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



[[Page 64995]]

Vol. 86

Friday,

No. 221

November 19, 2021

Part II





 Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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





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

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

[[Page 64996]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

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

[CMS-1751-F]
RIN 0938-AU42


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

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

ACTION: Final rule.

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

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

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

SUPPLEMENTARY INFORMATION:
    Addenda Available Only Through the Internet on the CMS Website: The 
PFS Addenda along with other supporting documents and tables referenced 
in this final rule are available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/index.html. Click on the link on the left side of the 
screen titled, ``PFS Federal Regulations Notices'' for a chronological 
list of PFS Federal Register and other related documents. For the CY 
2022 PFS final rule, refer to item CMS-1751-F. Readers with questions 
related to accessing any of the Addenda or other supporting documents 
referenced in this final rule and posted on the CMS website identified 
above should contact [email protected].
    CPT (Current Procedural Terminology) Copyright Notice:

[[Page 64997]]

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

I. Executive Summary

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

B. Summary of the Major Provisions

    The statute requires us to establish payments under the PFS based 
on national uniform relative value units (RVUs) that account for the 
relative resources used in furnishing a service. The statute requires 
that RVUs be established for three categories of resources: Work, 
practice expense (PE), and malpractice (MP) expense. In addition, the 
statute requires that we establish each year by regulation the payment 
amounts for physicians' services paid under the PFS, including 
geographic adjustments to reflect the variations in the costs of 
furnishing services in different geographic areas.
    In this major final rule, we are establishing RVUs for CY 2022 for 
the PFS to ensure that our payment systems are updated to reflect 
changes in medical practice and the relative value of services, as well 
as changes in the statute. This final rule also includes discussions 
and provisions regarding several other Medicare Part B payment 
policies.
    Specifically, this final rule addresses:

 Practice Expense RVUs (section II.B.)
 Potentially Misvalued Services Under the PFS (section II.C.)
 Telehealth and Other Services Involving Communications 
Technology (section II.D.)
 Valuation of Specific Codes (section II.E.)
 Evaluation and Management Visits (section II.F.)
 Billing for Physician Assistant Services (section II.G.)
 Therapy Services (section II.H.)
 Changes to Beneficiary Coinsurance for Additional Procedures 
Furnished During the Same Clinical Encounter as Certain Colorectal 
Cancer Screening Tests (section II.I.)
 Vaccine Administration Services (section II.J.)
 Payment for Medical Nutrition Therapy Services and Related 
Services (section II.K.)
 Rural Health Clinics (RHCs) and Federally Qualified Health 
Centers (FQHCs) (sections III.A., III.B., and III.C.)
 Requiring Certain Manufacturers to Report Drug Pricing 
Information for Part B and Determination of ASP for Certain Self-
administered Drug Products (sections III.D.1. and 2.)
 Medicare Part B Drug Payment for Drugs Approved under Section 
505(b)(2) of the Federal Food, Drug, & Cosmetic Act (section III.E.)
 Appropriate Use Criteria for Advanced Diagnostic Imaging 
(section III.F.)
 Removal of Selected National Coverage Determinations (section 
III.G.)
 Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive 
Cardiac Rehabilitation (section III.H.)
 Medical Nutrition Therapy (section III.I.)
 Medicare Shared Savings Program (section III.J.)
 Medicare Ground Ambulance Data Collection System (section 
III.K.)
 Medicare Diabetes Prevention Program (MDPP) (section III.L.)
 Clinical Laboratory Fee Schedule: Laboratory Specimen 
Collection and Travel Allowance for Clinical Diagnostic Laboratory 
Tests and Use of Electronic Travel Logs (section III.M.)
 Medicare Provider and Supplier Enrollment Changes (section 
III.N.1.)
 Provider/Supplier Medical Review Requirements: Addition of 
Provider/Supplier Requirements related to Prepayment and Post-payment 
Reviews (section III.N.2.)
 Modifications Related to Medicare Coverage for Opioid Use 
Disorder (OUD) Treatment Services Furnished by Opioid Treatment 
Programs (OTPs) (section III.O.)
 Updates to the Physician Self-Referral Regulations (section 
III.P.)
 Requirement for Electronic Prescribing for Controlled 
Substances for a Covered Part D Drug under a Prescription Drug Plan or 
an MA-PD Plan (section 2003 of the SUPPORT Act) (section III.Q.)
 Open Payments (section III.R.)
 Updates to the Quality Payment Program (section IV.)
 Collection of Information Requirements (section V.)
 Regulatory Impact Analysis (section VI.)
3. Summary of Costs and Benefits
    We have determined that this final rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VI., Regulatory Impact Analysis, of this final rule.

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

A. Background

    Since January 1, 1992, Medicare has paid for physicians' services 
under section 1848 of the Social Security Act (the Act), ``Payment for 
Physicians' Services.'' The PFS relies on national relative values that 
are established for work, practice expense (PE), and malpractice (MP), 
which are adjusted for geographic cost variations. These values are 
multiplied by a conversion factor (CF) to convert the RVUs into payment 
rates. The concepts and methodology underlying the PFS were enacted as 
part of the Omnibus Budget Reconciliation Act of 1989 (OBRA '89) (Pub. 
L. 101-239, December 19, 1989), and the Omnibus Budget Reconciliation 
Act of 1990 (OBRA '90) (Pub. L. 101-508, November 5, 1990). The final 
rule published in the November 25, 1991 Federal Register (56 FR 59502) 
set forth the first fee schedule used for payment for physicians' 
services.
    We note that throughout this final rule, unless otherwise noted, 
the term ``practitioner'' is used to describe both physicians and 
nonphysician practitioners (NPPs) who are permitted to bill Medicare 
under the PFS for the services they furnish to Medicare beneficiaries.
1. Development of the RVUs
a. Work RVUs
    The work RVUs established for the initial fee schedule, which was 
implemented on January 1, 1992, were developed with extensive input 
from the physician community. A research team at the Harvard School of 
Public Health developed the original work RVUs for most codes under a 
cooperative agreement with the Department of Health and Human Services 
(HHS). In constructing the code-specific vignettes used in

[[Page 64998]]

determining the original physician work RVUs, Harvard worked with 
panels of experts, both inside and outside the Federal Government, and 
obtained input from numerous physician specialty groups.
    As specified in section 1848(c)(1)(A) of the Act, the work 
component of physicians' services means the portion of the resources 
used in furnishing the service that reflects physician time and 
intensity. We establish work RVUs for new, revised and potentially 
misvalued codes based on our review of information that generally 
includes, but is not limited to, recommendations received from the 
American Medical Association/Specialty Society Relative Value Scale 
Update Committee (RUC), the Health Care Professionals Advisory 
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), 
and other public commenters; medical literature and comparative 
databases; as well as a comparison of the work for other codes within 
the Medicare PFS, and consultation with other physicians and health 
care professionals within CMS and the Federal Government. We also 
assess the methodology and data used to develop the recommendations 
submitted to us by the RUC and other public commenters, and the 
rationale for their recommendations. In the CY 2011 PFS final rule with 
comment period (75 FR 73328 through 73329), we discussed a variety of 
methodologies and approaches used to develop work RVUs, including 
survey data, building blocks, crosswalk to key reference or similar 
codes, and magnitude estimation. More information on these issues is 
available in that rule.
b. Practice Expense RVUs
    Initially, only the work RVUs were resource-based, and the PE and 
MP RVUs were based on average allowable charges. Section 121 of the 
Social Security Act Amendments of 1994 (Pub. L. 103-432, October 31, 
1994), amended by section 1848(c)(2)(C)(ii) of the Act and required us 
to develop resource-based PE RVUs for each physicians' service 
beginning in 1998. We were required to consider general categories of 
expenses (such as office rent and wages of personnel, but excluding MP 
expenses) comprising PEs. The PE RVUs continue to represent the portion 
of these resources involved in furnishing PFS services.
    Originally, the resource-based method was to be used beginning in 
1998, but section 4505(a) of the Balanced Budget Act of 1997 (BBA `97) 
(Pub. L. 105-33, August 5, 1997) delayed implementation of the 
resource-based PE RVU system until January 1, 1999. In addition, 
section 4505(b) of the BBA `97 provided for a 4-year transition period 
from the charge-based PE RVUs to the resource-based PE RVUs.
    We established the resource-based PE RVUs for each physicians' 
service in the November 2, 1998 final rule (63 FR 58814), effective for 
services furnished in CY 1999. Based on the requirement to transition 
to a resource-based system for PE over a 4-year period, payment rates 
were not fully based upon resource-based PE RVUs until CY 2002. This 
resource-based system was based on two significant sources of actual PE 
data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's 
Socioeconomic Monitoring System (SMS) data. These data sources are 
described in greater detail in the CY 2012 PFS final rule with comment 
period (76 FR 73033).
    Separate PE RVUs are established for services furnished in facility 
settings, such as a hospital outpatient department (HOPD) or an 
ambulatory surgical center (ASC), and in nonfacility settings, such as 
a physician's office. The nonfacility RVUs reflect all of the direct 
and indirect PEs involved in furnishing a service described by a 
particular HCPCS code. The difference, if any, in these PE RVUs 
generally results in a higher payment in the nonfacility setting 
because in the facility settings some resource costs are borne by the 
facility. Medicare's payment to the facility (such as the outpatient 
prospective payment system (OPPS) payment to the HOPD) would reflect 
costs typically incurred by the facility. Thus, payment associated with 
those specific facility resource costs is not made under the PFS.
    Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) 
(Pub. L. 106-113, November 29, 1999) directed the Secretary of Health 
and Human Services (the Secretary) to establish a process under which 
we accept and use, to the maximum extent practicable and consistent 
with sound data practices, data collected or developed by entities and 
organizations to supplement the data we normally collect in determining 
the PE component. On May 3, 2000, we published the interim final rule 
(65 FR 25664) that set forth the criteria for the submission of these 
supplemental PE survey data. The criteria were modified in response to 
comments received, and published in the Federal Register (65 FR 65376) 
as part of a November 1, 2000 final rule. The PFS final rules published 
in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended 
the period during which we would accept these supplemental data through 
March 1, 2005.
    In the CY 2007 PFS final rule with comment period (71 FR 69624), we 
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for 
CY 2010. In the CY 2010 PFS final rule with comment period, we updated 
the practice expense per hour (PE/HR) data that are used in the 
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, 
we began a 4-year transition to the new PE RVUs using the updated PE/HR 
data, which was completed for CY 2013.
c. Malpractice RVUs
    Section 4505(f) of the BBA `97 amended section 1848(c) of the Act 
to require that we implement resource-based MP RVUs for services 
furnished on or after CY 2000. The resource-based MP RVUs were 
implemented in the PFS final rule with comment period published 
November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and 
physician-owned insurers' MP insurance premium data from all the 
States, the District of Columbia, and Puerto Rico.
d. Refinements to the RVUs
    Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no 
less often than every 5 years. Prior to CY 2013, we conducted periodic 
reviews of work RVUs and PE RVUs independently from one another. We 
completed 5-year reviews of work RVUs that were effective for calendar 
years 1997, 2002, 2007, and 2012.
    Although refinements to the direct PE inputs initially relied 
heavily on input from the RUC Practice Expense Advisory Committee 
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to 
the use of the updated PE/HR data in CY 2010 have resulted in 
significant refinements to the PE RVUs in recent years.
    In the CY 2012 PFS final rule with comment period (76 FR 73057), we 
finalized a proposal to consolidate reviews of work and PE RVUs under 
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued 
codes under section 1848(c)(2)(K) of the Act into one annual process.
    In addition to the 5-year reviews, beginning for CY 2009, CMS and 
the RUC identified and reviewed a number of potentially misvalued codes 
on an annual basis based on various identification screens. This annual 
review of work and PE RVUs for

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

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

B. Determination of PE RVUs

1. Overview
    Practice expense (PE) is the portion of the resources used in 
furnishing a service that reflects the general categories of physician 
and practitioner expenses, such as office rent and personnel wages, but 
excluding MP expenses, as specified in section 1848(c)(1)(B) of the 
Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a 
resource-based system for determining PE RVUs for each physicians' 
service. We develop PE RVUs by considering the direct and indirect 
practice resources involved in furnishing each service. Direct expense 
categories include clinical labor, medical supplies, and medical 
equipment. Indirect expenses include administrative labor, office 
expense, and all other expenses. The sections that follow provide more 
detailed information about the methodology for translating the 
resources involved in furnishing each service into service-specific PE 
RVUs. We refer readers to the CY 2010 PFS final rule with comment 
period (74 FR 61743 through 61748) for a more detailed explanation of 
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
    We determine the direct PE for a specific service by adding the 
costs of the direct resources (that is, the clinical staff, medical 
supplies, and medical equipment) typically involved with furnishing 
that service. The costs of the resources are calculated using the 
refined direct PE inputs assigned to each CPT code in our PE database, 
which are generally based on our review of recommendations received 
from the RUC and those provided in response to public comment periods. 
For a detailed explanation of the direct PE methodology, including 
examples, we refer readers to the 5-year review of work RVUs under the 
PFS and proposed changes to the PE methodology CY 2007 PFS proposed 
notice (71 FR 37242) and the CY 2007 PFS final rule with comment period 
(71 FR 69629).
b. Indirect Practice Expense per Hour Data
    We use survey data on indirect PEs incurred per hour worked, in 
developing the indirect portion of the PE RVUs. Prior to CY 2010, we 
primarily used the PE/HR by specialty that was obtained from the AMA's 
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the 
Physician Practice Expense Information Survey (PPIS). The PPIS is a 
multispecialty, nationally representative, PE survey of both physicians 
and NPPs paid under the PFS using a survey instrument and methods 
highly consistent with those used for the SMS and the supplemental 
surveys. The PPIS gathered information from 3,656 respondents across 51 
physician specialty and health care professional groups. We believe the 
PPIS is the most comprehensive source of PE survey information 
available. We used the PPIS data to update the PE/HR data for the CY 
2010 PFS for almost all of the Medicare-recognized specialties that 
participated in the survey.
    When we began using the PPIS data in CY 2010, we did not change the 
PE RVU methodology itself or the manner in which the PE/HR data are 
used in that methodology. We only updated the PE/HR data based on the 
new survey. Furthermore, as we explained in the CY 2010 PFS final rule 
with comment period (74 FR 61751), because of the magnitude of payment 
reductions for some specialties resulting from the use of the PPIS 
data, we transitioned its use over a 4-year period from the previous PE 
RVUs to the PE RVUs developed using the new PPIS data. As provided in 
the CY 2010 PFS final rule with comment period (74 FR 61751), the 
transition to the PPIS data was complete for CY 2013. Therefore, PE 
RVUs from CY 2013 forward are developed based entirely on the PPIS 
data, except as noted in this section.
    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical 
oncology supplemental survey data submitted in 2003 for oncology drug 
administration services. Therefore, the PE/HR for medical oncology, 
hematology, and hematology/oncology reflects the continued use of these 
supplemental survey data.
    Supplemental survey data on independent labs from the College of 
American Pathologists were implemented for payments beginning in CY 
2005. Supplemental survey data from the National Coalition of Quality 
Diagnostic Imaging Services (NCQDIS), representing independent 
diagnostic testing facilities (IDTFs), were blended with supplementary 
survey data from the American College of Radiology (ACR) and 
implemented for payments beginning in CY 2007. Neither IDTFs, nor 
independent labs, participated in the PPIS. Therefore, we continue to 
use the PE/HR that was developed from their supplemental survey data.

[[Page 65000]]

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

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

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

[[Page 65001]]

(2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).
     Next, we add the greater of the work RVUs or clinical 
labor portion of the direct portion of the PE RVUs to this initial 
indirect allocator. In our example, if this service had a work RVU of 
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we 
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 
clinical labor portion) to the initial indirect allocator of 6.00 to 
get an indirect allocator of 10.00. In the absence of any further use 
of the survey data, the relative relationship between the indirect cost 
portions of the PE RVUs for any two services would be determined by the 
relative relationship between these indirect cost allocators. For 
example, if one service had an indirect cost allocator of 10.00 and 
another service had an indirect cost allocator of 5.00, the indirect 
portion of the PE RVUs of the first service would be twice as great as 
the indirect portion of the PE RVUs for the second service.
     Then, we incorporate the specialty-specific indirect PE/HR 
data into the calculation. In our example, if, based on the survey 
data, the average indirect cost of the specialties furnishing the first 
service with an allocator of 10.00 was half of the average indirect 
cost of the specialties furnishing the second service with an indirect 
allocator of 5.00, the indirect portion of the PE RVUs of the first 
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
    For procedures that can be furnished in a physician's office, as 
well as in a facility setting, where Medicare makes a separate payment 
to the facility for its costs in furnishing a service, we establish two 
PE RVUs: Facility and nonfacility. The methodology for calculating PE 
RVUs is the same for both the facility and nonfacility RVUs, but is 
applied independently to yield two separate PE RVUs. In calculating the 
PE RVUs for services furnished in a facility, we do not include 
resources that would generally not be provided by physicians when 
furnishing the service. For this reason, the facility PE RVUs are 
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
    Diagnostic services are generally comprised of two components: A 
professional component (PC); and a technical component (TC). The PC and 
TC may be furnished independently or by different providers, or they 
may be furnished together as a global service. When services have 
separately billable PC and TC components, the payment for the global 
service equals the sum of the payment for the TC and PC. To achieve 
this, we use a weighted average of the ratio of indirect to direct 
costs across all the specialties that furnish the global service, TCs, 
and PCs; that is, we apply the same weighted average indirect 
percentage factor to allocate indirect expenses to the global service, 
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum 
to the global.)
(5) PE RVU Methodology
    For a more detailed description of the PE RVU methodology, we refer 
readers to the CY 2010 PFS final rule with comment period (74 FR 61745 
through 61746). We also direct readers to the file titled ``Calculation 
of PE RVUs under Methodology for Selected Codes'' which is available on 
our website under downloads for the CY 2022 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html. This file 
contains a table that illustrates the calculation of PE RVUs as 
described in this final rule for individual codes.
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty-specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service.
    Step 2: Calculate the aggregate pool of direct PE costs for the 
current year. We set the aggregate pool of PE costs equal to the 
product of the ratio of the current aggregate PE RVUs to current 
aggregate work RVUs and the projected aggregate work RVUs.
    Step 3: Calculate the aggregate pool of direct PE costs for use in 
ratesetting. This is the product of the aggregate direct costs for all 
services from Step 1 and the utilization data for that service.
    Step 4: Using the results of Step 2 and Step 3, use the CF to 
calculate a direct PE scaling adjustment to ensure that the aggregate 
pool of direct PE costs calculated in Step 3 does not vary from the 
aggregate pool of direct PE costs for the current year. Apply the 
scaling adjustment to the direct costs for each service (as calculated 
in Step 1).
    Step 5: Convert the results of Step 4 to an RVU scale for each 
service. To do this, divide the results of Step 4 by the CF. Note that 
the actual value of the CF used in this calculation does not influence 
the final direct cost PE RVUs as long as the same CF is used in Step 4 
and Step 5. Different CFs would result in different direct PE scaling 
adjustments, but this has no effect on the final direct cost PE RVUs 
since changes in the CFs and changes in the associated direct scaling 
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
    Create indirect allocators.
    Step 6: Based on the survey data, calculate direct and indirect PE 
percentages for each physician specialty.
    Step 7: Calculate direct and indirect PE percentages at the service 
level by taking a weighted average of the results of Step 6 for the 
specialties that furnish the service. Note that for services with TCs 
and PCs, the direct and indirect percentages for a given service do not 
vary by the PC, TC, and global service.
    We generally use an average of the 3 most recent years of available 
Medicare claims data to determine the specialty mix assigned to each 
code. Codes with low Medicare service volume require special attention 
since billing or enrollment irregularities for a given year can result 
in significant changes in specialty mix assignment. We finalized a 
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use 
the most recent year of claims data to determine which codes are low 
volume for the coming year (those that have fewer than 100 allowed 
services in the Medicare claims data). For codes that fall into this 
category, instead of assigning specialty mix based on the specialties 
of the practitioners reporting the services in the claims data, we use 
the expected specialty that we identify on a list developed based on 
medical review and input from expert stakeholders. We display this list 
of expected specialty assignments as part of the annual set of data 
files we make available as part of notice and comment rulemaking and 
consider recommendations from the RUC and other stakeholders on changes 
to this list on an annual basis. Services for which the specialty is 
automatically assigned based on previously finalized policies under our 
established methodology (for example, ``always therapy'' services) are 
unaffected by the list of expected specialty assignments. We also 
finalized in the CY 2018 PFS final rule (82 FR 52982 through 52983) a 
policy to apply these service-level overrides for both PE and MP, 
rather than one or the other category.

[[Page 65002]]

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


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[[Page 65006]]


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

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

[[Page 65007]]

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[[Page 65008]]


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

[[Page 65009]]

for the code in question rises to over 100 services for an individual 
calendar year. The HCPCS codes and expected specialty assignment remain 
on the list, and will be applied should the volume fall below 100 
services in any calendar year; there is no need to ``reactivate'' 
individual codes as some commenters indicated in their submissions.
    Comment: Several commenters stated that in previous years, CMS has 
applied the expected specialty override to services with fewer than 100 
allowed services in a 3-year average of Medicare claims data without 
adjusting the utilization to interpret any CPT modifiers. Although 
commenters agreed with the use of a 3-year average to identify low 
volume services for expected specialty assignment, commenters stated 
that not adjusting for certain modifiers will result in undercounting 
or overcounting of certain services. For example, commenters stated 
that if a single procedure is performed by both a primary surgeon and 
an assistant at surgery, this service should only be counted once even 
though each of the practitioners would report the service on a separate 
claim. Commenters recommended that CMS should set the frequency to zero 
for post-operative only (modifier '55') and assistant at surgery 
(modifier '80') records, multiply the frequency by 2 for bilateral 
surgery records (modifier '50'), and divide the frequency by 2 for co-
surgery records (modifier '62').
    Response: We do not agree that it would be more appropriate to make 
the adjustments to utilization as described by the commenters to 
determine low volume status. As we stated in the CY 2020 PFS final rule 
(84 FR 62576), we finalized a policy in the CY 2018 PFS final rule (82 
FR 52982 through 59283) to use claims data to determine which codes are 
low volume for the coming year, defining ``low volume'' as those that 
had fewer than 100 allowed services in the Medicare claims data. We did 
not finalize a policy to discount this utilization based on modifiers 
that identify certain circumstances, and we do not believe that it 
would be more appropriate to do so, as a service is still furnished and 
billed in each case, even if payment is discounted. Additionally, we 
did not make any proposals concerning the methodology used to identify 
low volume services in the proposed rule, and therefore, we are not 
finalizing any changes to this methodology.
    After consideration of the public comments, we are finalizing the 
updates to the list of expected specialty assignments for low volume 
services as detailed above.
    Step 8: Calculate the service level allocators for the indirect PEs 
based on the percentages calculated in Step 7. The indirect PEs are 
allocated based on the three components: The direct PE RVUs; the 
clinical labor PE RVUs; and the work RVUs.
    For most services the indirect allocator is: Indirect PE percentage 
* (direct PE RVUs/direct percentage) + work RVUs.
    There are two situations where this formula is modified:
     If the service is a global service (that is, a service 
with global, professional, and technical components), then the indirect 
PE allocator is: indirect percentage (direct PE RVUs/direct percentage) 
+ clinical labor PE RVUs + work RVUs.
     If the clinical labor PE RVUs exceed the work RVUs (and 
the service is not a global service), then the indirect allocator is: 
indirect PE percentage (direct PE RVUs/direct percentage) + clinical 
labor PE RVUs.
    (Note: For global services, the indirect PE allocator is based on 
both the work RVUs and the clinical labor PE RVUs. We do this to 
recognize that, for the PC service, indirect PEs would be allocated 
using the work RVUs, and for the TC service, indirect PEs would be 
allocated using the direct PE RVUs and the clinical labor PE RVUs. This 
also allows the global component RVUs to equal the sum of the PC and TC 
RVUs.)
    For presentation purposes, in the examples in the download file 
titled ``Calculation of PE RVUs under Methodology for Selected Codes'', 
the formulas were divided into two parts for each service.
     The first part does not vary by service and is the 
indirect percentage (direct PE RVUs/direct percentage).
     The second part is either the work RVU, clinical labor PE 
RVU, or both depending on whether the service is a global service and 
whether the clinical PE RVUs exceed the work RVUs (as described earlier 
in this step).
    Apply a scaling adjustment to the indirect allocators.
    Step 9: Calculate the current aggregate pool of indirect PE RVUs by 
multiplying the result of step 8 by the average indirect PE percentage 
from the survey data.
    Step 10: Calculate an aggregate pool of indirect PE RVUs for all 
PFS services by adding the product of the indirect PE allocators for a 
service from Step 8 and the utilization data for that service.
    Step 11: Using the results of Step 9 and Step 10, calculate an 
indirect PE adjustment so that the aggregate indirect allocation does 
not exceed the available aggregate indirect PE RVUs and apply it to 
indirect allocators calculated in Step 8.
    Calculate the indirect practice cost index.
    Step 12: Using the results of Step 11, calculate aggregate pools of 
specialty-specific adjusted indirect PE allocators for all PFS services 
for a specialty by adding the product of the adjusted indirect PE 
allocator for each service and the utilization data for that service.
    Step 13: Using the specialty-specific indirect PE/HR data, 
calculate specialty-specific aggregate pools of indirect PE for all PFS 
services for that specialty by adding the product of the indirect PE/HR 
for the specialty, the work time for the service, and the specialty's 
utilization for the service across all services furnished by the 
specialty.
    Step 14: Using the results of Step 12 and Step 13, calculate the 
specialty-specific indirect PE scaling factors.
    Step 15: Using the results of Step 14, calculate an indirect 
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor 
for the entire PFS.
    Step 16: Calculate the indirect practice cost index at the service 
level to ensure the capture of all indirect costs. Calculate a weighted 
average of the practice cost index values for the specialties that 
furnish the service. (Note: For services with TCs and PCs, we calculate 
the indirect practice cost index across the global service, PCs, and 
TCs. Under this method, the indirect practice cost index for a given 
service (for example, echocardiogram) does not vary by the PC, TC, and 
global service.)
    Step 17: Apply the service level indirect practice cost index 
calculated in Step 16 to the service level adjusted indirect allocators 
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
    Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs 
from Step 17 and apply the final PE budget neutrality (BN) adjustment. 
The final PE BN adjustment is calculated by comparing the sum of steps 
5 and 17 to the aggregate work RVUs scaled by the ratio of current 
aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in 
the PFS account for the fact that certain specialties are excluded from 
the calculation of PE RVUs but included in maintaining overall PFS BN. 
(See ``Specialties excluded from ratesetting calculation'' later in 
this final rule.)
    Step 19: Apply the phase-in of significant RVU reductions and its

[[Page 65010]]

associated adjustment. Section 1848(c)(7) of the Act specifies that for 
services that are not new or revised codes, if the total RVUs for a 
service for a year would otherwise be decreased by an estimated 20 
percent or more as compared to the total RVUs for the previous year, 
the applicable adjustments in work, PE, and MP RVUs shall be phased in 
over a 2-year period. In implementing the phase-in, we consider a 19 
percent reduction as the maximum 1-year reduction for any service not 
described by a new or revised code. This approach limits the year one 
reduction for the service to the maximum allowed amount (that is, 19 
percent), and then phases in the remainder of the reduction. To comply 
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure 
that the total RVUs for all services that are not new or revised codes 
decrease by no more than 19 percent, and then apply a relativity 
adjustment to ensure that the total pool of aggregate PE RVUs remains 
relative to the pool of work and MP RVUs. For a more detailed 
description of the methodology for the phase-in of significant RVU 
changes, we refer readers to the CY 2016 PFS final rule with comment 
period (80 FR 70927 through 70931).
(e) Setup File Information
     Specialties excluded from ratesetting calculation: For the 
purposes of calculating the PE and MP RVUs, we exclude certain 
specialties, such as certain NPPs paid at a percentage of the PFS and 
low-volume specialties, from the calculation. These specialties are 
included for the purposes of calculating the BN adjustment. They are 
displayed in Table 4.
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BILLING CODE 4120-01-C
     Crosswalk certain low volume physician specialties: 
Crosswalk the utilization of certain specialties with relatively low 
PFS utilization to the associated specialties.
     Physical therapy utilization: Crosswalk the utilization 
associated with all physical therapy services to the specialty of 
physical therapy.
     Identify professional and technical services not 
identified under the usual TC and 26 modifiers: Flag the services that 
are PC and TC services but do not use TC and 26 modifiers (for example, 
electrocardiograms). This flag associates the PC and TC with the 
associated global code for use in creating the indirect PE RVUs. For 
example, the professional service, CPT code 93010 (Electrocardiogram, 
routine ECG with at least 12 leads; interpretation and report only), is 
associated with the global service, CPT code 93000 (Electrocardiogram, 
routine ECG with at least 12 leads; with interpretation and report).
     Payment modifiers: Payment modifiers are accounted for in 
the creation of the file consistent with current payment policy as 
implemented in claims processing. For example, services billed with the 
assistant at surgery modifier are paid 16 percent of the PFS amount for 
that service; therefore, the utilization file is modified to only 
account for 16 percent of any service that contains the assistant at 
surgery modifier. Similarly, for those services to which volume 
adjustments are made to account for the payment modifiers, time 
adjustments are applied as well. For time adjustments to surgical 
services, the intraoperative portion in the work time file is used; 
where it is not present, the intraoperative percentage from the payment 
files used by contractors to process Medicare claims is used instead. 
Where neither is available, we use the payment adjustment ratio to 
adjust the time accordingly. Table 5 details the manner in which the 
modifiers are applied.
[GRAPHIC] [TIFF OMITTED] TR19NO21.008

    We also make adjustments to volume and time that correspond to 
other payment rules, including special multiple procedure endoscopy 
rules and multiple procedure payment reductions (MPPRs). We note that 
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments 
for multiple imaging procedures and multiple therapy services from the 
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These 
MPPRs are not included in the development of the RVUs.
    Beginning in CY 2022, section 1834(v)(1) of the Act requires that 
we apply a 15 percent payment reduction for outpatient occupational 
therapy services and outpatient physical therapy services that are 
provided, in whole or in part, by a physical therapist assistant (PTA) 
or occupational therapy assistant (OTA). Section 1834(v)(2)(A) of the 
Act required CMS to establish modifiers to identify these services, 
which we did in the CY 2019 PFS final rule (83 FR 59654 through 59661), 
creating the CQ and CO payment modifiers for services provided in whole 
or in part by PTAs and OTAs, respectively. These payment modifiers are 
required to be used on claims for services with dates of service 
beginning January 1, 2020, as specified in the CY 2020 PFS final rule 
(84 FR 62702 through 62708). We will apply the 15 percent payment 
reduction to therapy services provided by PTAs (using the CQ modifier) 
or OTAs (using the CO modifier), as required by statute. Under sections 
1834(k) and 1848 of the Act, payment is made for outpatient therapy 
services at 80 percent of the lesser of the actual charge or applicable 
fee schedule amount (the allowed charge). The remaining 20 percent is 
the beneficiary copayment. For therapy services to which the new 
discount applies, payment will be made at 85 percent of the 80 percent 
of allowed charges. Therefore, the volume discount factor for therapy 
services to which the CQ and CO modifiers apply is: (0.20 + (0.80* 
0.85), which equals 88 percent.
    For anesthesia services, we do not apply adjustments to volume 
since we use the average allowed charge when simulating RVUs; 
therefore, the RVUs as calculated already reflect the payments as 
adjusted by modifiers, and no volume adjustments are necessary. 
However, a

[[Page 65012]]

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

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

Where:

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

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by section 1848(b)(4)(C) of the Act.
    Useful Life: In the CY 2005 PFS final rule we stated that we 
updated the useful life for equipment items primarily based on the 
AHA's ``Estimated Useful Lives of Depreciable Hospital Assets'' 
guidelines (69 FR 66246). The most recent edition of these guidelines 
was published in 2018. This reference material provides an estimated 
useful life for hundreds of different types of equipment, the vast 
majority of which fall in the range of 5 to 10 years, and none of which 
are lower than 2 years in duration. We believe that the updated 
editions of this reference material remain the most accurate source for 
estimating the useful life of depreciable medical equipment.
    In the CY 2021 PFS final rule, we finalized a proposal to treat 
equipment life durations of less than 1 year as having a duration of 1 
year for the purpose of our equipment price per minute formula. In the 
rare cases where items are replaced every few months, we noted that we 
believe it is more accurate to treat these items as disposable supplies 
with a fractional supply quantity as opposed to equipment items with 
very short equipment life durations. For a more detailed discussion of 
the methodology associated with very short equipment life durations, we 
refer readers to the CY 2021 PFS final rule (85 FR 84482 through 
84483).
     Maintenance: We finalized the 5 percent factor for annual 
maintenance in the CY 1998 PFS final rule with comment period (62 FR 
33164). As we previously stated in the CY 2016 PFS final rule with 
comment period (80 FR 70897), we do not believe the annual maintenance 
factor for all equipment is precisely 5 percent, and we concur that the 
current rate likely understates the true cost of maintaining some 
equipment. We also noted that we believe it likely overstates the 
maintenance costs for other equipment. When we solicited comments 
regarding sources of data containing equipment maintenance rates, 
commenters were unable to identify an auditable, robust data source 
that could be used by CMS on a wide scale. We noted that we did not 
believe voluntary submissions regarding the maintenance costs of 
individual equipment items would be an appropriate methodology for 
determining costs. As a result, in the absence of publicly available 
datasets regarding equipment maintenance costs or another systematic 
data collection methodology for determining a different maintenance 
factor, we did not propose a variable maintenance factor for equipment 
cost per minute pricing as we did not believe that we have sufficient 
information at present. We noted that we would continue to investigate 
potential avenues for determining equipment maintenance costs across a 
broad range of equipment items.
     Interest Rate: In the CY 2013 PFS final rule with comment 
period (77 FR 68902), we updated the interest rates used in developing 
an equipment cost per minute calculation (see 77 FR 68902 for a 
thorough discussion of this issue). The interest rate was based on the 
Small Business Administration (SBA) maximum interest rates for 
different categories of loan size (equipment cost) and maturity (useful 
life). The Interest rates are listed in Table 6.
[GRAPHIC] [TIFF OMITTED] TR19NO21.009

    We did not propose any changes to the equipment interest rates for 
CY 2022.
3. Changes to Direct PE Inputs for Specific Services
    This section focuses on specific PE inputs. The direct PE inputs 
are included in the CY 2022 direct PE input public use files, which are 
available on the CMS website under downloads for the CY 2022 PFS final 
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
    As we noted in the CY 2015 PFS final rule with comment period (79 
FR 67640 through 67641), we continue to make improvements to the direct 
PE input database to provide the number of clinical labor minutes 
assigned for each task for every code in the database instead of only 
including the number of

[[Page 65013]]

clinical labor minutes for the preservice, service, and post service 
periods for each code. In addition to increasing the transparency of 
the information used to set PE RVUs, this level of detail would allow 
us to compare clinical labor times for activities associated with 
services across the PFS, which we believe is important to maintaining 
the relativity of the direct PE inputs. This information would 
facilitate the identification of the usual numbers of minutes for 
clinical labor tasks and the identification of exceptions to the usual 
values. It would also allow for greater transparency and consistency in 
the assignment of equipment minutes based on clinical labor times. 
Finally, we believe that the detailed information can be useful in 
maintaining standard times for particular clinical labor tasks that can 
be applied consistently to many codes as they are valued over several 
years, similar in principle to the use of physician preservice time 
packages. We believe that setting and maintaining such standards would 
provide greater consistency among codes that share the same clinical 
labor tasks and could improve relativity of values among codes. For 
example, as medical practice and technologies change over time, changes 
in the standards could be updated simultaneously for all codes with the 
applicable clinical labor tasks, instead of waiting for individual 
codes to be reviewed.
    In the CY 2016 PFS final rule with comment period (80 FR 70901), we 
solicited comments on the appropriate standard minutes for the clinical 
labor tasks associated with services that use digital technology. After 
consideration of comments received, we finalized standard times for 
clinical labor tasks associated with digital imaging at 2 minutes for 
``Availability of prior images confirmed'', 2 minutes for ``Patient 
clinical information and questionnaire reviewed by technologist, order 
from physician confirmed and exam protocoled by radiologist'', 2 
minutes for ``Review examination with interpreting MD'', and 1 minute 
for ``Exam documents scanned into PACS'' and ``Exam completed in RIS 
system to generate billing process and to populate images into 
Radiologist work queue.'' In the CY 2017 PFS final rule (81 FR 80184 
through 80186), we finalized a policy to establish a range of 
appropriate standard minutes for the clinical labor activity, 
``Technologist QCs images in PACS, checking for all images, reformats, 
and dose page.'' These standard minutes will be applied to new and 
revised codes that make use of this clinical labor activity when they 
are reviewed by us for valuation. We finalized a policy to establish 2 
minutes as the standard for the simple case, 3 minutes as the standard 
for the intermediate case, 4 minutes as the standard for the complex 
case, and 5 minutes as the standard for the highly complex case. These 
values were based upon a review of the existing minutes assigned for 
this clinical labor activity; we determined that 2 minutes is the 
duration for most services and a small number of codes with more 
complex forms of digital imaging have higher values. We also finalized 
standard times for a series of clinical labor tasks associated with 
pathology services in the CY 2016 PFS final rule with comment period 
(80 FR 70902). We do not believe these activities would be dependent on 
number of blocks or batch size, and we believe that the finalized 
standard values accurately reflect the typical time it takes to perform 
these clinical labor tasks.
    In reviewing the RUC-recommended direct PE inputs for CY 2019, we 
noticed that the 3 minutes of clinical labor time traditionally 
assigned to the ``Prepare room, equipment and supplies'' (CA013) 
clinical labor activity were split into 2 minutes for the ``Prepare 
room, equipment and supplies'' activity and 1 minute for the ``Confirm 
order, protocol exam'' (CA014) activity. We proposed to maintain the 3 
minutes of clinical labor time for the ``Prepare room, equipment and 
supplies'' activity and remove the clinical labor time for the 
``Confirm order, protocol exam'' activity wherever we observed this 
pattern in the RUC-recommended direct PE inputs. Commenters explained 
in response that when the new version of the PE worksheet introduced 
the activity codes for clinical labor, there was a need to translate 
old clinical labor tasks into the new activity codes, and that a prior 
clinical labor task was split into two of the new clinical labor 
activity codes: CA007 (Review patient clinical extant information and 
questionnaire) in the preservice period, and CA014 (Confirm order, 
protocol exam) in the service period. Commenters stated that the same 
clinical labor from the old PE worksheet was now divided into the CA007 
and CA014 activity codes, with a standard of 1 minute for each 
activity. We agreed with commenters that we would finalize the RUC-
recommended 2 minutes of clinical labor time for the CA007 activity 
code and 1 minute for the CA014 activity code in situations where this 
was the case. However, when reviewing the clinical labor for the 
reviewed codes affected by this issue, we found that several of the 
codes did not include this old clinical labor task, and we also noted 
that several of the reviewed codes that contained the CA014 clinical 
labor activity code did not contain any clinical labor for the CA007 
activity. In these situations, we continue to believe that in these 
cases, the 3 total minutes of clinical staff time would be more 
accurately described by the CA013 ``Prepare room, equipment and 
supplies'' activity code, and we finalized these clinical labor 
refinements. For additional details, we direct readers to the 
discussion in the CY 2019 PFS final rule (83 FR 59463 and 59464).
    Following the publication of the CY 2020 PFS proposed rule, one 
commenter expressed concern with the published list of common 
refinements to equipment time. The commenter stated that these 
refinements were the formulaic result of the applying refinements to 
the clinical labor time and did not constitute separate refinements; 
the commenter requested that CMS no longer include these refinements in 
the table published each year. In the CY 2020 PFS final rule, we agreed 
with the commenter that these equipment time refinements did not 
reflect errors in the equipment recommendations or policy discrepancies 
with the RUC's equipment time recommendations. However, we believed 
that it was important to publish the specific equipment times that we 
were proposing (or finalizing in the case of the final rule) when they 
differed from the recommended values due to the effect that these 
changes can have on the direct costs associated with equipment time. 
Therefore, we finalized the separation of the equipment time 
refinements associated with changes in clinical labor into a separate 
table of refinements. For additional details, we direct readers to the 
discussion in the CY 2020 PFS final rule (84 FR 62584).
    Historically, the RUC has submitted a ``PE worksheet'' that details 
the recommended direct PE inputs for our use in developing PE RVUs. The 
format of the PE worksheet has varied over time and among the medical 
specialties developing the recommendations. These variations have made 
it difficult for both the RUC's development and our review of code 
values for individual codes. Beginning with its recommendations for CY 
2019, the RUC has mandated the use of a new PE worksheet for purposes 
of their recommendation development process that standardizes the 
clinical labor tasks and assigns them a clinical labor activity code. 
We believe the RUC's use of the new PE worksheet in

[[Page 65014]]

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

[[Page 65015]]

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

[[Page 65016]]

file as described below, however we received a public comment on these 
topics from one stakeholder. The following is a summary of the comments 
we received and our responses.
    Comment: One stakeholder contacted CMS identifying what appeared to 
be duplicate data in the utilization crosswalk file. The stakeholder 
stated that the first 15,875 rows of the file appeared to almost 
exclusively contain duplicate lines in sets of two, and requested 
clarification on whether the utilization file was in error.
    Response: Due to a technical error, the utilization for anesthesia 
services was unintentionally duplicated in the files associated with 
the proposed rule. We have corrected this error for the final rule and 
we apologize for any confusion which may have resulted from this 
inadvertent mistake in the utilization crosswalk file.
    Comment: One commenter stated that they believed the public use 
files contain an error in the clinical labor portion of the PE RVU 
calculation. The commenter stated that the CY 2022 PE RVU summary file 
provided the pre-, intra-, and post-service costs for CPT codes 65778 
and 65779. The commenter stated that this file showed no cost for pre-
service activities or post-service activities, however the accompanying 
Clinical Labor New Activity Detail public use file showed a series of 
staff activities associated with CPT codes 65778 and 65779. The 
commenter requested that CMS review the pre-service and post-service 
costs and correct or update the clinical labor values for these codes 
accordingly. The commenter also stated that the patient contact time 
reflected in the public use file is understated by approximately 50 
percent for CPT codes 65778 and 65779 and encouraged CMS to evaluate 
whether the public use file values should be updated prior to 
implementation of the PFS for CY 2022.
    Response: We reviewed the public use files described by the 
commenter and we can confirm that there was no error in the calculation 
of the rates for these services. The clinical labor tasks described by 
the commenter for CPT codes 65778 and 65779 all take place during the 
intra-service period, not the pre-service or post-service period, and 
the Clinical Labor New Activity Detail public use file correctly lists 
the clinical labor for these services. If the commenter has reason to 
believe that the clinical labor is undervalued for these services, we 
encourage them to nominate CPT codes 65778 and 65779 as potentially 
misvalued for additional review.
c. Updates to Prices for Existing Direct PE Inputs
    In the CY 2011 PFS final rule with comment period (75 FR 73205), we 
finalized a process to act on public requests to update equipment and 
supply price and equipment useful life inputs through annual 
rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2022, 
we proposed to update the price of six supplies and two equipment items 
in response to the public submission of invoices. Since this is the 
final year of the supply and equipment pricing update, the new pricing 
for each of these supply and equipment items will take effect for CY 
2022 as there are no remaining years of the transition. The six supply 
and equipment items with proposed updated prices are listed in the 
valuation of specific codes section of the preamble under Table 23, CY 
2022 Invoices Received for Existing Direct PE Inputs.
(1) Market-Based Supply and Equipment Pricing Update
    Section 220(a) of the Protecting Access to Medicare Act of 2014 
(PAMA) (Pub. L. 113-93, April 1, 2014) provides that the Secretary may 
collect or obtain information from any eligible professional or any 
other source on the resources directly or indirectly related to 
furnishing services for which payment is made under the PFS, and that 
such information may be used in the determination of relative values 
for services under the PFS. Such information may include the time 
involved in furnishing services; the amounts, types and prices of PE 
inputs; overhead and accounting information for practices of physicians 
and other suppliers, and any other elements that would improve the 
valuation of services under the PFS.
    As part of our authority under section 1848(c)(2)(M) of the Act, we 
initiated a market research contract with StrategyGen to conduct an in-
depth and robust market research study to update the PFS direct PE 
inputs (DPEI) for supply and equipment pricing for CY 2019. These 
supply and equipment prices were last systematically developed in 2004-
2005. StrategyGen submitted a report with updated pricing 
recommendations for approximately 1300 supplies and 750 equipment items 
currently used as direct PE inputs. This report is available as a 
public use file displayed on the CMS website under downloads for the CY 
2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html.
    The StrategyGen team of researchers, attorneys, physicians, and 
health policy experts conducted a market research study of the supply 
and equipment items currently used in the PFS direct PE input database. 
Resources and methodologies included field surveys, aggregate 
databases, vendor resources, market scans, market analysis, physician 
substantiation, and statistical analysis to estimate and validate 
current prices for medical equipment and medical supplies. StrategyGen 
conducted secondary market research on each of the 2,072 DPEI medical 
equipment and supply items that CMS identified from the current DPEI. 
The primary and secondary resources StrategyGen used to gather price 
data and other information were:
     Telephone surveys with vendors for top priority items 
(Vendor Survey).
     Physician panel validation of market research results, 
prioritized by total spending (Physician Panel).
     The General Services Administration system (GSA).
     An aggregate health system buyers database with discounted 
prices (Buyers).
     Publicly available vendor resources, that is, Amazon 
Business, Cardinal Health (Vendors).
     The Federal Register, current DPEI data, historical 
proposed and final rules prior to CY 2018, and other resources; that 
is, AMA RUC reports (References).
    StrategyGen prioritized the equipment and supply research based on 
current share of PE RVUs attributable by item provided by CMS. 
StrategyGen developed the preliminary Recommended Price (RP) 
methodology based on the following rules in hierarchical order 
considering both data representativeness and reliability.
    (1) If the market share, as well as the sample size, for the top 
three commercial products were available, the weighted average price 
(weighted by percent market share) was the reported RP. Commercial 
price, as a weighted average of market share, represents a more robust 
estimate for each piece of equipment and a more precise reference for 
the RP.
    (2) If no data were available for commercial products, the current 
CMS prices were used as the RP.
    GSA prices were not used to calculate the StrategyGen recommended 
prices, due to our concern that the GSA system curtails the number and 
type of suppliers whose products may be accessed on the GSA Advantage 
website, and that the GSA prices may often be lower than prices that 
are

[[Page 65017]]

available to non-governmental purchasers. After reviewing the 
StrategyGen report, we proposed to adopt the updated direct PE input 
prices for supplies and equipment as recommended by StrategyGen.
    StrategyGen found that despite technological advancements, the 
average commercial price for medical equipment and supplies has 
remained relatively consistent with the current CMS price. 
Specifically, preliminary data indicated that there was no 
statistically significant difference between the estimated commercial 
prices and the current CMS prices for both equipment and supplies. This 
cumulative stable pricing for medical equipment and supplies appears 
similar to the pricing impacts of non-medical technology advancements 
where some historically high-priced equipment (that is, desktop PCs) 
has been increasingly substituted with current technology (that is, 
laptops and tablets) at similar or lower price points. However, while 
there were no statistically significant differences in pricing at the 
aggregate level, medical specialties would experience increases or 
decreases in their Medicare payments if we were to adopt the pricing 
updates recommended by StrategyGen. At the service level, there may be 
large shifts in PE RVUs for individual codes that happened to contain 
supplies and/or equipment with major changes in pricing, although we 
note that codes with a sizable PE RVU decrease would be limited by the 
requirement to phase in significant reductions in RVUs, as required by 
section 1848(c)(7) of the Act. The phase-in requirement limits the 
maximum RVU reduction for codes that are not new or revised to 19 
percent in any individual calendar year.
    We believe that it is important to make use of the most current 
information available for supply and equipment pricing instead of 
continuing to rely on pricing information that is more than a decade 
old. Given the potentially significant changes in payment that would 
occur, both for specific services and more broadly at the specialty 
level, in the CY 2019 PFS proposed rule we proposed to phase in our use 
of the new direct PE input pricing over a 4-year period using a 25/75 
percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021), 
and 100/0 percent (CY 2022) split between new and old pricing. This 
approach is consistent with how we have previously incorporated 
significant new data into the calculation of PE RVUs, such as the 4-
year transition period finalized in CY 2007 PFS final rule with comment 
period when changing to the ``bottom-up'' PE methodology (71 FR 69641). 
This transition period will not only ease the shift to the updated 
supply and equipment pricing, but will also allow interested parties an 
opportunity to review and respond to the new pricing information 
associated with their services.
    We proposed to implement this phase-in over 4 years so that supply 
and equipment values transition smoothly from the prices we currently 
include to the final updated prices in CY 2022. We proposed to 
implement this pricing transition such that one quarter of the 
difference between the current price and the fully phased-in price is 
implemented for CY 2019, one third of the difference between the CY 
2019 price and the final price is implemented for CY 2020, and one half 
of the difference between the CY 2020 price and the final price is 
implemented for CY 2021, with the new direct PE prices fully 
implemented for CY 2022. An example of the transition from the current 
to the fully-implemented new pricing is provided in Table 7.
[GRAPHIC] [TIFF OMITTED] TR19NO21.010

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

[[Page 65018]]

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

[[Page 65019]]

data, we continue to believe that the equipment pricing we established 
for these items based on our past market-based research reflects the 
most accurate information for the equipment items in question.
    Comment: An anonymous commenter submitted an invoice that they 
stated could be used to update the pricing of the endovascular laser 
treatment kit (SA074) supply. The commenter stated that the PE may be 
overvalued for CPT code 36478, and the cost of $205.00 per kit detailed 
in this invoice may be more accurately reflective of SA074 kit costs.
    Response: We appreciate the invoice submission from the anonymous 
commenter. The SA074 supply has a current CY 2022 price of $438.60 
based on invoices submitted in last year's CY 2021 rulemaking cycle. 
The new invoice submission is less than half of this price, and when we 
compared the specific kit in question on the invoices, they described 
two different products. The CY 2021 invoices described a 65 cm kit 
while the CY 2022 invoice described a 45 cm version of the same kit. We 
believe that this explains the disparity in pricing between the 
different invoices. Since it is unclear to us which of these two 
products is more typical for use in CPT code 36478, we are maintaining 
the current CY 2022 price of $438.60 pending availability of additional 
information. We encourage stakeholders to submit additional invoices to 
assist in the pricing of the SA074 supply. These invoices can be 
submitted with public comments in next year's CY 2023 rulemaking cycle 
or, if outside the notice and comment rulemaking process, via email at 
[email protected].
    Comment: One commenter requested that CMS establish a national 
physician payment rate for Category III CPT code 0583T, also known as 
tympanostomy under local anesthesia (Tula). The commenter stated that 
this device-intensive procedure has inappropriately low physician MAC-
posted rates resulting from crosswalks to ENT codes that do not involve 
use of single-use implantable medical devices provided in the physician 
office setting. The commenter suggested work RVUs and direct PE inputs 
for Category III code 0583T to be used in national pricing of the 
service, and separately submitted six invoices showing prices paid by 
physicians for the tympanostomy under local anesthesia (Tula) 
implantable device and related supplies. The commenter requested a 
price of $995 for the Tula implantable device.
    Response: We appreciate the submission of invoices and other 
pricing information from the commenter regarding Category III CPT code 
0583T, but we did not propose to establish national pricing for this 
service. Category III CPT codes are typically contractor priced since 
they describe new and emerging technologies. We will review the 
materials provided by the commenter for potential use in future 
rulemaking; however, we are not finalizing national pricing for 
Category III CPT code 0583T or establishing a price for the Tula 
implantable device at this time.
    After consideration of the public comments, we are finalizing the 
supply and equipment prices as detailed individually above. We note 
that the supply and equipment prices finalized for CY 2022 represent 
the fourth and final year of the market-based supply and equipment 
pricing update.
(2) Invoice Submission
    The full list of updated supply and equipment pricing as 
implemented over the 4-year transition period will be made available as 
a public use file displayed on the CMS website under downloads for the 
CY 2022 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html.
    We routinely accept public submission of invoices as part of our 
process for developing payment rates for new, revised, and potentially 
misvalued codes. Often these invoices are submitted in conjunction with 
the RUC-recommended values for the codes. To be included in a given 
year's proposed rule, we generally need to receive invoices by the same 
February 10th deadline we noted for consideration of RUC 
recommendations. However, we will consider invoices submitted as public 
comments during the comment period following the publication of the PFS 
proposed rule, and would consider any invoices received after February 
10th or outside of the public comment process as part of our 
established annual process for requests to update supply and equipment 
prices. Stakeholders are encouraged to submit invoices with their 
public comments or, if outside the notice and comment rulemaking 
process, via email at [email protected].
(3) Autologous Platelet-Rich Plasma (HCPCS Code G0460) Supply Inputs
    We did not make any proposals associated with HCPCS code G0460 
(Autologous platelet rich plasma for chronic wounds/ulcers, including 
phlebotomy, centrifugation, and all other preparatory procedures, 
administration and dressings, per treatment) in the CY 2021 PFS 
proposed rule. Following publication of the rule, stakeholders 
contacted CMS regarding the creation of a new 3C patch system supply, 
which is topically applied for the management of exuding cutaneous 
wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and 
mechanically or surgically-debrided wounds. Stakeholders first sought 
clarification on how CMS calculated the underlying nonfacility PE RVUs 
for HCPCS code G0460. Stakeholders also stated that autologous platelet 
rich plasma administration procedures furnished in clinical trials 
(including the new 3C patch system) are reported using HCPCS code G0460 
and requested that CMS revalue the service to reflect the PEs 
associated with the new patch system supply. The stakeholders stated 
that the use of the new 3C patch system will represent the typical case 
for HCPCS code G0460, and suggested that, therefore, the cost inputs 
for this supply should be used to establish the RVUs for this code, as 
the current PFS payment rate is substantially less than the amount it 
costs to furnish the 3C patch.
    We want to clarify that the direct PE inputs for HCPCS code G0460 
increased for CY 2021 as a result of the ongoing market-based supply 
and equipment pricing update. However, there was also a minor decrease 
in the indirect PE allocation associated with this service for CY 2021, 
with the net result that the proposed PE RVU coincidentally ended up 
remaining the same as in the previous year. We also clarify that HCPCS 
code G0460 is not included in the Anticipated Specialty Assignment for 
Low Volume Services list, and therefore, was unaffected by low 
utilization in the claims data. In addition, as a contractor priced 
service, HCPCS code G0460 is unaffected by inclusion or exclusion from 
this list.
    We share the concerns of the stakeholders that patient access to 
the 3C patch could be materially impacted if CMS maintains the current 
PE RVUs for HCPCS G0460. In the CY 2021 PFS final rule, we established 
contractor pricing for HCPCS code G0460 for CY 2021. We believe that 
the use of contractor pricing again for CY 2022 will allow us 
additional time to consider the most appropriate resource inputs and PE 
RVUs for HCPCS code G0460. We also added the 3C patch system to our 
supply database under supply code SD343 at a price of $625.00 based on 
an average of the submitted invoices. We proposed to maintain 
contractor pricing for CY 2022 for HCPCS code G0460 as we do not 
currently have sufficient information to establish national pricing. It 
remains

[[Page 65020]]

unclear to us what the typical supply inputs would be for HCPCS code 
G0460 and whether they would include the use of the new 3C patch 
system. We believe that it would be more appropriate to maintain 
contractor pricing for the service, which will allow for more 
flexibility in pricing. We solicited any additional information that 
commenters can supply that CMS should consider to establish national 
payment for HCPCS code G0460.
    We did not receive public comments on this proposal and are 
finalizing contractor pricing for HCPCS code G0460 for CY 2022 as 
proposed.
d. Clinical Labor Pricing Update
    Section 220(a) of the PAMA provides that the Secretary may collect 
or obtain information from any eligible professional or any other 
source on the resources directly or indirectly related to furnishing 
services for which payment is made under the PFS, and that such 
information may be used in the determination of relative values for 
services under the PFS. Such information may include the time involved 
in furnishing services; the amounts, types and prices of PE inputs; 
overhead and accounting information for practices of physicians and 
other suppliers, and any other elements that would improve the 
valuation of services under the PFS.
    Since 2019, we have been updating the supply and equipment prices 
used for PE as part of a market-based pricing transition; CY 2022 will 
be the final year of this 4-year transition. We initiated a market 
research contract with StrategyGen to conduct an in-depth and robust 
market research study to update the supply and equipment pricing for CY 
2019, and we finalized a policy in CY 2019 to phase in the new pricing 
over a period of 4 years. However, we did not propose to update the 
clinical labor pricing, and the pricing for clinical labor has remained 
unchanged during this pricing transition. Clinical labor rates were 
last updated for CY 2002 using Bureau of Labor Statistics (BLS) data 
and other supplementary sources where BLS data were not available; we 
refer readers to the full discussion in the CY 2002 PFS final rule for 
additional details (66 FR 55257 through 55262).
    Stakeholders have raised concerns that the long delay since 
clinical labor pricing was last updated has created a significant 
disparity between CMS' clinical wage data and the market average for 
clinical labor. In recent years, a number of stakeholders have 
suggested that certain wage rates are inadequate because they do not 
reflect current labor rate information. Some stakeholders have also 
stated that updating the supply and equipment pricing without updating 
the clinical labor pricing could create distortions in the allocation 
of direct PE. Since the pool of aggregated direct PE inputs is budget 
neutral, if these rates are not routinely updated, clinical labor may 
become undervalued over time relative to equipment and supplies, 
especially since the supply and equipment prices are in the process of 
being updated. There has been considerable stakeholder interest in 
updating the clinical labor rates, and when we solicited comment on 
this topic in past rules, such as in the CY 2019 PFS final rule (83 FR 
59480), stakeholders supported the idea.
    Therefore, we proposed to update the clinical labor pricing for CY 
2022, in conjunction with the final year of the supply and equipment 
pricing update. We believe it is important to update the clinical labor 
pricing to maintain relativity with the recent supply and equipment 
pricing updates. We proposed to use the methodology outlined in the CY 
2002 PFS final rule (66 FR 55257), which draws primarily from BLS wage 
data, to calculate updated clinical labor pricing. As we stated in the 
CY 2002 PFS final rule, the BLS' reputation for publishing valid 
estimates that are nationally representative led to the choice to use 
the BLS data as the main source. We believe that the BLS wage data 
continues to be the most accurate source to use as a basis for clinical 
labor pricing and this data will appropriately reflect changes in 
clinical labor resource inputs for purposes of setting PE RVUs under 
the PFS. We used the most current BLS survey data (2019) as the main 
source of wage data for this proposal.
    We recognize that the BLS survey of wage data does not cover all 
the staff types contained in our direct PE database. Therefore, we 
crosswalked or extrapolated the wages for several staff types using 
supplementary data sources for verification whenever possible. In 
situations where the price wages of clinical labor types were not 
referenced in the BLS data, we have used the national salary data from 
the Salary Expert, an online project of the Economic Research Institute 
that surveys national and local salary ranges and averages for 
thousands of job titles using mainly government sources. (A detailed 
explanation of the methodology used by Salary Expert to estimate 
specific job salaries can be found at www.salaryexpert.com). We 
previously used Salary Expert information as the primary backup source 
of wage data during the last update of clinical labor pricing in CY 
2002. If we did not have direct BLS wage data available for a clinical 
labor type, we used the wage data from Salary Expert as a reference for 
pricing, then crosswalked these clinical labor types to a proxy BLS 
labor category rate that most closely matched the reference wage data, 
similar to the crosswalks used in our PE/HR allocation. For example, 
there is no direct BLS wage data for the Mammography Technologist 
(L043) clinical labor type; we used the wage data from Salary Expert as 
a reference and identified the BLS wage data for Respiratory Therapists 
as the best proxy category. We calculated rates for the ``blend'' 
clinical labor categories by combining the rates for each labor type in 
the blend and then dividing by the total number of labor types in the 
blend.
    As in the CY 2002 clinical labor pricing update, the proposed cost 
per minute for each clinical staff type was derived by dividing the 
average hourly wage rate by 60 to arrive at the per minute cost. In 
cases where an hourly wage rate was not available for a clinical staff 
type, the proposed cost per minute for the clinical staff type was 
derived by dividing the annual salary (converted to 2021 dollars using 
the Medicare Economic Index) by 2080 (the number of hours in a typical 
work year) to arrive at the hourly wage rate and then again by 60 to 
arrive at the per minute cost. To account for the employers' cost of 
providing fringe benefits, such as sick leave, we used the same 
benefits multiplier of 1.366 as employed in CY 2002. As an example of 
this process, for the Physical Therapy Aide (L023A) clinical labor 
type, the BLS data reflected an average hourly wage rate of $14.03, 
which we multiplied by the 1.366 benefits modifier and then divided by 
60 minutes to arrive at the proposed per-minute rate of $0.32.
    Table 8 lists our updates to the clinical labor prices. The BLS 
occupational code used as a source of wage data is listed for each 
clinical labor type; for the ``blend'' clinical labor types, this may 
include multiple BLS occupational codes and other clinical labor types 
which were calculated separately and then averaged together. Clinical 
labor types without a direct BLS labor category where we are employing 
a proxy BLS wage rate are indicated with an asterisk in Table 8.
BILLING CODE 4120-01-P

[[Page 65021]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.011

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

[[Page 65022]]

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

[[Page 65023]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.012


[[Page 65024]]


[GRAPHIC] [TIFF OMITTED] TR19NO21.013

BILLING CODE 4120-01-C
    The potential effects of the clinical labor pricing update on 
specialty payment impacts were largely driven by the share that labor 
costs represent of the direct PE inputs for each specialty. Specialties 
with a substantially lower or higher than average share of direct costs 
attributable to labor would experience significant declines or 
increases, respectively, if this proposal is finalized. For example, 
the Family Practice specialty had a higher share of direct costs 
associated with clinical labor, and payments to services comprising the 
specialty would be expected to increase as a result of this clinical 
labor pricing update. In contrast, Diagnostic Testing Facilities had a 
lower share of direct costs that are associated with clinical labor, 
and payments to services comprising the specialty would be expected to 
decrease. Other specialty-level payment impacts for the proposed 
clinical labor pricing changes were driven by changes in wage rates for 
a clinical labor category that affects a given specialty more than 
average. One such example would be the proposed increase of 11 percent 
for Oncology nurses as opposed to the average increase for nurses of 63 
percent. We emphasized that these are not the projected impacts by 
specialty of all the policies we proposed in the proposed rule for CY 
2022, only the anticipated effect of the isolated clinical labor 
pricing update, should this clinical labor pricing update be finalized 
as proposed.
    When updates to our payment methodology based on new data produce 
significant shifts in payment, we often consider whether it would be 
appropriate to implement the updates through a phased transition across 
several calendar years. For example, we utilized a 4-year transition 
for the market-based supply and equipment pricing update concluding in 
CY 2022. We are considering the use of a similar 4-year transition to 
implement the clinical labor pricing update. A multi-year transition 
could smooth out the increases and decreases in payment caused by the 
pricing update for affected stakeholders, promoting payment stability. 
However, a phased transition would delay the full implementation of 
updated pricing and continue to rely in part on outdated data for 
clinical labor pricing. We discuss a potential 4-year transition for 
the clinical labor pricing update as an alternative considered in the 
Regulatory Impact Analysis (section VI.I of this final rule).
    We received public comments on our proposal to update the clinical 
labor pricing. The following is a summary of the comments we received 
and our responses.
    Comment: Many commenters supported the proposal to update the 
clinical labor pricing. Commenters overwhelmingly agreed that the BLS 
was the most accurate source of wage data and the best source to use 
for updating the clinical labor pricing. Commenters stated that CMS 
needs recurring and accurate sources of data to keep PE RVUs up to date 
and that such data sources should capture the prices of equipment and 
supplies, wage rates for clinical staff, the types and quantities of 
direct PE inputs, and specialties' practice costs. Commenters stated 
that inaccurate prices for PE inputs could lead to distortions in the 
PE RVUs; for example, updating prices for equipment and supplies but 
not clinical labor could lead to undervaluing of services that use a 
high share of clinical labor. Several commenters stated that, after 
almost 20 years, an update to clinical labor pricing was long overdue. 
Several commenters urged CMS to update the prices for clinical labor 
immediately because inaccurate payment rates distort the market for 
clinician services and further prolonging the necessary improvement in 
CMS' PE RVU methodology will result in additional, unnecessary delays 
for an already overdue pricing update. These commenters recognized that 
this update may negatively impact certain specialties and procedures, 
but stated that the lack of pricing updates has likely disadvantaged 
services that rely heavily on clinical labor, such as family medicine, 
for several years.
    Response: We appreciate the support for our proposed policies from 
the commenters.
    Comment: Many commenters supported the proposal to update the 
clinical labor pricing, but stated that the update should be phased in 
using a 4-year transition. Commenters stated that the use of a 4-year 
transition would be consistent with previous PE updates such as the 
market-based supply and equipment pricing update and the implementation 
of the bottom-up PE methodology. Commenters stated that the phased in 
approach would help minimize the reimbursement reductions to specific 
services which rely heavily on supply and equipment costs that 
otherwise could prove detrimental to Medicare beneficiary access to 
services. Commenters stated that these PE decreases coupled with the 
3.75 percent reduction in the conversion factor resulting from the 
expiration of the temporary increase provided under the CY 2021 
Consolidated Appropriations Act are difficult for practices to absorb 
as the country struggles to contain the COVID-19 pandemic, and that 
mitigating the effects of the clinical labor pricing update through the 
use of a 4-year transition would help maintain payment stability.
    Response: We appreciate the support for the proposed clinical labor 
update from the commenters, with the additional request that we 
implement it using a 4-year transition. After consideration of the 
comments, we agree that the use of a multi-year transition will help 
smooth out the changes in payment resulting from the clinical labor 
pricing update, avoiding potentially disruptive changes in payment for 
affected stakeholders, and promoting payment stability from year-to-
year. We believe it would be appropriate to use a 4-year transition, as 
we have for several other broad-based updates or methodological 
changes. While we recognize that using a 4-year transition to implement 
the update means that we will continue to rely in part on outdated data 
for clinical labor pricing until the change is fully completed in CY 
2025, we agree with the commenters that these significant updates to PE 
valuation should be implemented in the same way, and for the same 
reasons, as for other major updates to pricing such as the recent 
supply and equipment update. We believe that the use of a 4-year 
transition in implementing the clinical labor pricing update will help 
to maintain payment stability, particularly given the ongoing public 
health emergency (PHE) for COVID-19.
    We are finalizing the implementation of the clinical labor pricing 
update over 4 years to transition from current prices

[[Page 65025]]

to the final updated prices in CY 2025. We considered, as an 
alternative to our proposal, implementing this pricing transition over 
4 years, such that one quarter of the difference between the current 
price and the fully phased-in price is implemented for CY 2022, one 
third of the difference between the CY 2022 price and the final price 
is implemented for CY 2023, and one half of the difference between the 
CY 2023 price and the final price is implemented for CY 2024, with the 
new direct PE prices fully implemented for CY 2025. An example of the 
transition from the current to the fully-implemented new pricing that 
we are finalizing is provided in Table 10.
[GRAPHIC] [TIFF OMITTED] TR19NO21.014

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

[[Page 65026]]

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

[[Page 65027]]

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

[[Page 65028]]

much greater than displayed on these tables. Commenters stated that it 
would be more transparent to share impacts for individual services when 
they had a potentially large negative effect on providers of office-
based procedures with high supply and equipment costs.
    Response: Although we share the concerns of commenters regarding 
the importance of providing transparency in the published data, we 
disagree that the specialty impacts tables included in the CY 2022 PFS 
proposed rule were misleading, or that commenters lacked sufficient 
information about the pricing of individual services. We noted in the 
CY 2022 PFS proposed rule (86 FR 39532) that the impact tables are for 
illustrative purposes for aggregate impacts on specialties, and are not 
meant to be code specific; therefore, they are averages, and may not 
necessarily be representative of what is happening to the particular 
services furnished by a single practitioner within any given specialty. 
This has been a feature of the specialty impact tables published in the 
PFS for many years, and we believe it is generally well understood by 
stakeholders. We also note that the proposed RVUs for every HCPCS code 
were published in Addendum B as part of the CY 2022 PFS proposed rule 
to allow stakeholders the opportunity to provide comment on the 
proposed valuations for each code. Due to the thousands of HCPCS codes 
affected by the clinical labor pricing update, we did not publish a 
service-level analysis of the pricing update in the preamble, but did 
include this information in Addendum B for consideration by 
stakeholders. We will consider suggestions to improve the information 
available to stakeholders for future rulemaking.
    Comment: Many commenters noted that 14 of the 32 clinical labor 
staff types had proposed valuations using a BLS crosswalk because an 
exact match was not available. Commenters stated that to maintain 
transparency CMS should publish the ``other sources'' wage data details 
for these clinical labor types. Commenters stated that CMS should 
update specific clinical labor wage rates based on stakeholder comments 
and data.
    Response: We agree with the commenters that stakeholder comments 
and data will be valuable in updating the clinical labor pricing, and 
we share the concerns of the commenters regarding transparency in the 
data used for pricing. As we stated in the proposed rule, we used the 
national salary data from the Salary Expert as a reference for pricing, 
then crosswalked these clinical labor types to a proxy BLS labor 
category rate that most closely matched the reference wage data. For 
example, there is no direct BLS wage data for the Mammography 
Technologist (L043) clinical labor type; we used the wage data from 
Salary Expert for Mammography Technologists as a reference and 
identified the BLS wage data for Respiratory Therapists as the best 
proxy category. In the interest of transparency, Table 11 lists the 
Salary Expert wage data used for the clinical labor types which did not 
have direct BLS matches.
[GRAPHIC] [TIFF OMITTED] TR19NO21.015

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

[[Page 65029]]

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

[[Page 65030]]

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

[[Page 65031]]

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

[[Page 65032]]

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

[[Page 65033]]

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

[[Page 65034]]

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[[Page 65035]]


[GRAPHIC] [TIFF OMITTED] TR19NO21.017

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

[[Page 65036]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.018


[[Page 65037]]


[GRAPHIC] [TIFF OMITTED] TR19NO21.019

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

[[Page 65038]]

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

[[Page 65039]]

to maintain it, SaMD does require ongoing upgrades, improvements, and 
security mitigation, as well as the same regulatory oversight by the 
Food and Drug Administration (FDA) as hardware medical devices. 
Commenters stated that the legal, regulatory, and financial burdens 
incumbent of a SaMD manufacturer are no different than those of 
hardware medical device manufacturers.
    Response: We appreciate the detailed feedback from the commenters 
regarding the issues surrounding software and analysis fees. We agree 
with the commenters that there have been occasions in the past where we 
have finalized the inclusion of software as a direct PE expense if it 
met our criteria as typical and medically necessary for the service in 
question and could be individually allocable to a particular patient 
for a particular service. For example, we included the sheer wave 
elastography software (ED060) as a direct PE input for CPT codes 76981-
76983 in CY 2019. In this case, the sheer wave elastography software 
was an additional resource cost added to the general ultrasound room 
(EL015) equipment without which the service cannot be performed. We 
have been more hesitant to classify software, licensing, and analysis 
fees that are not associated with physical equipment used in the 
performance of a service as they pose more significant challenges for 
our traditional PE methodology. Therefore, we wish to clarify that 
although we have typically considered software costs to be indirect PE 
under our methodology, as these costs were not individually allocable 
to a particular patient for a particular service, there have been 
exceptions to this general principle where software costs have been 
included directly in the service under review.
    As we stated in the proposed rule, we believe that costs associated 
with software, licensing, and analysis fees are not well accounted for 
in the PE methodology. Unlike a piece of equipment, such as the retinal 
camera, an analysis fee for software does not require physical space in 
an office or administrative staff hours to maintain it. These types of 
costs were much less prevalent when the Physician Practice Information 
Survey (PPIS) was last administered in 2007 and 2008 and of course did 
not exist at all in the case of AI-based services. We remain concerned 
that if we were to consider software analysis fees and software as a 
medical device expenses to be direct costs in all cases, we may 
inadvertently allocate too many indirect costs for supplies that may 
not require additional indirect expenses. The data underlying the PPIS 
assumes that direct expenses will require costs associated with 
physical space and physical maintenance that may not appropriate for 
these new types of software. However, we do recognize that 
practitioners are incurring resource costs for purchase of the software 
and its ongoing use, which is why we proposed the crosswalk to CPT code 
92325 to capture these resource costs for CPT code 92229. We believe 
that the use of this crosswalk and other similar crosswalks are the 
best way to value services that make use of software, licensing, and 
analysis fees at the moment while we explore ongoing potential updates 
to the PE methodology.
    Comment: One commenter stated that CMS should consider crosswalks 
to CPT codes 95249 (Ambulatory CGM of interstitial tissue fluid via a 
subcutaneous sensor for a minimum of 72 hours; patient provided 
equipment, sensor placement, hook-up, calibration of monitor, patient 
training, and printout of recording) and 92977 (Thrombolysis, coronary; 
by intravenous infusion). The commenter stated that these codes are 
expected to be utilized in primary care and diabetes care settings and 
reflect similar resource costs.
    Response: We appreciate the additional suggested crosswalk codes 
from the commenter. However, we continue to believe that our proposed 
crosswalk to CPT code 92325 is a more appropriate choice to use for 
valuing CPT code 92229 because it more closely matches the RUC-
recommended total direct PE costs for CPT code 92229. Although CPT 
codes 95249 and 92977 share some clinical similarities with CPT code 
92229, they both include additional resource costs which would result 
in an inappropriately higher valuation if we were to employ them as our 
crosswalk code.
    After consideration of the public comments, we are finalizing our 
proposal to establish values for CPT code 92229 based on a direct 
crosswalk to CPT code 92325.
    We are aware of other services that use similar innovative 
technologies to those used for the diagnostic test for diabetic 
retinopathy and trabecular bone score, and that those technologies also 
are not well-accounted for in our PE methodology. For CY 2018, the AMA 
CPT Editorial Panel established four new Category III CPT codes for 
fractional flow reserve derived from computed tomography (FFRCT): CPT 
code 0501T (Noninvasive estimated coronary fractional flow reserve 
(FFR) derived from coronary computed tomography angiography data using 
computation fluid dynamics physiologic simulation software analysis of 
functional data to assess the severity of coronary artery disease; data 
preparation and transmission, analysis of fluid dynamics and simulated 
maximal coronary hyperemia, generation of estimated FFR model, with 
anatomical data review in comparison with estimated FFR model to 
reconcile discordant data, interpretation and report); CPT code 0502T 
(Noninvasive estimated coronary fractional flow reserve (FFR) derived 
from coronary computed tomography angiography data using computation 
fluid dynamics physiologic simulation software analysis of functional 
data to assess the severity of coronary artery disease; data 
preparation and transmission); CPT code 0503T (Noninvasive estimated 
coronary fractional flow reserve (FFR) derived from coronary computed 
tomography angiography data using computation fluid dynamics 
physiologic simulation software analysis of functional data to assess 
the severity of coronary artery disease; analysis of fluid dynamics and 
simulated maximal coronary hyperemia, and generation of estimated FFR 
model); and CPT code 0504T (Noninvasive estimated coronary fractional 
flow reserve (FFR) derived from coronary computed tomography 
angiography data using computation fluid dynamics physiologic 
simulation software analysis of functional data to assess the severity 
of coronary artery disease; anatomical data review in comparison with 
estimated FFR model to reconcile discordant data, interpretation and 
report). FFRCT is a noninvasive diagnostic service that allows 
physicians to measure coronary artery disease in a patient through 
coronary CT scans. It uses a proprietary data analysis process 
performed at a central facility to develop a three-dimensional image of 
a patient's coronary arteries, which allows physicians to identify the 
fractional flow reserve to assess whether or not patients should 
undergo further invasive testing or treatment (typically, a coronary 
angiogram). We understand that FFRCT can show through non-invasive 
imaging whether a beneficiary has coronary artery disease thereby 
potentially avoiding an invasive coronary procedure. Medicare began 
payment for CPT code 0503T in the HOPD setting under the Outpatient 
Prospective Payment System (OPPS) in CY 2018 (82 FR 59284). For the 
PFS, we typically assign contractor pricing for Category III codes 
since they are temporary codes assigned to emerging

[[Page 65040]]

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

[[Page 65041]]

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

[[Page 65042]]

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

C. Potentially Misvalued Services Under the PFS

1. Background
    Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a 
periodic review, not less often than every 5 years, of the relative 
value units (RVUs) established under the PFS. Section 1848(c)(2)(K) of 
the Act requires the Secretary to periodically identify potentially 
misvalued services using certain criteria and to review and make 
appropriate adjustments to the relative values for those services. 
Section 1848(c)(2)(L) of the Act also requires the Secretary to develop 
a process to validate the RVUs of certain potentially misvalued codes 
under the PFS, using the same criteria used to identify potentially 
misvalued codes, and to make appropriate adjustments.
    As discussed in section II.E. of this final rule, Valuation of 
Specific Codes, each year we develop appropriate adjustments to the 
RVUs taking into account recommendations provided by the American 
Medical Association (AMA) Resource-Based Relative Value Scale (RVS) 
Update Committee (RUC), MedPAC, and other stakeholders. For many years, 
the RUC has provided us with recommendations on the appropriate 
relative values for new, revised, and potentially misvalued PFS 
services. We review these recommendations on a code-by-code basis and 
consider these recommendations in conjunction with analyses of other 
data, such as claims data, to inform the decision-making process as 
authorized by statute. We may also consider analyses of work time, work 
RVUs, or direct PE inputs using other data sources, such as Department 
of Veteran Affairs (VA), National Surgical Quality Improvement Program 
(NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based 
Incentive Payment System (MIPS) data. In addition to considering the 
most recently available data, we assess the results of physician 
surveys and specialty recommendations submitted to us by the RUC for 
our review. We also consider information provided by other 
stakeholders. We conduct a review to assess the appropriate RVUs in the 
context of contemporary medical practice. We note that section 
1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and 
other techniques to determine the RVUs for physicians' services for 
which specific data are not available and requires us to take into 
account the results of consultations with organizations representing 
physicians who provide the services. In accordance with section 1848(c) 
of the Act, we determine and make appropriate adjustments to the RVUs.
    In its March 2006 Report to the Congress (http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed 
the importance of appropriately valuing physicians' services, noting 
that misvalued services can distort the market for physicians' 
services, as well as for other health care services that physicians 
order, such as hospital services. In that same report, MedPAC 
postulated that physicians' services under the PFS can become misvalued 
over time. MedPAC stated, ``When a new service is added to the 
physician fee schedule, it may be assigned a relatively high value 
because of the time, technical skill, and psychological stress that are 
often required to furnish that service. Over time, the work required 
for certain services would be expected to decline as physicians become 
more familiar with the service and more efficient in furnishing it.'' 
We believe services can also become overvalued when PE costs decline. 
This can happen when the costs of equipment and supplies fall, or when 
equipment is used more frequently than is estimated in the PE 
methodology, reducing its cost per use. Likewise, services can become 
undervalued when physician work increases or PE costs rises.
    As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since 
MedPAC made the initial recommendations, CMS and the RUC have taken 
several steps to improve the review process. Also, section 
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the 
Secretary to specifically examine, as determined appropriate, 
potentially misvalued services in the following categories:
     Codes that have experienced the fastest growth.
     Codes that have experienced substantial changes in PE.
     Codes that describe new technologies or services within an 
appropriate time-period (such as 3 years) after the relative values are 
initially established for such codes.
     Codes which are multiple codes that are frequently billed 
in conjunction with furnishing a single service.
     Codes with low relative values, particularly those that 
are often billed multiple times for a single treatment.
     Codes that have not been subject to review since 
implementation of the fee schedule.
     Codes that account for the majority of spending under the 
PFS.
     Codes for services that have experienced a substantial 
change in the hospital length of stay or procedure time.
     Codes for which there may be a change in the typical site 
of service since the code was last valued.
     Codes for which there is a significant difference in 
payment for the same service between different sites of service.

[[Page 65043]]

     Codes for which there may be anomalies in relative values 
within a family of codes.
     Codes for services where there may be efficiencies when a 
service is furnished at the same time as other services.
     Codes with high intraservice work per unit of time.
     Codes with high PE RVUs.
     Codes with high cost supplies.
     Codes as determined appropriate by the Secretary.
    Section 1848(c)(2)(K)(iii) of the Act also specifies that the 
Secretary may use existing processes to receive recommendations on the 
review and appropriate adjustment of potentially misvalued services. In 
addition, the Secretary may conduct surveys, other data collection 
activities, studies, or other analyses, as the Secretary determines to 
be appropriate, to facilitate the review and appropriate adjustment of 
potentially misvalued services. This section also authorizes the use of 
analytic contractors to identify and analyze potentially misvalued 
codes, conduct surveys or collect data, and make recommendations on the 
review and appropriate adjustment of potentially misvalued services. 
Additionally, this section provides that the Secretary may coordinate 
the review and adjustment of any RVU with the periodic review described 
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of 
the Act specifies that the Secretary may make appropriate coding 
revisions (including using existing processes for consideration of 
coding changes) that may include consolidation of individual services 
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
    To fulfill our statutory mandate, we have identified and reviewed 
numerous potentially misvalued codes as specified in section 
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work 
examining potentially misvalued codes in these areas over the upcoming 
years. As part of our current process, we identify potentially 
misvalued codes for review, and request recommendations from the RUC 
and other public commenters on revised work RVUs and direct PE inputs 
for those codes. The RUC, through its own processes, also identifies 
potentially misvalued codes for review. Through our public nomination 
process for potentially misvalued codes established in the CY 2012 PFS 
final rule with comment period, other individuals and stakeholder 
groups submit nominations for review of potentially misvalued codes as 
well. Individuals and stakeholder groups may submit codes for review 
under the potentially misvalued codes initiative to CMS in one of two 
ways. Nominations may be submitted to CMS via email or through postal 
mail. Email submissions should be sent to the CMS emailbox 
[email protected], with the phrase ``Potentially 
Misvalued Codes'' and the referencing CPT code number(s) and/or the CPT 
descriptor(s) in the subject line. Physical letters for nominations 
should be sent via the U.S. Postal Service to the Centers for Medicare 
& Medicaid Services, Mail Stop: C4-01-26, 7500 Security Blvd., 
Baltimore, Maryland 21244. Envelopes containing the nomination letters 
must be labeled ``Attention: Division of Practitioner Services, 
Potentially Misvalued Codes''. Nominations for consideration in our 
next annual rule cycle should be received by our February 10th 
deadline. Since CY 2009, as a part of the annual potentially misvalued 
code review and Five-Year Review process, we have reviewed over 1,700 
potentially misvalued codes to refine work RVUs and direct PE inputs. 
We have assigned appropriate work RVUs and direct PE inputs for these 
services as a result of these reviews. A more detailed discussion of 
the extensive prior reviews of potentially misvalued codes is included 
in the Medicare Program; Payment Policies Under the Physician Fee 
Schedule, Five-Year Review of Work Relative Value Units, Clinical 
Laboratory Fee Schedule: Signature on Requisition, and Other Revisions 
to Part B for CY 2012; final rule (76 FR 73052 through 73055) 
(hereinafter referred to as the ``CY 2012 PFS final rule with comment 
period''). In the CY 2012 PFS final rule with comment period (76 FR 
73055 through 73958), we finalized our policy to consolidate the review 
of physician work and PE at the same time, and established a process 
for the annual public nomination of potentially misvalued services.
    In the Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the 
Requirement for Termination of Non-Random Prepayment Complex Medical 
Review and Other Revisions to Part B for CY 2013 (77 FR 68892) 
(hereinafter referred to as the ``CY 2013 PFS final rule with comment 
period''), we built upon the work we began in CY 2009 to review 
potentially misvalued codes that have not been reviewed since the 
implementation of the PFS (so-called ``Harvard-valued codes''). In the 
Medicare Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2009; and Revisions to 
the Amendment of the E-Prescribing Exemption for Computer Generated 
Facsimile Transmissions; Proposed Rule (73 FR 38589) (hereinafter 
referred to as the ``CY 2009 PFS proposed rule''), we requested 
recommendations from the RUC to aid in our review of Harvard-valued 
codes that had not yet been reviewed, focusing first on high-volume, 
low intensity codes. In the fourth Five-Year Review (76 FR 32410), we 
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000 services. 
In the CY 2013 PFS final rule with comment period, we identified 
specific Harvard-valued services with annual allowed charges that total 
at least $10,000,000 as potentially misvalued. In addition to the 
Harvard-valued codes, in the CY 2013 PFS final rule with comment period 
we finalized for review a list of potentially misvalued codes that have 
stand-alone PE (codes with physician work and no listed work time and 
codes with no physician work that have listed work time). We continue 
each year to consider and finalize a list of potentially misvalued 
codes that have or will be reviewed and revised as appropriate in 
future rulemaking.
3. CY 2022 Identification and Review of Potentially Misvalued Services
    In the CY 2012 PFS final rule with comment period (76 FR 73058), we 
finalized a process for the public to nominate potentially misvalued 
codes. In the CY 2015 PFS final rule with comment period (79 FR 67606 
through 67608), we modified this process whereby the public and 
stakeholders may nominate potentially misvalued codes for review by 
submitting the code with supporting documentation by February 10th of 
each year. Supporting documentation for codes nominated for the annual 
review of potentially misvalued codes may include the following:
     Documentation in peer reviewed medical literature or other 
reliable data that demonstrate changes in physician work due to one or 
more of the following: Technique, knowledge and technology, patient 
population, site-of-service, length of hospital stay, and work time.
     An anomalous relationship between the code being proposed 
for review and other codes.
     Evidence that technology has changed physician work.

[[Page 65044]]

     Analysis of other data on time and effort measures, such 
as operating room logs or national and other representative databases.
     Evidence that incorrect assumptions were made in the 
previous valuation of the service, such as a misleading vignette, 
survey, or flawed crosswalk assumptions in a previous evaluation.
     Prices for certain high cost supplies or other direct PE 
inputs that are used to determine PE RVUs are inaccurate and do not 
reflect current information.
     Analyses of work time, work RVU, or direct PE inputs using 
other data sources (for example, VA, NSQIP, the STS National Database, 
and the MIPS data).
     National surveys of work time and intensity from 
professional and management societies and organizations, such as 
hospital associations.
    We evaluate the supporting documentation submitted with the 
nominated codes and assess whether the nominated codes appear to be 
potentially misvalued codes appropriate for review under the annual 
process. In the following year's PFS proposed rule, we publish the list 
of nominated codes and indicate for each nominated code whether we 
agree with its inclusion as a potentially misvalued code. The public 
has the opportunity to comment on these and all other proposed 
potentially misvalued codes. In that year's final rule, we finalize our 
list of potentially misvalued codes.
a. Public Nominations
    In the proposed rule, we solicited comments regarding the codes 
that were nominated by the public and stakeholders as potentially 
misvalued. In this final rule, we review and summarize the comments we 
received regarding such codes, and we explain whether we are finalizing 
such codes as potentially misvalued. We received public nominations for 
potentially misvalued codes by February 10th and we displayed those 
nominations on our public website, where we also included the 
submitter's name and their associated organization for full 
transparency. Some submissions were for specific, PE-related inputs for 
codes, and we refer readers to section II.B. of this final rule 
Determination of PE RVUs for further discussions on PE-related 
submissions. Discussed below is the summary of this year's submissions 
under the potentially misvalued code initiative and the comments 
received from the proposed rule.
    A stakeholder nominated CPT code 22551 (Fusion of spine bones with 
removal of disc at upper spinal column, anterior approach, complex) 
``and common related services'' as potentially misvalued. Citing the CY 
2021 PFS final rule (84 FR 84501) where CMS agreed with the public 
nomination of CPT code 22867 (Insertion of interlaminar/interspinous 
process stabilization/distraction device, without fusion, including 
image guidance when performed, with open decompression, lumbar; single 
level) as potentially misvalued, and discussed the relationship between 
CPT code 22867 and CPT code 63047 (Laminectomy, facetectomy and 
foraminotomy (unilateral or bilateral with decompression of spinal 
cord, cauda equina and/or nerve root[s], [e.g., spinal or lateral 
recess stenosis]), single vertebral segment; lumbar), this stakeholder 
suggests that there are additional CPT code values related to spine 
procedures that are in need of contemporaneous review with CPT code 
22867. The stakeholder believes that CMS has an interest in reviewing 
associated anterior cervical discectomy and fusion (ACDF) procedures as 
well, and suggests that CPT code 22551 ``and common related services'' 
can result in cumulative RVUs that do not sufficiently reflect 
physician work, time, or outcomes.
    In their submission, the stakeholder expressed concern that there 
is a discrepancy between the typical total RVUs for codes billed for 
vertebral fusion procedures performed using three synthetic cage 
devices with plate and vertebral fusion procedures performed using 
three allografts with plate. Both methods of vertebral fusion are 
described by CPT code 22551 (includes a 90-day global period), which 
has a work RVU of 25.00. Both methods of vertebral fusion involve two 
units of CPT code 22552 (Arthrodesis, anterior interbody, including 
disc space preparation, discectomy, osteophytectomy and decompression 
of spinal cord and/or nerve roots; cervical below C2, each additional 
interspace (List separately in addition to code for primary procedure) 
(ZZZ global period)) with a total work RVU of 13.00 (6.50 x 2); and 
both methods of vertebral fusion involve 1 unit of CPT code 22846 
(Anterior instrumentation; 4 to 7 vertebral segments (List separately 
in addition to code for primary procedure) (ZZZ global period)) with a 
work RVU of 12.40. The vertebral fusion method employing three 
synthetic cage devices with a plate would involve CPT code 22853 
(Insertion of interbody biomechanical device(s) (e.g., synthetic cage, 
mesh) with integral anterior instrumentation for device anchoring 
(e.g., screws, flanges), when performed, to intervertebral disc space 
in conjunction with interbody arthrodesis, each interspace (List 
separately in addition to code for primary procedure) (ZZZ global 
period)) for the insertion of synthetic cage devices for a total work 
RVU of 12.75 (4.25 x 3), and CPT code 20930 (Allograft, morselized, or 
placement of osteopromotive material, for spine surgery only (List 
separately in addition to code for primary procedure)) with a work RVU 
of 0.00 (because Medicare considers this code to be bundled into codes 
for other services). The stakeholder stated that the total work RVUs 
for the typical vertebral fusion employing three synthetic cage devices 
with plate would be 63.15 work RVUs.
    In contrast, the stakeholder asserted that the vertebral fusion 
method employing three allografts with plate involves the same set of 
services and codes (CPT code 22551 (090 global period) and CPT code 
22846 (ZZZ global period)), but instead of CPT codes 22853 or 20930, 
involve CPT code 20931 (Allograft, structural, for spine surgery only 
(List separately in addition to code for primary procedure) (ZZZ global 
period)) with a work RVU of 1.81. Altogether, the total work RVUs for 
CPT codes involved in this vertebral fusion method is 52.21. The 
stakeholder suggested that this difference in total work RVUs, 63.15 
versus 52.21, is evidence that these services are misvalued, and that 
the total work RVUs do not reflect the differences in the amount of 
work, resources, and intensity between the two vertebral fusion 
methods.
    This stakeholder's description of the potential misvaluation of CPT 
code 22551 ``and common related services'' differs from the CMS 
approach to identifying potentially misvalued services by using certain 
criteria, as described in the beginning of this section. Our 
determination that one or more codes are potentially misvalued 
generally revolves around the specific RVUs assigned to an individual 
code, or several codes within a family of codes. CMS generally does not 
examine the summed differences in total RVUs based on billing patterns 
using different codes in different scenarios, representing different 
physician work, and then comparing the two methods of a procedure, in 
this case, the use or non-use, of the synthetic cage devices in the 
vertebral fusion with removal of the disc in the upper spinal column. 
We do not believe that the stakeholder has provided support for the 
premise that CPT code 22551 alone is misvalued, or

[[Page 65045]]

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

[[Page 65046]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.020

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

[[Page 65047]]

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

D. Telehealth and Other Services Involving Communications Technology, 
and Interim Final Rule With Comment Period for Coding and Payment of 
Virtual Check-In Services--Payment for Medicare Telehealth Services 
Under Section 1834(m) of the Act

    As discussed in prior rulemaking, several conditions must be met 
for Medicare to make payment for telehealth services under the PFS. See 
further details and full discussion of the scope of Medicare telehealth 
services in the CY 2018 PFS final rule (82 FR 53006) and CY 2021 PFS 
final rule (85 FR 84502) and in 42 CFR 410.78 and 414.65.
1. Payment for Medicare Telehealth Services Under Section 1834(m) of 
the Act
a. Changes to the Medicare Telehealth Services List
    In the CY 2003 PFS final rule with comment period (67 FR 79988), we 
established a regulatory process for adding services to or deleting 
services from the Medicare telehealth services list in accordance with 
section 1834(m)(4)(F)(ii) of the Act (42 CFR 410.78(f)). This process 
provides the public with an ongoing opportunity to submit requests for 
adding services, which are then reviewed by us and assigned to 
categories established through notice and comment rulemaking. 
Specifically, we assign any submitted request to add to the Medicare 
telehealth services list to one of the following two categories:
     Category 1: Services that are similar to professional 
consultations, office visits, and office psychiatry services that are 
currently on the Medicare telehealth services list. In reviewing these 
requests, we look for similarities between the requested and existing 
telehealth services for the roles of, and interactions among, the 
beneficiary, the physician (or other practitioner) at the distant site 
and, if necessary, the telepresenter, a practitioner who is present 
with the beneficiary in the originating site. We also look for 
similarities in the telecommunications system used to deliver the 
service; for example, the use of interactive audio and video equipment.
     Category 2: Services that are not similar to those on the 
current Medicare telehealth services list. Our review of these requests 
includes an assessment of whether the service is accurately described 
by the corresponding code when furnished via telehealth and whether the 
use of a telecommunications system to furnish the service produces 
demonstrated clinical benefit to the patient. Submitted evidence should 
include both a description of relevant clinical studies that 
demonstrate the service furnished by telehealth to a Medicare 
beneficiary improves the diagnosis or treatment of an illness or injury 
or improves the functioning of a malformed body part, including dates 
and findings, and a list and copies of published peer reviewed articles 
relevant to the service when furnished via telehealth. Our evidentiary 
standard of clinical benefit does not include minor or incidental 
benefits. Some examples of other clinical benefits that we consider 
include the following:
     Ability to diagnose a medical condition in a patient 
population without access to clinically appropriate in-person 
diagnostic services.
     Treatment option for a patient population without access 
to clinically appropriate in-person treatment options.
     Reduced rate of complications.
     Decreased rate of subsequent diagnostic or therapeutic 
interventions (for example, due to reduced rate of recurrence of the 
disease process).
     Decreased number of future hospitalizations or physician 
visits.
     More rapid beneficial resolution of the disease process 
treatment.
     Decreased pain, bleeding, or other quantifiable symptom.
     Reduced recovery time.
     Category 3: In the CY 2021 PFS final rule (85 FR 84507), 
we created a third category of criteria for adding services to the 
Medicare telehealth services list on a temporary basis following the 
end of the PHE for the COVID-19 pandemic. This new category describes 
services that were added to the Medicare telehealth services list 
during the PHE for which there is likely to be clinical benefit when 
furnished via telehealth, but there is not yet sufficient evidence 
available to consider the services for permanent addition under the 
Category 1 or Category 2 criteria. Services added on a temporary, 
Category 3 basis will ultimately need to meet the criteria under 
Category 1 or 2 in order to be permanently added to the Medicare 
telehealth services list. To add specific services on a Category 3 
basis, we conducted a clinical assessment to identify those services 
for which we could foresee a reasonable potential likelihood of 
clinical benefit when furnished via telehealth. We considered the 
following factors:
    ++ Whether, outside of the circumstances of the PHE for COVID-19, 
there are concerns for patient safety if the service is furnished as a 
telehealth service.
    ++ Whether, outside of the circumstances of the PHE for COVID-19, 
there are concerns about whether the provision of the service via 
telehealth is likely to jeopardize quality of care.
    ++ Whether all elements of the service could fully and effectively 
be performed by a remotely located clinician using two-way, audio/video 
telecommunications technology.
    In the CY 2021 PFS final rule (85 FR 84507), we also temporarily 
added several services to the Medicare

[[Page 65048]]

telehealth services list using the Category 3 criteria described above. 
In this final rule, we are considering additional requests to add 
services to the Medicare telehealth services list on a Category 3 basis 
using the previously described Category 3 criteria.
    The Medicare telehealth services list, including the additions 
described later in this section, is available on the CMS website at 
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
    Beginning in CY 2019, we stated that for CY 2019 and onward, we 
intend to accept requests through February 10, consistent with the 
deadline for our receipt of code valuation recommendations from the RUC 
(83 FR 59491). For CY 2022, requests to add services to the Medicare 
telehealth services list must have been submitted and received by 
February 10, 2021. Each request to add a service to the Medicare 
telehealth services list must have included any supporting 
documentation the requester wishes us to consider as we review the 
request. Because we use the annual PFS rulemaking process as the 
vehicle to make changes to the Medicare telehealth services list, 
requesters are advised that any information submitted as part of a 
request is subject to public disclosure for this purpose. For more 
information on submitting a request in the future to add services to 
the Medicare telehealth services list, including where to mail these 
requests, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
b. Requests To Add Services to the Medicare Telehealth Services List 
for CY 2022
    Under our current policy, we add services to the Medicare 
telehealth services list on a Category 1 basis when we determine that 
they are similar to services on the existing Medicare telehealth 
services list for the roles of, and interactions among, the 
beneficiary, physician (or other practitioner) at the distant site and, 
if necessary, the telepresenter. As we stated in the CY 2012 PFS final 
rule with comment period (76 FR 73098), we believe that the Category 1 
criteria not only streamline our review process for publicly requested 
services that fall into this category, but also expedite our ability to 
identify codes for the Medicare telehealth services list that resemble 
those services already on the Medicare telehealth services list.
    We received several requests to permanently add various services to 
the Medicare telehealth services list effective for CY 2022. We found 
that none of the requests we received by the February 10th submission 
deadline met our Category 1 or Category 2 criteria for permanent 
addition to the Medicare telehealth services list. The requested 
services are listed in Table 15.
BILLING CODE 4120-01-P

[[Page 65049]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.021


[[Page 65050]]


[GRAPHIC] [TIFF OMITTED] TR19NO21.022

BILLING CODE 4120-01-C
    We remind stakeholders that the criterion for adding services to 
the Medicare telehealth list under Category 1 is that the requested 
services are similar to professional consultations, office visits, and 
office psychiatry services that are currently on the Medicare 
telehealth services list, and that the criterion for adding services 
under Category 2 is that there is evidence of clinical benefit if 
provided as telehealth. As explained below, we find that none of the 
requested services met the Category 1 criterion.
    We received a request to permanently add CPT code 51741 (Complex 
uroflowmetry (e.g., calibrated electronic equipment)) to the Medicare 
telehealth services list. This CPT code describes the acquisition of 
uroflowmetric information and analysis of that information. The code 
includes a technical component and a professional component. The 
technical component describes the acquisition of the uroflowmetric 
information when billed as a standalone service. The professional 
component describes the analysis for the uroflowmetric information when 
it is billed as a standalone service. As we have explained in previous 
rulemaking (see 83 FR 59483), the remote interpretation of diagnostic 
tests is not considered to be a telehealth service under section 
1834(m) of the Act or our regulation at Sec.  410.78. We do not believe 
that the technical component, which includes acquisition of the 
uroflowmetric information, will meet the criterion to

[[Page 65051]]

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

[[Page 65052]]

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

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

[[Page 65053]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.024

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

[[Page 65054]]

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

[[Page 65055]]

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

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

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

[[Page 65056]]

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

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

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

[[Page 65057]]

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

[[Page 65058]]

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

[[Page 65059]]

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

[[Page 65060]]

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

[[Page 65061]]

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

[[Page 65062]]

is generally analogous to and must include the elements of the in-
person service, it is generally appropriate to continue to require the 
use of two-way, real-time audio/video communications technology to 
furnish the service. Therefore, we are maintaining the requirement that 
distant site physicians and practitioners must have the technical 
capability to use an interactive telecommunications system that 
includes two-way, real-time, interactive audio and video communications 
at the time that an audio-only telehealth service is furnished. With 
regard to documentation requirements, we are finalizing a requirement 
that the reason for using audio-only technology to furnish a telehealth 
service must be documented in the patient's medical record.
    Comment: A few commenters provided examples of services that they 
believe should not be conducted via audio-only communications 
technology. These included: Level 4 and 5 office visits as well as 
services describing psychotherapy for crisis (CPT codes 90839-90840), 
group psychotherapy (CPT code 90853), psychological and 
neuropsychological testing (CPT codes (96130-96133 and 96136-96139), 
psychological and neuropsychological testing), and Applied Behavior 
Analysis Therapy (CPT codes 97151-97157).
    Other commenters stated that there should be no restrictions on 
furnishing higher level mental health telehealth visits to patients in 
the home via audio-only technology.
    In response to our statement regarding utilization of CPT codes 
99441-99443 (telephone E/M services), a few commenters requested the 
agency share with the public the audio-only utilization data that has 
been collected during the public health emergency to provide 
stakeholders with a better understanding of how these services have 
been utilized outside of the treatment of mental health conditions.
    Response: We would like to thank commenters for their support and 
suggestions. We continue to believe that real-time, audio-video 
telehealth interactions are the standard for Medicare telehealth 
services in most instances. We will continue to consider how the 
delivery of certain services via telehealth impacts patient care, and 
we encourage stakeholders to submit requests with supporting 
documentation using our process for the addition or removal of services 
on the Medicare telehealth services list. Regarding CPT codes 99441-
99443, which describe telephone E/M services, please find our 
discussion earlier in this preamble. In response to the request for 
utilization data on audio-only telehealth services furnished during the 
PHE for COVID-19, we refer readers to publicly available utilization 
data (an example available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Research-Statistics-Data-and-Systems).
    After consideration of public comments, we are finalizing as 
proposed creation of a service-level modifier for use to identify 
mental health telehealth services furnished to a beneficiary in their 
home using audio-only communications technology. We are also amending 
our regulation at Sec.  410.78(a)(3) to specify that an interactive 
telecommunications system can include interactive, real-time, two-way 
audio-only technology for telehealth services furnished for the 
diagnosis, evaluation, or treatment of a mental health disorder as 
described under paragraph (b)(4)(iv)(D), under the following 
conditions: The patient is located in their home at the time of service 
as described at Sec.  410.78 (b)(3)(xiv); the distant site physician or 
practitioner has the technical capability at the time of the service to 
use an interactive telecommunications system that includes video; and 
the patient is not capable of, or does not consent to, the use of video 
technology for the service. We are also clarifying that SUD services 
are considered mental health services for purposes of the amended 
definition of ``interactive telecommunications system'' to include 
audio-only services under Sec.  410.78(a)(3). We anticipate that this 
will have a positive impact on access to care for mental health 
conditions and contribute to overall health equity.
2. Other Non-Face-to-Face Services Involving Communications Technology 
Under the PFS
a. Expiration of PHE Flexibilities for Direct Supervision Requirements
    Under section 1861 of the Act and at Sec.  410.32(b)(3) of the 
regulations, Medicare requires certain types of services to be 
furnished under specific levels of supervision of a physician or 
practitioner, including diagnostic tests, services incident to 
physician services, and other services. For professional services 
furnished incident to the services of a billing physician or 
practitioner (see Sec.  410.26) and many diagnostic tests (see Sec.  
410.32), direct supervision is required. Additionally, for pulmonary 
rehabilitation services (see Sec.  410.47) and for cardiac 
rehabilitation and intensive cardiac rehabilitation services (see Sec.  
410.49), requirements for immediate availability and accessibility of a 
physician are considered to be satisfied if the physician meets the 
requirements for direct supervision for physician office services at 
Sec.  410.26 and for hospital outpatient services at Sec.  410.27. 
Outside the circumstances of the PHE, direct supervision requires the 
immediate availability of the supervising physician or other 
practitioner, but the professional need not be present in the same room 
during the service, and we have interpreted this ``immediate 
availability'' requirement to mean in-person, physical, not virtual, 
availability.
    Through the March 31st COVID-19 IFC, we changed the definition of 
``direct supervision'' during the PHE for COVID-19 (85 FR 19245 through 
19246) as it pertains to supervision of diagnostic tests, physicians' 
services, and some hospital outpatient services, to allow the 
supervising professional to be immediately available through virtual 
presence using real-time audio/video technology, instead of requiring 
their physical presence. In the CY 2021 PFS final rule (85 FR 84538 
through 84540), we finalized continuation of this policy through the 
later of the end of the calendar year in which the PHE for COVID-19 
ends or December 31, 2021. In that rule, we also solicited comment on 
issues related to the policy allowing virtual provision of direct 
supervision, specifically whether there should be any additional 
guardrails or limitations put in place to ensure patient safety/
clinical appropriateness, beyond typical clinical standards, and 
whether we should consider potential restrictions to prevent fraud or 
inappropriate use. We also stated that we will consider this and other 
information as we contemplate future policy regarding use of 
communications technology to satisfy supervision requirements, as well 
as the best approach for safeguarding patient safety while promoting 
use of technology to enhance access.
    We also noted that the temporary exception to allow immediate 
availability for direct supervision through virtual presence 
facilitates the provision of telehealth services by clinical staff of 
physicians and other practitioners incident to their own professional 
services. This is discussed in the March 31st COVID-19 IFC (85 FR 
19246). This is especially relevant for services such as physical 
therapy, occupational therapy, and speech language pathology services, 
since those practitioners can only bill Medicare directly for 
telehealth services under telehealth waivers that are effective only 
during the PHE for COVID-19. We note that sections 1834(m)(4)(D) and 
(E) of the Act specifies the types of clinicians

[[Page 65063]]

who may furnish and bill for Medicare telehealth services, and include 
only physicians as defined in section 1861(r) of the Act and 
practitioners described in section 1842(b)(18)(C) of the Act.
    We solicited information on whether this flexibility should be 
continued beyond the later of the end of the PHE for COVID-19 or CY 
2021. Specifically, we solicited comments on the extent to which the 
flexibility to meet the immediate availability requirement for direct 
supervision through the use of real-time, audio/video technology is 
being used during the PHE, and whether physicians and practitioners 
anticipate relying on this flexibility after the end of the PHE. We 
solicited comments on whether this flexibility should potentially be 
made permanent, meaning that we would revise the definition of ``direct 
supervision'' at Sec.  410.32(b)(3)(ii) to include immediate 
availability through the virtual presence of the supervising physician 
or practitioner using real-time, interactive audio/video communications 
technology without limitation after the PHE for COVID-19, or if we 
should continue the policy in place for a short additional time to 
facilitate a gradual sunset of the policy. We solicited comment on 
whether the current timeframe for continuing this flexibility at Sec.  
410.32(b)(3)(ii), which is currently the later of the end of the year 
in which the PHE for COVID-19 ends or December 31, 2021, remains 
appropriate, or if this timeframe should be extended through some later 
date to facilitate the gathering of additional information in 
recognition that, due to the on-going nature of the PHE for COVID-19, 
practitioners may not yet have had time to assess the implications of a 
permanent change in this policy. We also solicited comment regarding 
the possibility of permanently allowing immediate availability for 
direct supervision through virtual presence using real-time audio/video 
technology for only a subset of services, as we recognize that it may 
be inappropriate to allow direct supervision without physical presence 
for some services, due to potential concerns over patient safety if the 
practitioner is not immediately available in-person. We also solicited 
comments on, if this policy to be made permanent, whether a service-
level modifier should be required to identify when the requirements for 
direct supervision were met using two-way, audio/video communications 
technology.
    We received public comments on the expiration of PHE flexibilities 
for direct supervision requirements. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters supported continuing to allow 
requirements for direct supervision of services to be met through 
virtual presence using telecommunications technology beyond the PHE. 
They stated that COVID-19 may not be completely eradicated for at least 
a year after the end of the PHE, and that health professionals will 
need time to recover from the pandemic's effects. Other commenters 
stated that CMS should permanently modify the definition of direct 
supervision to include the presence of the supervising practitioner via 
real-time, interactive audio/video technology in certain cases. Some 
commenters encouraged CMS to create a service-level modifier for 
purposes of identifying advanced practice provider involvement in care 
and requested that CMS consult with specialty societies as this change 
is developed.
    Some commenters supported use of a service-level modifier to 
identify services furnished under direct supervision where the 
supervising physician was available through two-way, audio/video 
communications technology.
    Some commenters specifically requested that CMS maintain the 
flexibility for the supervising physician to be available using two-
way, audio/video when a nurse practitioner is furnishing a behavioral 
health service, as these are services that do not require a physical 
exam.
    MedPAC, while supportive of our extension of this policy through 
the year in which the PHE ends, stated two concerns about making it 
permanent after the PHE in the absence of evidence about its effects on 
safety, quality, and spending. First, allowing clinicians to supervise 
``incident to'' services virtually could pose a safety risk to 
beneficiaries because the clinician would not be physically available 
to help the individual being supervised, if necessary, which is 
important if the service is a complex procedure. Second, allowing 
virtual supervision could potentially enable a clinician to supervise 
many individuals at multiple locations at the same time. It could be 
difficult for a clinician to address urgent, clinical needs while 
virtually supervising many people at multiple locations simultaneously. 
This scenario could also lead to higher spending by allowing clinicians 
to bill for more ``incident-to'' services during a single day.
    Some commenters stated that, if CMS were to make this policy 
permanent, certain services should be precluded, such as complex drug 
therapies or anesthesia services.
    Response: We thank commenters for their input and will consider 
addressing the issues raised by these comments in future rules or 
guidance, as appropriate.
b. Interim Final Provisions in the CY 2021 PFS Final Rule
    In the CY 2021 PFS final rule (85 FR 84536), we finalized the 
establishment of HCPCS code G2252 (Brief communication technology-based 
service, e.g., virtual check-in service, by a physician or other 
qualified health care professional who can report evaluation and 
management services, provided to an established patient, not 
originating from a related E/M service provided within the previous 7 
days nor leading to an E/M service or procedure within the next 24 
hours or soonest available appointment; 11-20 minutes of medical 
discussion) on an interim basis. We stated that, given the widespread 
concerns expressed by commenters about the continuing need for audio-
only conversations with patients and our determination that we will not 
continue to pay for audio-only E/M visits after the conclusion of the 
PHE (see 85 FR 84533 through 84535 for further discussion of that 
policy), we believed it will be expedient to establish additional 
coding and payment for an extended virtual check-in, which could be 
furnished using any form of synchronous communications technology, 
including audio-only, on an interim basis for CY 2021. We stated that 
we believed establishing payment for this service on an interim basis 
will support access to care for beneficiaries who may be reluctant to 
return to in-person visits unless absolutely necessary, and allow us to 
consider whether this policy should be adopted on a permanent basis. In 
that rule, we finalized a direct crosswalk to CPT code 99442, the value 
of which we believe most accurately reflects the resources associated 
with a longer service delivered via synchronous communications 
technology, which can include audio-only communications. Commenters 
supported the creation and interim final adoption of this service. 
Commenters stated that, as beneficiaries and practitioners may be 
reluctant to return to primarily in-person services post-PHE, payment 
for a longer virtual check-in will be necessary to account for 
circumstances where more time is spent determining whether an in-person 
visit is needed beyond the 5-10 minutes accounted for by HCPCS code 
G2012 (Brief communication technology-based service, e.g. virtual 
check-in, by a physician or other qualified health care

[[Page 65064]]

professional who can report evaluation and management services, 
provided to an established patient, not originating from a related e/m 
service provided within the previous 7 days nor leading to an e/m 
service or procedure within the next 24 hours or soonest available 
appointment; 5-10 minutes of medical discussion). Commenters also 
supported valuing HCPCS code G2252 through a direct crosswalk to CPT 
code 99442. We agree with commenters that additional time may be needed 
to assess the necessity of an in-person service given concerns over 
exposure to illnesses beyond the duration of the PHE for COVID-19 and 
that current coding may not accurately reflect that time. Based on 
support from commenters, we proposed to permanently adopt coding and 
payment for CY 2022, HCPCS code G2252 as described in the CY 2021 PFS 
final rule.
    We received public comments on the interim final provisions in the 
CY 2021 PFS final rule. The following is a summary of the comments we 
received and our responses.
    Comment: Commenters supported CMS' finalizing separate coding and 
payment for a longer virtual check-in.
    Some commenters, including the AMA RUC, supported valuing HCPCS 
code G2252 through a direct crosswalk to the value of CPT code 99442 
but recommended that CMS work with the CPT Editorial Panel to 
editorially revise CPT codes 99441-99443 so that the CPT codes may be 
consistently reported by all payors to describe audio-only services.
    Some commenters stated that CMS should create a parallel code to 
HCPCS code G2252 billable by those practitioners who cannot 
independently bill for E/M services. Commenters pointed out that, in 
the CY 2021 PFS final rule, CMS implemented a similar policy for HCPCS 
codes G2010 and G2012.
    Response: With regard to HCPCS code G2252 being billable by those 
practitioners who cannot independently bill for E/M services, we 
appreciate commenters bringing this issue to our attention, and we will 
consider these comments for future rulemaking.
    After consideration of public comments, we are finalizing our 
proposal to permanently establish separate coding and payment for the 
longer virtual check-in service described by HCPCS code G2252 for CY 
2022 using a crosswalk to the value of CPT code 99442, as proposed. As 
described in the CY 2021 PFS final rule (85 FR 84536), we believe that 
the value of CPT code 99442 most accurately reflects the resources 
associated with a longer service delivered via synchronous 
communications technology, which can include audio-only communications. 
This is consistent with our approach to valuing the virtual check-in 
service (HCPCS code G2012), which used CPT code 99441 as the basis for 
valuation. In the case of HCPCS code G2252 and CPT code 99442, both 
codes describe 11-20 minutes of medical discussion when the 
practitioner may not necessarily be able to visualize the patient, and 
is used when the acuity of the patient's problem is not necessarily 
likely to warrant a visit, but when the needs of the particular patient 
require more assessment time from the practitioner. In the case of 
HCPCS code G2252, the additional time would be used to determine the 
necessity of an in-person visit and result in a work time/intensity 
that is similar to the crosswalk code.
3. Telehealth Originating Site Facility Fee Payment Amount Update
    Section 1834(m)(2)(B) of the Act established the Medicare 
telehealth originating site facility fee for telehealth services 
furnished from October 1, 2001 through December 31, 2002, at $20.00.
    For telehealth services furnished on or after January 1 of each 
subsequent calendar year, the telehealth originating site facility fee 
is increased by the percentage increase in the Medicare Economic Index 
(MEI) as defined in section 1842(i)(3) of the Act. The originating site 
facility fee for telehealth services furnished in CY 2022 is $27.59.
    The MEI increase for CY 2022 is 2.1 percent and is based on the 
most recent historical percentage increase of the MEI for the second 
quarter of 2021 (2.3 percent), and the most recent historical 
productivity adjustment for calendar year 2020 (0.2 percent).
    Therefore, for CY 2022, the payment amount for HCPCS code Q3014 
(Telehealth originating site facility fee) is $27.59. The Medicare 
telehealth originating site facility fee and the MEI increase by the 
applicable time period is shown in Table 18.

[[Page 65065]]

[GRAPHIC] [TIFF OMITTED] TR19NO21.025

E. Valuation of Specific Codes

1. Background: Process for Valuing New, Revised, and Potentially 
Misvalued Codes
    Establishing valuations for newly created and revised CPT codes is 
a routine part of maintaining the PFS. Since the inception of the PFS, 
it has also been a priority to revalue services regularly to make sure 
that the payment rates reflect the changing trends in the practice of 
medicine and current prices for inputs used in the PE calculations. 
Initially, this was accomplished primarily through the 5-year review 
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 
2011, and revised MP RVUs in CY 2010, CY 2015, and CY 2020. Under the 
5-year review process, revisions in RVUs were proposed and finalized 
via rulemaking. In addition to the 5-year reviews, beginning with CY 
2009, CMS and the RUC identified a number of potentially misvalued 
codes each year using various identification screens, as discussed in 
section II.C. of this final rule, Potentially Misvalued Services under 
the PFS. Historically, when we received RUC recommendations, our 
process had been to establish interim final RVUs for the potentially 
misvalued codes, new codes, and any other codes for which there were 
coding changes in the final rule with comment period for a year. Then, 
during the 60-day period following the publication of the final rule 
with comment period, we accepted public comment about those valuations. 
For services furnished during the calendar year following the 
publication of interim final rates, we paid for services based upon the 
interim final values established in the final rule. In the final rule 
with comment period for the subsequent year, we considered and 
responded to public comments received on the interim final values, and 
typically made any appropriate adjustments and finalized those values.
    In the CY 2015 PFS final rule with comment period (79 FR 67547), we 
finalized a new process for establishing values for new, revised and 
potentially misvalued codes. Under the new process, we include proposed 
values for these services in the proposed rule, rather than 
establishing them as interim final in the final rule with comment 
period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the 
new process was applicable to all codes, except for new codes that 
describe truly new services. For CY 2017, we proposed new values in the 
CY 2017 PFS proposed rule for the vast majority of new, revised, and 
potentially misvalued codes for which we received complete RUC 
recommendations by February 10, 2016. To complete the transition to 
this new process, for codes for which we established interim final 
values in the CY 2016 PFS final rule with comment period (81 FR 80170), 
we reviewed the comments received during the 60-day public comment 
period following release of the CY 2016 PFS final rule with comment 
period (80 FR 70886), and re-proposed values for those codes in the CY 
2017 PFS proposed rule.
    We considered public comments received during the 60-day public 
comment period for the proposed rule before establishing final values 
in the CY 2017 PFS final rule. As part of our established process, we 
will adopt interim final values only in the case of wholly new services 
for which there are no predecessor codes or values and for which we do 
not receive recommendations in time to propose values.
    As part of our obligation to establish RVUs for the PFS, we 
thoroughly review and consider available information including 
recommendations and supporting information from the RUC, the Health 
Care Professionals Advisory Committee (HCPAC), public commenters, 
medical literature, Medicare claims data, comparative databases, 
comparison with other codes within the PFS, as well as consultation 
with other physicians and healthcare professionals within CMS and the 
Federal Government as part of our process for establishing valuations. 
Where we concur that the RUC's

[[Page 65066]]

recommendations, or recommendations from other commenters, are 
reasonable and appropriate and are consistent with the time and 
intensity paradigm of physician work, we proposed those values as 
recommended. Additionally, we continually engage with stakeholders, 
including the RUC, with regard to our approach for accurately valuing 
codes, and as we prioritize our obligation to value new, revised, and 
potentially misvalued codes. We continue to welcome feedback from all 
interested parties regarding valuation of services for consideration 
through our rulemaking process.
2. Methodology for Establishing Work RVUs
    For each code identified in this section, we conduct a review that 
includes the current work RVU (if any), RUC-recommended work RVU, 
intensity, time to furnish the preservice, intraservice, and 
postservice activities, as well as other components of the service that 
contribute to the value. Our reviews of recommended work RVUs and time 
inputs generally include, but have not been limited to, a review of 
information provided by the RUC, the HCPAC, and other public 
commenters, medical literature, and comparative databases, as well as a 
comparison with other codes within the PFS, consultation with other 
physicians and health care professionals within CMS and the Federal 
Government, as well as Medicare claims data. We also assess the 
methodology and data used to develop the recommendations submitted to 
us by the RUC and other public commenters and the rationale for the 
recommendations. In the CY 2011 PFS final rule with comment period (75 
FR 73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalks to key reference or similar codes, and magnitude 
estimation (see the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329) for more information). When referring to a survey, 
unless otherwise noted, we mean the surveys conducted by specialty 
societies as part of the formal RUC process.
    Components that we use in the building block approach may include 
preservice, intraservice, or postservice time and post-procedure 
visits. When referring to a bundled CPT code, the building block 
components could include the CPT codes that make up the bundled code 
and the inputs associated with those codes. We use the building block 
methodology to construct, or deconstruct, the work RVU for a CPT code 
based on component pieces of the code. Magnitude estimation refers to a 
methodology for valuing work that determines the appropriate work RVU 
for a service by gauging the total amount of work for that service 
relative to the work for a similar service across the PFS without 
explicitly valuing the components of that work. In addition to these 
methodologies, we frequently utilize an incremental methodology in 
which we value a code based upon its incremental difference between 
another code and another family of codes. Section 1848(c)(1)(A) of the 
Act specifically defines the work component as the resources that 
reflect time and intensity in furnishing the service. Also, the 
published literature on valuing work has recognized the key role of 
time in overall work. For particular codes, we refine the work RVUs in 
direct proportion to the changes in the best information regarding the 
time resources involved in furnishing particular services, either 
considering the total time or the intraservice time.
    Several years ago, to aid in the development of preservice time 
recommendations for new and revised CPT codes, the RUC created 
standardized preservice time packages. The packages include preservice 
evaluation time, preservice positioning time, and preservice scrub, 
dress and wait time. Currently, there are preservice time packages for 
services typically furnished in the facility setting (for example, 
preservice time packages reflecting the different combinations of 
straightforward or difficult procedure, and straightforward or 
difficult patient). Currently, there are three preservice time packages 
for services typically furnished in the nonfacility setting.
    We developed several standard building block methodologies to value 
services appropriately when they have common billing patterns. In cases 
where a service is typically furnished to a beneficiary on the same day 
as an E/M service, we believe that there is overlap between the two 
services in some of the activities furnished during the preservice 
evaluation and postservice time. Our longstanding adjustments have 
reflected a broad assumption that at least one-third of the work time 
in both the preservice evaluation and postservice period is duplicative 
of work furnished during the E/M visit.
    Accordingly, in cases where we believe that the RUC has not 
adequately accounted for the overlapping activities in the recommended 
work RVU and/or times, we adjust the work RVU and/or times to account 
for the overlap. The work RVU for a service is the product of the time 
involved in furnishing the service multiplied by the intensity of the 
work. Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which 
means that 1 minute of preservice evaluation or postservice time 
equates to 0.0224 of a work RVU.
    Therefore, in many cases when we remove 2 minutes of preservice 
time and 2 minutes of postservice time from a procedure to account for 
the overlap with the same day E/M service, we also remove a work RVU of 
0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in 
time had already been accounted for in the work RVU. The RUC has 
recognized this valuation policy and, in many cases, now addresses the 
overlap in time and work when a service is typically furnished on the 
same day as an E/M service.
    The following paragraphs contain a general discussion of our 
approach to reviewing RUC recommendations and developing proposed 
values for specific codes. When they exist we also include a summary of 
stakeholder reactions to our approach. We note that many commenters and 
stakeholders have expressed concerns over the years with our ongoing 
adjustment of work RVUs based on changes in the best information we had 
regarding the time resources involved in furnishing individual 
services. We have been particularly concerned with the RUC's and 
various specialty societies' objections to our approach given the 
significance of their recommendations to our process for valuing 
services and since much of the information we used to make the 
adjustments is derived from their survey process. We are obligated 
under the statute to consider both time and intensity in establishing 
work RVUs for PFS services. As explained in the CY 2016 PFS final rule 
with comment period (80 FR 70933), we recognize that adjusting work 
RVUs for changes in time is not always a straightforward process, so we 
have applied various methodologies to identify several potential work 
values for individual codes.
    We have observed that for many codes reviewed by the RUC, 
recommended work RVUs have appeared to be incongruous with recommended 
assumptions regarding the resource costs in time. This has been the 
case for a significant portion of codes for which we recently 
established or proposed work RVUs that are based on refinements to the 
RUC-recommended values. When we have adjusted work RVUs to account for 
significant changes in time, we have started by looking at the change 
in the time in the context of

[[Page 65067]]

the RUC-recommended work RVU. When the recommended work RVUs do not 
appear to account for significant changes in time, we have employed the 
different approaches to identify potential values that reconcile the 
recommended work RVUs with the recommended time values. Many of these 
methodologies, such as survey data, building block, crosswalks to key 
reference or similar codes, and magnitude estimation have long been 
used in developing work RVUs under the PFS. In addition to these, we 
sometimes use the relationship between the old time values and the new 
time values for particular services to identify alternative work RVUs 
based on changes in time components.
    In so doing, rather than ignoring the RUC-recommended value, we 
have used the recommended values as a starting reference and then 
applied one of these several methodologies to account for the 
reductions in time that we believe were not otherwise reflected in the 
RUC-recommended value. If we believe that such changes in time are 
already accounted for in the RUC's recommendation, then we do not make 
such adjustments. Likewise, we do not arbitrarily apply time ratios to 
current work RVUs to calculate proposed work RVUs. We use the ratios to 
identify potential work RVUs and consider these work RVUs as potential 
options relative to the values developed through other options.
    We do not imply that the decrease in time as reflected in survey 
values should always equate to a one-to-one or linear decrease in newly 
valued work RVUs. Instead, we believe that, since the two components of 
work are time and intensity, absent an obvious or explicitly stated 
rationale for why the relative intensity of a given procedure has 
increased, significant decreases in time should be reflected in 
decreases to work RVUs. If the RUC's recommendation has appeared to 
disregard or dismiss the changes in time, without a persuasive 
explanation of why such a change should not be accounted for in the 
overall work of the service, then we have generally used one of the 
aforementioned methodologies to identify potential work RVUs, including 
the methodologies intended to account for the changes in the resources 
involved in furnishing the procedure.
    Several stakeholders, including the RUC, have expressed general 
objections to our use of these methodologies and deemed our actions in 
adjusting the recommended work RVUs as inappropriate; other 
stakeholders have also expressed general concerns with CMS refinements 
to RUC-recommended values in general. In the CY 2017 PFS final rule (81 
FR 80272 through 80277), we responded in detail to several comments 
that we received regarding this issue. In the CY 2017 PFS proposed rule 
(81 FR 46162), we requested comments regarding potential alternatives 
to making adjustments that would recognize overall estimates of work in 
the context of changes in the resource of time for particular services; 
however, we did not receive any specific potential alternatives. As 
described earlier in this section, crosswalks to key reference or 
similar codes are one of the many methodological approaches we have 
employed to identify potential values that reconcile the RUC-recommend 
work RVUs with the recommended time values when the RUC-recommended 
work RVUs did not appear to account for significant changes in time.
    We received several comments regarding our methodologies for work 
valuation in response to the CY 2022 PFS proposed rule and those 
comments are summarized below.
    Comment: Several commenters disagreed with our reference to older 
work time sources, and stated that their use led to the proposal of 
work RVUs based on flawed assumptions. Commenters stated that codes 
with ``CMS/Other'' or ``Harvard'' work time sources, used in the 
original valuation of certain older services, were not surveyed, and 
therefore, were not resource-based. Commenters also stated that it was 
invalid to draw comparisons between the current work times and work 
RVUs of these services to the newly surveyed work time and work RVUs as 
recommended by the RUC.
    Response: We agree that it is important to use the recent data 
available regarding work times, and we note that when many years have 
passed since work time has been measured, significant discrepancies can 
occur. However, we also believe that our operating assumption regarding 
the validity of the existing values as a point of comparison is 
critical to the integrity of the relative value system as currently 
constructed. The work times currently associated with codes play a very 
important role in PFS ratesetting, both as points of comparison in 
establishing work RVUs and in the allocation of indirect PE RVUs by 
specialty. If we were to operate under the assumption that previously 
recommended work times had been routinely overestimated, this would 
undermine the relativity of the work RVUs on the PFS in general, in 
light of the fact that codes are often valued based on comparisons to 
other codes with similar work times. Such an assumption would also 
undermine the validity of the allocation of indirect PE RVUs to 
physician specialties across the PFS.
    Instead, we believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times 
that have been used in PFS ratesetting are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available, and that we 
are statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the CY 2017 PFS final rule 
(81 FR 80273 through 80274).
    Comment: Several commenters disagreed with the use of time ratio 
methodologies for work valuation. Commenters stated that this use of 
time ratios is not a valid methodology for valuation of physician 
services. Commenters stated that treating all components of physician 
time (preservice, intraservice, postservice and post-operative visits) 
as having identical intensity is incorrect, and inconsistently applying 
it to only certain services under review creates inherent payment 
disparities in a payment system, which is based on relative valuation. 
Commenters stated that in many scenarios, CMS selects an arbitrary 
combination of inputs to apply rather than seeking a valid clinically 
relevant relationship that would preserve relativity. Commenters 
suggested that CMS determine the work valuation for each code based not 
only on surveyed work times, but also the intensity and complexity of 
the service and relativity to other similar services, rather than 
basing the work value entirely on time.
    Response: We disagree and continue to believe that the use of time 
ratios is one of several appropriate methods for identifying potential 
work RVUs for particular PFS services, particularly when the 
alternative values recommended by the RUC and other commenters do not 
account for survey information that suggests the amount of

[[Page 65068]]

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

[[Page 65069]]

RUC's compelling evidence criteria include documented changes in 
physician work, an anomalous relationship between the code and multiple 
key reference services, evidence that technology has changed physician 
work, analysis of other data on time and effort measures, and evidence 
that incorrect assumptions were made in the previous valuation of the 
service. While we appreciate the submission of this additional 
information for review, we emphasize that the RUC developed the concept 
of compelling evidence for its own review process; an evaluation of 
``compelling evidence,'' at least as conceptualized by the RUC, is not 
part of our review process, as our focus is the time and intensity of 
services, in accordance with the statute. With that said, we do 
consider changes in technology, patient population, and other 
compelling evidence criteria, as such evidence may affect the time and 
intensity of a service under review. For example, new technology may 
cause a service to become easier or more difficult to perform, with 
corresponding effects on the time and intensity of the service. 
However, we are under no obligation to adopt the same review process or 
compelling evidence criteria as the RUC. We instead focus on evaluating 
and addressing the time and intensity of services when reviewing 
potentially misvalued codes because section 1848(c)(1)(A) of the Act 
specifically defines the work component as the resources that reflect 
time and intensity in furnishing the service.
    Comment: A commenter stated that there has been a disparate impact 
on the valuation of cardiothoracic services over the past decade. The 
commenter stated that CMS has taken a prejudicial approach to services 
from this specialty over the period 2009-2019 by making refinements to 
the RUC's recommended work RVUs at a higher percentage than all other 
specialties.
    Response: We disagree with the commenter that there has been any 
prejudicial approach to the valuation of services from the 
cardiothoracic specialty or any other specialty. We value services on 
an individual case-by-case basis using time and intensity as directed 
by the statute. When the recommended work RVUs from the RUC do not 
appear to account for significant changes in time, we have employed 
different approaches (such as survey data, building block, crosswalks 
to key reference or similar codes, and magnitude estimation) to 
identify potential values that reconcile the recommended work RVUs with 
the recommended time values. We continue to believe that the nature of 
the PFS relative value system is such that all services are 
appropriately subject to comparisons to one another, and the dominant 
specialty of the service under review is not part of our work valuation 
methodology.
    Comment: Several commenters raised the issue of the refinement 
panel which was last reformed in CY 2016. Commenters stated that the 
refinement panel was not obsolete and was not mutually exclusive with 
the change to include all proposed valuations in each year's proposed 
rule. Commenters stated that for two decades, the refinement panel 
process was considered by stakeholders to be an appeals process and its 
elimination discontinued CMS' reliance on outside stakeholders to 
provide accountability through a transparent appeals process. 
Commenters requested that CMS consider these issues and create an 
objective, transparent and consistently applied formal appeals process 
that would be open to any commenting organization.
    Response: We did not propose any changes to the refinement panel 
and we are not finalizing any changes to the refinement panel for CY 
2022. As we stated in the CY 2016 PFS final rule (80 FR 70917-70918), 
the refinement panel was established to assist us in reviewing the 
public comments on CPT codes with interim final work RVUs and in 
balancing the interests of the specialty societies who commented on the 
work RVUs with the budgetary and redistributive effects that could 
occur if we accepted extensive increases in work RVUs across a broad 
range of services. We did not believe that the refinement panel had 
generally served as the kind of ``appeals'' or reconsideration process 
that some stakeholders envisioned in their comments. We also believe 
that the refinement panel was not achieving its intended purpose. 
Rather than providing us with additional information, balanced across 
specialty interests, to assist us in establishing work RVUs, the 
refinement panel process generally served to rehash the issues raised 
and information already discussed at the RUC meetings and considered by 
CMS. In contrast to the prior process of establishing interim final 
values and using a refinement panel process that generally was not 
observed by members of the public, we continue to believe that the 
current process of proposing the majority of code values in a proposed 
rule, giving the public the opportunity to comment on those proposed 
values, and then finalizing those values in a final rule offers greater 
transparency and accountability.
    We also note that we did not finalize our proposal to eliminate the 
refinement panel completely in CY 2016. We retain the ability to 
convene refinement panels for codes with interim final values under 
circumstances where additional input provided by the panel is likely to 
add value as a supplement to notice and comment rulemaking. We also 
remind stakeholders that we have established an annual process for the 
public nomination of potentially misvalued codes. This process, 
described in the CY 2012 PFS final rule (76 FR 73058), provides an 
annual means for those who believe that values for individual services 
are inaccurate and should be readdressed through notice and comment 
rulemaking to bring those codes to our attention.
    Comment: Several commenters requested that CMS use the interim RUC 
recommendations from the April 2021 meeting for several code families 
which had previously been reviewed at the October 2020 RUC meeting or 
the January 2021 RUC meeting. Commenters stated that the earlier RUC 
recommendations were made on an interim basis and requested an 
expedited review of the recommendations from the April 2021 RUC 
meeting; the RUC resubmitted its recommendations for these code 
families as part of its comment submission.
    Response: We finalized a policy in the CY 2015 PFS final rule to 
make all changes in the work and MP RVUs and the direct PE inputs for 
new, revised, and potentially misvalued services under the PFS by 
proposing and then finalizing such changes through notice and comment 
rulemaking, as opposed to initially finalizing changes on an interim 
final basis (79 FR 67602 through 67609). As we stated when promulgating 
the CY 2015 PFS final rule, this approach has the significant advantage 
that the RVUs for all services under the PFS are established using a 
full notice and comment procedure, including consideration of the RUC 
recommendations, before they take effect, providing the public the 
opportunity to comment on a specific proposal prior to it being 
implemented. We continue to believe that this is a far more transparent 
process which assures that we have the full benefit of stakeholder 
comments before establishing values. Since we did not make proposals on 
the code families in question using the RUC's recommendations from the 
April 2021 meeting, we would be forced to finalize valuation for these 
codes on an interim

[[Page 65070]]

final basis, without the opportunity for public comment. This would 
contradict the policy that we finalized in the CY 2015 PFS final rule, 
and we do not believe that it would serve the interests of 
transparency. Although we will consider any information submitted by 
stakeholders for valuation during the comment period, as we do for all 
codes which are subject to notice and comment rulemaking, we will 
formally review the recommendations from the April 2021 RUC meeting 
next year as part of the CY 2023 PFS rulemaking cycle.
    In response to comments, in the CY 2019 PFS final rule (83 FR 
59515), we clarified that terms ``reference services'', ``key reference 
services'', and ``crosswalks'' as described by the commenters are part 
of the RUC's process for code valuation. These are not terms that we 
created, and we do not agree that we necessarily must employ them in 
the identical fashion for the purposes of discussing our valuation of 
individual services that come up for review. However, in the interest 
of minimizing confusion and providing clear language to facilitate 
stakeholder feedback, we will seek to limit the use of the term, 
``crosswalk,'' to those cases where we are making a comparison to a CPT 
code with the identical work RVU. We also occasionally make use of a 
``bracket'' for code valuation. A ``bracket'' refers to when a work RVU 
falls between the values of two CPT codes, one at a higher work RVU and 
one at a lower work RVU.
    We look forward to continuing to engage with stakeholders and 
commenters, including the RUC, as we prioritize our obligation to value 
new, revised, and potentially misvalued codes; and will continue to 
welcome feedback from all interested parties regarding valuation of 
services for consideration through our rulemaking process. We refer 
readers to the detailed discussion in this section of the valuation 
considered for specific codes. Table 21 contains a list of codes and 
descriptors for which we proposed work RVUs; this includes all codes 
for which we received RUC recommendations by February 10, 2021. The 
finalized work RVUs, work time and other payment information for all CY 
2022 payable codes are available on the CMS website under downloads for 
the CY 2022 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/index.html).
3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
    On an annual basis, the RUC provides us with recommendations 
regarding PE inputs for new, revised, and potentially misvalued codes. 
We review the RUC-recommended direct PE inputs on a code by code basis. 
Like our review of recommended work RVUs, our review of recommended 
direct PE inputs generally includes, but is not limited to, a review of 
information provided by the RUC, HCPAC, and other public commenters, 
medical literature, and comparative databases, as well as a comparison 
with other codes within the PFS, and consultation with physicians and 
health care professionals within CMS and the Federal Government, as 
well as Medicare claims data. We also assess the methodology and data 
used to develop the recommendations submitted to us by the RUC and 
other public commenters and the rationale for the recommendations. When 
we determine that the RUC's recommendations appropriately estimate the 
direct PE inputs (clinical labor, disposable supplies, and medical 
equipment) required for the typical service, are consistent with the 
principles of relativity, and reflect our payment policies, we use 
those direct PE inputs to value a service. If not, we refine the 
recommended PE inputs to better reflect our estimate of the PE 
resources required for the service. We also confirm whether CPT codes 
should have facility and/or nonfacility direct PE inputs and refine the 
inputs accordingly.
    Our review and refinement of the RUC-recommended direct PE inputs 
includes many refinements that are common across codes, as well as 
refinements that are specific to particular services. Table 22 details 
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this final rule, Determination of 
Practice Expense Relative Value Units (PE RVUs), we addressed certain 
refinements that will be common across codes. Refinements to particular 
codes are addressed in the portions of that section that are dedicated 
to particular codes. We noted that for each refinement, we indicated 
the impact on direct costs for that service. We noted that, on average, 
in any case where the impact on the direct cost for a particular 
refinement is $0.35 or less, the refinement has no impact on the PE 
RVUs. This calculation considers both the impact on the direct portion 
of the PE RVU, as well as the impact on the indirect allocator for the 
average service. In the proposed rule, we also noted that many of the 
refinements listed in Table 21 of the proposed rule resulted in changes 
under the $0.35 threshold and were unlikely to result in a change to 
the RVUs.
    We note that the direct PE inputs for CY 2022 are displayed in the 
CY 2022 direct PE input files, available on the CMS website under the 
downloads for the CY 2022 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs displayed there have been 
used in developing the CY 2022 PE RVUs as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
    Some direct PE inputs are directly affected by revisions in work 
time. Specifically, changes in the intraservice portions of the work 
time and changes in the number or level of postoperative visits 
associated with the global periods result in corresponding changes to 
direct PE inputs. The direct PE input recommendations generally 
correspond to the work time values associated with services. We believe 
that inadvertent discrepancies between work time values and direct PE 
inputs should be refined or adjusted in the establishment of proposed 
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
    Prior to CY 2010, the RUC did not generally provide CMS with 
recommendations regarding equipment time inputs. In CY 2010, in the 
interest of ensuring the greatest possible degree of accuracy in 
allocating equipment minutes, we requested that the RUC provide 
equipment times along with the other direct PE recommendations, and we 
provided the RUC with general guidelines regarding appropriate 
equipment time inputs. We appreciate the RUC's willingness to provide 
us with these additional inputs as part of its PE recommendations.
    In general, the equipment time inputs correspond to the service 
period portion of the clinical labor times. We clarified this principle 
over several years of rulemaking, indicating that we consider equipment 
time as the time within the intraservice period when a clinician is 
using the piece of equipment plus any additional time that the piece of 
equipment is not available for use for another patient due to its use 
during the designated procedure. For those services for which we 
allocate cleaning time to portable equipment items, because the

[[Page 65071]]

portable equipment does not need to be cleaned in the room where the 
service is furnished, we do not include that cleaning time for the 
remaining equipment items, as those items and the room are both 
available for use for other patients during that time. In addition, 
when a piece of equipment is typically used during follow-up 
postoperative visits included in the global period for a service, the 
equipment time will also reflect that use.
    We believe that certain highly technical pieces of equipment and 
equipment rooms are less likely to be used during all of the preservice 
or postservice tasks performed by clinical labor staff on the day of 
the procedure (the clinical labor service period) and are typically 
available for other patients even when one member of the clinical staff 
may be occupied with a preservice or postservice task related to the 
procedure. We also noted that we believe these same assumptions will 
apply to inexpensive equipment items that are used in conjunction with 
and located in a room with non-portable highly technical equipment 
items since any items in the room in question will be available if the 
room is not being occupied by a particular patient. For additional 
information, we refer readers to our discussion of these issues in the 
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
    In general, the preservice, intraservice, and postservice clinical 
labor minutes associated with clinical labor inputs in the direct PE 
input database reflect the sum of particular tasks described in the 
information that accompanies the RUC-recommended direct PE inputs, 
commonly called the ``PE worksheets.'' For most of these described 
tasks, there is a standardized number of minutes, depending on the type 
of procedure, its typical setting, its global period, and the other 
procedures with which it is typically reported. The RUC sometimes 
recommends a number of minutes either greater than or less than the 
time typically allotted for certain tasks. In those cases, we review 
the deviations from the standards and any rationale provided for the 
deviations. When we do not accept the RUC-recommended exceptions, we 
refine the proposed direct PE inputs to conform to the standard times 
for those tasks. In addition, in cases when a service is typically 
billed with an E/M service, we remove the preservice clinical labor 
tasks to avoid duplicative inputs and to reflect the resource costs of 
furnishing the typical service.
    Comment: Several commenters stated that CMS is proposing to refine 
the facility pre-service clinical labor times for major procedures to 
conform to the 000-day or 010-day global period standards for 
``Extensive use of clinical staff'' despite the RUC recommendation of 
standard 090-day preservice clinical labor times. Commenters stated 
that these procedures are performed under general anesthesia in the 
facility setting and require specialized supplies and equipment and 
pre-operative coordination between multiple specialists necessitating 
office clinical staff time typical of 90-day global procedures 
performed in the facility setting. Commenters stated that reassignment 
of global periods for select codes does not negate the fact that a 
major procedure is a major procedure and the pre-service facility 
clinical staff time for a major procedure is independent of the global 
period assignment. Commenters stated that each procedure should be 
evaluated on a case-by-case basis.
    Response: We agree with the commenters that the direct PE inputs 
for each service should be evaluated on a case-by-case basis based on 
our criteria of what would be reasonable and medically necessary in the 
typical case. We reviewed the individual codes in question and 
concluded that the use of 000-day or 010-day global period standards 
for ``Extensive use of clinical staff'' would be most typical in these 
cases. As we noted under the Standardization of Clinical Labor Tasks 
(section II.B) part of this final rule, we continue to believe that 
setting and maintaining clinical labor standards provides greater 
consistency among codes that share the same clinical labor tasks and 
could improve relativity of values among codes. For additional 
discussion, we direct readers to the individual code families affected 
by our proposed preservice clinical labor times (CPT codes 46020 and 
46030 and CPT codes 61736 and 61737).
    We refer readers to section II.B. of this final rule, Determination 
of Practice Expense Relative Value Units (PE RVUs), for more 
information regarding the collaborative work of CMS and the RUC in 
improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
    In some cases, the PE worksheets included with the RUC's 
recommendations include items that are not clinical labor, disposable 
supplies, or medical equipment or that cannot be allocated to 
individual services or patients. We addressed these kinds of 
recommendations in previous rulemaking (78 FR 74242), and we do not use 
items included in these recommendations as direct PE inputs in the 
calculation of PE RVUs.
(5) New Supply and Equipment Items
    The RUC generally recommends the use of supply and equipment items 
that already exist in the direct PE input database for new, revised, 
and potentially misvalued codes. However, some recommendations include 
supply or equipment items that are not currently in the direct PE input 
database. In these cases, the RUC has historically recommended that a 
new item be created and has facilitated our pricing of that item by 
working with the specialty societies to provide us copies of sales 
invoices. For CY 2022 we received invoices for several new supply and 
equipment items. Tables 23 and 24 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of this final rule, Determination of Practice Expense Relative 
Value Units, we encourage stakeholders to review the prices associated 
with these new and existing items to determine whether these prices 
appear to be accurate. Where prices appear inaccurate, we encourage 
stakeholders to submit invoices or other information to improve the 
accuracy of pricing for these items in the direct PE database by 
February 10th of the following year for consideration in future 
rulemaking, similar to our process for consideration of RUC 
recommendations.
    We remind stakeholders that due to the relativity inherent in the 
development of RVUs, reductions in existing prices for any items in the 
direct PE database increase the pool of direct PE RVUs available to all 
other PFS services. Tables 23 and 24 also include the number of 
invoices received and the number of nonfacility allowed services for 
procedures that use these equipment items. We provide the nonfacility 
allowed services so that stakeholders will note the impact the 
particular price might have on PE relativity, as well as to identify 
items that are used frequently, since we believe that stakeholders are 
more likely to have better pricing information for items used more 
frequently. A single invoice may not be reflective of typical costs and 
we encourage stakeholders to provide additional invoices so that we 
might identify and use accurate prices in the development of PE RVUs.
    In some cases, we do not use the price listed on the invoice that 
accompanies

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the recommendation because we identify publicly available alternative 
prices or information that suggests a different price is more accurate. 
In these cases, we include this in the discussion of these codes. In 
other cases, we cannot adequately price a newly recommended item due to 
inadequate information. Sometimes, no supporting information regarding 
the price of the item has been included in the recommendation. In other 
cases, the supporting information does not demonstrate that the item 
has been purchased at the listed price (for example, vendor price 
quotes instead of paid invoices). In cases where the information 
provided on the item allows us to identify clinically appropriate proxy 
items, we might use existing items as proxies for the newly recommended 
items. In other cases, we include the item in the direct PE input 
database without any associated price. Although including the item 
without an associated price means that the item does not contribute to 
the calculation of the final PE RVU for particular services, it 
facilitates our ability to incorporate a price once we obtain 
information and are able to do so.
(6) Service Period Clinical Labor Time in the Facility Setting
    Generally speaking, our direct PE inputs do not include clinical 
labor minutes assigned to the service period because the cost of 
clinical labor during the service period for a procedure in the 
facility setting is not considered a resource cost to the practitioner 
since Medicare makes separate payment to the facility for these costs. 
We address code-specific refinements to clinical labor in the 
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction 
(MPPR) and the OPPS Cap
    We note that the list of services for the upcoming calendar year 
that are subject to the MPPR on diagnostic cardiovascular services, 
diagnostic imaging services, diagnostic ophthalmology services, and 
therapy services; and the list of procedures that meet the definition 
of imaging under section 1848(b)(4)(B) of the Act, and therefore, are 
subject to the OPPS cap; are displayed in the public use files for the 
PFS proposed and final rules for each year. The public use files for CY 
2022 are available on the CMS website under downloads for the CY 2022 
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html. For more 
information regarding the history of the MPPR policy, we refer readers 
to the CY 2014 PFS final rule with comment period (78 FR 74261 through 
74263).
    Effective January 1, 2007, section 5102(b)(1) of the Deficit 
Reduction Act of 2005 (Pub. L. 109-171) (DRA) amended section 
1848(b)(4) of the Act to require that, for imaging services, if--(i) 
The TC (including the TC portion of a global fee) of the service 
established for a year under the fee schedule without application of 
the geographic adjustment factor, exceeds (ii) The Medicare OPD fee 
schedule amount established under the prospective payment system (PPS) 
for HOPD services under section 1833(t)(3)(D) of the Act for such 
service for such year, determined without regard to geographic 
adjustment under paragraph (t)(2)(D) of such section, the Secretary 
shall substitute the amount described in clause (ii), adjusted by the 
geographic adjustment factor [under the PFS], for the fee schedule 
amount for such TC for such year. As required by the section 
1848(b)(4)(A) of the Act, for imaging services furnished on or after 
January 1, 2007, we cap the TC of the PFS payment amount for the year 
(prior to geographic adjustment) by the Outpatient Prospective Payment 
System (OPPS) payment amount for the service (prior to geographic 
adjustment). We then apply the PFS geographic adjustment to the capped 
payment amount. Section 1848(b)(4)(B) of the Act defines imaging 
services as ``imaging and computer-assisted imaging services, including 
X-ray, ultrasound (including echocardiography), nuclear medicine 
(including PET), magnetic resonance imaging (MRI), computed tomography 
(CT), and fluoroscopy, but excluding diagnostic and screening 
mammography.'' For more information regarding the history of the cap on 
the TC of the PFS payment amount under the DRA (the ``OPPS cap''), we 
refer readers to the CY 2007 PFS final rule with comment period (71 FR 
69659 through 69662).
    For CY 2022, we identified new and revised codes to determine which 
services meet the definition of ``imaging services'' as defined above 
for purposes of this cap. Beginning for CY 2022, we proposed to include 
the following services on the list of codes to which the OPPS cap 
applies: CPT codes 0633T (Computed tomography, breast, including 3D 
rendering, when performed, unilateral; without contrast material), 
0634T (Computed tomography, breast, including 3D rendering, when 
performed, unilateral; with contrast material(s)), 0635T (Computed 
tomography, breast, including 3D rendering, when performed, unilateral; 
without contrast, followed by contrast material(s)), 0636T (Computed 
tomography, breast, including 3D rendering, when performed, bilateral; 
without contrast material(s)), 0637T (Computed tomography, breast, 
including 3D rendering, when performed, bilateral; with contrast 
material(s)), 0638T (Computed tomography, breast, including 3D 
rendering, when performed, bilateral; without contrast, followed by 
contrast material(s)), 0648T (Quantitative magnetic resonance for 
analysis of tissue composition (eg, fat, iron, water content), 
including multiparametric data acquisition, data preparation and 
transmission, interpretation and report, obtained without diagnostic 
MRI examination of the same anatomy (eg, organ, gland, tissue, target 
structure) during the same session), 0649T (Quantitative magnetic 
resonance for analysis of tissue composition (eg, fat, iron, water 
content), including multiparametric data acquisition, data preparation 
and transmission, interpretation and report, obtained with diagnostic 
MRI examination of the same anatomy (eg, organ, gland, tissue, target 
structure) (List separately in addition to code for primary 
procedure)), 77089 (Trabecular bone score (TBS), structural condition 
of the bone microarchitecture; using dual X-ray absorptiometry (DXA) or 
other imaging data on gray-scale variogram, calculation, with 
interpretation and report on fracture risk), 77090 (Trabecular bone 
score (TBS), structural condition of the bone microarchitecture; using 
dual X-ray absorptiometry (DXA) or other imaging data on gray-scale 
variogram, calculation, with interpretation and report on fracture 
risk, technical preparation and transmission of data for analysis to be 
performed elsewhere), 77091 (Trabecular bone score (TBS), structural 
condition of the bone microarchitecture; using dual X-ray 
absorptiometry (DXA) or other imaging data on gray-scale variogram, 
calculation, with interpretation and report on fracture risk, technical 
calculation only), 77092 (Trabecular bone score (TBS), structural 
condition of the bone microarchitecture; using dual X-ray 
absorptiometry (DXA) or other imaging data on gray-scale variogram, 
calculation, with interpretation and report on fracture risk 
interpretation and report on fracture risk only, by other qualified 
health care professional), 91113 (Gastrointestinal tract imaging, 
intraluminal (eg, capsule endoscopy), colon, with interpretation and 
report), and 93319 (3D echocardiographic

[[Page 65073]]

imaging and postprocessing during transesophageal echocardiography or 
transthoracic echocardiography for congenital cardiac anomalies for the 
assessment of cardiac structure(s) (eg, cardiac chambers and valves, 
left atrial appendage, intraterial septum, interventricular septum) and 
function, when performed). We believe that these codes meet the 
definition of imaging services under section 1848(b)(4)(B) of the Act, 
and thus, should be subject to the OPPS cap.
    We did not receive public comments on this proposal. We are 
finalizing the addition of the services listed above to the list of 
codes to which the OPPS cap applies, as proposed.
4. Valuation of Specific Codes for CY 2022
(1) Anesthesia for Cardiac Electrophysiologic Procedures (CPT Code 
00537)
    In October 2019, the RUC reviewed CPT code 00537 (Anesthesia for 
cardiac electrophysiologic procedures including radiofrequency 
ablation) and recommended that the code be surveyed for the October 
2020 meeting. This service was identified by the RUC via the high 
volume growth screen for services with total Medicare utilization of 
10,000 or more that have increased by at least 100 percent from 2009 
through 2014. Additionally, at the October 2019 RUC meeting, the RUC 
approved an anesthesia reference service list (RSL) and a method to 
assess the relativity among services on the anesthesia fee schedule 
that uses a revised building block methodology and a regression line 
analysis. The RUC has stated that the revised building block 
methodology generates ``proxy RVUs'' that are then compared against the 
RSL regression line to assess relativity among anesthesia services. The 
RUC has indicated that their primary and approved method for anesthesia 
base unit valuation continues to be the anesthesia survey results, and 
that the building block and regression line analysis are used as a 
supplemental validation measure.
    The RUC recommended a valuation of 12 base units for CPT code 
00537. We disagree with the RUC-recommended valuation of 12 base units 
for CPT code 00537. After performing a RUC database search of codes 
with similar total times and post-induction period procedure anesthesia 
(PIPPA) times, 12 base units appears to be on the very high range. We 
proposed a valuation of 10 base units supported by reference codes CPT 
code 00620 (anesthesia for procedures on the thoracic spine and cord, 
not otherwise specified) and CPT code 00600 (Anesthesia for procedures 
on cervical spine and cord; not otherwise specified), which both have a 
valuation of 10 base units. CPT code 00620 has a very similar total 
time of 235 minutes and CPT code 00600 has a higher total time of 257 
minutes and the same base unit value of 10, which indicates that this 
is an appropriate valuation. Additionally, we note that the survey 
total time for CPT code 00537 increased from 150 to 238 minutes, 
resulting in a survey result 25th percentile valuation of 10 base 
units.
    We proposed the RUC-recommended direct PE inputs for CPT code 
00537.
    Comment: Commenters disagreed with the proposed valuation of 10 
base units for CPT code 00537 and stated that CMS should instead 
finalize the RUC-recommended valuation of 12 base units. Commenters 
disagreed with CMS using reference codes CPT code 00620 (anesthesia for 
procedures on the thoracic spine and cord, not otherwise specified) and 
CPT code 00600 (Anesthesia for procedures on cervical spine and cord; 
not otherwise specified) as a basis for the valuation of 10 base units. 
Commenters stated that CMS ignored the reference codes chosen by the 
RUC and instead used reference codes that were not surveyed, which 
makes the time source unknown. They also stated that CMS ignored the 
validation measures that the RUC used to support their recommendations 
and that CMS only considered the total times of the reference codes and 
not all inputs of time, such as post induction time. Additionally, 
commenters stated that they believe CMS did not consider the intensity 
of the service for CPT code 00537, as the supporting reference codes 
have a lower intensity and are not clinically similar.
    Response: We disagree and continue to believe that using multiple 
methodologies for identifying potential base units for anesthesia 
services is appropriate. Codes are, and have been over many years, 
often valued by comparisons to codes with similar times, including the 
total time of a service. Therefore, we consider total time to be an 
appropriate measure for comparison. We also use reference codes to 
validate a base unit valuation. When using reference codes to support a 
proposed valuation, we do not consider them as a direct ``cross-walk'' 
between the CPT code that is being revalued and the chosen reference 
code. Instead, a reference code is used as a supportive check in 
validating times. For CPT code 00600 and CPT code 00620, we believe 
that the similarities in time, as well as the base unit value of 10 
being the survey 25th percentile result, make them appropriate 
reference codes. We continue to believe that the relative value system 
of the PFS is such that all services are appropriately subject to 
comparison to one another. We do not agree that codes must share the 
same patient population, utilization, age of the CPT code, or survey 
tool to serve as an appropriate reference code. We do consider clinical 
information associated with the intensity of a physician's work 
provided by the RUC and other stakeholders as part of our review 
process, although we remind readers again that we do not agree that 
codes must share the same clinical aspects of work to serve as an 
appropriate reference code. For CPT code 00537, we considered the 
intensity of the service as it relates to other CPT codes on the fee 
schedule, the total time of the service, as well as aspects of time 
compared to supporting reference codes to determine the base unit 
valuation for this CPT code. For additional information regarding our 
use of supporting reference codes and our use of time inputs as a tool 
for comparison, we refer readers to our discussion of the subject in 
the Methodology for Establishing Work RVUs section of this final rule 
(section II.E.2. of the final rule).
    Comment: We received one comment in support of our proposed 
valuation for CPT code 00537.
    Response: We acknowledge and appreciate the support of a base unit 
valuation of 10 for CPT code 00537.
    After consideration of these public comments, we are finalizing the 
base unit valuation and direct PE inputs for CPT code 00537 as 
proposed.
(2) Anesthesia Services for Image-Guided Spinal Procedures (CPT Codes 
01937, 01938, 01939, 01940, 01941, and 01942)
    In 2017, the RUC identified CPT code 01936 (Anesthesia for 
percutaneous image guided procedures on the spine and spinal cord; 
therapeutic) as possibly needing refinement due to inaccurate reporting 
via the high-volume growth screen. The Relativity Assessment Workgroup 
reviewed data on what procedures were reported with this anesthesia 
code. In October 2019, the Workgroup reviewed this service and 
recommended that it be referred to the CPT Editorial Panel to create 
more granular codes. In October 2020, the CPT Editorial Panel replaced 
CPT codes 01935 and 01936 with six new codes to report percutaneous 
image-guided spine and spinal cord anesthesia procedures. These CPT 
codes are 01937 (Anesthesia for percutaneous image-guided

[[Page 65074]]

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

[[Page 65075]]

level of medical decision making. When using time for code selection, 
20-29 minutes of total time is spent on the date of the encounter). CPT 
code 21320 is currently bundled with half of a post-operative follow up 
office visit, CPT code 99212 (Office or other outpatient visit for the 
evaluation and management of an established patient, which requires a 
medically appropriate history and/or examination and straightforward 
medical decision making. When using time for code selection, 10-19 
minutes of total time is spent on the date of the encounter). We do not 
believe the RUC adequately accounted for the loss of these E/M visits 
in their recommended work RVUs for CPT codes 21315 and 21320. The RUC's 
recommendations also seem to dismiss the significant changes in 
surveyed physician time, without a persuasive explanation of a 
significant increase in IWPUT that results from the RUC's recommended 
work RVUs for CPT codes 21315 and 21320. We believe the surveyed 
decreases in physician time in conjunction with the loss of the post-
operative visits for CPT codes 21315 and 21320 merit decreases in the 
work RVUs from the current work RVUs.
    We considered using a modified total time ratio methodology given 
the age and potentially flawed methodology used to arrive at the 
current valuation. The modified total time ratio calculation does not 
include the loss of 8 minutes of post-operative time attributable to 
the change from a 010-day global period to a 000-day global period for 
CPT code 21320 and loss of 23 minutes of post-operative time for CPT 
code 21315. This modified time ratio methodology reflects how the 
physician time is changing in the pre-, intra-, and postservice periods 
when a code's global period is changing, given that E/M services can be 
billed as medically necessary and appropriate for a 000-day global 
code. The total time ratio between the current and proposed total times 
for CPT code 21315, excluding the 23 minutes of post-operative time in 
the current total time, equals 1.64. We arrived at 1.64 by modifying 
the original total time ratio equation to equal the proposed new total 
time divided by the current time, less any time attributable to the 
post-operative global period, then multiplied by the current work RVU. 
The current total time for CPT code 21315 without the 23 minutes of 
post-operative time that will be lost by going from a 010-day to a 000-
day global period code is 76 minutes, therefore, the modified total 
time ratio = (68 minutes/(99 minutes - 23 minutes)) * 1.83 = 1.64. When 
using the original total time ratio methodology for CPT code 21315, it 
shows a 31 percent decrease in total time [(68 minutes - 99 minutes)/99 
minutes = -0.31], whereas the modified methodology shows that there is 
only an 11 percent decrease in newly proposed pre-, intra-, and 
postservice time from the current times [(68 minutes - 76 minutes)/76 
minutes = -0.11].
    The same modified total time ratio methodology could be applicable 
to CPT code 21320. The current total time for CPT code 21320 without 
the 8 minutes of post-operative time that will be lost by going from a 
010-day to a 000-day global period code is 70 minutes, therefore, the 
modified total time ratio = (75 minutes/(78 minutes-8 minutes) * 1.88 = 
2.01. The modified methodology shows that the pre-, intra-, and 
postservice time is increasing by 7 percent for CPT code 21320, whereas 
the original methodology, which accounts for the loss of the 8 post-
operative minutes in the total time ratio, shows a 4 percent decrease 
in total time that would indicate the need for a work RVU decrease. We 
recognize that we have not previously used a modified total time 
approach to consider work RVU values when there is a change in the 
global period for a service in conjunction with significant surveyed 
changes to the pre-, intra-, and postservice times; therefore, we 
solicited comment on application of the modified total time ratio 
approach to value services that have a global period change and 
significant surveyed physician time changes. We believe this 
methodology may account for the loss of post-operative visits and the 
surveyed changes in the pre-, intra-, and postservice times in this 
unique situation.
    Comment: Commenters stated that CMS did not address the compelling 
evidence submitted with the RUC recommendations for CPT codes 21315 and 
21320. Commenters stated that CMS dismisses the fact that services may 
change due to technological advances, changes in the patient 
population, shifts in the specialty of physicians providing services or 
changes in the physician work or intensity required to perform 
services, and CMS only proposes blanket reductions instead of 
considering how a service may have changed or increased over time. 
Commenters requested that CMS address the compelling evidence submitted 
with the RUC recommendations when the agency does not accept the RUC's 
recommended work RVUs.
    Response: The concept of compelling evidence was developed by the 
RUC as part of its work RVU review process for individual codes. The 
RUC determines whether there is compelling evidence to justify an 
increase in valuation. The RUC's compelling evidence criteria include 
documented changes in physician work, an anomalous relationship between 
the code and multiple key reference services, evidence that technology 
has changed physician work, analysis of other data on time and effort 
measures, and evidence that incorrect assumptions were made in the 
previous valuation of the service. While we appreciate the submission 
of this additional information for review, we emphasize that the RUC 
developed the concept of compelling evidence for its own review 
process; an evaluation of ``compelling evidence,'' at least as 
conceptualized by the RUC, is not part of our review process, as our 
focus is the time and intensity of services, in accordance with the 
statute. With that said, we do consider changes in technology, patient 
population, and other compelling evidence criteria, as such evidence 
may affect the time and intensity of a service under review. For 
example, new technology may cause a service to become easier or more 
difficult to perform, with corresponding effects on the time and 
intensity of the service. However, we are under no obligation to adopt 
the same review process or compelling evidence criteria as the RUC. We 
instead focus on evaluating and addressing the time and intensity of 
services when reviewing potentially misvalued codes because section 
1848(c)(1)(A) of the Act specifically defines the work component as the 
resources that reflect time and intensity in furnishing the service.
    Comment: Commenters disagreed with our reference to older work time 
sources, and stated that their use led to the proposal of work RVUs 
based on flawed assumptions. Commenters also stated that it was invalid 
to draw comparisons between the current work times and work RVUs to the 
newly surveyed work time and work RVUs as recommended by the RUC, 
particularly with regards to the removal of RVUs that we believed were 
attributable to the global period. Commenters unanimously disagreed 
with the subtraction of the increased CY 2021 office/outpatient E/M 
work RVUs of 0.70 and 1.30 for CPT codes 99212 and 99213, respectively, 
to arrive at our proposed work RVUs for CPT codes 21315 and 21320.
    Response: The global period changes from 010-day to 000-day allow 
for separately billable E/M visits relating to CPT codes 21315 and 
21320, therefore we removed RVUs that we believed

[[Page 65076]]

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

[[Page 65077]]

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

[[Page 65078]]

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

[[Page 65079]]

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

[[Page 65080]]

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

[[Page 65081]]

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

[[Page 65082]]

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

[[Page 65083]]

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

[[Page 65084]]

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

[[Page 65085]]

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

[[Page 65086]]

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

[[Page 65087]]

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

[[Page 65088]]

global period. We continue to believe that the RUC did not adequately 
account for the removal of these E/M visits as a result of the global 
period changes in their recommended work RVUs for CPT codes 46020 and 
46030.
    We agree with commenters that it is important to use the recent 
data available regarding work times, and we note that when many years 
have passed between when time is measured, significant discrepancies 
can occur. However, we also believe that our operating assumption 
regarding the validity of the existing values as a point of comparison 
is critical to the integrity of the relative value system as currently 
constructed. The work times currently associated with codes play a very 
important role in PFS ratesetting, both as points of comparison in 
establishing work RVUs and in the allocation of indirect PE RVUs by 
specialty. If we were to operate under the assumption that previously 
recommended work times had routinely been underestimated, this would 
undermine the relativity of the work RVUs on the PFS in general, given 
the process under which codes are often valued by comparisons to codes 
with similar times.
    Instead, we believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times 
that have been used in PFS ratesetting are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available, and that we 
are statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the CY 2017 PFS final rule 
(81 FR 80273 through 80274).
    Comment: Some commenters stated that they were concerned about CMS' 
lack of consideration for compelling evidence that services have 
changed. Commenters stated that CMS appeared to dismiss the fact that 
services may change due to technological advances, changes in the 
patient population, shifts in the specialty of physicians providing 
services or changes in the physician work or intensity required to 
perform services. Commenters requested that CMS address the compelling 
evidence submitted with the RUC recommendations when the agency does 
not accept the RUC's recommended work RVUs.
    Response: The concept of compelling evidence was developed by the 
RUC as part of its work RVU review process for individual codes. The 
RUC determines whether there is compelling evidence to justify an 
increase in valuation. The RUC's compelling evidence criteria include 
documented changes in physician work, an anomalous relationship between 
the code and multiple key reference services, evidence that technology 
has changed physician work, analysis of other data on time and effort 
measures, and evidence that incorrect assumptions were made in the 
previous valuation of the service. While we appreciate the submission 
of this additional information for review, we emphasize that the RUC 
developed the concept of compelling evidence for its own review 
process; an evaluation of ``compelling evidence,'' at least as 
conceptualized by the RUC, is not part of our review process, as our 
focus is on the time and intensity of services, in accordance with the 
statute. With that said, we do consider changes in technology, patient 
population, and other compelling evidence criteria, as such evidence 
may affect the time and intensity of a service under review. For 
example, new technology may cause a service to become easier or more 
difficult to perform, with corresponding effects on the time and 
intensity of the service. However, we are under no obligation to adopt 
the same review process or compelling evidence criteria as the RUC. We 
instead focus on evaluating and addressing the time and intensity of 
services when reviewing potentially misvalued codes because section 
1848(c)(1)(A) of the Act specifically defines the work component as the 
resources that reflect time and intensity in furnishing the service.
    Based on the aforementioned references and consideration of the 
comments, we are finalizing the work RVUs as proposed for CPT codes 
46020 and 46030 based on the reverse building block methodology. We 
continue to believe the proposed work RVU for CPT code 46020 adequately 
accounts for the 5-minute decrease in intraservice time, 26-minute 
decrease in total time, 51-minute decreased in postservice time, and a 
change to a 000-day global period which will allow for separately 
billable E/M visits as medically necessary. We continue to believe that 
the 1.48 work RVUs for CPT code 46030 adequately accounts for the 3-
minute decrease in intraservice time, 8-minute decrease in post-service 
time, and a change to a 000-day global period which will allow for 
separately billable E/M visits as medically necessary.
    Comment: Some commenters stated that CMS is proposing to refine the 
preservice clinical labor times for major procedures to conform to the 
000-day global period standards despite the RUC recommendation of 
standard 090-day preservice clinical labor times. Commenters stated 
that CPT codes 46020 and 46030 are major procedures performed under 
general anesthesia when performed the facility setting. Commenters 
stated that the change to a 000-day global period was requested to 
account for variable post-operative care and does not change the need 
for clinical staff time typical of 90-day global procedures performed 
in the facility setting. Commenters stated that reassignment of global 
periods for select codes does not negate the fact that a major 
procedure is a major procedure and the pre-service facility clinical 
staff time for a major procedure is independent of the global period 
assignment. Commenters stated that each procedure should be evaluated 
on a case-by-case basis.
    Response: We agree with the commenters that the direct PE inputs 
for each service should be evaluated on a case-by-case basis based on 
our criteria of what would be reasonable and medically necessary in the 
typical case. We reviewed the individual codes in question and 
concluded that the use of 000-day global period standards for 
``Extensive use of clinical staff'' for CPT code 46020 and 000-day 
global period standards for ``Minimal use of clinical staff'' for CPT 
code 46030 in the facility would be most typical in these cases. As we 
noted under the Standardization of Clinical Labor Tasks section 
(section II.B) of this final rule, we continue to believe that setting 
and maintaining clinical labor standards provides greater consistency 
among codes that share the same clinical labor tasks and could improve 
relativity of values among codes.
    We refer readers to section II.B of this final rule, Determination 
of Practice Expense Relative Value Units (PE RVUs), for more 
information regarding the collaborative work of CMS and the RUC in 
improvements in standardizing clinical labor tasks.
    After consideration of the comments, we are finalizing the work 
RVUs as proposed for CPT codes 46020 and 46030. We are also finalizing 
our

[[Page 65089]]

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

[[Page 65090]]

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

[[Page 65091]]

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

[[Page 65092]]

for all services under the PFS are established using a full notice and 
comment procedure, including consideration of the RUC recommendations, 
before they take effect, providing the public the opportunity to 
comment on a specific proposal prior to it being implemented. We 
continue to believe that this is a far more transparent process which 
assures that we have the full benefit of stakeholder comments before 
establishing values. Since we did not make proposals on the code 
families in question using the RUC's recommendations from the April 
2021 meeting, we would be forced to finalize valuation for these codes 
on an interim final basis, without the opportunity for public comment. 
This would contradict the policy that we finalized in the CY 2015 PFS 
final rule and we do not believe that it would serve the interests of 
transparency. Although we will consider any information submitted by 
stakeholders for valuation during the comment period, as we do for all 
codes which are subject to notice and comment rulemaking, we will 
formally review the recommendations from the April 2021 RUC meeting 
next year as part of the CY 2023 rule cycle.
    Comment: Commenters unanimously disagreed with the intraservice 
time ratio between CPT codes 63048 and 63052, stating that CPT code 
63048 is an inappropriate comparator because of differences in 
procedure and patient elements. Commenters stated that part of the work 
and time involved in CPT code 63048 is that of exposure of bony and 
soft tissue elements of the adjacent level. Commenters stated that CPT 
code 63052 does not require additional work of exposure because it is 
completed as part of the base interbody fusion code, and therefore, CPT 
code 63052 describes only the high intensity, dangerous aspects of 
neural element and spinal cord decompression. Commenters agreed that 
the procedures are similar, but differ in intensity.
    Response: We appreciate the additional information provided by the 
commenters and are compelled to utilize a different methodology than 
the proposed intraservice time ratio between CPT codes 63048 and 63052, 
to value CPT code 63052 because the commenters provided sufficient 
information about how CPT codes 63048 and 63052 differ in intensity.
    After consideration of the public comments regarding CPT code 
63052, we are finalizing a work RVU of 4.25 for CPT code 63052 based on 
a crosswalk to CPT code 22853 (Insertion of interbody biomechanical 
device(s) (e.g., synthetic cage, mesh) with integral anterior 
instrumentation for device anchoring (e.g., screws, flanges), when 
performed, to intervertebral disc space in conjunction with interbody 
arthrodesis, each interspace (List separately in addition to code for 
primary procedure)), which has a work RVU of 4.25 and an intraservice 
time of 45 minutes. CPT code 22853 has only 5 more minutes of 
intraservice time than CPT code 63052, is a spinal procedure, and is an 
add-on code to the same base codes as CPT code 63052. We note that the 
finalized work RVU of 4.25 is supported by the commenters. Commenters 
supported the bracket of key reference service CPT code 22552 
(Arthrodesis, anterior interbody, including disc space preparation, 
discectomy, osteophytectomy and decompression of spinal cord and/or 
nerve roots; cervical below C2, each additional interspace (List 
separately in addition to code for primary procedure)) and MPC CPT code 
34812 (Open femoral artery exposure for delivery of endovascular 
prosthesis, by groin incision, unilateral (List separately in addition 
to code for primary procedure)). CPT code 22552 has a work RVU of 6.50 
and an intraservice time of 45 minutes, and commenters noted that CPT 
code 22552 has a higher intensity as anticipated for a surgical 
procedure and in comparison, with a lumbar procedure. CPT code 34812 
has a work RVU of 4.13 and 40 minutes of intraservice time, and 
commenters noted that this code involves open femoral artery exposure 
by groin incision and closure of the wound, typically for separately 
reported delivery of an endovascular prosthesis for an asymptomatic 
infrarenal abdominal aortic aneurysm. In comparison, exposure and 
closure for CPT code 63052 are performed as part of the primary 
arthrodesis code and the intraservice time includes higher intensity 
bony and soft tissue resection, therefore, although both codes require 
the same time, the physician work and intensity of CPT code 63052 is 
greater than CPT code 34812.
    After consideration of the public comments regarding CPT code 
63053, we are finalizing a work RVU of 3.19 for CPT code 63053 based on 
an intraservice time ratio between CPT codes 63052 and 63053 ((30 
minutes/40 minutes) * 4.25 = 3.19). As we stated above, we are also 
finalizing a work RVU of 4.25 for CPT code 63052 based on a crosswalk 
to CPT code 22853. The RUC did not recommend any direct PE inputs for 
these codes and we are not finalizing any direct PE inputs.
(17) Hypoglossal Nerve Stimulator Services (CPT Codes 64582, 64583, and 
64584)
    In October 2020, the CPT Editorial Panel added three new CPT 
Category I codes to report open implantation, revision or replacement, 
and removal of hypoglossal nerve stimulator array. These new CPT codes 
replaced three CPT Category III codes which were reported with CPT 
codes 64568 (Incision for implantation of cranial nerve (e.g., vagus 
nerve) neurostimulator electrode array and pulse generator), 64569 
(Revision or replacement of cranial nerve (e.g., vagus nerve) 
neurostimulator electrode array, including connection to existing pulse 
generator) and 64570 (Removal of cranial nerve (e.g., vagus nerve) 
neurostimulator electrode array and pulse generator).
    CPT code 64582 (Open implantation of hypoglossal nerve 
neruostimulator array, pulse generator, and distal respiratory sensor 
electrode or electrode array) was previously reported using the now 
deleted Category III CPT code 0466T (Insertion of chest wall 
respiratory sensor electrode or electrode array, including connection 
to pulse generator (List separately in addition to code for primary 
procedure)) along with CPT code 64568. We did not propose the RUC-
recommendation to use the survey median work RVU of 16.00 for CPT code 
64582. We proposed a work RVU of 14.00 based on the intraservice time 
ratio of CPT code 64568 compared to the RUC-recommended intraservice 
time for CPT code 64582. CPT code 64568 has a work RVU of 9.00, 
intraservice time of 90 minutes and total time of 275 minutes. CPT code 
64582 has a RUC-recommended work RVU of 16.00, intraservice time of 140 
minutes and total time of 294 minutes. Additionally, when we reviewed 
CPT code 64582, we found that the RUC-recommended work RVU was higher 
than other global 90-day codes with similar time values. We did not 
agree that it would be typical to value this code so much higher than 
services with similar work time values. Additionally, we note that the 
proposed work RVU of 14.00 is also the survey 25th percentile. 
Therefore, as previously stated, we believe 14.00 is a more appropriate 
value overall than 16.00 when compared to the range of codes with 
similar work times.
    We did not propose the RUC-recommended work value of 16.50 for CPT 
code 64583 (Revision or replacement of hypoglossal nerve 
neruostimulator array and distal respiratory sensor electrode or 
electrode

[[Page 65093]]

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

[[Page 65094]]

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

[[Page 65095]]

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

[[Page 65096]]

aqueous outflow canal; with retention of device or stent), as we 
believe these values do not adequately reflect the surveyed reductions 
in physician time. These RVUs will rank these codes among the highest 
valued 090-day global period codes of similar time values. We proposed 
a work RVU of 9.34 for CPT code 66175 using a reverse building block 
methodology. We then subtract the incremental difference between the 
two RUC-recommended work RVUs, an increment of 1.72, from our proposed 
work RVU of 9.34 for CPT code 66175 to propose a work RVU of 7.62 for 
CPT code 66174. We believe this approach is consistent with the RUC's 
assumption that the intensity and complexity of CPT code 66174 is the 
same as that of CPT code 66175, the only difference between the two 
procedures being the additional intraservice time associated with 
placement of the stent. As further support for these values, we note 
that they fall between CPT code 66984 (Extracapsular cataract removal 
with insertion of intraocular lens prosthesis (1 stage procedure), 
manual or mechanical technique (e.g., irrigation and aspiration or 
phacoemulsification); without endoscopic cyclophotocoagulation), with 
7.35 work RVUs, and CPT code 15150 (Tissue cultured skin autograft, 
trunk, arms, legs; first 25 sq cm or less), with 9.39 work RVUs.
    We proposed the RUC-recommended PE inputs without refinement.
    Comment: The RUC urged CMS to accept a work RVU of 8.53 for CPT 
code 66174 and 10.25 for CPT code 66175. The RUC disagreed with CMS 
utilizing reverse building block methodology for valuing services and 
stated that both CMS recommended work values are below the survey 25th 
percentile and well below the current values. The RUC stated that the 
reverse building block methodology, or any other purely formulaic 
approach, should not be used as the primary methodology to value 
services. Commenters stated that this was inappropriate as magnitude 
estimation has been used to establish work RVUs for services since the 
publication of the first Medicare PFS in 1992.
    Response: We disagree with the commenter regarding the validity of 
the building block methodology. We note that our reviews of recommended 
work RVUs and time inputs generally include, but have not been limited 
to, a review of information provided by the RUC, the HCPAC, and other 
public commenters, medical literature, and comparative databases, as 
well as a comparison with other codes within the PFS, consultation with 
other physicians and health care professionals within CMS and the 
Federal Government, as well as Medicare claims data. We also assess the 
methodology and data used to develop the recommendations submitted to 
us by the RUC and other public commenters and the rationale for the 
recommendations. In the CY 2011 PFS final rule with comment period (75 
FR 73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalks to key reference or similar codes, and magnitude 
estimation (see the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329) for more information). We believe an alternative 
valuation methodology, in this case the building block methodology, 
more accurately reflects the reductions in physician time values.
    We continue to believe that our proposed values more accurately 
reflect both the surveyed physician time, as well as the relative 
relationship among these codes and other services of similar time 
values as compared to the RUC-recommended values, which would overvalue 
these codes relative to other 090-day global period codes. The proposed 
work RVUs for CPT codes 66174 and 66175 are among the highest of 90-day 
global period codes with these time values. Therefore, we are 
finalizing work RVUs of 7.62 for CPT code 66174 and 9.34 for CPT code 
66175, as proposed. We are finalizing the RUC-recommended direct PE 
inputs without refinement.
(21) Cataract Removal With Drainage Device Insertion (CPT Codes 66989, 
66991, 66982, 66984, 66987, 66988, and 0671T)
    The RUC identified CPT code 0191T (Insertion of anterior segment 
aqueous drainage device, without extraocular reservoir, internal 
approach, into the trabecular meshwork; initial insertion) via the 
Category III codes with High Utilization screen (2018 estimated 
Medicare utilization over 1,000). In January 2020, the RUC recommended 
that the specialty societies develop a coding application for Category 
I status for CPT code 0191T and CPT code 0376T (each additional device 
insertion (List separately in addition to code for primary procedure). 
In October 2020, the CPT Editorial Panel replaced two Category III 
codes (CPT codes 0191T and 0376T) with two new codes, CPT codes 66989 
and 66991, to report extracapsular cataract removal with insertion of 
intraocular lens prosthesis and one Category III code to report 
insertion of anterior segment aqueous drainage device without 
concomitant cataract removal.
    The RUC recommended a work RVU of 12.13 for CPT code 66989 
(Extracapsular cataract removal with insertion of intraocular lens 
prosthesis (1-stage procedure), manual or mechanical technique (e.g., 
irrigation and aspiration or phacoemulsification), complex, requiring 
devices or techniques not generally used in routine cataract surgery 
(e.g., iris expansion device, suture support for intraocular lens, or 
primary posterior capsulorrhexis) or performed on patients in the 
amblyogenic developmental stage; with insertion of intraocular (e.g., 
trabecular meshwork, supraciliary, suprachoroidal) anterior segment 
aqueous drainage device, without extraocular reservoir, internal 
approach, one or more) based on the survey 25th percentile.
    In its recommendation, the RUC noted that the recommended 
intraservice time of 28 minutes for CPT code 66989 is 2 minutes less 
than the intraservice time of 30 minutes associated with CPT code 66982 
(Extracapsular cataract removal with insertion of intraocular lens 
prosthesis (1-stage procedure), manual or mechanical technique (e.g., 
irrigation and aspiration or phacoemulsification), complex, requiring 
devices or techniques not generally used in routine cataract surgery 
(e.g., iris expansion device, suture support for intraocular lens, or 
primary posterior capsulorrhexis) or performed on patients in the 
amblyogenic developmental stage; without endoscopic 
cyclophotocoagulation). The RUC further noted this should not be the 
case, as the insertion of the intraocular lens prosthesis should take 
the same amount of time and be represented by the same relative work 
for both procedures and that it is counterintuitive that the 
intraservice time for CPT code 66989 will be lower than the 
intraservice time for CPT code 66982, as CPT code 66989 includes both 
complex cataract surgery and the insertion of the intraocular anterior 
segment aqueous drainage device. The specialty society that surveyed 
the codes explained that this is likely because the early adopters of 
this new technology service are highly skilled surgeons who will likely 
perform these procedures quickly. They stated that as this procedure 
diffuses into the wider population of ophthalmologic surgeons over the 
next few years, the intraservice time will likely rise above the 
intraservice time associated with CPT codes 66982 and 66984 and will 
come

[[Page 65097]]

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

[[Page 65098]]

(22) Retinal Detachment Prophylaxis (CPT Codes 67141 and 67145)
    CPT code 67145 (Prophylaxis of retinal detachment (e.g., retinal 
break, lattice degeneration) without drainage, 1 or more sessions; 
photocoagulation (laser or xenon arc)) was identified in October 2019 
as a Harvard Valued service with utilization over 30,000. In January 
2020, the RUC agreed with the specialty societies that surveyed the 
service and recommended that CPT code 67145, as well as its parent CPT 
code 67141 (Prophylaxis of retinal detachment (e.g., retinal break, 
lattice degeneration) without drainage, 1 or more sessions; 
cryotherapy, diathermy), be referred to the CPT Editorial Panel for a 
descriptor and global period change. The codes were edited to remove 
the reference to ``1 or more sessions'' so that the services may be 
valued as a 010-day procedure versus the current 090-day global. At the 
May 2020 CPT Editorial Panel meeting, the Panel approved revision of 
the two codes to remove ``1 or more sessions'' from the descriptors and 
deletion of the Eye and Ocular Adnexa Prophylaxis guidelines.
    For CY 2022, we proposed the RUC-recommended work RVU of 2.53 for 
CPT codes 67141 and 67145. We also proposed the RUC-recommended direct 
PE inputs without refinements.
    Comment: One commenter urged CMS to adopt the 25th percentile 
survey work values reviewed by the RUC and recommended to CMS.
    Response: We appreciate the commenters feedback. For CPT codes 
67141 and 67145, we are finalizing the RUC-recommended work RVU of 2.53 
for CPT codes 67141 and 67145 and the RUC-recommended direct PE inputs 
without refinements, as proposed.
(23) Strabismus Surgery (CPT Codes 67311, 67312, 67314, 67316, 67318, 
67320, 67331, 67332, 67334, 67335, and 67340)
    In April 2020, The RUC recommend that add-on CPT codes 67320, 
67331, 67332, 67334, 67335, and 67340 be surveyed along with the base 
codes in which these services are typically reported (CPT codes 67311, 
67312, 67314, 67316 and 67318). When AMA staff compiled a list of 010-
day and 090-day services for increases in physician work and time 
during the surgical global period, they noticed that several low volume 
codes that were converted to ZZZ global periods in 1999 still included 
office visits (specifically CPT codes 67320, 67331, 67332, 67334, 
67340). It appeared that these office visits may not be appropriate for 
these services. This issue was deferred until October 2020.
    We proposed the RUC-recommended work RVUs for all base codes within 
this family. This includes a work RVU of 5.93 for CPT code 67311 
(Strabismus surgery, recession or resection procedure; 1 horizontal 
muscle), 9.50 for CPT code 67312 (Strabismus surgery, recession or 
resection procedure; 2 horizontal muscles), 5.93 for CPT code 67314 
(Strabismus surgery, recession or resection procedure; 1 vertical 
muscle (excluding superior oblique)), 10.31 for CPT code 67316 
(Strabismus surgery, recession or resection procedure; 2 or more 
vertical muscles (excluding superior oblique)), and 9.80 for CPT code 
67318 (Strabismus surgery, any procedure, superior oblique muscle).
    We also proposed the RUC-recommend work RVUs for all of the add-on 
codes within this family. This includes a work RVU of 3.00 for CPT code 
67320 (Transposition procedure (e.g., for paretic extraocular muscle), 
any extraocular muscle (specify)(List separately in addition to code)), 
2.00 for CPT code 67331 (Strabismus surgery on patient with previous 
eye surgery or injury that did not involve the extraocular muscles 
(List separately in addition to code for primary procedure)), 3.50 for 
CPT code 67332 (Strabismus surgery on patient with scarring of 
extraocular muscles (e.g., prior ocular injury, strabismus or retinal 
detachment surgery) or restrictive myopathy (e.g., dysthyroid 
opthalmopathy) (List separately in addition to code for primary 
procedure)), 2.06 for CPT code 67334 (Strabismus surgery by posterior 
fixation suture technique, with or without muscle recession (List 
separately in addition to code for primary procedure)), 3.23 for CPT 
code 67335 (Strabismus surgery by posterior fixation suture technique, 
with or without muscle recession (List separately in addition to code 
for primary procedure)), and 5.00 for CPT code 67340 (Strabismus 
surgery by posterior fixation suture technique, with or without muscle 
recession (List separately in addition to code for primary procedure)).
    We proposed the RUC-recommended direct PE inputs for this code 
family without refinements.
    Comment: Commenters unanimously opposed the RUC-recommended RVUs 
for every code in this family. Commenters did not agree with the 
reference codes used by the RUC to support their recommended values. 
They stated that they believe it is inappropriate to use reference 
codes to support a valuation that is lower than the 25th percentile 
survey result for CPT code 67311, CPT code 67314, and CPT code 67320, 
while valuing all other CPT codes within the family at the 25th 
percentile. Commenters asked that CMS raise the RVUs for these CPT 
codes to also be the 25th percentile survey result, which would make 
the family consistently valued. Commenters also asked that the 
reduction in RVUs be phased in over a 3 to 5-year timeframe instead of 
the statutory 2 years.
    Response: We generally agree that there should be consistency 
within code families. The recommendations presented to us by the RUC 
for this CPT code family, however, include a review of surveys for time 
changes, intensity, clinical aspects, and a thoughtful review of survey 
results with the intent for the revaluation to minimize rank order 
anomalies and have valuations consistent with and accounting for the 
reductions in intraservice and total times for each CPT code. In 
regards to the possibility of an extended phase-in, section 1848(c)(7) 
of the Act, as added by section 220(e) of the PAMA, specifies that for 
services that are not new or revised codes, if the total RVUs for a 
service for a year would otherwise be decreased by an estimated 20 
percent or more as compared to the total RVUs for the previous year, 
the applicable adjustments in work, PE, and MP RVUs shall be phased-in 
over a 2-year period. CPT codes 67311, 67314, 67320, 67331, 67332, and 
67334 were subject to the phase-in transition and it was applied in 
calculating their proposed RVUs; we direct readers to the Codes Subject 
to Phase-In public use file for the CY 2022 PFS proposed rule for 
additional details. The statute defines the phase-in transition as 
taking place over 2 years. For additional information regarding the 
phase-in of significant RVU reductions, we direct readers to the CY 
2016 PFS final rule with comment period (80 FR 70927 through 70929).
    Comment: Commenters stated that CMS should revise the policy 
finalized in the 2021 PFS final rule (85 FR 84472) that revalued E/M 
office visits but excluded the valuations from 90 and 10-day 
postoperative global surgery packages. Commenters requested the revised 
values be applied to the postoperative visits in global surgery CPT 
code families as well, and they noted this is particularly relevant to 
this and other CPT code families.
    Response: We did not address the exclusion of postoperative office 
visits within global surgery packages from the E/M revaluation for this 
service, or other services, in the proposed rule. Therefore, this 
policy is out of scope for the CY 2022 PFS proposed and final

[[Page 65099]]

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

[[Page 65100]]

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

[[Page 65101]]

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

[[Page 65102]]

review of patient's history and medical records. The commenter also 
noted that the descriptor for 80502 described a clinical pathology 
consultation for a ``complex diagnostic problem'', whereas new code 
80505 describes a ``highly complex clinical problem''.
    Response: In the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalk to key reference or similar codes, and magnitude 
estimation. As we have previously stated, section 1848(c)(1)(A) of the 
Act requires CMS to consider time and intensity when developing work 
RVUs. Therefore, we believe it is appropriate to compare CPT code 80503 
to CPT code 80500 and CPT code 80505 to code 80502, which CPT code 
80505 replaced, as the PFS is a relative value system. We continue to 
believe that the increases or decreases in work times should be 
commensurate with the increase or decrease in the work RVU, which is 
why we proposed a work RVU of 0.43 for CPT code 80503 and a work RVU of 
1.71 for CPT code 80505 based on the time methodology detailed above.
    Comment: Several commenters disagreed with the proposal to remove 
the equipment time associated with EP024 (microscope, compound) from 
CPT codes 80503, 80504, 80505, and 80506. Commenters noted that the 
RUC's Summary of Recommendation (SOR) states that a patient's medical 
record is reviewed focusing on recent and relevant remote clinical and 
diagnostic findings and all applicable diagnostic material, slides, 
primary analytical data are retrieved/unarchived for the pathologist's 
examination and review. Commenters stated it is typical for a 
consulting pathologist performing CPT codes 80503-80506 to review all 
relevant information about the patient that is available, and a 
physical component of the patient material within the case review is 
the patient's specimen slides. Commenters stated that these slides are 
typically reviewed on a high grade professional microscope at the 
pathologist's workstation and during the service, the microscope itself 
is not available for other personnel to use on other patients, as the 
pathologist may review the slides multiple times during the service. 
Commenters stated that the RUC understood that pathologists require a 
microscope to perform this and numerous other pathology related 
professional services which is why the RUC included equipment time for 
the EP024 compound microscope in its recommendations. Therefore, 
commenters urged CMS to accept and implement the RUC-recommended times 
of 15, 30, 54, and 30 minutes of equipment time for EP024 (microscope, 
compound) for CPT codes 80503, 80504, 80505, and 80506.
    Response: We appreciate the additional information provided by 
commenters. We found the affirmation from commenters that pathologists 
typically review the patient's specimen slides compelling, and we agree 
that the use of the EP024 microscope would be typical for these codes 
based on this additional information. Therefore, we are finalizing a 
policy to restore the RUC-recommended times of 15, 30, 54, and 30 
minutes of equipment time for EP024 (microscope, compound) for CPT 
codes 80503, 80504, 80505, and 80506.
    Comment: Commenters urged CMS to accept and implement the RUC-
recommended time of 4 minutes for clinical labor activity PA001 for CPT 
codes 80503, 80504, and 80505. Commenters stated for these services, 
accessioning and entering information on the patient case is a 
preservice clinical labor task that is not duplicative with the post 
service work of filing specimen slides, filing reports and all relevant 
patient information retrieved for the pathologist to review. The 
preservice clinical labor work here involves the careful documentation 
of the connection between the requesting physician and the pathologist 
onto a worksheet or accession form. The form is used to transcribe the 
request for consult, the primary complaint, patient encounter, and 
other related information so that it becomes part of the patient's EHR. 
This is one of the first steps of the complete service.
    Response: We thank commenters for the additional information. 
However, we believe the majority of the accessioning tasks performed in 
the PA001 activity constitute forms of indirect PE. Although we agree 
that the unique nature of pathology and laboratory services can make 
comparisons across codes more difficult than for other services, we 
believe the comparison of similar clinical labor activities across 
different services is important to maintaining the relativity of the 
direct PE inputs. As we stated in the CY 2017 PFS final rule (81 FR 
80324), we agree with the commenters that patient documentation and 
entering patient data into information systems is an important task, 
and we agree that these would take more than zero minutes to perform. 
However, we continue to believe that these activities are correctly 
categorized as indirect PE as administrative functions, and therefore, 
we do not recognize the entry of patient data as direct PE inputs, and 
we do not consider this task as typically performed by clinical labor 
on a per-service basis. While we do not agree that the data entry tasks 
described in this activity would constitute direct PE, we note that the 
recommended materials for these codes state that multiple existing 
forms of data will need to be identified and incorporated into this 
accession. We believe that these interpretive tasks do constitute a 
form of direct PE as they are individually allocable to a particular 
patient for a particular service. Therefore, we are finalizing 1 minute 
of clinical labor activity associated with PA001 for CPT codes 80503, 
80504, and 80505 to capture the labor performed in these interpretive 
tasks. We note that we have also previously finalized 1 minute for the 
PA001 clinical labor activity in other pathology services such as CPT 
codes 88360 and 88361.
    For CY 2022, we are finalizing the work RVUs of 0.43, 0.91, 1.71, 
and 0.80 for 80503, 80504, 80505, and 80506 as proposed. For the direct 
PE, we are finalizing a policy to restore the RUC-recommended times of 
15, 30, 54, and 30 minutes of equipment time for EP024 (microscope, 
compound) for CPT codes 80503, 80504, 80505, and 80506 and 1 minute of 
clinical labor activity associated with PA001 for CPT codes 80503, 
80504, and 80505 to capture the labor performed in these interpretive 
tasks.
    We reiterate that CMS will monitor the use of these replacement 
codes per our usual practice to ensure appropriate billing and inform 
future rulemaking as needed. We continue to look for stakeholder input 
on how these replacement codes will most typically be billed relative 
to use of existing pathology coding. Such information will also inform 
future rulemaking as needed.
(29) Revaluing End-Stage Renal Disease (ESRD) Monthly Capitation 
Payment Services (MCP) (CPT Code 90954)
    In the CY 2021 PFS final rule (85 FR 84551 through 84554), we 
revalued most, but not all, of the ESRD MCP services. We finalized an 
increase in valuations for those ESRD MCP codes with values tied to the 
values of Outpatient/Office Evaluation and Management (O/O E/M) codes. 
We did not revalue CPT code 90954 (End-stage renal disease (ESRD) 
related services monthly, for patients 2-11 years of age to include 
monitoring for the adequacy of nutrition, assessment of growth and 
development, and counseling of parents; with 4 or more face-to-face 
visits by a physician or other qualified health care

[[Page 65103]]

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

[[Page 65104]]

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

[[Page 65105]]

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

[[Page 65106]]

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

[[Page 65107]]

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

[[Page 65108]]

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

[[Page 65109]]

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

[[Page 65110]]

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

[[Page 65111]]

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

[[Page 65112]]

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

[[Page 65113]]

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

[[Page 65114]]

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

[[Page 65115]]

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

[[Page 65116]]

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

[[Page 65117]]

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

[[Page 65118]]

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

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

[[Page 65119]]

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

[[Page 65120]]

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

[[Page 65121]]

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

[[Page 65122]]

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

[[Page 65123]]

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

[[Page 65124]]

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

[[Page 65125]]

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

[[Page 65126]]

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

[[Page 65127]]

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

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

[[Page 65128]]

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

[[Page 65129]]

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

F. Evaluation and Management (E/M) Visits

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

[[Page 65151]]

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

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

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

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

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

[[Page 65152]]

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

[[Page 65153]]

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

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

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


[[Page 65154]]


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

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

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

[[Page 65155]]

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

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

[[Page 65156]]

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

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

[[Page 65157]]

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

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

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

[[Page 65158]]

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

[[Page 65159]]

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

[[Page 65160]]

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

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

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

[[Page 65161]]

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

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

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

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

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

[[Page 65162]]

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

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

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

[[Page 65163]]

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

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

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

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

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

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

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

[[Page 65164]]

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

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

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

[[Page 65165]]

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

[[Page 65166]]

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

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

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

[[Page 65167]]

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

G. Billing for Physician Assistant (PA) Services

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

[[Page 65168]]

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

[[Page 65169]]

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

H. Therapy Services

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

[[Page 65170]]

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

[[Page 65171]]

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

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

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

[[Page 65172]]

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

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


[[Page 65173]]


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

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

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

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

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

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

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

[[Page 65174]]

the assistant modifier. We proposed to add this policy to our 
regulations at Sec. Sec.  410.59(a)(4)(v) and 410.60(a)(4)(v) for 
outpatient occupational therapy and physical therapy services, 
respectively and at Sec.  410.105(d)(3)(iv) for CORF services.
    As noted previously, when we finalized the policy to consider each 
15-minute unit of a service for purposes of determining whether the de 
minimis standard applies, we neglected to revise our regulations at 
Sec. Sec.  410.59, 410.60 and 410.105 to reflect this change. As such, 
we proposed to amend the regulations at Sec. Sec.  410.59(a)(4)(iii)(B) 
and 410.60(a)(4)(iii)(B) for outpatient occupational therapy and 
physical therapy services, respectively, and at Sec.  410.105(d)(3)(ii) 
for CORF services to specify that we consider a service to be furnished 
in part by a PTA or an OTA when the PTA/OTA furnishes a portion of a 
service, or in the case of a 15-minute timed code, a portion of a unit 
of a service, separately from the portion of the service or unit of 
service furnished by the therapist such that the minutes for that 
portion of a service or a unit of a service furnished by the PTA/OTA 
exceed 10 percent of the total minutes for that service or unit of a 
service.
    To accommodate the proposed refinement of the de minimis policy, we 
proposed to amend the same regulations at Sec. Sec.  410.59(a)(4)(iv) 
and 410.60(a)(4)(iv) for outpatient occupational therapy and physical 
therapy services, respectively, and at Sec.  410.105(d)(3)(iii) for 
CORF services to provide that, for the final 15-minute unit billed for 
a patient for a date of service, when the PT/OT provides more than the 
midpoint (at least 8 minutes) of a service such that they could bill 
for the service without any additional minutes being furnished by the 
PTA/OTA, the service may be billed without a CQ or CO modifier, and any 
remaining minutes of service furnished by the PTA/OTA are considered 
immaterial.
    Beginning January 1, 2022, therapy services furnished in whole or 
in part by a PTA or OTA will be identified based on the inclusion by 
the billing therapy services provider (whether a therapist in private 
practice or therapy provider) of the CQ or CO modifier, respectively, 
on claim lines for therapy services, and the payment for those services 
will be adjusted as required by section 1834(v)(1) of the Act. Per our 
usual system update process, we plan to issue instructions in a change 
request to prepare our shared systems and Medicare Administrative 
Contractors (MACs) to pay the reduced amount for therapy services 
furnished in whole or in part by a PTA or OTA. We will issue a Medlearn 
Learning Network[supreg] (MLN) article once the CR is released, after 
the CY 2022 PFS final rule is issued.
    When we identified a limited number of cases in which there are two 
15-minute units left to bill and the PTA/OTA and the PT/OT each provide 
between 9 and 14 minutes with a total time of 23 through 28 minutes, 
where we proposed that one unit is billed with an assistant modifier 
and one unit is billed without it, we have identified four additional 
examples of PTA/OTA:PT/OT (or vice versa) time splits that we would 
like to acknowledge--these instances include 10:14, 11:13, 11;14, and 
13:12. The full complement of these time splits are: 9:14, 10:13, 
10:14, 11:12, 11:13, 11:14, 12:12, 12:13, 12:14, 13:12, 13:13, 13:14, 
and 14:14.
    We are making a technical correction to the proposed regulation 
text at Sec.  410.105(d)(3)(iii) that appeared in the CY 2022 PFS 
proposed rule, to remove an extra parenthesis ``('' as it appeared in 
``((ii)'' so that the CORF regulation at Sec.  410.105(d)(3)(iii) 
correctly reads as ``(iii) Paragraph (d)(3)(ii)''.
    We solicited comment on all of our proposals.
    We received over 12,000 public comments on our proposals. The 
following is a summary of the comments we received and our responses.
    Comment: Many commenters, including the major therapy stakeholders, 
expressed appreciation that we updated the interpretation of the de 
minimis standard to take into account the ``8-minute rule'' for the 
final unit billed. One commenter conveyed their belief that this policy 
is sound and will ensure that therapists and therapy providers are not 
paid less for providing more care. A few commenters also supported our 
explanation and proposal to bill one unit of a service with the CQ/CO 
modifier and one unit without a CQ/CO modifier when the PTA/OTA and the 
PT/OT each provide between 9 and 14 minutes of a 15-minute timed 
service with a total time of 23 to 28 minutes where there are two units 
left to bill.
    Response: We appreciate that commenters are supportive that we 
revised our de minimis policy in response to specific requests from the 
major therapy stakeholders regarding the ``8-minute rule'' for the 
final unit billed; and, thank the commenter for their remark about the 
soundness of this policy that permits therapists and therapy providers 
to furnish proper care without being paid less for the service. We also 
appreciate that others specif