[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

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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 http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-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.

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    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: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments. CMS will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the 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/index.html. Click on the link on the left side of the 
screen titled, ``PFS Federal Regulations Notices'' for a chronological 
list of PFS Federal Register and other related documents. For the CY 
2022 PFS 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.)

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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

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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 http://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 http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Allocation of PE to Services
    To establish PE RVUs for specific services, it is necessary to 
establish the direct and indirect PE associated with each service.
(1) Direct Costs
    The relative relationship between the direct cost portions of the 
PE RVUs for any two services is determined by the relative relationship 
between the sum of the direct cost resources (that is, the clinical 
staff, medical supplies, and medical equipment) typically involved with 
furnishing each of the services. The costs of these resources are 
calculated from the refined direct PE inputs in our PE database. For 
example, if one service has a direct cost sum of $400 from our PE 
database and another service has a direct cost sum of $200, the direct 
portion of the PE RVUs of the first service would be twice as much as 
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
    We allocate the indirect costs at the code level based on the 
direct costs specifically associated with a code and the greater of 
either the clinical labor costs or the work RVUs. We also incorporate 
the survey data described earlier in the PE/HR discussion. The general 
approach to developing the indirect portion of the PE RVUs is as 
follows:
     For a given service, we use the direct portion of the PE 
RVUs calculated as previously described and the average percentage that 
direct costs represent of 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 http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file 
contains a table that illustrates the calculation of PE RVUs as 
described in this proposed rule for individual codes.
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty-specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service.
    Step 2: Calculate the aggregate pool of direct PE costs for the 
current year. We set the aggregate pool of PE costs equal to the 
product of the ratio of the current aggregate PE RVUs to current 
aggregate work RVUs and the projected aggregate work RVUs.
    Step 3: Calculate the aggregate pool of direct PE costs for use in 
ratesetting. This is the product of the aggregate direct costs for all 
services from Step 1 and the utilization data for that service.
    Step 4: Using the results of Step 2 and Step 3, use the CF to 
calculate a direct PE scaling adjustment to ensure that the aggregate 
pool of direct PE costs calculated in Step 3 does not vary from the 
aggregate pool of direct PE costs for the current year. Apply the 
scaling adjustment to the direct costs for each service (as calculated 
in Step 1).
    Step 5: Convert the results of Step 4 to 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 http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
    As we noted in the CY 2015 PFS final rule with comment period (79 
FR 67640 through 67641), we continue to make improvements to the direct 
PE input database to provide the number of clinical labor minutes 
assigned for each task for every code in the database instead of only 
including the number of clinical labor minutes for the preservice, 
service, and post service periods for each code. In addition to 
increasing the transparency of the information used to set PE RVUs, 
this level of detail would allow us to compare clinical labor times for 
activities associated with services across the PFS, which we believe is 
important to maintaining the relativity of the direct PE inputs. This 
information would facilitate the identification of the usual numbers of 
minutes for clinical labor tasks and the identification of exceptions 
to the usual values. It would also allow for greater transparency and 
consistency in the assignment of equipment minutes based on clinical 
labor times. Finally, we believe that the detailed information can be 
useful in maintaining standard times for particular clinical labor 
tasks that can be applied consistently to many codes as they are valued 
over several years, similar in principle to the use of physician 
preservice time packages. We believe that setting and maintaining such 
standards would provide greater consistency among codes that share the 
same clinical labor tasks and could improve relativity of values among 
codes. For example, as medical practice and technologies change over 
time, changes in the standards could be updated simultaneously for all 
codes with the applicable clinical labor tasks, instead of waiting for 
individual codes to be reviewed.
    In the CY 2016 PFS final rule with comment period (80 FR 70901), we 
solicited comments on the appropriate standard minutes for the clinical 
labor tasks associated with services that use digital technology. After 
consideration of comments received, we finalized standard times for 
clinical labor tasks associated with digital imaging at 2 minutes for 
``Availability of prior images confirmed'', 2 minutes for ``Patient 
clinical information and questionnaire reviewed by technologist, order 
from physician confirmed and exam protocoled by radiologist'', 2 
minutes for ``Review examination with interpreting MD'', and 1 minute 
for ``Exam documents scanned into PACS'' and ``Exam completed in RIS 
system to generate billing process and to populate images into 
Radiologist work queue.'' In the CY 2017 PFS final rule (81 FR 80184 
through 80186), we finalized a policy to establish a range of 
appropriate standard minutes for the clinical labor activity, 
``Technologist QCs images in PACS, checking for all images, reformats, 
and dose page.'' These standard minutes will be applied to new and 
revised

[[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 
http://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 http://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 http://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

[[Page 39120]]

[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 (http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed 
the importance of appropriately valuing physicians' services, noting 
that misvalued services can distort the market for physicians' 
services, as well as for other health care services that physicians 
order, such as hospital services. In that same report, MedPAC 
postulated that physicians' services under the PFS can become misvalued 
over time. MedPAC stated, ``When a new service is added to the 
physician fee schedule, it may be assigned a relatively high value 
because of the time, technical skill, and psychological stress that are 
often required to furnish that service. Over time, the work

[[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 (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since 
MedPAC made the initial recommendations, CMS and the RUC have taken 
several steps to improve the review process. Also, section 
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the 
Secretary to specifically examine, as determined appropriate, 
potentially misvalued services in the following categories:
     Codes that have experienced the fastest growth.
     Codes that have experienced substantial changes in PE.
     Codes that describe new technologies or services within an 
appropriate time-period (such as 3 years) after the relative values are 
initially established for such codes.
     Codes which are multiple codes that are frequently billed 
in conjunction with furnishing a single service.
     Codes with low relative values, particularly those that 
are often billed multiple times for a single treatment.
     Codes that have not been subject to review since 
implementation of the fee schedule.
     Codes that account for the majority of spending under the 
PFS.
     Codes for services that have experienced a substantial 
change in the hospital length of stay or procedure time.
     Codes for which there may be a change in the typical site 
of service since the code was last valued.
     Codes for which there is a significant difference in 
payment for the same service between different sites of service.
     Codes for which there may be anomalies in relative values 
within a family of codes.
     Codes for services where there may be efficiencies when a 
service is furnished at the same time as other services.
     Codes with high intraservice work per unit of time.
     Codes with high PE RVUs.
     Codes with high cost supplies.
     Codes as determined appropriate by the Secretary.
    Section 1848(c)(2)(K)(iii) of the Act also specifies that the 
Secretary may use existing processes to receive recommendations on the 
review and appropriate adjustment of potentially misvalued services. In 
addition, the Secretary may conduct surveys, other data collection 
activities, studies, or other analyses, as the Secretary determines to 
be appropriate, to facilitate the review and appropriate adjustment of 
potentially misvalued services. This section also authorizes the use of 
analytic contractors to identify and analyze potentially misvalued 
codes, conduct surveys or collect data, and make recommendations on the 
review and appropriate adjustment of potentially misvalued services. 
Additionally, this section provides that the Secretary may coordinate 
the review and adjustment of any RVU with the periodic review described 
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of 
the Act specifies that the Secretary may make appropriate coding 
revisions (including using existing processes for consideration of 
coding changes) that may include consolidation of individual services 
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
    To fulfill our statutory mandate, we have identified and reviewed 
numerous potentially misvalued codes as specified in section 
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work 
examining potentially misvalued codes in these areas over the upcoming 
years. As part of our current process, we identify potentially 
misvalued codes for review, and request recommendations from the RUC 
and other public commenters on revised work RVUs and direct PE inputs 
for those codes. The RUC, through its own processes, also identifies 
potentially misvalued codes for review. Through our public nomination 
process for potentially misvalued codes established in the CY 2012 PFS 
final rule with comment period, 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/index.html.
    Beginning in CY 2019, we stated that for CY 2019 and onward, we 
intend to accept requests through February 10, consistent with the 
deadline for our receipt of code valuation recommendations from the RUC 
(83 FR 59491). For CY 2022, requests to add services to the Medicare 
telehealth services list must have been submitted and received by 
February 10, 2021. Each request to add a service to the Medicare 
telehealth services list must have included any supporting 
documentation the requester wishes us to consider as we review the 
request. Because we use the annual PFS rulemaking process as the 
vehicle to make changes to the Medicare telehealth services list, 
requesters are advised that any information submitted as part of a 
request is subject to public disclosure for this purpose. For more 
information on submitting a request in the future to add services to 
the Medicare telehealth services list, including where to mail these 
requests, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
b. Requests To Add Services to the Medicare Telehealth Services List 
for CY 2022
    Under our current policy, we add services to the Medicare 
telehealth services list on a Category 1 basis when we determine that 
they are similar to services on the existing Medicare telehealth 
services list for the roles of, and interactions among, the 
beneficiary, physician (or other practitioner) at the distant site and, 
if necessary, the telepresenter. As we stated in the CY 2012 PFS final 
rule with comment period (76 FR 73098), we believe that the Category 1 
criteria not only streamline our review process for publicly requested 
services that fall into this category, but also expedite our ability to 
identify codes for the Medicare telehealth services list that resemble 
those services already on the Medicare telehealth services list.
    We received several requests to permanently add various services to 
the Medicare telehealth services list effective for CY 2022. We found 
that none of the requests we received by the February 10th submission 
deadline met our Category 1 or Category 2 criteria for permanent 
addition to the Medicare telehealth services list. The requested 
services are listed in Table 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/index.html).
3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
    On an annual basis, the RUC provides us with recommendations 
regarding PE inputs for new, revised, and potentially misvalued codes. 
We review the RUC-recommended direct PE inputs on a code by code basis. 
Like our review of recommended work RVUs, our review of recommended 
direct PE inputs generally includes, but is not limited to, a review of 
information provided by the RUC, HCPAC, and other public commenters, 
medical literature, and comparative databases, as well as a comparison 
with other codes within the PFS, and consultation with physicians and 
health care professionals within CMS and the federal government, as 
well as Medicare claims data. We also assess the methodology and data 
used to develop the recommendations submitted to us by the RUC and 
other public commenters and the rationale for the recommendations. When 
we determine that the RUC's recommendations appropriately estimate the 
direct PE inputs (clinical labor, disposable supplies, and medical 
equipment) required for the typical service, are consistent with the 
principles of relativity, and reflect our payment policies, we use 
those direct PE inputs to value a service. If not, we refine the 
recommended PE inputs to better reflect our estimate of the PE 
resources required for the service. We also confirm whether CPT codes 
should have facility and/or nonfacility direct PE inputs and refine the 
inputs accordingly.
    Our review and refinement of the RUC-recommended direct PE inputs 
includes many refinements that are common across codes, as well as 
refinements that are specific to particular services. Table 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 http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs 
displayed there have been used in developing the CY 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 http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. 
For more information regarding the history of the MPPR policy, we refer 
readers to the CY 2014 PFS final rule with comment period (78 FR 74261 
through 74263).
    Effective January 1, 2007, section 5102(b)(1) of the Deficit 
Reduction Act of 2005 (Pub. L. 109-171) (DRA) amended section 
1848(b)(4) of the Act to require that, for imaging services, if--(i) 
The 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

[[Page 39161]]

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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    \4\ Daubresse M, Chang HY, Yu Y, Viswanathan S, Shah ND, 
Stafford RS, Kruszewski SP, Alexander GC. Ambulatory diagnosis and 
treatment of non-malignant pain in the United States, 2000-2010. 
Medical care. 2013 Oct;51(10).
    \5\ Erratum: Vol. 66, No. 29. MMWR Morb Mortal Wkly Rep 
2017;66:1238. DOI: http://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: 
http://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.
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    At the same time individuals are experiencing difficulties finding 
pain care, the country is also coping with a worsening opioid and SUD 
crisis. The current environment involves shifting ``waves'' of overdose 
deaths associated with heroin, synthetic opioids, and prescription 
drugs, and intensifying stimulant and polysubstance use. Preliminary 
Centers for Disease Control and Prevention data released in April 2021 
show a 29 percent rise in overdose deaths from October 2019 through 
September 2020--the most recent data available--compared with the 
previous 12-month period.\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.
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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.
---------------------------------------------------------------------------

    \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/index.html.
    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\ http://medpac.gov/docs/default-source/reports/mar21_medpac_report_ch14_sec.pdf?sfvrsn=0.
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    Widespread use of telecommunications technology to furnish services 
during the PHE has illustrated interest within the medical community 
and among Medicare beneficiaries in furnishing and receiving care 
through the use of technology beyond the PHE. During the PHE for COVID-
19 pandemic, RHCs and FQHCs, much like other provider types, have had 
to change how they furnish care in order to meet the needs of their 
patients, and use of the temporary authority to bill Medicare for PFS 
telehealth services has been widely utilized by RHCs and FQHCs during 
the PHE. This shift in how care is furnished has prompted us to 
reevaluate the regulations regarding visit requirements for encounters 
between an RHC or FQHC patient and an RHC or FQHC practitioner to 
ensure that they reflect contemporary medical practice.
    Recently enacted legislation modified the circumstances under which 
Medicare makes payment for mental health services furnished via 
telehealth technology under the PFS following the PHE. Division CC, 
section 123 of the Consolidated Appropriations Act of 2021 (CAA) (Pub. 
L. 116-260, December 27, 2020) removed the domestic geographic 
originating site restrictions and added the home of the individual as a 
permissible originating site for telehealth services billed under the 
PFS when furnished for the purposes of diagnosis, evaluation, or 
treatment of a mental health disorder. This change correlates with a 
growing acceptance of the use of technology in the provision of mental 
health care. Clinicians furnishing telepsychiatry services at 
Massachusetts General Hospital Department of Psychiatry during the PHE 
observed several advantages of the virtual format for furnishing 
psychiatric services, noting that patients with psychiatric pathologies 
that interfere with their ability to leave home (for example, 
immobilizing depression,

[[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 http://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.)
---------------------------------------------------------------------------

    \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.
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    \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/index.html.

G. Removal of Selected National Coverage Determinations

    CMS periodically identifies and removes National Coverage 
Determinations (NCDs) that no longer contain clinically pertinent and 
current information, in other words those items and services that no 
longer reflect current medical practice, or that involve items or 
services that are used infrequently by beneficiaries. Clinical science 
and technology 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/index.html.
---------------------------------------------------------------------------

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 http://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

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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

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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 relativel