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 would be on the 
subgroup's behalf. If the affiliated group chooses to report as a group 
for the Promoting Interoperability performance category, the group 
still would be required to submit its own data separately and pursuant 
to the reporting rules for groups.
    Alternatively, we considered proposing that for the 2023 and 2024 
MIPS performance periods/2025 and 2026 MIPS payment years that each 
subgroup would be required to submit either their affiliated group's 
data or their subgroup data for the Promoting Interoperability 
performance category. We considered requiring subgroups to indicate 
whether they would be submitting data for the Promoting 
Interoperability performance category at the group or subgroup level. 
However, we believe that the advantages of

[[Page 39372]]

reporting Promoting Interoperability performance category data at the 
subgroup level are not clear at this time and such a proposal, may 
introduce additional and unnecessary complexity.
    In a future state, we could reassess whether subgroups should be 
required to submit subgroup level performance data for the Promoting 
Interoperability performance category. We refer readers to section 
IV.A.1.c.(5) of this proposed rule for details on the Digital Quality 
Measurement Blueprint and the Fast Healthcare Interoperability 
Resources (FHIR)-standard. Some subgroups may prefer to have the 
ability to report Promoting Interoperability performance category data 
at the subgroup level.
    We request public comment on whether subgroups should be allowed or 
required to submit subgroup level performance data for the Promoting 
Interoperability performance category beginning with the performance 
period in 2023/2025 MIPS payment year, or in the future. We also 
request comment on any technical challenges that clinicians may 
encounter in reporting on Promoting Interoperability measures for a 
subgroup using technology certified to the existing certification 
criteria for reporting and capturing this information at Sec.  
170.315(g)(1) and (2). In addition, we request public comment on the 
aforementioned issues that would give us a better understanding on 
whether we should reconsider subgroup reporting in the future.
    As previously discussed in the CY 2020 PFS proposed rule (84 FR 
40734), in future years we may consider customizing the Promoting 
Interoperability measures in each MVP and we are seeking comment on how 
the Promoting Interoperability performance category could evolve in the 
future to meet our goal of greater cohesion between the MIPS 
performance categories. We believe that eligible clinicians could 
benefit from more targeted approaches to assessing the meaningful use 
of certified EHR technology which aligns with clinically relevant MVPs 
cutting across the MIPS performance categories. For instance, we may 
consider how measures in the Promoting Interoperability performance 
could align with specific MVPs.
    We may also consider developing Promoting Interoperability measures 
which are better tailored to specific MVPs, or that seek to assess the 
use of health IT associated with reporting measures in other categories 
and could be paired with these measures under an MVP. Finally, we may 
consider whether existing Promoting Interoperability measures could be 
tailored to specific populations addressed under an MVP. We invite 
comment on these concepts, as well as other suggestions for how the 
Promoting Interoperability performance category could align with the 
MVP framework in the future.
(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, at Sec.  
414.1365(c)(4)(ii), we propose 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 proposed 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 wouldn't 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 
propose 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 request comments on our proposal as discussed above and refer 
readers to section IV.A.3.b.(5) of this proposed rule for details on 
the scoring of population health measures.
(vi) Subgroup Reporting
(A) Subgroup Reporting Overview
    As discussed in section IV.A.3.b.(3) of this proposed 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.(5) of this proposed 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 proposed rule, we believe cost data 
should be assessed at the subgroup level as well.
(B) Proposed Subgroup Reporting Limits
    As described in section IV.A.3.b.(2)(d)(i) of this proposed rule, 
we are proposing 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.(4)(d), 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 propose 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

[[Page 39373]]

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. We refer readers to section IV.A.3.b.(2)(e) of this proposed 
rule, where we discuss subgroups reporting the APP. 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 request public comment on whether there 
are strategies we should consider to enable formation of subgroups 
comprised of MIPS eligible clinicians from multiple billing TINS to 
report MVPs or the APP.
    We request public comment on this proposal.
(vii) Proposed MVP Reporting Requirements Summary
    Table 34 summarizes the proposed MVP reporting requirements:
    [GRAPHIC] [TIFF OMITTED] TP23JY21.057
    
(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. of this proposed rule for proposals related to 
requiring third party intermediaries to support MVP and subgroup 
reporting.
(f) MVP Participant Registration
    We strive to limit administrative burden and offer as much 
flexibility as possible. With this principle in mind, we propose 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 would 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) Proposed Registration Timeline
(A) General Timeline
    We considered whether registration should occur at the time of data 
submission (as described at Sec.  414.1325(e)) or at a specific point 
during the performance period (for example, by July 1 of the applicable 
performance period to coincide with the CAHPS for MIPS registration 
period (81 FR 77072)). On January 7, 2021, we held the MVP Town Hall 
(85 FR 74729) and publicly shared the MVP Town Hall Preparation 
Guide,\201\ as well as these two potential options and solicited 
feedback from stakeholders.
---------------------------------------------------------------------------

    \201\ MVP Town Hall Preparation Guide (https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1233/MVP%20Town%20Hall%20Preparation%20Guide.pdf).
---------------------------------------------------------------------------

    This first option would require registering at the time of 
performance data submission because: It would provide clinicians 
additional time and flexibility to submit the identification 
information; better account for TIN/NPI changes during the performance 
period; allow third-party intermediaries time to accommodate reporting; 
streamline

[[Page 39374]]

reporting; minimize burden; allow time to review APM participation 
lists and confirm QP status in order to determine the clinicians to be 
included in subgroups. Many commenters supported this. A few commenters 
recommended that the election process take place during the performance 
period in conjunction with the CAHPS for MIPS registration process and 
stated that the increased burden associated in enrolling clinicians in 
a subgroup during the performance period was worth it for subgroups to 
be scored on administrative claims quality measures and cost measures 
specific to their subgroup.
    We also considered the second option: Having the registration 
window coincide with performance data submission given that this would 
provide the additional time and flexibility for clinicians and 
practices to identify the clinicians in a subgroup. Even though this 
option would not require a prior registration process to identify 
clinicians in a subgroup and would allow groups to internally account 
for clinicians joining or leaving their group throughout the 
performance period, it would also have significant tradeoffs such as 
not allowing enough time for CMS to provide enhanced performance 
feedback as proposed in section IV.A.3.b.(5)(d) of this proposed rule. 
We are also concerned that this option would result in subgroups that 
are assessed on less information due to insufficient operational time 
for CMS to pull and reconcile claims data and CAHPS beneficiary 
sampling for the subgroup that informs performance measurement of the 
subgroup. Furthermore, this option would also require clinicians in 
subgroups to be assessed on the overall group's administrative claims 
quality measures and cost measures instead of the subgroup's 
performance on those measures; this means that if subgroups would like 
to be assessed on the subgroup level for claims data and CAHPS, this 
would delay feedback and scoring.
    In consideration of stakeholder feedback and to ensure timelines 
are feasible for CMS and stakeholders alike, we believe the first 
option is more appropriate--a registration period that begins on April 
1st and ends November 30th of the applicable performance period (h). 
Therefore, we propose 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, MVP population health 
measure, 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 otherwise, make changes to their participation status in subgroups, 
before the end of the registration period.
    We request public comment on our proposals as discussed above.
(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 this proposed rule, 
we propose 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 would 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 request public comment on these proposals.
(ii) Proposed 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 
propose at Sec.  414.1365(b)(2)(i) and (ii), that at the time of 
registration, an MVP Participant 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 propose 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 request comments on this proposal.
    In addition, for our consideration for future rulemaking, we 
request public comment on whether MVP Participants would be interested 
in the ability to select multiple MVPs at the time of registration. If 
so, we would like to

[[Page 39375]]

understand what value MVP Participants might find with this allowance. 
Specifically, we would like to know if MVP Participants believe they 
will likely report on multiple MVPs. Also, we would like to know if MVP 
Participants would want to submit data on multiple MVPs. We also refer 
readers to section IV.A.3.b.(3)(h) of this proposed rule, where we 
discuss a similar comment request for subgroups.
(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 
proposed in section IV.A.3.b.(4)(d)(V)(B) of this proposed rule, we 
propose 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 propose 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 request comments on 
this proposal.
(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 propose 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 proposed in section IV.A.3.b.(4)(d)(ii) above 
in this proposed rule and at Sec.  414.1365(c)(1), 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 request comments 
on this proposal.
(D) Subgroup Participants
    As part of the registration process, to accurately capture all the 
clinicians participating in a subgroup, we propose 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. We considered an alternative 
option to allow flexibility for groups to choose their own naming 
convention for subgroups. We are concerned that this option may result 
in the use of naming conventions that may not be meaningful for 
patients. Additionally, we believe that this option may increase 
operational complexity for CMS and stakeholders due to the potential 
for duplicate naming of subgroups.
    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 proposed 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 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.h.(2)(b) of this 
proposed rule.
    We request public comment on these proposals. Additionally, we 
request feedback on if there are any additional operational 
considerations or recommendations for the implementation of this policy 
for future consideration.
(iii) Summary of the Overall Proposed Registration Process
    Table 35 presents a comprehensive perspective of the overall 
proposed registration timeline:
BILLING CODE 4120-01-P

[[Page 39376]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.058

    Table 36 presents a crosswalk of the various clinician types, the 
information expected at the time of registration, and a reminder of the 
MVP reporting requirements if our proposals are finalized as proposed.

[[Page 39377]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.059

BILLING CODE 4120-01-C
(5) Scoring MVP Performance
(a) Overview of MVP Scoring
    In the CY 2020 PFS proposed rule, we requested comments on how we 
should address scoring policies as we transition to MVPs (84 FR 40741 
through 40742). Generally, commenters indicated scoring for MVPs should 
include policies for simplification and alignment of the scores for 
measures and activities within the performance categories and the final 
score. We subsequently held an MVP Town Hall on January 7, 2021 (85 FR 
74729 through 74730) and publicly shared the MVP Town Hall Preparation 
Guide (https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1233/MVP%20Town%20Hall%20Preparation%20Guide.pdf) to aid MVP Town Hall 
participants in understanding the direction we may take with MVPs 
scoring. We received feedback opposing the use of policies that may 
differentiate the way we score measures and activities within MVPs 
compared to traditional MIPS because of concerns over adding complexity 
to the program. Stakeholders urged us to apply simple scoring rules for 
MVPs whenever possible to ease burden and help clinicians to predict 
and understand their MVP scores. Wherever possible, stakeholders 
requested that we align with traditional MIPS scoring.

[[Page 39378]]

    In general, in this proposed rule, we propose 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; performance standards for each of the performance 
categories; calculation of achievement and improvement scores; and 
calculation of the final score. We strive to ensure our methodology to 
convert the scores of activities and measures into a final score 
balances the statutory requirements and goals of the program with the 
ease of use, stability, and meaningfulness to MIPS eligible clinicians 
(83 FR 59840). Our proposed scoring methodology would allow for 
accountability and alignment across the performance categories and 
minimizes burden on MIPS eligible clinicians (85 FR 50305). We believe 
these proposed scoring policies would ensure the meaningful evaluation 
of performance of MVP Participants based on measures and activities in 
the MVP. 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.
    We propose 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 accordance with paragraphs Sec.  414.1365(d)(1) through Sec.  
414.1365(d)(3). We also propose 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). Additionally, 
we propose 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. Lastly, we propose at Sec.  414.1365(d)(3) that an 
MVP Participant is scored under MIPS in four performance categories.
    We request public comments on these proposals.
    In sections IV.A.3.b.(5)(b) and IV.A.3.b.(5)(c) we propose scoring 
policies for MVPs that address scoring population health measures 
within the quality performance category, scoring an outcomes-based 
administrative claims measure selected as an outcome measure at the 
time of registration, scoring only the cost measures specified in the 
MVP for the cost performance category, assigning 20 points for each 
medium-weighted and 40 points for each high-weighted improvement 
activity in the improvement performance category, scoring subgroups on 
the Promoting Interoperability performance category using the 
affiliated group score, circumstances in which we would reweight 
performance categories within an MVP, and application of the complex 
patient bonus to MVPs. We also propose using enhanced performance 
feedback in MVPs.
    As discussed in section IV.A.3.b.(5)(b), we propose scoring 
policies that apply to MVP Participants. We do not anticipate the need 
for separate scoring policies for MVPs that might be reported by a 
single specialty, for example a group of specialists that perform the 
procedure addressed by an MVP, or for MVPs that could be reported by 
multiple specialties engaged in team-based care; we believe all scoring 
policies would apply in each scenario.
(b) Performance Category Scores
(i) Scoring the Quality Performance Category in MVPs
(A) Scoring Based on Achievement
    We propose 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 
section IV.A.3.e.(1)(c) of this proposed rule. We refer readers to 
section IV.A.3.e.(1)(c)(iii) of this proposed rule for our proposals to 
remove the 3-point floor for Class 1 and Class 2 measures for the 2024 
MIPS payment year for traditional MIPS, and for Class 4 measures (new 
measures) to provide a score from 5 to 10 points in the first two 
performance periods a measure is used in MIPS. We propose to align with 
these policies as well to maintain consistency between MVPs and 
traditional MIPS.
    We propose 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.
(B) Population Health Measures
    Population health measures are administrative claims measures that 
are part of the foundational layer of MVPs, as described in section 
IV.A.3.b.(4)(b)(i)(C)(aa) of this proposed rule. As proposed in section 
IV.A.3.b.(4)(f)(ii)(B) of this proposed rule, MVP participants would 
select a population health measure during the registration process. We 
would score the selected measure as proposed at Sec.  
414.1365(d)(3)(i). Since we are proposing 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 propose 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.
    We are concerned about the ability of subgroups to meet the case 
minimum for an administrative claims measure but are interested in 
including population health measures in the subgroup's score for the 
MVP. We propose 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. We believe 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 also propose at Sec.  414.1365(d)(3)(i)(A)(1) 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.
    We request public comments on this proposal.
    We note that we are also concerned about scoring individual 
clinicians on population health measures. 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

[[Page 39379]]

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 would remove the population health 
measure from the denominator 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 request comment on approaches to scoring individual 
clinicians on population health measures given the importance of these 
measures.
    We request public comments on this proposal.
(C) Outcomes-Based Administrative Claims Measures
    We want to clarify that MVPs may include outcomes-based 
administrative claims measures that are identified as outcome measures 
but are not population health measures as defined at Sec.  414.1305. As 
described in section IV.A.3.b.(4)(f)(ii)(C) of this proposed rule, 
clinicians will be able to select outcomes-based administrative claims 
measures as their required outcome measure during MVP registration, if 
an outcomes-based administrative claims measure is available within the 
MVP. For example, if a clinician selects an outcomes-based 
administrative claims measure during registration to be used as an 
outcome measure and submits three additional measures, and the 
outcomes-based administrative claims measure has a benchmark and meets 
the case minimum, all four measures will be scored. If the clinician 
selects an outcomes-based administrative claim measure to fulfill their 
outcome measure requirement, and the outcomes-based administrative 
claims measure does not meet the benchmark or meet the case minimum. 
Therefore, we propose 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. This scoring aligns 
with our proposal at IV.A.3.e.(1)(c) of this proposed rule to score 
Class 2 measures in traditional MIPS. If the clinician selects the 
outcomes-based administrative claims measure, which can be calculated 
and submits more than three measures, including an additional outcome 
measure, scores from the highest four measures will be used to 
determine the quality performance category score.
    Below is an example of scoring for a MIPS eligible clinician who 
selects an outcomes-based administrative claims measure as the required 
outcome measure, does not meet case minimum for the measure, and does 
not submit an additional outcome measure to meet the outcome measure 
requirement:
     Measure #1: 10/10 points.
     Measure #2: 10/10 points.
     Measure #3: 10/10 points.
     Outcomes-based administrative claims measure: Does not 
meet case minimum, no other outcome measure submitted: 0/10 points.
     Total quality performance category points: 30/40.
    We request comment on this proposal.
(D) Scoring for MVP Participants That Do Not Meet the Quality 
Performance Category Requirements
    We believe it is important that MVP Participants submit the 
required quality measures specified in the MVP they selected to report. 
For traditional MIPS, we implemented a validation process to determine 
if measures are available and applicable (81 FR 77290 through 77291, 
and 82 FR 30108 through 30109). We have received feedback from 
stakeholders that this process may be confusing for clinicians. 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.
(E) Scoring Example
    Table 37 includes examples of scoring within the quality 
performance category for MVPs. Quality scoring example #1 includes a 
group that reports four measures and has one population health measure 
automatically calculated for them and receives 2 percentage points for 
improvement scoring for an MVP. For quality scoring example #2, the 
group is a small practice who reports all the Medicare Part B claims 
measures in an MVP. Because there are only three Medicare Part B claims 
measures available in this example, the group has a reduced 
denominator, so the group is not penalized for not reporting four 
quality measures specified in MVP reporting requirements. The second 
example also includes 2 percentage points for improvement scoring.

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(ii) Scoring the Cost Performance Category in MVPs
    We propose 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 section IV.A.3.e.(1)(d) of 
this proposed rule. We refer readers to Sec.  414.1380(b)(2)(i) through 
(v) for our 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 propose 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.
    Although we expect MVP Participants will submit MVPs that align 
clinically with their practice, we are concerned clinicians could use 
the reporting of MVPs to avoid being measured on clinically appropriate 
cost measures. For example, we are concerned larger groups could 
attempt to have the cost performance category reweighted by splitting 
into smaller subgroups that might not meet the case minimums for the 
cost measures within the MVP they choose to report. We intend to 
monitor the reporting of MVPs to ensure the use of MVPs reflects the 
clinical nature of the MVP Participants that report.
    We request public comments on this proposal.
(iii) Scoring the Improvement Activities Performance Category in MVPs
    Under traditional MIPS, we scored 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, which indicates that MIPS eligible clinicians 
participating in APMs receive a score of at least 50 percent in the 
improvement activities performance category. As a result, APM entities 
that report an MVP will receive an improvement activities performance 
category score of at least 50 percent.
    We believe we should continue scoring high-weighted and medium-
weighted improvement activities that support the linked activities and 
measures specified within the MVP using a similar scoring methodology. 
However, for MVPs, we are proposing to assign 20 points for each 
medium-weighted improvement activity and 40 points for each high-
weighted improvement activity to align with the reporting requirements 
proposed in section IV.A.3.b.(4)(d)(iv) of this proposed rule, that 
require that MVP Participants report on one high weighted improvement 
or two medium weighted improvement activities. We believe that this 
would help to incentivize clinicians to report on MVPs versus 
traditional MIPs by reducing reporting burden, since fewer submissions 
are required to receive a full score.
    Therefore, we propose 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 are also proposing 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 must submit one high-weighted improvement 
activity or two medium-weighted improvement activities included in the 
MVP.
    We request public comments on this proposal.
(iv) Scoring the Promoting Interoperability Performance Category in 
MVPs
    We propose to use the scoring methodology established for the 
Promoting Interoperability performance category in traditional MIPS, 
and as proposed to be revised in section IV.A.3.d.(4) of this proposed 
rule, for MVP Participants, except for subgroups who would be scored 
based on their

[[Page 39381]]

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 propose to use 
for MVPs. We propose 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).
    As discussed in section IV.A.3.b.(4), 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 propose 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 request public comments on these proposals.
(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. Please refer to 83 FR 59856 through 
59865, regulation text at Sec.  414.1380(e), and section 
IV.A.3.e.(2)(b)(v) of this proposed rule for our finalized and proposed 
policies for facility-based scoring. We propose at Sec.  414.1365(e)(3) 
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 as proposed in section IV.A.3.e.(2)(b)(v) of this 
proposed rule and at Sec.  414.1380(e)(6)(vi).
(c) Calculating the Final Score in MVPs
(i) Final Score Calculation
    We propose 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). This 
includes what is established for traditional MIPS, including proposed 
updates section IV.A.3.e.(2) of this proposed rule.
    We request public comment on the proposal.
(A) General Performance Category Weights
    We propose 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 propose 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 refer readers to section 
IV.A.3.d.(5)(c) of this proposed rule where we propose additions to the 
regulation text at Sec.  414.1317(b)(2).
    We request public comments on these proposals.
(B) Flexibility for Weighting Performance Categories
(aa) Reweighting Performance Categories for MVPs
    For MVP Participants, we are proposing reweighting policies that 
generally align with our current policies for traditional MIPS with a 
few minor modifications. We propose 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.  
414.1380(c)(2)(i)(A)(2) through (9), and Sec.  414.1380(c)(2)(i)(C). We 
also propose 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) (see section 
IV.A.3.d.(5)(c) of this proposed rule for further information on 
proposed additions to the regulation text at Sec.  414.1317(b)(2)).
    As discussed in section IV.A.3.b.(5)(b)(i) of this 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. Therefore, we do not believe the 
traditional MIPS policy for reweighting the quality performance 
category as specified at Sec.  414.1380(c)(2)(i)(A)(1) should be 
applicable to MVP Participants. We believe MVP Participants should 
select an MVP with four quality measures which can be scored based on 
achievement (unless clinicians report the Medicare Part B collection 
type and fewer than four measures are included in the MVP for that 
reporting option). We do not believe we should reweight the quality 
performance category if no quality measures in the MVP can be scored.
    We propose 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 propose at Sec.  
414.1365(e)(2)(ii) that if reweighting is not applied to the affiliated 
group, the subgroup may receive reweighting independent of the 
affiliated group in the following circumstances. We believe a subgroup 
may be subject to extreme and uncontrollable circumstances that do not 
impact the entire affiliated group. For example, a subgroup might 
represent a single practice location that is affected by a natural 
disaster, while the affiliated group's other practice locations are not 
affected. Accordingly, we propose 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 propose 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 are also concerned that subgroups, independent of their 
affiliated groups, may be subject to data that are inaccurate, unusable 
or otherwise compromised. We propose to add at Sec.  
414.1365(e)(2)(ii)(B) that, 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).
    We request public comments on these proposals.
(C) Redistributing Performance Category Weights
    We propose to redistribute the performance category weights for 
MVPs in accordance with the redistribution policies we propose for 
traditional MIPS in section IV.A.3.e.(2)(b)(iii) of this proposed rule. 
We propose at

[[Page 39382]]

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 propose 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) (see 
section IV.A.3.d.(5)(c) of this proposed rule for further information 
on proposed additions to the regulation text at Sec.  414.1317(b)(2)).
    We request public comments on this proposal.
(D) Complex Patient Bonus
    We refer the reader to Sec.  414.1380(c)(3) and section 
IV.A.3.e.(2)(a) of this proposed rule for our previously established 
and proposed policies on applying a complex patient bonus. We propose 
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 request public comments on these proposals.
(E) Scoring Example
    Table 38 includes an example of calculation of the final score for 
MVPs. The example continues the example #1 from the quality scoring 
example in Table 37.
    We note that the small practice bonus may constitute a larger 
proportion of the quality performance category score as compared with 
MIPS eligible clinicians reporting under traditional MIPS with a 
quality performance category denominator of 60 points, where the small 
practice bonus would add 10 percent to the quality performance category 
score. In cases where the quality performance category denominator is 
50 points, as a result of 4 quality measures and one population health 
measure, a small practice bonus of 6 points would add 12 percent to the 
quality performance category score. We note that within traditional 
MIPS the quality performance category denominator can sometimes be less 
than 60 points (in cases where there are not 6 quality measures are 
relevant to the MIPS clinician, for example), and therefore, the small 
practice bonus is sometimes greater than 10 percent. We believe this 
variability is appropriate and believe that modifying the value of the 
small practice bonus for MVPs would cause unnecessary confusion.
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(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) Proposed Enhanced Performance Feedback in MVPs
    A goal of enhanced performance feedback would be to compare similar 
clinicians to one another. For example, we could compare clinicians 
within a group or subgroup that practice in similar ways. We considered 
two options for providing enhanced performance feedback. 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 the current performance feedback 
under traditional MIPS. This method does not require clinicians to 
submit data earlier than they currently do. In addition, we anticipate 
that we could provide comparative performance feedback at the time of 
annual performance feedback. The second option is to provide 
performance feedback during the performance period. We acknowledge 
stakeholders would like to receive more timely and actionable feedback 
during the performance period. However, there are complexities that 
need mitigation to pursue this option. These complexities include 
requiring clinicians to submit data earlier to provide enhanced 
performance feedback during the performance period, and requiring 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, we 
propose 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. The comparative feedback would only be 
available to those who report on MVPs, and would be incorporated into 
the annual performance feedback that we currently provide in 
traditional MIPS.
    We request public comments on this proposal.
(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 request 
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 request public comments on the above.
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 39 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, with such quality 
reporting option no longer available beginning with the CY 2022 
performance period. However, 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 are proposing 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 are proposing that for the 2023 performance year, 
we would only score Web Interface submissions for ACOs that have also 
submitted at least one eCQM/MIPS CQM measure from the APP measure set. 
While we understand that there may be barriers to ACOs transitioning 
away from the CMS Web Interface along the timeline

[[Page 39385]]

originally contemplated, 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 believe that by also 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.
    We note 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 higher submission. 
We believe these proposed policies will 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 seek comment on these proposals.
    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, 
we are proposing 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 proposed rule.
    We are also proposing to replace the MCC for ACOs measure with the 
MCC for MIPS measure within the APP beginning with the 2022 MIPS 
performance period. 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 believe 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 believe 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 seek comment on our proposal to include the measures listed in 
Table 40 in the quality measure set for the APP for the 2022 MIPS 
performance period.
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d. MIPS Performance Category Measures and Activities
---------------------------------------------------------------------------

    \202\ We note that 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 Use: Screening and Cessation Intervention 
(Quality ID# 236) do not have benchmarks and are therefore not 
scored for PY 2022; they are, however, required to be reported in 
order to complete the Web Interface dataset.
    * ACOs will have the option to report via Web Interface for the 
2022 & 2023 MIPS performance periods only.
---------------------------------------------------------------------------

(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 this proposed rule, we propose to:
     Maintain the data completeness criteria threshold of at 
least 70 percent for 2021 and 2022 MIPS performance periods (2023 and 
2024 MIPS payment years), and increase the data completeness criteria 
threshold to at least 80 percent for the 2023 MIPS performance period 
(2025 MIPS payment year).
     Extend the availability of the CMS Web Interface as a 
collection and submission type for the 2022 MIPS performance period.
     Make changes to the MIPS quality measure set as described 
in Appendix 1 of this proposed rule, including addition of new 
measures, updates to specialty sets, removal of existing measures, and 
substantive changes to existing measures.
     Establish criteria for determining whether a measure 
change is considered substantive starting with 2022 MIPS performance 
period.

[[Page 39387]]

     Beginning with the 2021 MIPS performance period 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 are proposing 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 QPP 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 would 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 
would 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.
    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 proposed rule).
    Since the inception of MIPS under the Quality Payment Program 
starting with the 2017 MIPS performance period, 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). With CMS conducting the assessment and 
calculations of administrative claims measures, the reporting burden 
for individual MIPS eligible clinicians, groups, and virtual groups is 
reduced (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. As more outcome-based administrative claims measures are 
implemented in MIPS, we would like to further reduce the reporting 
burden by allowing such measures (not applicable to administrative 
claims measures that are considered population health measures) to 
fulfill the outcome measure requirement, when applicable. For the 2022 
MIPS performance period, we are proposing 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 proposed rule).
    In section IV.A.3.b.(4)(d)(ii) of this proposed rule, we are 
proposing 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 2023 MIPS performance 
period. 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. Once an outcomes-based 
administrative claims measure is selected during the MVP registration 
process, the measure would meet the outcome-based measure reporting 
requirement and count as 1 of the 4 minimum required measures if the 
MVP Participants 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 Participants 
would not meet the minimum reporting requirement of 4 measures. 
However, if the MVP Participants select an outcomes-based 
administrative claims measure available within the MVP and report on 4 
measures, the MVP Participants 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 we analyzed the allowance and utilization of outcome-based 
administrative claims measures (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

[[Page 39388]]

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 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

[[Page 39389]]

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 are not 
making a proposal for the implementation of such policy, we would like 
to obtain 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 are seeking 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?
(c) Data Completeness Criteria
(i) 2021 MIPS 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 Sec.  414.1340(b)(3) for the 2020 
MIPS 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 2020 
MIPS 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 are proposing to modify the data completeness threshold 
criteria established at Sec.  414.1340(b)(3) for the 2020 MIPS 
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 would be 
contrary to the public interest because it would 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 2021 
MIPS performance period (2023 MIPS payment year), we are proposing 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 2021 MIPS 
performance period (2023 MIPS payment year); we only included a 
reference to the data completeness criteria of at least 70 percent for 
the 2021 MIPS 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, we are proposing to establish the data completeness criteria for 
the 2021 MIPS performance period (2023 MIPS payment year) 
retroactively, effective January 1, 2021, in accordance with section 
1871(e)(1)(A)(ii) of the Act. We believe that failure to apply the 
change retroactively would 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

[[Page 39390]]

adjustments and public reporting. For the 2021 MIPS performance period 
(2023 MIPS payment year), we are proposing: 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 would 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 2021 MIPS 
performance period to which the measure applies for MIPS payment year 
2023.
    We believe that it is imperative to establish the data completeness 
criteria for the 2023 MIPS payment year in this proposed 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 2021 MIPS 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 2021 MIPS performance period and any data 
submitted for the quality performance category would need to meet the 
data completeness criteria. We believe that such approach would: 
Establish the data completeness criteria prior to the timeframe in 
which data submission would 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 2021 MIPS 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.
(ii) 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 2020 MIPS 
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 are proposing to maintain the data completeness 
criteria threshold of at least 70 percent for the 2021 MIPS 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 2020 
MIPS performance period (2022 MIPS payment year) and continued into the 
2021 MIPS performance period (2023 MIPS payment year), we believe that 
it would be appropriate to continue to maintain the data completeness 
criteria of at least 70 percent for the 2022 MIPS 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 are proposing:
     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 would 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 2022 
MIPS 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 2022 MIPS 
performance period to which the measure applies for MIPS payment year 
2024.
(iii) 2023 MIPS 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 strongly 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 2023 MIPS performance period (2025 MIPS 
payment year). We are proposing: 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 would 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 2023 
MIPS performance period (2025 MIPS payment year); and at Sec.  
414.1340(b)(4) to increase the data completeness

[[Page 39391]]

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 2023 
MIPS performance period to which the measure applies for MIPS payment 
year 2025. We believe that MIPS eligible clinicians, groups, and 
virtual groups would be provided with adequate time to prepare for the 
data completeness criteria threshold to increase.
    We seek public comment on our proposals to maintain the data 
completeness criteria threshold of at least 70 percent for the 2021 and 
2022 MIPS performance periods (2023 and 2024 MIPS payment years), and 
increase the data completeness criteria threshold from at least 70 
percent to at least 80 percent for the 2023 MIPS performance period 
(2025 MIPS payment year).
(d) Groups and Virtual Groups Reporting via the CMS Web Interface
    At Sec.  414.1335(a)(2), the CMS Web Interface measures is a 
collection type in which groups and virtual groups with 25 or more 
eligible clinicians are able to report data on a set of pre-determined 
quality measures. For the 2021 MIPS performance period, the total 
number of CMS Web Interface measures required to complete reporting on 
is 10 CMS Web Interface measures (83 FR 59713 through 79715 and 59756). 
In the CY 2021 PFS final rule, at Sec.  414.1325(c)(1) et seq., the CMS 
Web Interface was sunset and removed as an available collection and 
submission type under MIPS starting with the 2022 MIPS performance 
period (85 FR 84870). In addition, starting with the 2022 MIPS 
performance period, the definition of the terms collection type and 
submission type would no longer include the CMS Web Interface measures 
as an available option. It was our belief that the sunset and removal 
of the CMS Web Interface as a collection and submission type starting 
with the 2022 MIPS performance period would reduce the potential burden 
experienced by groups and virtual groups during the COVID-19 PHE. Based 
on the public comments received during the notice-and-comment 
rulemaking process for the CY 2021 PFS proposed rule, we believed that 
the 1-year delay to sunset and 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 2022 
MIPS performance period.
    However, following the close of the submission period for the 2020 
MIPS performance period (March 31, 2021), stakeholders utilizing the 
CMS Web Interface contacted CMS to convey concerns regarding the 
technological challenges and resource limitations they face that would 
prevent them from being able to adequately transition to implementing 
and utilizing an alternative collection and/or submission type starting 
with the 2022 MIPS performance period. Also, they emphasized that some 
practices around the country continue to endure a fiscal impact 
resulting from the COVID-19 pandemic and would need additional time to 
prepare for a transition to an alternative collection and/or submission 
type. They indicated that if the availability of the CMS Web Interface 
was extended for an additional year (the 2022 MIPS performance period), 
they would have sufficient time to address 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.
    We recognize that an adequate and sufficient timeframe is a 
critical factor in the success of a group or virtual group 
transitioning to an alternative collection and/or submission type, 
particularly with such transition occurring amidst the mitigation of 
the COVID-19 pandemic. It seems that as CMS Web Interface users began 
the actualization of preparing and taking steps to transition to 
utilizing a different collection and/or submission type, the timeframe 
identified by most CMS Web Interface users (starting with the 2022 MIPS 
performance period) during the notice-and-comment rulemaking process 
for the CY 2021 PFS proposed rule, which is reflective of our policy to 
sunset the CMS Web Interface starting with the 2022 MIPS performance 
period, would not have provided an adequate or sufficient timeframe for 
CMS Web Interface users to fully transition to an alternative 
collection and/or submission type. In considering the concerns 
expressed by CMS Web Interface users such as the technological 
challenges that they would need to overcome, their inability to update 
systems and workflows in time for the 2022 MIPS performance period, and 
the fiscal implications they endure from mitigating and responding the 
COVID-19 PHE, we believe it is appropriate to reduce the burden of 
groups and virtual groups at this juncture and postpone the sunset of 
the CMS Web Interface by extending the availability of the CMS Web 
Interface as a collection and submission type for the 2022 MIPS 
performance period. We recognize that groups and virtual groups are on 
a continuum with regard to technological readiness for transitioning to 
a different collection type, but we believe that the availability of 
the CMS Web Interface for the 2022 MIPS performance period would reduce 
burden by providing additional time, and enable more groups and virtual 
groups to be able to successfully transition to another collection type 
by the start of the 2023 MIPS performance period. Moreover, we want to 
ensure that groups utilizing the CMS Web Interface are prepared to 
participate in MIPS as it evolves from traditional MIPS to MVPs, in 
which such groups could begin voluntary participation in an MVP as the 
availability of MVPs become an option starting with the 2023 MIPS 
performance period.
    We are proposing at Sec.  414.1325(c)(1) et seq. to sunset the CMS 
Web Interface measures as a collection type/submission type starting 
with the 2023 performance period. Specifically, at Sec.  414.1305, we 
are proposing 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 MIPS performance period/2024 
MIPS payment year. We are proposing 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 2022 MIPS 
performance periods/2019 through 2024 MIPS payment years, CMS Web 
Interface measures; the CAHPS for MIPS Survey; and administrative 
claims measures. We are proposing 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 2022 MIPS performance periods/2019 through 2024 MIPS payment 
years, the CMS Web Interface.
    For the 2022 MIPS performance period, the total number of CMS Web 
Interface measures required to complete reporting on would be 10 CMS 
Web

[[Page 39392]]

Interface measures (83 FR 59713 through 79715 and 59756). In Table 
Group B of Appendix 1 of this proposed rule, we are proposing 
modifications to the CMS Web Interface measures and in Table Group D of 
Appendix 1 of this proposed rule, we are proposing 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 2022 MIPS performance period given that the 
CMS Web Interface measures have remained the same for 3 consecutive 
(2019, 2020, and 2021) MIPS performance periods.
    We solicit public comment on our proposals: To extend the 
availability of the CMS Web Interface as a submission and collection 
type for the 2022 MIPS performance period, which would sunset and 
remove the collection and submission type under MIPS starting with the 
2023 performance period; and update the CMS Web Interface measures with 
substantive changes for the 2022 MIPS performance period as outlined in 
Table Group B of Appendix 1 of this proposed rule.
(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 this proposed rule, include 
the following: Addition of new measures; updates to specialty sets; 
removal of existing measures, and substantive changes to existing 
measures. For the 2022 MIPS performance period, we are proposing a 
measure set of 195 MIPS quality measures.
    The new MIPS quality measures proposed for inclusion in MIPS for 
the 2022 performance period and future years are found in Table Group A 
of Appendix 1 of this proposed rule. For the 2022 MIPS performance 
period, we are proposing 5 new MIPS quality measures, which includes 2 
administrative claims measures. Also, in Table Group AA of Appendix 1, 
we outline 1 potential new MIPS quality measure, the COVID-19 
Vaccination by Clinicians measure, which we intend to propose in a 
future rulemaking cycle. We refer readers to section IV.A.3.d.(1)(f) of 
this proposed rule for our request for information pertaining to the 
COVID-19 Vaccination by Clinicians measure specifications.
    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 are outlined in Table 
Group B of Appendix 1 of this proposed rule. Specialty sets may 
include: New measures, previously finalized measures with 
modifications, previously finalized measures with no modifications, the 
removal of certain previously finalized quality measures, or the 
addition of existing MIPS quality measures. Please note that the 
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.\203\ These recommendations were based on the MIPS 
quality measures finalized in the CY 2020 PFS final rule, the 2020 
Measures Under Consideration list, and provides recommendations to add 
or remove the current MIPS quality measures from existing specialty 
sets, or provides recommendations for the creation of new specialty 
sets. All specialty set recommendations submitted for consideration 
were assessed and vetted, and as a result, the recommendations that we 
agree with are being proposed in this proposed rule.
---------------------------------------------------------------------------

    \203\ Listserv messaging was distributed through the Quality 
Payment Program listserv on January 7, 2021, entitled: ``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.''
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    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 this proposed 
rule, we refer readers to Table Group C of Appendix 1 of this proposed 
rule for a list of quality measures and rationales for removal. For the 
2022 MIPS performance period, we are proposing 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 believe our proposal to remove 
the quality measures outlined in Table Group C will lead to a more 
parsimonious inventory of meaningful, robust measures in the program, 
and that our approach to remove measures should occur through an 
iterative process that will include 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 this proposed rule. We are 
proposing 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) would 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) would not be 
included in the rulemaking process.
    We are not proposing any changes to our current approach of 
identifying substantive measures changes during the rulemaking process. 
However, in order to more precisely distinguish between substantive 
measure changes and non-substantive measure changes, we are proposing 
to consider the following criteria for determining whether a measure 
change is substantive starting with 2022 MIPS 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;

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     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 note 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 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 (that is, 
release notes applicable to a measure). We believe 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 note 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 a 
benchmark or meet case minimum (class 2 measures), they would be scored 
in accordance to our proposed scoring policy as outlined in section 
IV.A.3.e.(1)(c)(iii)(B) of this proposed rule.
    In addition, we intend 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 2022 MIPS 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 seek public comment on our proposal to establish measure 
substantive change criteria that would be utilized by CMS to identify 
such measures.
(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 \204\ caused by COVID-19 at the time 
of publication of this 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.\205\ 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. 
The EUA allows the Pfizer-BioNTech, Moderna, and Janssen COVID-19 
vaccines to be distributed in the United States.\206\ As of July 7, 
2021, 331,651,464 vaccine doses have been administered.\207\
---------------------------------------------------------------------------

    \204\ https://covid.cdc.gov/covid-data-tracker/#cases_totalcases.
    \205\ https://www.scientificamerican.com/article/covid-19-is-now-the-third-leading-cause-of-death-in-the-u-s1/.
    \206\ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine.
    \207\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/.
---------------------------------------------------------------------------

    To address this urgent public health emergency, 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 (see Table Group AA of Appendix 1 of this proposed rule) 
allows 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 allows 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.\208\ 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

[[Page 39394]]

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

    \208\ https://www.qualityforum.org/map/.
---------------------------------------------------------------------------

    We seek 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 are seeking 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 this 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 this 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 2022 MIPS performance period 
that could be improved upon for the 2023 MIPS performance period? If 
this measure would be mandated, how would the collection of the measure 
data be useful after the 2023 MIPS performance period?
(g) Quality Data Submission Criteria
(i) CAHPS for MIPS Background
    As part of the CY 2021 PFS final rule (85 FR 84718), we finalized 
the 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 2021 MIPS performance period, 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 
previously established in the CY 2019 PFS final rule that MIPS quality 
benchmarks will be based on collection type, from all available 
sources, 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 2022 MIPS performance period 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 2022 MIPS 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 are proposing to adopt certain 
policies that had been part of the CAHPS for ACOs survey administration 
process, but have not previously been a part of CAHPS for MIPS. These 
policies fall into 3 broad categories: Sampling, case mix adjustment, 
and scoring; for policies related to certified survey vendors rendering 
the CAHPS for MIPS survey for subgroups, please see section IV.A.3.h. 
of this rule. We are requesting comment 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 the 2018 performance period, 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 2020 performance period 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 2020 performance period, 
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 propose beginning with the 2022 
MIPS performance period 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 expect that this change will better 
identify and exclude from the sample those patients likely to be 
institutionalized at the time the survey is fielded, and by extension, 
will improve response rates on the survey.
    Other CMS programs use different CAHPS surveys to gather 
information on patient experience in a variety of health

[[Page 39395]]

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 
2019 and 2020 performance periods 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 2020 performance period, 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 2019 performance period, no participating 
groups would have been excluded. Therefore, we propose beginning with 
the 2022 MIPS performance period for the CAHPS for MIPS survey to 
remove patients who were sampled for the Spring ICH CAHPS survey from 
the sampling frames for CAHPS for MIPS. We expect 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 avoid 
burdening patients with multiple surveys.
(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 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 2021 MIPS performance 
period, we propose beginning with the 2022 MIPS performance period 
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. 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 2019 performance period 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.
(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 2018 performance period (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 (2018 performance period), 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 2018, 2019, and 2020 performance 
period(s), compared to less than 20 percent in 2017 performance period. 
Therefore, because CMS no longer has analytic concerns about scoring 
the measure, we propose beginning with the 2022 MIPS performance period 
for the CAHPS for MIPS survey to 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.
    We request comments on these proposed changes to the CAHPS for MIPS 
policies and scoring process.
(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 this proposed rule, we are proposing to add 5 new episode-based 
measures to the cost performance category beginning with the 2022 
performance period, and to update the operational list of care episode 
and patient condition groups and codes. Additionally, we are proposing 
a new process for stakeholders to develop cost measures for MIPS. 
Finally, we are proposing to establish criteria for determining whether 
a cost measure change is considered substantive starting with the 2022 
MIPS performance period. 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 will 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

[[Page 39396]]

CMS on performance measures for use in federal health programs--more 
information is available at https://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 
(NQS)'s three aims of better care, healthy people/communities, and 
affordable care, as well as fill critical measure gaps and increase 
alignment among programs.
    We would 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 section IV.A.3.d.(2)(b)(ii) of this proposed rule, we have 
summarized the timeline for measure development, including stakeholder 
engagement activities undertaken by the measure development contractor, 
an entity that oversees the development, implementation and maintenance 
of cost measures in accordance with a contract with CMS. In sections 
IV.A.3.d.(2)(b)(iii) through IV.A.3.d.(2)(b)(vii) of this proposed 
rule, we summarize the new measures that would be included in the cost 
performance category for the 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'').
(ii) Overview of Measure Development Timeline for New Episode-Based 
Measures
    We develop episode-based measures to represent the cost to Medicare 
and beneficiaries for the items and services furnished during an 
episode. Episode-based measures are developed to compare clinicians on 
the basis of the cost of care that is clinically related to their 
treatment and management of a patient and provided during the episode's 
timeframe. Specifically, we define cost based on the allowed amounts on 
Medicare claims, which include both Medicare trust fund payments and 
any applicable beneficiary deductible and coinsurance amounts.
    The measure development contractor has continued to seek extensive 
stakeholder feedback during measure development, building on the 
processes outlined in the CY 2018 QPP final rule (82 FR 53644 through 
53645) and discussed in detail in the CY 2019 PFS final rule (83 FR 
59767 through 59769). These processes include the measure development 
contractor convening multiple panels for different purposes, conducting 
national field testing of the developed measures, and seeking input 
from clinicians and stakeholders through engagement activities. The 
technical expert panel (TEP) serves a high-level advisory role and 
provides guidance to the measure development contractor on the overall 
direction of development; clinical subcommittees provide the measure 
development contractor with recommendations on the measures to 
prioritize for development within specific clinical areas and on the 
scope for the measures; and measure-specific clinician expert 
workgroups provide the measure development contractor recommendations 
on clinical specifications for each measure. More information about the 
measure development process for the 5 measures we are proposing to 
include is available in the measure development process document 
located on the MACRA Feedback Page at https://www.cms.gov/files/document/macra-cmft-ebcm-process-2020.pdf. Summaries of the clinical 
subcommittee and clinician expert workgroup meetings organized by 
measure development contractor are also available on the MACRA Feedback 
Page under the ``Wave 3 MACRA cost measure development (2019-2020)'' 
section located at https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Give-Feedback.
    We provided stakeholders an opportunity to review their performance 
under the new episode-based measures through national field testing, 
from August 17, 2020, to September 18, 2020. Clinicians and clinician 
groups meeting a minimum threshold of episodes for each measure could 
review their field test report and an episode-level file with detailed 
information to understand the types of services that comprise a large 
or small share of their episode costs. In response to stakeholder input 
from previous field-testing periods, the field test reports were 
changed to a portable document format (PDF) and distributed through the 
Quality Payment Program portal, which clinicians routinely access to 
review their MIPS performance feedback reports. In addition, 
stakeholders could review a number of supporting documents, including 
draft measure specifications, an overview of the development process, a 
fact sheet and frequently asked questions (FAQ) document and summary 
statistics on each of the measures. These documents were available 
through the MACRA Feedback Page (https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Give-Feedback). A summary of 
stakeholder feedback from the field testing period is also available on 
the website (https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Give-Feedback).
    During field-testing, the measure development contractor also 
collected person and family engagement (PFE) input from patients with 
lived experience of the condition in question. The measure development 
contractor summarized input about their experience of care, including 
clinicians who were part of their care team, the types of services they 
received, and areas they identified for improvement in their care. For 
more information, we refer readers to the Summary of Person and Family 
Engagement (PFE) and Input for Wave 3 Episode-Based Cost Measure 
Development, which summarizes PFE input that the measure development 
contractor gathered for the measures (https://www.cms.gov/files/document/summary-person-and-family-engagement.pdf).
    Similar to previous years, the measure development contractor has 
continued

[[Page 39397]]

to engage clinicians and stakeholders, conducting extensive outreach 
activities. These activities included general informational email 
blasts, targeted email outreach to specialty societies, hosting office 
hours to gather information on additional opportunities for 
participation and outreach, and posting a pre-recorded MACRA Cost 
Measures Field Testing Webinar to provide information about the measure 
development process and field test reports (available at https://qpp.cms.gov/resources/webinars).
(iii) New Episode-Based Measures for CY 2022 and Future Performance 
Periods
    In this section of the proposed rule, we discuss the 5 new episode-
based measures, including 2 new chronic condition measures, which we 
propose to add for the CY2022 and future performance periods. These 
measures are listed in Table 41. 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)(vi) of this proposed 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 proposed 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 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 propose to define 
under Sec.  414.1305 in this proposed 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 proposed 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 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 five 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).
    We seek public comment on the proposed episode-based measures, 
which are listed in Table 41.

[[Page 39398]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.064

(iv) Attribution
    In this section of the proposed 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.  [thinsp]414.1350(b)(8) that 
beginning with the 2020 performance period, 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, we refer readers to the proposed 
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 
would 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). The first claim must have an 
evaluation and management (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. The 
trigger event opens a year-long attribution window from the date of the 
initial E/M primary care 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 may extend the initial 
attribution window and the clinician group's responsibility by another 
year each time we see additional E/M codes for primary care 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 can span multiple years and vary in length for 
different patients. Because the total attribution window can span 
multiple performance periods, we measure it 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 primary care services or 
condition-related HCPCS/CPT codes with a relevant chronic condition 
diagnosis. We employ two additional checks to confirm the qualifying 
clinician's role in the ongoing management of the patient's chronic 
condition. First, we check to ensure that the qualifying clinician(s) 
have rendered at least one E/M code for primary care 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 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 ensures 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 proposed 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 proposed attribution rules for chronic condition 
episode-based measures, we are providing 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 primary care 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

[[Page 39399]]

indicating the start of a clinician-patient relationship. This trigger 
event opens a one-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 primary care 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 would 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.
(v) Discussion of MAP Recommendations for New Episode-Based Measures
    In this section of the rule, we discuss the results of the 2020-
2021 MAP review cycle for the 5 measures we are proposing and address 
the points raised by the MAP. Following the measure development 
process, we describe in section IV.A.3.d.(2)(b)(ii) of this proposed 
rule, the MAP Clinician Workgroup and the MAP Coordinating Committee 
reviewed the 5 measures in January 2021. The MAP conditionally 
supported Melanoma Resection and Colon and Rectal Resection contingent 
on NQF endorsement. We intend to submit these 2 measures to a future 
NQF endorsement cycle, as we have done for other episode-based 
measures. The MAP recommended ``do not support with potential for 
mitigation'' for the Sepsis, Diabetes, and Asthma/COPD measures; we 
address these mitigation points in turn, below in this section.
    The mitigation factors across the 3 measures focused primarily on 
testing. Across the 3 measures, the MAP noted the following mitigation 
points: (1) Explore the correlations between the cost measure and 
quality measures; and (2) NQF endorsement. For the Asthma/COPD and 
Diabetes measures, the MAP noted the following points: (1) Explore the 
concern that good care may result in higher episode costs but with 
global cost savings; and (2) evaluate the connection between upstream 
interventions and downstream cost savings. For the Sepsis measure, the 
MAP's recommendation was contingent on an analysis into the potential 
for gaming associated with the over-diagnosis of sepsis. For all 3 
measures, the MAP noted that should testing data show that the measure 
appropriately assesses episode-based cost and can be used alongside 
quality measures, the measures would be valuable to add to the program. 
The MAP's final recommendations are available at https://www.qualityforum.org/Publications/2021/03/MAP_2020-2021_Considerations_for_Implementing_Measures_Final_Report_-_Clinicians,_Hospitals,_and_PAC-LTC.aspx.
    We appreciate the MAP's review and their comments regarding the 
measures. We believe that we have addressed the mitigating factors by 
sharing additional testing information and clarifying the measure 
construction and intent at the MAP Coordinating Committee meeting on 
January 25, 2021.
    The first mitigation factor common to the Asthma/COPD, Diabetes, 
and Sepsis episode-based measures is to explore the correlations with 
quality measures to address concerns about the potential for care 
stinting. We presented empirical testing results to the MAP 
Coordinating Committee on January 25, 2021. The MAP's concern about 
care stinting would be evidenced by a strong, inverse cost-quality 
correlation between cost and quality measures; that result would 
indicate that good performance on cost would be associated with poor 
performance on quality and that variation in cost is solely reflecting 
variation in quality. We do not see this relationship in any of the 
correlations. The correlation results instead indicate a modest and 
generally positive correlation between the 3 cost measures and related 
quality measures demonstrating that there is variation in cost, 
regardless of quality level. These results suggest that performance on 
these 3 episode-based measures can be improved without negatively 
impacting quality. More information on the results of this exploration 
of the relationship between cost and quality measures is available in 
the supplemental testing document at https://www.cms.gov/files/document/testing-updates-wave-3.pdf.
    The second mitigation factor common to the Asthma/COPD, Diabetes, 
and Sepsis episode-based measures is NQF endorsement. We intend to 
submit these measures to a future NQF endorsement cycle, as we have 
done with other cost measures. For example, the MAP in the 2018-2019 
review cycle had recommended ``do not support with potential for 
mitigation'' for the total per capita cost measure. This measure was 
endorsed by NQF in December 2020.
    For the Asthma/COPD and Diabetes measures, the MAP raised two 
points for further evaluation. The first point is to evaluate the 
relationship between condition-specific costs and global patient costs, 
as the MAP was concerned that there may be tension between these types 
of costs. We tested the correlation between the episode-based measures 
and NQF #3575 total per capita cost, a population-based cost measure 
that assesses the overall costs of care. The correlation results show a 
moderately positive correlation between Asthma/COPD and Diabetes and 
the total per capita cost measure, indicating that clinicians who have 
lower costs for the specific care of asthma/COPD and diabetes tend to 
also have lower overall global costs. These results suggest that there 
is no concern that high quality care results in higher episode-specific 
costs and lower overall costs. These results also show that there is no 
redundancy between the measures; for instance, a correlation of 1 would 
indicate duplication across the episode-based and population-based cost 
measures. The results of this correlation testing are available at 
https://www.cms.gov/files/document/testing-updates-wave-3.pdf.
    For the Asthma/COPD and Diabetes measures, the MAP's second point 
was to evaluate the potential for actionability, providing the example 
of the connection between upstream medical interventions and downstream 
costs. The MAP's recommendations note that this example was clarified 
as cost measures do not attempt to dictate clinician practice; that 
would be outside of their scope. Rather, the cost measures aim to 
fairly capture costs related to a clinician's care and account for 
factors outside of their influence. Regarding the overall 
actionability, we selected these measures to develop based on the 
evidence from the literature and input from clinical experts which 
identified the care and management of asthma, COPD, and diabetes as 
important in the goal of making care affordable, due to their 
prevalence and costliness, and the nature of the care as clinicians can 
make

[[Page 39400]]

care decisions that reduce the likelihood of high costs. For example, 
opportunities for clinicians to take action in the Asthma/COPD episode-
based measure identified through an environmental scan, clinician 
input, and input from persons with lived experience of the conditions 
include enhancing education programs, support, and care continuity; 
providing appropriate medication and encouraging adherence to these 
medications; promoting pulmonary rehabilitation through physical 
activity and exercise; and encouraging smoking cessation. For the 
Diabetes episode-based measure, actions to decrease the likelihood of 
high costs include providing self-management education and support, 
providing appropriate medication, screening for other impairments, and 
encouraging adherence to preventive treatment guidelines.
    The MAP noted a mitigation point for the Sepsis measure to explore 
a concern related to over-diagnosis of sepsis which could result in 
potential gaming of the measure. The variation in diagnosis coding has 
been considered extensively throughout development, including by the 
Sepsis clinician expert workgroup convened by the measure development 
contractor. The specifications reflect these careful considerations by 
defining a homogenous patient cohort while retaining the breadth of 
coverage needed to address coding issues. The measure uses a risk 
adjustment approach and exclusions to ensure fair comparisons, for 
example by adjusting for source of infection and source of admission 
(to account for patients transferred from another facility), and 
stratifying the patient population based on severity (with and without 
septic shock). As such, the measure construction itself is designed to 
capture costs accurately to compare clinician cost performance. We also 
tested the relationship between cost measure performance and types of 
variation in coding, such as the attributed clinician's share of 
episodes triggered by MS-DRGs 870-872 for sepsis and share of episodes 
out of all hospitalizations with 24 MS-DRGs for other infectious 
disease. The results of these correlations show no meaningful 
relationship between cost measure scores and coding patterns, 
addressing the concern about the impact of diagnosis coding on measure 
scores.
    We appreciate the MAP's comment that the Asthma/COPD, Diabetes, and 
Sepsis measures would be valuable to add to MIPS, should testing data 
show that the measures appropriate assess costs. We believe that the 
extensive empirical testing throughout and after development (beyond 
the testing referenced in this section), national field testing, and 
engagement with clinician experts and incorporation of the patient 
voice demonstrate that the measures appropriately capture costs related 
to the care of these conditions. For more testing information, see 
https://www.cms.gov/files/document/testing-updates-wave-3.pdf.
(vi) Proposed 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 requested 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 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 are proposing 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 section IV.A.3.d.(2)(b)(ii) of this rule. 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 
are proposing for the cost performance category in section 
IV.A.3.d.(2)(b)(iii) of this rule. We request comments on our proposal 
to revise the operational list to include these 5 new care episode and 
patient condition groups.
(vii) Reliability and Case Minimum
    In this section of the rule, we discuss the case minima for the 5 
proposed cost

[[Page 39401]]

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.\209\ We appreciate the 
concerns commenters had raised that this may be too low and as we noted 
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.210 211 212 213 214 215 216 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.\217\ As such, we believe that the 
0.4 threshold for mean reliability continues to be appropriate for 
moderate reliability.
---------------------------------------------------------------------------

    \209\ Mathematica, Inc., ``Memorandum: Reporting Period and 
Reliability of AHRQ, CMS 30-Day and HAC Quality Measures--Revised,'' 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/hospital-value-based-purchasing/Downloads/HVBP_Measure_Reliability-.pdf.
    \210\ Portney, L.G. and Watkins, M.P. (2000) Foundations of 
clinical research: Applications to practice. 2nd Edition, Prentice 
Hall Health, Upper Saddle River.
    \211\ 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.
    \212\ 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.
    \213\ 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.
    \214\ 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.
    \215\ 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.
    \216\ 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).
    \217\ 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. 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.'' \218\ 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).
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    \218\ 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 42 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

[[Page 39402]]

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 42, 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 propose 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 propose 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.
[GRAPHIC] [TIFF OMITTED] TP23JY21.065

(c) Proposed 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)) with 5 more proposed to 
be added in 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

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about the Meaningful Measures Framework can be found at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page). 
Episode-based measures developed by stakeholders that meet the 
standards and criteria we propose below 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 propose 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 would comprise our proposed 
process of cost measure development by stakeholders.
(ii) Measure Prioritization Criteria
    As described in section IV.A.3.d.(2)(b)(ii) 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 propose 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 seek public comment 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.
(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 propose 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

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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 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)(iv) of this proposed 
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 propose 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 seek public comment 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.
(iv) Cost Measure Submission to the Measures Under Consideration (MUC) 
List and Development Support
    We propose 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 call for quality measures, we 
propose 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 propose 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 seek comments on this proposed approach, and challenges 
stakeholders may encounter in the development of cost measures.
(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 are proposing to establish several 
criteria for determining whether a cost measure change is substantive 
starting with the 2022 MIPS performance period. The criteria include, 
but are not limited to, the following:

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     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 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 seek 
public comment on our proposed criteria for determining whether a 
change to a cost measure is substantive.
(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 42 CFR 
414.1305 for the definition of improvement activities and attestation, 
Sec.  414.1320 for the performance period, Sec.  414.1325 for the data 
submission requirements, Sec.  414.1355 for the improvement activity 
performance category generally, Sec.  414.1360 for data submission 
criteria, and Sec.  414.1380(b)(3) for improvement activities 
performance category scoring.
    In this proposed rule, beginning with the CY 2022 performance 
period and future years, we propose: (1) To revise group reporting 
requirements for the 50 percent threshold to address subgroups; (2) to 
revise timeframe for improvement activities nominated during a public 
health emergency; (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 for the CY 2022 performance period and future 
years; (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 for CY 2022 performance period 
and future years.
(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 2020 
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 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 year.
    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 would 
result in providing comparative performance data that is valuable to 
patients and caregivers in evaluating 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 this proposed rule, we are proposing the details of subgroup 
reporting for MVPs. We refer readers to section IV.A.3.b. of this 
proposed rule for further details. In order to implement group 
requirements in relation to subgroup reporting, we need to modify our 
policy regarding group reporting for improvement activities. We 
continue to believe 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,

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care delivery, and outcomes. Similarly, we believe 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. Our policy codified at Sec.  414.1360 does not currently 
include a subgroup option. Therefore, we are proposing to revise Sec.  
414.1360(a)(2) to state that, 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.
    We receive many inquiries through the Quality Payment Program help 
desk requesting clarification on how to apply the 50 percent threshold 
to groups. Many commenters requested that their groups be allowed to 
account for the 50 percent threshold by specialty or as a subgroup as 
they have more in common when considering applicable improvement 
activities. 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]. We 
believe the ability to attest to improvement activities at the subgroup 
level responds to this stakeholder concern, as this proposal, if 
finalized, would allow eligible clinicians the ability to compose 
subgroups by specialty for reporting MVPs.
    For example, if a TIN that includes 100 clinicians and decides that 
they will be participating in MIPS as a group, at least 50 percent (in 
this example, at least 50 clinicians) would need to attest to the same 
improvement activity for a continuous 90 days within the current 
performance year. However, if among this group, there are 30 clinicians 
that represent the orthopedic specialty, they may decide to form a 
subgroup to report measures and activities, more closely linked to 
their improvement goals. We refer readers to section IV.A.3.b. of this 
proposed rule for requirements when forming a subgroup. If the 30 
clinicians that represent the orthopedic specialty register as a 
subgroup, at least 15 of these orthopedic clinicians would be required 
to complete an improvement activity for the required performance period 
at some point during the performance year to receive full credit for 
the subgroup. The 70 clinicians from the original group would need at 
least 50 percent (in this example, at least 35 clinicians) to complete 
a given improvement activity for this group to receive credit for the 
improvement activity.
    We request public comments on our proposal.
(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 numerous interviews with 
highly performing organizations of all sizes, 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 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 
information required 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 are not proposing any changes to 
this policy in this proposed rule. However, we refer readers to section 
IV.A.3.d.(3)(c)(i) of this proposed rule where we are proposing changes 
to the timeframe for nominating new improvement activities during a 
public health emergency.
(B) Proposed 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 the established criteria; rather, it was compiled via stakeholder 
input, an environmental scan, MIPS and APMs RFI comments, and 
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 that included establishing the 
required criteria. In the CY 2019 PFS final rule (83 FR 59778 through 
59779), we adopted 1 new criterion and removed a criterion from the 
improvement activities nomination criteria. We also clarified our 
considerations in selecting improvement activities. In this proposed 
rule, we are proposing: (1) Changes to the timeframe for improvement 
activities nomination during a public health emergency (PHE); (2) 2 new 
improvement activities criteria; (3) to increase the minimum 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 in section IV.A.3.d.(3)(c) of this proposed rule.
(aa) Proposed Changes to the Timeframe for Nominating New Improvement 
Activities During a Public Health Emergency
    In the CY 2021 PFS final rule (85 FR 84882 through 84883), we 
finalized an exception stating that during public health emergencies 
(PHE) stakeholders

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can nominate improvement activities outside of the established Annual 
Call for Activities timeframe. Instead of only accepting nominations 
and modifications submitted February 1st 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 aspects 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 would all 
still apply). We noted that we continue to believe 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 would need be finalized through rulemaking.
    In 2020, we used several interim final rules with comment period 
(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 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 are proposing to 
modify our policy such that these nominations should be submitted by 
January 5th, 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 request public comments on this proposal.
(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, we formalized the Annual Call for Activities process for Year 3 
and future years and added additional criteria; stakeholders should 
apply 1 or more of the below criteria when submitting nominations for 
improvement activities (82 FR 53660). In addition, in the CY 2019 PFS 
final rule (83 FR 59779) we finalized to add a ``public health 
emergency as determined by the Secretary'' and in the CY 2021 PFS final 
rule (85 FR 84883 through 84884) we finalized to add ``Include 
activities which can be linked to existing and related MIPS quality and 
cost measures, as applicable and feasible'' to the criteria 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;
     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 public health emergency as determined by the 
Secretary; or
     CMS is able to validate the activity.
(cc) Proposed 2 New Criteria
    In addition to the aforementioned considerations, when considering 
improvement activities for possible inclusion in MIPS, we propose 2 new 
criteria 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 standard clinical practices. Regarding the first proposed 
criterion, we believe that there should not be duplication in the 
Inventory as 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 with which an 
improvement activity may be reported would be 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 clinicians could attest to for the same activity. Regarding the 
second proposed criterion, we believe 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 clinicians learn and implement the activities.
    We request public comments on our proposals.
(dd) Proposed 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 nomination is not clear.
    Our current policy requires that stakeholders apply a minimum of 1 
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 Call for Activities, we 
have found that many of the nominations that we receive meet the 
minimum 1 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 upfront. 
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 are proposing to increase the number of 
criteria stakeholders are required to meet when submitting an activity 
proposal, from a minimum of 1 to 8 criteria, which includes the 2 
proposed criteria in section IV.A.3.d(3)(c)(i)(B)(cc) of this proposed 
rule should they be finalized.
    We believe that the following 8 criteria, 6 of which are on the 
current list and 2 of which are proposed (in

[[Page 39408]]

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 in areas designated as geographic Health 
Professional Shortage Areas (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.
    While we previously finalized the first 6 criteria in prior 
rulemakings, we did not specifically require all. 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.
    In crafting this proposal, we also considered whether any of the 
above proposed required criteria should be optional instead (see 
proposal in the next section (IV.A.3.d(3)(c)(i)(B))). Ultimately, we 
proposed the above criteria as required, because we believe these 
reflect the minimum standard for improvement activities in the 
Inventory and would help increase transparency in our decisions.
    We request public comments on our proposal. In addition, for future 
rulemaking, we also request comment on any other potential required 
criteria that should be considered for future adoption.
(ee) Proposed Optional Factors
    Additionally, we are proposing the remaining 6 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. Meeting 1 or more of the optional factors may 
increase a nomination's chances of being added to the Inventory. The 
proposed optional factors are:
    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 public health emergency 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 example, primary care, 
specialty care) (82 FR 53660).
    We request public comments on our proposal.
(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. We stated that we would fully examine each activity prior 
to removal and that commenters would have an opportunity to provide 
their input during notice-and-comment rulemaking.
(aa) Proposed Improvement Activity Suspension Policy
    A circumstance has come to our attention that requires we 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 1 of the improvement activities in the Inventory had 
expired on March 31, 2020. Therefore, 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). 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 year, this timing could affect an improvement activity that 
needs to be urgently addressed.
    As a result, beginning with the 2022 performance period, we are 
proposing that in the case of an improvement activity for which there 
is a reason to believe that the continued collection raises possible 
patient safety concerns or is obsolete, we would promptly suspend the 
improvement activity and immediately notify clinicians and the public 
through the usual communication channels, such as listservs and Web 
postings. We would then propose to remove or modify the improvement 
activity as appropriate in the next rulemaking cycle.
    We request public comments on our proposal.
(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 proposed rule, we are proposing 
to add 7 new improvement activities, modify 15 existing improvement 
activities, and remove 6 previously adopted improvement activities for 
the CY 2022 performance period and future years. We refer readers to 
the below and Appendix 2 of this proposed rule for more details.
(B) Proposed Changes to Adopted Improvement Activities
(aa) Proposed 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

[[Page 39409]]

tools'' beginning with the 2020 performance year and for subsequent 
years. This activity description reads as follows: 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 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 real-time benefit tool (RTBT) to 
be one source of information for 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) B 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 amended section 1848(q)(2)(B)(iii)(IV) of 
the Act by adding text noting that this subcategory shall include as an 
activity, for performance periods beginning on or after January 1, 
2022, use of a real-time benefit tool as described in section 1860D-
4(o) of the Act. In addition, the Secretary may establish this activity 
as a standalone or as a component of another activity.
    In accordance with this statutory requirement, in this proposed 
rule, we propose to modify this improvement activity such that 
beginning with the CY 2022 performance year and for subsequent years, 
the activity would require use of an RTBT. As previously finalized, use 
of an RTBT was optional. We refer readers to Appendix 2 of this 
proposed rule for additional details.
    We request public comments on our proposal.
(bb) Proposed Changes to the COVID-19 Clinical Data Reporting With or 
Without Clinical Trial (IA_ERP_3) Improvement Activity
    We refer readers to the March 31st IFC for COVID-19 (85 FR 19276 
through 19277) and September 2nd COVID-19 IFC (85 FR 54848 through 
54851) for a regulatory history of this improvement activity. In the 
September 2nd COVID-19 IFC (85 FR 54848 through 54851), 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 infection 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 
would reassess whether there remains a need for additional data sharing 
or if preventive measures and clinical treatments have advanced to the 
point where these type of data are not needed.
    In this proposed rule, we are proposing to extend the COVID-19 
Clinical Data Reporting with or without Clinical Trial improvement 
activity for CY 2022 performance period and future years due to 
continued COVID-19 infections we are experiencing nationwide and the 
need for further research. 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. Each year, 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 type of data are not needed. We believe it is important for 
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 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 type of data are not needed and would discontinue the 
activity through notice-and-comment rulemaking as needed. We also refer 
readers to Appendix 2 of this proposed rule for details on our 
proposals to add 7 new improvement activities, modify 15 previously 
adopted improvement activities, and remove 6 previously adopted 
improvement activities.
    We request public comments on our proposal.
(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 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 stated that we 
believe this would be an appropriate performance period because it 
would offer stability and consistency for MIPS eligible clinicians 
reporting for the Promoting Interoperability performance category. We 
are not proposing 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) Proposed 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

[[Page 39410]]

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/2023 MIPS payment year.
(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 concern 
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. Feedback received from 
health IT vendors and MIPS eligible clinicians expressed that 
flexibility in the measure presents unintended challenges such as 
significant burden associated with IT system design and additional 
development needed to accommodate the measure and any future changes to 
it.
    We understand that there is wide variation across the country in 
how health care providers are implementing and integrating PDMP queries 
into health IT and clinical workflows, and that it could be burdensome 
for health care providers if we were to narrow the measure to specify a 
single approach to PDMP-EHR integration at this time. At the same time, 
we have heard extensive feedback from EHR developers that effectively 
incorporating the ability to count the number of PDMP queries in the 
EHR would require more robust measurement specifications. These 
stakeholders stated that health IT developers may face significant cost 
burdens if they either fully develop numerator and denominator 
calculations for all the potential use cases and are required to change 
the specification at a later date. Stakeholders have noted that the 
cost of additional development will likely be passed on to health care 
providers without additional benefit as this development would be 
solely for the purpose of calculating the measure rather than 
furthering the clinical goal of the measure (for public comments 
discussed in last year's final rule, we refer readers to 85 FR 84887 
through 84888).
    In support of efforts to expand the use of PDMPs, there are 
currently a number of federally supported activities underway aimed at 
developing a more robust and standardized approach to EHR-PDMP 
integration. federal partners, including the CDC and ONC, and private 
sector stakeholders, are focused on developing and refining standard-
based approaches to enable effective integration into clinical 
workflows, exploring emerging technical solutions to enhance access and 
use of PDMP data, and providing technical resources to a variety of 
stakeholders to advance and scale the interoperability of health IT 
systems and PDMPs. Moreover, a number of enhancements to PDMPs are 
occurring across the country, including enhancements to RxCheck, which 
is a federally supported interstate exchange hub for PDMP data.\219\ 
The ONC Interoperability Standards Advisory describes monitoring of 
current and emerging standards related to PDMP and opioid use disorder 
(OUD) data capture and exchange that would allow a provider to request 
a patient's medication history from a state PMDP and for PDMP data to 
be exchanged between systems and states.\220\ We believe these 
standards and technical approaches are likely to rapidly reach maturity 
to support exchange across health care system stakeholders.
---------------------------------------------------------------------------

    \219\ https://www.pdmpassist.org/RxCheck.
    \220\ https://www.healthit.gov/isa/allows-a-provider-request-a-patients-medication-history-a-state-prescription-drug-monitoring.
---------------------------------------------------------------------------

    The SUPPORT for Patients and Communities Act (Pub. L. 115-271), 
enacted in 2018, is an important investment in combating the opioid 
epidemic. Several of the provisions of the SUPPORT for Patients and 
Communities Act address opioid use disorder prevention, recovery, and 
treatment, including legislative changes specific to the Medicare and 
Medicaid programs intended to increase access to evidence-based 
treatment and follow-up care. Specifically, with respect to PDMPs, the 
SUPPORT for Patients and Communities Act included new requirements and 
federal funding for PDMP enhancement, integration, and 
interoperability, and established mandatory use of PDMPs by certain 
Medicaid providers to help reduce opioid misuse and overprescribing and 
to help promote the overall effective prevention and treatment of 
opioid use disorder beginning in October of 2021.
(C) Proposed 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 it 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, we are proposing to maintain the Electronic Prescribing 
Objective's Query of PDMP measure as optional and worth 10 bonus points 
for the CY 2022 performance period/2024 MIPS payment year. We seek 
comments on this proposal.
(D) Health IT Updates and Measure Direction
    Given recent progress in a variety of areas, we believe that there 
is now a clearer trajectory forward to potentially requiring the Query 
of PDMP measure. These developments include updated requirements for 
certified health IT, standards development activities around PDMPs, and 
other projects which can more tangibly inform future policy changes. 
For example, under final policies recently adopted in the CY 2021 PFS 
final rule (85 FR 84815 through 84828), participants in the Medicare 
Promoting Interoperability Program for eligible hospitals and critical 
access hospitals (CAHs) and the Promoting Interoperability performance 
category are scheduled to begin using certified EHR technology 
incorporating application programming interfaces (APIs) based on 
HL7[supreg] FHIR[supreg] standard version Release 4 in CY 2023 
consistent with updates to certified health IT which were finalized in 
the ``21st Century Cures Act: Interoperability, Information Blocking, 
and the ONC Health IT Certification Program'' final rule (hereinafter 
referred to as the ``ONC 21st Century Cures Act final rule''), 
published in the May 1, 2020 Federal Register (85 FR 25642 through 
25961,

[[Page 39411]]

25740).\221\ Updates to 2015 Edition health IT certification criteria 
in the ONC 21st Century Cures Act final rule also incorporated NCPDP 
SCRIPT standard version 2017071 for electronic prescribing. The 
availability of both standardized APIs and updated standards for e-
prescribing within certified health IT could serve as a stepping stone 
to future technical approaches that enable more seamless exchange of 
data between CEHRT and PDMP systems.
---------------------------------------------------------------------------

    \221\ HL7[supreg] and FHIR[supreg] are registered trademarks of 
Health Level Seven International.
---------------------------------------------------------------------------

    A number of recent efforts have sought to improve interoperability 
between EHRs and PDMPs. In 2020, ONC completed work to map the NCPDP 
SCRIPT standard version 2017071, the Prescription Monitoring 
Information eXchange (PMIX) standard version 2, and the 2015 American 
Society for Automation in Pharmacy (ASAP) Prescription Monitoring 
Program Web Service standard version 2.1A to the Health Level Seven 
International (HL7[supreg]) Fast Healthcare Interoperability Resources 
(FHIR[supreg]) standard version Release 4.
    ONC also began work in partnership with the CDC, the Department of 
Justice's Bureau of Justice Assistance, and the eHealth Exchange to 
develop a prototype to pilot an innovative technical solution for the 
delivery of patient medication histories across state lines via 
HL7[supreg] FHIR[supreg]. The eHealth Exchange is a network of networks 
that is active in all 50 states connecting federal and non-federal 
healthcare organizations to improve patient care and public health. To 
date, the prototype has been successfully tested in several states. 
Early prototype testing used synthetic data to evaluate system capacity 
to send and receive a patient's medication history request and 
response. The goal of the project is to allow any provider who is live 
on the eHealth Exchange to use that existing connection to query a 
patient's record on the RxCheck Hub, which routes the query to 
individual state PDMPs who are also live on RxCheck. This solution will 
enable health care providers to query PDMPs via existing connections to 
health information exchange (HIE) networks as a way to: (1) Leverage 
existing technology; (2) reduce burden associated with multiple, 
disparate system interfaces and workflows; and (3) allow for the 
exchange and full integration of data within allowable law from the 
point of exchange for medication reconciliation, allergy checks, and 
other forms of clinical decision support.
    Based upon these developments, which are advancing enhanced 
certified functionality, effective functional data exchange, and the 
use of open, mature standards, we believe there is a much better 
informed roadmap for achieving better integration between PDMPs and 
EHRs with enhanced interoperability of controlled prescription data 
across states and systems. We believe that as these activities develop, 
they can help to address some of the previous concerns raised by 
stakeholders around this measure, and we will continue to work with ONC 
to monitor these activities.
    While we believe the Query of PDMP measure is very important to 
avoid and address the over-prescribing of opioids, we also recognize 
that some states and systems may not be ready at this time to 
effectively exchange this data. In light of further work in this area 
and our stated goals for increasing the impact of this measure, we are 
seeking stakeholder comment on plans for requiring the Query of PDMP 
measure in the Promoting Interoperability performance category in the 
near future. To advance in this direction with both transparent 
proposals and informed guidance, we request public comment on the 
future direction for the measure, specifically:
     To what degree would all MIPS eligible clinicians be 
prepared to report on the current Query of PDMP measure (Yes/No 
response) in the near future? What additional considerations would need 
to be addressed before transitioning to a version of the measure that 
requires the submission of a numerator/denominator?
     Would changes to the Query of PDMP measure be necessary to 
accommodate other technical approaches that may be implemented in the 
future, such as exchange of information with a PDMP or with multiple 
PDMPs using HL7[supreg] FHIR[supreg]?
     What, if any, exclusions should be made available as part 
of the measure's specifications with regard to MIPS eligible 
clinicians?
     When will state PDMPs be ready to effectively exchange 
data with provider systems using HL7[supreg] FHIR[supreg] to support 
this measure? What are the most common standards and approaches used to 
access PDMP data through provider systems currently?
     What technical considerations exist for intrastate vs. 
interstate PDMP queries? How could health information exchange networks 
play a role in expanding access to PDMP data? In what ways could 
FHIR[supreg] applications be supported to safely share PDMP data within 
a clinician's workflow?
(ii) Proposed 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) Proposed 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 62999-63000 and 82 FR 53674). We 
are proposing 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 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

[[Page 39412]]

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 want 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 believe, 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 are seeking public comment on our proposal to modify the Provide 
Patients Electronic Access to Their Health Information measure, as well 
as the alternatives we have considered.
(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.
    The Promoting Interoperability performance category for eligible 
clinicians has been an important mechanism for encouraging health care 
data exchange. But in an attempt to reduce burden, we previously stated 
our intention to propose in future rulemaking to remove the Public 
Health and Clinical Data Exchange objective and measures no later than 
CY 2022 (83 FR 59816). Many commenters opposed this potential policy 
change and noted that interoperability of public health data is still 
evolving and incentivizes MIPS eligible clinicians to share data with 
public health agencies (83 FR 59816). In response to these comments, we 
stated that we will continue to monitor the data we compile specific to 
the public health reporting requirements and take the commenters' 
concerns into consideration related to future actions (83 FR 59816).
    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, and local 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) Proposed Modifications to the Reporting Requirements for the Public 
Health and Clinical Data Exchange Objective
    In this section, we are proposing 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. These two measures would 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 would enable automated case reporting for fast public 
health response; and local and national visibility on immunization 
uptake so PHAs can tailor vaccine distribution strategies.
(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.\222\ 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.
---------------------------------------------------------------------------

    \222\ Ten Great Public Health Achievements--United States, 2001-
2010 (cdc.gov).
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    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

[[Page 39413]]

children 0-6 years, 82 percent of adolescents, and 60 percent of 
adults.\223\ 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.
---------------------------------------------------------------------------

    \223\ https://www.cdc.gov/vaccines/programs/iis/annual-report-iisar/2019-data.html.
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    We are proposing 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 performance period in CY 2022 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 would provide an immediate 
benefit by increasing the COVID-19 vaccination records reported to 
these systems. Making the measure required would 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 would 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 would 
provide a better view of the vaccines administered and distributed at 
national, state and local levels. This is a function 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 would 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 would reduce the regulatory and 
administrative burden health care providers experience when exchanging 
information with immunization registries.
    We are not proposing 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.
(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.\224\ 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 would 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.
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    \224\ 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 and jurisdictions, 
streamlining reporting forms for EHR vendors and health care providers.
    As a result of the CDC effort to scale up eCR Now for COVID-19, all 
50 states, the District of Columbia, Puerto Rico and 12 large local 
jurisdictions have connected to the shared services platform and are 
currently receiving electronic case reports, with more than 8,800 
healthcare facilities on board and 8.6 million reports for COVID-19

[[Page 39414]]

received by PHAs as of June 28, 2021.\225\ 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.
---------------------------------------------------------------------------

    \225\ Healthcare Facilities in Production for COVID-19 
Electronic Case Reporting [verbar] CDC.
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    We believe the uneven adoption of electronic case reporting creates 
a public health vulnerability. We are proposing 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 would 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 would be feasible and beneficial for MIPS 
eligible clinicians. This change would encourage EHR vendors to make 
electronic case reporting available to their customers, which would 
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 45 CFR 
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.\226\ 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.
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    \226\ 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 
would not only provide certainty to EHR vendors and facilitate an 
organized and industry-wide rollout of electronic case reporting 
capabilities, but would also help health care providers reduce their 
public health reporting burden.
    We are not proposing 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.
(cc) Proposed Scoring of the Public Health and Clinical Data Exchange 
Objective
    We are proposing that beginning with the performance period in CY 
2022, a MIPS eligible clinician would 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 are proposing they would 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 are proposing 
that the MIPS eligible clinician would 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 an 
MIPS eligible clinician claims applicable exclusions for which they 
qualify for both required measures, we propose to redistribute the 
points associated with the objective to the Provider to Patient 
Exchange objective.
    We are proposing 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. 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 are proposing 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 would not yield 
additional bonus points.
    In connection with our proposal to make these measures optional, we 
are proposing 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 are seeking comment on these proposals.
(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.\227\ 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 to optimize the safety and safe use of EHRs in 
the three areas listed in Table 43. The SAFER Guides are intended to be 
utilized by EHR users, developers, patient safety organizations, and 
those who are concerned with optimizing the safe use of health IT. 
Completing a self-assessment using the SAFER Guides is one of the first 
steps MIPS eligible clinicians can take to support a ``culture of 
safety'' within their organization, 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.
---------------------------------------------------------------------------

    \227\ https://www.healthit.gov/topic/safety/safer-guides.
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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

[[Page 39415]]

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 would support consistent safety practices for all EHR 
users.
    The High Priority Practices SAFER Guide identifies ``high risk'' 
and ``high priority'' recommended safety practices, intended to 
optimize the safety and safe use of EHRs.\228\ 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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    \228\ https://www.healthit.gov/sites/default/files/safer/guides/safer_high_priority_practices.pdf.
[GRAPHIC] [TIFF OMITTED] TP23JY21.066

(ii) Proposed New SAFER Guides Measure
    We are proposing 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 are 
proposing 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 statement accounting for 
the complete self-assessment using the guide. We propose that this 
measure would be required, but it would not be scored, and that 
reporting ``yes'' or ``no'' would 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 are also proposing 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 would 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 follows the 
checklist section of the Guide. These worksheets also include likely 
sources of information the practice can turn to in order to complete 
their assessment of a recommended 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. We note that 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 of this proposed requirement is for MIPS eligible clinicians to 
regularly 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. However, 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 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 (for example, an HIE). 
Regarding the frequency of completing the self-assessment for the High 
Priority Practices Guide, we are proposing 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, if finalized). 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 as 
proposed 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 
review of 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

[[Page 39416]]

may be able to assist with completing a self-assessment.
    We are inviting public comment on these proposals.
(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 would be the SAFER 
Guides measure (as proposed in section IV.A.3.d.(4)(d) in this proposed 
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 44 lists the objectives and measures 
for the Promoting Interoperability performance category for the 
performance period in CY 2022 as revised to reflect the proposals made 
in this proposed rule. Table 45 lists the 2015 Edition certification 
criteria required to meet the objectives and measures.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TP23JY21.072

    Table 46 reflects the scoring methodology for the Promoting 
Interoperability performance category for the performance period in CY 
2022, if the proposed changes discussed earlier in this section are 
adopted as final, including the continuation of the optional Query of 
PDMP measure worth 10 bonus points for CY 2022, changes to the Provide 
Patients Electronic Access to Their Health Information Measure under 
the Provider to Patient Exchange objective, the adoption of a SAFER 
Guides measure, and modified requirements for the Public Health and 
Clinical Data Exchange objective.

[[Page 39423]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.073

BILLING CODE 4120-01-C
    We also refer readers to section IV.A.3.e. of this proposed rule, 
where we are proposing 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 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

[[Page 39424]]

federal law, as the Secretary sets forth through notice and comment 
rulemaking'' (section 3022(b)(2)(B) of the PHSA).
(ii) Proposed 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 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 
are proposing 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 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 are proposing 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, as discussed, we 
are proposing to no longer require attestation statements B and C 
beginning with the performance period in CY 2022, and we are proposing 
corresponding regulatory text amendments at Sec.  414.1375(b)(3)(ii) 
and (iii). We made a similar proposal for the Medicare Promoting 
Interoperability Program in the FY 2022 IPPS/LTCH PPS proposed rule (86 
FR 25639 through 25641).
    We invite public comment on our proposal.
(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 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 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

[[Page 39425]]

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, we are proposing a modification of our policy. Beginning 
with the CY 2022 performance period/CY 2024 MIPS payment year, we are 
proposing to no longer require an application for clinicians and small 
practices seeking to qualify for the small practice hardship exception 
and reweighting. We are proposing 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 this 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 are proposing that if 
data is submitted for a MIPS eligible clinician in a small practice, 
they would be scored on the Promoting Interoperability performance 
category like all other MIPS eligible clinicians, and the performance 
category would be given the weight prescribed by section 1848(q)(5)(E) 
of the Act. We are proposing the small practice significant hardship 
exception still would be subject to annual renewal, and we would verify 
whether a practice meets the definition of a small practice under Sec.  
414.1305 on an annual basis. We are proposing corresponding revisions 
to Sec.  414.1380(c)(2)(i)(C)(9).
    While we are proposing 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 would like to facilitate small practices successfully reporting data 
for the Promoting Interoperability performance category and are 
therefore seeking comment on potential options to increase small 
practice participation in the future. We are also seeking comment on 
why small practices that have not successfully reported for the 
Promoting Interoperability performance category not applied for the 
small practice hardship exception. Are practices choosing not to apply 
due to the requirement that they must have overwhelming barriers that 
prevent them from complying with the requirements for the Promoting 
Interoperability performance category? Is there confusion about what 
would be considered an overwhelming barrier? Are they aware that the 
small practice hardship exception is available? We are also interested 
in hearing about barriers that exist that prevent the adoption of CEHRT 
and/or the ability to submit Promoting Interoperability performance 
category measures. Are small practices wanting to adopt CEHRT but lack 
the resources?
    Have practices previously adopted CEHRT but face barriers in 
upgrading to the edition of certified health IT currently required to 
meet the CEHRT definition for the Quality Payment Program? 
Alternatively, have these practices consciously chosen not to adopt 
CEHRT because of impending retirement or other factors? Are there other 
policies that we could pursue to remove barriers to or incentivize 
participation in the Promoting Interoperability performance category by 
small practices?
    We are proposing that in the case of an APM Entity that also meets 
the definition of a small practice, we would 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) would be eligible for this exception, 
and therefore the Promoting Interoperability performance category would 
be reweighted for the APM Entity and the performance category 
reweighting described above would be applied.
    We are seeking comments on this proposal.
(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

[[Page 39426]]

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 although we do not yet have data from 
submissions for the CY 2020 performance period and do not expect it to 
be available prior to the release of this proposed rule.
    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 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 are 
requesting 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 the Promoting Interoperability performance 
category for NPs, PAs, CRNAs, and CNSs for the performance period in 
2022. Thus, we are proposing to continue the existing policy for the 
2022 performance period/2024 MIPS payment year and are proposing 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 request comments on this proposal.
(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 2020, we do not have data to rely on 
to modify our current policy and do not anticipate it being available 
prior to the release of this proposed rule. Therefore, we are proposing 
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 2022 performance period/
2024 MIPS payment year. We propose 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 request comments on this proposal.
(iv) Clinical Social Workers and Certified Nurse-Midwives
    In section IV.A.3.a. of this proposed rule, we are proposing to add 
clinical social workers and certified nurse-midwives 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. 
Certified nurse-midwives 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 are proposing 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 would 
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 are proposing 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 certified nurse-midwives 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 are not proposing to apply the same 
Promoting Interoperability reweighting policy we adopted previously for 
NPs, PAs, CNSs, CRNAs, and other types of MIPS eligible clinicians to 
certified nurse-midwives. However, we are requesting comment on whether 
there are in fact sufficient measures applicable and available to 
certified nurse-midwives under the Promoting Interoperability 
performance category, and whether barriers exist that prevent certified 
nurse-midwives from complying with the requirements of the Promoting 
Interoperability performance category and may warrant reweighting. Like 
other types of MIPS eligible clinicians, a certified nurse-midwife 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 request comments on this proposal.
(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 would 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 2021 
and 2022 MIPS

[[Page 39427]]

payment years. We are proposing 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 request comments on this 
proposal.
(j) Requests for Information
(i) Request for Information on Additional Objectives Adopting 
FHIR[supreg]-Based API Standards
    Fast Healthcare Interoperability Resources (FHIR[supreg]) (https://hl7.org/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 IT, it allows systems to communicate and 
information to be shared seamlessly with a lower burden on 
stakeholders. Through the HL7[supreg] FHIR[supreg] standard, cost and 
burden for health care providers and patients are reduced since it 
simplifies implementation without sacrificing information integrity, 
establishes fast, efficient, and flexible health data exchange as a 
stand-alone standard or combined with existing standards. Essentially, 
HL7[supreg]'s FHIR[supreg] standard framework provides an interoperable 
platform for a variety of health care data by defining a standard way 
to structure this information as `resources' and allows the developer-
friendly automated data-exchange to occur via APIs. The use of APIs 
utilizing the FHIR[supreg] standard has the potential to improve data 
exchange by providing consistent security, performance, scalability, 
and structure to all users. Given the progress of such emerging health 
IT innovation standards to promote interoperability at large, we see 
increased adoption of approaches utilizing the latest HL7[supreg] 
FHIR[supreg] standard as an opportunity to consider how these 
approaches can support other program goals.
    In the CY 2021 PFS final rule, we finalized alignment of the CEHRT 
definition for the Promoting Interoperability programs with updates to 
2015 Edition certification criteria as finalized in the ONC 21st 
Century Cures Act final rule. As part of the ONC 21st Century Cures Act 
final rule, ONC finalized a new certification criterion ``Standardized 
API for patient and population services'' at 45 CFR 170.315(g)(10) 
which supports the availability in certified health IT of an API using 
the FHIR[supreg] Release 4 standard and other implementation 
specifications. We noted that technology certified to this criterion 
will be used to support the API requirements in the Provide Patients 
Access to their Health Information objective. Regarding the bi-
directional HIE measure finalized for MIPS eligible clinicians in the 
CY 2021 PFS final rule (85 FR 84888 through 84893), we also noted that 
the standards-based API criterion at 45 CFR 170.315(g)(10) could be 
used to support connections to an HIE in order to complete the 
measure's actions.
    We are seeking comments on our intention to align additional 
Promoting Interoperability performance category objectives with 
approaches utilizing HL7[supreg] FHIR[supreg] standard Release 4-based 
API functionality (or the appropriately evolved standard), specifically 
targeting the Health Information Exchange as well as the Public Health 
and Clinical Data Exchange objectives. Throughout this ongoing 
developmental process, we are partnering with ONC and continuing to 
strengthen collaboration on the implementation of the 21st Century 
Cures Act final rule.
    We are interested in public comments on how these two program 
objectives could be furthered through the use of FHIR[supreg]-based API 
solutions. Specifically, we are interested in the following questions:
     To what degree are stakeholders currently using or 
interested in using APIs to exchange information in support of the 
numerator/denominator measures under the HIE objective? What revisions 
to the measures under the HIE objective should CMS explore to 
facilitate use of standards-based APIs in health IT modules certified 
under the 2015 Edition Cures Update?
     How could technical approaches utilizing the FHIR[supreg] 
standard enhance existing data flows required under the public health 
measures? What are promising FHIR[supreg]-based approaches to public 
health reporting use cases that ONC and CMS should explore for 
potential future consideration as part of the Promoting 
Interoperability performance category and the ONC Health IT 
Certification Program?
     To what degree are PHAs and individual states currently 
exploring API-based approaches to conducting public health registry 
reporting? What other factors do stakeholders see as critical factors 
to adopting FHIR[supreg]-based approaches?
     What potential policy and program changes in CMS and other 
HHS programs could reduce health care provider and health IT developer 
burden related to measures under the Health Information Exchange and 
the Public Health and Clinical Data Exchange objectives?
(ii) Request for Information on a Patient Access Outcomes Measures
    The evolution of EHRs has created a greater and more seamless flow 
of information within a digital health care infrastructure which allows 
for comprehensive records to be made available wherever and whenever 
they are needed in the clinical setting. These advances have led to: 
(1) Improved patient care; (2) increased patient participation; (3) 
improved care coordination; (4) greater practice efficiencies and cost 
savings; and (5) improved diagnostics and patient outcomes.\229\ Much 
research effort has been dedicated to looking at the implementation of 
health IT in practice settings with its wide array of potential 
benefits, but equally important to the success of this EHR-advancement 
is better understanding the patient's role as an active end-user as 
well.
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    \229\ https://www.healthit.gov/topic/health-it-basics/benefits-ehrs.
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    Several large, nationally representative surveys have been 
completed annually in order to collect and evaluate the public's access 
and use of health information. One of these endeavors operated by the 
National Cancer Institute (with support from ONC) is The Health 
Information National Trends Survey (HINTS) \230\ that produces a 
plethora of key utilization data specifically pertaining to consumers' 
access and use of their online medical records via patient portals. The 
HINTS results point to an overall year-over-year rise in the number of 
Americans who are not only accessing their medical records online (from 
51 percent in 2018 to 58 percent in 2019) \231\ but are increasingly 
doing so to perform meaningful actions such as to view lab test 
results, transmit their data to a third-party, and to securely message 
their health care provider. While sources like the HINTS survey are 
revealing preferential trends, habits, and other key utilization 
points, the data also show some strong barriers associated with 
patients accessing CEHRT and continue to stress the need for further 
work in understanding these users' access outcomes.
---------------------------------------------------------------------------

    \230\ https://hints.cancer.gov/.
    \231\ Patel, V. Johnson, C. (2020). The Current State of 
Patients' Access and Use of their Electronic Health Information 
[PowerPoint presentation]. The Office of the National Coordinator 
for Health Information Technology Annual Meeting.
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    We believe a strong partnership between EHR vendors, health care 
providers, and beneficiary users' outcomes is critical to improving the 
future of health care and furthering interoperability. Therefore, we 
are seeking comments surrounding changes

[[Page 39428]]

to the Promoting Interoperability performance category and related 
efforts which could better target patient access outcomes related to 
use of patient portals or third-party application(s). This request for 
information is an opportunity to garner general interest, solicit 
stakeholder feedback on how to best evaluate issues of patient 
behavior, and to explore additional key outcome variables to capture 
for measurement.
    Specifically, we are looking for feedback on the following 
questions:
     What do stakeholders believe would be useful ways to 
measure patients' access to their electronic health information using 
health IT methods such as patient portals and/or third-party 
applications? What actionable figures related to users' medical record 
behavior, including but not limited to, the frequency of logins, number 
of messages sent, or lab results viewed could be captured?
     How effectively is the Promoting Interoperability 
performance category currently measuring the use of health IT-enabled 
processes to improve patient outcomes? What measures in the current 
performance category are most relevant to patient outcomes?
     Should we consider requiring health care providers to 
maintain a record of third-party applications which patients have used 
to access their patient health information through APIs incorporated 
within certified technology so that this information could be used to 
assess patient usage of these applications?
     What are specific technologies, capabilities, or system 
features (beyond those currently addressed in the Promoting 
Interoperability performance category) that can increase patient 
utilization of tools to access their health information? How do these 
technologies and features support improved access or usability within 
EHR systems and other applications (for instance, alternate 
authentication technologies that can simplify consumer logon)? How 
could CMS reward health care providers for higher adoption rates and 
use of these available technologies?
     What are key administrative processes that could benefit 
from more efficient electronic workflows? How could CMS measure and 
reward participating MIPS eligible clinicians for either greater uptake 
of patient portal access or subsequent health outcomes?
(iii) Request for Information on Clinical Notes
    OpenNotes is an international movement aimed to spread and study 
the effects of transparent communication among patients, families, and 
clinicians.\232\ With more than 50 million patients in the U.S. and 
Canada having gained access to their clinical notes, the push for 
patient engagement and transparent communication continues to 
grow.\233\ Alongside this movement, ``Clinical notes'' have been 
regarded as highly desirable data necessary for the interoperable 
exchange of health information and patient access. Comprised of 
structured and unstructured data, clinical notes may include the 
assessment, diagnosis, plan of care and evaluation of plan, patient 
teaching, and other relevant data (85 FR 25674).
---------------------------------------------------------------------------

    \232\ https://www.opennotes.org/about/.
    \233\ https://www.opennotes.org/history/.
---------------------------------------------------------------------------

    While the ability to share clinical notes has been previously 
supported for certified health IT in different ways, ONC took 
additional steps to ensure this important patient information is 
available as part of the recent ONC 21st Century Cures Act final rule 
(85 FR 25674 through 25677). In the rule, ONC finalized eight types of 
``clinical notes'' required under the USCDI version 1: (1) Discharge 
Summary Note; (2) History & Physical; (3) Progress Note; (4) 
Consultation Note; (5) Imaging Narrative; (6) Laboratory Report 
Narrative; (7) Pathology Report Narrative; and (8) Procedure Note.\234\
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    \234\ Link to the Clinical Notes Argonaut Project https://www.healthit.gov/isa/uscdi-data/clinical-notes#uscdi-v1.
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    As previously discussed in the CY 2021 PFS final rule (85 FR 
84825), we finalized to align the CEHRT definition under the Promoting 
Interoperability performance category with the timelines established 
under the ONC 21st Century Cures Act final rule for implementation of 
the 2015 Edition Cures Update. This alignment includes updates to 
several certification criteria to refer to the USCDI and the expanded 
support for clinical notes specified in the USCDI version 1 standard. 
New and updated certification criteria incorporating the USCDI, include 
the ``view, download, and transmit'' criterion at 45 CFR 170.315(e)(1), 
and the ``Standardized API for patient and population services'' 
criterion at 45 CFR 170.315(g)(10). Once EHR developers and MIPS 
eligible clinicians have completed implementation of these updates, 
certified health IT required for participation in the Promoting 
Interoperability performance category will support availability of 
clinical notes as part of the data set made available to patients under 
the Provide Patients Access to their Health Information measure. 
According to the policy finalized in the CY 2021 PFS final rule, MIPS 
eligible clinicians may begin using updated technology as soon as it is 
available from their vendors (effective upon the effective date of the 
CY 2021 PFS final rule), with updated technology being required for 
performance periods beginning in CY 2023.
    Under this RFI, we are seeking stakeholder feedback on changes we 
can make that will better support the goals of the OpenNotes movement 
to ensure that clinical notes are widely available to patients. Given 
the implementation of updates to certified technology described above 
that support the Provide Patients Access to their Health Information 
measure, are there additional changes to this measure, or other program 
guidance, which could further facilitate ensuring clinical notes are 
available to patients consistent with the goals of the OpenNotes 
movement? We are also seeking feedback on the development of a required 
and independently scored measure for the Promoting Interoperability 
performance category to allocate points for the use of ``clinical 
note'' types supported by certified health IT. Finally, we are seeking 
comment on the types of clinical notes that are commonly sought, but 
not easily accessible to patients. We included a similar RFI under the 
Medicare Promoting Interoperability Program in the FY 2022 IPPS/LTCH 
proposed rule (86 FR 25654).
(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

[[Page 39429]]

whether APM Entities may be eligible for facility-based scoring. We 
would like to clarify that because facility-based measures are not 
submitted, but rather 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 note 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. For purposes of clarity, we propose 
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.
    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)(a) of this proposed rule where we 
propose 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.
d. 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 are updating many of our scoring policies, 
focusing on removing transition policies. Specifically, we are 
proposing 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 are not proposing changes to scoring policies for the 
improvement activities performance category.
    We have maintained our approach that MIPS eligible clinicians are 
scored against performance standards for each performance category and 
receive a final score, comprised of their performance category scores, 
and calculated according to the final score methodology. We refer 
readers to Sec.  414.1380 for policies on scoring.
(b) Terminology Updates
    We are proposing updates to Sec.  414.1380 in an effort to more 
clearly and concisely capture previously established policies. These 
proposed updates are not intended to be substantive in nature, but 
rather to bring more clarity to the regulatory text. We are proposing 
to change the term ``performance category percent score'' to 
``performance category score'' in Sec.  414.1380(b)(1)(vi)(C) and (E) 
related to improvement scoring, Sec.  414.1380(b)(1)(vii) related to 
scoring the quality performance category score, Sec.  
414.1380(b)(2)(iii) and (v) related to scoring the cost performance 
category, Sec.  414.1380(c) and (c)(2)(ii)(A) on calculating the final 
score and final score reweighting, and Sec.  414.1380(e)(6)(iv) and (v) 
related to facility-based scoring. Again, these changes are 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 are proposing to consolidate 
our language and use only the latter aforementioned term.
(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 propose to amend policies

[[Page 39430]]

finalized in prior years to simplify scoring in MIPS as we transition 
to MVPs.
(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 
would 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 would assess the measure on 9 
months of data, and if 9 consecutive months of data are not available, 
we would 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) 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 propose 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 propose 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,

[[Page 39431]]

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 invite public comments on our proposal to provide scoring 
flexibilities in response to account for errors included in the 
finalized measures.
(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 would 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 would 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 would 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 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 would 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 consider two benchmarking options for the CY 
2022 performance period/2024 MIPS payment year. We propose 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 would 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 are also considering and seeking 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 believe 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 remain 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 public 
health emergency. 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 
will 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 can 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, evaluate the suitability of the alternatives.
    Additionally, we propose to expand the definition of the baseline 
period. In instances in which a measure is suppressed 2 performance 
periods prior in the standard baseline period and cannot be used to 
calculate a benchmark, we propose to use the data from 3 performance 
periods prior to calculate benchmarks in the event that a performance 
period benchmark cannot be calculated. This would 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 would 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 believe it is important to continue using the most up-to-date

[[Page 39432]]

data to drive clinical quality improvement. We believe 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 invite public comments on our intent to use performance period 
benchmarks for the CY 2022 performance period and to expand the 
baseline period to 3 performance periods prior for measures that are 
suppressed two performance periods prior. Table 47 reflects a summary 
of the benchmarking hierarchy as a result of this proposal.
[GRAPHIC] [TIFF OMITTED] TP23JY21.074

(iii) Assigning Quality Measure Achievement Points
    We refer readers to Sec.  414.1380(b)(1)(i) for more details on our 
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) would 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 would 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 propose 
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. We are 
scoring from 1-10 for clinicians with a performance rate greater than 
0% for non-inverse measures or lesser than 100 percent for inverse 
measures in accordance with our original intent outlined in the CY 2017 
Quality Payment Program final rule (81 FR 77282). 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 proposing to 
remove 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 propose to revise Sec.  414.1380(b)(1)(i) to add 
beginning the 2022 performance period/2024 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 invite public comment 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.

[[Page 39433]]

(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 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 would not apply to measures 
submitted with the CMS Web Interface or administrative claims-based 
measures.
    We propose to modify how we score these measures within MIPS, as we 
consider policies for transitioning to MVPs. For class 2 measures, for 
the 2022 performance period/2024 MIPS payment year, we propose 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 will now receive zero points.
    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, it is imperative that we are able to 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 remain concerned that it may be harder to 
reach case minimums for smaller practices and as such are maintaining 
the three-point floor policy for small practices. We believe that 
measure selection that is better reflective of the care most commonly 
provided in a practice will 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 would 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 believe that clinician choice of measure allows us to 
move forward with this option. 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 
(section VII.F.18 of this proposed rule). We considered other 
approaches to address this issue such as a denominator reduction for 
class 2 measures; however, we remain 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 do 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 are proposing 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 will 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 will 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 will be considered class 4b and receive a 
score of 5. Measures that cannot be scored because they do not meet the 
data completeness requirement will remain subject to the class 3 
measure policy and receive a score of 0 for clinicians other than small 
practices, while small practices will continue to receive 3 points.
    We believe that a 5-point floor for new measures will allow us to 
introduce new, applicable measures into the program, by reducing the 
burden to clinicians in selecting them. We believe that this policy is 
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 believe that the possibility of 
earning 5 points for a measure that lacks a benchmark would 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 will 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

[[Page 39434]]

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 propose 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 0 measure achievement points for each such 
submitted measures and small practices receive 3 measure achievement 
points.
    We also propose to add the policy for new measures at Sec.  
414.1380(b)(1)(i)(C)(1) to provide that beginning with the CY 2022 
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 propose 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 invite 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 48 reflects a summary of our proposed policies.
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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 would 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 are proposing 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 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 are proposing to update our policy.
    We invite public comments on our proposal 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.
(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 
will 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 would 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 are intending to use performance 
period benchmarks again for the 2022 performance period/2024 MIPS 
payment year, these problems would occur again. We believe 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 believe that if a measure is not 
topped out in the 2022 performance period benchmark, then it should 
have the ability to achieve up to 10 measure achievement points.
    In this year's proposed rule, we are proposing to use performance 
period benchmarks again and subsequently need to the topped out measure 
lifecycle to account for this. Therefore, in the event that we finalize 
the use of performance period benchmarks for the CY 2022 performance 
period/2024 MIPS payment year, as an exception from the general rule at 
Sec.  414.1380(b)(1)(iv)(B), we propose at paragraph (b)(1)(iv)(B)(1) 
to provide that for the CY 2022 MIPS performance period/2024 MIPS 
payment year, MIPS eligible clinicians receive no more than 7 measure 
achievement points for each measure (except for measures in the CMS Web 
Interface) for which the applicable benchmark is 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 would 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 invite public comments on our proposal to apply the 7 measures 
achievement point cap to measures that meet the two criteria.
(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 
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 this proposed rule, we are proposing 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

[[Page 39436]]

of 11 patient-reported items to assess the broad scope of primary care. 
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 would 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 are proposing to modify our minimum case 
requirements policy that would broaden the type of measures (to not 
only include administrative claims-based measures) having an exception 
for meeting the minimum case requirement threshold of 20 cases and 
provide for 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 are proposing 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 seek public comment on our proposal to modify the minimum case 
requirement policy that expands the exception to meeting the minimum 
case requirement threshold of 20 cases to measures with measure-
specific case minimum requirements identified and determined by CMS.
    We request feedback on our proposal.
(vii) Incentives To Report High-Priority Measures
    We refer readers to 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, 
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 this proposed rule, we propose 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-priority measures by usage of bonus points in MIPS and 
MVPs as we increase the share of high-priority measures in the program.
    We propose to end measure points for reporting high priority 
measures beginning the 2022 performance period/2024 MIPS payment year. 
Accordingly, we propose 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 invite public comments on our proposal to end measure points for 
reporting high priority measures beginning the 2022 performance period/
2024 MIPS payment year.
(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 this proposed rule, we propose to end measure bonus points for 
end-to-end electronic reporting. 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

[[Page 39437]]

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 act to 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 believe that we can 
fulfill the statutory requirement at sections 1848(q)(5)(B)(ii)(I) of 
the Act to encourage the usage of certified electronic health record 
technology (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 intend 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. of this proposed 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 invited comments on other methods we can use to 
encourage the use of CEHRT for electronic reporting.
    Accordingly, we proposed to add the policy at Sec.  
414.1380(b)(1)(v)(B) to provide that for the 2017 through 2021 
performance period/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. 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 invite 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.
(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 
policy stating that for the 2020 through 2023 MIPS payment years, for 
the purpose of improvement scoring, 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 this proposed rule, we propose 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 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. 
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 invite public comments on our proposal to 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 
for the 2022 performance period/2024 MIPS payment year.
(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 
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 
propose a policy to provide scoring flexibility in instances where 
changes during a performance period impede the effective measurement of 
resource use. 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. An example of the type of external factor that could affect 
cost measurement is the PHE for COVID-19. We refer readers to section 
IV.A.3.e.(2)(b)(ii)(A) of this proposed rule, where we summarize our 
assessment of the impact of COVID-19 on the calculation of cost measure 
scores for the 2020 performance period. In this discussion, we conclude 
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

[[Page 39438]]

to calculate cost measures, we cannot reliably calculate scores for the 
cost measures that adequately capture and reflect clinician performance 
for 2020. This example demonstrates 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 will 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 
note 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 would not necessarily lead to misleading or 
inaccurate results as the measure would be appropriately capturing the 
costs of care for that condition and appropriately reflecting changes 
in clinician practice. 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 note 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 expect 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 expect 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 believe this would 
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 propose 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 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.
    We seek comments on this proposal.
(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 are proposing 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 are proposing 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 section 
IV.3.d.(4)(c)1. of this proposed rule, we are proposing that the Query 
of Prescription Drug Monitoring Program measure would be worth 10 bonus 
points, and in section IV.3.d.(4)(c)3 of this proposed rule, we are 
proposing 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. To reflect these policies, we are proposing a change to

[[Page 39439]]

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 invite public comments on our proposal to make these revisions.
(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 weights, reweighting the performance categories, 
and the complex patient bonus.
    As described in more detail in the following sections, we:
     Propose to continue doubling the complex patient bonus for 
the CY 2021 MIPS performance period/CY 2023 MIPS payment year, as was 
previously finalized with a cap of 10 bonus points for the CY 2020 MIPS 
performance period/CY 2022 MIPS payment year (85 FR 50311).
     Propose 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 MIPS 
performance period/CY 2024 MIPS payment year the complex patient bonus 
better target clinicians who treat a higher caseload of more complex 
and high-risk patients.
     Request comment 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 
MIPS performance period/CY 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.
     Propose to continue performance category weight 
redistribution policies finalized for the CY 2022 MIPS performance 
period/CY 2024 MIPS payment year.
     Propose policies for redistributing the weight of the 
performance categories for small practices.
     Clarify how our application-based and automatic extreme 
and uncontrollable circumstances policies intersect.
     Propose a new policy to determine the MIPS final score for 
clinicians and groups who are eligible for facility-based measurement.
(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 MIPS Performance Period/CY 
2023 MIPS Payment Year
    In this section of the proposed rule, we are proposing to modify 
the complex patient bonus for the CY 2021 MIPS performance period/CY 
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/CY 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 MIPS 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

[[Page 39440]]

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 (subject to the 10-point cap) is added to the 
final score.
    We believe we have made significant progress against COVID-19. As 
noted by the Centers for Disease Control and Prevention (CDC), the 
number of COVID-19 cases are predicted to decrease through the week of 
July 17th, 2021 in the United States and territories.\235\ As of June 
1, 2021, the number of daily new cases in the United States is at a 
similar level compared to the number of daily new cases during this 
time last year.\236\ While we are encouraged by these results, we 
believe that there may be some residual direct and indirect effects 
from the PHE that could affect the CY 2021 MIPS performance period/CY 
2023 MIPS payment year. In particular, for the first quarter, we had 
high COVID cases in multiple regions.\237\ Additionally, we cannot 
quantify the effect of beneficiaries who delayed care because of the 
PHE and are now seeking care.
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    \235\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/forecasts-cases.html.
    \236\ https://www.nytimes.com/interactive/2021/us/covid-cases.html.
    \237\ Ibid.
---------------------------------------------------------------------------

    Because of the concerns of the direct and indirect effects of the 
COVID-19 PHE, we propose 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 propose corresponding revisions to the regulation text at 
Sec.  414.1380(c)(3)(iv). The doubled numerical value (subject to the 
10-point cap) would 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 seek comment on 
this proposal and whether a different multiplier should be applied as 
we plan to consider the options based on public comment.
(iii) Complex Patient Bonus Beginning With the CY 2022 MIPS Performance 
Period/CY 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 MIPS performance period/CY 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. The HHS 
Assistant Secretary for Planning and Evaluation (ASPE) completed its 
first report in December 2016, which examined the effect of 
individuals' socioeconomic status on quality, resource use, and other 
measures under the Medicare program, and included analyses of the 
effects of Medicare's current value-based payment programs on 
clinicians serving socially at-risk beneficiaries and simulations of 
potential policy options to address these issues. ASPE's second report, 
Social Risk and Performance in Medicare's Value-Based Purchasing 
Programs, was -released in June 2020, which 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.\238\ 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. Further, the report 
suggested that we should not include the complex patient bonus within 
the final score that is publicly reported to ensure that patients can 
see the true clinician performance. Based on the ASPE report's 
suggestion, in the future we expect to also publicly report the final 
score without the complex patient bonus included. 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.
---------------------------------------------------------------------------

    \238\ 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.
---------------------------------------------------------------------------

    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

[[Page 39441]]

APM entity or virtual group, respectively, x 5].
    For this proposed rule, we continue to explore 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. The Johnston KJ, Hockenberry JM et al. 
article \239\ found that the current complex patient bonus formula 
appears unlikely to mitigate the most regressive effects of MIPS. The 
article stated this is particularly concerning for future years in MIPS 
as the performance threshold increases over time. Additionally, the 
Johnston KJ, Wiemken TL et al. article \240\ indicated that lower 
composite MIPS scores in the higher-risk quintile reflected lower 
scores in each of the performance categories rather than one specific 
performance category. Essentially, both articles concluded that in the 
first year of the Medicare MIPS program, clinicians with the highest 
proportion of patients dually eligible for Medicare and Medicaid had 
significantly lower MIPS scores compared with clinicians with the 
lowest proportion of dually eligible patients. Two other research 
studies we considered are related to how risk scores, specifically 
related to HCCs, differ between both rural and urban areas. The Tyler 
Malone, Denise Kirk et al. study \241\ 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. The study also 
emphasized the differences in average CMS-HCC risk scores may be driven 
partially by differences in the intensity of types of health care 
interventions received by rural versus urban beneficiaries. However, 
further research is needed to account for differences in coding 
patterns and/or resource limitations between urban versus rural 
counties. The second study \242\ found CMS-HCC risk scores provide 
utility in predicting which patients are expected to be more costly. 
However, the results also suggested there are systematic differences in 
the risk adjustment model's predictive capabilities in rural versus 
urban populations, as rural beneficiaries in the Tyler Malone, Denise 
Kirk et al. study generally had greater health care utilization even 
after controlling for risk scores. In conclusion, both studies 
suggested Medicare provider payment models using CMS-HCC risks scores 
may underestimate the costs associated with treatment of rural 
beneficiaries.
---------------------------------------------------------------------------

    \239\ 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.
    \240\ 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.
    \241\ 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.
    \242\ UNC Rural Health Research Program, ``Association of 
CMS[hyphen]HCC Risk Scores with Health Care Utilization Among Rural 
and Urban Medicare Beneficiaries'', December 2020.
---------------------------------------------------------------------------

    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 describe the findings below. We also note that the 
analyses reported in the Johnston KJ, Wiemken TL et al. studies include 
all MIPS eligible clinicians irrespective of whether they submitted 
data, while our data analyses with 2018 actual scored MIPS data were 
restricted to MIPS clinicians who submitted data. We restricted our 
analyses to MIPS eligible clinicians who submit MIPS data because under 
current policy as established at Sec.  414.1380(c)(3), the MIPS 
eligible clinician must engage in, that is submit data for, at least 
one MIPS performance category for the applicable performance period for 
the MIPS payment year to receive the complex patient bonus. Our 
analysis of 2018 actual MIPS data was further limited to MIPS eligible 
clinicians scored as individuals or groups because the HCC and dual 
proportion individual data elements were not available for virtual 
groups and APM Entities at the time of our analysis.
    For our updated analysis, we used actual 2018 MIPS scored data to 
evaluate whether the complex patient bonus sufficiently supports MIPS 
eligible clinicians scored as a group or individual who submit data and 
treat high risk and medically complex patients. We grouped the MIPS 
eligible clinicians into quintiles based on the complex patient bonus 
points they would receive. Quintiles were created by first ranking the 
actual complex patient bonus scores from lowest to highest for MIPS 
eligible clinicians who submitted data and were scored as an individual 
or group. All clinicians who received the same group score had the same 
complex patient bonus scores. Then, five groupings were created, each 
containing 20 percent of the MIPS eligible clinicians in our analysis. 
We found that MIPS final scores, prior to assigning the complex patient 
bonus points, were substantially lower for clinicians in the top two 
quintiles for the complex patient bonus compared to clinicians in the 
lower quintiles for the complex patient bonus when we refined the 
analysis by examining the HCC and dual proportion quintiles separately, 
we observed a similar pattern.
    Currently, the complex patient bonus is awarded to all engaged 
clinicians, meaning those who have submitted data for at least one MIPS 
performance category or are facility-based, even clinicians serving 
beneficiaries with below-average dual proportion or HCC scores. Given 
our updated analysis showed that the MIPS performance of clinicians in 
the top two quintiles for each risk indicator, HCC and dual proportion, 
is substantially affected by the complexity of their patients among 
clinicians who submitted data and were scored as individuals and 
groups, we compared the respective contributions of the two risk 
indicators to the total points assigned. We found that approximately 55 
percent of the points assigned are for the HCC risk indicator component 
and 45 percent for the dual proportion risk indicator component. 
However, we also observed that the additional points attributable to a 
one standard deviation increase in dual proportion were greater than 
those attributable to a similar increase in the HCC score.
    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

[[Page 39442]]

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 49 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] TP23JY21.076

    Furthermore, we found that, while the two risk indictors, dual 
proportion and HCC risk score, are 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 current complex 
patient bonus formula gives 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) Proposed Updates to the Complex Patient Bonus Beginning With the CY 
2022 MIPS Performance Period/CY 2024 MIPS Payment Year
    Based on the ASPE report and our analyses, we are proposing 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 include five separate proposals to 
update our complex patient bonus for the CY 2022 MIPS performance 
period/CY 2024 MIPS payment years and future MIPS performance periods/
MIPS payment years. We note that in section IV.A.3.e.(2)(a)(iii)(B) of 
this proposed 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 propose 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 propose at Sec.  414.1380(c)(3)(v) that 
beginning with the CY 2022 MIPS performance period/CY 2024 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. Third, 
we propose 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 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. Fourth, we propose 
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 propose 
at Sec.  414.1380(c)(3)(viii) that beginning with the CY 2022 MIPS 
performance period/CY 2024 MIPS payment years,

[[Page 39443]]

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 MIPS 
performance period/CY 2024 MIPS payment years, we are proposing 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 
proposed 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 MIPS performance period/CY 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.
(bb) Cutoff at the Median for Complex Patient Bonus Beginning With the 
CY 2022 MIPS Performance Period/CY 2024 MIPS Payment Year
    Beginning with the CY 2018 MIPS performance period/CY 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 are proposing at 
Sec.  414.1380(c)(3)(v), beginning with the CY 2022 MIPS performance 
period/CY 2024 MIPS payment, 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. 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 propose 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)(cc) of this 
proposed rule, would 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 propose 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 means those who have 
submitted data for at least one MIPS performance category or are 
facility-based. We would also use this same final score distribution to 
determine the standardized score discussed in section 
IV.A.3.e.(2)(a)(iii)(B)(cc) of this proposed rule. 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. For example, the 
median 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 MIPS performance period/CY 2024 MIPS 
payment year complex patient bonus. 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 would 
receive complex patient bonus points. Based on this proposed rule's 
regulatory impact analysis (see section VII.F.17 of this proposed 
rule), we estimate 64 percent of clinicians would 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 would 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 would be targeting the complex patient bonus points 
to clinicians treating a higher caseload of highly complex patients.
    Additionally, the complex patient bonus points would be more 
impactful as the difference in awarded bonus points between those with 
high caseloads of complex patients and those with low caseloads, would 
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 would result in about 50 percent of clinicians no longer 
receiving any complex patient bonus points because outliers could 
increase the mean.
    We acknowledge that alternate approaches could be used to target 
the bonus at clinicians with higher caseloads of complex patients. For 
example, we could consider 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/CY 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 could also consider 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 
request comments on alternate approaches for calculating the complex 
patient bonus.

[[Page 39444]]

(cc) Revised Complex Patient Bonus Formulas Beginning With the CY 2022 
MIPS Performance Period/CY 2024 MIPS Payment Year
    Under the third proposal, we propose 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, 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. For example, we would 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 MIPS performance period/CY 2024 MIPS 
payment year.
    Under the fourth proposal, we also propose 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, 
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.
    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 would 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 note that those with a 
mean score would 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 would have a negative standardized score. The 
proposed formulas would 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)(cc) of the proposed rule, at Sec.  
414.1380(c)(3)(vi) and (vii), the new bonus components would 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, would 
receive bonus points for each component that is equivalent to the 
constant, additive factor within the new formula, 1.5. The proposed 
formulas acknowledge 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 would 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 intend to incorporate a 
standardized score multiplied by 4 to ensure the score gets 
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, would 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, would receive at 
least 1.5 complex patient bonus points. Further, the additive factor of 
1.5 would 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 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 would 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 would 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 would 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 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 MIPS performance period/CY 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

[[Page 39445]]

indicator at or above the risk indicator calculated median.
(dd) Cap for the Complex Patient Bonus Beginning With the CY 2022 MIPS 
Performance Period/CY 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), 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, have proposed the cap of 10 bonus 
points. 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.
    As discussed in section IV.A.3.e.(2)(a)(iii)(B)(cc) of this 
proposed rule, we are proposing 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 request feedback on this alternate approach and 
additional alternate approaches we should consider.
    Under the fifth proposal, we are proposing 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 would then be capped at the 10 points overall. 
The benefit would be targeted toward those clinicians treating 
medically and socially complex patients.
    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 seek 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.
    In summary, we propose the five separate proposals for the CY 2022 
MIPS performance period/CY 2024 MIPS payment year and future MIPS 
performance periods/MIPS payment years as follows:
     To revise 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 propose 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.
     At Sec.  414.1380(c)(3)(vi), beginning with the CY 2022 
MIPS performance period/CY 2024 MIPS payment year, we 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 pursuant to 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

[[Page 39446]]

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 propose 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 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 propose the 
complex patient bonus cannot exceed 10.0 and cannot be below 0.0.
    We seek comments on these proposals including the different aspects 
of the updated complex patient bonus formulas, such as the additive and 
multiplicative components, the cutoff point (the median), and the 10-
point overall cap. For all of the reasons described above in sections 
IV.A.3.e.(2)(a)(iii), IV.A.3.e.(2)(a)(iii)(A) and (B), and 
IV.A.3.e.(2)(a)(iii)(B)(aa) through (dd) of this rule, we have proposed 
such policies. However, we did also consider 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 also seek 
comment on that alternative.
(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 50 summarizes 
the weights established in prior rulemaking (85 FR 84913) for each 
performance category for the CY 2022 MIPS performance period/CY 2024 
MIPS payment year and each subsequent MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TP23JY21.077

(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

[[Page 39447]]

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 this section of the proposed rule, we are requesting 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 weight to the cost performance category and redistribute its 
prescribed weight to another performance category or categories. 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. 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 this proposed rule, as it 
applies to the performance category as a whole and not on a measure-by-
measure basis.
    In the CY 2021 PFS final rule (85 FR 84880), we responded to 
commenters' concerns regarding the potential for COVID-19 to impact 
cost measures, noting various features of the cost measures could allow 
us to calculate cost measures without penalizing practices in COVID-19 
hotspots, and policies were in place to account for circumstances when 
a cost measure cannot be reliably calculated to adequately capture and 
reflect clinician performance. First, we noted service assignment 
allows the episode-based measures to capture the cost of services 
clinically related to the triggering event for the episode, reducing 
the likelihood of the measures to capture costs resulting from high 
volumes of COVID-19 treatment services. Then, we noted the measures are 
adjusted for clinical risk to account for different levels of care 
beneficiaries may require due to comorbidities, disability, age, and 
other risk factors (including clinical characteristics based on the 
beneficiary's recent medical history) to ensure attributed clinicians 
are not penalized for factors beyond their influence. Finally, we noted 
the cost measures use standardized claims to account for differences in 
Medicare payments for the same services across health care providers, 
removing the effect of regional differences in health care costs and 
the payment standardization process removes the 20 percent increase in 
the IPPS relative weight under the CARES Act for individuals diagnosed 
with COVID-19.
    After the publication of the CY 2021 PFS final rule, we continued 
to monitor the cost measures to determine whether we could reliably 
calculate the cost measures for the 2020 performance period. Due to the 
claims run-out period, there is an inherent delay between the time at 
which we can observe trends in claims and when we can test for 
potential impact on cost measures, to ensure that the data included in 
our analyses reflect final claims for all services in episodes. In 
addition, a drop-in service utilization early in 2020 would only affect 
the amount of information available to risk adjust for patient clinical 
factors for episodes beginning in the second half of the year as the 
episode-based measures use a 120-day look back period during which we 
look for HCC indicators. When considering these factors, along with the 
length of the episode windows for the measures and the need to include 
as many episodes in our study as possible, we had to complete our 
monitoring and assessment after the end of the CY 2020 MIPS performance 
period.
    Based on our analyses using the full year of data from 2020, we 
considered many factors and concluded we cannot reliably calculate 
scores for the cost measures that adequately capture and reflect 
clinician performance due to the unique changes to healthcare in the 
COVID-19 pandemic. Our analyses showed substantial decreases in service 
utilization in 2020 compared to 2019 across all care settings. This can 
affect risk adjustment and the ability to adequately reflect clinician 
performance on cost measures. Since we look for diagnosis information 
in a beneficiary's claims history during a lookback period before the 
start of the episode to capture HCC indicators and other clinical risk 
factors used in risk adjustment, a decrease in service utilization 
means that there are fewer claims from which we can identify risk 
adjustors. There was a systematic decrease in the ratio of the number 
of HCCs identified for risk adjustment in 2020 compared to 2019 in the 
second half of the year across all the measures. We note this finding 
coincides with when we observed the steepest drops in service 
utilization due to the length of the lookback period. There was also a 
systematic decrease in the ratio of the number of episodes in 2020 
compared to 2019. This indicates the overall decrease in service 
utilization is indeed reflected in fewer episodes being triggered and 
demonstrates the wide-ranging impact of COVID-19 across the range of 
care that the cost measures capture. Separately from the decrease in 
service utilization, our analyses demonstrate that episodes with COVID-
19 diagnoses generally have higher observed, payment-standardized costs 
than episodes without COVID-19 diagnoses. These differences are also 
present when comparing risk-adjusted costs for episodes with and 
without COVID-19 diagnoses. This shows despite service assignment rules 
for episode-based measures, beneficiaries diagnosed with COVID-19 had 
higher payment-standardized costs of care which was not sufficiently 
accounted for through risk adjustment or other features of cost 
measures.
    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 MIPS performance period/CY 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 note as 
with all measures, we continue to monitor the evolving impact of COVID-
19.
    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 discussed

[[Page 39448]]

in the FY 2022 IPPS/LTCH PPS proposed rule (86 FR 25473), 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 request comment 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 request comment 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).
(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 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 MIPS performance 
period/CY 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 would be 
beneficial to establish the redistribution policies for the CY 2023 
MIPS performance period/CY 2025 MIPS payment year and future years to 
provide as much notice as possible to clinicians and other 
stakeholders. Hence, we propose to apply the redistribution 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, and we propose 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. Our proposed redistribution 
policies for the 2025 MIPS payment year and each subsequent MIPS 
payment year are included in Table 51. We note that not all the 
redistribution scenarios described in Table 51 would apply to MIPS 
eligible clinicians in small practices, so we also propose at Sec.  
414.1380(c)(2)(ii)(F) an exception for a new paragraph (G) which 
applies to small practices. Please refer to Table 52 for the proposed 
redistribution policy for small practices.
    We request public comment on this proposal.
    [GRAPHIC] [TIFF OMITTED] TP23JY21.078
    
(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

[[Page 39449]]

Promoting Interoperability performance category.
    In this section of the proposed rule, we discuss how we would 
redistribute the Promoting Interoperability performance category weight 
for small practices. Within the reweighting policy for the CY 2022 MIPS 
performance period/CY 2024 MIPS payment year, the Promoting 
Interoperability performance category weight is redistributed fully to 
the quality performance category, unless the 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 
\243\ 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 propose 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.
---------------------------------------------------------------------------

    \243\ 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.
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    We anticipate that our proposal noted in the two rows in Table 52 
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 MIPS performance period/CY 2024 MIPS payment year, we propose at 
Sec.  [thinsp]414.1380(c)(2)(ii)(G) redistribution policies for small 
practices, as shown in Table 52.
    We request public comment on this proposal.
    [GRAPHIC] [TIFF OMITTED] TP23JY21.079
    

[[Page 39450]]


(iv) MIPS Reweighting Based on Extreme and Uncontrollable Circumstances
(A) MIPS Applications for Reweighting for the CY 2021 MIPS Performance 
Period/CY 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/CY 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 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 would 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 MIPS 
performance period/CY 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

[[Page 39451]]

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 2019 
MIPS 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 2019 MIPS 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 would 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 53 shows 
these two scenarios.
[GRAPHIC] [TIFF OMITTED] TP23JY21.080

    In the CY 2020 PFS final rule, we established a redistribution 
policy for the CY 2020 MIPS performance period/CY 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 54 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] TP23JY21.081

    We established similar redistribution policies for CY 2021 MIPS 
performance period/CY 2023 MIPS payment year and CY 2022 MIPS 
performance period/CY 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 proposed 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

[[Page 39452]]

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 propose a new policy to 
determine the MIPS final score for clinicians and groups who are 
eligible for facility-based measurement. We propose at Sec.  
414.1380(e)(6)(vi)(B) 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. Under this proposed policy, we 
would calculate two final scores for clinicians and groups who are 
facility-based. One score would 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 would be based on the 
application of facility-based measurement. The example below shows how 
this proposed policy would 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] TP23JY21.082

    As a result of this proposed policy, the group in this example 
would 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 request comments on this proposal.
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 this proposed rule, we are proposing: (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 
expected timeframe 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

[[Page 39453]]

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 56.
[GRAPHIC] [TIFF OMITTED] TP23JY21.083

    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 three years. Thus, we 
considered whether to use the mean or median as the methodology for 
determining the performance threshold. We would use this methodology to 
determine a performance threshold for each of the following three 
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 would 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 publication of this proposed rule, we have final score 
data from the 2017 MIPS performance period/2019 MIPS payment year 
through the 2019 MIPS performance period/2021 MIPS payment year to use 
in our assessment of whether to use the mean or median as our 
methodology for the next 3 years.
    From our review of the available data, we have identified the mean 
and median final scores for each of the 2019 through 2021 MIPS payment 
years, as shown in Table 57. These six values represent all available 
prior year mean and median final scores that could be utilized for the 
2024 MIPS payment year performance threshold.
[GRAPHIC] [TIFF OMITTED] TP23JY21.084

    As shown in Table 57, 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 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 57, 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

[[Page 39454]]

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 are proposing 
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 would use the final scores for all MIPS eligible 
clinicians to calculate the mean or median. As shown in Table 57, 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 57). This 
value would be an increase of almost exactly15 points from the MIPS 
payment year 2023 performance threshold of 60 points, which is 
identical to the increases of the previous three 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 are proposing 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 request comments on these proposals, as well as the alternative 
methodology of the median that we considered but did not propose. 
Additionally, we request comments on calculating the performance 
threshold using an alternative year's final scores that we considered 
but did not propose.
(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] TP23JY21.085

    For illustrative purposes, the possible additional performance 
thresholds are shown in Table 58. Note that mean or median refers to 
the methodology for calculation of the performance threshold. As can be 
seen in Table 58, 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 have 
proposed to use the mean as our methodology for setting the performance 
threshold during the next 3 years and we have proposed to use the final 
score data from MIPS payment year 2019. 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 58 for where we 
can set the additional performance threshold.
    As stated above, with a proposed 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),

[[Page 39455]]

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 would 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 likely 
would 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 would be 
a gradual increase. Therefore, using the second calculation method 
described above, we are proposing at Sec.  414.1405(d)(7) to set the 
additional performance threshold for the 2024 MIPS payment year at 89 
points.
    We request comments on these proposals as well as the alternative 
additional performance thresholds listed that we considered but did not 
propose.
(4) Example of Adjustment Factors
    Figure A provides an illustrative example of how various final 
scores would be converted to a MIPS payment adjustment factor and 
potentially an additional MIPS payment adjustment factor, using the 
statutory formula and based on our proposed 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 proposed performance threshold of 75 
points for the 2024 MIPS payment year). All MIPS eligible clinicians 
with a final score in this range would 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 would 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 would be greater than 9 
percent.
    Only those MIPS eligible clinicians with a final score equal to 75 
points (which is the proposed performance threshold) would 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 would 
be less than 1 and the MIPS payment adjustment factor for each MIPS 
eligible clinician with a final score of 100 points would be less than 
9 percent.
BILLING CODE 4120-01-P

[[Page 39456]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.086

    Table 59 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 proposed policies for the 
2024 MIPS payment year, as well as the applicable percent required by 
section 1848(q)(6)(B) of the Act.

[[Page 39457]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.087

(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 60. 
Beginning with the 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] TP23JY21.088

    In section IV.A.3.b.(3) of this proposed rule, we are proposing 
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

[[Page 39458]]

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 propose 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 61. We are seeking comment on 
this proposal.
[GRAPHIC] [TIFF OMITTED] TP23JY21.089

BILLING CODE 4120-01-C
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 Public Health Emergency (PHE) and COVID-
19, we estimated that we would provide performance feedback for the 
performance period in 2019 in late July or early August of 2020. The 
third performance feedback (for the 2019 performance period) was 
provided on August 5, 2020. We note that similar to the 2019 
performance period, due to the PHE for COVID-19, we may provide 
performance feedback for the 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 estimate that we will 
provide performance feedback for the performance period in 2020 in 
early August of 2021, although this timeframe could be subject to 
change. 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.
    In the CY 2022 PFS proposed rule, we propose 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 QCDR and qualified registries; (4) 
new requirements specific to only QCDRs; and (5) remedial action and 
termination of third parties.
(1) Proposed 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 are proposing 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 proposed 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) Proposed 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), and further revised in the 
Quality Payment Program provisions in the CY 2019 and

[[Page 39459]]

CY 2020 PFS final rules ((83 FR 60088 and 84 FR 63049 through 63052, 
respectively), and further clarified our requirements of QCDRs, 
qualified registries, and health IT vendors with regards to submitting 
data for purposes of the MIPS program in the Quality Payment Program 
provisions in the CY 2021 PFS final rule, at Sec.  414.1400(a)(2), for 
our current policy regarding the types of MIPS data that third party 
intermediaries may submit. Our current requirements at Sec.  
414.1400(a)(2) state, beginning with the CY 2021 MIPS 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 (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 propose reorganizing existing language 
at Sec.  414.1400(a)(2). Specifically, we propose 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 propose 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 MIPS 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 MIPS 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 performance categories 
described in paragraphs (c)(1)(i) through (iii) of this section.
     We propose 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'' below at IV.A.3.h.(2)(b)(i).
     To move the current Health IT vendor requirements from 
paragraphs Sec.  414.1400 (a)(2)(ii) through (iii) and Sec.  414.1400 
(d) to a proposed new section 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 proposed new section 
applicable to CMS-approved survey vendor requirements at Sec.  
414.1400(d). We propose 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 propose 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 request public comment on our proposals.
(b) Proposed Reorganization for Requirements Related QCDR and Qualified 
Registries Self-Nomination
    We are proposing 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 are 
proposing 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 are also 
proposing 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 propose to state at Sec.  414.1400 
(b)(2), Self-nomination. For the 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 2020 MIPS 
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

[[Page 39460]]

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 2019 MIPS 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 propose removing the last two sentences of existing Sec.  
414.1400(b)(1), which are duplicative with existing Sec.  
414.1400(b)(3)(iii). We propose consolidating this language with 
existing paragraph (b)(3)(iii). We request public comment on our 
proposals.
(c) Proposed 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 proposed rule, we are 
proposing 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 propose to redesignate existing paragraph (b)(2) to 
proposed paragraph (b)(3) and revising the paragraph heading as, 
Conditions for approval.
     We also propose updating the reference to both QCDR and 
qualified registry in proposed paragraph (b)(3).
     We propose to revise to include both QCDR and qualified 
registry and redesignate existing paragraph (b)(2)(i) to proposed 
paragraph (b)(3)(i).
     We propose to revise and redesignate existing paragraph 
(b)(2)(ii) to proposed paragraph (b)(3)(ii). We also propose 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'' below at section IV.A.3.h.(3)(a)(ii) of this 
proposed rule.
     As discussed above, we are proposing 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 propose to revise and redesignate existing paragraph 
(b)(2)(iii) to proposed paragraph (b)(3)(iii) to state, beginning with 
the 2021 MIPS 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 propose 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.
     We propose to consolidate and redesignate paragraphs 
(b)(2)(v) and (c)(3)(iv), in their entirety, into a new paragraph 
(b)(3)(vi).
    We invite public comment on our proposals.
(d) Proposed Reorganization for Requirements Related to QCDR Measures
(i) Proposed 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 propose moving the QCDR measure 
definition to the definitions section at Sec.  414.1305. We are also 
proposing 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 proposed rule:
     We propose to redesignate paragraphs (b)(3)(i), 
(b)(3)(i)(A), and (b)(3)(i)(B) to definitions at Sec.  414.1305.
     We propose to revise and redesignate existing paragraphs 
at (b)(3)(ii) to proposed paragraphs (b)(4)(i) to state, for the 2018 
MIPS 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 propose 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 propose moving existing paragraph at (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 propose moving existing paragraphs at (b)(3)(v) through 
(v)(C)(1) in its entirety, to proposed paragraph (b)(4)(iii) through 
(b)(4)(iii)(A)(3).
     We propose to revise and redesignate existing paragraph at 
(b)(3)(v)(C)(2) to proposed paragraph (b)(4)(iii)(A)(3)(i) to state, to 
be included in an MVP for the 2022 MIPS performance period/2024 MIPS 
payment year and future years, a QCDR measure must be fully tested.
     We propose moving existing paragraph at (b)(3)(vii) in its 
entirety, to proposed paragraph (b)(4)(iv).
(ii) Proposed 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

[[Page 39461]]

63059), where we finalized existing Sec.  414.1400(b)(3)(v).
    We propose to reorganize and make minor updates to the existing 
requirements at Sec.  414.1400(b)(3)(v) to proposed Sec.  
414.1400(b)(4)(iii). We propose to reorganize the existing requirements 
so that QCDR measure approval at Sec.  414.1400(b)(3)(v) is discussed 
before QCDR measure considerations at Sec.  414.1400(b)(3)(iv). 
Therefore, we propose 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 propose to include 
the following updates:
    ++ Move existing (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 2022 
MIPS performance period/2024 MIPS payment year, all QCDR measures must 
meet face validity. To be approved for the 2023 MIPS 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, 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 invite public comment on our proposals.
(iii) Proposed 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 propose to reorganize and make minor updates to the 
language at existing Sec.  414.1400(b)(3)(iv) to proposed Sec.  
414.1400(b)(4)(iii)(B). We propose to reorganize the existing 
requirements so that QCDR measure approval at Sec.  414.1400(b)(3)(v) 
is discussed before QCDR measure considerations at Sec.  
414.1400(b)(3)(iv).
    We also propose to redesignate existing Sec.  414.1400(b)(3)(vi) to 
proposed Sec.  414.1400(b)(4)(iii)(C). Specifically, we propose the 
following revisions:
     To revise and redesignate existing paragraph (b)(3)(iv) 
``QCDR measure considerations for approval include'' to proposed 
paragraph (b)(4)(iii)(B) ``QCDR measure considerations for approval 
include, but are not limited to''.
     Move existing paragraph (b)(3)(iv)(A) in its entirety to 
proposed paragraph (b)(4)(iii)(B)(1).
     Move existing paragraph (b)(3)(iv)(B) in its entirety to 
proposed paragraph (b)(4)(iii)(B)(2).
     Move existing paragraph (b)(3)(iv)(C) in its entirety to 
proposed paragraph (b)(4)(iii)(B)(3).
     Move existing paragraph (b)(3)(iv)(D) in its entirety to 
proposed paragraph (b)(4)(iii)(B)(4).
     Move existing paragraph (b)(3)(iv)(E) in its entirety to 
proposed paragraph (b)(4)(iii)(B)(5).
     Move existing paragraph (b)(3)(iv)(F) in its entirety to 
proposed paragraph (b)(4)(iii)(B)(6).
     Move existing paragraph (b)(3)(iv)(G) in its entirety to 
proposed paragraph (b)(4)(iii)(B)(7).
     Revise and consolidate existing paragraph (b)(3)(iv)(G)(1) 
to proposed 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.
     Move existing paragraph (b)(3)(iv)(G)(2) in its entirety 
to proposed paragraph (b)(4)(iii)(B)(7)(ii).
     Move existing paragraph (b)(3)(iv)(H) in its entirety to 
proposed paragraph (b)(4)(iii)(B)(8).
     Move existing paragraph (b)(3)(iv)(I) in its entirety to 
proposed paragraph (b)(4)(iii)(B)(9).
     Move existing paragraph (b)(3)(iv)(J) in its entirety to 
proposed paragraph (b)(4)(iii)(B)(10).
     Move existing paragraph (b)(3)(iv)(J)(2) to proposed 
paragraph Reserve (b)(4)(iii)(B)(10)(ii).
     Move existing paragraph (b)(3)(vi) in its entirety to 
proposed paragraph (b)(4)(iii)(C).
    We invite public comment on our proposals.
(iv) QCDR Measure Rejection Criteria
    We refer readers to the existing requirements at Sec.  
414.1400(b)(3)(vii). We propose reorganizing existing requirements at 
Sec.  414.1400(b)(3)(vii) to proposed Sec.  414.1400(b)(4)(iv). 
Therefore, we propose the following revisions:
     To revise and redesignate existing paragraph (b)(3)(vii) 
``QCDR measure rejection criteria'' to proposed 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 propose 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 2020 MIPS 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 proposed (b)(4)(iv)(A) through (L).
    We invite public comment on our proposals.
(e) Proposed 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 propose to redesignate the following sections:
     We propose to redesignate current paragraph (f) as 
paragraph (e) and to update cross-references to correspond to the new 
section numbers as reflected in this proposed rule.
     We also propose to redesignate current paragraph (g) as 
paragraph (f) and to update cross-references to correspond to the new 
section numbers as reflected in this proposed rule.
    We invite public comment on our proposals.
(2) Third Party Intermediaries General Requirements
    We refer readers to previously established Sec.  414.1400(a) and 
the CY 2017 Quality Payment Program final

[[Page 39462]]

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 this proposed rule, we propose a couple 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 are also requesting comment on third 
party intermediaries that derive data from CEHRT. These proposals and 
request for comment 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 this proposed rule, we are proposing 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 request comment on this proposal.
(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 this proposed rule, we are proposing new requirements in 
alignment with our proposals in section IV.A.3.b. of this proposed rule 
to adopt MVPs and subgroups.
(i) Proposed 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. of this proposed rule, we discuss our proposals 
related to furthering our transition to MIPS Value Pathways (MVPs). As 
MVPs are implemented, proposed beginning with the 2023 MIPS performance 
period/2025 MIPS payment year, we believe it is important to also 
propose 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 propose to create a new requirement at Sec.  
414.1400(b)(1)(ii) to state that, beginning with the 2023 MIPS 
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 propose to create 
a new requirement at paragraph Sec.  414.1400(c)(1)(iii) to state that 
beginning with the 2023 MIPS 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.
    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 proposed in section IV.A.3.b of this proposed rule, MVPs would 
start with the 2023 MIPS performance period/2025 MIPS payment year. We 
believe this delay in implementation would allow third party 
intermediaries sufficient time for programming and system preparation 
for MVP reporting success. We request comment on our proposals.
(ii) Proposed Requirements for All Third Party Intermediaries To 
Support Subgroup Reporting
    As proposed in section IV.A.3.b.(3) of this proposed 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 this proposed rule, we propose to require QCDRs, qualified 
registries, health IT vendors, and CAHPS for MIPS survey vendors to 
support subgroup reporting, beginning with the 2023 MIPS performance 
period/2025 MIPS payment year. Therefore, we propose 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

[[Page 39463]]

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 proposed 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 note that as proposed in section IV.A.3.b.(4)(f) of this 
proposed 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 request comments on our proposal.
(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 are not proposing 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 
request feedback on this topic.
(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 this proposed rule, we propose 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) Proposed 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 are proposing a two-tiered approach to solve this issue. First, 
we propose 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 (2017 MIPS performance period/2019 MIPS 
payment year) through the 2020 MIPS 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 2021 MIPS 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.
    Secondly, we propose to codify a new requirement at paragraph 
(b)(3)(viii) to state, beginning with the 2024 MIPS 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

[[Page 39464]]

2 years preceding the applicable self-nomination period must submit a 
participation plan for CMS's approval. For example, for the 2024 MIPS 
performance period/2026 MIPS payment year, vendors will be required to 
have submitted performance data for the 2021 and 2022 MIPS 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 Sec.  
414.1400(b)(4)(iii)(B)(10)(i)). We request comments on this proposal.
(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 
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 who wish to collaborate to become a qualified 
registry, as well because extending this policy to qualified registries 
would also help smaller 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 this proposed rule, 
we propose 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 request comments on 
this proposal.
(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 Sec.  
414.1400(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 propose 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 propose 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 propose to codify a new requirement at Sec.  
414.1400(b)(3)(iv) to state that, beginning with the CY 2023 MIPS 
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 propose to codify at Sec.  414.1400(b)(3)(iv) 
to provide further clarity to better align with previous policies. 
Therefore, we propose to reorganize at Sec.  414.1400(b)(2)(iv) though 
(viii) to better align with the above changes. We propose with the 
following revisions:
     We propose to revise and redesignate existing paragraph 
(b)(2)(iv) to proposed paragraph (b)(3)(v) to state, that beginning 
with the 2021 MIPS

[[Page 39465]]

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 propose to revise and redesignate existing paragraph 
(b)(2)(iv)(A) to proposed 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 propose to revise and redesignate existing paragraph 
(b)(2)(v) to proposed paragraph (b)(3)(vi) to state that beginning with 
the 2021 MIPS performance period/2023 MIPS payment year, the QCDR or 
qualified registry must conduct targeted audits in accordance with this 
paragraph (b)(3)(vi).
     We propose to revise and redesignate paragraph (b)(2)(vi) 
to proposed paragraph (b)(3)(vii), to state for the 2023 MIPS 
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 2017 
through 2021 MIPS performance periods/2019 through 2023 MIPS payment 
years must submit a participation plan for CMS's 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 propose to revise and redesignate existing paragraph 
(b)(2)(vii) to proposed paragraph (b)(4)(viii) to state that beginning 
with the 2024 MIPS 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's approval.
(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 propose to update 
policies related to QCDR measure rejections.
(b) QCDR Measures
(i) QCDR Measure Rejections
(A) Proposed 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 this proposed rule, we are proposing 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.
(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 63070 through 
63073), we propose 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 request comment on this proposal.
(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 
propose 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 request comment 
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 seek comment on the above circumstances.
(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

[[Page 39466]]

(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 are 
proposing to update the existing language at Sec.  414.1400(f)(3)(ii) 
to broadly explain that it is up CMS's discretion on whether third 
party intermediaries' inaccuracies may lead to possible remedial action 
or termination. As discussed earlier, we propose consolidating and 
redesignating the existing language at Sec.  414.1400(f) as Sec.  
414.1400(e) and Sec.  414.1400(g) as Sec.  414.1400(f) to provide 
clarity and alignment with the aforementioned proposals to consolidate 
the duplicative criteria of QCDRs and qualified registries. Therefore, 
we propose to revise and redesignate existing language at Sec.  
414.1400(f)(3)(ii) to proposed Sec.  414.1400(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.
i. Public Reporting on the Compare Tools Hosted by the U.S. Department 
of Health & Human Services (HHS)
    In this section of the proposed rule, we propose 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 propose 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 proposed rule, available at https://www.medicare.gov/care-compare/ and data.medicare.gov, as technically feasible. We are 
proposing 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 seek comment on publicly reporting utilization data on 
clinician and group profile pages.
    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 propose, for individuals, 
groups, and subgroups reporting via MVP, to add a 1-year delay for 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. Table 62 further clarifies when this 1-year delay 
would apply.
[GRAPHIC] [TIFF OMITTED] TP23JY21.090

    We recognize 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

[[Page 39467]]

measure information reported via MVP by 1 additional year, for a total 
of 3 years. We request 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 propose 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 
propose 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 are proposing to 
change ``first year measures'' to ``new measures''.
    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 propose 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. 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 propose 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 would also be available on https://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 propose 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. We would publicly 
report PY 2024 subgroup performance information and for each 
performance year 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 seek comment on these considerations. We note 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 seek comment 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, 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 seek comment on this proposal and additional ways public 
reporting may encourage MVP participation.
(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 seek comment on

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alternative ways to publicly report performance information reporting 
via APPs and 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, 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.
    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 propose 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 [email protected] 
if they believe their facility affiliations are displayed incorrectly. 
We seek comment 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 seek 
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.
(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 Physician 
Compare.\244\ 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 
would 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.
---------------------------------------------------------------------------

    \244\ 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

[[Page 39469]]

determined, which is why we are seeking comment 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 too 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 seek comment 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 seek comment on these considerations as well as if 
there are others.
    We also seek comment 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 seek comment 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.
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 would 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. 
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. 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, would provide 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. 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 would prioritize identifying an alternate TIN 
with which the QP is affiliated at the time the APM Incentive Payment 
is made, and to which it would be appropriate to make the payment. The 
approach we adopted

[[Page 39470]]

also serves to reduce uncertainty for QPs as they anticipate their 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 propose 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 propose 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 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 now propose 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 would make the payment to such TINs 
associated with QP during the payment year, according to this section. 
If no such TIN or TINs can be identified at a particular step, we would 
move to the next and successive steps listed in Sec.  414.1450(c)(1) 
through (8) until we identify one or more solvent TIN or 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 propose to codify in 
the regulation under Sec.  414.1450(c), we 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 propose, 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 would continue at each step in the hierarchy to first attempt 
to identify the relevant base year TIN or TINs associated with the QP 
because 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 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 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 anticipate that many eligible clinicians 
who earned QP status in 2020 through a practice participating in the 
CPC+ model would 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 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 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 seek comment 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.

[[Page 39471]]

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, is applicable 
beginning in the 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.  [thinsp]414.1430(a) and the All-
Payer Option at Sec.  [thinsp]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), specifically by 
freezing for such years the applicable payment amount and patient count 
thresholds used to make determine an eligible clinician's QP 
determinations 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, 2021 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 payment years 2023 and 2024 (for 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 the Partial QP thresholds that 
are established for payment years 2021 and 2022 through payment year 
2024. 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.

[[Page 39472]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.091

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 are soliciting 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 (https://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 64 presents the mean hourly wage, 
the cost of fringe benefits and overhead (calculated at 100 percent of 
salary), and the adjusted hourly wage.
BILLING CODE 4120-01-P

[[Page 39473]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.092

    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, 
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] TP23JY21.093

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

[[Page 39474]]

B. Proposed Information Collection Requirements (ICRs)

1. ICRs Requiring Certain Manufacturers To Report Drug Pricing 
Information for Part B (Sec. Sec.  414.802 and 414.806)
    Pending our finalization of the following provisions, the proposed 
changes 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 
the CMS-1751-F final rule.
    The new provisions at Sec. Sec.  414.802 and 414.806 would 
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 proposed 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 are proposing 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 this section (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 Medicare Payment Advisory Commission 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--as the Secretary determines to be 
necessary to carry out this section, to permit the Comptroller General 
to review the information provided, and to permit the Director of the 
Congressional Budget Office 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 proposed 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, 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.

[[Page 39475]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.094

    We welcome comment on the likely costs or savings manufacturers 
from this provision.
2. ICRs Regarding the Medicare Shared Savings Program (Sections 
VII.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 VII.F.8.a. and 
b. of this proposed rule for a discussion of the impacts associated 
with this rule's proposed changes to the Shared Savings Program's 
quality reporting requirements, 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. Please see section VII. of 
this preamble for a discussion of the estimated impacts.
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 proposed rule, we propose 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 propose to add a provision 
to waive the provider enrollment Medicare application fee for all 
organizations enrolling in Medicare as MDPP suppliers during the MDPP 
expanded model. We expect the proposed 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 
proposed provisions. Please see section VII. of this preamble 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 proposed rule, we are proposing 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 would 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 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, if finalized, would 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 proposed regulations simply codify certain 
requirements by clarifying definitions, timeframes, and results for 
noncompliance.
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 proposed 
changes will be subject to the standard PRA process under OMB control 
number 0938-1396 (CMS-10755) to give

[[Page 39476]]

stakeholders optimal opportunity to comment on our proposed 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 proposal 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 proposed rule is 
to propose delaying the date for CMS to begin taking compliance 
actions, proposing certain exceptions to the mandate, and proposing 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,\245\ 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 propose that 
long term care facilities will have an extension 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.
---------------------------------------------------------------------------

    \245\ 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 the 
Table 67.\246\ We do not anticipate that our proposal to include a 
compliance threshold of 70 percent will have any material impact 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.
---------------------------------------------------------------------------

    \246\ This information is based on PDE data pulled on April 6, 
2021.
[GRAPHIC] [TIFF OMITTED] TP23JY21.095

    Table 67 gives our estimate of the number of prescribers affected 
by our proposed exceptions broken down by the type of exception. As 
shown in Table 67, 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 \247\ (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, should this provision be finalized, as proposed.
---------------------------------------------------------------------------

    \247\ This information is based on PDE data pulled on April 6, 
2021.
---------------------------------------------------------------------------

    However, for individual prescribers who have to implement this 
mandate,

[[Page 39477]]

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 CY2021 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 would 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 * $36.82/hr).
    We have 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 public health 
emergency. Due to the high prevalence of EPCS, the miniscule compliance 
actions that we are proposing 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 would take 
10 minutes (0.1667 hr) for a prescriber at $210.44/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 $3,508.04 
(16.67 hr x $210.44/hr). In addition, we solicit comment on any other 
potential information collection implications.
[GRAPHIC] [TIFF OMITTED] TP23JY21.096

7. ICRs Regarding Open Payments Proposals 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 as proposed by this proposed rule.
a. Payment Context Field for Teaching Hospitals
    The proposed 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 would 
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 proposed 
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 proposal would 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

[[Page 39478]]

package. We estimate that it would 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 proposed new definition is not subject to the PRA since it 
would not revise, add, or remove any collection of information 
requirements or burden.
d. Disallowing Record Deletion Without Reason (Sec.  403.904(a)(3))
    This proposal 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 would 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 would 
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 * $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 proposal.
f. Short Term Loans (Sec.  403.902)
    This proposal 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 would still meet 
reporting requirements if they add up to 91 days or greater. We do not 
believe this proposal 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 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 would 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 proposal 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 would 
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 would 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] TP23JY21.097


[[Page 39479]]


8. The Quality Payment Program (QPP) (42 CFR Part 414 and Section IV. 
of This Proposed Rule)
    The following QPP-specific ICRs reflect this rule's proposed 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 
proposed rule); QCDR self-nomination applications and other 
requirements (see section V.B.8.c.(2) of this proposed rule); qualified 
registry self-nomination applications and other requirements (see 
section V.B.8.c.(3) of this proposed rule); CAHPS survey vendor 
applications (see section V.B.8.c.(4) of this proposed rule); Health IT 
vendors (see section V.B.8.c.(5) of this proposed rule); Open 
Authorization credentialing and token request process (see section 
V.B.8.d of this proposed rule); Quality Payment Program Identity 
Management Application Process (see section V.B.8.e.(3) of this 
proposed rule); quality performance category data submission by 
Medicare Part B claims collection type (see section V.B.8.e.(4) of this 
proposed rule), QCDR and MIPS CQM collection type (see section 
V.B.8.e.(5) of this proposed rule), eCQM collection type (see section 
V.B.8.e.(6) of this proposed rule), MVP Quality submission (see section 
V.B.8.e.(7)(a)(iii) of this proposed rule), and CMS Web Interface 
collection type (see section V.B.8.e.(8) of this proposed rule); CAHPS 
for MIPS survey beneficiary participation (see section V.B.8.e.(9) of 
this proposed rule); group registration for CMS Web Interface (see 
section V.B.8.e.(10) of this proposed rule); group registration for 
CAHPS for MIPS survey (see section V.B.8.e.(11) of this proposed rule); 
MVP registration (see section V.B.8.e.(7)(a)(i) of this proposed rule); 
subgroups registration (see section V.B.8.e.(7)(a)(ii) of this proposed 
rule); and call for quality measures (see section V.B.8.f of this 
proposed rule); reweighting applications for Promoting Interoperability 
and other performance categories (see section V.B.8.g.(2) of this 
proposed rule); Promoting Interoperability performance category data 
submission (see section V.B.8.g.(3) of this proposed rule); call for 
Promoting Interoperability measures (see section V.B.8.h of this 
proposed rule); improvement activities performance category data 
submission (see section V.B.8.i of this proposed rule); nomination of 
improvement activities (see section V.B.8.j of this proposed rule); 
nomination of MVPs (see section V.B.8.k of this proposed rule); and 
opt-out of Physician Compare for voluntary participants (see section 
V.B.8.o of this proposed rule).
    The ICRs for Advanced APMs consist of: Partial Qualifying APM 
Participant (QP) election (section V.B.8.m of this proposed 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 proposed rule); and submission of data for QP determinations under 
the All-Payer Combination Option (section V.B.8.n.(3) of this proposed 
rule).
(2) Summary of Quality Payment Program Changes: MIPS
    The following 10 MIPS ICRs show changes in burden due to the 
proposed policies in this rule: (1) QCDR self-nomination applications; 
(2) Qualified Registry self-nomination applications; (3) Quality 
performance category data submission by Medicare Part B Claims 
collection type; (4) Quality performance category data submission by 
QCDR and MIPS CQM collection type; (5) Quality performance category 
data submission by eCQM collection type; (6) Group registration for CMS 
Web Interface; (7) CMS Web Interface submission burden; (8) Reweighting 
applications for Promoting Interoperability and other performance 
categories; (9) Promoting Interoperability performance category data 
submission; and (10) Nomination of improvement activities. In 
aggregate, we estimate the proposed policies will result in a net 
decrease in burden of 40,010 hours and $4,053,151 for the CY 2022 MIPS 
performance period/2024 MIPS payment year and 84,803 hours and 
$8,577,728 for the CY 2023 MIPS performance period/2025 MIPS payment 
year. The remaining changes to our currently approved burden estimates 
are adjustments due to the revised assumptions based on the data 
available at the time of publication of this proposed rule.
    We have also added 3 new ICRs (MVP Registration, MVP Quality 
Submissions, and Subgroups Registration) for the associated burden 
related to the proposals for implementation of MVPs and subgroups 
beginning with the CY 2023 MIPS performance period/2025 MIPS payment 
year. The MVP and subgroup registration ICRs reflect the burden 
associated with the proposed 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 
proposed requirements for the quality performance category of MVPs 
described in section IV.A.3.b(4)(d)(ii) of this rule.
    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; call for Promoting 
Interoperability measures; and improvement activities performance 
category data submission. See section V.B.8. of this proposed rule for 
a summary of the ICRs, the overall burden estimates, and a summary of 
the assumption and data changes affecting each ICR.
    The accuracy of our proposed estimates of the total burden for data 
submission under the quality, Promoting Interoperability, and 
improvement activities performance categories may be impacted due to 
two primary reasons. First, we are unable to predict with absolute 
certainty who will be a QP for the CY 2022 MIPS performance period/2024 
MIPS payment year. New eligible clinician participants in Advanced APMs 
who become QPs would be excluded from MIPS reporting requirements and 
payment adjustments, and as such, unlikely to report under MIPS; while 
some current Advanced APM participants may end participation such that 
the APM Entity's eligible clinicians would 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 MIPS performance 
period/2024 MIPS payment year compared to the CY 2019 MIPS 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.

[[Page 39480]]

    We acknowledge a recent JAMA article (Khullar, et al., 2021) \248\ 
which includes 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 does not indicate the time 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 seek comment on our assumptions for estimating the 
burden for clinicians submitting data for the Quality Payment Program.
---------------------------------------------------------------------------

    \248\ JAMA Health Forum.2021;2(5):e210527.doi:10.10001/
jamahealthforum.2021.527.
---------------------------------------------------------------------------

(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 
MIPS performance period/2024 MIPS payment year. We are not proposing 
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 70 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 70, 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 70 due to the proposed 
introduction of subgroups for clinicians choosing to report MVPs or the 
APP in the CY 2023 MIPS performance period/2025 MIPS payment year 
described in section IV.A.3.b.(2)(d)(ii) of this 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 70.
    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 proposed 
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 would use the APM 
Performance Pathway versus the traditional MIPS submission mechanism 
for the CY 2022 MIPS 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 
would participate through traditional MIPS, thereby submitting as an 
individual or group rather than as an entity.
    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).

[[Page 39481]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.098

    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 proposed rule create some additional data 
collection requirements not listed in Table 70. 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:

[[Page 39482]]

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 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 proposing any new or revised collection of 
information requirements or burden related to the virtual group 
election. The virtual group election requirements and burden are 
currently approved by OMB under control number 0938-1343 (CMS-10652). 
Consequently, we are not proposing any changes under that control 
number.
c. ICRs Regarding Third-Party Intermediaries (Sec.  414.1400)
    In section IV.A.3.h. of this rule, we propose multiple changes to 
the third-party intermediary regulations at Sec.  414.1400. 
Specifically, we are proposing: (1) Requirement for third-party 
intermediaries to submit MIPS data for APM Entities; (2) requirement 
for QCDRs and qualified registries to support MVPs and 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 proposed burden associated with each of these 
topics are 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.\249\ 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.
---------------------------------------------------------------------------

    \249\ As stated in the CY 2019 PFS final rule (83 FR 53998), 
health IT vendors are not included in the burden estimates for MIPS.
---------------------------------------------------------------------------

(2) QCDR Self-Nomination Applications
    The proposed requirements and burden associated with this rule's 
data submission changes related to QCDRs will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621). As explained 
below, in this rule we propose to: Adjust the number of self-nomination 
applications based on current data (from 82 to 90), 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 proposing 
reorganization and consolidation of Sec.  414.1400 generally. We assume 
that this proposal 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 proposals. 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 propose to: Add APM 
Entities to Sec.  414.1400(a)(1), and expand the general

[[Page 39483]]

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 MIPS. We are also proposing that beginning with the CY 
2023 MIPS 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 
proposal 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 proposed 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 proposals. Additionally, 
we are proposing to require QCDRs, qualified registries, health IT 
vendors, and CAHPS for MIPS survey vendors to support subgroup 
reporting, beginning with the CY 2023 MIPS 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 proposed 
requirement to support data submission for subgroups beginning with the 
CY 2023 MIPS performance period/2025 MIPS payment year. We assume that 
this would not impact the overall time estimated for QCDRs to submit 
their information at the time of self-nomination. Therefore, we are not 
proposing to make any adjustments in the time required for QCDRs during 
the simplified or full self-nomination process because of this 
proposal. 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 MIPS performance period/2025 MIPS 
payment year. We refer readers to section VII.C.17.f.(2)(f) of this 
proposed 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 proposing to codify 
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 
proposing to codify a new requirement at Sec.  414.1400(b)(3)(iv) to 
state that, beginning with the CY 2023 MIPS 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 proposal does not make 
any changes to the existing data validation requirements for QCDRs and 
qualified registries. Through this proposal, CMS is codifying the 
finalized policies related to data validation for QCDRs and qualified 
registries in previous rules. We are not revising our burden estimates 
as a result of the above proposal and 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 proposed rule, we are 
proposing new requirements for approved QCDRs and qualified registries 
that have not submitted performance data. First, we are proposing 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 MIPS performance period/2019 MIPS payment 
year) through the 2020 MIPS 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 proposing to 
codify a new requirement at paragraph (b)(3)(viii) to state that, 
beginning with the CY 2024 MIPS 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's approval. 
Under this proposal, 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 MIPS 
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 proposed 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 MIPS 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 would need to develop and 
submit a participation plan.
    In section IV.A.3.h.(4) of this rule, we are proposing 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 propose to codify a new requirement 
in section IV.A.3.h.(1)(d)(iv) 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 MIPS 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

[[Page 39484]]

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 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 MIPS performance period/2023 MIPS payment 
year, we assume that 82 QCDRs will submit 984 measures for 
consideration in the CY 2022 MIPS performance period/2024 MIPS payment 
year, approximately 12 measures per QCDR, on average. We anticipate 
that out of the 984 measures, 820 measures would be existing or 
borrowed measures, approximately 10 measures submitted per QCDR self-
nomination application. The remaining 104 measures would 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 proposing 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 are proposing to revise 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.
    Based on the trends noticed in the number of QCDRs that submit 
applications for self-nominations and consistent with our assumptions 
in the CY 2021 PFS final rule (85 FR 84965), we estimate that 90 QCDRs 
will submit applications for consideration during the self-nomination 
process for the CY 2022 MIPS performance period/2024 MIPS payment year, 
an increase of 8 applications from the currently approved estimate of 
82. 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 proposing 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 the number of targeted audits received for the 2020 
self-nomination period, we estimate that 20 QCDRs will submit targeted 
audits for the CY 2022 MIPS performance period/2024 MIPS payment year, 
an increase of 3 from the currently approved estimate of 17 QCDRs 
submitting targeted audits in the CY 2021 PFS final rule. Using the 
currently approved unchanged burden per respondent estimate, the 
proposed estimated burden associated with QCDRs completing targeted 
audits will range from 100 hours (20 audits x 5 hr/audit) at a cost of 
$9,522 (20 audits x $476.10/audit) for the simplified self-nomination 
process to 200 hours (20 audits x 10 hr/audit) at a cost of $19,044 (20 
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 +15 hours (+3 respondents x 5 hr/
audit) at a cost of $1,428.30 (15 hrs x $95.22/hr) and +30 hours (+3 
respondents x 10 hr/audit) at a cost of $2,856.60 (30 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 71, 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 proposed annual burden for the 
simplified and full-self nomination process will range from 855 hours 
(90 QCDRs x 9.5 hr) to 1,035 hours (90 QCDRs x 11.5 hr) at a cost 
ranging from $81,413 (855 hr x $95.22/hr) and $98,553 (1,035 hr x 
$95.22/hr), respectively.
    As shown in Table 71, combined with our proposed adjusted estimate 
of annual burden for targeted audits and the proposed burden for 
submission of participation plans, we are proposing to

[[Page 39485]]

revise our estimated burden for the QCDR self-nomination process, 
ranging from 985 hours [855 hr (90 QCDRs x 9.5 hr) + 100 hr (20 audits 
x 5 hr) + 30 hr (10 participation plans x 3 hr)] at a cost of $93,792 
[$81,414 (855 hr x $95.22/hr) + $9,522 (20 audits x $476.10/audit) + 
$2,857 (30 hr x $95.22/hr)] for a simplified self-nomination process to 
1,265 hours [1,035 hr (90 QCDRs x 11.5 hr) + 200 hr (20 audits x 10 hr) 
+ 30 hr (10 participation plans x 3 hr)] at a cost of $120,454 [$98,553 
(1,035 hr x $95.22/hr) + $19,044 (20 audits x $952.20/audit) + $2,857 
(30 hr x $95.22/hr)] for the full self-nomination process.
[GRAPHIC] [TIFF OMITTED] TP23JY21.099

    As shown in Table 72, for the CY 2022 MIPS performance period/2024 
MIPS payment year, independent of the proposed change to our per 
response time estimate, the estimated increase in 8 respondents from 
the currently approved 82 respondents to 90 results in an increase of 
between +76 hours (+8 respondents x 9.5 hrs/respondent for the 
simplified self-nomination process) and +92 hours (+8 respondents x 
11.5 hrs/respondent for the full self-nomination process) at a cost of 
between +$7,237 (+8 respondents x $904.60/respondent for the simplified 
self-nomination process) and +$8,760 (+8 respondents x $1,095.03/
respondent for the full self-nomination process) (see Table 71 for the 
cost per QCDR).
    Accounting for the proposed 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, as shown in Table 72, when these impacts are combined 
with the proposed estimate for targeted audits and participation plans 
discussed above, the net impact ranges between +449 hours [76 hr (+8 
respondents x 9.5 hrs/respondent) + 15 hr (+3 targeted audits x 5 hrs/
audit) + 30 hr (10 participation plans x 3 hr/plan) + 328 hr (82 
respondents x 4 hr)] at a cost of $42,754 ($7,237 + $1,428 + $2,857 + 
$31,232) for the simplified self-nomination process (also referred to 
as minimum burden) and +439 hours [92 hr (+8 respondents x 11.5 hrs/
respondent) + 30 hr (+3 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 $41,802 [$8,760 (+8 respondents x $1,095.03/respondent + 
$2,857 (30 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 MIPS performance 
period/2024 MIPS payment year.

[[Page 39486]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.100

(b) QCDR Measure Requirements
    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. 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 proposing 
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 proposing 
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 
proposed policies for transfer of ownership of QCDR measures. This 
proposal is to codify the existing requirements for the QCDR self-
nomination process. We are not proposing to revise our burden estimates 
as result of this proposal 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 proposing 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 are not revising our burden estimates as a result of the above 
proposal because we assume that there would 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 proposing 
reorganization and consolidation of Sec.  414.1400 generally. We assume 
that this proposal 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 proposals.
    In section IV.A.3.h.(2)(a) of this rule, we are proposing 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 proposing that beginning with the CY 2023 MIPS 
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. Like our discussion for QCDRs above, we anticipate no additional 
steps being added to the qualified registry self-nomination process as 
a result of this proposal 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 proposed rule, we assume that there 
will be no impact on the time required for qualified registries to 
complete either the simplified or full self-nomination process because 
of the above proposals. Additionally, we are proposing to require 
QCDRs, qualified registries, health IT vendors, and CAHPS for MIPS 
survey vendors to support subgroup reporting, beginning with the CY 
2023 MIPS 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 proposed requirement to 
support data submission

[[Page 39487]]

for subgroups beginning with the CY 2023 MIPS 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 proposing to make 
any adjustments in the time required for qualified registries during 
the simplified or full self-nomination process because of this 
proposal. 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 MIPS performance period/2025 MIPS 
payment year. We refer readers to section VII.C.17.f.(2)(f) of this 
rule where we discuss our impact analysis.
    Based on previous trends for the number of self-nominations for 
qualified registries received during the 2020 self-nomination period 
for the CY 2021 MIPS performance period/2023 MIPS payment year and 
consistent with our assumptions in the CY 2021 PFS final rule (85 FR 
84967), we anticipate an increase in the number of submissions from 
qualified registries for the CY 2022 MIPS performance period/2024 MIPS 
payment year. Therefore, we estimate that we will receive 210 
nomination applications from qualified registries for the CY 2022 MIPS 
performance period/2024 MIPS payment year, an increase of 27 from the 
currently approved estimate of 183. Based on our estimates in the CY 
2021 PFS final rule (85 FR 84967), we are proposing to adjust the 
estimated number of qualified registries that will submit targeted 
audits for the CY 2022 MIPS performance period/2024 MIPS payment year. 
Similar to our assumptions in the CY 2021 PFS final rule (85 FR 84967) 
and based on the number of targeted audits received from qualified 
registries for the CY 2019 MIPS performance period/2021 payment year, 
we estimate 63 qualified registries would be required to conduct 
targeted audits, an increase of 7 from the currently approved estimate 
of 56. Therefore, we estimate the total impact associated with 
qualified registries completing targeted audits will range from 315 
hours (63 registries x5 hours/audit) at a cost of $29,994 (63 
registries x $476.10/audit) to 630 hours (63 registries x 10 hours/
audit) at a cost of $59,989 (63 registries x $952.20/audit) for the 
simplified and full self-nomination process, respectively (see Table 71 
for the cost per audit). We assume that this would adjust our burden 
estimates for targeted audits by +35 hours (+7 respondents x 5 hr/
audit) at a cost of $3,332.70 (35 hrs x $95.22/hr) and +70 hours (+7 
respondents x 10 hr/audit) at a cost of $6,665.40 (70 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)(1) of this proposed rule, we are 
proposing new requirements for approved QCDRs and qualified registries 
that have not submitted performance data. First, we are proposing to 
create a new requirement at paragraph Sec.  414.1400(b)(3)(vii) to 
require QCDRs and qualified registries that have never submitted data 
since the inception of MIPS (CY 2017 MIPS performance period/2019 MIPS 
payment year) through the CY 2020 MIPS 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 MIPS performance period/2023 MIPS 
payment year. Under this scenario, QCDRs and qualified registries would 
not need to submit a participation plan for the 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 2023 MIPS self-nomination period and must be accepted by CMS to 
continue to be an approved QCDR or qualified registry. We are also 
proposing to codify a new requirement that, beginning with the CY 2024 
MIPS 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 proposal, 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 MIPS performance period/2019 MIPS payment year), we 
estimate that 19 qualified registries will submit participation plans 
for the CY 2023 MIPS 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 proposed 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 MIPS 
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 2021 MIPS performance period/2023 MIPS payment year, we are 
proposing to adjust the estimated number of qualified registries that 
would self-nominate for the CY 2023 performance period to 210, an 
increase of 27 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 propose to revise our 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 estimate that the annual burden will range from 105 
hours (210 qualified registries x 0.5 hr) to 420 hours (210 qualified 
registries x 2 hr) at a cost ranging from $9,998 (105 hr x $95.22/hr) 
and $39,992 (420 hr x $95.22/hr), respectively (see Table 73).
    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 507 
hours [105 hr (210 qualified registries x 0.5 hr) + 57 hr (+19 
participation plans x 3hr/plan)

[[Page 39488]]

+ 315 hr (63 targeted audits x 5 hours/audit) + 30 hr (10 CAPs x 3 hr) 
at a cost of $48,277 [$9,998 (105 hr x $95.22/hr) + $5,428 (57 hr x 
$95.22/hr) + $29,994 (63 registries x $476.10/audit) + $2,857 (30 hours 
x $95.22/hr)] to 1,137 hours [420 hr (210 qualified registries x 2 hr) 
+ 57 hr (+19 participation plans x 3hr/plan) + 630 hr (63 targeted 
audits x 10 hours/audit) + 30 hr (10 CAPs x 3 hr)] at a cost of 
$108,266 [$39,992 (420 hr x $95.22/hr) + $5,428 (57 hr x $95.22/hr) + 
$59,989 (63 registries x $952.20/audit) + $2,857 (30 hours x $95.22/hr) 
for the simple self-nomination process (see minimum burden in Table 73 
below) and full self-nomination process (see maximum burden in Table 
73) respectively.
    Based on the assumptions discussed in this section, we provide a 
proposed 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.
[GRAPHIC] [TIFF OMITTED] TP23JY21.101

    As shown in Table 74, for the CY 2022 MIPS performance period/2024 
MIPS payment year, independent of the proposed change to our per 
response time estimate, the estimated increase in 27 respondents from 
the currently approved 183 respondents to 210 results in an increase of 
between +13.5 hours (+27 respondents x 0.5 hrs/respondent) at a cost of 
+$1,285 (13.5 hours x $95.22/hr) and +54 hours (+27 respondents x 2 
hrs/respondent) at a cost of +$5,142 (54 hours x $95.22/hr). Accounting 
for the proposed 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 proposed estimates for 
targeted audits, participation plans and corrective action plans 
discussed above, the net impact ranges between +106 hours [13.5 hr (+27 
respondents x 0.5 hrs/respondent) + 0 hr + 35 hr (+7 audits x 5 hr/
audit) + 57 hr (+19 participation plans x 3hr/plan) + 0 hr)] at $10,046 
[($1,286 (13.5 hours x $95.22/hr) + $0 + $3,333 (35 hrs x $95.22/hr) + 
$5,428 (+57 hr x $95.22/hr) + $0)] for the simplified self-nomination 
process and -2 hours [(54 hr (+27 respondents x 2 hrs/respondent) -183 
hr (183 respondents x -1 hours) + 70 hr (+7 audits x 10hr/audit) + 57 
hr (+19 participation plans x 3hr) + 0 hr)] at a cost of -$190 [($5,142 
(54 hours x $95.22/hr)-$17,425 (-183 hours x $95.22/hr) + $6,665 (70 
hrs x $95.22/hr) + $5,428 (+57 hr x $95.22/hr) + $0)] for the full 
self-nomination process for the CY 2022 MIPS performance period/2024 
MIPS payment year.

[[Page 39489]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.102

(4) Survey Vendor Requirements
    In section IV.A.3.h(2)(b)(ii) of this rule, we are proposing to 
require CAHPS for MIPS survey vendors to support subgroup reporting, 
beginning with the CY 2023 MIPS performance period/2025 MIPS payment 
year. Because of this proposal, we anticipate no additional steps being 
added to the requirements for CAHPS for MIPS survey vendors to submit a 
participation form and assume there will be no impact on the time 
required for the survey vendors. Therefore, we are not proposing to 
make any adjustments in the time required for CAHPS survey vendors to 
submit the because of this proposal. 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 proposing any changes under that control 
number.
(5) Health IT Vendors
    In section IV.A.3.h.(2)(b) of this rule, we propose to create a new 
requirement at paragraph Sec.  414.1400(c)(1)(iii) to state that, 
beginning with the CY 2023 MIPS 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 propose to require 
health IT vendors to support subgroup reporting beginning with the CY 
2023 MIPS performance period/2025 MIPS payment year. We do not 
anticipate any requirement/burden changes as it relates to the support 
of reporting data.
d. ICR Regarding Open Authorization (OAuth) Credentialing and Token 
Request Process
    This rule is not proposing any new or revised collection of 
information requirements or burden related to the identity management 
application process. The requirements and burden are currently approved 
by OMB under control number 0938-1314 (CMS-10621). Consequently, we are 
not proposing any changes 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 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 MIPS 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 MIPS 
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 MIPS 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 MIPS performance period/2021 MIPS 
payment year data to estimate the number of respondents in the CY 2022 
PFS proposed 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 MIPS 
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 MIPS 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 proposing to 
continue the CMS Web Interface measures as a collection type for the CY 
2022 MIPS performance period/2024 MIPS payment year. Additionally, we 
are proposing to sunset the CMS Web Interface measures as a collection 
type/submission type starting with the CY 2023 MIPS 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 MIPS

[[Page 39490]]

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 
MIPS 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 MIPS 
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 MIPS 
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 MIPS 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 MIPS 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 MIPS 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 MIPS 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. Note that the 114 groups is an increase of 114 from 
our currently approved estimate of 0 groups in the CY 2022 performance 
period/2024 payment year. We also performed this analysis to determine 
the number of clinicians that would be affected and would need to 
submit quality data via an alternate collection type beginning with the 
CY 2023 performance period/2025 payment year. In total, of the 
estimated 45,599 individual clinicians affected by this provision, we 
estimate that 11,432 would submit quality data as part of a group via 
the MIPS CQM and QCDR collection type and 34,167 would submit quality 
data as part of a group via the eCQM collection type. These estimates 
are reflected in Tables 78 and 80 and the associated changes in burden 
are reflected in Tables 79 and 81. In aggregate, as discussed in 
section V.B.8.p of this proposed 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 VII.F.17.f.(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 made at the 
individual or TIN-level in our respondent estimates. As stated in 
section V.B.8.e.(2) of this proposed rule, we assume non-ACO APM 
Entities will participate through traditional MIPS and submit as an 
individual or group rather than as an entity. To estimate who will be a 
MIPS APM participant in the CY 2022 MIPS 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 MIPS performance 
period/2021 MIPS payment year enabled the exclusion of Partial QPs that 
elected to not participate in MIPS and required fewer assumptions as to 
who is a QP or not. Based on this information, if we determine that a 
MIPS eligible clinician will not be scored as a MIPS APM, then their 
reporting assumption is based on their reporting as a group or 
individual for the CY 2019 MIPS 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 proposed rule because 
sections 1899(e) and 1115A(d)(3) of the Act (42 U.S.C. 1395jjj(e) and 
1315a(d)(3), respectively) state that the Shared Savings Program and 
the testing, evaluation, and expansion of Innovation Center models 
tested under section 1115A of the Act (or section 3021 of the 
Affordable Care Act) are not subject to the PRA.\250\ Tables 72, 73, 
and 74 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.
---------------------------------------------------------------------------

    \250\ 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 75 provides our estimated counts of clinicians that will 
submit quality performance category data as MIPS individual clinicians 
or groups in the CY 2022 and 2023 MIPS performance periods/2024 and 
2025 MIPS payment years based on data from the CY 2019 MIPS performance 
period/2021 MIPS payment year.
    For the CY 2022 MIPS 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 MIPS performance 
period/2025 MIPS payment year, respondents would 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 maintain consistency with previous 
rulemaking.
    For the CY 2023 MIPS performance period/2025 MIPS payment year, we 
propose in section IV.A.3.b.(2)(d) of this rule that clinicians in MIPS 
would have the option to submit measures and activities in MVPs. We 
refer readers to section IV.A.3.b.(4) of this rule for additional 
details on the proposed reporting requirements for MVPs. For the 
quality performance category of MVPs, we assume that MVP Participants 
would choose to report via the Medicare

[[Page 39491]]

Part B claims, QCDR, MIPS CQMs, and eCQMs collection type. Table 87 of 
this rule includes the estimated burden for collecting data for the 
quality performance category of MVPs.
    As shown in Table 75, using participation data from the CY 2019 
MIPS performance period/2021 MIPS payment year, combined with the 
estimate of QPs for the CY 2022 MIPS 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 2023 
MIPS performance periods/2024 and 2026 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 MIPS 
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 MIPS performance 
period/2021 MIPS payment year and the delay in sunsetting the CMS Web 
Interface from the CY 2022 MIPS performance period/2024 MIPS payment 
year to the CY 2023 MIPS performance period/2025 MIPS payment year. For 
the CY 2023 performance period/2025 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 75 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.
[GRAPHIC] [TIFF OMITTED] TP23JY21.103

    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 2019 MIPS 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 76 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 MIPS performance 
periods/2024 and 2025 MIPS payment years. For the CY 2022 MIPS 
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 MIPS 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

[[Page 39492]]

QCDR, and eCQM collection types, respectively.
    As shown in Table 76, for the CY 2023 MIPS 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. Based on performance data from the CY 2019 MIPS 
performance period/2021 MIPS payment year, these are decreases of -
3,846, -4,884, and -5,854 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.
[GRAPHIC] [TIFF OMITTED] TP23JY21.104

    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 76 are not mutually exclusive.
    Table 77 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 2023 MIPS performance period/2024 
and 2025 MIPS payment years. We assume that clinicians that submitted 
quality data as groups in the CY 2019 MIPS 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 MIPS performance 
periods/2024 and 2025 MIPS payment years. Specifically, for the CY 2022 
MIPS 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 77, for the CY 2023 MIPS 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. These 
are decreases of -1,170 and -861 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, respectively. The 
reason for the difference in estimated number of respondents from the 
estimates for the CY 2022 MIPS performance period/2024 MIPS payment 
year describe 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 MIPS 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 would participate 
through traditional MIPS and base our estimates on submissions received 
in the CY 2019 MIPS performance period/2021 MIPS payment year.

[[Page 39493]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.105

    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 MIPS 
performance period/2025 MIPS payment year we refer readers to section 
IV.A.3.b.(4) 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 MIPS performance 
period/2024 MIPS payment year, we are proposing that the total number 
of quality measures will be 195. The new MIPS quality measures proposed 
for inclusion in MIPS for the CY 2022 MIPS performance period/2024 MIPS 
payment year and future years are found in Table Group A of Appendix 1; 
MIPS quality measures with proposed substantive changes can be found in 
Table Group D of Appendix 1; and MIPS quality measures proposed for 
removal can be found in Table Group C of Appendix 1. These proposed 
measures are stratified by collection type in Table 78, as well as 
counts of new, removed, and substantively changed measures.

[[Page 39494]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.106

    For the CY 2022 MIPS performance period/2024 MIPS payment year, we 
are proposing a net reduction of 15 quality measures across all 
collection types compared to the 209 measures finalized for the CY 2021 
MIPS performance period/2023 MIPS payment year (85 FR 84974). 
Specifically, as discussed in section IV.A.3.c.(1)(d), we are proposing 
to add 2 new administrative claims outcome measures, remove 19 quality 
measures, and make substantive updates to 84 quality measures. We do 
not anticipate that our proposal 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 proposals 
introducing MVP and subgroup reporting beginning in the CY 2023 MIPS 
performance period/2025 MIPS payment year, we refer readers to Table 87 
of this section.
(3) Quality Payment Program Identity Management Application Process
    This rule is not proposing 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 proposing any changes under that control number.
(4) Quality Data Submission by Clinicians: Medicare Part B Claims-Based 
Collection Type
    This rule is not proposing 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 proposals 
introducing MVP and subgroup reporting beginning in the CY 2023 MIPS 
performance period/2025 MIPS payment year, we refer readers to Table 87 
of this section.
    The following proposed 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 76, based on data from the CY 2019 MIPS 
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. This rule is proposing 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 MIPS 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 79, 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 79, 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 MIPS 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 [(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 MIPS performance period/2024 MIPS payment year ranges from a 
minimum of $21,407,105 (28,252 clinicians x $758) to a maximum of

[[Page 39495]]

$40,372,673 (28,252 clinicians x $1,429).
    As shown in Table 79, for purposes of calculating total burden 
associated with the Claims collection type for the CY 2023 MIPS 
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 361,061 hours (14.2 hr x 25,427 
clinicians) for the CY 2023 MIPS performance period/2025 MIPS payment 
year. Using the currently approved unchanged estimate for cost per 
respondent, the total annual cost for the CY 2023 MIPS performance 
period/2025 MIPS payment year is $36,335,692 (25,427 clinicians x 
$1,429 per respondent).
    Table 79 summarizes our proposed estimated range of total annual 
burden associated with clinicians submitting quality data via Medicare 
Part B claims for both the CY 2022 and 2023 MIPS performance periods/
2024 and 2025 MIPS payment years.
[GRAPHIC] [TIFF OMITTED] TP23JY21.107

    As shown in Table 76, 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 would 
range from $758 to $1,429. 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 -$167,945 (-
1,021 respondents x $758/respondent) and -14,499 hours (-1,021 
respondents x 14.2 hr/respondent) at a cost of -$1,257,748 (-1,021 
respondents x $1,429/respondent). For purposes of calculating total 
burden associated with the proposed rule as shown in Tables 113, 114, 
115, and 116, only the maximum burden is used.
    As shown in Table 80, for purposes of calculating total burden 
associated the CY 2023 MIPS performance period/2025 MIPS payment year 
only the maximum burden is used. 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 would be $1,429. The decrease in number of respondents from 29,273 
to 25,427 results in a total adjustment of -54,616 hours (-25,427 
respondents x 14.2 hr/respondent) at a cost of -$5,294,729 (-25,427 
respondents x $1,429/respondent).

[[Page 39496]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.108

(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 proposals introducing MVP 
and subgroup reporting beginning in the CY 2023 MIPS performance 
period/2025 MIPS payment year, we refer readers to Table 87.
    As noted in Tables 72, 73, and 74, and based on data from the CY 
2019 MIPS 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 a 
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 MIPS 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 MIPS performance period/2025 MIPS payment year, in 
aggregate, we estimate a burden of 425,787 hours [9.083 hr/response x 
(36,456 clinicians submitting as individuals + 10,432 groups submitting 
via QCDR or MIPS CQM on behalf of individual clinicians or 46,877 
responses)] at a cost of $43,256,221 (46,877 responses x $922.76/
response). Based on these assumptions, we have estimated in Table 81 
the burden for these submissions.

[[Page 39497]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.109

    As shown in Table 82, using the unchanged currently approved hours 
per respondent burden estimate, the decrease of 913 respondents from 
52,949 to 52,036 for the CY 2022 MIPS performance period/2024 MIPS 
payment year results in a decrease of -8,293 hours (-913 respondents x 
9.083 hr/respondent) and -$842,483 (913 respondents x $922.76/
respondent).
    For the CY 2023 MIPS performance period/2025 MIPS payment year, 
using the unchanged currently approved hours per respondent burden 
estimate, the decrease of 6,072 respondents from 52,949 to 46,877 
results in a decrease of -55,149 hours (-6,072 respondents x 9.083 hr/
respondent) and -$5,602,649 (-6,072 respondents x $922.76/respondent).

[[Page 39498]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.110

(6) Quality Data Submission by Clinicians and Groups: eCQM Collection 
Type
    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 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 proposals introducing 
MVP and subgroup reporting beginning in the CY 2023 MIPS performance 
period/2025 MIPS payment year, we refer readers to Table 87 of this 
section.
    Based on CY 2019 MIPS performance period/2021 MIPS payment year 
data, for the CY 2022 MIPS 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 MIPS 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 MIPS 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 83 
the burden for these submissions.

[[Page 39499]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.111

    As shown in Table 84, using the unchanged currently approved hours 
per respondent burden estimate, the decrease of 1,897 respondents from 
50,470 to 48,573 for the CY 2022 MIPS performance period/2024 MIPS 
payment year results in a total difference of -15,176 hours at a cost 
of -$1,544,857. For CY 2023 MIPS performance period/2025 MIPS payment 
year, using the unchanged currently approved hours per respondent 
burden estimate, the decrease of 6,697 respondents from 50,470 to 
43,773 results in a total difference of -53,574 hours at a cost of -
$5,488,883.

[[Page 39500]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.112

(7) ICRs Regarding Burden for MVP Reporting
    Section IV.A.3.b.(2)(d) of this rule describes proposals related to 
implementing MVPs beginning with the CY 2023 MIPS performance period/
2025 MIPS payment year. The MVPs would 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 MIPS 
performance period/2025 MIPS payment year, CMS is proposing 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)(c)(i) of this rule, 
we propose to use the term ``MVP Participant'' to refer to clinicians 
who would 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 proposed implementation of MVPs 
and subgroup reporting in the CY 2023 MIPS performance period/2025 MIPS 
payment year as described in section IV.A.3.b.(2)(d) of this rule. The 
proposed 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 proposed 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 proposing 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 would not be of value to clinicians.
    We seek 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.
(a) Burden for MVP Quality Submission
    In section IV.A.3.b.(2)(d)(i) of this rule, we propose to implement 
voluntary MVP reporting beginning with the CY 2023 MIPS performance 
period/2025 MIPS payment year. If this proposal is finalized, 
clinicians participating in MIPS would have the option to voluntarily 
submit data using MVPs starting with the CY 2023 MIPS 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 proposed 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 would 
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 2021 MIPS performance period/2023 MIPS 
payment year. Based on our review of the proposed 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 MIPS performance period/2024 MIPS 
payment year will report MVPs in the CY 2023 MIPS performance period/
2025 MIPS payment year. Given that MVPs are new, voluntary, and 
represent a reduction in burden per response, we believe that we should 
be conservative

[[Page 39501]]

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 MIPS performance period/2025 MIPS payment 
year.
    As described in section IV.A.3.b.(2)(d)(ii) of this rule, beginning 
with the CY 2023 MIPS performance period/2025 MIPS payment year, we are 
proposing 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. We believe that 
subgroup participation option would 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 would 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 
would choose to participate as subgroups for reporting the MVP or the 
APP. We refer readers to section IV.A.3.b.(3) of this proposed rule for 
details on the proposals related to subgroup composition.
    We anticipate that the subgroup reporting option would 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 MIPS 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 would 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 would choose 
to participate as subgroups in the CY 2023 MIPS performance period/2025 
MIPS payment year. Therefore, we assume there will be 20 subgroups 
reporters in the CY 2023 MIPS performance period/2025 MIPS payment 
year. We assume that more clinicians will choose to participate as 
subgroups in future years. We seek comment on our MVP and subgroup 
reporting assumptions for the CY 2023 MIPS performance period/2025 MIPS 
payment year.
(i) Burden for MVP Registration: Individuals, Groups and APM Entities
    Beginning with the CY 2023 MIPS performance period/2025 MIPS 
payment year, we propose 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 in the CY 2023 MIPS 
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 85, 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 MIPS 
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 MIPS performance 
period/2021 MIPS payment year, we assume that approximately 10 percent 
of the clinicians that currently participate in MIPS will 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 proposed sunset of 
Web Interface in the CY 2023 MIPS performance period/2025 MIPS payment 
year. For the CY 2023 MIPS performance period/2025 MIPS payment year, 
we assume that a total of 25,798 submissions would be received for the 
measures and activities included in MVPs. This total includes our 
estimate of 20 subgroup reporters that will 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 
12,918. We estimate that the total cost to clinicians participating as 
individuals and groups associated with the MVP registration process 
will be approximately $307,513. Table 85 includes our burden 
assumptions related to the MVP registration process for clinicians 
participating in MIPS for reporting MVPs as individuals, groups, 
subgroups, and APM Entities.

[[Page 39502]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.113

(ii) Burden for Subgroup Registration
    We propose to add a separate ICR to estimate the burden associated 
with subgroup registration to capture the proposed subgroup 
registration requirements in section IV.A.3.b.(4)(f)(ii)(D) of this 
rule. In section IV.A.3.b.(3)(c)(ii) of this rule, we propose to define 
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 would 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 would 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 would require a minimum of 0.5 hours per 
subgroup respondent to submit the proposed 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.
    As all subgroups will report MVPs, the burden associated with 
subgroup quality reporting will be included with the MVP quality 
reporting ICR. Burden associated with subgroup submissions for 
Promoting Interoperability and improvement activities will be included 
with those ICRs.
[GRAPHIC] [TIFF OMITTED] TP23JY21.114

(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 proposed rule, we 
propose that except as provided in paragraph

[[Page 39503]]

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 proposed rule. Therefore, we estimate that the time 
for submitting the measures in the MVP quality performance category 
will, 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 proposed rule, we 
estimate that 10 percent of the clinicians who participated in MIPS for 
the CY 2019 MIPS performance period/2021 MIPS payment year would submit 
data for the quality performance category of MVPs beginning with the CY 
2023 MIPS performance period/2025 MIPS payment year. We anticipate that 
there will be 20 subgroups reporters in the CY 2023 MIPS performance 
period/2025 MIPS payment year. As shown in Table 87, 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 will submit data using 
MIPS CQM and QCDR collection type; and approximately 4,862 clinicians 
and 10 subgroups will 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 87, 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

[[Page 39504]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.115

BILLING CODE 4120-01-C
(8) Quality Data Submission via CMS Web Interface
    The proposed 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 MIPS performance period/2024 MIPS payment 
year. As a result of this provision, for the CY 2022 MIPS 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 proposing to 
continue the CMS Web Interface measures as a collection type for the CY 
2022 MIPS performance period/2024 MIPS payment year. Additionally, we 
are proposing to sunset the CMS Web Interface measures as a collection 
type for the CY 2023 MIPS performance period/2025 MIPS payment year. 
For this proposed rule, we are providing a burden estimate for the CY 
2022 and CY 2023 MIPS performance periods/2024 and 2025 MIPS payment 
years.
    For the CY 2022 MIPS 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 MIPS 
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 proposal to continue 
with the CMS Web Interface as a collection type for the CY 2022 MIPS 
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 proposed estimated burden associated with the group submission 
requirements is the time and effort associated with submitting data on 
a sample of the organization's

[[Page 39505]]

beneficiaries that is prepopulated in the CMS Web Interface. Our 
proposed 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 MIPS 
performance period/2024 MIPS payment year of 7,030 hours (114 groups x 
61.67 hr) at a cost of $669,432 (114 groups x $5,872.21/group). For the 
CY 2023 MIPS performance period/2025 MIPS payment year, we propose to 
revise our estimated burden to zero due to our assumption that with the 
proposed 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 88 summarizes the proposed estimated 
burden for groups submitting to MIPS via the CMS Web Interface.
[GRAPHIC] [TIFF OMITTED] TP23JY21.116

[GRAPHIC] [TIFF OMITTED] TP23JY21.117

(9) Beneficiary Responses to CAHPS for MIPS Survey
    This rule does not propose 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 proposing any changes under that control 
number.
(10) Group Registration for CMS Web Interface
    The proposed 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 MIPS performance period/2024 MIPS payment year. As a 
result, we estimated that there would be zero hours and $0 burden for 
group registration for the CMS Web Interface for the CY 2022 MIPS 
performance period/2024 MIPS payment year (85 FR 84984). As discussed 
in section IV.A.3.d.(1)(d) of this proposed rule, we are proposing to 
continue the CMS Web Interface measures as a collection type for the CY 
2022 MIPS performance period/2024 MIPS payment year. We are also 
proposing to sunset the CMS Web Interface as a collection type starting 
with the CY 2023 MIPS performance period/2025 MIPS payment year.
    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 90, we estimate that the registration process for 
groups under MIPS involves approximately 0.25 hours at $95.22/hr for a 
computer

[[Page 39506]]

systems analyst (or their equivalent) to register the group.
    Because we are finalizing to sunset the CMS Web Interface beginning 
with the CY 2023 MIPS 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 MIPS performance period/2025 MIPS payment year based on the 
estimated number of new registrations during the CY 2021 MIPS 
performance period/2023 MIPS payment year. As shown in Table 90, we 
estimate a burden of 22.5 hours (90 new registrations x 0.25 hr/
registration) at a cost of $2,142 (22.5 hr x $95.22/hr).
[GRAPHIC] [TIFF OMITTED] TP23JY21.118

    As shown in Table 91, the proposed 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 +22.5 
hours (+90 respondents x 0.25 hr/respondent) at a cost of $2,142 for 
the CY 2022 MIPS performance period/2024 MIPS payment year. For the CY 
2023 MIPS performance period/2025 MIPS payment year, our proposed 
burden estimate is $0.
[GRAPHIC] [TIFF OMITTED] TP23JY21.119

(11) Group Registration for CAHPS for MIPS Survey
    This rule is not proposing 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 proposing any changes under that 
control number.
f. ICRs Regarding the Call for MIPS Quality Measures
    This rule is not proposing 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 are replacing 
the existing tool for stakeholders beginning with the 2021 Annual Call 
for Measures. To account for the updated tool (MERIT), we are proposing 
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 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

[[Page 39507]]

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 would 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 propose to 
revise 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 92) 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 proposing 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 -$3,656.
[GRAPHIC] [TIFF OMITTED] TP23JY21.120

g. ICRs Regarding Promoting Interoperability Data (Sec. Sec.  414.1375 
and 414.1380)
(1) Background
    For the CY 2022 MIPS 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 the 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 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

[[Page 39508]]

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 for the quality, cost, 
and/or improvement activities performance categories have the option of 
applying for reweighting for 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 93 summarizes the burden for clinicians to apply for 
reweighting 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 MIPS 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 MIPS performance period/2024 MIPS payment 
year, we estimate that a total of 42,797 reweighting applications would 
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 proposal in section 
IV.A.3.e.(2)(b)(iii)(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 MIPS 
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. 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 MIPS 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 above in this section of this proposed rule, due to data 
limitations and our inability to determine who would use the APP versus 
the traditional MIPS submission mechanism for the 2022 MIPS performance 
period/2024 MIPS payment year, we assume ACO APM Entities will submit 
data through the APP and non-ACO APM Entities would 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 2020 MIPS 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 MIPS 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 MIPS 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 93, 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] TP23JY21.121


[[Page 39509]]


    As shown in Table 94, using our currently approved burden 
estimates, the proposed decrease in the estimate 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 
$184,747.
[GRAPHIC] [TIFF OMITTED] TP23JY21.122

(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.
    We did not propose any changes to our current criteria for 
automatic reweighting of the Promoting Interoperability performance 
category for certain MIPS eligible clinicians or MIPS eligible 
clinicians who have experienced a significant hardship or 
decertification of an EHR. In section IV.A.3.d.(4)(d)(ii) of this 
proposed rule, we proposed 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 2022 
performance period. 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 time it takes to complete the submission of 
promoting interoperability data. We also proposed 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. The proposed requirement would 
apply beginning with the performance period in 2022, and would include 
all patient health information from encounters on or after January 1, 
2016. We do not believe this proposal will impact the burden of 
Promoting Interoperability data submission. Therefore, we are not 
revising the currently approved burden per respondent estimate.
    As shown in Table 95, based on data from the CY 2019 MIPS 
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 proposed 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. As we receive updated 
information which reflects the actual number of Promoting 
Interoperability data submissions submitted by Shared Savings Program 
ACO participants, we will update our burden estimates accordingly.

[[Page 39510]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.123

    As discussed in section IV.A.3.b.(2)(d)(ii) of this proposed rule, 
we will be introducing subgroup reporting in CY 2023 MIPS performance 
period/2025 MIPS payment year. As we discussed above in this section of 
the proposed rule, we estimate that there will be 20 subgroup 
submissions in CY 2023 MIPS 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 96.
[GRAPHIC] [TIFF OMITTED] TP23JY21.124

    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 proposing to update 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 97, 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] TP23JY21.125

    As shown in Table 98, with the introduction of subgroup reporting 
in CY 2023 MIPS performance period/2025 MIPS payment year, the total 
proposed burden estimate 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 39511]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.126

    Table 99, using our updated per respondent burden estimate (+0.02 
hr/response), the decrease in number of respondents and proposed SAFER 
guide attestation requirement results in a total adjustment of -4,099 
hours at a cost of -$390,338 for the CY 2022 MIPS performance period/
2024 MIPS payment year and -4,045 hours at a cost of -$385,175 for the 
CY 2023 MIPS performance period/2025 MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TP23JY21.127

h. ICRs Regarding the Nomination of Promoting Interoperability (PI) 
Measures
    This rule is not proposing 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 proposing any changes under that control 
number.
i. ICR Regarding Improvement Activities Submission (Sec. Sec.  
414.1305, 414.1355, 414.1360, and 414.1365)
    The following proposed 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 proposing 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 MIPS 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 MIPS performance period/2024 MIPS payment year and future years. 
Additionally, we are proposing to adjust our currently approved burden 
estimates based on more recent data.
    Specifically, we are proposing to revise Sec.  414.1360(a)(2) to 
state that, beginning with the CY 2023 MIPS performance period/2025 
MIPS payment 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. In section

[[Page 39512]]

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 
would find applicable and meaningful activities specific to practice 
size, specialty, or practice setting. Therefore, we assume that the 
proposal 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 MIPS performance period/2025 MIPS payment year would 
not present additional complexity or burden.
    We do not believe the proposed 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 proposing to revise the 
estimated time of 5 minutes (per response) currently approved for 
improvement activities submission.
    As represented in Table 100, based on data from the CY 2019 MIPS 
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 2022 MIPS 
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 due to availability of updated data (85 FR 50362).
    As discussed in sections V.B.8.e. and V.B.8.g.(3) of this proposed 
rule regarding our estimate of clinicians and groups submitting data 
for the quality and Promoting Interoperability performance categories, 
we are proposing 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 MIPS performance period/2021 
MIPS payment year but will be QPs in the CY 2022 MIPS performance 
period/2024 MIPS payment year, and will therefore not be required to 
submit improvement activities data.
[GRAPHIC] [TIFF OMITTED] TP23JY21.128

    As discussed in section IV.A.3.b.(2)(d)(ii) of this proposed rule, 
we are proposing subgroup reporting in the CY 2023 MIPS performance 
period/2025 MIPS payment year. As we discussed in section 
V.B.8.e.(7)(a) of this proposed rule, we estimate that there will be 20 
subgroup reporters in the CY 2023 MIPS 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 101.

[[Page 39513]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.129

    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 102, we estimate an annual burden of 6,797 hours 
(81,562 responses x 5 minutes/60) and $647,210 (6,797 hr x $95.22/hr)) 
in CY 2022 MIPS performance period/2024 MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TP23JY21.130

    As shown in Table 103, with the introduction of subgroup reporting 
in the CY 2023 MIPS performance period/2025 MIPS payment year, we 
estimate an annual burden of 6,799 hours (81,582 responses x 5 minutes/
60) and $647,401 (6,799 hr x $95.22/hr)).

[[Page 39514]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.131

    As shown in Table 104, using our unchanged currently approved per 
respondent burden estimate, the increase of 1,635 in the number of 
respondents results in an adjustment of 136 hours (1,635 responses x 5 
minutes/60) at a cost of $12,973 (136 hr x $95.22/hr).
[GRAPHIC] [TIFF OMITTED] TP23JY21.132

j. ICRs Regarding the Nomination of Improvement Activities (Sec.  
414.1360)
    The proposed 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 proposing: 
(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 
public health emergency (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 proposing 
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 proposing to increase the number of criteria 
stakeholders are required to meet when submitting an activity proposal 
from a minimum of 1 to all 8 criteria, which includes the two new 
proposed criteria. We believe that this proposal would 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 proposed new requirement to meet 
all 8 criteria would 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 
propose 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 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

[[Page 39515]]

8 criteria are new, we assume that stakeholders are familiar with the 
existing criteria and would not need additional time to review but 
would need the additional time to verify and confirm if the considered 
activity meets all the 8 criteria. We seek comment on our proposed 
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 proposals to revise the criteria.
    In the CY 2021 PFS final rule, we finalized an exception stating 
that during public health emergencies (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 
proposing to clarify that in order to implement a new improvement 
activity for a PHE during the same year as the nomination, the 
nomination would 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 proposal will not affect our currently approved 
burden estimates since we assume 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. 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 proposed revisions to our currently approved burden 
estimate.
    In section IV.A.3.d.(3)(c)(i)(C)(aa) of this rule, we are proposing 
that beginning with the CY 2022 MIPS performance period/2024 MIPS 
payment year we are proposing that 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 
proposal as described, the proposed policy does not change requirements 
for the nomination of improvement activities. This proposal would help 
avoid stakeholder confusion and ensure the accuracy of the available 
activities in the Inventory. Therefore, we are not proposing to revise 
our estimated burden due to the above proposed 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. The 2021 Annual Call for Activities 
ends on July 1, 2021; assuming updated information is available, we 
will update our estimate in the final rule.
    As shown in Table 105, 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 propose to revise 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] TP23JY21.133

    As shown in Table 106, 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)]).

[[Page 39516]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.134

k. Nomination of MVPs
    This rule does not propose any new or revised collection of 
information requirements or burden related to the nomination of MVPs 
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 proposing any changes 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 proposed policies in this rule do not result in the need 
to add or revise or delete any claims data fields. Consequently, we are 
not proposing any changes under that control number.
m. ICRs Regarding Partial QP Elections (Sec. Sec.  414.1310(b) and 
414.1430)
    This rule does not propose 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 
proposing to adjust our currently approved burden estimates based on 
updated projections for the CY 2022 MIPS performance period/2024 MIPS 
payment year. The proposed adjusted burden will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621).
    As shown in Table 107, based on our predictive QP analysis for the 
2022 QP performance period/2024 payment year, which accounts for 
historical response rates in the CY 2020 MIPS performance period/2022 
MIPS payment year, we propose to revise 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 propose to revise 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] TP23JY21.135

    As shown in Table 108, using our unchanged currently approved per 
respondent burden estimate, the proposed 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) (85 FR 
84991).

[[Page 39517]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.136

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 proposing any new or revised collection of 
information requirements related to the Payer-Initiated Process. 
However, we are proposing to adjust our currently approved burden 
estimates based on updated projections for the CY 2022 MIPS performance 
period/2024 MIPS payment year.
    As shown in Table 109, based on the actual number of requests 
received in the 2020 QP performance period, we propose to revise 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 propose to revise our estimated annual 
burden to 150 hours (15 submissions x 10 hr/submission) and $14,283 
(150 hr x $95.22/hr).
[GRAPHIC] [TIFF OMITTED] TP23JY21.137

    As shown in Table 110, using our unchanged currently approved per 
respondent burden estimate, the proposed 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) (85 FR 84992).

[[Page 39518]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.138

(2) Eligible Clinician Initiated Process (Sec.  414.1445)
    This rule does not propose any new or revised collection of 
information requirements or burden related to the Eligible-Clinician 
Initiated Process. However, we are proposing to adjust our currently 
approved burden estimates based on updated projections for the CY 2022 
MIPS 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 111, 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 propose to revise our estimated annual burden to 150 
hours (15 submissions x 10 hr/submission) and $14,283 (150 hr x $95.22/
hr).
[GRAPHIC] [TIFF OMITTED] TP23JY21.139

    As shown in Table 112, using our unchanged currently approved per 
respondent burden estimate, the proposed 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) (85 FR 84993).

[[Page 39519]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.140

(3) Submission of Data for QP Determinations Under the All-Payer 
Combination Option (Sec.  414.1440)
    This rule does not propose 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 proposing 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 does not propose any new or revised collection of 
information requirements related to the election by voluntary 
participants to opt-out of public reporting on Physician Compare. 
However, we are proposing adjustments to our currently approved burden 
estimates based on data from the CY 2019 MIPS performance period/2021 
MIPS payment year. The proposed 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 MIPS performance period/2021 MIPS payment year, we propose to 
revise our estimates. We anticipate that 0.1 percent of the total 
clinicians and groups who will voluntarily participate in the CY 2022 
MIPS 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 113 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 9.5 hours (38 requests x 0.25 hr/request) and $904 (9.5 hr x $95.22/
hr).
[GRAPHIC] [TIFF OMITTED] TP23JY21.141

    As shown in Table 108, 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).

[[Page 39520]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.142

p. Summary of Annual Quality Payment Program Burden Estimates
    Table 115 summarizes this proposed rule's total burden estimates 
for the Quality Payment Program for both the CY 2022 and CY 2023 MIPS 
performance periods/2024 and 2025 MIPS payment years. 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 MIPS performance period/2024 MIPS 
payment year is 1,468,547 hours at a cost of $148,093,881. These 
represent a decrease of 5,194 hours and an increase of $4,058,913. To 
understand the burden implications of the proposed 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 MIPS performance periods/2024 MIPS 
payment year. This burden estimate of 1,424,726 hours at a cost of 
$143,682,174 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 43,821 hours and 
$4,411,707. 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 
MIPS performance period/2024 MIPS payment year is 1,428,537 hours and 
$144,040,730, which represents a decrease of 40,010 hours and 
$4,053,151 from the CY 2021 PFS final rule. The difference of +3,811 
hours (43,821 hours-40,010 hours) and +$358,556 ($4,385,824-$4,026,590) 
between this estimate and the total burden shown in Table 115 is the 
reduction in burden associated with impacts of the policies proposed 
for the CY 2022 MIPS performance period/2024 MIPS payment year, which 
includes the re-introduction of the CMS Web Interface measures as a 
collection type/submission type.
    Table 115 also offers a comparison between the total currently 
approved estimated burden from the CY 2021 PFS final rule and our 
proposed estimated burden for the CY 2023 MIPS performance period/2025 
MIPS payment year. Our total burden estimate for the CY 2023 MIPS 
performance period/2025 MIPS payment year is 1,383,744 hours and 
$139,516,153, which represents a decrease of 84,803 hours and 
$8,577,728 from the CY 2021 PFS final rule. The difference of -40,982 
hours (43,821 hours-84,803 hours) and -$4,166,021 ($4,411,707-
$8,577,728) between this estimate and the total burden shown in Table 
115 is the reduction in burden associated with impacts of the policies 
proposed for the CY 2023 MIPS performance period/2025 MIPS payment 
year. These policy changes include the proposals to sunset the CMS Web 
Interface measures as a collection type/submission type and to 
implement a new information collection for MVPs and subgroups.
    We have included Table 115 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 proposed 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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[[Page 39524]]


[GRAPHIC] [TIFF OMITTED] TP23JY21.146

    The following table represents averages for the estimated changes 
in burden for the CY 2022 and CY 2023 MIPS performance periods/2024 and 
2025 MIPS payment years.
[GRAPHIC] [TIFF OMITTED] TP23JY21.147

    Table 119 provides the reasons for changes in the estimated burden 
for information collections in the Quality Payment Program segment of 
this proposed rule. We have divided the reasons for our change in 
burden into those related to 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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[[Page 39526]]


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[GRAPHIC] [TIFF OMITTED] TP23JY21.150

C. Summary of Annual Burden Estimates for Proposed Changes

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[GRAPHIC] [TIFF OMITTED] TP23JY21.151

D. Submission of Comments

    We have submitted a copy of this rule to OMB for its review of the 
rule's proposed information collection requirements and burden. The 
requirements are not effective until they have been approved by OMB.
    To obtain copies of the supporting statement and any related forms 
for the proposed collections previously discussed, please visit CMS's 
website at https://www.cms.gov/RegulationsandGuidance/Legislation/PaperworkReductionActof1995/PRAListing.html, or call the Reports 
Clearance Office at (410) 786-1326.
    We invite public comments on the proposed information collection 
requirements and burden. If you wish to comment, please submit your 
comments electronically as specified in the DATES and ADDRESSES 
sections of this proposed rule and identify the rule (CMS-1751-P) and 
where applicable the ICR's CFR citation, CMS ID number, and OMB control 
number.

VI. Response to Comments

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

VII. Regulatory Impact Analysis

A. Statement of Need

    In this proposed rule, we are proposing to make payment and policy 
changes under the Medicare PFS and required statutory changes under the 
Consolidated Appropriations Act, 2016 and sections 2003 and 2005 of the 
SUPPORT for Patients and Communities Act of 2018. We are also proposing 
changes to payment policy and other related policies for Medicare Part 
B. In addition, if finalized, this proposed rule would 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 proposed rule is necessary to make policy changes under 
Medicare fee-for-service and to address various provider and supplier 
enrollment issues. Therefore, we include 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 proposed

[[Page 39529]]

rule would 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 https://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. The analysis 
must include a justification concerning the reason action is being 
taken, the kinds and number of small entities the rule affects, and an 
explanation of any meaningful options that achieve the objectives with 
less significant adverse economic impact on the small entities.
    Approximately 95 percent of practitioners, other providers, and 
suppliers are considered to be small entities, based upon the SBA 
standards. There are over 1 million physicians, other practitioners, 
and medical suppliers that receive Medicare payment under the PFS. 
Because many of the affected entities are small entities, the analysis 
and discussion provided in this section, as well as elsewhere in this 
proposed rule is intended to comply with the RFA requirements regarding 
significant impact on a substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 603 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area for Medicare 
payment regulations and has fewer than 100 beds. Medicare does not pay 
rural hospitals for their services under the PFS; rather, the PFS pays 
for physicians' services, which can be furnished by physicians and NPPs 
in a variety of settings, including rural hospitals. We did not prepare 
an analysis for section 1102(b) of the Act because we determined, and 
the Secretary certified, that this proposed rule will not have a 
significant impact on the operations of a substantial number of small 
rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits on state, 
local, or tribal governments or on the private sector before issuing 
any rule whose mandates require spending in any 1 year of $100 million 
in 1995 dollars, updated annually for inflation. In 2021, that 
threshold is approximately $158 million. This proposed 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 proposed 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 proposed rule; details the costs and benefits of the rule; 
analyzes alternatives; and presents the measures we would use to 
minimize the burden on small entities. As indicated elsewhere in this 
proposed rule, we discussed a variety of changes to our regulations, 
payments, or payment policies to ensure that our payment systems 
reflect changes in medical practice and the relative value of services, 
and implementing statutory provisions. We provide information for each 
of the policy changes in the relevant sections of this proposed rule. 
We are unaware of any relevant federal rules that duplicate, overlap, 
or conflict with this proposed rule. The relevant sections of this 
proposed rule contain a description of significant alternatives 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 budget neutrality.
    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 
proposed rule reflect averages by specialty based on Medicare 
utilization. The payment impact for an individual practitioner could 
vary from the average and would 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 required by 
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 budget neutrality 
adjustment required as described in the preceding paragraphs. We 
estimate the CY 2022 PFS CF to be 33.5848 which reflects the budget

[[Page 39530]]

neutrality adjustment under section 1848(c)(2)(B)(ii)(II) of the Act, 
the 0.00 percent update adjustment factor specified under section 
1848(d)(19) of the Act, and the 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 21.0442 which reflects the same overall 
PFS adjustments with the addition of anesthesia-specific PE and MP 
adjustments.
[GRAPHIC] [TIFF OMITTED] TP23JY21.152

    Table 123 shows the payment impact of the policies contained in 
this proposed rule on PFS services, should CMS finalize this rule as 
proposed. 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 
123 (CY 2022 PFS Estimated Impact on Total Allowed Charges by 
Specialty). The following is an explanation of the information 
represented in Table 123.
     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.
BILLING CODE 4120-01-P

[[Page 39531]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.153


[[Page 39532]]


[GRAPHIC] [TIFF OMITTED] TP23JY21.154

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 portable x-ray, family practice, hand surgery, general 
practice, and endocrinology, reflect increases relative to other 
physician specialties. These increases can be attributed largely to the 
proposed update to clinical labor pricing as the services that these 
specialties furnish rely primarily on clinical labor for their PE 
costs. These increases are also due to proposed increases in value for 
particular services in response to 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 
oral/maxillofacial surgery reflect decreases in payments relative to 
payment to other physician specialties which are largely the result of 
the redistributive effects of the proposed clinical labor pricing 
update. The services furnished by these specialties involve PE costs 
that rely primarily on supply or equipment items and therefore are 
affected negatively by the proposed 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 proposed 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 123), including comments received 
in response to the proposed 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 123 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 52 percent of 
practitioners, representing more than 48 percent of the changes in 
Total RVUs for all practitioners, with variation by specialty. Some 
specialties, such as chiropractic, clinical social worker, and 
emergency medicine, exhibit little variation in changes in total RVUs 
per practitioner. For these specialties, more than 90 percent of these 
practitioners would 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, 32 percent of IDTFs would experience a 5 percent or 
more decrease in Total RVUs, but these suppliers represent only 28 
percent of Total RVUs for this specialty. Meanwhile, one percent of 
IDTFs would experience 10 percent or more increases in Total RVUs and 
these suppliers account for 28 percent of Total RVUs for this 
specialty.
b. Impact
    Column F of Table 123 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 proposed rule website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We selected these 
procedures for sake of illustration from among the procedures most 
commonly furnished by a broad spectrum of specialties. The change in 
both facility rates and the nonfacility rates are shown. For an 
explanation of facility and nonfacility PE, we refer readers to 
Addendum A on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.

D. Effect of Proposed Changes Related to Telehealth Services

    Before the PHE for COVID-19, approximately 15,000 fee-for-service 
Medicare beneficiaries received a Medicare telemedicine service each

[[Page 39533]]

week. According to a report prepared by the Assistant Secretary for 
Planning and Evaluation (ASPE),\251\ 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 270 services currently included on the 
list of Medicare telehealth services, including more than 160 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.
---------------------------------------------------------------------------

    \251\ Medicare Beneficiary Use of Telehealth Visits: Early Data 
from the Start of the Covid-19 Pandemic (hhs.gov).
---------------------------------------------------------------------------

    As discussed in section II.D. of this proposed rule, we are 
proposing 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 would occur without the change. The estimated cost 
impact on overall Medicare services is unclear, though these changes 
would 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.
    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 
requires 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 proposed rule, we are proposing to require 
that, as a condition of payment for a telehealth service described in 
section 1834(m)(7) of the Act, 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.
    We are also seeking 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. 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.
    With regard to our proposal to retain all services added to the 
Medicare telehealth services list on a Category 3 basis until the end 
of CY 2023, we believe our proposals would 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. The 
statutory payment requirements 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 utilization outside of the COVID-19 PHE; 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. 
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., we are proposing 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 would apply 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 proposed 
revision to the policy would 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 our proposal, the PT/OT services would not be inadvertently 
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 PTA/OTA service with 5 minutes remaining. Under the 
proposed 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

[[Page 39534]]

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 would lead to 
a reduced payment for a unit of a service. There may be a cost 
implication to our proposal as fewer billing scenarios may result in 
application of the CQ/CO modifiers and consequent payment reduction. 
However, we believe that basing our proposed 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 proposed rule, we make multiple proposals 
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 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 H.R. 1868, 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, is 
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 is to 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 124 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 calendar year (CY) 2021 is $87.52, which is 1.4 percent higher than 
the CY 2020 payment limit of $86.31.
[GRAPHIC] [TIFF OMITTED] TP23JY21.155

    In section III.B. of this proposed rule, we discuss that we are 
proposing 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 proposal is 
unclear, the proposed requirement that a modifier be appended to the 
claim to identify that the service was furnished via audio-only 
communication technology would allow us to closely monitor utilization 
and address any potential concerns

[[Page 39535]]

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 proposed 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 proposed 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 
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 proposed rule.)
    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 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 proposed rule 
would necessitate the revision of existing Medicaid Drug Rebate 
Agreements.
    We welcome comment on (1) the likely costs or savings to 
beneficiaries, the government, and other stakeholders and (2) other 
related impacts of this provision.
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 proposed rule, hereinafter is 
referred to as ``section 405''). As identified by the OIG studies 
discussed in section III.D.2. of this proposed 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 proposed 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 would 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 proposed 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 a 
comprehensive regulatory impact analysis for this program. In this 
proposed rule, we are proposing 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 proposals, the payment penalty phase will be further delayed, we 
are updating the estimates for incremental changes from the regulatory 
impact analysis from the CY 2019 PFS final rule. Since we are not 
proposing 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)

[[Page 39536]]

we are only updating the analysis to reflect 2019 Medicare claims data 
(updated from 2014). We identify four incremental changes from the CY 
2019 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 would be performed by a medical assistant (occupation 
code 31-9092) and 10 percent of consultations would 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 
propose to change the methodology used to determine the volume of 
consultations and propose 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 propose to change the method of 
counting the total number of advanced diagnostic imaging services that 
would 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 propose 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

[[Page 39537]]

and potential decreases in inappropriate utilization of advanced 
diagnostic imaging services. This assumption was based on literature 
describing prior 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 125 summarizes the substantive changes from the CY 2019 PFS 
final rule to the CY 2022 PFS proposed 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] TP23JY21.156

5. Proposal To Remove Select National Coverage Determinations (NCDs)
    We are proposing 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 would 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 we are proposing to go from limited coverage 
to MAC discretion, claims data from 2019 shows that less than one 
percent of the Medicare population is affected. Specifically, we 
provide coverage with limitations for enteral nutrition and parenteral 
nutrition therapy under NCD 180.2, 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 proposed rule, 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 not result in significant changes to payments.
    For the one non-covered NCD proposed to be eliminated, Positron 
Emission Tomography (PET) Scans under NCD 220.6, we would 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

[[Page 39538]]

beneficiaries. As discussed in section III.F. of this proposed 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 candidates and provides a framework that better 
serves the needs of the Medicare program and its beneficiaries. For 
clarity, we are not proposing to change any other subsections of 220.6. 
Thus, the NCDs listed at 220.6.1 through 220.6.20 would not be changed 
by this proposal.
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 proposed rule, we are proposing 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 are proposing 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 are also proposing 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.
    In assessing the impact of these proposals, we note that the 
proposed expansion of PR coverage may increase utilization. Based on 
the low utilization rate discussed below, we do not believe the other 
proposed revisions will significantly impact utilization and the 
Medicare program.
    To estimate the potential increase from the proposed 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).\252\ 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.\253\ Using claims data from fee-for-service Medicare 
beneficiaries hospitalized for COPD in 2014, Lindenauer et al. (2020) 
reported that only 3 percent initiated PR within 1 year of their 
hospital discharge.\254\ 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.
---------------------------------------------------------------------------

    \252\ 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.
    \253\ 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.
    \254\ 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 
proposed expansion of coverage (hospitalized with COVID-19 and 
experiencing persistent symptoms, including respiratory dysfunction, 
for at least 4 weeks after discharge) will participate in PR.
    To identify the eligible beneficiaries under our proposal, we first 
identify the number of beneficiaries hospitalized with COVID-19 using 
the Preliminary Medicare COVID-19 Data Snapshot.\255\ At the time of 
writing, the Snapshot included data from January 1, 2020 to March 20, 
2021, and identified 1,141,592 total COVID-19 hospitalizations for 
Medicare beneficiaries. The Snapshot indicates that 18 percent of these 
patients expired so we reduce this number by 18 percent to 936,105 
beneficiaries. A paper published by the Tony Blair Institute for Global 
Change \256\ 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 proposing to expand PR coverage to, those who were hospitalized 
with a COVID-19 diagnosis and experienced persistent symptoms, 
including respiratory dysfunction, for at least 4 weeks after hospital 
discharge, to be 93,611 beneficiaries (936,105 x 0.10). Based on our 
assumption of utilization above, 3 percent, for the newly proposed 
covered patient population, we estimate 2,808 beneficiaries will 
receive PR (93,611 x 0.03).
---------------------------------------------------------------------------

    \255\ https://www.cms.gov/files/document/medicare-covid-19-data-snapshot-fact-sheet.pdf.
    \256\ 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 proposed expansion of coverage 
would participate, on average, in the same number of sessions, we 
estimate the proposed expansion of coverage will increase PR 
utilization by 39,312 sessions annually (2,808 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 $2,134,279 (39,312 PR sessions x 0.9754 x 
$55.66). The remaining 2.46

[[Page 39539]]

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 hospital outpatient department which has a national 
average price of $13.96. Taken together, the estimated total for this 
remaining 2.46 percent of PR sessions is $27,168 ((39,312 PR sessions x 
0.0212 x $30.36) + (39,312 PR sessions x 0.0034 x $13.96)). We estimate 
the total added cost to the Medicare program of this proposed expansion 
of coverage to be $2,161,447 ($2,134,279 + $27,168) annually during and 
immediately following the public health emergency (PHE) for COVID-19. 
As hospitalizations and 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 proposals 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 proposed rule, we are proposing 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 proposed 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.257 258 259 The Academy of 
Nutrition and Dietetics recognizes that research specific to the 
underuse of MNT services is scant.\260\ 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.\261\ Of about 100,000 RDs in the US, only 1,589 
submitted Medicare fee-for-service 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.\262\
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    \257\https://www.eatrightpro.org/payment/nutrition-services/medicaid/medicaid-and-rdns
    \258\ 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.
    \259\ 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.
    \260\ 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.
    \261\ Ibid.
    \262\ 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.
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    Our proposed revisions may increase beneficiary access to the MNT 
benefit and reduce primary care physician burden since we are proposing 
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 proposed 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 III.J.1.d. of this proposed rule, we are proposing to 
freeze the quality performance standard at the 30th percentile MIPS 
Quality Performance Category Score for performance year 2023, 
increasing to the 40th percentile MIPS Quality performance category 
score in performance year 2024. Without this proposed change, the 
quality standard would have increased to the 40th percentile in 2023. 
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.
    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 as 
would apply for PY 2023 without the proposed 1-year delay. There is 
significant uncertainty whether PY 2023 would play out similarly to the 
baseline data. The fraction of ACOs ultimately failing 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 would 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.
    In addition, in section III.J.1.c. of this proposed rule, we are 
proposing an update to the quality reporting requirements under the APM

[[Page 39540]]

Performance Pathway or APP for performance years 2022 and 2023.
    For performance year 2022: An ACO would be required to report on 
either
    (a) 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
    (b) The three eCQM/MIPS CQM measures 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 at Sec.  414.1340 and the case minimum requirement at 
Sec.  414.1380 for all three eCQM/MIPS CQM measures, and achieves a 
quality performance score equivalent to or higher than the 30th 
percentile 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 six measures in the APP measure set would 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 eCQM/MIPS 
CQM measures, 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 eCQM/MIPS CQM measures and does not administer a 
CAHPS for MIPS survey under the APP, the ACO will not meet the quality 
performance standard.
    For performance year 2023: An ACO would be required to report on 
either:
    (a) The ten CMS Web Interface measures and at least one eCQM/MIPS 
CQM measure and administer a CAHPS for MIPS survey and CMS would 
calculate the two claims-based measures included under the APP or
    (b) The three eCQM/MIPS CQM measures 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 eCQM/MIPS CQM measures, and 
achieves a quality performance score equivalent to or higher than the 
30th percentile on 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 six measures in the APP measure set would 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 eCQM/MIPS CQM measures, it 
will receive the higher of the two quality scores for purposes of the 
MIPS Quality performance category.
    If an ACO does not report at least one eCQM/MIPS CQM measure the 
ACO would not meet the quality performance standard.
    Absent the related proposal analyzed above to reduce the 
performance standard to the 30th percentile MIPS Quality performance 
category score, the proposed 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 would 
have likely provided an easier path for a meaningful subset of ACOs 
that would have otherwise faced difficulty meeting the quality 
threshold previously established in rulemaking for PY 2023. However, we 
estimate that nearly all such ACOs would already meet the lower 30th 
percentile performance standard in PY 2023 without the additional 
reporting flexibility. Of the relatively few, remaining ACOs, that we 
estimate would fail to meet the proposed lower 30th percentile 
performance standard, we estimate that about half (on average) would 
meet the quality performance standard as a result of the proposed 
quality reporting flexibility, and thereby further increase shared 
savings payments to ACOs by about $20 million in PY 2023.
b. Modifications to Other Shared Savings Program Requirements
    We do not anticipate a material aggregate impact for the other 
changes we are proposing 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 proposed 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 
proposed 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 proposed 
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 proposed rule).
    However, as we note in section III.J.3. of this proposed 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 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).
    We also note that the proposed revisions 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 
changing the competing ACO to which a beneficiary ultimately is 
assigned, for a small subset of beneficiaries. We do not anticipate 
such ACO-level changes would result in a net impact on program spending 
overall.
9. Medicare Ground Ambulance Data Collection System
    In section III.K. of this proposed rule, we propose a series of 
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.
    While we believe that these changes and clarifications will be well 
received by the ground ambulance stakeholders, we do not believe that 
these changes would have any substantive impact on the cost or time 
associated with completing the Medicare Ground Ambulance Data 
Collection Instrument. We note that the overall length of the Medicare 
Ground Ambulance Data Collection Instrument is the same as previously 
finalized (84 FR 62888) with these changes. Additionally, some of the

[[Page 39541]]

instructions which we propose to add are intended to improve clarity 
and may therefore reduce the time the ground ambulance organizations 
spend addressing the questions.
10. Medicare Diabetes Prevention Program Expanded
a. Effects of Proposals Relating to the Medicare Diabetes Prevention 
Program Expanded Model
(1) Effects on Beneficiaries
    We propose 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 
proposed 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 to beneficiaries. Eligible beneficiaries receive these 
services as preventive services, which require no copays or cost 
sharing. These proposed changes address MDPP supplier and beneficiary 
needs based upon all available monitoring and evaluation data. The 
proposed 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. Since a second year of the MDPP 
deviates from both the DPP model test and the National DPP clinical 
trial protocol, we propose 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 program.
(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 would not qualify and the 
hardship application process would 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 would 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 would neither enroll nor be able 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 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 permanent waiver of the fee for 
MDPP suppliers to extend beyond the COVID-19 Emergency Declaration 
Blanket Waiver, along with the other proposed change to MDPP, may 
stimulate MDPP supplier enrollment and enhance the MDPP evaluation. We 
propose 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 propose, 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

[[Page 39542]]

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 
proposed 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 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 interval, and after attending the two (2) sessions 
during each of the core maintenance intervals. We have increased 
performance payments for beneficiary achievement of the 5 percent 
weight loss goal as well as continued attendance during the core 
maintenance intervals. Although the proposed maximum payment of $661 
over a 1-year service period is less 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 financially 
sustainable expanded model.
    Increasing the first year MDPP payment amounts should not 
negatively affect a supplier's performance (for example, participants' 
weight loss). The increase to the payment amounts are not applied until 
after the 4th core session and the largest payments to suppliers are 
still driven by weight loss achievement. 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.
(4) Effects on the Medicare Program
(a) Estimated 10-Year Impact of MDPP
    Table 126 shows estimates (in millions) for the impact on Medicare 
spending of two proposed changes to the Medicare Diabetes Prevention 
Program (MDPP) to be implemented in 2022:
     Waiving the Medicare enrollment fee for all new MDPP 
suppliers; and
     Shortening the MDPP services period to 1 year and shifting 
some of the Ongoing Maintenance reimbursement amounts to year one.
[GRAPHIC] [TIFF OMITTED] TP23JY21.157

    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. 
In the most recent year prior to the Public Health Emergency (PHE), 
1,742 Medicare 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 2,000 
beneficiaries would have entered the program each year without 
including the proposed changes. After including these changes, we will 
now assume 2,500 beneficiaries will enter the program each year. This 
assumption has a high level of uncertainty and we revisit it in the 
Sensitivity Analysis section.
(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 proposed changes is highly uncertain. Table 127 shows 
the 10-year impact estimates (in millions) for different levels of 
additional beneficiary participation as a result of the proposed 
changes:
[GRAPHIC] [TIFF OMITTED] TP23JY21.158

    Finally, higher projected savings are associated with increases in 
beneficiary participation, while no additional beneficiaries would 
result in an estimated cost.
b. Alternatives Considered
    No alternatives were considered. The 2-year MDPP service period has 
depressed interest in MDPP among would-be MDPP suppliers. These 
proposed 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

[[Page 39543]]

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 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 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 ends 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 have started the MDPP expanded model or are 
interested in MDPP.
11. Medicare Provider and Supplier Enrollment Changes--Provider 
Enrollment
    As explained in section III.N. of this proposed rule, we propose 
changes to three of our existing revocation reasons:
     We propose to expand Sec.  424.535(a)(2) to permit 
revocation based on the OIG exclusion of an individual serving in an 
administrative or management services role for the provider/supplier, 
such as a billing specialist, accountant, or human resources 
specialist.
     We propose 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 propose 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 would 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). Accordingly, since our expansion of these three revocation 
reasons would be fairly modest, we do not foresee more than a very 
slight increase in revocations thereunder.
    Table 128 outlines the number of revocations we estimate would 
ensue under our proposed revocation expansions. These numbers only 
account for additional revocations stemming from our changes:
[GRAPHIC] [TIFF OMITTED] TP23JY21.159

    Internal CMS data indicates that the average provider/supplier that 
would 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 proposed revocation expansions would thus not receive these 
payments. Hence, multiplying our $50,000 estimate by the revocation 
totals in Table 128 results in a projected transfer from these 
providers/suppliers to the federal government of $750,000 ($50,000 x 15 
revocations).
12. Provider/Supplier Medical Review Requirements--Prepayment and Post-
payment Reviews
    In section III.N.2. of this proposed rule, we are proposing 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 proposals involve any additional impact or burden on providers, 
suppliers, or states; however, we welcome feedback from stakeholders 
regarding the potential costs of these proposals.
    The proposed regulations would incorporate already established key 
terms and definitions as well as processing requirements pertaining to 
prepayment and post-payment medical review into regulation. Although 
placing this information in regulation could improve provider and 
supplier understanding of the medical review process and their 
responsibilities in complying with our review contractor's requests, 
the proposed regulations represent no change to medical review 
requirements. As such, we do 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.
13. Effect of Proposed 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 proposed rule, we are 
proposing 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

[[Page 39544]]

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 the Part B cost impact of this proposal would 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 proposal would increase the frequency at which 
medically necessary counseling and therapy services are billed using 
the counseling and therapy add-on code (HCPCS code G2080). However, we 
are also proposing 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 this proposed change would facilitate broader 
access to these services for beneficiaries.
    Additionally, as discussed in section III.O. of this proposed 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 would be provided with a box of two 4mg nasal spray 
products. At the time of drafting this proposed rule, we do 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 are proposing to create a new G-code describing a 
take-home supply of this higher dose naloxone hydrochloride nasal spray 
product. Since pricing information is unavailable for this new product 
at the time of drafting this proposed rule, the estimated cost impact 
is unclear at this time, however, we believe utilization would be low 
based on CY 2021 claims data received so far for HCPCS code G2215.
14. Physician Self-Referral Update
    The physician self-referral law provisions are discussed in section 
III.P. of this proposed rule.
    As discussed in section III.P. of this proposed rule, we are 
proposing to amend the provisions of Sec.  411.354(c)(2) identifying 
unbroken chains of financial relationships that constitute ``indirect 
compensation arrangements'' to ensure that a long-standing prohibition 
on certain per-unit of service 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 
compensation formulas for the rental of office space and equipment as 
they have done since the requirements became effective on October 1, 
2009. In response to stakeholder inquiries, we are also proposing to 
add provisions to assist stakeholders in identifying the individual 
unit to be analyzed under the provisions of Sec.  
411.354(c)(2)(ii)(A)(i) through (iii) and proposed Sec.  
411.354(c)(2)(ii)(A)(iv). We believe that the clarity provided by this 
proposal would facilitate compliance without adding burden.
    As discussed in section III.P. of this proposed rule, we are 
proposing to permit the use of the exception for preventive screening 
tests, immunizations, and vaccines 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. We believe that this proposal would ensure that the 
physician self-referral law would not impede the availability of 
critically important COVID-19 vaccines for Medicare and other patients.
    As discussed in section III.P. of this proposed rule, we are 
proposing regulatory updates related to the process for publication of 
the Code List for Certain Designated Health Services (the Code List). 
Specifically, we would update the Code List each calendar quarter. We 
would provide public notification on the CMS website in advance of each 
Code List update, followed by a 30-day public comment period. We would 
provide information on the CMS 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. In addition, 
instead of publishing in the PFS final rule, we would publish the Code 
List solely on the CMS website. Finally, we would revise 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 proposals would make available the most recent 
updates in a timelier manner and allow easier access to the most up-to-
date Code List.
15. 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 proposed 
rule, we expect that there would 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, we have 
estimated the costs of (A) development of operational strategy for the 
new program, (B) reviewing PDE data, and (C) prescriber case work. We 
solicit stakeholder feedback on this estimate and all our assumptions.
    (A) Development of policy: We estimate 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 estimate 
that it would an operations manager and compliance officer working 
together at a combined hourly wage of $193.60/hr ($120.90/hr + $72.70/
hr) would need a full 40-hour work week to operationalize this aspect 
of it. Therefore, the aggregate cost would be $7,744 (40 hr * $193.60/
hr).
    (B) Since systems already exist to collect the appropriate PDE 
data, our contractor would only have to review the data for compliance 
with the EPCS mandate. We therefore estimate that it would take 2 
computer systems analyst each working at $95.22/hr, a week and a half 
of work, 60 hours. Therefore, the aggregate cost is $5,713.20 (60 hr * 
$95.22/hr).
    (C) We estimate 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,

[[Page 39545]]

which means that it would cost our contractor $2,209.20/year (60 hr * 
$36.82/hr) in administrative support costs. We estimate 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 expect that our contractor will 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 seek 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
16. Open Payments
a. Payment Context Field for Teaching Hospitals
    This proposal is for a mandatory freeform text context field. We 
have created this proposal 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 attribute it 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 also 
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 compared to physician covered recipient payments, 
the number of teaching hospital payments is much lower. In addition, we 
have given flexibility to 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 definition of a POD that would be appropriate 
for the program's needs. Though 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 proposal 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 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.
17. Updates to the Quality Payment Program
    In section IV.A. of this proposed rule, we included our proposed 
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 
2022

[[Page 39546]]

MIPS performance period based on various proposed policies, including 
to modify MIPS eligibility, the MIPS final score and the performance 
threshold and additional performance threshold as discussed in sections 
IV.A.3.a.(1) and IV.A.3.f. of this proposed rule.
    This RIA uses the 2019 MIPS performance period submissions that 
were used for the CY 2021 PFS final rule RIA (85 FR 85011 through 
85023). The submissions for the 2020 MIPS performance period were not 
available in time to incorporate into this model and to assess whether 
the data for 2020 can be used to effectively predict future 
performance. 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 Public Health Emergency 
(PHE) (https://qpp.cms.gov/resources/covid19?py=2020). Due to these 
extreme and uncontrollable circumstances policy, not all clinicians or 
groups may have submitted performance category data for the 2020 MIPS 
performance period. We will evaluate for the final rule whether it is 
appropriate to use the 2020 performance period data and whether 
adjustments would need to be made if CY 2020 performance category 
submissions data are used.
    We ran two RIA models: A baseline and proposed policies RIA model. 
The aim of the baseline model is to reflect the CY 2022 performance 
period/2024 MIPS payment year if this proposed rule did not take 
effect, and therefore, reflects previously finalized policies for the 
CY 2022 performance period/CY 2024 MIPS payment year. Select examples 
of the baseline policies scheduled to start in the CY 2022 MIPS 
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. Our baseline model used the performance threshold and 
additional performance threshold of the CY 2021 MIPS performance 
period/2023 MIPS payment year since those values were not previously 
defined for the CY 2022 MIPS performance period/2024 MIPS payment year. 
The aim of the proposed policies model is to estimate the incremental 
effect of the proposed policies for the CY 2022 performance period/CY 
2024 MIPS payment year on MIPS eligibility, MIPS final scores, and 
payment adjustments. Select examples of the proposed 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 new complex 
patient bonus. Refer to section VII.F.17.d.(2) of this proposed rule 
for the detailed methods on how we integrated the policies into the 
baseline and proposed policies models.
a. Estimated APM Incentive Payments to QPs in Advanced APMs and Other 
Payer Advanced APMs
    For payment years from 2019 through 2024, through the Medicare 
Option, eligible clinicians who have a sufficient percentage of their 
Medicare Part B payments for covered professional services or Medicare 
patients through Advanced APMs will be QPs in the applicable QP 
performance period for a year. These QPs will receive a lump-sum APM 
Incentive Payment equal to 5 percent of 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, would 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 another exemption category, the eligible 
clinician would be subject to MIPS, would report to MIPS, and would 
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 would 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 be excluded from MIPS, and 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 proposed 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 VII.F.17.a. of this proposed rule, we projected the 
number of eligible clinicians that will be QPs, and thus excluded from 
MIPS, using several sources of information. First, the projections are 
anchored in the most recently available public information on Advanced 
APMs. The projections reflect Advanced APMs that will be operating 
during the 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 would 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. 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;

[[Page 39547]]

     Kidney Care Choices Model (Kidney Care First; Professional 
Option and Global Option);
     Maryland Total Cost of Care Model (Care Redesign Program; 
Maryland Primary Care 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 would 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.
b. Impact for the CY 2021 MIPS Performance Period/2023 MIPS Payment 
Year
    In section IV.A.3.e.(2)(a)(ii) of this proposed rule, we proposed 
to double the complex patient bonus, and to increase its cap to 10 
points. We expect this proposed policy to result in the median bonus to 
increase by 3 points, 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 2021 MIPS 
performance period (85 FR 85012 through 85019). Directionally, 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 lowering 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.
c. Estimated Number of Clinicians Eligible for MIPS Eligibility for the 
2022 MIPS 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 2022 
MIPS performance period and the effect of the proposed policies in this 
proposed rule, we ran two models as described in section VII.F.17.: A 
baseline model and proposed policies model.
    For the baseline and proposed policies models, we used the same 
eligibility files and approach as 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 proposed 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 proposed 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 
proposed rule for the 2022 QP performance period for both models.
    (3) In the proposed policies model, we included in our estimated 
MIPS eligible population for the CY 2022 performance period/2024 
payment year clinical social workers and certified nurse-midwives as 
proposed in section IV.A.3.a.(1) of this proposed rule.
    (4) In the proposed policies model, we are integrating the proposal 
that starting with the CY2022 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 proposed policy is described at 
section IV.A.3.a. 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 or at 
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 proposed 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 VII.F.17.c.(1)(c) the incremental impact of the 
proposed policies from the baseline model for the CY 2022 performance 
period/2024 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 would receive an APM 
Performance Pathway (APP) score consistent with the policy as finalized 
in the CY 2021 PFS final rule (85 FR

[[Page 39548]]

84897).\263\ We assumed APM TINs that qualified for opt-in and 
submitted data as a TIN would also be eligible. Finally, we did not 
consider clinicians in groups as MIPS eligible clinicians and start a 
group score for clinicians in small practices with only Medicare Part B 
claims submissions to reflect the proposed policy at section IV.A.3.a. 
of this rule.
---------------------------------------------------------------------------

    \263\ Under the proposed 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.
---------------------------------------------------------------------------

    For the proposed policies model, we estimate approximately 212,000 
clinicians \264\ 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. We identify these 
clinicians as having ``required eligibility'' in Table 129. We estimate 
approximately 595,000 additional MIPS eligible clinicians will be 
eligible because they belong to an APM entity, group or virtual group 
that meets the low-volume threshold and submits to MIPS. These 
clinicians are identified as having ``group eligibility'' in Table 129. 
Finally, we estimate about 3,000 clinicians would 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 2022 performance period/2024 payment year.
---------------------------------------------------------------------------

    \264\ The count of 212,000 MIPS eligible clinicians for required 
eligibility includes those who participated in MIPS (approximately 
185,000 MIPS eligible clinicians), as well as those who did not 
participate (approximately 27,000 MIPS eligible clinicians).

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

[[Page 39549]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.160

    Furthermore, we estimate there will be approximately 412,000 
clinicians who are not MIPS eligible, but could be if their practice 
decides to participate or they elect to opt-in. We describe this group 
as ``Potentially MIPS eligible'' in Table 129. These clinicians would 
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.

[[Page 39550]]

    Finally, we estimate approximately 101,000 clinicians would not be 
MIPS eligible because they and their group are below the low-volume 
threshold on all three criteria and another approximately 304,000 would 
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 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 proposed policies model analysis, we use the estimated population 
of 809,625 MIPS eligible clinicians described above.
(c) Estimated Impact of the Proposed Policies on MIPS Eligibility and 
PFS Allowed Charges
    We illustrate in Table 130 how the proposed policy to add clinical 
social workers and certified nurse-midwives as MIPS eligible clinician 
types as proposed in section IV.A.3.a.(1) of this proposed rule affects 
the estimated number of MIPS eligible clinicians. The first row 
presents the estimates from the RIA baseline model with the number of 
individuals that would be MIPS eligible clinicians for the 2022 MIPS 
performance period/2024 MIPS payment year if this proposed rule did not 
take effect. The second row presents estimates from the RIA proposed 
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 MIPS performance period/2024 MIPS payment year. As shown in 
Table 130, the proposed policy to add clinical social workers and 
certified nurse-midwives as MIPS eligible clinician types leads 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 payment year.
[GRAPHIC] [TIFF OMITTED] TP23JY21.161

d. Estimated Impacts on Payments to MIPS Eligible Clinicians for the CY 
2022 Performance Period/2024 Payment Year
(1) Summary of Approach
    In sections IV.A.3.d., IV.A.3.e. and IV.A.3.f. of this proposed 
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 VII.F.17.d. of this RIA as we describe our 
methodology to estimate MIPS payments for the CY 2022 performance 
period/2024 payment year. We then present the impact of the overall 
proposed policies on the CY 2022 performance period/2024 payment year 
and then compare select metrics to the baseline model, which only 
incorporates previously finalized policies for the CY 2022 performance 
period/2024 payment year. By comparing the baseline model to the 
proposed policies model, we are able to estimate the incremental impact 
of the proposed policies for the CY 2022 performance period/2024 
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 VII.F.17. of this 
proposed rule, we generally used the most recently available 
submissions data from the Quality Payment Program which is data 
submitted for the 2019 MIPS performance period. For the cost 
performance category, we used the same data as the CY 2020 PFS final 
rule (84 FR 63169).
    The estimated payment impacts presented in this proposed rule are 
averages by practice size weighted by Medicare utilization. The payment 
impact for a MIPS eligible clinician will vary from the average and 
would depend on the measure submissions, scores and their performance. 
The average percentage change in total revenues that clinicians earn 
would be less than the impact displayed here because MIPS eligible 
clinicians generally furnish services to both Medicare and non-Medicare 
patients; this program does not impact payment from non-Medicare 
patients. In addition, MIPS eligible clinicians may receive Medicare 
revenues for services under other Medicare payment systems, such as the 
Medicare FQHC PPS, that would not be affected by MIPS payment 
adjustment factors.
(2) Methodology To Assess Impact
    To estimate participation in MIPS for the CY 2022 performance 
period/2024 MIPS payment year for this proposed rule, we generally used 
2019 MIPS performance period data for both the baseline and proposed 
policies models. Our baseline and proposed policies scoring models 
included the 801,013 and 809,625 estimated MIPS eligible

[[Page 39551]]

clinicians, respectively, as described in section VII.F.17.c.(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 the most recent 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.\265\ We calculated a 
hypothetical final score for the 2022 MIPS performance period/2024 MIPS 
payment year for the baseline and proposed policies scoring models for 
each MIPS eligible clinician using score estimates for quality, cost, 
Promoting Interoperability, and improvement activities performance 
categories, where each are described in detail in the following 
subsections.
---------------------------------------------------------------------------

    \265\ 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 proposed policies RIA models for 
the CY 2022 MIPS performance period/2024 payment year.
    For the baseline policies RIA model, which does not reflect the 
proposed policies for CY 2022 MIPS performance period/2024 payment 
year, we made the following modifications to reflect the previously 
finalized policies for the CY 2022 performance period/2024 payment year 
for the quality performance category:
    (1) As previously finalized in the CY 2021 PFS final rule, 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 (85 FR 
84870 and 85 FR 84843). Although the Web Interface is proposed to be 
reinstated for groups for the CY 2022 MIPS performance period/2024 MIPS 
payment year and ACOs for CY 2022 MIPS performance period/2024 MIPS 
payment year and CY 2023 MIPS performance period/2025 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 
MIPS performance period/2024 MIPS payment year as if this proposal 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 would use the other two other collection 
types (MIPS CQMs and eCQMs) available in the 2022 MIPS 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).
    (2) 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).\266\
---------------------------------------------------------------------------

    \266\ Data downloaded on April 9 2021 from https://qpp.cms.gov/resources/resource-library.
---------------------------------------------------------------------------

    For the proposed policies model, we made the following 
modifications to the baseline model to reflect the newly proposed 
policies for the 2022 MIPS performance period/2024 MIPS payment year 
for the quality performance category:
    (1) As discussed in section IV.A.3.d.(1)(e) of this proposed rule, 
we propose for this proposed rule two new administrative claims 
measures for those for whom it is applicable: (1) Risk-Standardized 
Acute Unplanned Cardiovascular-Related Admission Rates for Patients 
with Heart Failure for the Merit-based Incentive Payment System; and 
(2) Clinician and Clinician Group Risk-standardized Hospital Admission 
Rates for Patients with Multiple Chronic Conditions. To implement this 
policy in our proposed policies RIA model for the 2022 MIPS performance 
period/2024 MIPS payment year, we used testing data for these new 
administrative claims measures.
    (2) As discussed in section IV.A.3.e.(1)(c) of this proposed rule, 
we proposed 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. Therefore, we used 2019 MIPS 
performance period benchmarks calculated from the CY 2019 MIPS 
submissions data because the performance data for this analysis came 
primarily from the 2019 MIPS performance period.
    (3) As discussed in section IV.A.3.e.(1)(c)(iii)(A) of this 
proposed rule, we proposed 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. As described in section IV.A.3.e.(1)(c)(iii)(B) of 
this proposed rule, we also proposed to make the following changes: (1) 
Remove the special scoring policy of scoring 3 points for class 2 
measures, except for clinicians in small practices; (2) introduce a 5-
point floor for new measures for their first two performance periods 
that meet data completeness and can be reliably scored against a 
benchmark (class 4a measures); and (3) introduce 5 points 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 incorporated these scoring changes into our proposed 
policies model. Because we are using 2019 MIPS performance period data, 
we assume that measures new to the 2018 and 2019 MIPS performance 
periods could qualify as class 4 measures.
    (4) As discussed in sections IV.A.3.e.(1)(c)(vi) and 
IV.A.3.e.(1)(c)(vii) of this proposed rule, we also propose to end 
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 
proposed rule model for all MIPS collection types.
    (5) As discussed in section IV.A.3.d.(1)(d), we are proposing to 
extend 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 proposed 
policy, we used the same methodology described in the CY 2021 PFS final 
rule (85 FR 85016 through 85017) using 2019 MIPS submissions data.
    (6) Finally, we are also proposing to extend the CMS Web Interface 
as a means of reporting quality under the APM Performance Pathway for 
Shared Savings Program ACOs for the CY 2022 and CY 2023 MIPS 
performance periods and 2024 and 2025 MIPS payment years as described 
in section IV.A.3.c.(2)(a) of

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this proposed rule. Under the proposal, for the CY 2022 and CY 2023 
MIPS performance periods and 2024 and 2025 MIPS payment years, 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. To estimate 
the impact of this proposed 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 proposed policies RIA model 
described in this section.
    In the baseline policies RIA 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 MIPS 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 proposed policies RIA model, we modified the baseline model 
to incorporate the proposal to add five new episode-based cost 
performance category measures in the CY 2022 MIPS performance period/
2024 payment year as described in section IV.A.3.d.(2) of this proposed 
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 
newly proposed 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 CY2018 Quality Payment Program 
final rule (82 FR 53763) and the methodology described in the CY 2020 
PFS final rule (84 FR 63169). For the proposed policies model, we used 
the methodology proposed for the CY 2022 MIPS performance period/2024 
MIPS payment year as discussed in section IV.A.3.e.(2)(b)(v)(B) of this 
proposed rule. We propose 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 RIA 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 proposed 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 and how these clinicians 
would score, we only used past reporting on the existing Health 
Information Exchange Objective measures to estimate CY 2022 Promoting 
Interoperability performance.
    For the proposed rule model, we considered the following policy 
proposals as potential modifications to the baseline RIA model:
    (1) In section IV.A.3.d.(4)(c)(i) of this proposed rule, we 
proposed for the PDMP measure to remain optional and at 10 points. 
Modifications were not made to reflect this proposed policy in the 
proposed policies model since the baseline model already incorporated 
this policy.
    (2) In section IV.A.3.d.(4)(c)(iii) of this rule, we proposed 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. Because we lacked data, we did not integrate this 
requirement into our proposed rule model.
    (3) In section IV.A.3.d.(4)(h)(i) of this rule, we proposed to 
automatically reweight the Promoting Interoperability performance 
category to another performance category and assigned 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 proposed policies model.
    (4) In section IV.A.3.d.(4)(h)(ii) of this proposed rule, we 
proposed to reweight the Promoting Interoperability performance 
category for clinical social workers. This policy was implemented in 
the proposed policies model.
    (5) In section IV.A.3.d.(4)(d) of this proposed rule, we proposed 
the additional requirement that eligible clinicians must attest to 
conducting an annual assessment of the High Priority Guides of the 
SAFER Guides beginning with the 2022 MIPS performance period. This 
policy was not implemented in the proposed 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.
(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 MIPS performance period 
data and APM participation identified in section VII.F.17.c.(1) of this 
proposed rule. For clinicians and groups not participating in a MIPS 
APM, we used the CY 2019 submissions improvement activities

[[Page 39553]]

score. We did not model the policy finalized in 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 VII.F.17.c.(1) of this proposed rule, we assigned an 
improvement activity performance category score of 100 percent.
    For the proposed policies model, we did not make modifications to 
the baseline model to reflect the proposed policies in section 
IV.A.3.d.(3) of this proposed rule since we did not have the data to 
model those changes.
(f) Methodology To Estimate the Complex Patient Bonus Points
    In section IV.A.3.e.(2)(a)(iii)(B) of this proposed rule, we 
proposed to continue the complex patient bonus, with updates, for the 
CY 2022 MIPS performance period/2024 payment year. For the baseline RIA 
model, we used the complex patient bonus information calculated for the 
2019 performance period data for the 2022 MIPS performance period/2024 
payment year, as was previously done in the CY 2021 PFS final rule (85 
FR 85017).
    For the proposed policies RIA model, we calculated the complex 
patient bonus using the calculation proposed in section 
IV.A.3.e.(2)(a)(iii)(B)(cc) of this proposed rule for the CY 2022 
performance period/2024 payment year. In section 
IV.A.3.e.(2)(a)(iii)(B)(aa) of this proposed rule, we propose updates 
to the complex patient bonus for the CY 2022 performance period/2024 
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 proposed policy for the 2022 
performance period, our proposed policies RIA model calculated and 
applied the separate risk indicator complex patient bonus components 
methodology with a single overall cap described in section 
IV.A.3.e.(2)(a)(iii)(B)(dd) of this proposed rule.
(g) Methodology To Estimate the Final Score
    We did not propose any changes for how we calculated the MIPS final 
score. Our baseline and proposed policies RIA models assigned a final 
score for each TIN/NPI by multiplying each estimated performance 
category score by the corresponding performance category weight, adding 
the products together, multiplying the sum by 100 points, adding the 
complex patient bonus, and capping at 100 points.
    For the baseline policies RIA model, we applied the performance 
category weights and redistribution weights finalized in the CY 2021 
PFS final rule (85 FR 84913 through 84916).
    For the proposed policies RIA model, we proposed to modify the 
redistribution policy for small practices. Therefore, we applied 
redistribution weights proposed in section IV.A.3.e.(2)(b)(iii)(A) of 
this proposed 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 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 proposed rule.
(h) Methodology to Estimate the MIPS Payment Adjustment
    For the baseline and proposed policies RIA models, we applied the 
hierarchy as finalized in the CY 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. 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 (as proposed under Sec.  414.1405).
    For the baseline policies 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 proposed policies model, we used the performance 
threshold of 75 points as proposed in section IV.A.3.f. (2) and the 
additional performance threshold of 89 points as proposed 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 proposed policies RIA 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 and proposed policies RIA 
models.
    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 would be redistributed through budget neutrality and that $500 
million would 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 proposed policies 
model estimates that $587 million would be redistributed through budget 
neutrality. For clinicians who meet or exceed the additional 
performance threshold, an additional $425 million was estimated to be 
distributed. The mean and median final scores for the proposed policies 
model are 75.86 and 80.30, respectively.
    In the proposed 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 were sharing the funds available through the 
additional bonus for exceptional performance.

[[Page 39554]]

    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 proposed policies model estimates the maximum MIPS 
positive payment adjustment based on the budget neutral pool at 4.0 
percent and the maximum positive additional MIPS payment adjustment for 
exceptional performance bonus at 10.0 percent for a combined maximum 
payment adjustment of 14.0 percent.
    Finally, we no longer observe large differences in performance 
across practice sizes due to the shift from MIPS transition policies. 
Table 131 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 proposed policies model. We estimate performance 
under the proposed policies will be similar across all practice sizes. 
The smallest proportion of clinicians receiving a positive or neutral 
payment adjustment is among clinicians in practices with 16 to 24 
clinicians compared to other sized practices among those who submit 
data. Table 131 also shows that overall 67.5 percent of MIPS eligible 
clinicians that participate in MIPS are expected to receive positive or 
neutral payment adjustments. In Table 132, we present the overall 
impact of the baseline and the proposed policies models among 
clinicians who submit data to assess the incremental impact of the 
proposed policies. The overall proportion of clinicians receiving a 
positive or neutral payment adjustment decreases from 91.7 percent to 
67.5 percent with the implementation of the proposed policies that 
shift away from MIPS transition policies. Among clinicians who receive 
a positive payment adjustment in the baseline model and receive a 
negative payment adjustment in the proposed policies model, only 30 
percent receive a negative payment adjustment greater than 1 percent. 
In addition, we no longer observe a disproportionate number of 
clinicians in small practices receiving a negative payment adjustment 
when implementing the proposed 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 VII.F.17.f.(2)(e) of this 
proposed rule. The intention of the proposed 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 proposed policies reflect movement away from the 
transition policies implemented during the early years of MIPS and how 
MIPS is focusing on 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 would not 
submit data to MIPS, 85 percent are in small practices (23,056 out of 
27,108 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 2022 performance period/2024 
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 
MIPS performance period/2024 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 for the CY 
2022 performance period/2024 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 2019 performance period/2021 payment year and had a 
performance threshold of 30 points, and that participation may change 
for the 2022 performance period/2024 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 
was not the maximum negative payment adjustment of 9 percent possible 
because some MIPS eligible clinicians that do not submit data to MIPS 
receive a non-zero score for the cost performance category, which 
utilizes administrative claims data and does not require separate data 
submission to MIPS.
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e. Estimated Impacts on Payments to MIPS Eligible Clinicians for the 
2023 MIPS Performance Period/2025 MIPS Payment Year
    We are proposing 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)(d) of the proposed 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 
MIPS performance period/2025 payment year, we do not have the data to 
report who would select MVP and who would report through subgroup in 
the first year and how these clinicians will score. For this regulatory 
impact analysis, 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. As discussed in section V.B.8.e.(7)(a) of this proposed rule, 
for the purposes of estimating burden associated with the proposal to 
implement MVP and subgroup reporting, we assume that 10 percent of MIPS 
eligible clinicians in the CY 2022 MIPS performance period/2024 payment 
year will report as MVP participants in the CY 2023 MIPS performance 
period/2025 payment year. In addition, we assume that there will be 20 
subgroup reporters in the CY 2023 MIPS performance period/2025 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 MIPPS performance period/2025 payment 
year. We refer readers to section V.B.8.e.(7)(a)(iii) of the proposed 
rule for further discussion of burden associated with MVPs and 
subgroups.
f. Additional Impacts from Outside Payment Adjustments
(1) Burden Overall
    In addition to policies affecting the payment adjustments, we are 
proposing several policies that have an impact on burden in the CY 2022 
and CY 2023 MIPS performance periods/2024 and 2025 payment years. In 
section V.B.8 of this proposed rule, we outline estimates of the costs 
of data collection that includes both the effect of proposed policy 
updates and adjustments due to the use of updated data sources. For 
each proposal included in this regulation which impacts our estimate of 
collection burden, the incremental burden for each is summarized in 
Table 133. We also provide proposed additional burden discussions that 
we are not able to quantify.

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BILLING CODE 4120-01-C
(2) Additional Impacts to Clinicians
(a) Web Interface
    As discussed in section IV.A.3.d.(1)(d) of this proposed rule, we 
are proposing 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 MIPS performance period/2024 MIPS 
payment year. We are also proposing to sunset 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 MIPS performance 
period/2025 MIPS payment year. We refer readers to sections V.B.8.e.(8) 
and V.B.8.e.(10) of this proposed rule for our discussion on the 
estimated burden associated with the extension of the CMS Web Interface 
collection type in CY 2022 MIPS performance period/2024 MIPS payment 
year and the sunset of the CMS Web Interface collection type in the CY 
2023 MIPS performance period/2025 payment year. 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).
    As discussed in section IV.A.3.c.(2)(a), we are proposing to extend 
the CMS Web Interface as a means of reporting quality under the APP for 
Shared Savings Program ACOs for the CY 2022 MIPS performance period/
2024 payment year and the CY 2023 MIPS performance period/2025 payment 
year.
(b) Administrative Claims Measure
    As discussed in section IV.A.3.d.(1)(e), we are proposing to add 
the following two new administrative claims measures beginning in the 
2022 MIPS performance period and for future performance periods: (1) 
Risk-Standardized Acute Unplanned Cardiovascular-Related Admission 
Rates for Patients with Heart Failure for the Merit-based Incentive 
Payment System; and (2) 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 proposed rule, 
we are proposing the removal of 7 previously adopted improvement 
activities, modification of 15 existing improvement activities, and 
adoption of 5 new improvement activities. We refer readers to Appendix 
2 of this proposed rule for further details. We do not believe these 
proposed 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 proposed 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

[[Page 39559]]

policies, would continue to perform the same activities under the 
policies in this proposed rule because previously finalized improvement 
activities continue to apply for the current and future years unless 
otherwise modified per rulemaking (82 FR 54175). Most of the 
improvement activities in the Inventory remain unchanged for the CY 
2022 MIPS performance period.
(d) Stakeholders Nominating Improvement Activities
    In section IV.A.3.d.(3)(c)(i)(B) of this rule, we are proposing: 
(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 
public health emergency (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.
    With regard to the proposal to clarify the timeline for an 
improvement activity nominated during the PHE, we believe this proposal 
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 are proposing that in order 
to implement a new improvement activity for a PHE during the same year 
as the nomination, the nomination would 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 proposal, but we do not 
have any data with which to estimate what the additional number may be. 
As a result, we are not making any proposed revisions to our currently 
approved burden estimate.
    Regarding the proposal 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 
proposal described above as the proposed 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 proposals to add two new criteria and to increase the number of 
criteria stakeholders are required to meet when submitting an activity 
proposal from a minimum of 1 to all 8 criteria, which includes the two 
new proposed criteria, we propose 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 VII.F.17.d.(3) of this proposed 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 payment year 
since more clinicians may choose to submit data after 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 made several proposals 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 payment 
year. Based on our RIA model findings described in section 
VII.F.17.d.(3) of this proposed rule, the proposed 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 are proposing multiple 
changes to the third-party intermediary regulations at Sec.  414.1400. 
Specifically, we are proposing: (1) Reorganization and consolidation of 
Sec.  414.1400 generally; (2) 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; (3) 
beginning with the CY 2023 MIPS performance period/2025 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) require QCDRs, qualified 
registries, health IT vendors, and CAHPS for MIPS survey vendors to 
support subgroup reporting, beginning with the CY 2023 MIPS performance 
period/2025 payment year; (5) require QCDRs and qualified registries 
that have never submitted data since the inception of MIPS (CY 2017 
MIPS performance period/2019 payment year) through the 2020 MIPS 
performance period/2022 payment year, to submit a participation plan as 
part of their self-nomination for CY 2023; (6) beginning with the 2024 
MIPS performance period/2026 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) beginning with the CY 2023 
MIPS performance period/2025 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) 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 are proposing to state, 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.
    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 proposal 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

[[Page 39560]]

participants in MIPS, we do 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 are proposing to require QCDRs, qualified registries, health 
IT vendors, and CAHPS for MIPS survey vendors to support subgroup 
reporting, beginning with the CY 2023 MIPS performance period/2025 
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 subgroup reporting to the existing CEHRT requirements. 
Given our proposal described in section IV.A.3.b.(2)(d) of this rule to 
delay the implementation of subgroup reporting option to the CY 2023 
MIPS performance period/2025 payment year, we assume that the proposed 
delay would 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 MIPS performance period/
2025 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 proposal 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 similar to 
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 proposed 
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 
proposal to require QCDRs and qualified registries that have never 
submitted data since the inception of MIPS (CY 2017 MIPS performance 
period/2019 payment year) through the CY 2020 MIPS performance period/
2022 payment year to submit a participation plan as part of their self-
nomination for CY 2023 MIPS performance period, 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, due to the 
proposal related to new rejection criteria for QCDR measures, we 
estimate that the annual burden will range from 855 hours (90 QCDRs x 
9.5 hr) to 1,035 hours (90 QCDRs x 11.5 hr) at a cost ranging from 
$81,413 (855 hr x $95.22/hr) and $98,553 (1,035 hr x $95.22/hr).
(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 
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 2022 performance year/2024 payment year that we 
are not able to model with our historic data sources. The scoring model 
results presented in this proposed 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 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 submit 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 payment year. It is difficult to predict whether 
clinicians will elect to opt-in to participate in MIPS with the 
proposed policies.
    There are additional limitations to our estimates in addition to 
the limitations described throughout the methodology sections: (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 129; and (2) our cost data does not overlap with CY 2019 
so we may not be capturing performance for all clinicians. Due to the 
limitations described, there is considerable uncertainty around our 
estimates that is difficult to quantify.

G. Alternatives Considered

    This proposed rule contains a range of policies, including some 
provisions related to specific statutory provisions. The preceding 
preamble provides descriptions of the statutory provisions that are 
addressed, identifies those policies when 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 proposed 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 proposed CY 2022 
RVUs, as well as in determining the proposed CY 2022 budget neutrality 
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

[[Page 39561]]

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 134 illustrates specialty-specific impacts 
using CY 2019 data.
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    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 123, 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 
proposed rule, we used CY 2019 claims data to estimate the CY 2021 PFS 
CF to be 33.6184 which reflects a budget neutrality 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 budget neutrality 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.
2. Alternatives Considered for Clinical Labor Pricing Update
    As discussed in the PE section of this rule (section II.B. of this 
proposed rule), we are proposing 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 noted in regard to the specialty 
impacts in Table 123 that the proposed clinical labor pricing update 
will have a significant effect on the valuation of many services. We 
have occasionally implemented significant updates based on new data 
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 which will conclude in CY 2022. We 
considered, as an alternative, the use of a similar 4-year transition 
to implement the clinical labor pricing update that could smooth out 
the increases and decreases caused by the pricing update for affected 
stakeholders. In order to evaluate a phased approach to the clinical 
labor pricing update, we modeled the PFS ratesetting process using 
clinical labor prices which transitioned one quarter of the distance to 
their fully implemented updated price. Table 135 illustrates specialty-
specific impacts using the first year of a potential 4-year phase-in 
for clinical labor pricing:

[[Page 39563]]

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BILLING CODE 4120-01-C
    Table 135 reflects all other proposed policies for CY 2022 with the 
only difference from Table 123 being the phased approach to updating 
the clinical labor pricing. Due to the budget neutral nature of PE 
under the PFS, we do not project that there would be any changes to the 
conversion factor if we were to use a 4-year transition for clinical 
labor pricing. We note that a phased transition would delay the full 
implementation of updated pricing and continue to rely on outdated data 
for clinical labor pricing.
3. Alternatives Considered for Split (or Shared) Visits
    In section II.F of this proposed rule, we proposed to continue our 
current policy allowing billing of certain ``split'' or ``shared'' 
evaluation and management (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 proposed to 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). We proposed that 
the physician or NPP who performed 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.
    We considered several alternative approaches. First, we considered 
the option of proposing to disallow 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 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. However, our 
understanding is 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 choose to propose to disallow 
billing for split (or shared) visits and we are instead seeking comment 
to confirm current practice patterns and whether there is a need for 
this kind of split billing, and how often.
    We also considered, but did not propose, several alternatives for 
how to define the substantive portion of split (or shared) visit. We 
considered proposing to define ``substantive portion'' as any face-to-
face portion of the split (or shared) visit, consistent with our 
current definition. We do 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 do 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 do 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 are proposing 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 choose 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 (for example, risk). We believe 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 believe 
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/

[[Page 39565]]

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 is not a viable approach.
    Lastly, we considered not defining substantive portion in this 
proposed rule 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 seek 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 proposed 
definition of ``substantive portion''.
    We considered disallowing split (or shared) billing in critical 
care, skilled nursing facility (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 believe we 
should allow shared visit billing for other visits that can be 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 believe current 
clinical practice generally allows sharing of critical care visits by 
appropriately trained and qualified practitioners, and we are seeking 
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.
    We are proposing 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 believe 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 
electronic health records (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 see 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 are proposing 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 believe 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.
4. 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 proposed 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 proposed 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 regulatory impact analysis, we are 
unable to quantitatively estimate the impacts of this provision. We 
welcome 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.
5. 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 proposed 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.
6. Alternatives Considered for the Quality Payment Program
    For purposes of the payment impact on the Quality Payment Program, 
we view the performance threshold as a critical factor affecting the 
distribution of payment adjustments. We ran a separate proposed 
policies RIA model based on the actual mean for the CY 2019 performance 
period/2021 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 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 proposed policies RIA model since the performance threshold does 
not change the final score. We estimate that $ 885 million would be 
redistributed through budget neutrality.

[[Page 39566]]

For clinicians who meet or exceed the additional performance threshold, 
an additional $294 million was distributed. The maximum positive 
payment adjustment would be 15.5 percent prior to the maximum 
additional payment adjustment and 25.5 percent after considering the 
MIPS maximum positive payment adjustment and the additional MIPS 
payment adjustment for exceptional performance. In addition, 70.3 
percent of MIPS eligible clinicians would receive a negative payment 
adjustment among those that submit data.
    We report the findings for the baseline RIA model which describes 
the impact for the 2022 MIPS performance period/2024 MIPS payment year 
if this regulation did not exist. The baseline RIA model has a final 
score mean of 78.13 and median of 82.59. We estimate that $428 million 
would be redistributed through budget neutrality. There would 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 would 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 budget neutrality.
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 regulatory 
impact analysis (see section VII.G.4. of this proposed 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.
    We welcome comment on: (1) The likely costs or savings to 
beneficiaries; and (2) other related impacts of this provision.
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 proposed 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 proposed 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.
    We welcome comment on: (1) The likely costs or savings to 
beneficiaries; and (2) other related impacts of this provision.
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 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 proposals if finalized 
will lead to meaningful feedback to beneficiaries on the type and scope 
of care provided by clinicians. Additionally, beneficiaries could use 
the publicly reported information on clinician performance in subgroups 
to identify and choose clinicians in multispecialty groups relevant to 
their care needs. Consequently, we anticipate 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

[[Page 39567]]

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 proposed 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 would be a 
fair estimate of the number of reviewers of last year's rule. We 
welcome any comments on the approach in estimating the number of 
entities which will review this 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. We are seeking comments on 
this assumption.
    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 would take approximately 8.0 hours 
for the staff to review half of this rule. For each facility that 
reviews the rule, the estimated cost is $913.92 (8.0 hours x $114.24). 
Therefore, we estimated that the total cost of reviewing this 
regulation is $36,764,260 ($885.92 x 40,227 reviewers on last year's 
proposed rule).

J. Accounting Statement

    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Tables 132 and 133 
(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] TP23JY21.170

[GRAPHIC] [TIFF OMITTED] TP23JY21.171

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.

List of Subjects

42 CFR Part 403

    Grant programs--health, Health insurance, Hospitals, 
Intergovernmental relations, Medicare, Reporting and recordkeeping 
requirements.

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.

[[Page 39568]]

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 proposes to amend 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 the definition of ``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 the definitions of ``Additional 
documentation'', ``Additional documentation request (ADR)'', ``Post-
payment medical review'', and ``Prepayment medical review'' in 
alphabetical order to read as follows:


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

[[Page 39569]]

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.  405.929 under the ``Initial Determinations'' heading 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.
0
9. Add Sec.  405.930 under the ``Initial Determinations'' heading in 
Subpart I to read as follows:


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
10. Amend Sec.  405.986 by revising paragraph (a) introductory text to 
read as follows:


Sec.  405.986  Good cause for reopening.

    (a) Establishing good cause for reopening. Good cause may be 
established when--
* * * * *
0
11. Amend Sec.  405.2411 by--
0
a. Revising paragraph (b)(2);
0
b. Redesignating paragraph (b)(3) as (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 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; and
* * * * *
0
12. 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
13. Amend Sec.  405.2462 by--
0
a. Redesignating paragraphs (c) through (g) as paragraphs (e) through 
(i), respectively;
0
b. Revising paragraphs (a) through (c)
0
c. Adding new paragraph (d); and
0
d. In newly redesignated paragraph (e) introductory text, by removing 
the reference to ``paragraph (d)'' and adding in its place the 
reference to ``paragraph (f)''.
    The additions and revisions 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.
    (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

[[Page 39570]]

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 (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 (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 (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 part, 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 chapter. 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 part 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 chapter. 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 part, for each beneficiary visit for covered services when it 
meets the specified qualifications in paragraph(d) of this part. 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 section (b)(3) of this part.
    (1) As of December 31, 2020, was in a hospital with less than 50 
beds (as determined in Sec.  412.105(b) of this chapter) 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
14. 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 between an RHC or FQHC patient 
and one of the following:
* * * * *
0
15. 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
16. 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.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
17. The authority citation for part 410 continues to read as follows:

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

0
18. Amend Sec.  410.33 by revising paragraphs (c), (g)(6)(i), 
(g)(6)(ii), (g)(8)(i), (g)(8)(ii), and (g)(9) to read as follows:

[[Page 39571]]

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:
    (A) The name, address, telephone number, and health insurance claim 
number of the beneficiary.
    (B) The date the complaint was received, the name of the person 
receiving the complaint, and a summary of actions taken to resolve the 
complaint.
    (C) If an investigation was not conducted, the name of the person 
making the decision and the reason for the decision.
    (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
19. 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) 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
20. Amend Sec.  410.47 by--
0
a. Revising the section heading as set forth below;
0
b. In paragraph (a), revising the definitions of ``Individualized 
treatment plan'', ``Medical director'', Outcomes assessment'', 
``Physician prescribed exercise'', ``Psychosocial assessment'', and 
``Supervising physician'';
0
c. Revising paragraphs (b), (c), (d), and (e);
0
d. Removing paragraph (f).
0
e. Redesignating paragraph (g) as new paragraph (f).
    The revisions read as follows:


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 were hospitalized with a COVID-19 diagnosis and experience 
persistent symptoms, including respiratory dysfunction, for at least 
four weeks after hospital discharge;
    (iii) Additional medical indications for coverage for pulmonary

[[Page 39572]]

rehabilitation may be established through a national coverage 
determination (NCD).
    (2) Components. Pulmonary rehabilitation must include all of the 
following components:
    (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
21. Amend Sec.  410.49 by--
0
a. In paragraph (a), 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. Revising paragraphs (b)(1) introductory text, (b)(2) paragraph 
heading and introductory text, (b)(2)(ii), (b)(3)(i) introductory text, 
(d) paragraph heading and introductory text, (e) paragraph heading and 
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.
* * * * *
    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
22. Amend Sec.  410.59 by--
0
a. Revising paragraph (a)(4)(iii)(B); and
0
b. Adding paragraphs (a)(4)(iv) and (v).
    The revision and additions 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

[[Page 39573]]

15-minute 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
23. Amend Sec.  410.60 by--
0
a. Revising paragraph (a)(4)(iii)(B); and
0
b. Adding paragraphs (a)(4)(iv) and (v).
    The revision and additions 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 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
24. Amend Sec.  410.67 by--
0
a. In paragraph (b), revising paragraphs (3) and (4) in the definition 
of ``Opioid use disorder treatment service'';
0
b. Revising paragraphs (d)(4)(ii) and (iii), and (d)(5);
0
c. 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 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 chapter.
    (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 chapter.
    (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) 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 Public 
Health Emergency as defined in Sec.  400.200 of this chapter, 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 adjustment to the bundled payment 
under paragraph (d)(4)(i)(A) of this section, the practitioner must 
also 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
25. 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.

[[Page 39574]]

    (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 personally performed by them.
    (e) Telehealth services. MNT and DMST services may be provided as 
telehealth service (meeting the requirements in Sec.  410.78) when 
registered dietitians or nutrition professionals act as distant site 
practitioners.
    (f) Restrictions. The services are provided on an assignment-
related basis, and a registered dietitian or nutrition professional may 
not charge a beneficiary for a service not payable under this 
provision. If a beneficiary has made payment for a service, the 
registered dietitian or nutrition professional must make the 
appropriate refund to the beneficiary.
0
26. Amend Sec.  410.74 by revising paragraph (a)(2)(v) 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
* * * * *
0
27. Amend 410.78 by--
0
a. Revising paragraph (a)(3); and
0
b. Adding paragraphs (b)(3)(xiii) and (xiv), and (b)(4)(iv)(D).
    The revision and additions 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. 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 at least once within 6 
months prior to the initial telehealth service and at least once within 
6 months before any subsequent Medicare telehealth service.
    (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
28. Amend Sec.  410.79 by--
0
a. Revising paragraph (c)(1)(ii);
0
b. Removing the second duplicate paragraph (c)(3)(ii); and
0
c. Revising paragraph (e)(3)(v)(C).
    The revisions 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, 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
29. Amend Sec.  410.105 by--

[[Page 39575]]

0
a. Revising paragraph (d)(3)(ii); and
0
b. Adding paragraphs (d)(3)(iii) and (iv).
    The revision and additions 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 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 
physical therapist or occupational therapist.
0
30. Amend Sec.  410.130 by--
0
a. Revising the definition of ``Chronic renal insufficiency''; and
0
b. 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/1.73m2).
* * * * *
0
31. 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
32. 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
33. 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 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) of this part, 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
34. 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
35. 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 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 each calendar 
quarter and posted on the CMS website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.
* * * * *
0
36. Amend Sec.  311.354 by--
0
a. Revising paragraphs (c)(2)(ii)(A)(2) and (3);
0
b. Adding paragraph (c)(2)(ii)(A)(4); and
0
c. Revising paragraph (c)(2)(ii)(B).
    The revisions and addition read as follows:

[[Page 39576]]

Sec.  411.354   Financial relationship, compensation, and ownership or 
investment interest.

* * * * *
    (c) * * *
    (2) * * *
    (ii) * * *
    (A) * * *
    (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).
    (B) For purposes of applying paragraph (c)(2)(ii)(A) of this 
section:
    (1) A positive correlation between two variables exists when one 
variable decreases as the other variable decreases, or one variable 
increases as the other variable increases.
    (2) The individual unit is:
    (i) 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.
    (ii) Service, where the compensation paid to the physician (or 
immediate family member) is based solely on the service provided.
    (iii) 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.
    (3) 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 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).
* * * * *
0
37. 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 
(h) 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 (h) is 
applicable.
* * * * *

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

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

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

0
39. 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) or the 
lesser of the actual charges or 85 percent of the physician fee 
schedule amount.
* * * * *
0
40. Amend Sec.  414.84 by--
0
a. 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. 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. 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. Revising paragraph (b)(4)(i)(A);
0
h. In paragraphs (b)(4)(i)(B) and (b)(4)(ii)(B) by removing the 
reference ``CY 2018'' and adding in its place the reference ``CY 2022''
0
i. Revising paragraph (b)(4)(ii)(A); and
0
j. 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 $26.
* * * * *
    (2) * * *
    (i) For the fourth core session furnished January 1, 2022 through 
December 31, 2022 the amount is $78.
* * * * *
    (3) * * *
    (i) For the ninth core session furnished January 1, 2022 through 
December 31, 2022 the amount is $130.
* * * * *
    (4) * * *
    (i) * * *
    (A) For a second core maintenance session January 1, 2022 through 
December 31, 2022 the amount is $106.
* * * * *
    (ii) * * *
    (A) For a second core maintenance session January 1, 2022 through 
December 31, 2022 the amount is $52.
* * * * *
    (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:

[[Page 39577]]

    (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 $189.
* * * * *
    (7) * * *
    (i) For a core session or core maintenance session, as applicable, 
furnished January 1, 2022 through December 31, 2022 the amount is $26.
    (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 chapter, and MDPP 
suppliers must accept the Medicare allowed charge as payment in full 
and may not bill or collect from the beneficiary any amount. CMS will 
make a 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 $26.
    (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
41. 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
42. 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
43. 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) 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
44. 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

[[Page 39578]]

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
45. Amend Sec.  414.1300 by revising paragraphs (a)(2) and (3) to read 
as follows:


Sec.  414.1300  Basis and scope.

    (a) * * *
    (2) Section 1848(k)--Quality Reporting System.
    (3) Section 1848(m)--Incentive Payments for Quality Reporting.
* * * * *
0
46. Amend Sec.  414.1305 by--
0
a. Revising the definitions of ``Collection type'' and ``Meaningful EHR 
user for MIPS'';
0
b. In the definition of ``MIPS determination period'', revising 
paragraph (2).
0
c. In the definition of ``MIPS eligible clinician'', revising the 
introductory text, paragraph (2) introductory text, and adding 
paragraph (3);
0
d. 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. Revising the definition of ``Submission type''.
    The revision 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; for the CY 2017 through 2022 MIPS 
performance periods/2019 through 2024 MIPS payment years, CMS Web 
Interface measures; the CAHPS for MIPS survey; and administrative 
claims measures.
* * * * *
    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 as identified by eligible clinicians in the Medicare 
Provider Enrollment, Chain, and Ownership System (PECOS).
    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 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.
* * * * *
    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 as identified by eligible clinicians in the PECOS.
* * * * *
    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

[[Page 39579]]

    (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) For the CY 2017 through 2022 MIPS performance periods/2019 
through 2024 MIPS payment years, the CMS Web Interface.
* * * * *
0
47. Amend Sec.  414.1310 by revising paragraph (e)(1) to read as 
follows:


Sec.  414.1310  Applicability.

* * * * *
    (e) * * * (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
48. 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
49. 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)(iii)(A) or Sec.  414.1310(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
50. Amend Sec.  414.1320 by--
0
a. Redesignating paragraphs (d) through (g) as paragraphs (e) through 
(h).
0
b. Adding a new paragraph (d).
    The addition reads as follows:


Sec.  414.1320  MIPS performance period.

* * * * *
    (d) For purposes of the 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
51. 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, for the CY2017 through 2022 MIPS performance periods/2019 through 
2024 MIPS payment years, CMS Web Interface (for groups consisting of 25 
or more eligible clinicians or a third party intermediary submitting on 
behalf of a group) submission types.
* * * * *
0
52. Amend Sec.  414.1340 by--
0
a. Revising paragraph (a)(3);
0
b. Adding paragraph (a)(4);
0
c. Revising paragraph (b)(3); and
0
d. Adding paragraph (b)(4).
    The revisions and additions 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, and 2024.
    (4) At least 80 percent of the MIPS eligible clinician or group's 
patients that meet the measure's denominator criteria, regardless of 
payer for MIPS payment year 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, and 2024.
    (4) At least 80 percent of the applicable Medicare Part B patients 
seen during the performance period to which the measure applies for 
MIPS payment year 2025.
* * * * *
0
53. 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 2019 performance period, the case minimum is 10, unless 
otherwise specified for individual measures. Beginning with the 2022 
performance period, 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 2022 performance period, the case minimum is 20.
* * * * *
0
54. 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

[[Page 39580]]

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
55. 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.
    (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) 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 (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).

[[Page 39581]]

    (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 Sec.  
414.1380(c)(2)(i)(C)(2). 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.
    (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 Sec.  414.1380(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
56. Amend Sec.  414.1375 by--
0
a. Revising paragraphs (b)(2)(ii);
0
b. Revising paragraphs (b)(3) paragraph heading and (b)(3)(ii) 
introductory text; and
0
c. Adding paragraph (b)(3)(iii).
    The revisions and additions 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
57. 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) and (b)(1)(iv)(B);
0
d. Revising paragraphs (b)(1)(v)(A) introductory text and (b)(1)(v)(B) 
introductory text;
0
e. Adding paragraph (b)(1)(v)(B)(1)(iii);
0
f. 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
g. Adding paragraphs (b)(2)(v)(A) and (B);
0
h. Revising paragraph (b)(4)(ii) introductory text and (b)(4)(ii)(C);
0
i. Revising the table in paragraph (c) introductory text;
0
j. Revising paragraph (c)(2)(i)(A)(4);
0
k. Removing and reserving paragraph (c)(2)(i)(A)(5);
0
l. Revising paragraphs (c)(2)(i)(C)(9), (c)(2)(ii)(A) and 
(c)(2)(ii)(F);
0
m. Adding paragraph (c)(2)(ii)(G);
0
n. Revising paragraph (c)(3);
0
o. Revising paragraph (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 2022 
performance period/2024 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

[[Page 39582]]

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 for each such 
measure, and small practices receive 3 measure achievement points for 
each such measure.
* * * * *
    (3) Beginning with the CY 2022 performance period/2024 MIPS payment 
year, MIPS eligible clinicians receive 5 measure achievement points for 
each submitted new measure that meets the data completeness 
requirement, but does not have a benchmark or meet the case minimum 
requirement.
* * * * *
    (C) New measures. (1) Beginning with the CY 2022 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.
    (2) For purposes of this section, ``new measure'' means a quality 
measure that is in its first 2 years in the program.
* * * * *
    (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.
    (iv) * * *
    (B) Except as provided in paragraph (b)(1)(iv)(B)(1) of this 
section, beginning with the 2021 MIPS payment year, each measure 
(except for measures in the CMS Web Interface) for which the benchmark 
for the applicable collection type is identified as topped out for 2 or 
more consecutive years receives no more than 7 measure achievement 
points in the second consecutive year it is identified as topped out, 
and beyond.
    (1) For the CY 2022 MIPS performance period/2024 MIPS payment year, 
MIPS eligible clinicians receive no more than 7 measure achievement 
points for each measure (except for measures in the CMS Web Interface) 
for which the applicable benchmark is 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.
    (2) [Reserved]
* * * * *
    (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,

[[Page 39583]]

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.
* * * * *
    (C) Each optional measure is worth five or ten bonus points, as 
specified by CMS.
* * * * *
    (c) * * *
    [GRAPHIC] [TIFF OMITTED] TP23JY21.172
    
* * * * *
    (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

[[Page 39584]]

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:
BILLING CODE 4120-01-C
[GRAPHIC] [TIFF OMITTED] TP23JY21.173

* * * * *
    (F) Except as provided in paragraph (c)(2)(ii)(G) of this section, 
beginning with the 2024 MIPS payment year:
[GRAPHIC] [TIFF OMITTED] TP23JY21.174

    (G) For small practices beginning with the 2024 MIPS payment year:

[[Page 39585]]

[GRAPHIC] [TIFF OMITTED] TP23JY21.175

BILLING CODE 4120-01-C
* * * * *
    (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 (c)(3)(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 (c)(3)(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/CY2024 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.
    (vi) Beginning with the CY2022 MIPS performance period/CY2024 MIPS 
payment year, 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 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 CY2022 MIPS performance period/CY2024 MIPS 
payment year, for APM Entities and

[[Page 39586]]

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 CY2022 MIPS performance period/CY2024 
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
58. 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
59. 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 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 MIPS performance period/2023 
MIPS payment year, QCDRs and qualified registries must be able to 
submit data for all of the following MIPS performance categories:

[[Page 39587]]

    (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:
    (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) Beginning with the 2023 MIPS 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 2018 and 2019 MIPS 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 2020 MIPS 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 2019 MIPS 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 2020 MIPS 
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 2021 MIPS 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 2023 MIPS 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's 
approval and may not change the plan once approved without the prior 
approval of the agency.
    (v) Beginning with the 2021 MIPS 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) of this 
section.
    (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 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 2021 MIPS 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

[[Page 39588]]

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 2023 MIPS 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's 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 2024 MIPS 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's 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 2018 MIPS 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 2022 MIPS performance period/2024 MIPS 
payment year, all QCDR measures must meet face validity. To be approved 
for the 2023 MIPS 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, 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 2022 MIPS performance period/
2024 MIPS payment year and future years, a QCDR measure must be fully 
tested.
    (ii) [Reserved]
    (4) Beginning with the 2022 MIPS 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 2020 MIPS 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 2021 performance period--
    (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, we would consider 
exceptions if the potential QCDR measure otherwise meets the QCDR 
measure requirements and considerations.
    (8) Beginning with the 2020 MIPS 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:
    (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 2020 MIPS performance period/2022 MIPS 
payment year, we place 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 2020 MIPS performance period/2022 MIPS 
payment year, in instances where a QCDR believes the low-reported QCDR

[[Page 39589]]

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 2021 MIPS 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 2020 MIPS 
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 MIPS 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 2023 MIPS 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.
    (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

[[Page 39590]]

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 paragraph (e) of this section, 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
60. 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
61. Amend Sec.  414.1430 by--
0
a. Revising paragraph (a)(1)(iii); and
0
b. Adding paragraph (a)(1)(iv).
    The revision and addition 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
* * * * *
0
62. 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 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
63. The authority citation for part 415 continues to read as follows:

    Authority: 42 U.S.C. 1302 and 1395hh.

0
64. 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:
    (1) 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.
    (2) 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).
    (3) Substantive portion means more than half of the total time 
spent by the physician and nonphysician

[[Page 39591]]

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
65. 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
66. 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. Compliance actions against prescribers writing prescriptions 
for beneficiaries in long-term care facilities, and who do not meet the 
compliance threshold, will commence on or after January 1, 2025. 
Compliance actions against other prescribers who do not meet the 
compliance threshold 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 who issue 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 with 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
67. The authority for part 424 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.

0
68. Amend Sec.  424.205 by--
0
a. Redesignating paragraphs (b)(5) and (6) as paragraphs (b)(6) and 
(7), respectively; and
0
b. 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
69. 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
70. 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
71. Amend Sec.  424.535 by revising paragraphs (a)(2) introductory 
text, (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.
* * * * *

[[Page 39592]]

Sec.  424.545  [Amended]

0
72. 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
73. 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
74. The authority citation for part 425 continues to read as follows:

    Authority: 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.

0
75. 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
76. Amend Sec.  425.204 by--
0
a. Revising paragraphs (b), (c)(6), (f)(4)(ii)(A) and (B), (f)(4)(iii) 
introductory text, and (f)(4)(iii)(A); and
0
b. Adding paragraph (f)(4)(v).
    The revisions and addition 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. 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

[[Page 39593]]

(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 
paragraph (f) of this section.
* * * * *
0
77. Amend Sec.  425.312 by--
0
a. Revising paragraph (a)(2)(ii); and
0
b. Adding paragraph (a)(2)(iii).
    The revision and addition 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
78. 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 addition and revisions 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) 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) 99X21, 99487, 99489, 99490 and 99491 (codes for chronic care 
management).
    (12) 99495 and 99496 (codes for transitional care management 
services).
    (13) 99497 and 99498 (codes for advance care planning; services 
identified by these codes furnished in an inpatient setting are 
excluded).
    (14) 99X22, 99X23, 99X24, and 99X25 (codes for principal care 
management services).
    (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).
    (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 chapter.
* * * * *
    (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
79. 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);
0
e. Adding paragraph (a)(6);
0
f. Revising paragraphs (b)(2)(i) and (ii) and (b)(3)(i);
0
g. Redesignating paragraph (b)(3)(ii) as paragraph (b)(3)(iii);
0
h. Adding a new paragraph (b)(3)(ii); and

[[Page 39594]]

0
i. Revising newly redesignating paragraph (b)(3)(iii).


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 chapter and the case minimum requirement at Sec.  414.1380 of 
this chapter 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 year 2022. The ten CMS Web Interface measures 
or the three eCQM/MIPS CQM measures, and the CAHPS for MIPS survey.
    (ii) For performance year 2023. The ten CMS Web Interface measures 
and at least one eCQM/MIPS CQM measure or the three eCQM/MIPS CQM 
measures, and the CAHPS for MIPS survey.
    (iii) For performance year 2024 and subsequent performance years. 
The three eCQM/MIPS CQM measures 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 chapter, 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 eCQM/MIPS CQM measures and does not 
administer a CAHPS for MIPS survey under the APP, the ACO will not meet 
the quality performance standard.
    (4) For performance year 2022--(i) Except as specified in paragraph 
(a)(2) of this section, CMS designates the quality performance standard 
as the ACO reporting via the APP established under Sec.  414.1367 of 
this chapter either:
    (A) 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, or
    (B) The three eCQM/MIPS CQM measures in the APP measure set, 
meeting the data completeness requirement at Sec.  414.1340 of this 
chapter and the case minimum requirement at Sec.  414.1380 of this 
chapter for all three eCQM/MIPS CQM measures, and achieving 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.
    (ii) If an ACO does not report any of the ten CMS Web Interface 
measures or any of the three eCQM/MIPS CQM measures 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 2023--(i) Except as specified in paragraph 
(a)(2) of this section, CMS designates the quality performance standard 
as the ACO reporting via the APP established under Sec.  414.1367 of 
this chapter either:
    (A) According to the method of submission established by CMS, 
including at least one eCQM/MIPS CQM measure, 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, or
    (B) The three eCQM/MIPS CQM measures in the APP measure set, 
meeting the data completeness requirement at Sec.  414.1340 of this 
chapter and the case minimum requirement at Sec.  414.1380 of this 
chapter for all three eCQM/MIPS CQM measures, and achieving 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.
    (ii) If the ACO does not report at least one eCQM/MIPS CQM in the 
APP measure set, the ACO will not meet the quality performance 
standard.
    (6) For performance years 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 
chapter, 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 eCQM/MIPS CQM 
measures 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 through 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 and 2022, if the ACO reports quality 
data via the APP and meets data completeness and case minimum 
requirements, CMS will use the higher of the ACO's quality performance 
score or the equivalent of the 30th percentile MIPS Quality performance 
category score across all MIPS Quality performance category scores, 
excluding entities/providers eligible for facility-based scoring, for 
the relevant performance year.
    (ii) For performance year 2023, if the ACO reports quality data via 
the APP, including at least one eCQM/MIPS CQM measure, and meets data 
completeness and case minimum requirements, CMS will use the higher of 
the ACO's quality performance score or the equivalent of the 30th 
percentile MIPS Quality performance category score across all MIPS 
Quality performance category scores, excluding entities/providers 
eligible for facility-based scoring, for the performance year.
    (iii) For performance year 2024 and subsequent performance years, 
if the ACO reports quality data via the APP and meets data completeness 
and case minimum requirements, CMS will use the higher of the ACO's 
quality performance score or the equivalent of the 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.
* * * * *

    Dated: July 9, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.

    Note: The following appendices will not appear in the Code of 
Federal Regulations.


[[Page 39595]]



Appendix 1: MIPS Quality Measures

    Note: Except as otherwise noted in this proposed rule, 
previously finalized measures and specialty measure sets will 
continue to apply for the 2022 MIPS performance period/2024 MIPS 
payment year and future years. In addition, electronic clinical 
quality measures (eCQMs) that are National Quality Forum (NQF) 
endorsed are shown in Table A as follows: NQF #/eCQM NQF #.
BILLING CODE 4120-01-P
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A
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Appendix 2: Improvement Activities

    Note: In this proposed rule, for the 2022 MIPS performance/2024 
MIPS payment year and future years, we are proposing to add 7 new 
improvement activities, modify 15 previously adopted improvement 
activities, and remove 6 previously adopted improvement activities. 
These proposals are discussed in detail below. We request comments on 
our proposals.

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Appendix 3: Mvp Inventory

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[FR Doc. 2021-14973 Filed 7-13-21; 4:15 pm]
BILLING CODE 4120-01-C