[Federal Register Volume 86, Number 221 (Friday, November 19, 2021)]
[Rules and Regulations]
[Pages 64996-66031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23972]
[[Page 64995]]
Vol. 86
Friday,
No. 221
November 19, 2021
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 403, 405, 410, et al.
Medicare Program; CY 2022 Payment Policies Under the Physician Fee
Schedule and Other Changes to Part B Payment Policies; Medicare Shared
Savings Program Requirements; Provider Enrollment Regulation Updates;
and Provider and Supplier Prepayment and Post-Payment Medical Review
Requirements; Final Rule
Federal Register / Vol. 86 , No. 221 / Friday, November 19, 2021 /
Rules and Regulations
[[Page 64996]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 403, 405, 410, 411, 414, 415, 423, 424, and 425
[CMS-1751-F]
RIN 0938-AU42
Medicare Program; CY 2022 Payment Policies Under the Physician
Fee Schedule and Other Changes to Part B Payment Policies; Medicare
Shared Savings Program Requirements; Provider Enrollment Regulation
Updates; and Provider and Supplier Prepayment and Post-Payment Medical
Review Requirements
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Final rule.
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SUMMARY: This major final rule addresses: Changes to the physician fee
schedule (PFS); other changes to Medicare Part B payment policies to
ensure that payment systems are updated to reflect changes in medical
practice, relative value of services, and changes in the statute;
Medicare Shared Savings Program requirements; updates to the Quality
Payment Program; Medicare coverage of opioid use disorder services
furnished by opioid treatment programs; updates to certain Medicare
provider enrollment policies; requirements for prepayment and post-
payment medical review activities; requirement for electronic
prescribing for controlled substances for a covered Part D drug under a
prescription drug plan, or a Medicare Advantage Prescription Drug (MA-
PD) plan; updates to the Medicare Ground Ambulance Data Collection
System; changes to the Medicare Diabetes Prevention Program (MDPP)
expanded model; and amendments to the physician self-referral law
regulations.
DATES: These regulations are effective on January 1, 2022.
FOR FURTHER INFORMATION CONTACT:
[email protected], for any issues not
identified below.
Michael Soracoe, (410) 786-6312, or
[email protected], for issues related to
practice expense, work RVUs, conversion factor, and PFS specialty-
specific impacts.
Larry Chan, (410) 786-6864, for issues related to potentially
misvalued services under the PFS.
Patrick Sartini, (410) 786-9252, and Larry Chan, (410) 786-6864,
for issues related to telehealth services and other services involving
communications technology.
Julie Adams, (410) 786-8932, for issues related to payment for
anesthesia services.
Sarah Leipnik, (410) 786-3933, or
[email protected], for issues related to split
(or shared) services.
Michelle Cruse, (410) 786-7540, and Michael Konieczny, (410) 786-
0825, for issues related to payment for vaccine administration
services.
Regina Walker-Wren, (410) 786-9160, for issues related to billing
for services of physician assistants and PFS payment for teaching
physician services.
Pamela West, (410) 786-2302, for issues related to PFS payment for
therapy services, medical nutrition therapy services, and services of
registered dietitians and nutrition professionals.
Liane Grayson, (410) 786-6583, for issues related to coinsurance
for certain colorectal cancer screening services and PFS payment for
critical care services.
Lisa Parker, (410) 786-4949, and Michele Franklin, (410) 786-9226,
for issues related to RHCs and FQHCs.
Laura Kennedy, (410) 786-3377, for issues related to drugs payable
under Part B.
Heather Hostetler, (410) 786-4515, and Elizabeth Truong, 410-786-
6005, for issues related to removal of selected national coverage
determinations.
Sarah Fulton, (410) 786-2749, for issues related to Appropriate Use
Criteria for Advanced Diagnostic Imaging (AUC); and Pulmonary
Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac
Rehabilitation.
Rachel Katonak, (410) 786-8564, for issues related to Medical
Nutrition Therapy.
Sabrina Ahmed, (410) 786-7499, for issues related to the Medicare
Shared Savings Program (Shared Savings Program) quality reporting
requirements and quality performance standard.
Janae James, (410) 786-0801, Elizabeth November, (410) 786-4518, or
[email protected], for issues related to Shared Savings
Program beneficiary assignment, repayment mechanism requirements, and
benchmarking methodology.
Naseem Tarmohamed, (410) 786-0814, or
[email protected], for inquiries related to Shared
Savings Program application, compliance and beneficiary notification
requirements.
Amy Gruber, [email protected], for issues related
to the Medicare Ground Ambulance Data Collection System.
Juliana Tiongson, (410) 786-0342, for issues related to the
Medicare Diabetes Prevention Program (MDPP).
Laura Ashbaugh, (410) 786-1113, for issues related to Clinical
Laboratory Fee Schedule: Laboratory Specimen Collection and Travel
Allowance and Use of Electronic Travel Logs.
Frank Whelan, (410) 786-1302, for issues related to Medicare
provider enrollment regulation updates.
Katie Mucklow, (410) 786-0537, for issues related to provider and
supplier prepayment and post-payment medical review requirements.
Lindsey Baldwin, (410) 786-1694, and Michele Franklin, (410) 786-
9226, for issues related to Medicare coverage of opioid use disorder
treatment services furnished by opioid treatment programs.
Lisa O. Wilson, (410) 786-8852, or Meredith Larson, (410) 786-7923,
for inquiries related to the physician self-referral law.
Joella Roland, (410) 786-7638, for issues related to requirement
for electronic prescribing for controlled substances for a covered Part
D drug under a prescription drug plan or an MA-PD plan.
Kathleen Ott, (410) 786-4246, for issues related to open payments.
Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
Brittany LaCouture, (410) 786-0481, for inquiries related to
Alternative Payment Models (APMs).
SUPPLEMENTARY INFORMATION:
Addenda Available Only Through the Internet on the CMS Website: The
PFS Addenda along with other supporting documents and tables referenced
in this final rule are available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/index.html. Click on the link on the left side of the
screen titled, ``PFS Federal Regulations Notices'' for a chronological
list of PFS Federal Register and other related documents. For the CY
2022 PFS final rule, refer to item CMS-1751-F. Readers with questions
related to accessing any of the Addenda or other supporting documents
referenced in this final rule and posted on the CMS website identified
above should contact [email protected].
CPT (Current Procedural Terminology) Copyright Notice:
[[Page 64997]]
Throughout this final rule, we use CPT codes and descriptions to refer
to a variety of services. We note that CPT codes and descriptions are
copyright 2020 American Medical Association. All Rights Reserved. CPT
is a registered trademark of the American Medical Association (AMA).
Applicable Federal Acquisition Regulations (FAR) and Defense Federal
Acquisition Regulations (DFAR) apply.
I. Executive Summary
This major final rule revises payment polices under the Medicare
PFS and makes other policy changes, including to the implementation of
certain provisions of the Consolidated Appropriations Act, 2021 (CAA,
2021) (Pub. L. 116-260, December 27, 2020), Bipartisan Budget Act of
2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018) and the
Substance Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment for Patients and Communities Act (SUPPORT Act) (Pub. L. 115-
271, October 24, 2018), related to Medicare Part B payment. In
addition, this major final rule includes revisions to other Medicare
payment policies described in sections III. and IV.
B. Summary of the Major Provisions
The statute requires us to establish payments under the PFS based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: Work,
practice expense (PE), and malpractice (MP) expense. In addition, the
statute requires that we establish each year by regulation the payment
amounts for physicians' services paid under the PFS, including
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas.
In this major final rule, we are establishing RVUs for CY 2022 for
the PFS to ensure that our payment systems are updated to reflect
changes in medical practice and the relative value of services, as well
as changes in the statute. This final rule also includes discussions
and provisions regarding several other Medicare Part B payment
policies.
Specifically, this final rule addresses:
Practice Expense RVUs (section II.B.)
Potentially Misvalued Services Under the PFS (section II.C.)
Telehealth and Other Services Involving Communications
Technology (section II.D.)
Valuation of Specific Codes (section II.E.)
Evaluation and Management Visits (section II.F.)
Billing for Physician Assistant Services (section II.G.)
Therapy Services (section II.H.)
Changes to Beneficiary Coinsurance for Additional Procedures
Furnished During the Same Clinical Encounter as Certain Colorectal
Cancer Screening Tests (section II.I.)
Vaccine Administration Services (section II.J.)
Payment for Medical Nutrition Therapy Services and Related
Services (section II.K.)
Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) (sections III.A., III.B., and III.C.)
Requiring Certain Manufacturers to Report Drug Pricing
Information for Part B and Determination of ASP for Certain Self-
administered Drug Products (sections III.D.1. and 2.)
Medicare Part B Drug Payment for Drugs Approved under Section
505(b)(2) of the Federal Food, Drug, & Cosmetic Act (section III.E.)
Appropriate Use Criteria for Advanced Diagnostic Imaging
(section III.F.)
Removal of Selected National Coverage Determinations (section
III.G.)
Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive
Cardiac Rehabilitation (section III.H.)
Medical Nutrition Therapy (section III.I.)
Medicare Shared Savings Program (section III.J.)
Medicare Ground Ambulance Data Collection System (section
III.K.)
Medicare Diabetes Prevention Program (MDPP) (section III.L.)
Clinical Laboratory Fee Schedule: Laboratory Specimen
Collection and Travel Allowance for Clinical Diagnostic Laboratory
Tests and Use of Electronic Travel Logs (section III.M.)
Medicare Provider and Supplier Enrollment Changes (section
III.N.1.)
Provider/Supplier Medical Review Requirements: Addition of
Provider/Supplier Requirements related to Prepayment and Post-payment
Reviews (section III.N.2.)
Modifications Related to Medicare Coverage for Opioid Use
Disorder (OUD) Treatment Services Furnished by Opioid Treatment
Programs (OTPs) (section III.O.)
Updates to the Physician Self-Referral Regulations (section
III.P.)
Requirement for Electronic Prescribing for Controlled
Substances for a Covered Part D Drug under a Prescription Drug Plan or
an MA-PD Plan (section 2003 of the SUPPORT Act) (section III.Q.)
Open Payments (section III.R.)
Updates to the Quality Payment Program (section IV.)
Collection of Information Requirements (section V.)
Regulatory Impact Analysis (section VI.)
3. Summary of Costs and Benefits
We have determined that this final rule is economically
significant. For a detailed discussion of the economic impacts, see
section VI., Regulatory Impact Analysis, of this final rule.
II. Summary of the Proposed Provisions, Analysis of and Response to
Public Comments, and the Provisions of the Final Rule for the PFS
A. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Social Security Act (the Act), ``Payment for
Physicians' Services.'' The PFS relies on national relative values that
are established for work, practice expense (PE), and malpractice (MP),
which are adjusted for geographic cost variations. These values are
multiplied by a conversion factor (CF) to convert the RVUs into payment
rates. The concepts and methodology underlying the PFS were enacted as
part of the Omnibus Budget Reconciliation Act of 1989 (OBRA '89) (Pub.
L. 101-239, December 19, 1989), and the Omnibus Budget Reconciliation
Act of 1990 (OBRA '90) (Pub. L. 101-508, November 5, 1990). The final
rule published in the November 25, 1991 Federal Register (56 FR 59502)
set forth the first fee schedule used for payment for physicians'
services.
We note that throughout this final rule, unless otherwise noted,
the term ``practitioner'' is used to describe both physicians and
nonphysician practitioners (NPPs) who are permitted to bill Medicare
under the PFS for the services they furnish to Medicare beneficiaries.
1. Development of the RVUs
a. Work RVUs
The work RVUs established for the initial fee schedule, which was
implemented on January 1, 1992, were developed with extensive input
from the physician community. A research team at the Harvard School of
Public Health developed the original work RVUs for most codes under a
cooperative agreement with the Department of Health and Human Services
(HHS). In constructing the code-specific vignettes used in
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determining the original physician work RVUs, Harvard worked with
panels of experts, both inside and outside the Federal Government, and
obtained input from numerous physician specialty groups.
As specified in section 1848(c)(1)(A) of the Act, the work
component of physicians' services means the portion of the resources
used in furnishing the service that reflects physician time and
intensity. We establish work RVUs for new, revised and potentially
misvalued codes based on our review of information that generally
includes, but is not limited to, recommendations received from the
American Medical Association/Specialty Society Relative Value Scale
Update Committee (RUC), the Health Care Professionals Advisory
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC),
and other public commenters; medical literature and comparative
databases; as well as a comparison of the work for other codes within
the Medicare PFS, and consultation with other physicians and health
care professionals within CMS and the Federal Government. We also
assess the methodology and data used to develop the recommendations
submitted to us by the RUC and other public commenters, and the
rationale for their recommendations. In the CY 2011 PFS final rule with
comment period (75 FR 73328 through 73329), we discussed a variety of
methodologies and approaches used to develop work RVUs, including
survey data, building blocks, crosswalk to key reference or similar
codes, and magnitude estimation. More information on these issues is
available in that rule.
b. Practice Expense RVUs
Initially, only the work RVUs were resource-based, and the PE and
MP RVUs were based on average allowable charges. Section 121 of the
Social Security Act Amendments of 1994 (Pub. L. 103-432, October 31,
1994), amended by section 1848(c)(2)(C)(ii) of the Act and required us
to develop resource-based PE RVUs for each physicians' service
beginning in 1998. We were required to consider general categories of
expenses (such as office rent and wages of personnel, but excluding MP
expenses) comprising PEs. The PE RVUs continue to represent the portion
of these resources involved in furnishing PFS services.
Originally, the resource-based method was to be used beginning in
1998, but section 4505(a) of the Balanced Budget Act of 1997 (BBA `97)
(Pub. L. 105-33, August 5, 1997) delayed implementation of the
resource-based PE RVU system until January 1, 1999. In addition,
section 4505(b) of the BBA `97 provided for a 4-year transition period
from the charge-based PE RVUs to the resource-based PE RVUs.
We established the resource-based PE RVUs for each physicians'
service in the November 2, 1998 final rule (63 FR 58814), effective for
services furnished in CY 1999. Based on the requirement to transition
to a resource-based system for PE over a 4-year period, payment rates
were not fully based upon resource-based PE RVUs until CY 2002. This
resource-based system was based on two significant sources of actual PE
data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's
Socioeconomic Monitoring System (SMS) data. These data sources are
described in greater detail in the CY 2012 PFS final rule with comment
period (76 FR 73033).
Separate PE RVUs are established for services furnished in facility
settings, such as a hospital outpatient department (HOPD) or an
ambulatory surgical center (ASC), and in nonfacility settings, such as
a physician's office. The nonfacility RVUs reflect all of the direct
and indirect PEs involved in furnishing a service described by a
particular HCPCS code. The difference, if any, in these PE RVUs
generally results in a higher payment in the nonfacility setting
because in the facility settings some resource costs are borne by the
facility. Medicare's payment to the facility (such as the outpatient
prospective payment system (OPPS) payment to the HOPD) would reflect
costs typically incurred by the facility. Thus, payment associated with
those specific facility resource costs is not made under the PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA)
(Pub. L. 106-113, November 29, 1999) directed the Secretary of Health
and Human Services (the Secretary) to establish a process under which
we accept and use, to the maximum extent practicable and consistent
with sound data practices, data collected or developed by entities and
organizations to supplement the data we normally collect in determining
the PE component. On May 3, 2000, we published the interim final rule
(65 FR 25664) that set forth the criteria for the submission of these
supplemental PE survey data. The criteria were modified in response to
comments received, and published in the Federal Register (65 FR 65376)
as part of a November 1, 2000 final rule. The PFS final rules published
in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended
the period during which we would accept these supplemental data through
March 1, 2005.
In the CY 2007 PFS final rule with comment period (71 FR 69624), we
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for
CY 2010. In the CY 2010 PFS final rule with comment period, we updated
the practice expense per hour (PE/HR) data that are used in the
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010,
we began a 4-year transition to the new PE RVUs using the updated PE/HR
data, which was completed for CY 2013.
c. Malpractice RVUs
Section 4505(f) of the BBA `97 amended section 1848(c) of the Act
to require that we implement resource-based MP RVUs for services
furnished on or after CY 2000. The resource-based MP RVUs were
implemented in the PFS final rule with comment period published
November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and
physician-owned insurers' MP insurance premium data from all the
States, the District of Columbia, and Puerto Rico.
d. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no
less often than every 5 years. Prior to CY 2013, we conducted periodic
reviews of work RVUs and PE RVUs independently from one another. We
completed 5-year reviews of work RVUs that were effective for calendar
years 1997, 2002, 2007, and 2012.
Although refinements to the direct PE inputs initially relied
heavily on input from the RUC Practice Expense Advisory Committee
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to
the use of the updated PE/HR data in CY 2010 have resulted in
significant refinements to the PE RVUs in recent years.
In the CY 2012 PFS final rule with comment period (76 FR 73057), we
finalized a proposal to consolidate reviews of work and PE RVUs under
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued
codes under section 1848(c)(2)(K) of the Act into one annual process.
In addition to the 5-year reviews, beginning for CY 2009, CMS and
the RUC identified and reviewed a number of potentially misvalued codes
on an annual basis based on various identification screens. This annual
review of work and PE RVUs for
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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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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.
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We are not finalizing the recommended changes in expected specialty
assignment for the CPT codes in Table 3 associated with the thoracic
surgery specialty.
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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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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.
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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]]
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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]]
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[[Page 65024]]
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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
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[[Page 65035]]
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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]]
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[[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.
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[[Page 65050]]
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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.
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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]]
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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\
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\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.
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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\
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\2\ American Medical Association. (2020). CPT 2021 professional
edition. Chicago, Ill.: American Medical Association.
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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]]
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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
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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
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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.
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\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.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
F. Evaluation and Management (E/M) Visits
Over the past several years, CMS has engaged with the AMA and other
stakeholders in a process to update coding and payment for office/
outpatient evaluation and management (E/M) visits, with recent changes
taking effect January 1, 2021 (see 85 FR 84548 through 84574). In light
of these changes, we are engaged in an ongoing review of other E/M
visit code sets and 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.
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\22\ 2021 CPT Codebook, p.5.
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In the CY 2021 PFS final rule (85 FR 84549), we stated that we are
generally adopting the CPT E/M Guidelines for the new office/outpatient
E/M visit codes. However, the CPT E/M Guidelines do not address many
issues that arise in the context of PFS payment for split (or shared)
visits, such as which practitioner should report the visit when
elements of the visit are performed by different practitioners; whether
a substantive portion of the visit must be performed by the billing
practitioner; whether practitioners must be in the same group to bill
for a split (or shared) visit; or the settings of care where split (or
shared) visits may be furnished and billed. The CPT E/M Guidelines
simply state, ``A split or shared visit is defined as a visit in which
a physician and other qualified health care professional(s) jointly
provide the face-to-face and non-face-to-face work related to the
visit. When time is being used to select the appropriate level of
services for which time-based reporting of shared or split visits is
allowed, the time personally spent by the physicians and other
qualified health care professional(s) assessing and managing the
patient on the date of the encounter is summed to define total time.
Only distinct time should be summed for split or shared visits (that
is, when two or more individuals jointly meet with or discuss the
patient, only the time of one individual should be counted).'' \23\
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\23\ 2021 CPT Codebook, p.7.
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In contrast, to ensure appropriate PFS payment, our policy for
split (or shared) visits, as expressed in the recently withdrawn manual
provisions, is that the physician may bill for a split (or shared)
visit only if they perform a substantive portion of the visit, and the
practitioners must be in the same group and furnishing the visit in
specified settings in order to bill for a split (or shared) visit. Our
manual also limited billing for split (or shared) visits to services
furnished to established patients. In 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.
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\24\ 2021 CPT Codebook, p. 14.
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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.
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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.
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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.
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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\
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\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.
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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.
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\32\ Medicare Benefit Policy Manual (Pub. 100-04) Chapter 15,
Section 30.D.
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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\
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\33\ 2021 CPT Codebook (Evaluation and Management (E/M) Services
Guidelines), p.7.
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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\
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\34\ Medicare Claims Processing Manual (Pub. 100-02), Chapter
12, Section 30.6.5, Physicians In Group Practice.
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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\
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\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\
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\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.
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\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.
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\38\ 2021 CPT Codebook, p. 8, as clarified in the CPT 2021
Errata and Technical Corrections dated June 7, 2021 and available on
the AMA website at https://www.ama-assn.org/system/files/2021-06/cpt-corrections-errata-2021.pdf.
---------------------------------------------------------------------------
Comment: Several commenters urged CMS to make permanent beyond the
COVID-19 pandemic, the ability of teaching physicians to include in the
total time considered for visit level selection, their virtual presence
through audio/video, real-time communications technology, when billing
for office/outpatient E/M visits in residency training centers located
inside, as well as outside of a metropolitan statistical area (MSA).
Response: We appreciate the commenters' recommendation. However,
the issue of making the virtual presence flexibility permanent beyond
the COVID-19 pandemic and extending this flexibility to include
residency training centers located inside an MSA was not part of our
proposal for general primary care office/outpatient E/M visit level
selection.
Comment: A few commenters requested that CMS use ``provider-
neutral'' language in all regulatory rulemaking, including in the
definition of ``teaching physician services'' to reflect the full
spectrum of healthcare professionals delivering care to their
communities. A commenter encouraged CMS to clarify that physician
assistants (PAs) and advanced practice registered nurses (APRNs) can
count the total time they were present with residents, students, and
other trainees toward selecting the E/M visit level.
Response: Payment is made under the Medicare PFS for teaching
physicians' services as described in part 415 of our regulations. We
define a teaching physician in Sec. 415.152 as a physician other than
a resident who involves residents in the care of their patients.
Additionally, teaching physicians are involved in training residents as
part of an approved GME residency program in a teaching hospital, which
includes only programs in medicine, osteopathy, dentistry, or podiatry.
For each of these program areas under a GME residency program, section
1861(r) of the Act uses the term ``physician'' in connection with the
performance of any function or action by a doctor of medicine or
osteopathy, a doctor of dental surgery or dental medicine, and a doctor
of podiatric medicine. NPPs are not included under the statutory
definition of a physician.
After considering the public comments, we are finalizing our
proposal that only the teaching physician's total time is counted when
total time is used to determine the office/outpatient E/M visit level,
not including the time spent by the resident furnishing care without
the presence of the teaching physician. We are clarifying that only
time spent by the teaching physician performing qualifying activities
listed by CPT (with or without direct patient contact on the date of
the encounter), including time the teaching physician is present when
the resident is performing those activities, may be counted for
purposes of visit level selection. This excludes teaching time that is
general and not limited to discussion that is required for the
management of a specific patient.
b. Primary Care Exception Policy
The regulation at Sec. 415.174 sets forth an exception to the
conditions for PFS payment for services furnished in teaching settings
in the case of certain E/M services furnished in certain primary care
centers. Under the so-called ``primary care exception,'' Medicare makes
PFS payment in certain teaching hospital primary care centers for
certain services of lower and mid-level complexity furnished by a
resident without the physical presence of a teaching physician. We
expanded the list of services that residents could furnish without the
physical presence of the teaching physician for the duration of the PHE
to include all levels of an office/outpatient E/M visit, among other
services. Upon the conclusion of the PHE, levels 4-5 office/outpatient
E/M visits will no longer be included in the primary care exception (85
FR 84585 through 84590).
Section 415.174(a)(3) requires that the teaching physician must not
direct the care of more than four residents at a time, and must direct
the care from such proximity as to constitute immediate availability
(that is, provide direct supervision), and must review with each
resident during or immediately after each visit, the beneficiary's
medical history, physical examination, diagnosis, and record of tests
and therapies. Section 415.174(a)(3) also requires that the teaching
physician must have no other responsibilities at the time, assume
management responsibility for the beneficiaries seen by the residents,
and ensure that the services furnished are appropriate.
We proposed that under the primary care exception, only MDM can be
used to select office/outpatient E/M visit level. The intent of the
primary care exception as described in Sec. 415.174 is that E/M visits
of lower and mid-level complexity furnished by residents are simple
enough to permit a teaching
[[Page 65167]]
physician to be able to direct and manage the care of up to four
residents at any given time and direct the care from such proximity as
to constitute immediate availability. In the context of teaching
hospital primary care centers that are staffed by residents and
teaching physicians, we believe that MDM will be a more accurate
indicator of the complexity of the visit as opposed to time. Because
residents are in training, they may need more time than is reflected in
the code descriptor to furnish a visit that has a low-level of medical
decision making. For example, CPT code 99213 (Office or other
outpatient visit for the evaluation and management of an established
patient, which requires a medically appropriate history and/or
examination and low level of medical decision making. When using time
for code selection, 20-29 minutes of total time is spent on the date of
the encounter) involves a low level of MDM and between 20-29 minutes of
total time. If time was used for level selection instead of MDM, it is
possible that residents may need more than 20-29 minutes of time,
including any conferring with the teaching physician, to furnish CPT
code 99213. Thus, residents may be less efficient relative to a
teaching physician in furnishing care.
Office/outpatient E/M visits requiring 30 or more minutes of total
time are described by visit levels 4-5. After the expiration of the
COVID-19 PHE, office/outpatient levels 4-5 will no longer be included
in the primary care exception. In the CY 2021 PFS final rule, we
expressed concern that the teaching physician may not be able to
maintain sufficient personal involvement in all of the care to warrant
PFS payment for the services being furnished by up to four residents
when some or all of the residents might be furnishing services that are
more than lower and mid-level complexity. We noted that when the
teaching physician is directing the care of a patient that requires
moderate or higher medical decision-making, the ability to be
immediately available to other residents could be compromised,
potentially putting patients at risk (85 FR 84586). Thus, to guard
against the possibility of residents furnishing visits that are of more
than lower and mid-level complexity, we proposed that only MDM may be
used for office/outpatient E/M visit level selection for services
furnished by residents under the primary care exception.
We acknowledge that under the new CPT office/outpatient E/M visit
coding framework, it is possible that time is an accurate indicator of
the complexity of the visit. Thus, we solicited public comments on this
proposal, including our assumption that MDM is a more accurate
indicator of the appropriate level of the visit relative to time in the
context of the primary care exception for services furnished by
residents and billed by teaching physicians in primary care centers. We
also solicited comments on whether time is an accurate indicator of the
complexity of the visit and how teaching physicians might select
office/outpatient E/M visit level using time when directing the care of
a patient that is being furnished by a resident in the context of the
primary care exception.
We received public comments on the primary care exception policy.
The following is a summary of the comments we received and our
responses.
Comment: Most of the commenters support and concur with our
proposal to use medical decision making (MDM) only to select the visit
level for office/outpatient E/M visits under the primary care
exception.
Response: We appreciate the commenters' support for our approach.
Comment: Several commenters opposed our proposal to use MDM
exclusively to select the office/outpatient E/M visit level for
services furnished under the primary care exception. These commenters
were concerned that the exclusive use of MDM may create incentives for
physicians to quickly move residents from patient to patient, rather
than furnish the appropriate clinical care. They stated that without
evidence that MDM is a more accurate indicator than time in selecting
the E/M visit level under the primary care exception, both time and MDM
should be allowed as options for visit level selection. The commenters
noted that time spent by the teaching physician reviewing the chart,
looking at images, discussing with consultants, etc., should all still
count in determining the E/M level, just as it does in a non-teaching
situation.
Response: We acknowledge the commenters' opposition to our proposal
to allow MDM as the only option for E/M visit level selection under the
primary care exception. However, under our primary care exception
policy, we believe that using MDM to inform office/outpatient E/M visit
level selection rather than time is appropriate given our concerns
about the accuracy of counting time spent by residents in training to
inform office/outpatient E/M visit level selection. We believe that the
use of MDM is far more practical and less burdensome, because it allows
for the likelihood that residents in training might take more time to
perform services because they are potentially less efficient. As a
result, time is not necessarily an accurate reflection of the visit
level. Also, under the primary care exception, the teaching physician
is allowed to participate simultaneously in the services furnished by
up to four residents and bill separately for teaching physician
services under the PFS for each of these residents. Under these
circumstances, when a teaching physician must direct and manage the
care of up to four residents at a given time and direct the care from
such proximity as to constitute immediate availability, it is difficult
to discern which time should be counted.
Comment: We received some comments that are outside the scope of
the teaching physician proposals and comment solicitation we included
in the proposed rule. One of these comments stated that the increased
investment in primary care expected from the 2021 E/M visit code
revaluation has not materialized in many cases, expressing the view
that this is because the employers of many family physicians are not
reflecting the increased RVUs or Medicare payment allowances in their
employment contracts. The other commenter suggested that CMS should
adjust the values of the E/M postoperative visits included in the 10-
and 90-day global codes to reflect the 2021 updates to the office/
outpatient E/M code payment increases.
Response: We will not be addressing the concerns raised in these
comments in this final rule because they are not within the scope of
topics addressed in this CY 2022 PFS rulemaking.
After considering public comments, we are finalizing our proposal
that MDM is used to determine the visit level for office/outaptient E/M
visits furnished under the primary care exception.
G. Billing for Physician Assistant (PA) Services
Under the respective Medicare statutory benefit categories for the
services of PAs, nurse practitioners (NPs), and clinical nurse
specialists (CNSs), these nonphysician practitioners (NPPs) are
authorized to furnish services that would be physicians' services if
they were furnished by a physician, and which they are legally
authorized to perform by the State in which the services are furnished;
and such services that are provided incident to these NPPs'
professional services (but only if no facility or other provider
charges or is paid any amount for the services). Additionally, the
payment amount for the services of PAs, NPs, and CNSs, as specified
under section 1833(a)(1)(O) of
[[Page 65168]]
the Act, is equal to 80 percent of the lesser of the NPP's actual
charge or 85 percent of the amount that would be paid to a physician
under the PFS. However, while NPs and CNSs are authorized to bill the
Medicare program and be paid directly for their professional services,
section 1842(b)(6)(C)(i) of the Act has required since the inception of
the PA benefit (with a narrow exception not relevant here), that
payment for PA services must be made to the PA's employer. Accordingly,
our regulation at Sec. 410.74(a)(2)(v) specifies that PA services are
covered under Medicare Part B only when billed by the PA's employer.
Our regulation that addresses to whom Medicare Part B payment is made,
at Sec. 410.150(b)(15), further provides that payment is made to the
qualified employer of a PA, and specifies that the PA could furnish
services under a W-2 employment relationship, an employer-employee
relationship, or as an independent contractor through a 1099 employment
relationship. The regulation also specifies that a group of PAs that
incorporate to bill for their services is not a qualified employer.
Given the statutory requirement that we make payment to the PA's
employer, PAs are precluded from directly billing the Medicare program
and receiving payment for their services, and do not have the ability
to reassign Medicare payment rights for their services to any employer,
facility, or billing agent.
Section 403 of the Consolidated Appropriations Act, 2021 (CAA)
(Pub. L. 116-260, December 27, 2020), amended section 1842(b)(6)(C)(i)
of the Act to remove the requirement to make payment for PA services
only to the employer of a PA effective January 1, 2022. With the
removal of this requirement, PAs will be authorized to bill the
Medicare program and be paid directly for their services in the same
way that NPs and CNSs do. Effective with this amendment, PAs also may
reassign their rights to payment for their services, and may choose to
incorporate as a group comprised solely of practitioners in their
specialty and bill the Medicare program, in the same way that NPs and
CNSs may do. We note that the amendment made by section 403 of the CAA
changed only the statutory billing construct for PA services. It
changed neither the statutory benefit category for PA services,
including the requirement that PA services are performed under
physician supervision, at section 1861(s)(2)(K)(i) of the Act, nor the
statutory payment percentage applicable to PA services specified in
section 1833(a)(1)(O) of the Act. However, with the amendments to the
PA physician supervision requirement under Sec. 410.74(a)(2)(iv) made
beginning in CY 2020, PAs have flexibility to meet the statutory
physician supervision requirement through collaborating with physicians
and forming partnerships as long as this is in accordance with their
State scope of practice laws. Now that PAs are authorized to bill
Medicare directly, we believe that PAs will furnish more services under
collaborative relationships with physicians, likely in rural areas or
underserved communities where Medicare beneficiaries may have less
direct access to care by physicians because of a lack of physicians.
We proposed to amend pertinent sections of our regulations to
reflect the amendment made by section 403 of the CAA. Specifically, we
proposed to amend Sec. 410.74(a)(2)(v) to specify that the current
requirement that PA services must be billed by the PA's employer in
order to be covered under Medicare Part B is effective only until
December 31, 2021. We also proposed to amend Sec. 410.150(b) to
redesignate the current requirements in paragraph (b)(15) as Sec.
410.150(b)(15)(i), and to provide that Medicare payment is made for PA
services to the qualified employer of the PA for services furnished
prior to January 1, 2022. In Sec. 410.150, we further proposed to add
a new paragraph (b)(15)(ii) to state that, effective for services
furnished on or after January 1, 2022, payment is made to a PA for
their professional services, including services and supplies provided
incident to their services. We proposed to conform this new paragraph
with the regulation at Sec. 410.150(b)(16) regarding to whom payment
is made for NP or CNS services. As such, the new paragraph at Sec.
410.150(b)(15)(ii) would provide that payment is made to a PA for
professional services furnished by a PA in all settings in both rural
and non-rural areas; and that payment is made only if no facility or
other provider charges or is paid any amount for services furnished by
a PA. We would also update our program manual instructions to reflect
the statutory change made by section 403 of the CAA and the changes to
our regulations.
We received public comments on these proposals to amend the current
requirements. The following is a summary of the comments we received
and our responses.
Comment: Overall, the commenters supported this proposal that
authorizes PAs to bill the Medicare program and be paid directly for
their services. Commenters stated that this billing authorization
simplifies the billing process for PAs in that it does not tie billing
for PA services directly to employment which eliminates an
administrative burden for employers; and, it provides billing parity
between PAs and other NPPs such as NPs and CNSs, which may help to
increase access to PA services, particularly in rural areas.
Additionally, these commenters expressed their appreciation for this
new billing authority that makes PAs eligible for the option to
reassign payment for their services to their employer, independent
contractor, or group practice and, to incorporate as a group of PAs and
bill the Medicare program for PA services.
Response: We appreciate that commenters support the changes we
proposed to implement section 403 of the CAA effective January 1, 2022.
Comment: A few commenters opposed our proposals to implement
section 403 of the CAA. These commenters disapprove of the change to
the statutory billing construct that authorizes PAs to bill the
Medicare Part B program directly beginning January 1, 2022. Instead,
these commenters support continued third-party payment to the PA's
employer or independent contractor for PA services furnished
collaboratively with physicians to deliver care led by physicians in
integrated practice arrangements.
Response: While we appreciate the commenters' concerns, section 403
of the CAA amended the statute effective January 1, 2022. Our proposals
simply implement the amended Medicare law.
Comment: Several commenters expressed concerns that this direct
billing authority for PAs might undermine the proven physician-led-team
based care model under which PAs, NPs and CNSs are integral team
members, and instead encourage independent practice by these NPPs.
These commenters requested that CMS establish oversight of PA billing
practices to ensure that PAs are practicing in accordance with State
law and scope of practice rules; that quality of care for Medicare
beneficiaries is maintained; and, that the Medicare Trust Fund is
protected.
Response: We do not anticipate that this change will impact the
participation of NPPs as vital team members of physician-directed-team
care models, or otherwise diminish the quality of health care furnished
to Medicare beneficiaries. As provided in Medicare law at section
1861(s)(2)(K)(i) of the Act, PA services must be furnished under the
supervision of a physician and, also in our regulation at Sec.
410.74(a), PA services are covered
[[Page 65169]]
only when furnished in accordance with State law and scope of practice
rules.
Comment: One commenter suggested that allowing PAs to bill the
Medicare program directly would require updates to Medicare enrollment
and billing for PAs, and that the program should consider adopting a
grace period to allow CMS to implement revisions to the CMS-855I, CMS-
855R and related enrollment forms.
Response: We appreciate the concerns the commenter raised about the
time required to update necessary reassignment and enrollment forms.
However, we have prepared to update these forms to accommodate the
change to allow direct billing by PAs effective January 1, 2022.
After considering public comments, we are finalizing our proposals
to implement section 403 of the CAA as proposed.
H. Therapy Services
1. Payment for Outpatient PT and OT Services Furnished by Therapy
Assistants
We are implementing the third and final part of the amendments made
by section 53107 of the Bipartisan Budget Act (BBA of 2018) (Pub. L.
115-123, February 9, 2018). The BBA of 2018 added a new section 1834(v)
of the Act. Section 1834(v)(1) of the Act requires CMS to make a
reduced payment for physical therapy and occupational therapy services
furnished in whole or in part by PTAs and OTAs at 85 percent of the
otherwise applicable Part B payment for the service, effective January
1, 2022.
Section 1834(v)(2) of the Act requires that: (1) By January 1,
2019, CMS must establish a modifier to indicate that a therapy service
was furnished in whole or in part by a PTA or OTA; and, (2) beginning
January 1, 2020, each claim for a therapy service furnished in whole or
in part by a PTA or an OTA must include the modifier. Section
1834(v)(3) of the Act requires CMS to implement these amendments
through notice and comment rulemaking.
In the CY 2019 PFS final rule (83 FR 59654 through 59660), we
established the CQ and CO modifiers that were required to be used by
the billing practitioner or therapy provider to identify therapy
services provided in whole or in part by PTAs and OTAs, respectively,
beginning January 1, 2020. We require these payment modifiers to be
appended on claims for therapy services, alongside the GP and GO
therapy modifiers which are used to indicate the services are furnished
under a physical therapy or occupational therapy plan of care,
respectively. The payment modifiers are defined as follows:
CQ modifier: Physical therapy services furnished in whole
or in part by PTAs.
CO modifier: Occupational therapy services furnished in
whole or in part by OTAs.
In the CY 2019 PFS final rule (83 FR 59654 through 59660), we did
not finalize our proposed definition of ``furnished in whole or in part
by a PTA or OTA'' as a service for which any minute of a therapeutic
service is furnished by a PTA or OTA. Instead, in response to public
comments, we finalized a de minimis standard under which a service is
considered to be furnished in whole or in part by a PTA or OTA when
more than 10 percent of the service is furnished by the PTA or OTA.
In the CY 2019 PFS proposed and final rules (83 FR 35850 through
35852, and 83 FR 59654 through 59660, respectively), we explained that
the CQ and CO modifiers would not apply to claims for outpatient
therapy services that are furnished by, or incident to, the services
of, physicians or NPPs including NPs, PAs, and CNSs. This is because
our outpatient physical and occupational therapy services regulations
require that the individual who performs outpatient therapy services
incident to the services of a physician or NPP must meet the
qualifications and standards for a therapist (other than State
licensure). As such, only therapists, and not therapy assistants, can
perform outpatient therapy services incident to the services of a
physician or NPP (83 FR 59655 through 59656); and the modifiers to
describe services furnished in whole or in part by a PTA or OTA are not
applicable to the claim for a therapy service billed by a physician or
NPP incident to their professional services. We indicated that we would
add this distinction in the provision of the Medicare Benefit Policy
Manual (MBPM) Chapter 15 that discusses therapy services furnished
incident to the physician's or NPP's services at section 230.5, as well
as the sections that discuss PTA and OTA services at sections 230.1 and
230.2, respectively.
In the CY 2020 PFS proposed and final rules (84 FR 40558 through
40564 and 62702 through 62708, respectively), we explained that the CQ/
CO modifiers and the de minimis policy would apply to both untimed and
timed codes. The untimed codes are evaluation and reevaluation codes,
group therapy and supervised modalities, and when these are billed,
only one unit is reflected in the ``units'' portion of the claim. When
the PTA/OTA provides more than 10 percent of the service, the code is
billed with a CQ/CO modifier. For timed codes, that is, those codes
defined in 15-minute increments, the services are typically performed
in multiple units of the same and/or different codes for a patient on
one treatment day. We explained that under our policy, the therapist or
therapy assistant needs to find the total time of all these 15-minute
timed codes in order to determine the number of units that can be
billed for that day. For example, if the PT/OT and/or the PTA/OTA, as
appropriate, furnished between 8 minutes through 22 minutes, one unit
can be billed; if 23 minutes through 37 minutes are provided, 2 units
can be billed; if 38 minutes through 52 minutes are furnished, 3 units
can be billed. Once the total number of units to bill is determined,
the qualified professional (therapist or assistant) then needs to
decide whether the CQ/CO modifier is applicable.
In the CY 2020 PFS proposed rule (84 FR 40558 through 40564), we
proposed that the time the PTA/OTA spent together with the PT/OT in
performing a service, as well as the time the PTA/OTA spent independent
of the PT/OT treating the patient, is considered time for which the
service is furnished in whole or in part by the PTA/OTA. As explained
in the CY 2020 PFS final rule (84 FR 62702 through 62708), many
commenters objected to our proposal to include as time that the therapy
service is furnished ``in whole or in part'' by the PTA/OTA both the
minutes spent by the PTA/OTA concurrently with and separately from the
therapist. These commenters also expressed concerns that this policy
would unfairly discount services that are fully furnished by
therapists, and in which the therapy assistant supports them while they
provide a service. We were persuaded by commenters to finalize a policy
to not include as minutes furnished in whole or in part by a PTA/OTA
the minutes in which the PTA/OTA worked concurrently with the PT/OT. We
agreed with the commenters that when a therapy assistant and therapist
furnish care to a patient at the same time, the patient requires both
professionals, and this reflects a clinical scenario where the
assistant is helping the therapist to provide a highly skilled
procedure or one in which both professionals are needed for safety
reasons. We modified our proposed regulation text at Sec. Sec. 410.59
(outpatient occupational therapy), 410.60 (physical therapy), and
410.105 (for PT and OT Comprehensive
[[Page 65170]]
Outpatient Rehabilitation Facility (CORF) services) accordingly.
For purposes of deciding whether the 10 percent de minimis standard
is exceeded, we offered two different ways to compute this.
The simple method: Divide the total of the PTA/OTA + PT/OT
minutes by 10, round to the nearest integer then add 1 minute to get
the number of minutes needed to exceed the de minimis standard at and
above which the CQ/CO modifier applies.
The percentage method: Divide the PTA/OTA minutes by the
sum of the PTA/OTA and therapist minutes and then multiply this number
by 100 to calculate the percentage of the service that involves the
PTA/OTA, if this number is greater than 10 percent the CQ/CO modifier
applies.
Hypothetical examples of each of these methods are included later
in this section. In response to our proposal that all the units of one
service needed to be considered when determining if the de minimis is
applied, commenters requested that we consider each 15-minute unit
instead--noting that they would be able to apply the CQ/CO modifier on
one claim line for a service that was provided by the PTA/OTA and
report another claim line without the CQ/CO for the service provided by
the PT/OT. We were persuaded by stakeholders, and finalized a policy
under which the de minimis standard is applied for each 15-minute unit
of a service. This allows the separate reporting, on two different
claim lines, of the number of 15-minute units of a code to which the
therapy assistant modifiers do not apply, and the number of 15-minute
units of a code to which the therapy assistant modifiers do apply.
However, we neglected to modify the text of our regulations to reflect
this final policy for applying the de minimis standard; therefore, we
proposed to revise our regulation text to specify that the de minimis
rule is applied to each 15-minute unit of a service, rather than to all
the units of a service at Sec. Sec. 410.59(a)(4)(iii)(B),
410.60(a)(4)(iii)(B), and 410.105(d)(3)(ii). The specific revisions are
discussed below.
To recap, we finalized a de minimis standard to identify when the
CQ/CO modifiers apply and when they do not apply as follows:
Portions of a service furnished by the PTA/OTA independent
of the physical therapist/occupational therapist, as applicable, that
do not exceed 10 percent of the total service (or 15-minute unit of a
service) are not considered to be furnished in whole or in part by a
PTA/OTA, so are not subject to the payment reduction;
Portions of a service that exceed 10 percent of the total
service (or 15-minute unit of a service) when furnished by the PTA/OTA
independent of the therapist must be reported with the CQ/CO modifier,
alongside of the corresponding GP/GO therapy modifier; are considered
to be furnished in whole or in part by a PTA/OTA, and are subject to
the payment reduction; and
Portions of a service provided by the PTA/OTA together
with the physical therapist/occupational therapist are considered for
this purpose to be services provided by the therapist.
In the CY 2020 PFS proposed rule (84 FR 40558 through 40564), we
proposed to adopt a documentation requirement that a short phrase or
statement must be added to the daily treatment note to explain whether
the therapy assistant modifier was or was not appended for each therapy
service furnished. We also sought comment on whether it would be
appropriate to also require documentation of the minutes spent by the
therapist or therapy assistant along with the CQ/CO modifier
explanation as a means to avoid possible additional burden associated
with a contractor's medical review process conducted for these
services. Many commenters stated that: (1) The statute does not require
documentation to explain why a modifier was or was not applied for each
code; (2) the proposed documentation requirements are exceedingly
burdensome and conflict with the agency's ``Patients over Paperwork
Initiative''; (3) the proposed documentation requirement that calls for
a narrative phrase in the treatment note and requires documentation of
the minutes is duplicative of current requirements that requires adding
the total timed code minutes and total treatment time (includes timed
and untimed codes) to the daily treatment note; and, (4) the Medicare
Benefit Policy Manual (MBPM) already includes extensive documentation
requirements. In response to the feedback, we did not finalize the
proposed documentation requirement; nor did we finalize a requirement
that the therapist and therapy assistant minutes be included in the
documentation. Instead, we reminded therapists and therapy providers
that correct billing requires sufficient documentation in the medical
record to support the codes and units reported on the claim, including
those reported with and without an assistant modifier. Further, in
agreement with many commenters, we clarified that we would expect the
documentation in the medical record to be sufficient to know whether a
specific service was furnished independently by a therapist or a
therapist assistant, or was furnished ``in part'' by a therapist
assistant, in sufficient detail to permit the determination of whether
the 10 percent standard was exceeded.
In the CY 2020 PFS proposed rule, we also provided multiple typical
clinical billing scenarios to illustrate when the CQ/CO modifier would
and would not be applicable. Because these clinical scenarios did not
convey our finalized policies as modified in response to public
comments, we indicated in the CY 2020 PFS final rule that we would
provide further detail regarding the clinical scenario examples to
illustrate how to use the therapy assistant modifiers through
information we would post on the cms.gov website. We clarified that our
revised finalized policy applied generally in the same way as
illustrated in those examples, except for the difference in the minutes
of time that are counted toward the 10 percent standard (not counting
the minutes furnished together by a therapist and therapy assistant),
the application of the 10 percent standard to each billed unit of a
timed code rather than to all billed units of a timed code, and the
billing on two separate claim lines of the units of a timed code to
which the therapy assistant modifiers do and do not apply.
In early March 2021, we posted on our Therapy Services website at
https://www.cms.gov/Medicare/Billing/TherapyServices general guidance
on how to assign the CQ/CO modifiers for multiple billing scenarios. In
the guidance, we provided general examples for 8 different billing
scenarios in which multiple units of 15-minute codes are provided by
PTs/OTs and PTAs/OTAs and one billing example that used the untimed
code for group therapy performed for equal minutes by a PT and a PTA.
We noted that prior to applying our rules to determine appropriate
application of the CQ/CO modifiers, the PTA/OTA or PT/OT first needs to
determine how many 15-minute units can be billed in a single treatment
day for a patient. For information on this topic, we referred readers
to the chart in section 20.2.C of Chapter 5 of the Medicare Claims
Processing Manual (MCPM) that describes how to count minutes for timed
codes defined by 15-minute units, since the therapist or assistant
should use the same counting rule, commonly known as the ``8-minute
rule,'' that they have used previously.
Once the therapist or therapy assistant has identified the number
of 15-minute units that can be billed for a patient on
[[Page 65171]]
a single treatment day, we provided the following information to
clarify how to apply our policy for application of the CQ and CO
modifiers, as follows:
Step 1. Identify the Timed HCPCS Codes Furnished for 15 Minutes or
More: List the code numbers of each of the services furnished along
with the number of minutes in total done by the PT, PTA, OT, or OTA.
When a PT, PTA, OT, or OTA provides at least 15 minutes and less than
30 minutes of a service on a single treatment day, assign 1 unit; when
multiples of 15 minutes are furnished, for example, 30 minutes (assign
2 units) and 45 minutes (assign 3 units), etc. This needs to be the
first step whenever it is applicable to the billing scenario. When any
of these services, that is, full 15-minute increments, are provided by
a PTA/OTA, the CQ/CO modifiers apply.
Step 2. Identify Services for Which the PT/OT and PTA/OTA Provide
Minutes of the Same HCPCS Code: After applying Step 1, where
applicable, identify any minutes (including remaining minutes from Step
1) performed by a PT/OT and PTA/OTA for the same service/code. Add the
minutes furnished by the PT/OT and the PTA/OTA together, then divide
the total by 10 and round to the nearest integer--this is the 10
percent de minimis time standard. Then add 1 minute to get the fewest
number of minutes performed by the PTA/OTA that would exceed the 10
percent time standard for that service--if the PTA/OTA minutes meet or
exceed this number, the CQ/CO modifier would be appended. This is the
``simple'' method for calculating the de minimis number of minutes.
Step 3. Identify Services Where the PT/OT and PTA/OTA Furnish
Services of Two Different Timed HCPCS Codes: After applying Step 1 for
each service, compare the remaining minutes furnished by the PT/OT for
one service with the remaining minutes furnished by the PTA/OTA for a
different service. Assign the CQ/CO modifier to the service provided by
the PTA/OTA when the time they spent is greater than the time spent by
the PT/OT performing the different service. The CQ/CO modifier does not
apply when the minutes spent delivering a service by the PT/OT are
greater than the minutes spent by the PTA/OTA delivering a different
service.
Step 4. Identify the Different HCPCS Codes Where the PT/OT and the
PTA/OTA Each Independently Furnish the Same Number of Minutes: Once
Step 1 is completed for each service (when applicable), and when the
remaining minutes for each service--one provided by the PT/OT and the
other provided by the PTA/OTA--are the same, either service may be
billed. If the service provided by the PT/OT is billed, the CQ/CO
modifier does not apply. However, if the service provided by the PTA/
OTA is billed, the CQ/CO modifier does apply.
The below two examples are taken from our guidance on the CMS
website. These are examples of when the PT and PTA provide minutes of
the same service:
Example #1
PTA--23 minutes 97110
PT--13 minutes 97110
PT--30 minutes 97140
Total = 66 minutes--qualifies for billing 4 units (53 minutes through
67 minutes)
Billing Explanation:
First Step: Assign units to services based on those that
have at least 15 minutes or codes that were provided in multiples of 15
minutes. For 97110, assign one unit of 97110 with the CQ modifier
because the PTA furnished at least 15 minutes of 97110 (therapeutic
exercise). Then, assign two units of 97140 without the modifier,
because the PT furnished the full 30 minutes of manual therapy.
Second Step: Determine if the PTA furnished more than 10
percent of the remaining minutes of the 97110 service. To do this via
the simple method: Add the PTA's 8 remaining minutes to the PT's 13
minutes for a total time of 21 minutes. Divide the total by 10 to get
2.1 minutes and round to the nearest integer, which is 2 minutes (the
10 percent time standard for this service). Add 1 minute to find the
threshold number of minutes that would exceed the de minimis standard,
which in this example is 3 minutes. Using the percentage method, divide
the PTA's remaining 8 minutes by the total 21 minutes of the service (8
PTA + 13 PT = 21 minutes) to get 0.38, then multiply the result x 100 =
38 percent.
Final Step: Because 8 minutes meets or exceeds the 3-minute
threshold, and 38 percent is greater than 10 percent, a second unit of
97110 is billed with the CQ modifier.
Example #2
PTA--19 minutes of 97110
PT--10 minutes of 97110
Total = 29 minutes--two units of 97110 can be billed (23 minutes
through 37 minutes).
Billing Explanation:
First Step: Bill one unit of 97110 with the CQ modifier
because a full 15 minutes was provided by the PTA, with 4 minutes
remaining.
Second Step: Determine if the PTA's 4 remaining minutes
exceed the 10 percent de minimis standard. Simple method: Add together
the PTA's 4 remaining minutes and the 10 PT minutes to get the total
time of 14 minutes and divide by ten to get 1.4 minutes and round to
the nearest integer = 1 minute to get the 10 percent de minimis
standard. Then add 1 minute to get a threshold minimum of 2 minutes for
PTA time. If the PTA minutes are at or above the threshold, the CQ
modifier applies. Percentage method: Divide the PTA's 4 remaining
minutes by the total time of 14 to get 0.29 then multiply by 100 = 29
percent. If the resulting percentage is greater than 10 percent, the
PTA modifier applies.
Final Step: Bill another unit of 97110 with the CQ
modifier since 4 minutes is greater than the 2-minute threshold minimum
and 29 percent is greater than 10 percent.
After reviewing the information posted on the CMS Therapy Services
web page, therapy stakeholders reached out to CMS to express concern
that certain aspects of the billing scenarios described in the guidance
contradict their interpretation of our de minimis policy, especially as
it applies to a final unit of a multiple-unit timed service. The
therapy stakeholders suggested that the guidance we offered would lead
to confusion for the same-service billing scenarios (including examples
#1 and #2 above). We consider the unit of measure for a timed therapy
service code to be 15 minutes. In billing scenarios with multiple
units, we would consider the combined time for same or different
services in 15-minute unit increments.
The stakeholders agree that the de minimis standard is applied to
the last unit of a timed therapy service code in two separate cases.
The first case happens when the PTA/OTA and the PT/OT each furnish less
than 8 minutes for that final unit of a service. For example, if the
PTA/OTA provided 7 minutes and the PT/OT furnished 5 minutes--using the
simple method: 12 minutes divided by 10 equals 1.2, rounded to the
nearest integer is 1, plus 1 equals 2--if the PTA/OTA provides 2 or
more minutes, the CQ/CO modifier is applied. The second case occurs
when the PTA/OTA provides 8 or more minutes and the PT/OT furnishes
less than 8 minutes--in which event, the de minimis standard is
exceeded and the CQ/CO modifier is applied.
We note that the therapy stakeholders' interpretation of when the
de minimis policy applies for a final 15-minute unit of a multiple unit
timed service is based on what is commonly termed the ``8-minute rule''
which recognizes a unit of a 15-minute timed therapy service code
[[Page 65172]]
as 8 minutes (more than the midpoint of the service or 7.5 minutes),
but only when it applies to the final unit billed. Applied to the above
two examples, the stakeholders informed us that they believe the second
unit of CPT code 97110 in both examples should not be billed with an
assistant modifier because the therapist provided enough minutes of the
service on their own, that is, 8 minutes or more, to bill for the last
unit without the assistant's additional minutes. The stakeholders
indicated that the therapist would have a financial incentive to not
have the PTA/OTA provide the additional minutes at all if the CQ or CO
modifier would apply. We note that, in addition to the two cases
discussed above, there is another billing scenario to address in the
context of our de minimis policy--specifically, where the PT/OT and
PTA/OTA each furnish between 9 and 14 minutes of a 15-minute timed
service when the total time of therapy services furnished in
combination by the PTA/OTA and PT/OT is at least 23 but no more than 28
minutes, and there are two remaining units left to be billed. These
``two remaining unit'' cases with time ranges between 9 and 14 minutes
include the following PTA/OTA:PT/OT (or vice versa) time splits: 9:14,
10:13, 11:12, 12:12, 12:13, 12:14, 13:13; 13:14; and 14:14.
We believe that the stakeholder's interpretation of the de minimis
standard is not consistent with the de minimis policy we finalized in
the CY 2020 PFS final rule (84 FR 62702 through 62708). However, in
working through the billing scenarios with the stakeholders, we
identified where we could make refinements to our policy to address
some of the confusion and concerns expressed by stakeholders and to
address the ``two remaining unit'' cases noted above. These refinements
may also avoid implementing a payment policy that could be perceived to
penalize the provision of additional care by a therapy assistant when
those minutes of service would lead to a reduced payment for a unit of
a service. The stakeholders criticized the finalized de minimis policy
because they believed it provides an inherent financial incentive for
the therapist to ensure that PTAs/OTAs provide services in exactly 15-
minute intervals--to avoid any leftover PTA/OTA minutes that could
necessitate application of the CQ/CO modifier, and reduced payment, for
the service that the therapist is also providing--without regard to the
clinical needs of the individual patient. The stakeholders suggested
that if we were to recognize their ``8-minute rule'' and recommended
policy, we would remove the incentive for the therapist to avoid
providing appropriate minutes of therapy services performed by the PTA/
OTA.
To address the concerns expressed by the stakeholders and the ``two
remaining unit'' cases we identified in our review, we proposed to
modify our existing policy, specifically for billing scenarios when
only one unit of a timed therapy service remains to be billed (the
majority of all billing scenarios) and the ``two remaining unit'' cases
described above. As shown in Table 28, this policy requires the
application of the CQ/CO modifier when the PTA/OTA provides at least 8
minutes or more and the PT/OT provides less than 8 minutes of the
service; or, when both the PT/OT and the PTA/OTA provide less than 8
minutes of the same service.
[GRAPHIC] [TIFF OMITTED] TR19NO21.050
Under this modification, the CQ/CO modifier would not apply when
the PT/OT furnishes 8 minutes or more, or both the PT/OT and the PTA/
OTA furnish 8 minutes or more, of a timed service. This ``midpoint
rule'' policy was suggested to us by the therapy stakeholders. We agree
that since, in this circumstance, the PT/OT provided enough minutes of
the service on their own to bill the last unit of the service, the
additional minutes of service performed by the PTA/OTA are not
material, and thus, should be disregarded, as shown in the examples in
Table 29.
[GRAPHIC] [TIFF OMITTED] TR19NO21.051
[[Page 65173]]
With these policy adjustments, the CQ/CO modifiers apply when the
PTA/OTA provides all the minutes of a timed service, and to some
services (as illustrated in Table 28) when the PTA/OTA and PT/OT each,
independent of the other, furnish portions of the same timed service.
The CQ/CO modifiers also apply if the portion of an untimed code
furnished by the PTA/OTA exceeds the de minimis standard. The CQ/CO
modifiers do not apply when the PTA/OTA and the PT/OT furnish different
services. Time spent by the PT/OT and PTA/OTA providing services
together is considered time spent by the PT/OT for purposes of applying
the de minimis standard. Finally, we proposed to modify our policy so
that the CQ/CO modifiers would not apply when the PT/OT provides enough
minutes of the service on their own to bill for the last unit of a
timed service, (more minutes than the midpoint or 8 minutes of a 15-
minute timed code) regardless of any additional minutes for the service
provided by the PTA/OTA.
Examples of Billing Scenarios using the CQ/CO modifiers when the de
minimis standard applies, and the proposed policy for the last billed
unit of a service:
Example #A
PTA--10 minutes of 97110
PT--5 minutes of 97110
Total = 15 minutes--qualifies to bill one 15-minute unit (8 minute to
22 minutes).
Analysis: Bill one unit of 97110 with the CQ modifier because the
PTA provided 8 minutes or more and the PT provided less than 8 minutes.
The de minimis standard applies in these cases.
Example #B
PTA--5 minutes of 97110
PT--6 minutes of 97110
Total = 11 minutes--qualifies to bill one 15-minute unit (8 minute
through 22 minutes).
Analysis: Bill one unit of 97110 with the CQ modifier because the
PTA and the PT both provided less than 8 minutes. In this case, the PT
provided 6 minutes and the PTA furnished 5 minutes independent of each
other. The de minimis standard applies in these cases.
Example #C
PTA-22 minutes of 97110
PT--23 minutes of 97110
Total = 45 minutes--qualifies to bill three 15-minute units (38 minutes
through 52 minutes).
Analysis:
Apply Step One of the general policy rules and bill one
unit of 97110 with the CQ modifier because the PTA provided 15 full
minutes with 7 minutes remaining.
Apply Step One to the PT's 23 minutes and bill one unit
without the assistant modifier with 8 minutes remaining.
The third unit of 97110 is billed without the assistant
modifier because the therapist provided enough minutes (8 or more
minutes) without the PTAs minutes to bill the final unit.
Example #D--Also See the Below Regulatory Proposal Using This `Two
Remaining Unit' Example
PT--12 minutes of 97110
PTA--14 minutes of 97110
PT--20 minutes of 97140
Total = 46 minutes--qualifies to bill three units (38 minutes through
52 minutes)
Analysis:
Apply Step One of the general policy rules and bill one
unit of 97140 without the CQ modifier because the PT provided 15 full
minutes of one unit with 5 minutes remaining.
Two units remain to be billed and the PT and the PTA each
provided between 9 and 14 minutes independent of one another with a
total time between 23 and 28 minutes--in these ``two remaining unit''
scenarios, one unit is billed with the CQ modifier for the PTA and the
other unit is billed without it for the PT.
The PT's 5 remaining minutes of 97140 are counted towards
the total timed minutes but are not billable in this scenario.
Example #E
OTA--11 minutes of 97535
OT--11 minutes of 97530
Total = 22 minutes--qualifies to bill one (1) unit (8 minutes through
22 minutes)
Billing Analysis: Since two different services were furnished for
an equal number of minutes--the ``tie-breaker'' scenario applies.
Either code 97530 by the OT or code 97535 by the OTA can be billed in
accordance with a billing example in the MCPM, Chapter 5, section
20.2.C. Either one unit of 97530 is billed without the CO modifier or
one unit of 97535 is billed with the CO modifier.
Example #F: Untimed Code--1 Unit Is Billed for All Untimed Codes
Including Evaluations, Reevaluations, Supervised Modalities, and Group
Therapy
OTA--20 minutes 97150 independent of the OT
OT--20 minutes 97150 independent of the OTA
Total = 40 minutes of Group Therapy = 1 unit of 97150 is billed for
each group member
Billing Analysis: One unit of group therapy 97150 is billed with
the CO modifier because the OTA provided more than the 10 percent time
standard in this example. Either method can be used to determine if the
OTA's time exceeded the 10 percent time standard for this clinical
scenario, see below:
The simple method: First add the OTA's 20 minutes to the
OT's 20 minutes to get 40, then divide by 10 to get 4.0 and add 1 to
equal 5 minutes. The OTA's 20 minutes is equal to or greater than 5
minutes so the CO modifier is required on the claim.
The percentage method: Divide the number of minutes that
an OTA independently furnished a service by the total number of minutes
the service was furnished as a whole--20 divided by 40 equals 0.50.
Then multiple by 100 to get 50 percent, which is greater than 10
percent. The CO modifier is applied to 97150.
Tie breaker: The tie breaker does not apply in this
scenario because the example does not contain two different timed codes
described in 15-minute intervals. For ``tie breaker'' see Example #F
above.
As noted above and illustrated in Example #D, there are a finite
number of cases where there are two 15-minute units left to bill. In
these ``two remaining unit'' cases, the PTA/OTA and the PT/OT each
provide between 9 and 14 minutes with a total time of at least 23
minutes through 28 minutes. Under our proposed policy, one unit of the
service would be billed with the CQ/CO modifier for the minutes
furnished by the PTA/OTA (who furnished between 9 and 14 minutes of the
service), and one unit would be billed without the CQ/CO modifier for
the service provided by the PT/OT (who also furnished between 9 and 14
minutes of the same service). This is because the PTA/OTA and the PT/OT
each independently furnished part of each unit of the same service, and
these cases are not addressed by the proposed midpoint rule that would
apply when there is only one single unit left to bill. We proposed to
amend our regulation to address the scenario where there are two
remaining 15-minute units of the same service for which the PTA/OTA and
the PT/OT each provided between 9 and 14 minutes with a total time of
at least 23 minutes and no more than 28 minutes. In this scenario, we
proposed that one unit of the service will be billed with the CQ/CO
modifier and the other unit of the service will be billed without
[[Page 65174]]
the assistant modifier. We proposed to add this policy to our
regulations at Sec. Sec. 410.59(a)(4)(v) and 410.60(a)(4)(v) for
outpatient occupational therapy and physical therapy services,
respectively and at Sec. 410.105(d)(3)(iv) for CORF services.
As noted previously, when we finalized the policy to consider each
15-minute unit of a service for purposes of determining whether the de
minimis standard applies, we neglected to revise our regulations at
Sec. Sec. 410.59, 410.60 and 410.105 to reflect this change. As such,
we proposed to amend the regulations at Sec. Sec. 410.59(a)(4)(iii)(B)
and 410.60(a)(4)(iii)(B) for outpatient occupational therapy and
physical therapy services, respectively, and at Sec. 410.105(d)(3)(ii)
for CORF services to specify that we consider a service to be furnished
in part by a PTA or an OTA when the PTA/OTA furnishes a portion of a
service, or in the case of a 15-minute timed code, a portion of a unit
of a service, separately from the portion of the service or unit of
service furnished by the therapist such that the minutes for that
portion of a service or a unit of a service furnished by the PTA/OTA
exceed 10 percent of the total minutes for that service or unit of a
service.
To accommodate the proposed refinement of the de minimis policy, we
proposed to amend the same regulations at Sec. Sec. 410.59(a)(4)(iv)
and 410.60(a)(4)(iv) for outpatient occupational therapy and physical
therapy services, respectively, and at Sec. 410.105(d)(3)(iii) for
CORF services to provide that, for the final 15-minute unit billed for
a patient for a date of service, when the PT/OT provides more than the
midpoint (at least 8 minutes) of a service such that they could bill
for the service without any additional minutes being furnished by the
PTA/OTA, the service may be billed without a CQ or CO modifier, and any
remaining minutes of service furnished by the PTA/OTA are considered
immaterial.
Beginning January 1, 2022, therapy services furnished in whole or
in part by a PTA or OTA will be identified based on the inclusion by
the billing therapy services provider (whether a therapist in private
practice or therapy provider) of the CQ or CO modifier, respectively,
on claim lines for therapy services, and the payment for those services
will be adjusted as required by section 1834(v)(1) of the Act. Per our
usual system update process, we plan to issue instructions in a change
request to prepare our shared systems and Medicare Administrative
Contractors (MACs) to pay the reduced amount for therapy services
furnished in whole or in part by a PTA or OTA. We will issue a Medlearn
Learning Network[supreg] (MLN) article once the CR is released, after
the CY 2022 PFS final rule is issued.
When we identified a limited number of cases in which there are two
15-minute units left to bill and the PTA/OTA and the PT/OT each provide
between 9 and 14 minutes with a total time of 23 through 28 minutes,
where we proposed that one unit is billed with an assistant modifier
and one unit is billed without it, we have identified four additional
examples of PTA/OTA:PT/OT (or vice versa) time splits that we would
like to acknowledge--these instances include 10:14, 11:13, 11;14, and
13:12. The full complement of these time splits are: 9:14, 10:13,
10:14, 11:12, 11:13, 11:14, 12:12, 12:13, 12:14, 13:12, 13:13, 13:14,
and 14:14.
We are making a technical correction to the proposed regulation
text at Sec. 410.105(d)(3)(iii) that appeared in the CY 2022 PFS
proposed rule, to remove an extra parenthesis ``('' as it appeared in
``((ii)'' so that the CORF regulation at Sec. 410.105(d)(3)(iii)
correctly reads as ``(iii) Paragraph (d)(3)(ii)''.
We solicited comment on all of our proposals.
We received over 12,000 public comments on our proposals. The
following is a summary of the comments we received and our responses.
Comment: Many commenters, including the major therapy stakeholders,
expressed appreciation that we updated the interpretation of the de
minimis standard to take into account the ``8-minute rule'' for the
final unit billed. One commenter conveyed their belief that this policy
is sound and will ensure that therapists and therapy providers are not
paid less for providing more care. A few commenters also supported our
explanation and proposal to bill one unit of a service with the CQ/CO
modifier and one unit without a CQ/CO modifier when the PTA/OTA and the
PT/OT each provide between 9 and 14 minutes of a 15-minute timed
service with a total time of 23 to 28 minutes where there are two units
left to bill.
Response: We appreciate that commenters are supportive that we
revised our de minimis policy in response to specific requests from the
major therapy stakeholders regarding the ``8-minute rule'' for the
final unit billed; and, thank the commenter for their remark about the
soundness of this policy that permits therapists and therapy providers
to furnish proper care without being paid less for the service. We also
appreciate that others specifically supported our proposal to further
refine our de minimis policy for those limited number of cases where
there are 2 15-minute units remaining to be billed.
Comment: Many commenters supported and welcomed the refinement to
the de minimis standard; however, many others requested that CMS delay
implementation of the therapy assistant payment policy until CY 2023 so
that: (a) Therapists and therapy assistants would have the time to
implement the final policy changes; (b) we have additional time to
provide education and technical assistance to providers on what some
term as a complex policy; (c) electronic medical record (EMR) vendors
have time to program, test, and finalize their systems; and (d)
therapists in private practice and therapy providers have time to
recover financially from the coronavirus pandemic. We also received
several positive comments regarding the implementation of the therapy
assistant payment policy, effective January 1, 2022.
In requesting the one-year delay of the 15 percent payment
reduction for services furnished in whole or in part by PTAs, one
commenter noted that the reduction alone would be a challenge in non-
pandemic times, and stated that the total reduction in payment to
physical therapists and therapy providers will total nearly 28 percent
in the midst of the ongoing pandemic. The commenter described the
nearly 28 percent reduction as the cumulative 27.75 percent reduction
in payment that includes the 15 percent reduction for services
furnished in whole or in part by PTAs, plus the 3.75 percent reduction
in Medicare payment, and a 7 percent (on average) reduction in payment
due to the MPPR, and the 2 percent Medicare sequester that is scheduled
to return in CY 2022. The commenter cited these reductions in
combination with the ongoing effects of the PHE for COVID-19 as support
to delay the implementation of the 15 percent PTA payment differential
until January 1, 2023.
Response: We are not able to change the implementation date as the
statute at section 1834(v)(1) of the Act specifies that the payment
adjustment for physical therapy and occupational therapy services
furnished in whole or in part by PTAs and OTAs begins January 1, 2022.
The revision we proposed to incorporate, the ``8-minute rule'' for the
final 15-minute unit billed, according to discussions with the major
therapy association stakeholders, reflects typical billing for some
private insurers. We plan to add billing scenarios to our Therapy
Services website located at https://www.cms.gov/Medicare/Billing/TherapyServices that
[[Page 65175]]
are similar to or the same as the above Billing Scenarios #A through #F
we discussed in the proposed rule. We will also include the general
rules and steps involved with applying these rules to the various
billing scenarios.
Comment: A majority of commenters asked that we provide an
exemption of the 15 percent payment differential for rural and
underserved areas, where they stated that a disproportionate amount of
therapy services are provided by OTAs and PTAs. Some of these
commenters noted that physical and occupational therapists, together
with their therapy assistants, work as teams to play a critical role in
assisting access to care in rural areas where they report a shortage of
therapists exist.
One commenter told us that implementing the payment differential
for services provided in whole or in part by PTAs and OTAs in January
2022 will further increase existing health disparities in rural areas.
The commenter stated that they agree with the two mechanisms that were
recommended by congressional members in a May 14, 2021 letter to help
mitigate potential harm to rural beneficiaries from the 15 percent
payment reduction for PTA/OTA services. Although the letter containing
the recommendations from congressional members was not submitted as a
comment to our CY 2022 PFS proposed rule, we note that the
recommendations are the same as those that the commenter shared
directly with us as a public comment to the CY 2020 PFS proposed rule.
Those recommendations were for us to use our discretionary authority to
help mitigate potential harm to rural beneficiaries from the 15 percent
payment reduction for PTA/OTA services through one of two means based
on provisions of section 1848 of the Act: (a) Create a class-specific
geographic index for physical and occupational therapy services
furnished by PTAs and OTAs; or (b) establish incentive payments for RVU
data collected from physical and occupational therapists practicing in
rural areas.
Response: While we empathize with commenters about a shortage of
therapists and other healthcare workers in rural areas, section
1834(v)(1) of the Act does not provide us with statutory authority to
exempt rural areas or other underserved areas from the 15 percent
payment differential for therapy services provided in whole or in part
by PTAs and OTAs. The suggested methods to mitigate the effects of the
reduced payment amounts involving section 1848 of the Act cannot be
used to supersede the requirements of section 1834(v)(1) of the Act
that requires CMS to make the reduced payment for physical and
occupational therapy services furnished in whole or in part by PTAs and
OTAs in all areas at 85 percent of the otherwise applicable PFS amount.
We are hopeful that the revised de minimis standard will improve the
access issues in rural areas and underserved communities.
Comment: Many commenters requested that we change the requirement
that PTs and OTs provide direct supervision of PTAs and OTAs in the
private practice setting, claiming that the requirement is burdensome
and inconsistent with CMS supervision requirements in all other
settings where general supervision is allowed. Many commenters stated
that the direct supervision requirement is more restrictive than the
majority of State practice acts for physical and occupational
therapists, does not allow therapists to practice within the full scope
of their license, and that this impedes employment opportunities for
PTAs and OTAs. Commenters also told us that changing the private
practice direct supervision requirement to general supervision that
allows audio-only contact between the PT/OT and the PTA/OTA,
respectively, would also help to ensure continued patient access to
needed therapy services, especially in rural and underserved areas
where beneficiaries rely on assistant services to access therapy,
assist in the ongoing recovery from the COVID-19 pandemic, and provide
support for small outpatient therapy businesses that are facing the 15
percent cut to services provided by therapist assistants beginning in
CY 2022. Many commenters informed us that they would support
permanently allowing direct supervision via audio/video communications
that they have appreciated using during the PHE, if we could not change
the direct supervision requirement to general; however, they also
reminded us to consider that some patients in rural and underserved
areas may not have access to broadband, which may not allow patients to
receive therapy services in their homes under this requirement.
Response: We did not address supervision requirements for PTAs and
OTAs in the CY 2022 PFS proposed rule. As such, it would not be
appropriate to modify those requirements in this final rule. We also
received other comments raising issues that were well outside the scope
of the issues we discussed in the CY 2022 PFS proposed rule, and for
that reason, we decline to address those comments here.
While we are still reviewing the comments received in response to
our comment solicitation about whether the flexibility we adopted to
permit direct supervision through virtual presence should be continued,
as discussed in section II.D. of this final rule, we want to
acknowledge that the virtual presence definition for direct supervision
is effective until the later of the end of the calendar year in which
the PHE ends or December 31, 2021. The presence of the supervising
practitioner includes virtual presence through audio/video, real-time
communications technology (excluding audio-only). This allows the
private practice therapist to provide direct supervision of therapy
assistants through virtual presence via real-time audio/video
communications technology (excluding audio-only).
Comment: Several commenters requested that we confirm the order of
claims processing for therapy services billed with a CQ or CO modifier.
Some questioned whether the 15 percent reduction is taken before or
after the therapy MPPR. While some commenters thanked us for clarifying
in the proposed rule that the 15 percent reduction for PTA/OTA services
does not impact the beneficiary's 20 percent coinsurance, two
commenters requested that we verify that the 20 percent beneficiary
copay was not impacted, as they believed was suggested by the
ratesetting formula we used to estimate the volume discount factor of
88 percent for services provided by PTAs and OTAs billed with a CQ or
CO modifier that appeared in the PE section of the CY 2022 PFS proposed
rule (86 FR 39112).
Response: In the CY 2022 PFS proposed rule (86 FR 39112), we
clarified that the 15 percent payment reduction applicable to some PTA/
OTA services applies to the 80 percent of the lesser of the actual
charge or applicable fee schedule amount and that the remaining 20
percent is the beneficiary copayment. We explained that for therapy
services to which the 15 percent reduction applies, payment will be
made at 85 percent of the 80 percent of allowed charges, or 68 percent
of allowed charges. We confirm that the beneficiary's copayment for a
therapy service is deducted right after the application of the MPPR to
the PE payment. CMS applies the MPPR to ``always therapy'' codes (as
explained below), which occurs right before the 15 percent reduction is
applied to 80 percent of the lesser of the actual charge or applicable
fee schedule amount for claims with a CQ or CO modifier.
For the majority of therapy claims, the beneficiary copay is less
than the 20
[[Page 65176]]
percent PFS allowed amount because it is always determined after the
application of the therapy MPPR that applies to all ``always therapy''
codes. ``Always therapy'' codes include almost all therapy applicable
codes in the Physical Medicine and Rehabilitation section of the 2021
CPT Professional Codebook with the exception of the codes for active
wound care management (which are not ``always therapy'' codes). When
therapy claims have more than one unit of a service or two or more
``always therapy'' codes, and they also have a CQ or CO modifier for
each unit or code, the beneficiary's deductible (where it applies) is
calculated first, then the MPPR is applied to the PE payment, and then
the 20 percent coinsurance is deducted, as per the usual process. After
that, the 15 percent reduction is taken for PTA/OTA services, followed
by the 2 percent sequestration that is always last (when applicable).
Comment: We received many comments objecting to our determination
(see section II.E.37. of this final rule) that physical therapists are
not able to bill for the Remote Therapeutic Monitoring (RTM) codes
because services cannot be billed incident to the services of a
physical therapist (86 FR 39173 through 39174). The commenters maintain
that, when billed by physical therapists, the RTM services would not be
considered ``incident to'' as they are when billed by physicians. The
commenters urged us to reconsider our interpretation of the RTM codes
to permit physical therapists to bill and be paid for these services.
Response: The RTM codes addressed in section II.E.37. of this final
rule were intended to be furnished by physical therapists and other
practitioners who do not bill for E/M visits. (Please see section
II.E.37. of this final rule for full discussion of the RTM codes and
their use by therapists.) Payment for these RTM codes is being
finalized for CY 2022, and we are now designating the five RTM CPT
codes as ``sometimes therapy'' codes. (Please refer to section II.E.37.
of this final rule for the discussion on code valuation for these RTM
services.) As sometimes therapy codes, the RTM services can be billed
outside a therapy plan of care when provided by a physician and certain
NPPs, but only when appropriate. While therapists' services must always
be provided under therapy plans of care, RTM services that relate to an
RTM device that is specific to therapy services, such as the ARIA
Physical Therapy device supply in CPT code 98977, must also be
furnished under a therapy plan of care when furnished by physicians and
NPPs. RTM services must be provided under direct supervision when not
directly performed by physicians, NPPs, or therapists; and RTM services
delegated by PTs and OTs to PTAs and OTAs, respectively, are subject to
the de minimis standard.
The RTM codes we are finalizing as described in section II.E.37. of
this final rule include two 20-minute codes, which is a different time
interval from the existing 15-minute timed therapy codes. To
accommodate the two 20-minute CPT codes 98980 and 98981 under our de
minimis policy, we are making a technical amendment to the regulatory
text to recognize this 20-minute time interval (or any other potential
time intervals that may arise in the future) as an ``other time
interval.'' Specifically, we will add ``or other time interval'' after
the ``15-minute'' term in our de minimis regulations at Sec. Sec.
410.59(a)(4)(iii)(B) (for outpatient occupational therapy),
410.60(a)(4)(iii)(B) (for outpatient physical therapy) and
410.105(d)(3)(ii) for CORF physical and occupational therapy services.
We are also providing a billing example to illustrate how the de
minimis standard would be applied for the RTM treatment management
services that describe the interactive communications between the
therapist and/or therapy assistant and the patient/caregiver during the
calendar month. CPT code 98980 represents the first 20 minutes provided
in the month while CPT code 98981 reflects each additional full 20-
minute unit, so the midpoint rule is not applicable to these codes.
Billing Scenario #AA: The PT and PTA independently provide a total
of 80 minutes of RTM services during the month.
For purposes of billing 98980: The first full 20 minutes were
provided by the PT--therefore, CPT code 98980 is billed without a CQ
modifier.
For purposes of bulling CPT code 98981, the remaining 60 minutes
qualifies for billing three 20-minute units, they were furnished as
follows:
PTA--23 minutes of 98981
PT--37 minutes of 98981
Total = 60 minutes of 98981 (qualifies to bill three 20-minute units)
Billing Analysis: The 60 total minutes allows three full 20-minute
units of CPT code 98981 to be billed:
One unit is billed with the CQ modifier for 20 minutes of
the 23 minutes provided by the PTA (with 3 minutes leftover).
One unit is billed without the CQ modifier for the PT's 20
minutes of the 37 minutes--(with 17 minutes left over).
The final 20-minute unit is billed with a CQ modifier
because the PTA's 3 minutes is greater than 10 percent of the 20-minute
total--that is, 3 minutes divided by 20 equals 15 percent which is
greater than the 10 percent standard of 2 minutes.
The two device codes, CPT codes 98976 and 98977, are not subject to
the de minimis standard, but, the devices' initial set up and patient
education on its use represented by CPT code 98975 is subject to the de
minimis policy as an untimed code.
Comment: We heard from many commenters on issues of interest to
PTs, OTs, and SLPs, most relating to services included on the Medicare
telehealth services list that are primarily provided by PTs, OTs, and
SLPs (see section II.D. of this final rule). We also received several
comments addressing issues other than those related to the reduced
payment for services furnished in whole or in part by a PTA/OTA, such
as requests to modify the plan of care certification requirement and
recognize PTs as eligible to furnish and bill the CPT codes 20560 and
20561 for needle insertion without injection--a prohibition that falls
under the Acupuncture NCD (NCD 30.3.3).
Response: These comments are outside of the scope of policies
addressed in the CY 2022 PFS proposed rule, and therefore, we decline
to address the comments here.
After consideration of public comments, we are implementing the
final requirement of the amendments made by section 53107 of the BBA of
2018 to make payment for physical and occupational therapy services
furnished in whole or in part by PTAs and OTAs at 85 percent of the
otherwise applicable PFS payment amount for dates of service on and
after January 1, 2022. We are finalizing our regulations as proposed at
Sec. Sec. 410.59(a)(4)(iii)(B) and 410.60(a)(4)(iii)(B) for outpatient
occupational and physical therapy services, respectively, and at Sec.
410.105(d)(3)(iii) for CORF occupational and physical therapy services
to specify that the de minimis rule is applied to each 15-minute unit
of a service, rather than to all the units of a service. We are also
finalizing amendments to these sections of the regulations to account
for the 20-minute codes for RTM services--specifically we are adding
the phrase ``or other timed'' after ``each 15-minute'' and before
``unit'' such the phrase will correctly read as ``to specify that the
de minimis rule is applied to each 15-minute or other timed unit of a
service.'' We are also finalizing our regulations as proposed at
Sec. Sec. 410.59(a)(4)(iv) and
[[Page 65177]]
410.60(a)(4)(iv) for outpatient occupational and physical therapy
services, respectively, and at Sec. 410.105(d)(3)(ii) for CORF
occupational and physical therapy services to note that the de minimis
rule is not applied when the OT/PT provides more than the midpoint of a
15-minute timed code, that is, 8 or more minutes, regardless of any
minutes for the same service furnished by the OTA or PTA. We are also
finalizing our regulations as proposed at Sec. Sec. 410.59(a)(4)(v)
and 410.60(a)(4)(v) for outpatient occupational and physical therapy
services, respectively, and Sec. 410.105(d)(3)(iv) for CORF services
to clarify the two remaining unit scenarios, to allow one unit to be
billed with a CO/CQ modifier and the other unit to be billed without
the CO/CQ modifier when the OTA/PTA and the OT/PT each provide between
9 and 14 minutes, independent of one another, with a total time between
23 and 28 minutes. We plan to add Billing Scenarios to our Therapy
Services website located at https://www.cms.gov/Medicare/Billing/TherapyServices that are similar to or the same as the above Billing
Scenarios #A through #F that we discussed in the proposed rule. We plan
to add a de minimis example of the 20-minute RTM services defined by
CPT codes 98980 and 98981. We will also include the general rules and
steps involved with applying the rules to the various billing
scenarios.
2. Therapy KX Modifier Threshold Amounts
The KX modifier thresholds were established through section 50202
of the Bipartisan Budget Act (BBA) of 2018. Formerly referred to as
therapy caps, these KX modifier thresholds are a permanent provision of
the statute, meaning that the statute does not specify an end date.
These per-beneficiary amounts under section 1833(g) of the Act (as
amended by section 4541 of the Balanced Budget Act of 1997) (Pub. L.
105-33, August 5, 1997) are updated each year based on the Medicare
Economic Index (MEI). Specifically, these amounts are calculated by
updating the previous year's amount by the MEI for the upcoming
calendar year and rounding to the nearest $10.00. Increasing the CY
2021 KX modifier threshold amount of $2,110 by the CY 2022 MEI of 2.1
percent and rounding to the nearest $10.00 results in a CY 2022 KX
threshold amount of $2,150 for PT and SLP services combined and $2,150
for OT services.
Section 1833(g)(7)(B) of the Act was also added by section 50202 of
the BBA of 2018 and it retains the targeted medical review process, but
at a lower threshold amount of $3,000 (until CY 2028 when it is updated
by the MEI). Accordingly, for CY 2022, the MR threshold is $3,000 for
PT and SLP services combined and $3,000 for OT services. Under the
established targeted review process, some, but not all, claims
exceeding the MR threshold amount are subject to review. Information on
the targeted manual medical review process is available at https://www.cms.gov/ResearchStatistics-Data-and-Systems/MonitoringPrograms/Medicare-FFSCompliancePrograms/Medical-Review/TherapyCap.html.
We track each beneficiary's incurred expenses for therapy services
annually and count them towards the KX modifier and MR thresholds by
applying the PFS rate for each service less any applicable MPPR amount
for services of CMS-designated ``always therapy'' services.
We apply the same PFS-rate accrual process noted above to
outpatient therapy services furnished by critical access hospitals
(CAHs), even though they are not paid for their therapy services under
the PFS and may be paid on a cost basis (effective January 1, 2014).
When the expenses incurred for the beneficiary's outpatient therapy
services for the year have exceeded one or both of the KX modifier
thresholds, therapy suppliers and providers use the KX modifier on
claims for subsequent medically necessary services. By using the KX
modifier, the therapist and therapy provider attest that the services
above the KX modifier thresholds are reasonable and necessary and that
documentation of the medical necessity for the services is in the
beneficiary's medical record. Claims for outpatient therapy services
exceeding the KX modifier thresholds without the KX modifier included
are denied.
I. Changes to Beneficiary Coinsurance for Additional Procedures
Furnished During the Same Clinical Encounter as Certain Colorectal
Cancer Screening Tests
Section 122 of Division CC of the Consolidated Appropriations Act
(CAA) of 2021, Waiving Medicare Coinsurance for Certain Colorectal
Cancer Screening Tests, amends section 1833(a) of the Act to offer a
special coinsurance rule for screening flexible sigmoidoscopies and
screening colonoscopies, regardless of the code that is billed for the
establishment of a diagnosis as a result of the test, or for the
removal of tissue or other matter or other procedure, that is furnished
in connection with, as a result of, and in the same clinical encounter
as the colorectal cancer screening test. The reduced coinsurance will
be phased-in beginning January 1, 2022. Currently, the addition of any
procedure beyond a planned colorectal cancer screening test (for which
there is no coinsurance), results in the beneficiary having to pay
coinsurance.
Section 1861(pp) of the Act defines ``colorectal cancer screening
tests'' and, under sections 1861(pp)(1)(B) and (C) of the Act,
identifies ``screening flexible sigmoidoscopy'' and ``screening
colonoscopy'' as two of the recognized procedures. During the course of
either one of these two procedures, removal of tissue or other matter
may become necessary for diagnostic purposes. Among other things,
section 1861(pp)(1)(D) of the Act authorizes the Secretary to include
in the definition other tests or procedures and modifications to the
tests and procedures described under this subsection, with such
frequency and payment limits as the Secretary determines appropriate,
in consultation with appropriate organizations. Section 1861(s)(2)(R)
of the Act includes colorectal cancer screening tests in the definition
of the medical and other health services that fall within the scope of
Medicare Part B benefits described in section 1832(a)(1) of the Act.
Section 1861(ddd)(3) of the Act includes colorectal cancer screening
tests within the definition of ``preventive services.'' In addition,
section 1833(a)(1)(Y) of the Act provides for payment for a preventive
service under the PFS at 100 percent of the lesser of the actual charge
or the fee schedule amount for these colorectal cancer screening tests,
and under the OPPS at 100 percent of the OPPS payment amount, when the
preventive service is recommended by the United States Preventive
Services Task Force (USPSTF) with a grade of A or B. As such, there is
no beneficiary coinsurance for recommended colorectal cancer screening
tests as defined in section 1861(pp)(1) of the Act.
Under these statutory provisions, we have issued regulations
governing payment for colorectal cancer screening tests at Sec.
410.152(l)(5). We pay 100 percent of the Medicare payment amount
established under the applicable payment methodology for the setting
for providers and suppliers, and beneficiaries are not required to pay
Part B coinsurance for colorectal cancer screening tests (except for
barium
[[Page 65178]]
enemas, which are not recommended by the USPSTF with a grade of A or
B).\39\
---------------------------------------------------------------------------
\39\ We refer readers to the CY 2022 OPPS final rule for a
detailed discussion of Changes to Beneficiary Coinsurance for
Colorectal Cancer Screening Tests in outpatient and ambulatory
surgical settings.
---------------------------------------------------------------------------
In addition to colorectal cancer screening tests, which typically
are furnished to patients in the absence of signs or symptoms of
illness or injury, Medicare also covers various diagnostic tests (see
Sec. 410.32). In general, diagnostic tests must be ordered by the
physician or practitioner who is treating the beneficiary and who uses
the results of the diagnostic test in the management of the patient's
specific medical condition. Under Part B, Medicare may cover flexible
sigmoidoscopies and colonoscopies as diagnostic tests when those tests
are reasonable and necessary as specified in section 1862(a)(1)(A) of
the Act. When these services are furnished as diagnostic tests rather
than as screening tests, patients are responsible for the Part B
coinsurance (20 or 25 percent depending upon the setting) associated
with these services.
We define colorectal cancer screening tests in our regulation at
Sec. 410.37(a)(1) to include ``flexible screening sigmoidoscopies''
and ``screening colonoscopies, including anesthesia furnished in
conjunction with the service.'' Under our current regulations, we
exclude from the definition of colorectal screening services,
colonoscopies and sigmoidoscopies that begin as screening services, but
where a polyp or other growth is found and removed as part of the
procedure. The exclusion of these services from the definition of
colorectal cancer screening tests is based upon longstanding provisions
under sections 1834(d)(2)(D) and (d)(3)(D) of the Act dealing with the
detection of lesions or growths during procedures (see CY 1998 PFS
final rule at 62 FR 59048, 59082 for a more detailed explanation).
Prior to the enactment of section 122 of the CAA, section
1834(d)(2)(D) of the Act provided that if, during the course of a
screening flexible sigmoidoscopy, a lesion or growth is detected which
results in a biopsy or removal of the lesion or growth, payment under
Medicare Part B shall not be made for the screening flexible
sigmoidoscopy, but shall be made for the procedure classified as a
flexible sigmoidoscopy with such biopsy or removal. Similarly, prior to
the recent legislative change, section 1834(d)(3)(D) of the Act
provided that if, during the course of a screening colonoscopy, a
lesion or growth is detected that results in a biopsy or removal of the
lesion or growth, payment under Medicare Part B shall not be made for
the screening colonoscopy but shall be made for the procedure
classified as a colonoscopy with such biopsy or removal. In these
situations, Medicare pays for the flexible sigmoidoscopy and
colonoscopy tests as diagnostic tests rather than as screening tests
and the 100 percent payment rate for recommended preventive services
under section 1833(a)(1)(Y) of the Act, as codified in our regulation
at Sec. 410.152(l)(5), has not applied. As such, beneficiaries
currently are responsible for the usual coinsurance that applies to the
services (20 or 25 percent of the cost of the services depending upon
the setting).
Under section 1833(b) of the Act, before making payment under
Medicare Part B for expenses incurred by a beneficiary for covered Part
B services, beneficiaries must first meet the applicable deductible for
the year. Section 4104 of the Affordable Care Act (that is, the Patient
Protection and Affordable Care Act (Pub L. 111-148, March 23, 2010),
and the Health Care and Education Reconciliation Act of 2010 (Pub. L.
111-152, March 30, 2010), collectively referred to as the ``Affordable
Care Act'') amended section 1833(b)(1) of the Act to make the
deductible inapplicable to expenses incurred for certain preventive
services that are recommended with a grade of A or B by the USPSTF,
including colorectal cancer screening tests as defined in section
1861(pp) of the Act. Section 4104 of the Affordable Care Act also added
a sentence at the end of section 1833(b)(1) of the Act specifying that
the exception to the deductible shall apply with respect to a
colorectal cancer screening test regardless of the code that is billed
for the establishment of a diagnosis as a result of the test, or for
the removal of tissue or other matter or other procedure that is
furnished in connection with, as a result of, and in the same clinical
encounter as the screening test. Although amendments made by the
Affordable Care Act addressed the applicability of the deductible in
the case of a colorectal cancer screening test that involves biopsy or
tissue removal, they did not alter the coinsurance provision in section
1833(a) of the Act for such procedures. Public commenters encouraged
the agency to eliminate the coinsurance in these circumstances;
however, the agency found that statute did not provide for elimination
of the coinsurance (75 FR 73170 at 73431).
Beneficiaries have continued to contact us noting their concern
that a coinsurance percentage applies (20 or 25 percent depending upon
the setting) under circumstances where they expected to receive only a
colorectal screening test to which coinsurance does not apply. Instead,
these beneficiaries received what Medicare considers to be a diagnostic
procedure because, for example, polyps were discovered and removed
during the procedure. Similarly, physicians have expressed concern
about the reactions of beneficiaries when they are informed that they
will be responsible for coinsurance if polyps are discovered and
removed during a procedure that they had expected to be a screening
procedure to which coinsurance does not apply.
Section 122 of the CAA addresses this coinsurance issue by
successively reducing, over a period of years, the percentage amount of
coinsurance for which the beneficiary is responsible. Ultimately, for
services furnished on or after January 1, 2030, the coinsurance will be
zero.
To implement the amendments made by section 122 of the CAA, we
proposed to modify our regulations to reflect the changes to Medicare
statute. As amended, the statute effectively provides that, for
services furnished on or after January 1, 2022, a flexible
sigmoidoscopy or a colonoscopy can be considered a screening flexible
sigmoidoscopy or a screening colonoscopy test even if an additional
procedure is furnished to remove tissue or other matter during the
screening test. Specifically, section 122(a)(3) of the CAA added a
sentence to the end of section 1833(a) of the Act to include as
colorectal screening tests described in section 1833(a)(1)(Y) of the
Act, a colorectal cancer screening test, regardless of the code that is
billed for the establishment of a diagnosis as a result of the test, or
for the removal of tissue or other matter or other procedure that is
furnished in connection with, as a result of, and in the same clinical
encounter as the screening test. We noted that only flexible screening
sigmoidoscopies and screening colonoscopies are recognized currently as
colorectal cancer screening tests that might involve removal of tissue
or other matter. This new sentence added under section 1833(a) of the
Act uses the same language that was used to amend the statute at
section 1833(b)(1) of the Act and to broaden the scope of colorectal
cancer screening tests to which a deductible does not apply. Section
122(b)(1) of the CAA then limits application of the 100 percent
Medicare payment rate (that is, no beneficiary coinsurance) under
section 1833(a)(1)(Y) of the Act for the additional colorectal cancer
screening
[[Page 65179]]
tests (those that are not screening tests ``but for'' the new sentence
at the end of section 1833(a) of the Act) by making payment for them
subject to a new section 1833(dd) of the Act. Section 1833(dd) of the
Act provides for a series of increases in the Medicare payment rate
percentage for those services over successive periods of years through
CY 2029. Thereafter, section 1833(dd) of the Act has no effect, so
payment for all colorectal cancer screening tests would be made at 100
percent under section 1833(a)(1)(Y) of the Act.
To codify the amendments made by section 122 of the CAA in our
regulations, we proposed to make two modifications to current
regulations.
At Sec. 410.37, we proposed to modify our regulation where we
define conditions for and limitations on coverage for colorectal cancer
screening tests by adding a new paragraph (j). That paragraph would
provide that, effective January 1, 2022, when a planned colorectal
cancer screening test, that is, screening flexible sigmoidoscopy or
screening colonoscopy test, requires a related procedure, including
removal of tissue or other matter, furnished in connection with, as a
result of, and in the same clinical encounter as the screening test, it
is considered to be a colorectal cancer screening test.
At Sec. 410.152(l)(5), we also proposed to modify our regulation.
Here we describe payment for colorectal cancer screening tests.
Effective January 1, 2022, we proposed to provide for an increase in
the Medicare payment percentage that is phased in over time. As the
Medicare payment percentage increases, the beneficiary coinsurance
percentage decreases. We proposed to revise Sec. 410.152(l)(5) to
provide that Medicare payment in a specified year is equal to a
specified percent of the lesser of the actual charge for the service or
the amount determined under the fee schedule that applies to the test.
The phased in Medicare payment percentages for colorectal cancer
screening services described in the proposed regulation at Sec.
410.37(j) (and the corresponding reduction in coinsurance) are as
follows:
80 percent payment for services furnished during CY 2022
(with coinsurance equal to 20 percent);
85 percent payment for services furnished during CY 2023
through CY 2026 (with coinsurance equal to 15 percent);
90 percent payment for services furnished during CY 2027
through CY 2029 (with coinsurance equal to 10 percent); and
100 percent payment for services furnished from CY 2030
onward (with coinsurance equal to zero percent).
Thus, between CYs 2022 and 2030, the coinsurance required of
Medicare beneficiaries for planned colorectal cancer screening tests
that result in additional procedures furnished in the same clinical
encounter will be reduced over time from the current 20 or 25 percent
to zero percent beginning CY 2030 and will remain at zero percent
thereafter.
We received several public comments on our proposed modifications
to the regulations. The following is a summary of the comments we
received and our responses.
Comment: Overall, commenters expressed support for our proposals to
implement, as required, section 122 of Division CC of the CAA of 2021.
Response: We thank commenters for supporting our proposals to
implement the amendments made by section 122 of the CAA.
Comment: One commenter expressed concern about the length of the
phase-in period for the reduction in the beneficiary's coinsurance
percentage, and asked whether it could be changed to next year.
Response: We proposed to implement the amendments made by section
122 of the CAA. Those amendments clearly specify the applicable
coinsurance percentages for each calendar year, and we do not have
discretion to modify them.
Comment: A commenter requested that the beneficiary should not be
responsible for coinsurance for anesthesia services when a screening
flexible sigmoidoscopy or a screening colonoscopy becomes a diagnostic.
Response: In the CY 2015 PFS final rule (79 FR 67730 through
67732), we amended the definition of colorectal cancer screening tests
that are colonoscopies at Sec. 410.37(a)(1)(iii) to include anesthesia
that was furnished in conjunction with screening colonoscopies. We did
not make a corresponding modification to the definition of colorectal
cancer screening tests that are flexible sigmoidoscopies at Sec.
410.37(a)(1)(ii). Section 122 of the CAA did not change these
regulatory definitions of colorectal cancer screening tests and we did
not propose to modify them in the CY 2022 PFS proposed rule. Therefore,
we are not making any changes in the regulation with respect to
anesthesia with screening flexible sigmoidoscopy in this final rule.
However, we will take these public comments into consideration for
possible future rulemaking.
Comment: A commenter requested that we allow suppliers to waive the
coinsurance even earlier than 2030 if they elect to do so without fear
of violating any CMS rules.
Response: Through this rulemaking we are adopting Medicare
regulations regarding beneficiary coinsurance that reflect the
decreasing beneficiary financial obligations over time as established
by statute. Prior to the complete phaseout of Medicare coinsurance
amounts for colorectal cancer screening tests in CY 2030, suppliers may
waive coinsurance amounts only if they comply with applicable law,
including the Federal Anti[hyphen]Kickback Statute and the civil
monetary penalty provision prohibiting inducements to
beneficiaries.\40\
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\40\ For further information see the OIG website at https://oig.hhs.gov/compliance/physician-education/fraud-abuse-laws/.
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Comment: A commenter urged CMS to conduct patient education and
outreach about the changes to their coinsurance when a screening
becomes a diagnostic.
Response: We agree it is important for Medicare beneficiaries to
understand the changes that will affect their coinsurance percentage
for certain colorectal cancer screening services and expect to develop
articles and update other media to announce and explain the changes.
We received several comments that were outside the scope of the
proposals made in the CY 2022 PFS proposed rule. Comments included
questions about coverage of bowel preparation products, coverage of
non-invasive screening tests that require a follow-up colonoscopy, and
cost-sharing for new colorectal screening technologies. Although we are
not summarizing and responding to these comments in this final rule, we
will take them into consideration for possible future healthcare
provider education or rulemaking.
After considering public comments, we are finalizing the proposals
made in the CY 2022 PFS proposed rule to implement section 122 of the
CAA without modification.
J. Vaccine Administration Services: Medicare Payments for Administering
Preventive Vaccines
As we discussed in the CY 2022 PFS proposed rule (86 FR 39220), on
January 31, 2020, under section 319 of the Public Health Service (PHS)
Act (42 U.S.C. 247d), the Secretary of the Department of Health and
Human Services (the Secretary) determined that a public health
emergency (PHE) as a result of confirmed cases of 2019 Novel
[[Page 65180]]
Coronavirus exists nationwide and has existed since January 27, 2020
(hereafter referred to as the PHE for COVID-19). The Secretary has
since renewed this declaration for successive 90-day periods, the
latest on October 18, 2021.
The PHE for COVID-19 has reinforced the important and positive
impact that preventive vaccines can have on the health of Medicare
beneficiaries and the broader public. At the time of publishing this
final rule, the PHE for COVID-19 declaration is still in effect and the
United States is in the middle of a national effort to vaccinate as
many people against COVID-19 as quickly as possible. This national
effort has at least temporarily altered the landscape for vaccines and
vaccine administration by, for example, encouraging existing providers
and suppliers to dramatically expand their vaccination capabilities and
by encouraging new (and new types) of providers and suppliers to
furnish vaccines.
Over the past several years, stakeholders have expressed concerns
about the reduction in Medicare payment rates for the service to
administer preventive vaccines covered by Medicare Part B under section
1861(s)(10) of the Act, including the influenza, pneumococcal, and
hepatitis B virus (HBV) vaccines. In the last two PFS rulemaking cycles
(that is, for CY 2020 and CY 2021), we have attempted to address some
of these concerns and these efforts are discussed in more detail below.
However, CY 2021 payment rates for administration of these vaccines by
suppliers including physicians, NPPs, and mass immunizers remain the
same as in CY 2019: A national average rate of $16.94, which is
geographically adjusted. In the CY 2022 PFS proposed rule (86 FR
39221), we requested feedback on how we should update the payment rate
for administration of these preventive vaccines under Medicare Part B.
1. Medicare Part B Payment for Vaccines
As we discussed in the CY 2022 PFS proposed rule (86 FR 39220
through 39224), under section 1861(s)(10) of the Act, Medicare Part B
covers both the vaccine and its administration for the preventive
vaccines specified--the influenza, pneumococcal, HBV, and COVID-19
vaccines. Under sections 1833(a)(1)(B) and (b)(1) of the Act, there is
no applicable beneficiary coinsurance, and the annual Part B deductible
does not apply for these vaccinations or the services to administer
them. In CY 2021, payment for these vaccines is based on 95 percent of
the Average Wholesale Price (AWP) for a particular vaccine product
except where furnished in the settings for which payment is based on
reasonable cost, such as a HOPD, RHC, or FQHC. For example, for the
2020-2021 influenza season, payment limits for adult influenza vaccine
products range from about $19 to $61 per adult dose. We noted that most
other preventive vaccines not specified for Medicare Part B coverage
under section 1861(s)(10) of the Act, such as the shingles vaccine, are
covered and paid for under Medicare Part D.
Section 3713 of the Coronavirus Aid, Relief, and Economic Security
Act (CARES Act) (Pub. L. 116-136) added the COVID-19 vaccine and its
administration to section 1861(s)(10)(A) of the Act in the same
subparagraph as the influenza and pneumococcal vaccines and their
administration. We implemented this change through an interim final
rule with comment period (November 4th COVID-19 IFC (85 FR 71145
through 71150)) which established that payments for COVID-19 vaccines
and vaccine administration would be made in the same manner as payments
for the influenza and pneumococcal vaccines. The IFC specifically
amended Sec. Sec. 414.707(a)(2)(iii) and 414.904(e)(1) to include the
COVID-19 vaccine in the list of vaccines with payment limits calculated
using 95 percent of the AWP (85 FR 71147). We noted that Medicare does
not pay providers and suppliers for the vaccine product when the
Federal Government purchases it and gives it to the provider or
suppliers for free, as has been the case for all COVID-19 vaccines as
of the publication of the proposed rule.
We noted that the vaccine administration services described under
section 1861(s)(10) of the Act are not technically valued or paid under
the PFS, as they are not included within the statutory definition of
physicians' services in section 1848(j)(3) of the Act. Despite this, we
have historically based payment rates for the administration of these
preventive vaccines by suppliers such as physicians, NPPs, and mass
immunizers on an evaluation of the resource costs involved in
furnishing the service, which is similar to the methodology that we use
to establish payment rates for the PFS. We noted further that we also
assign a payment rate for administering these preventive vaccines under
the Outpatient Prospective Payment System (OPPS), and those payment
rates are for hospitals and home health agencies for preventive vaccine
administration. Certain other types of providers and suppliers, such as
RHCs, FQHCs and critical access hospitals (CAHs), are paid based on
reasonable cost for vaccine administration. We also noted that payments
for the administration of the preventive vaccines by suppliers such as
physicians, NPPs, and mass immunizers are geographically adjusted based
on the provider's wage index.
As discussed in the CY 2021 PFS proposed rule (85 CFR 50162), many
stakeholders raised concerns about the reductions in payment rates for
the preventive vaccine administration services that had occurred over
the past several years. We generally have established payment rates for
the three Healthcare Common Procedural Coding System (HCPCS) codes
G0008, G0009, and G0010--which describe the services to administer an
influenza, pneumococcal and HBV vaccines, respectively, based on a
direct crosswalk to the PFS payment rate for CPT code 96372
(Therapeutic, prophylactic, or diagnostic injection (specify substance
or drug); subcutaneous or intramuscular). Because we proposed and
finalized reductions in valuation for that code for CY 2018, the
payment rate for the vaccine administration codes was concurrently
reduced. Further, because the reduction in RVUs for CPT code 96372 was
significant enough to be required to be phased in over several years
under section 1848(c)(7) of the Act, the reductions in overall
valuation for the vaccine administration codes were likewise subject to
reductions over several years. As we noted in the CY 2022 PFS proposed
rule (86 FR 39222) in Table 21, Table 30 shows the national payment
rate for administering these preventive vaccines has declined more than
30 percent since 2015.
[[Page 65181]]
[GRAPHIC] [TIFF OMITTED] TR19NO21.052
We explained that we have attempted to address the reduction in
payment rates for these vaccine administration HCPCS codes in the last
two PFS rulemaking cycles. In the CY 2020 PFS final rule, we
acknowledged that it is in the public interest to ensure appropriate
resource costs are reflected in the valuation of the immunization
administration services that are used to deliver these vaccines, and
noted that we planned to review the valuations for these services in
future rulemaking. For CY 2020, we maintained the CY 2019 national
payment amount for immunization administration services described by
HCPCS codes G0008, G0009 and G0010.
In the CY 2021 PFS proposed rule, we proposed to crosswalk G0008,
G0009 and G0010 to CPT code 36000 (Introduction of needle or
intracatheter, vein) (85 FR 50163). In the proposed rule, we noted that
CPT code 36000 is a service with a similar clinical vignette, and that
the additional clinical labor, supply, and equipment resources
associated with furnishing CPT code 36000 were similar to costs
associated with these vaccine administration codes. We also noted that
this crosswalk would have resulted in a payment rate for vaccine
administration services that is approximately the same as the CY 2017
rate (as noted in Table 30) that was in place prior to the revaluation
of CPT code 96372 (the original crosswalk code). In the CY 2021 PFS
final rule, we did not finalize the proposed policy, and instead
finalized a policy to maintain the CY 2019 payment amount for G0008,
G0009 and G0010 (85 FR 84628). In the final rule, we also noted that we
continued to seek additional information that specifically identifies
the resource costs and inputs that should be considered to establish
payment for vaccine administration services on a long-term basis.
As noted above, section 3713 of the CARES Act added the COVID-19
vaccine and its administration to the preventive vaccines covered under
Medicare Part B under section 1861(s)(10)(A) of the Act in the same
subparagraph as the influenza and pneumococcal vaccines and their
administration. We noted in the CY 2022 PFS proposed rule (86 FR 39222)
that section 3713 of the CARES Act allows us to implement the
amendments made by that section through ``program instruction or
otherwise.'' In implementing section 3713 of the CARES Act in the
November 4th COVID-19 IFC (85 FR 71147), we indicated that we would
establish specific coding and payment rates for the COVID-19 vaccine
and its administration through technical direction to Medicare
Administrative Contractors (MACs) and information posted publicly on
the CMS website.
In December 2020, we publicly posted the applicable CPT codes for
the Pfizer-BioNTech and Moderna COVID-19 vaccines and initial Medicare
payment rates for administration of these vaccines upon the FDA's
authorization of these vaccines. We announced an initial Medicare
payment rate for COVID-19 vaccine administration of $28.39 to
administer single-dose vaccines. For a COVID-19 vaccine requiring a
series of two or more doses--for example, for both the Pfizer-BioNTech
and Moderna products--we announced a payment rate for administration of
the initial dose(s) of $16.94, which was based on the Medicare payment
rate for administering the other preventive vaccines under section
1861(s)(10) of the Act. We also announced a payment rate for
administering the second dose of $28.39, which was based on the payment
rate that was proposed, but not finalized, for administration of the
other preventive vaccines under section 1861(s)(10) of the Act in the
CY 2021 PFS proposed rule, discussed in more detail above.
On March 15, 2021, we announced an increase in the payment rate for
administering a COVID-19 vaccine to $40 per dose, effective for doses
administered on or after March 15, 2021, which means the payment rate
is $40 to administer a single dose product, and $40 each to administer
the first and second dose in a two-dose regime ($80 total).
[[Page 65182]]
[GRAPHIC] [TIFF OMITTED] TR19NO21.053
As discussed above, payment rates for suppliers such as physicians,
NPPs, and mass immunizers for administering the Part B covered
preventive vaccines (other than for COVID-19) have generally been based
on a direct crosswalk to CPT code 96372 (Therapeutic, prophylactic, or
diagnostic injection (specify substance or drug); subcutaneous or
intramuscular). The service described by this crosswalk code is paid
under the PFS, and Medicare's process to value codes under the PFS
relies in part on recommended resource inputs provided by the AMA RUC
and steps to translate those recommended inputs into national RVUs.
In 2020, the RUC resubmitted its 2009 valuation recommendation for
vaccine administration services described by CPT codes, including CPT
codes 90460 (Administration of first vaccine or toxoid component
through 18 years of age with counseling), 90471 (Administration of 1
vaccine), and 90473 (Administration of 1 nasal or oral vaccine). The
AMA RUC also recently provided valuation recommendations for the CPT
codes that describe the service to administer the COVID-19 vaccines.
As noted earlier, we also assign a payment rate for administering
preventive vaccines under the OPPS by assigning each service to an
ambulatory payment classification (APC) based on clinical and resource
cost similarity to other services assigned to the APC. Geometric mean
costs, which are generally used in establishing the prospective OPPS
payments for each APC, are calculated using historical claims and cost
report information. In CY 2021, CMS assigned HCPCS codes G0008, G0009
and G0010 to APC 5691 (level 1 drug administration), which has a
national payment rate of $40 for CY 2021.
In the CY 2022 PFS proposed rule (86 FR 39223), we explained that
our practice of setting payment rates for preventive vaccine
administration services described by HCPCS codes G0008, G0009 and G0010
for physicians, NPPs, and mass immunizers by using the PFS approach
(for example, a crosswalk to an existing CPT code) means that costs
incorporated into the rate primarily reflect costs of furnishing the
service in a physician office setting. It also means that the payment
rate can be affected by other aspects of the PFS rate-setting
methodology, such as the allocation of indirect PE, and broader changes
to PFS codes and rates, including the multi-year phase-in of
significant reductions in RVUs discussed earlier. We noted that we have
not historically collected or used information from other providers and
suppliers, including pharmacies which are commonly enrolled as mass
immunizers to furnish vaccines and vaccine administration services, for
purposes of establishing a rate for these codes.
We requested feedback from stakeholders that would support the
development of an accurate and stable payment rate for administration
of the preventive vaccines described in section 1861(s)(10) of the Act
for physicians, NPPs, mass immunizers and certain other providers and
suppliers. We invited commenters to submit their detailed feedback to
the following questions and requests that we believe may assist us in
establishing payment rates for these services that could be appropriate
for use on a long-term basis.
What are the different types of providers and suppliers
that furnish preventive vaccines, and have these types of providers/
suppliers changed as a result of the PHE for COVID-19? (We noted that
our claims data reflect the type of Medicare enrollment for those
billing for the vaccine administration, but we are particularly
interested in understanding additional, specific characteristics of the
providers and suppliers that may not be distinguishable under the more
general Medicare enrollment data.) Do different providers and suppliers
furnish different aspects of the vaccine administration for the same
beneficiary?
What are the differences in incurred costs of furnishing
influenza, pneumococcal and HBV vaccines compared to furnishing COVID-
19 vaccines? Are there differences in the costs (per dose or otherwise)
of furnishing a one-dose vaccine product vs. a two-dose vaccine
product? Also, are there differences in cost of administering
preventive vaccines furnished under the Part D benefit, such as the
shingles vaccines, compared to those furnished under Part B?
What are the resource costs that physicians, NPPs, mass
immunizers and certain other suppliers incur when furnishing vaccines
safely and effectively? Specifically, what are the costs related to
staffing/labor, infrastructure, patient onboarding/enrollment, vaccine
storage and handling, vaccine procurement and coordination, supplies,
CDC and State reporting requirements, patient counseling about safety
and efficacy, and other costs we may not have considered? We also
sought information on specific resource costs per vaccine dose within
each cost category, if that is available.
What are the impacts of the PHE for COVID-19 on resource
costs incurred by vaccination providers, and do stakeholders envision
that these impacts will continue after the PHE has ended? Following the
end of the PHE, do you expect that the same types of vaccination
providers and suppliers will continue to administer vaccines, or do you
envision that this will change (if so,
[[Page 65183]]
how, and what would be the primary factors driving the change)?
How should Medicare assess costs associated with
furnishing these preventive vaccines outside of the physician office
setting, such as in pharmacies, mass immunization sites, mobile vaccine
clinics or other locations? In addition, as we noted in the CY 2022 PFS
proposed rule (86 FR 39224), we understand that there could be
administrative burden associated with the routine collection of cost
data to support more accurate rate-setting for suppliers that are
vaccinating patients. Are there other ways to update and validate costs
for a broader range of entities using existing data?
Payment rates for vaccine administration currently vary by
setting. For HCPCS codes G0008, G0009 and G0010, the CY 2021 national
average payment rate for physicians, practitioners and other suppliers
is $16.94, which is geographically adjusted, while for HOPDs it is $40.
However, for COVID-19 vaccine administration, Medicare now pays $40 per
administration in all settings, unless the vaccine in administered
under certain circumstances in the home or residence (as discussed in
more detail below). Should Medicare continue to pay differently for
non-COVID-19 preventive vaccines furnished in certain settings or under
certain conditions? If not, what factors contribute to higher costs for
administration of non-COVID-19 vaccines that are not currently
reflected in the Medicare payment rates?
Should CMS use a different process to update the payment
rates for administration of the preventive vaccines described in
section 1861(s)(10) of the Act on an annual basis?
In the last few years we have also crosswalked vaccine
administration CPT codes 90460 (Administration of first vaccine or
toxoid component through 18 years of age with counseling), 90461
(Administration of vaccine or toxoid component through 18 years of age
with counseling), 90471 (Administration of 1 vaccine), 90472
(Administration of vaccine), 90473 (Administration of 1 nasal or oral
vaccine), and 90474 (Administration of nasal or oral vaccine) to the
same rate used by G0008, G0009 and G0010. How should Medicare address
payment rates for these CPT codes under the PFS?
Are there major differences between what Medicare pays
physicians, NPPs and mass immunizers for non-COVID-19 preventive
vaccine administration and what commercial insurers pay? To the extent
possible, we also sought comments on the specific rates used by other
insurers.
We received feedback from a wide variety of stakeholders in
response to our comment solicitation on payment rates for the
administration of COVID-19 vaccines and other preventive vaccines
covered under the Medicare Part B vaccine benefit. Commenters
overwhelmingly emphasized the importance of vaccination in achieving
positive health outcomes for Medicare beneficiaries and the broader
American public. At the same time, they observed that immunization
rates overall continue to fall short of national objectives, and that
troubling disparities exist with respect to vaccination among racial
and ethnic minorities. Commenters also confirmed that many different
types of healthcare providers have contributed to the vaccination
effort in the United States, and provided detailed feedback on the
challenges and resource costs experienced by these vaccine providers,
especially in the context of the COVID-19 public health emergency. In
what follows, we summarize the comments that we received on these
topics, and explain how they have informed the policies we are adopting
in this final rule.
Comment: The comments we received are a testament to the complex
landscape of vaccination that has emerged in the wake of the COVID-19
pandemic. We received feedback from representatives of many different
types of healthcare providers who stated that they significantly
increased their vaccination capabilities in an effort to immunize as
many Americans as possible against COVID-19. These include primary care
physicians, NPs, pharmacies, urgent care centers, podiatrists,
community health centers, Urban Indian Organizations, and schools of
nursing. Commenters cited Federal financial assistance and
flexibilities, in particular the March 2020 Declaration under the
Public Readiness and Emergency Preparedness (PREP) Act (Division C of
Pub. L. 109-148), as factors that have enabled a broader scope of
healthcare providers to participate in the COVID-19 vaccination effort.
In addition, commenters noted that healthcare providers such as
hospitals, pharmacies and FQHCs have sought to expand the reach of
their vaccination campaigns by establishing mobile and outreach
clinics, as well as operating mass immunization sites in their
communities.
We also received numerous responses to our request for feedback on
the specific types of expenses incurred by healthcare providers of
COVID-19 and other preventive vaccines, including the ways in which
these expenses have evolved as a result of the COVID-19 PHE. Many
commenters indicated that the costs of administering the COVID-19
vaccines are higher than those associated with other preventive
vaccines, citing factors such as the needs for ultra-cold storage,
manual filling of syringes, scheduling for subsequent doses, post-
injection monitoring, stocking of EPI pens, distribution of CDC fact
sheets, disposal and logging of wasted doses, and State and Federal
reporting obligations, which in turn have required hiring of additional
staff and various software and IT enhancements. With respect to the
specific impacts of the pandemic on resource costs, commenters cited
the need for personal protective equipment, increased sanitization
measures, community outreach efforts, and high patient volumes combined
with staffing shortages. One commenter added that costs and
administrative burdens have increased because patients do not want to
go to provider locations to risk other illnesses. In addition, several
commenters pointed specifically to misinformation and vaccine hesitancy
as factors that have impeded the national immunization effort, and
recommended that payment rates should take into consideration the time
required to counsel and educate patients, including in the event that a
patient ends up declining the vaccine. A few commenters indicated that
they expect the effects of the pandemic to persist into CY 2022 and
beyond, and that we should therefore maintain the $40 payment rate for
COVID-19 vaccines for the foreseeable future.
Finally, commenters also provided feedback on the expenses
associated with setting up outreach clinics and mass immunization
sites, which require significant upfront infrastructure investments, as
well as back-end costs to break down these operations when they are
concluded. Specific expenses associated with such ventures include
tents, generators, portable restrooms, relocation of computers and
other equipment, security services, and staffing. Some commenters
recommended that the payment rate for mass community vaccination events
organized by FQHCs be increased from $40 to at least $120 per dose to
reflect these additional costs incurred by FQHCs.
One commenter representing pharmacists stated that cost reporting
would be the best approach to valuing vaccine administration at
pharmacies, and that the current crosswalk to the PFS does not
accurately reflect the costs incurred by pharmacies in furnishing
[[Page 65184]]
these services. The commenter cited costs including vaccine packaging
and storage, ancillary supplies such as syringes and gloves, patient
outreach and counseling, staffing and training, reporting requirements,
seasonal fluctuations in patient volume, and reporting requirements. In
response to our inquiry about the differences in costs of administering
preventive vaccines furnished under the Part B and Part D benefits, a
couple of commenters noted that the Part B claims submission process is
more complex and labor-intensive than the process under Part D and
results in greater costs for pharmacies.
Given the various expenses outlined above, commenters generally
applauded CMS for establishing a payment rate for COVID-19 vaccines of
$40 per dose as of March 15, 2021, with several commenters noting that
this amount accurately reflects the resource costs involved in COVID-19
vaccine administration. On the other hand, a majority of commenters
also expressed concern regarding the payment rate for other Part B
preventive vaccines, that is, influenza, pneumococcal, and HBV
vaccines--which, as noted above, currently stands at $16.94. Commenters
stated that this amount does not take full account of the expenses
associated with administering these vaccines, and that, as a result,
many healthcare providers, especially smaller, independent practices
and those in underserved areas, might be discouraged from offering
vaccines to their patients. Indeed, many commenters cited adequate
reimbursement as one of the principal factors that contribute to higher
immunization rates, and several cited a recent survey in which 80
percent of respondents indicated that increasing vaccine administration
payment rates would help overcome vaccination barriers and costs
created by the pandemic.\41\ A couple of commenters added that Medicare
payment rates impact the rates paid by Medicaid and private payers,
with one commenter asserting that some regional and private payers pay
as little as half of the Medicare rate. One commenter therefore
commended CMS for taking efforts to ensure appropriate, predictable and
stable payment for vaccines and their administration as a key lever to
improving immunization rates among Medicare beneficiaries. Another
commenter added that contracting influenza concurrently with COVID-19
may increase the risk of adverse health outcomes, and recommended
increasing payment rates for influenza vaccines for this reason.
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\41\ Belowich, E., Pratt, K., Fifer, S., Solis, P., & Hughes IV,
R. (2020, December 9). Increased Reimbursement May Help Overcome
Barriers To Administration Of Seasonal And Routine Vaccines [verbar]
Health Affairs. Health Affairs. https://www.healthaffairs.org/do/10.1377/hblog20201208.111539/full/.
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Commenters generally recommended that payment rates for the
influenza, pneumococcal and HBV vaccines should be updated and that
payment for the administration of these vaccines and of the COVID-19
vaccines should be determined using consistent methodologies, as
discussed below. One group of commenters recommended that CMS pay for
these services on the basis of resource-based relative value scale
(RBRVS) principles using recommendations submitted by the AMA RUC. In
May 2021, the RUC submitted its recommendations for Immunization
Administration codes 90460, 90461, 90471, 90472, 90473, 90474, G0008,
G0009 and G0010. In particular, the RUC recommended that CMS crosswalk
HCPCS codes G0008-10 to CPT code 90471, using inputs that would result
in a payment of approximately $21 per dose.
Furthermore, in December 2020, the RUC submitted recommendations
for CPT codes 0001A, 0002A, 0011A, 0012A, and 0031A (the first and
second doses of the Pfizer-BioNTech and Moderna COVID-19 vaccines and
the first dose of the Janssen vaccine, respectively). Specifically, the
RUC recommended crosswalking these codes to CPT code 90460, which would
result in a payment of approximately $30 for the vaccine administration
codes, and additionally recommended that for the duration of the PHE
CMS approve payment of approximately $10 for new CPT code 99072
(Additional supplies, materials, and clinical staff time over and above
those usually included in an office visit or other non-facility
service(s), when performed during a Public Health Emergency, as defined
by law, due to respiratory-transmitted infectious disease) to reflect
the additional PEs associated with administration of the COVID-19
vaccines during the PHE. The RUC submitted similar recommendations for
the third doses of the Pfizer and Moderna vaccines in August 2021.
Thus, using the RUC recommendations would result in a payment for
COVID-19 vaccine administration of approximately $35-$40 per dose
during the PHE, and approximately $25-$30 after the PHE is terminated.
Another group of commenters recommended decoupling payment for
preventive vaccine administration from the crosswalk to a code valued
under the PFS. These commenters generally supported a site-neutral
payment of $40 per dose for administration of all Part B preventive
vaccines, in line with the current payment rate for COVID-19 vaccine
administration and with the payment rate for administration of all
preventive vaccines under the OPPS. Several commenters who supported
this recommendation stated that equal payment for COVID-19 and other
preventive vaccines would be appropriate, since the work involved in
administering the different types of vaccines is essentially the same.
A few commenters also stated that costs associated with vaccine
administration do not vary significantly across different sites of
service, with some adding that a site-neutral payment would help
address inequities across healthcare provider settings and maximize
access to the vaccines. Additionally, a few commenters stated that, if
CMS does not decouple payment for vaccine administration from the PFS
and adopt a payment rate of $40 per dose as discussed above, then an
acceptable alternative would be to value these services by means of a
crosswalk to CPT code 36000 (Introduction of needle or intracatheter,
vein), as originally proposed in the CY 2021 PFS proposed rule. As
explained in the CY 2021 PFS proposed rule (85 FR 50163), CPT code
36000 is a service with a similar clinical vignette, and the additional
clinical labor, supply, and equipment resources associated with
furnishing CPT code 36000 are similar to costs associated with these
vaccine administration codes. This proposal, which was not finalized,
would have resulted in a payment for Part B vaccine administration
services of approximately $28.39 per dose.
One commenter suggested that CMS base payment for vaccine
administration services on average rates paid by commercial payers or
on the 2015 Medicare rate adjusted for inflation to 2022. Another
commenter provided data indicating that rates set by commercial payers
for CPT code 90471 (Immunization, initial) and CPT code 90472
(Immunization administration, each additional vaccine) are about 41
percent and 23 percent higher than rates set by Medicare, respectively.
Response: We appreciate the feedback received from the wide range
of providers and suppliers that furnish preventive vaccinations. We
agree with commenters on the need to establish stable payment rates
that take into account the costs associated with administering the
preventive vaccines included in the Part B vaccine benefit. In
particular, we agree that the payment
[[Page 65185]]
rates for administration of the influenza, pneumococcal and hepatitis B
vaccines are too low and need to be adjusted to reflect the costs
incurred by healthcare providers. Furthermore, we agree with commenters
who stated that we should decouple payment for these vaccine
administration services from the crosswalk to the PFS and treat them
independently. We took a number of factors into consideration in
developing our final policy.
First, we considered the impact of the pandemic on the costs
associated with vaccine administration, as well as the specific costs
associated with administration of the COVID-19 vaccines. We generally
agree with the commenters who stated that the service to administer
these vaccines is essentially the same and does not vary significantly
across different types of healthcare providers. At the same time, we
recognize that the PHE has posed and continues to pose unique
challenges for vaccination providers, particularly with respect to the
administration of vaccines for COVID-19. For example, we anticipate
that healthcare providers will continue to experience unusual costs
associated with staffing, scheduling, and reporting requirements as
increasing numbers of patients receive additional doses and boosters of
the COVID-19 vaccines in the near future, and as health care providers
adapt their vaccine delivery infrastructure accordingly. After the PHE,
however, we anticipate that these costs will go down as patient volumes
stabilize and as healthcare providers incorporate tasks such as
scheduling and reporting into their routine clinical practice. In
addition, we note that healthcare providers will have already made
certain capital investments associated with the COVID-19 vaccines, such
as ultra-cold storage freezers and software upgrades, during the course
of the PHE, and thus after the PHE such investments will no longer
represent a significant additional cost over and above the costs of
administering other preventive vaccines. At the same time, we recognize
that the formal termination of the PHE will not necessarily coincide
with an immediate return to pre-pandemic circumstances, and that some
of the additional costs mentioned above may persist while conditions
normalize. For these reasons, we believe that it is appropriate to
establish a single, consistent payment rate for the administration of
all Part B preventive vaccines following the end of the calendar year
in which the PHE expires. That is, effective January 1 of the year
following the year in which the PHE ends, the $40 payment rate for
administration of the COVID-19 vaccines will be adjusted to equal the
payment rate for the administration of other Part B preventive
vaccines.
We also considered the empirical data sources available to us for
establishing an appropriate vaccine-neutral payment. On the one hand,
we considered the recommendations submitted by the AMA RUC, which, as
noted above, would result in payment rates of approximately $21 for
administration of the influenza, pneumococcal and hepatitis B vaccines,
and approximately $25-$30 for administration of the COVID-19 vaccine
following the end of the PHE. On the other hand, we considered the
payment rate for vaccine administration services established using the
APC methodology under the hospital OPPS, which currently stands at
approximately $40. Finally, we considered the recommendation made by
commenters who stated that we should base the payment rate on a
crosswalk to CPT code 36000, which would result in a payment rate of
approximately $30 after adjusting the CY 2021 rate of $28.39 for
inflation. Based on these data and on the feedback we received from
commenters, we believe that $30 is the most appropriate payment rate
for administration of Part B preventive vaccines. Specifically, this
amount is approximately equivalent to the CY 2021 valuation of CPT code
36000 adjusted for inflation to CY 2022, and also near the upper range
of the approximate payment rates that would result if we adopted the
RUC recommendations for administration of the COVID-19 vaccines.
Based on the history and status of payment for preventive vaccine
administration discussed above and given the concerns gathered through
the comment solicitation we believe that we need to act expeditiously
to update payment rates for the administration of preventive vaccines
paid under Medicare Part B, effective January 1, 2022. In addition, we
believe that the timing is appropriate for establishing a predictable
payment rate for preventive vaccine administration since the PHE has
ignited a hypervigilance for infectious diseases.
In setting the payment rate for administration of preventive
vaccines, we carefully considered how to move forward with what we
believe is the appropriate payment mechanism that would align with the
goal of vaccinating as many Medicare beneficiaries as possible each
year in an effort to prevent illnesses that are known to lead to
negative outcomes. For example, we considered the value of establishing
a site-neutral payment rate versus recognition that cost structures are
different between an office, hospital, or temporary remote COVID-19
vaccination administration site. We concluded that establishing payment
rates that are intended to address the unique costs experienced across
the wide variety of providers and suppliers that administer
vaccinations would require the development of an unnecessarily complex
payment methodology and potentially delay implementation.
We also recognize the value of a site-neutral payment rate,
especially with regard to vaccine administration, since the procedure
itself is practically the same across settings. However, we are unable
to establish a single Medicare program payment rate that is site-
neutral since there are several settings in which different Medicare
payment methodologies dictate different payment rates for vaccine
administration under Part B. Payment rates for administration of
preventive vaccines by suppliers such as physicians, NPPs, and mass
immunizers historically have been based on an evaluation of the
resource costs involved in furnishing the service, which is analogous
to the methodology that we use to establish payment rates under the
PFS. We also assign a payment rate under the OPPS for administration of
preventive vaccines by hospitals. Certain other types of providers and
suppliers, such as RHCs, FQHCs and CAHs, are paid on a reasonable cost
basis for vaccine administration.
We believe we have gathered sufficient resource cost data that can
be used to set an appropriate payment rate for suppliers such as
physicians, NPPs, and mass immunizers, who administer the majority of
preventive vaccines to Medicare beneficiaries. In addition, we believe
a stable vaccine-neutral payment rate is appropriate in this space so
providers and suppliers that furnish preventive vaccinations can rely
on predictable payments for this service, which we anticipate would
allow them to forecast their business plans and engage in activities
that could continue to build and sustain robust vaccination programs.
As we discuss above, we recognize there are cost differentials that
exist with regard to the COVID-19 vaccine versus the other preventive
vaccines at the time of this final rule and that those may continue to
exist into and potentially throughout CY 2022. Therefore, beginning for
services furnished in CY 2022, we are finalizing a uniform payment rate
of $30 for the administration of an influenza, pneumococcal or HBV
vaccine covered
[[Page 65186]]
under the Medicare Part B preventive vaccine benefit at section
1861(s)(10) of the Act.
The AMA RUC develops recommended valuations for services by
contemplating the typical case and then deciding how many minutes the
typical case takes and what supplies are typically used. The RUC
developed specific estimates for COVID-19 vaccine administration and
for pediatric and other immunizations, but not for the Part B
preventive vaccines. The RUC recommendations would produce a payment
for COVID-19 vaccine administration of approximately $35-$40 per dose
during the PHE, and approximately $25-$30 after the PHE is terminated.
The best cost data we have available comes from the hospital outpatient
setting, which, as mentioned above, suggests a cost of approximately
$40 for administration of a preventive vaccine. However, most
immunizers will not have a cost structure similar to an acute care
hospital. As such, we believe it is appropriate to finalize a payment
rate that approximates the RUC's estimates of the costs involved in the
typical case of COVID-19 vaccine administration after the PHE, (that
is, $30).
In addition, as explained above, we will maintain the current
payment rate of $40 per dose for the administration of the COVID-19
vaccines through the end of the calendar year in which the PHE ends;
effective January 1 of the year following the year in which the PHE
ends, the payment rate for COVID-19 vaccine administration will be set
at a rate that aligns with the per dose payment rate for administration
of other Part B preventive vaccines. We recognize that it is difficult
to predict when resource costs relating to COVID-19 vaccination will
align with those for other vaccinations after the PHE ends, as we
believe the scale of this PHE is unique in recent Medicare payment
history. We will continue to actively monitor vaccination utilization
and may consider refinements in the future.
We note that the administration of the preventive vaccines
described under section 1861(s)(10) of the Act is not included within
the statutory definition of physicians' services, that the payment
rates finalized above are independent of the PFS, and that these
payment rates will be updated as necessary independently of the
valuation of any specific codes under the PFS. We believe that the
payment rates finalized above accurately reflect the resource costs
involved in the administration of Part B preventive vaccines, and that
a payment differential limited to the duration of the PHE recognizes
the additional costs involved in the administration of the COVID-19
vaccines in the context of the pandemic.
Comment: Some commenters, while supporting payment rates based on
AMA RUC recommendations for CY 2022, encouraged CMS to consider whether
it would be more effective and sustainable to develop a payment
methodology for vaccine administration that considers the value of
preventive vaccinations instead of only considering the cost of
furnishing these services, and whether such an approach might boost
vaccination rates among Medicare beneficiaries. Commenters who
advocated for this approach stated that cost-based reimbursement has
been ineffective, whereas moving away from a cost-based methodology
would give vaccine providers more flexibility to furnish additional
counseling services or implement innovative clinical workflows to
optimize vaccination among their patients.
Response: We thank the commenters for their suggestion. We plan to
monitor immunization rates among Medicare beneficiaries after the
payment rates for vaccine administration services finalized in this
final rule go into effect, and will continue to engage with members of
the public on potential refinements to our policies.
As we stated above, we believe we have gathered sufficient resource
cost data to set a payment rate for vaccine providers such as
physicians, NPPs, and mass immunizers, who administer the majority of
preventive vaccines to Medicare beneficiaries. Therefore, beginning
January 1, 2022, these providers and suppliers will be paid $30 for the
administration of an influenza, pneumococcal or HBV vaccine under the
Medicare Part B vaccine benefit. In addition, through the end of the
year in which the COVID-19 PHE ends, we will maintain the current
payment rate of $40 per dose for the administration of the COVID-19
vaccines; following the end of the year in which the PHE ends, the
payment rate for COVID-19 vaccine administration will be set at a rate
that aligns with the rate for other preventive vaccines.
Comment: A couple of commenters provided feedback in response to
our inquiry about the process to update the payment rates for
administration of preventive vaccines on an annual basis. One commenter
suggested that incremental updates should be made to the payment rate
each year. Another commenter stated that annual updates to the vaccine
administration payment rates based on OPPS claims data would be a
reliable and data-based method for updating the payment rate and would
prevent the issues that have occurred in the past with the crosswalk to
CPT code 96372.
Response: We thank the commenters for their suggestions. We
continue to seek feedback on an appropriate mechanism for updating
these payments on a yearly basis by, for example, applying an annual
inflation factor, for example the MEI, to the payment rate in order to
reflect increases in costs faced by providers and suppliers that
furnish the service, and plan to address updating the payment rate for
Part B preventive vaccine administration in future rulemaking.
Comment: We received feedback from several commenters who
emphasized the role of primary care physicians in vaccinating Medicare
beneficiaries and the general public. The commenters cited a study
indicating that primary care practices provide over half of all vaccine
administration services for Medicare beneficiaries,\42\ and noted that
these healthcare professionals are an important resource for addressing
vaccine hesitancy and encouraging patients to receive vaccinations. On
the other hand, commenters expressed concern that inadequate payment
rates may discourage small family practices with limited resources from
offering vaccines, and that patients may be less likely to follow
through on their physician's advice to receive a vaccine if it is not
immediately available onsite.
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\42\ Wilkinson, E., Jetty, A., Petterson, S., Jabbarpour, Y., &
Westfall, J. M. (2021). Primary Care's Historic Role in Vaccination
and Potential Role in COVID 19 Immunization Programs. Annals of
Family Medicine, 19 (4), 351. 355. https://doi.org/10.1370/AFM.2679.
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Several commenters emphasized the role of pharmacists in providing
both routine seasonal vaccines and vaccines against COVID-19, and
anticipated that pharmacies will continue to play a leading role in
immunization efforts after the PHE is over and COVID-19 becomes
endemic. Commenters pointed to the widespread presence of pharmacies in
local communities across the country, with one commenter asserting that
pharmacists are the most accessible healthcare professionals,
interacting regularly with patients and providing education and
recommendations that may have a positive impact on a person's decision
to receive a vaccine.
Response: We appreciate the contributions that primary care
physicians and pharmacists make in the national immunization effort,
including their role in educating patients on the issue of vaccines. We
believe that the payment rates for vaccine administration services
finalized in this
[[Page 65187]]
final rule more accurately reflect the costs incurred by primary care
physicians, pharmacists and other healthcare providers in furnishing
vaccines.
Comment: We also received comments related to payment to FQHCs for
COVID-19 vaccine administration services, vaccination efforts among
American Indian/Alaska Native (AI/AN) populations and payment for
vaccine administration to Indian health care providers, suggestions on
ways to promote effective and equitable distribution of preventive
vaccines, and potential barriers to access that may prevent
beneficiaries from receiving vaccines covered under the Medicare Part D
benefit.
Response: We appreciate the commenters' feedback. However, we did
not discuss or include proposals on these issues in the CY 2022 PFS
proposed rule. As such, these comments are outside the scope of this
rulemaking, but we will take these comments into consideration for the
future.
2. Payment for COVID-19 Vaccine Administration in the Home
As we discussed in the CY 2022 PFS proposed rule (86 FR 39224),
effective June 8, 2021, we announced a new add-on payment with a
national rate of $35.50 when a COVID-19 vaccine is administered in the
home.\43\ Under this policy, providers and suppliers that administer a
COVID-19 vaccine in the home under certain circumstances can bill
Medicare for one of the existing COVID-19 vaccine administration CPT
codes (0001A, 0002A, 0011A, 0012A, 0031A) along with HCPCS code M0201
(COVID-19 vaccine administration inside a patient's home; reported only
once per individual home per date of service when only COVID-19 vaccine
administration is performed at the patient's home). Providers and
suppliers administering a COVID-19 vaccine in the home will be paid a
national average payment $75.50 dollars per dose ($40 for COVID-19
vaccine administration and $35.50 for the additional payment for
administration in the home, and both payments are geographically
adjusted).
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\43\ https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
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In establishing the additional payment for COVID-19 vaccine
administration in the home, we also established certain conditions for
the add-on payment described by HCPCS code M0201. More specifically,
for purposes of this additional payment for administration of the
COVID-19 vaccine in the home, we established that Medicare will make
this payment when either of these situations applies:
The patient has difficulty leaving the home to get the
vaccine, which could mean any of these:
(1) They have a condition, due to an illness or injury, that
restricts their ability to leave home without a supportive device or
help from a paid or unpaid caregiver;
(2) They have a condition that makes them more susceptible to
contracting a pandemic disease like COVID-19; or
(3) They are generally unable to leave the home, and if they do
leave home, it requires a considerable and taxing effort;
The patient is hard-to-reach because they have a
disability or face clinical, socioeconomic, or geographical barriers to
getting a COVID-19 vaccine in settings other than their home. These
patients face challenges that significantly reduce their ability to get
vaccinated outside the home, such as challenges with transportation,
communication, or caregiving. We also specified that payment is made
for HCPCS code M0201 if the sole purpose of the visit is to administer
the COVID-19 vaccine. However, Medicare will not pay the additional
amount if the provider or supplier furnished another Medicare covered
service in the same home on the same date.
For purposes of this add-on payment for in-home COVID-19 vaccine
administration, we announced that a home can be a private residence,
temporary lodging (for example, a hotel or motel, campground, hostel,
or homeless shelter), an apartment in an apartment complex or a unit in
an assisted living facility or group home, or a patient's home that is
made provider-based to a hospital during the PHE for COVID-19. As such,
a home may be a domiciliary or rest home, meaning a facility, which
provides room, board, and other personal assistance services (for
example, an assisted living facility).
We also announced that the following locations are not considered
to be the patient's home for purposes of the add-on payment for COVID-
19 vaccine administration: Communal spaces of a multi-unit living
arrangement; hospitals; Medicare SNFs, and Medicaid NFs, regardless of
whether they are the patient's permanent residence; assisted living
facilities participating in the CDC's Pharmacy Partnership for Long-
Term Care Program when their residents are vaccinated through this
program. In the CY 2022 PFS proposed rule (86 FR 39224), we clarified
that an institution is not considered to be a patient's home if the
institution meets the requirements of sections 1861(e)(1), 1819(a)(1),
or 1919(a)(1) of the Act, which includes hospitals and skilled nursing
facilities (SNFs), as well as most nursing facilities under
Medicaid.\44\
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\44\ 42 CFR 409.42(a).
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Additionally, we established that assisted living facilities
participating in the CDC Pharmacy Partnership for Long-Term Care
Program partnership would not be eligible for this higher payment for
COVID-19 vaccine administration in the home when their residents were
vaccinated through this program.
In addition, we established that the COVID-19 vaccine
administration service must be furnished inside an individual's home.
For this purpose, an individual unit in a multi-dwelling building is
considered a home. For example, an individual apartment in an apartment
complex or an individual bedroom inside an assisted living facility or
group home is considered a home. We established that communal spaces
of, or related to, congregate living arrangements (such as a communal
area of an apartment or condominium complex, assisted living facility,
group home) were not considered a home for purposes of this add-on
payment because multiple people could be vaccinated and monitored
either simultaneously or in tandem in such communal spaces.
As noted in the code descriptor for HCPCS code M0201, this code
could be billed only once per individual home per date of service. In
situations where more than one Medicare beneficiary lives in the same
individual home, the additional payment for COVID-19 vaccine
administration in the home was limited to one time in that home on that
day, while any additional COVID-19 vaccine administration services for
other individuals in that same home would be paid at the generally
applicable rate of approximately $40 without the additional in-home
add-on payment amount.
We established the payment amount for HCPCS code M0201 for in-home
vaccination to reflect the additional costs associated with
administering the vaccine in the home, such as upfront administration
costs like scheduling, the additional clinical time needed for post
administration monitoring of a single patient, and public health
reporting requirements. To identify an appropriate payment rate for
HCPCS code M0201, we used the home health low utilization payment
adjustment add-on factor for skilled nursing as a proxy for the
increased resource costs, above those reflected in the base payment
rate for COVID-19 vaccine administration, involved in arranging
[[Page 65188]]
and furnishing COVID-19 vaccine administration services in the home.
For home health services, we make a low utilization payment adjustment
(LUPA) when, during a 30-day period of home health care (or prior to
January 1, 2020, a 60-day episode of home health care) a patient
receives minimal services (less visits than a predetermined threshold)
and the home health agency is paid per visit rather than the full 30-
day (previously 60-day) bundled payment amount (see 42 CFR 484.230). As
stated in the CY 2008 HH PPS proposed rule, after the HH PPS went into
effect we received comments and correspondence stating that the LUPA
per-visit payment rates do not adequately account for the front-loading
of costs in an episode. Commenters suggested that because of the small
number of visits in a LUPA episode, HHAs have little opportunity to
spread the costs of lengthy initial visits over a full episode (72 FR
25424). As such, under the Medicare home health payment system, LUPA
add-on payments are made to account for the upfront fixed costs and
prolonged visit lengths in a LUPA period/episode compared to those for
non-LUPA periods/episodes. We believe the LUPA add-on factor for
skilled nursing is an appropriate proxy for the upfront fixed costs and
prolonged visit lengths that exemplify and constitute the increased
resource costs involved in arranging and furnishing COVID-19 vaccine
administration services in the home.
The CY 2021 LUPA add-on factor for skilled nursing is 1.8451, and
we applied this to the base rate for COVID-19 vaccine administration of
$40 per dose (effective March 15, 2021). This calculation results in a
total proxy payment rate for in-home COVID-19 vaccine administration of
approximately $74. Subtracting the $40 base rate for COVID-19 vaccine
administration, which applies across most other settings, results in an
additional proxy payment rate of roughly $34. To expedite access to
this service and ensure consistency in payment rates for HCPCS code
M0201 between health care professionals, other suppliers, and
institutional providers, we established a payment rate that corresponds
to the proxy we calculated based on the LUPA add-on factor using a
reference to another proxy payment rate under the hospital OPPS.
Specifically, we looked to APC payment amounts under the hospital OPPS
that were similar to the $34 proxy amount and could be implemented with
speed under the COVID-19 vaccine benefit (which relies on both
institutional and professional claims processing systems). We
identified New Technology APC 1494 under the hospital OPPS with a
national payment rate of $35.50 as an appropriate reference payment
amount for this service for most providers and suppliers, and
established that amount as the national payment rate for HCPCS code
M0201. That is, the national payment rate for HCPCS code M0201 is
$35.50 for all providers and suppliers not paid reasonable cost.
Although we announced a payment rate of approximately $35 on June 8,
2021, in order to accelerate implementation of the new payment for
claims processing purposes, it was expedient to choose a proxy payment
rate that was already in place under the OPPS.
In announcing the add-on payment for in-home COVID-19 vaccine
administration, we noted that we established these policies on a
``preliminary basis to ensure access to COVID-19 vaccines during the
public health emergency'' and that ``we continue to evaluate the needs
of Medicare patients and these policies, and will address them in the
future, as needed.'' \45\
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\45\ https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
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On August 24, 2021, after the publication of the CY 2022 PFS
proposed rule, we announced a number of changes to our policies.
Effective August 24, 2021, communal spaces of a multi-unit or communal
living arrangement, as well as assisted living facilities participating
in the CDC's Pharmacy Partnership for Long-Term Care Program when their
residents are vaccinated through this program, can qualify as a
Medicare patient's home for purposes of the additional in-home payment
amount. Furthermore, effective August 24, 2021, Medicare pays the
additional payment amount for up to a maximum of 5 vaccine
administration services per home unit or communal space within a single
group living location; but only when fewer than 10 Medicare patients
receive a COVID-19 vaccine dose on the same day at the same group
living location.\46\
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\46\ https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
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We used the proposed rule as a way to collect feedback on our
policies and potential future changes.
We sought feedback on our requirements, including the
definition of the ``home'' and the types of clinical and non-clinical
circumstances that make it difficult for a beneficiary to receive a
COVID-19 vaccine outside the home. Do these requirements strike the
appropriate balance of ensuring access to vaccines for vulnerable
beneficiaries while also protecting against potential fraud? Should we
maintain these requirements during the PHE as-is, and if not, what
changes should we consider? Outside of the circumstances of the PHE
that create a need for beneficiaries to be vaccinated as quickly and
broadly as possible, under what circumstances do health care providers,
suppliers, or others find particular need to vaccinate people at home
rather than periodically in association with routine in-person visits?
As noted, we established an add-on payment of $35.50,
which is based on applying the LUPA add-on factor for skilled nursing
to the national $40 payment rate for the base service as a proxy to
reflect the additional resources involved in furnishing services in the
home setting. What are the costs associated with furnishing COVID-19
vaccines in the home, and how do these costs differ from costs of
furnishing vaccines in traditional locations, such as a physician's
office or mass immunization site?
What other steps should we take related to program
integrity and beneficiary protection with this new add-on payment for
administering the COVID-19 vaccine in the home? What documentation
should providers and suppliers that furnish vaccines in the home be
required to maintain and/or provide?
As we noted in the CY 2022 PFS proposed rule (86 FR 39225), this
add-on payment of $35.50 only applies when providers or suppliers
furnish the COVID-19 vaccine in the home, and is not billable when
providers and suppliers furnish a different preventive vaccine
(influenza, pneumococcal, HBV) in the home. Furthermore, we explained
that we believe the additional payment is only appropriate for COVID-19
vaccines due to the unique circumstances of the PHE, as well as the
upfront fixed costs and prolonged visit lengths that exemplify and
constitute the increased resource costs involved in arranging and
furnishing COVID-19 vaccine administration services in the home.
However, we sought feedback on whether the same barriers that could
prevent a beneficiary from obtaining a COVID-19 vaccine would also
prevent them from obtaining other preventive vaccines, whether Medicare
should make a similar add-on vaccine administration payment in those
circumstances, and whether the costs to furnish other preventive
vaccines in the home would be consistent with the costs to furnish the
COVID-19 vaccine.
Comment: We received numerous comments in support of our policy to
provide an additional payment in the
[[Page 65189]]
amount of $35.50 when a COVID-19 vaccine is administered in the home
under certain circumstances. Commenters overwhelmingly recommended that
we continue making the additional payment beyond the end of the PHE,
and many commenters also supported extending the payment to other
preventive vaccines, either permanently or until the end of the
pandemic. In support of this policy, commenters emphasized the
importance of increasing vaccination rates and making the vaccines
available to vulnerable homebound beneficiaries, who face barriers
including chronic illness, financial and social precarity, and lack of
access to digital resources. Several commenters stated that the same
circumstances that currently prevent a beneficiary from leaving their
home to receive a COVID-19 vaccine apply to other preventive vaccines
as well and will continue beyond the end of the PHE. With respect to
the specific resource costs involved in providing vaccine services in
the home, commenters cited travel, vaccine storage and handling
requirements, scheduling challenges, security, and sanitization; some
commenters observed that similar costs apply to the administration of
both the COVID-19 and other preventive vaccines in a beneficiary's
home. A few commenters agreed that the Home Health LUPA is a reasonable
proxy for the additional resource costs involved with administering
COVID-19 vaccines in the home, while others asserted that the current
payment amount of $35.50 is too low.
Response: We agree with the feedback that we received regarding the
need to incentivize providers to administer COVID-19 vaccines in the
home during the PHE, and especially with commenters who cited the need
to protect beneficiaries who would be at increased risk of contracting
COVID-19 and developing a serious illness if exposed. We also thank
suppliers such as family physicians who have gone to great lengths to
vaccine hard-to-reach populations under the difficult circumstances of
the pandemic.
Given the commenters' concurrence with the added costs and
compelling needs that led CMS to adopt the in-home add-on payment, we
believe this policy is an appropriate one. In addition, since we do not
expect those needs or costs to diminish immediately with the end of the
PHE, we believe it would be appropriate to leave the in-home add-on
payment rate in place through the end of the CY in which the PHE ends.
For example, we anticipate that additional booster doses will be
needed. In addition, we believe that that this policy would set clear
expectations for vaccine providers and suppliers and allow for a more
gradual transition to a permanent payment policy.
Therefore, we are finalizing our policy to continue making the
additional payment of $35.50 when a COVID-19 vaccine is administered in
a beneficiary's home under certain circumstances until the end of the
year in which the PHE expires. We believe that this extension will
maximize access to COVID-19 vaccines for vulnerable homebound
beneficiaries during the gradual return to normal conditions following
the formal termination of the PHE. At the same time, it will afford CMS
the opportunity to monitor vaccine uptake data. We also note that a
policy to continue this payment in place through the end of the year in
which the PHE ends is in keeping with our policies outlined elsewhere
regarding the payment rate of $40 for COVID-19 vaccine administration,
as well as the coverage and payment of COVID-19 monoclonal antibody
therapies for COVID-19 under the Part B vaccine benefit.
We note that for purposes of this add-on payment for in-home COVID-
19 vaccine administration, we are maintaining the policy that a home
can be a private residence, temporary lodging (for example, a hotel or
motel, campground, hostel, or homeless shelter), an apartment in an
apartment complex or a unit in an assisted living facility or group
home, or a patient's home that is made provider-based to a hospital
during the PHE for COVID-19; however, an institution is not considered
to be a patient's home if the institution meets the requirements of
sections 1861(e)(1), 1819(a)(1), or 1919(a)(1) of the Act, which
includes hospitals and SNFs, as well as most nursing facilities under
Medicaid.
We are grateful for the additional feedback we received from
commenters who advocated maintaining the additional payment for in-home
COVID-19 vaccination beyond the PHE and extending it to other
preventive vaccines, and we will continue to engage with stakeholders
on this topic.
Comment: Several commenters expressed concern that our policies
regarding eligibility for the additional in-home payment are too
restrictive, and encouraged CMS to consider incorporating flexibilities
that would make this payment available under a greater variety of
circumstances. Among the restrictions cited most frequently by
commenters was our policy that Medicare does not pay the additional
payment if another Medicare service is provided in the same home on the
same date. For example, one commenter observed that home providers are
not eligible to receive the additional payment if they offer the
vaccine during an E/M visit or in conjunction with an influenza
vaccine.
Another commenter stated that it is important for CMS to consider
the unique cultural dynamics in households in Indian Country and
provide flexibility to consider the family size composition and
intergenerational living arrangements that are common in AI/AN
communities; specifically, the commenter urged CMS to provide the
additional payment when services are furnished to other family members
in the same household. Commenters also cited restrictions on the number
of vaccine administration services that may be furnished during a
single visit and in a single home unit or communal space, as well as on
the types of providers that are eligible to receive the additional
payment. In addition, one commenter requested that CMS classify mobile
vaccination as a patient's ``home'' to reflect the increased costs of
safely vaccinating patients in this setting.
Response: We thank the commenters and will take their feedback into
consideration if we contemplate any future changes to our policy
concerning COVID-19 vaccine administration in the home.
Comment: One commenter urged CMS to offer explicit guidance on how
the concept of ``home'' should be documented in individual patient
medical records to reflect the various circumstances supported by
COVID-19 vaccination payment policies as outlined on the CMS
website.\47\ The commenter also requested that CMS clarify whether the
10-patient limit applies to the capacity of the living facility or
whether it is based on the number of patients given vaccination on a
date of service.
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\47\ https://www.cms.gov/medicare/covid-19/coding-covid-19-vaccine-shots.
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Response: We have not established any specific medical record
documentation requirements for the additional in-home COVID-19
vaccination payment. We have issued guidance explaining the
circumstances under which the payment is available; and vaccine
providers should ensure that the medical record documentation is
sufficient support payment. We note that the documentation should
additionally support the beneficiary's appropriateness for home
vaccination as
[[Page 65190]]
indicated in the CMS Coronavirus vaccination toolkit.\48\
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\48\ https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
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In response to the second part of the commenter's question, we are
clarifying that, effective August 24, 2021, Medicare pays for up to a
maximum of 5 vaccine administration services per home unit or communal
space within a single group living location, but only when fewer than
10 Medicare patients receive a COVID-19 vaccine dose on the same day at
the same group living location. When 10 or more Medicare patients
receive a COVID-19 vaccine dose at a group living location on the same
day, the additional payment can only be billed once per home (whether
the home is an individual living unit or a communal space). We are
further clarifying that the limit applies to the number of patients who
receive a COVID-19 vaccine dose on the same day, regardless of the
total number of patients residing at the location or the total capacity
of the facility. For example, if 8 Medicare patients all reside in a
location that houses 100 patients total, and those 8 Medicare patients
receive a COVID-19 vaccine dose on the same day at that location, then,
effective August 24, 2021, Medicare pays approximately $497.50 (5 x
$35.50 for the in-home vaccine administration, plus 8 x $40 for each
dose of the COVID-19 vaccine). On the other hand, if 12 Medicare
patients all reside in a location that houses 100 patients total, and
those 12 Medicare patients receive a COVID-19 vaccine dose on the same
day at that location, then, effective August 24, 2021, Medicare pays
approximately $515.50 (12 x $40 for each dose of COVID-19 vaccine, and
1 x $35.50 for one in-home vaccine administration--only one home add-on
payment is billable in this circumstance because 10 or more Medicare
patients were vaccinated at the same group living location on the same
date).
Comment: One commenter stated that most COVID-19 vaccinations in
the home have been administered by community pharmacists, and requested
retroactive payment for pharmacists and other providers who
administered the vaccine in communal spaces and other previously
ineligible locations prior to the new flexibilities effective as of
August 24, 2021.
Response: The additional flexibilities effective on August 24,
2021, were introduced, among other reasons, in order to enable a
greater number of healthcare providers to furnish vaccine services to
Medicare beneficiaries in their homes. We are grateful to community
pharmacists and other healthcare providers who furnished these services
in communal spaces and other ineligible locations prior to August 24,
2021, but we are not adopting the commenter's suggestion to make
additional payments to providers retroactively.
3. Monoclonal Antibodies Used To Treat COVID-19
As we discussed in the CY 2022 PFS proposed rule (86 FR 39226), on
November 9, 2020, the FDA issued an Emergency Use Authorization (EUA)
for bamlanivimab monotherapy.\49\ On November 21, 2020 the FDA issued
an EUA for casirivimab and imdevimab, which are administered
together.\50\ On February 9, 2021, the FDA issued an EUA for
bamlanivimab and etesevimab, which are administered together and which
are also authorized for post-exposure prophylaxis for certain high risk
patients.\51\ On April 16, 2021, the FDA revoked the EUA for
bamlanivimab monotherapy.\52\ On May 26, 2021, the FDA issued an EUA
for sotrovimab monotherapy.\53\ On June 3, 2021, the FDA revised the
EUA for casirivimab and imdevimab, which revised the dosing regimen
from 2,400 mg (1200 mg of casirivimab and 1 200 mg of imdevimab) to 1
200 mg (600 mg of casirivimab and 600 mg of imdevimab), authorized the
addition of a new presentation consisting of a single vial of
casirivimab and imdevimab co-formulated in a 1:1 ratio, and also
authorized casirivimab and imdevimab to be administered together via
subcutaneous injection in certain limited circumstances.\54\ On June
24, 2021, the FDA issued an EUA for tocilizumab monotherapy.\55\ We
explained that under the EUAs, all of these products, except for
tocilizumab could be used for certain high-risk patients with mild-to-
moderate COVID-19 with the goal of preventing further deterioration and
hospitalization. Tocilizumab is authorized for hospitalized patients
who are receiving systemic corticosteroids and require supplemental
oxygen, non-invasive or invasive mechanical ventilation, or
extracorporeal membrane oxygenation (ECMO).
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\49\ https://www.fda.gov/media/143602/download.
\50\ https://www.fda.gov/media/143891/download.
\51\ https://www.fda.gov/media/145801/download.
\52\ https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab.
\53\ https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-monoclonal-antibody-treatment-covid-19.
\54\ https://www.regeneron.com/downloads/treatment-covid19-eua-fda-letter.pdf.
\55\ https://www.fda.gov/media/150319/download.
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When these products were granted EUAs during the PHE for COVID-19,
we made the determination to cover and pay for them under the COVID-19
vaccine benefit in section 1861(s)(10) of the Act. When we announced
this approach, we also indicated that we would address ``potential
refinements to payment for administering monoclonal antibody products
to treat COVID-19 through future notice-and-comment rulemaking''.\56\
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\56\ https://www.cms.gov/medicare/covid-19/monoclonal-antibody-covid-19-infusion.
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We make a separate payment for the products (when not given to the
provider or supplier for free by the government) and for the service to
administer them. We noted that as of June 30, 2021, the monoclonal
antibody products authorized by the FDA under an EUA include two
products involving drugs administered together, casirivimab and
imdevimab and bamlanivimab and etesevimab, sotrovimab monotherapy, and
tocilizumab monotherapy. All four products may be administered through
intravenous (IV) infusion, and casirivimab and imdevimab may be
administered via subcutaneous injection in certain limited
circumstances under the updated June 3rd EUA.
Initially, we established a national payment rate of $309.10 for
the service to administer (through IV infusion only at the time) these
products, which was based on one hour of infusion and post-infusion
monitoring in the hospital outpatient setting. We noted that while
these products are typically infused over a period of roughly one hour,
the EUA for casirivimab and imdevimab allows the product to be infused
over a shorter time-period, such as 20 minutes, when appropriate. We
noted that, as of June 15, 2021, the EUAs require at least one hour of
post-infusion monitoring for all of the products available. On May 6,
2021, we increased the payment rate for administration of these
products to $450.00 and established a separate payment rate of $750.00
when a monoclonal antibody product used to treat COVID-19 is
administered in a home or residence.\57\
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\57\ https://www.cms.gov/newsroom/press-releases/cms-increases-medicare-payment-covid-19-monoclonal-antibody-infusions.
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As we further explained in the CY 2022 PFS proposed rule (86 FR
39226), the decision to cover and pay for monoclonal antibody products
used to treat COVID-19 under the COVID-19 vaccine benefit prioritized
access to
[[Page 65191]]
these products during the COVID-19 pandemic by allowing almost all
Medicare enrolled providers and suppliers, as permitted by State law
and consistent with the terms of the EUA, to furnish and bill for
administering these products across settings of care. Covering and
paying for these services under the COVID-19 vaccine benefit also means
that beneficiaries are not responsible for any cost sharing for the
product or the service to administer it. We noted that Medicare
considers other monoclonal antibody products--that is, monoclonal
antibody products used in the treatment of other health conditions--
``biologicals'' and pays for them based on the methodology in section
1847A of the Act when they are furnished in physician offices,
ambulatory infusion clinics and under a similar methodology under the
hospital OPPS. We also noted that, for these care settings, we
typically rely on the applicable AMA CPT codes to describe and pay for
drug administration services performed by providers and suppliers.
As noted above, bamlanivimab monotherapy and casirivimab and
imdevimab, administered together, were authorized in late 2020. At that
time, we made the determination to cover and pay for them under the
vaccine benefit in section 1861(s)(10) of the Act, and this decision
prioritized beneficiary access for purposes of addressing the PHE for
COVID-19. Since that time, the EUA for bamlanivimab monotherapy has
been revoked, the EUA for casirivimab and imdevimab administered
together has been revised to include a new presentation, a new dosing
regimen, and a new route of administration (in certain limited
circumstances) and post-exposure prophylaxis for certain high-risk
patients, sotrovimab monotherapy has been authorized and tocilizumab
monotherapy has been authorized. In the CY 2022 PFS proposed rule (86
FR 39226) we stated that it was also becoming clear that, as more
products enter the market, the Federal Government might not purchase
them for distribution to providers and suppliers for free, as is the
case with sotrovimab monotherapy and tocilizumab monotherapy. We note
that subsequent to the issuance of the CY 2022 PFS proposed rule, the
Federal Government has purchased sotrovimab and will be directing the
distribution of the product beginning mid-October, 2021.
Given these fast-moving changes, we solicited feedback on our
approach to coverage and payment for COVID-19 monoclonal antibody
products under the COVID-19 vaccine benefit. We explained that we are
considering whether we should align payment and coverage for these
products with our approach for other monoclonal antibody products
following the end of the PHE. We further explained that we believe the
context in which these products are furnished to beneficiaries after
the end of the PHE may more closely resemble the circumstances under
which similar drugs and biologics are ordinarily furnished,
specifically to a more targeted patient population outside of a
pandemic. Outside the context of the PHE, we believe treating these
products like other drugs and biologics paid under section 1847A of the
Act may better align Medicare coverage and payment policies for COVID-
19 monoclonal antibody products with other monoclonal antibody
products, which are purchased by providers and suppliers through
similar channels and administered using similar modalities. As noted
above, coverage and payment for COVID-19 monoclonal antibodies under
the COVID-19 vaccine benefit has meant that Medicare beneficiaries are
not responsible for any cost-sharing, which is typically 20 percent of
the allowed amount in most settings. We noted that if Medicare were to
pay for COVID-19 monoclonal antibody products under the methodologies
in 1847A of the Act, it would mean that beneficiary co-insurance would
apply, similar to the way it applies to other drugs and biologics that
are not paid for under a preventive vaccine benefit.
We also noted that tocilizumab--typically sold under the brand name
Actemra[supreg]--was previously approved by the FDA for several
indications.\58\ As a result, during the PHE for COVID-19, Medicare has
separate coding and payment rules for tocilizumab when it is furnished
to patients with COVID-19 and in a manner consistent with the terms of
the EUA, and for when tocilizumab is used for other clinical purposes.
This may be confusing for hospital providers and we believe that
treating these monoclonal antibody products like other drugs and
biologics paid under section 1847A of the Act may help clarify these
inconsistencies. We invited feedback on these issues.
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\58\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125472s044lbl.pdf.
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We also invited additional feedback on the resource costs to
administer COVID-19 monoclonal antibody products, such as costs
associated with infrastructure, clinical labor, and equipment,
including personal protective equipment. We recognize that
administering monoclonal antibodies used to treat COVID-19 may be
complex due the need to interact with beneficiaries that have active
infections and manage the potential for spreading disease. We requested
information on how the costs to furnish monoclonal antibodies used to
treat COVID-19 compare with infusions of other complex biologics, and
how the costs to furnish these products may be different when these
products are administered in the home.
Comment: Commenters offered diverging opinions in response to our
request for information on the coverage of monoclonal antibodies for
the treatment of COVID-19 under the Medicare Part B vaccine benefit.
Several commenters urged CMS to extend payment for COVID-19 monoclonal
antibodies as vaccines beyond the end of the PHE. A few commenters
cited continuing uncertainty regarding the pandemic and the emergence
of new variants as reasons why CMS should defer any changes to its
current policy to future rulemaking cycles, while others emphasized the
importance of maintaining beneficiary access to these treatments,
especially among minority communities. In addition, several commenters
pointed to the development of monoclonal antibodies used for pre-
exposure prophylaxis against COVID-19, stating that such products are
functionally equivalent to vaccines and should therefore be covered
under the COVID-19 statutory vaccine benefit in section 1861(s)(10) of
the Act. On the other hand, we also received comments supporting a
transition to regular Part B payment for COVID-19 monoclonal antibody
treatments following the end of the PHE, including payment for the
products themselves as biologics under section 1847A of the Act. In
particular, several commenters recommended a transition to payment for
COVID-19 monoclonal antibody therapies as biologics following the end
of the year in which the PHE expires, as long as CMS provides clear
guidance about the process and takes steps to mitigate out-of-pocket
expenses for Medicare beneficiaries. One commenter recommended an
extension beyond the PHE of at least two calendar quarters and urged
CMS provide clear guidance to manufacturers on ASP reporting
obligations.
With respect to the specific expenses incurred by providers of
monoclonal antibodies, commenters observed that the current infusion
infrastructure is tailored to non-infectious patients, and indicated
that increased costs for administration of COVID-19 monoclonal antibody
therapies result primarily from measures necessary to mitigate risk and
isolate infectious
[[Page 65192]]
patients. Specific resource costs cited by respondents include:
Isolation of infectious patients in separate rooms or infusion suites;
personal protective equipment for staff; staff training and
implementation of new clinical workflows; reporting requirements; and,
sometimes, increased pharmacy labor to deal with inconsistent product
packaging and labeling.
While several commenters encouraged CMS to extend the additional
payment and associated flexibilities for administration of COVID-19
monoclonal antibody therapies in the home beyond the end of the PHE,
other commenters recommended against in-home administration of these
products, citing concerns over patient safety and the potential for
adverse reactions.
Response: We agree with commenters who recommended CMS transition
to treating COVID-19 monoclonal antibody therapies as biologicals that
are paid using methodologies under section 1847A of the Act following
the end of the calendar year in which the PHE expires. In particular,
we believe that the public health needs that prompted coverage of these
products as vaccines will gradually restabilize following the end of
the PHE, and that extending the current payment approach to the end of
the year will give healthcare providers adequate time to prepare for
the change in payment methodology while continuing to maximize access
to beneficiaries, including those who receive these treatments in the
home. Similar to the continuation policies we are adopting for the $40
payment rate and the in-home add-on payment for COVID-19 vaccine
administration, given the commenters' concurrence with the added costs
and compelling needs that led CMS to provide payment and coverage for
COVID-19 monoclonal antibody therapies under the Medicare Part B
vaccine benefit, we believe this policy is an appropriate one. In
addition, since we do not expect those needs or costs to diminish
immediately with the end of the PHE, we believe it would be appropriate
to continue to provide payment and coverage for COVID-19 monoclonal
antibody therapies under the Medicare Part B vaccine benefit in place
through the end of the CY in which the PHE ends. We recognize that once
the COVID-19 PHE declaration is terminated, EUAs issued under that
declaration will no longer remain in effect,\59\ which may affect the
availability of some products either for the diagnosis, treatment, or
prevention of COVID-19, because they will need to have the requisite
marketing authorization to remain on the market. To the extent there
are products that would no longer have the requisite marketing
authorization to remain on the market after a revocation of an EUA, we
believe a transition period would be appropriate to allow for
adjustments, as needed, to care plans that included such products.
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\59\ https://www.fda.gov/media/97321/download.
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Therefore, we are finalizing a policy to continue to pay for COVID-
19 monoclonal antibody therapeutic products as vaccines under section
1861(s)(10) of the Act until the end of the calendar year in which the
PHE expires. During this interim time, we will continue to pay
providers and suppliers for the products themselves at 95 percent of
Average Wholesale Price (AWP) except when they are provided for free by
the government; we will also maintain the $450 payment rate for
administering a COVID-19 monoclonal antibody in a healthcare setting,
as well as the payment rate of $750 for administering a COVID-19
monoclonal antibody therapy in the home. Starting at the beginning of
the calendar year following the year in which the PHE ends, we will
treat COVID-19 monoclonal antibody therapies as biologics paid under
section 1847A of the Act, and discontinue the unique payment rates of
$450 and $750 for administering a COVID-19 monoclonal antibody product,
which were established to ensure access during the PHE. We note that
under section 1847A of the Act, physicians and suppliers furnishing
COVID-19 monoclonal antibody therapies typically will be paid based on
Average Sales Price (ASP) + 6 percent. In addition, providers and
suppliers will be paid under the applicable payment system, and using
the appropriate coding and payment rates, for administering COVID-19
monoclonal antibodies similar to the way they are paid for
administering other complex biological products.
Comment: A few commenters stated that CMS should continue to make
enhanced payments for COVID-19 monoclonal antibodies even after
transitioning to regular coverage of these services under Medicare Part
B as discussed above. One commenter stated that if payment for COVID-19
monoclonal antibodies is aligned with that for other monoclonal
antibody products, then additional work and PE costs must be factored
in, and CMS must address steep reductions in drug administration
services due to clinical labor pricing update proposal, for example by
providing an enhanced payment when a COVID-19 diagnosis is present on a
claim. Another commenter recommended a $300 COVID-19 therapy modifier
to offset what they described as grossly undervalued professional
service payments for infusion centers.
Response: We believe that the public health needs that prompted
enhanced payments for COVID-19 monoclonal antibodies and administration
services will gradually restabilize following the end of the PHE. As
described in the previous section, extending the current payment
approach to the end of the year in which the PHE ends will give
healthcare providers adequate time to prepare for the change in payment
methodology while continuing to maximize access to beneficiaries.
Comment: One commenter stated that CMS should adjust the
eligibility standards for home-based administration of COVID-19
monoclonal antibodies to align with the more flexible standards that
apply when determining eligibility for the additional payment when a
COVID-19 vaccine is administered in a beneficiary's home. That is, in
order to qualify as homebound for purposes of receiving monoclonal
antibody services in the home, a beneficiary would need to meet the
requirements set forth in the CMS COVID-19 vaccination toolkit.
Response: We thank the commenter for their feedback and will take
it into consideration if we contemplate any future changes to our
policy concerning in-home administration of COVID-19 monoclonal
antibodies.
Comment: We received several comments pertaining to the role of
specific provider types in administering and billing for COVID-19
monoclonal antibodies.
One commenter stated that pharmacists are well-positioned to
increase awareness of and expand access to monoclonal antibody
therapies, and urged CMS to consider supplemental funding for community
pharmacies to develop the infrastructure to administer monoclonal
antibodies onsite. Additionally, the commenter stated that a
significant barrier to maximizing the use of pharmacists to develop
these treatments is inadequate reimbursement for administrative costs
and delays in the processing of claims by Medicare; the commenter
therefore urged CMS to issue pharmacist/pharmacy specific guidance on
pharmacy billing for these therapies outlining specific, rapid turn-
around of Medicare reimbursements for MACs that covers the entirety of
administration costs in a pharmacy setting.
One commenter emphasized the role of urgent care centers in
furnishing
[[Page 65193]]
monoclonal antibody treatment, and stated that simplification of
administrative and reporting requirements would improve urgent care
centers' ability to offer these services.
Another commenter urged CMS to establish a protocol allowing long-
term care pharmacies (LTCPs) to bill independently for the procurement,
preparation and reporting of monoclonal antibody treatment administered
by a long-term care facility (LTCF). The commenter stated that
splitting this fee is currently allowed by CMS, but the division is
conducted as a private, two-party contract between LTCFs and LTCPs, and
that providing a mechanism to reimburse each party for their efforts
would provide CMS with better data related to the use of monoclonal
antibodies to combat COVID-19 and other public health threats.
In addition, one commenter emphasized the role of home infusion
pharmacies in providing monoclonal antibody treatment, both in
beneficiaries' homes and in pharmacy-owned infusion suites. The
commenter observed that, after the PHE, administration of monoclonal
antibodies for COVID-19 in the home would not be covered under the
standard Part B benefit without additional flexibilities, and
therefore, urged CMS to maintain coverage of these products as vaccines
until the establishment of a similar benefit that allows a licensed
home infusion pharmacy to provide COVID-19 treatments in the home or in
a pharmacy-owned and operated infusion suite at the current payment
rates for each site of care.
Response: We believe that, following the end of the PHE, the public
health needs that prompted coverage and payment of COVID-19 monoclonal
antibody therapies (and their administration) under the Part B vaccine
benefit will gradually restabilize. As discussed in the previous
section, extending the current payment approach to the end of the year
in which the PHE ends will give healthcare providers adequate time to
prepare for the change in payment methodology while continuing to
maximize access to beneficiaries, including those who receive these
therapies in the home.
Comment: Several commenters urged CMS to update the FQHC cost
report to ensure adequate reimbursement for monoclonal antibody
infusions at 100 percent of reasonable cost.
Response: We appreciate the commenters' feedback. However, we did
not discuss or include proposals on FQHC cost reports in the CY 2022
PFS proposed rule. As such, these comments are outside the scope of
this rulemaking, but we will take these comments into consideration for
the future.
4. Summary
We have taken several steps to promote broad and timely access to
COVID-19 vaccines, including monoclonal antibody products used to treat
COVID-19 paid for as vaccines, during the PHE for COVID-19. We
appreciate the feedback we have received from the public on these
important issues regarding preventive vaccine administration, vaccine
administration in the home, and administration of monoclonal antibody
products used to treat COVID-19.
In summary, for CY 2022, we are finalizing the following policies:
Administration of Preventive Vaccines
Effective January 1, 2022, CMS will pay $30 per dose for the
administration of the influenza, pneumococcal and hepatitis B virus
vaccines. In addition, CMS will maintain the current payment rate of
$40 per dose for the administration of the COVID-19 vaccines through
the end of the calendar year in which the ongoing PHE ends. Effective
January 1 of the year following the year in which the PHE ends, the
payment rate for COVID-19 vaccine administration will be set at a rate
to align with the payment rate for the administration of other Part B
preventive vaccines.
In-Home Administration of COVID-19 Vaccines
CMS will continue the additional payment of $35.50 for COVID-19
vaccine administration in the home under certain circumstances through
the end of the calendar year in which the PHE ends.
COVID-19 Monoclonal Antibody Products
CMS will continue to pay for COVID-19 monoclonal antibodies under
the Medicare Part B vaccine benefit through the end of the calendar
year in which the PHE ends. During this interim time, we will maintain
the $450 payment rate for administering a COVID-19 monoclonal antibody
in a healthcare setting, as well as the payment rate of $750 for
administering a COVID-19 monoclonal antibody therapy in the home.
Effective January 1 of the year following the year in which the PHE
ends, CMS will pay physicians and other suppliers for COVID-19
monoclonal antibody products as biological products paid under section
1847A of the Act; healthcare providers and practitioners will be paid
under the applicable payment system, and using the appropriate coding
and payment rates, for administering COVID-19 monoclonal antibodies
similar to the way they are paid for administering other complex
biological products.
Table 32 summarizes the policy changes finalized in this final
rule.
[[Page 65194]]
[GRAPHIC] [TIFF OMITTED] TR19NO21.054
K. Payment for Medical Nutrition Therapy Services and Related Services
Section 105 of the Medicare, Medicaid, and SCHIP Benefits
Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554,
December 21, 2000) added section 1861(vv)(1) to the Act which provided
Medicare coverage under Part B for Medical Nutrition Therapy (MNT)
services when performed by registered dietitians and nutrition
professionals pursuant to a referral from a physician.
Under section 1842(b)(18)(C) of the Act, registered dietitians and
nutrition professionals are included in the list of NPPs that may bill
Medicare and be paid directly for their services, effective January 1,
2002. To submit claims for MNT services, the registered dietitian or
nutrition professional must enroll as such in accordance with our
regulations at 42 CFR 414.64 and 424.510. Like other NPPs listed in
section 1842(b)(18)(C) of the Act, registered dietitians and nutrition
professionals who are employees or independent contractors of hospitals
or physician groups may reassign their rights to receive payment to
that hospital or physician group, as appropriate. The Medicare
specialty code for ``dietitian/nutritionist'' is 71.
Under section 1833(a)(1)(T) of the Act, we were originally required
to pay for MNT services at 80 percent of the lesser of the actual
charge for the services or 85 percent of the amount determined under
the PFS for the same services if the services had been furnished by a
physician. We established payment regulations for MNT in our regulation
at Sec. 414.64 in the CY 2002 PFS final rule (66 FR 55278 through
55281 and 55332).
MNT services are defined as nutritional diagnostic, therapeutic,
and counseling services that are furnished by a registered dietitian or
nutrition professional for the purpose of managing diabetes or a renal
disease. These practitioners use three CPT[supreg] codes to bill for
MNT assessment and intervention services with the referral of a
physician. In cases where there is a second physician referral for MNT
for the same patient within a calendar year (for example, based on a
change in the patient's condition, diagnosis, or treatment regimen),
the furnishing practitioner uses two other HCPCS codes to report these
episodes. We have worked with stakeholders over the years to establish
values for the services described by the five MNT codes.
The importance of MNT services for managing diabetes or renal
disease, as well as the underutilization of the benefit by Medicare
beneficiaries were discussed in the proposed rule at section III.I. (86
FR 39259 through 39261). More recently, stakeholders who were concerned
about the low utilization rate for the services have requested that CMS
make changes geared toward making MNT services more accessible to
Medicare beneficiaries. These stakeholders believe the underutilization
of MNT services is due to multiple factors. Some of these factors and
our proposals to address them are discussed elsewhere in this final
rule (see section III.I.), including proposals to remove the
requirement that the MNT referral be made by the ``treating physician''
and update the glomerular filtration rate (GFR) eligibility criteria to
reflect current medical practice. First, stakeholders recommended that
we modify the Medicare Claims Processing Manual (MCPM) to increase the
visibility of MNT services by moving the provisions that address these
services to appear near the provisions addressing other preventive
services. (We note that MNT services are included in the definition of
preventive services under section 1861(ddd)(3)(A) of the Act). Second,
the stakeholders recommended that we revise our Medicare Benefit Policy
Manual to address registered dietitians and nutrition professionals,
and the MNT services they furnish, in a way that aligns with the
provisions addressing other types of practitioners and the services
they furnish.
We established the MNT regulations in the CY 2002 PFS final rule at
Sec. 410.130 through Sec. 410.134 and Sec. 414.64. There have since
been two significant changes to payment for MNT services, which are
discussed in more detail below: (1) We added MNT services to the
Medicare telehealth services list and recognized that registered
dietitians and nutrition professionals can furnish and bill for these
services as distant site practitioners; and (2) section 4104 of the
[[Page 65195]]
Affordable Care Act (ACA) amended the statute to remove application of
the Medicare Part B deductible and coinsurance for MNT services
effective January 1, 2011. In the CY 2006 PFS final rule (70 FR 70155
through 70157), we amended our regulation to add registered dietitians
and nutrition professionals to the list of distant site practitioners
for telehealth services at Sec. 410.78(b)(2)(viii), and to add the
three individual MNT services to the Medicare telehealth services list
by adding ``individual medical nutrition therapy'' to Sec.
414.65(a)(1). In the CY 2011 PFS final rule, we also added one of the
group MNT codes (97804) to the Medicare telehealth services list (75 FR
73314 through 73315). Although the codes for individual MNT services
were recognized as telehealth services beginning in CY 2006, a recent
claims query (prior to the PHE for COVID-19) showed low utilization of
MNT services via telehealth by registered dietitians and nutrition
professionals.
In the CY 2011 PFS final rule, (75 FR 73412 through 73430), we
implemented the amendments made by section 4104 of the ACA, which were
designed to remove financial barriers that may have prevented
beneficiaries from obtaining certain preventive services. Section 4104
of the ACA amended section 1833(a)(1) of the Act by adding a new
subparagraph (Y), which provides for Medicare Part B payment at 100
percent for preventive services described in section 1861(ddd)(3)(A) of
the Act that are recommended with a grade of A or B by the United
States Preventive Services Task Force (USPSTF); and, amended section
1833(b)(1) of the Act to specify that the annual Medicare Part B
deductible does not apply to preventive services with a recommended
grade of A or B by the USPSTF. Section 1861(ddd)(3) of the Act defines
``preventive services'' and includes MNT services as a preventive
service through a cross reference to section 1861(ww)(2) of the Act.
Additionally, section 4104 of the ACA amended section 1833(a)(1)(T) of
the Act to specify that Medicare Part B payment is made at 100 percent
(instead of 80 percent) of the lesser of the actual charge or 85
percent of the PFS payment amount for these services if they are
recommended with an A or B rating by the USPSTF, thereby removing
beneficiary coinsurance for these services. In the CY 2011 PFS final
rule, we listed all preventive services and their recommended ratings
from the USPSTF in Table 66 (66 FR 73420 through 73430), noting that
all 5 MNT services received a grade of B from the USPSTF; and the last
column in the table noted that the coinsurance and deductible are not
applicable to these services beginning January 1, 2011. We codified the
coinsurance exception for MNT services at Sec. 410.152(l)(7) to
indicate that Medicare Part B pays 100 percent of the Medicare payment
amount; and codified the exception for the Medicare Part B deductible
at Sec. 410.160(b)(11).
At that time, the preventive services coinsurance and deductible
changes were implemented through Change Request 7012 (Transmittal 864);
however, we neglected to update the payment regulation for MNT services
at Sec. 414.64(a). As a result, we proposed in the CY 2022 PFS
proposed rule to modify the regulation at Sec. 414.64(a) to clarify
that MNT services, with their USPSTF recommended B rating, are paid at
100 percent of the lesser of the actual charges or 85 percent of the
PFS amount. In the proposed regulation text at Sec. 414.64(a), we made
an inadvertent typographical error, using ``or'' instead of ``of.'' We
are correcting the error here in this final rule so that Sec.
414.64(a) provides that payment is made at 80 percent, or 100 percent
if the service is recommended by the United States Preventive Services
Task Force with a grade of A or B, ``of'' the lessor of the actual
charge or 85 percent of the physician fee schedule amount.
Because the registered dietitian and nutrition professional are the
only practitioner types listed at section 1842(b)(18)(C) of the Act
without a specific regulatory provision addressing them as a type of
practitioner and specifying payment policies for their services, we
proposed to create a new section at Sec. 410.72 to reflect these
practitioners and related payment policies. We proposed to include in
the regulation at Sec. 410.72 a cross reference to the regulation at
Sec. 410.134 that addresses the qualifications for registered
dietitians and nutrition professionals. For covered services described
at Sec. 410.72(b), we proposed as a condition of coverage to refer to
medical nutrition therapy services as defined at Sec. 410.130, and
also to refer to the conditions for coverage of MNT services at Sec.
410.132(a). Section 410.132(a) requires a referral for MNT services
from a physician (an M.D. or D.O.), and that MNT services are performed
by the registered dietitian or nutrition professional in a face-to-face
encounter except when those services are furnished as a telehealth
service as provided in Sec. 410.78 of our regulations.
Because registered dietitians and nutrition professionals are also
the primary specialty that furnishes diabetes self-management training
(DSMT) services, we proposed to include DSMT at Sec. 410.72(b)(2) as
an ``other service'' that registered dietitians and nutrition
professionals can provide in cases where the registered dietitian or
nutrition professional is a certified provider of DSMT services as
specified at section 1861(qq)(2)(A) of the Act; and they have submitted
necessary documentation to, and are accredited by, a CMS-approved
accreditation organization, as specified in Sec. 410.141(e) for DSMT
services. We also proposed to address in the regulation at Sec.
410.72(b)(2) the current requirement that, as specified in the
regulation at Sec. 410.141(b)(1), DSMT services require a referral
from the physician or qualified NPP (as defined in Sec. 410.32(a)(2))
who is treating the beneficiary's diabetes condition. We also proposed
to specify in the regulation at Sec. 410.72(b)(3) that MNT and DSMT
services cannot be furnished together on the same date of service as
detailed in the national coverage determination for MNT services (see
https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?ncdid=252); and, that neither MNT nor DSMT services can be
furnished incident to the professional services of a physician or other
practitioner. For MNT services, we proposed to clarify that MNT
services cannot be provided incident to the services of a billing
physician. As a distinct, stand-alone benefit under Medicare Part B at
section 1861(s)(2)(V) of the Act, MNT services cannot be furnished
incident to a physician's professional service that is separately
specified at section 1861(s)(2)(A) of the Act. Further, if a physician
also meets the qualifications to bill Medicare as a registered
dietitian or nutrition professional (although not necessarily enrolled
as one), they would have to personally provide any MNT services as
explained above, meaning that those services could not be furnished by
auxiliary personnel incident to their own professional services. For
DSMT services, we also proposed to clarify that DSMT services cannot be
provided incident to the services of a billing physician or
practitioner. DSMT is a distinct benefit under Medicare Part B, as
specified in a stand-alone statutory provision at section 1861(s)(2)(S)
of the Act. Approved DSMT entities are separately recognized programs,
rather than individuals or practitioners, that provide DSMT services in
accordance with their accreditation from a CMS-approved organization
under Sec. 410.142, indicating that the entity meets a set of quality
standards described in
[[Page 65196]]
Sec. 410.144. Even when the DSMT services are billed by a physician or
other practitioner, such as the DSMT certified provider, the physician
or other practitioner could not provide DSMT services directly, unless
they themselves are also an approved DSMT entity. If a physician or
practitioner is an approved entity, the DSMT services must be provided
in accordance with the requirements to furnish such services. For these
reasons, we proposed to add at Sec. 410.72(b)(3)(ii) that neither MNT
nor DSMT may be furnished and billed incident to the professional
services of a physician or practitioner, where applicable.
Given the foregoing, we proposed to add at Sec. 410.72(d) that the
registered dietitian or nutrition professional can be paid for their
professional services only if those services have been personally
performed by them. Section 1861(vv) of the Act clearly indicates that
MNT services are only provided by registered dietitians and nutrition
professionals; and this was reiterated at Sec. 410.134 as established
in the CY 2002 PFS final rule (66 FR 55331). In addition, the
regulation at Sec. 410.132(a) specifies that MNT services consist of
face-to-face nutritional assessments and interventions in accordance
with nationally accepted dietary or nutritional protocols. After we
issued the CY 2022 PFS proposed rule, we reviewed the proposed
regulation text at Sec. 410.72(d) regarding the requirement that
professional services of registered dietitians and nutrition
professionals must be ``personally performed'' by them. We noted that
the term, ``personally performed'' is used in 42 CFR part 410 of the
regulations to describe services furnished both directly and incident
to the services of other types of practitioners that are authorized by
the statute to furnish and bill Medicare for covered services incident
to their own professional services. Registered dietitians and nutrition
professionals are not authorized by the statute to furnish and bill
Medicare for services incident to their professional services. Upon
further reflection, we are concerned that the reference to ``personally
performed'' in the proposed regulation text at Sec. 410.72(d) could
potentially be confusing when applied to services of registered
dietitians and nutrition professionals. To avoid any potential
confusion, we are clarifying that registered dietitians and nutrition
professionals may bill Medicare only for professional services that
they furnish directly to the beneficiary. For the same reasons, we are
also modifying and finalizing our proposed regulation text to
substitute ``directly'' for ``personally'' in Sec. 410.72(d).
In the CY 2022 PFS proposed rule, we included proposed regulation
text at Sec. 410.72(g) to specify that MNT and DSMT services may be
provided as telehealth services (meeting the requirements in Sec.
410.78) when registered dietitians or nutrition professionals act as
distant site practitioners. While we did explain as noted above that
registered dietitians and nutrition professionals were added to the
list of distant site practitioners for telehealth services in Sec.
410.78 of our regulation in the CY 2006 PFS final rule, we neglected to
discuss the proposed regulation text at Sec. 410.72(g) in the preamble
to the CY 2022 PFS proposed rule. The proposed regulation text at Sec.
410.72(g) essentially provides a cross-reference to longstanding policy
codified in Sec. 410.78 beginning in CY 2006. We received no comments
on this proposed regulation text. We also discovered typographical
errors in the proposed regulation text at Sec. 410.72(g) after the CY
2022 PFS proposed rule was issued. The DSMT acronym was misspelled as
``DMST'' and we left out the ``s'' at the end of ``telehealth
services.'' In this final rule, we are correcting these two errors and
otherwise finalizing the regulation text at Sec. 410.72(g) as
proposed.
In the CY 2002 PFS final rule (which we cited correctly but
inadvertently misidentified in the CY 2022 PFS proposed rule as the CY
2001 PFS final rule), we discussed that registered dietitians and
nutrition professionals who are enrolled in Medicare could furnish
services in various settings including private practices and outpatient
hospitals, but that separate payment for MNT services would not be made
when beneficiaries are inpatients in Part A stays in hospitals and SNFs
(66 FR 55279). We explained that our payment to hospitals and SNFs
includes payment for MNT services. We established these conditions of
payment in the regulation at Sec. 414.64(e) (which we inadvertently
cited incorrectly in the CY 2022 PFS proposed rule as Sec. 414.64(c)).
We proposed to add these conditions of payment to our regulation at
Sec. 410.72(c)(1) and (2), to address payment for services of
registered dietitians and nutrition professionals when beneficiaries
are inpatients of hospitals and SNFs. Also, in the CY 2002 PFS final
rule, we finalized, in accordance with section 1861(s)(2)(V)(ii) of the
Act, that there is no coverage for MNT services available for
beneficiaries who are receiving maintenance dialysis for which payment
is made under section 1881 of the Act, that is, services from an end-
stage renal disease (ESRD) facility. We codified this policy at Sec.
410.132(b) of our regulations. We proposed to add this rule to our
regulation at Sec. 410.72(c)(3) through a cross-reference to Sec.
410.132(b).
In accordance with section 1842(b)(18)(B) of the Act, the
registered dietitian or nutrition professional must accept assignment,
meaning that they must accept the payment amount Medicare approves as
payment in full and collect nothing from the beneficiaries for those
services for which Medicare pays 100 percent of the Medicare approved
amount or only collect the difference between the Medicare approved
amount and the Medicare Part B payment in accordance with Sec. 424.55.
We proposed to add at Sec. 410.72(f) that the services of a registered
dietitian or nutrition professional are provided on an assignment-
related basis. Because Medicare pays 100 percent of the Medicare
approved amount for MNT covered services, this means that beneficiaries
cannot be billed any amount for MNT covered services. For other
services, including DSMT, for which the Medicare Part B coinsurance
percentage is 20 percent, a registered dietitian or nutrition
professional must not collect amounts in excess of the limits specified
in Sec. 424.55 of our regulation, and if they do, they must refund the
full amount of the impermissible charge to the beneficiary. Finally, we
noted that the proposed regulatory text for Sec. 410.72(f) is
consistent with the text in existing regulations for other types of
NPPs at Sec. Sec. 410.74(d)(2), 410.75(e)(2), 410.76(e)(2) and
410.77(d)(2). We also considered whether alternate regulatory text that
cross-references the assignment requirements in Sec. 424.55 would
provide additional clarity. Specifically, we considered whether to
specify within Sec. 410.72(f) that the services of a registered
dietitian or nutrition professional are provided on an assignment-
related basis; the registered dietitian or nutrition professional may
not charge a beneficiary in excess of the amounts permitted under 42
CFR 424.55; and if a beneficiary has made payment for a service in
excess of these limits, the registered dietitian or nutrition
professional must refund the full amount of the impermissible charge to
the beneficiary.
To ensure maximum consistency in our regulations, we stated that if
we finalize the alternate regulatory text for Sec. 410.72(f), we would
also make corresponding revisions to Sec. Sec. 410.74(d)(2),
410.75(e)(2), 410.76(e)(2) and 410.77(d)(2). We
[[Page 65197]]
solicited public comments on the clearest language to describe the
assignment requirements, as well as the rest of our proposals.
We received public comments on our proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters appreciated and commended our proposal
to clarify and codify payment for MNT services at Sec. 414.64(a) to
reflect that MNT services, with their USPSTF recommended B rating, are
paid at 100 percent of the PFS amount, rather than 80 percent.
Response: We thank the commenters for their support.
Comment: Some commenters offered support for all the proposed
changes to regulations related to the Part B MNT benefit and expressed
their agreement with our reasons for proposing the changes. Other
commenters expressed support for the proposed regulatory text that
includes specific payment policies for registered dietitians and
nutrition professionals who are recognized to bill Medicare directly
for the MNT services they provide.
Response: CMS appreciates the many commenters' support.
Comment: One commenter asked whether a physician (MD or DO) can
``co-sign'' an MNT referral made by an NPP they are supervising, for
example, when the physician and NP or PA are practicing under a
collaborative practice agreement as required by State law. The
commenter added that NPPs manage and coordinate care for many
individuals with diabetes and earlier stages of chronic kidney disease
(CKD) in both urban and rural areas--suggesting that it would be
appropriate to permit these NPPs to refer patients for MNT. We also
received several comments about the possibility of expanding the
referral requirement for MNT services to include other physicians such
as optometrists and certain NPPs, including PAs and NPs.
Response: As discussed in the proposed rule, section 1861(vv)(1) of
the Act expressly requires that the referral for MNT services must be
from a physician--an M.D. or D.O. as defined in section 1861(r)(1) of
the Act. We interpret this requirement to mean that the MNT referral
must come directly from an M.D. or D.O., and not through a
``cosignature'' on a referral from another type of physician or
practitioner. Therefore, we are not expanding the referral requirement
to include other physicians or practitioners as these commenters
requested.
Comment: One commenter requested that we provide clarification for
our statement in the proposed rule regarding limitations on payment to
registered dietitians and nutrition professionals at Sec. 410.72(c).
The commenter specifically asked us to explain our statement that the
payment CMS makes to hospitals and SNFs for their Medicare
beneficiaries who are inpatients includes payment for MNT services.
Response: We appreciate the commenter's interest in payment for MNT
services under the PFS and the opportunity to clarify our statement. In
developing the proposed regulation at Sec. 410.72, we included the
restrictions on separate payment for MNT as discussed in the CY 2002
PFS final rule and codified at Sec. 414.64(e), which specifies that
separate payment for MNT services is made only if the beneficiary is
not an inpatient of a hospital, SNF, nursing home or hospice; and is
not receiving services in an RHC, FQHC or ESRD facility. We did not
propose to revise our policy in this regard; only to reiterate it under
the proposed new regulation at Sec. 410.72 that pertains to registered
to dietitians and nutrition professionals and the services they
furnish.
Comment: We received comments from several organizations that were
supportive of our proposals to reduce barriers and improve access to
MNT services, but expressed the view that the proposals did not go far
enough to achieve those goals. They noted that Medicare Advantage plans
often cover MNT for other conditions in addition to the Medicare
coverage of MNT for patients with diabetes and CKD, and urged us to
expand access to MNT for other conditions as appropriate, including
mental health conditions (such as eating disorders).
Response: Currently, section 1861(s)(2)(V) of the Act provides a
benefit for MNT services only for beneficiaries with diabetes or a
renal disease. The scope of the statutory Medicare Part B benefit for
MNT does not allow for expansion to additional diagnoses/conditions.
Comment: We received other comments that were not specific to the
discussion and proposals made in the CY 2022 PFS proposed rule. For
example, a few commenters requested that we provide additional clarity
in the Medicare Claims Processing and Benefit Policy Manuals on
coverage and billing procedures for MNT and DSMT services under the PFS
in all settings, including hospital clinics, FQHCs, RHCs, and CAHs; and
one commenter wanted CMS and Congress to address multiple access
barriers to the DSMT benefit.
Response: We thank the commenters for their feedback and will take
this information into consideration for the future. We look forward to
working with stakeholders to consider and work toward increasing
appropriate access to MNT and DSMT services. However, these comments
are outside the scope of this rulemaking, and we decline to respond to
them here.
We did not receive comments in response to our request for comments
on the clearest language to describe the assignment requirements for
registered dietitians and nutrition professionals. As noted in the
proposed rule and specified at section 1842(b)(18)(B) of the Act,
registered dietitians and nutrition professionals are required to
provide services on an assignment-related basis. We proposed to add
regulation text at the new Sec. 410.72(f) that mirrors the current
regulation text to reflect the requirements for payment on an
assignment-related basis for other types of NPPs in Sec. Sec.
410.74(d)(2), 410.75(e)(2), 410.76(e)(2) and 410.77(d)(2). We also
indicated that we were considering whether to adopt alternate
regulation text at Sec. 410.72(f) that would reflect the requirements
for payment on an assignment-related basis through a cross-reference to
the regulation at Sec. 424.55, and whether that approach would provide
greater clarity. Specifically, we said we were considering whether to
specify in Sec. 410.72(f) that the services of a registered dietitian
or nutrition professional are provided on an assignment-related basis,
and the registered dietitian or nutrition professional may not charge a
beneficiary in excess of the amounts permitted under Sec. 424.55; and
that if a beneficiary has made payment for a service in excess of these
limits, the registered dietitian or nutrition professional must refund
the full amount of the impermissible charge to the beneficiary. We
stated that if we finalized the alternate approach to regulation text
for Sec. 410.72(f), to ensure maximum consistency across our
regulations, we would make corresponding revisions to the regulations
at Sec. Sec. 410.74(d)(2), 410.75(e)(2), 410.76(e)(2), and
410.77(d)(2). After further reflection, we believe that alternate text
that cross-refers to the assignment requirements at Sec. 424.55
provides greater clarity, and helpfully cross-refers to the current
regulation that specifies the requirement for billing on an assignment-
related basis. Therefore, we are adopting the alternate approach we
described in the proposed rule and finalizing alternate
[[Page 65198]]
regulatory text to specify that the registered dietitian's or nutrition
professional's services are provided on an assignment-related basis,
and the registered dietitian or nutrition professional may not charge a
beneficiary in excess of the amounts permitted under 42 CFR 424.55.
Additionally, the registered dietitian or nutrition professional must
refund the full amount of the impermissible charge to the beneficiary,
if a beneficiary has made payment for a service in excess of these
limits.
Given that we are finalizing the alternate regulatory text for
Sec. 410.72(f), as we noted in describing the alternate approach to
the regulation text at Sec. 410.72(f) in our proposed rule, to ensure
consistency in our regulations, we are also finalizing conforming
revisions to Sec. Sec. 410.74(d)(2), 410.75(e)(2), 410.76(e)(2) and
410.77(d)(2), of our regulations for PAs, NPs, CNSs, and certified
nurse mid-wives, respectively.
After consideration of public comments, we are finalizing our
proposals, with modifications explained above, to amend the regulation
at Sec. 414.64(a) to reflect that MNT services are paid at 100 percent
(instead of 80 percent) of 85 percent of the Medicare PFS approved
amount without cost sharing; and to add the regulation at Sec. 410.72
to address registered dietitians and nutrition professionals and
payment for their services. We are also finalizing revisions to the
regulations at Sec. Sec. 410.74(d)(2), 410.75(e)(2), 410.76(e)(2) and
410.77(d)(2) to remove current language addressing the requirements of
payment on an assignment-related basis and to instead cross-refer to
those requirements as specified in the current regulation at Sec.
424.55.
III. Other Provisions of the Proposed Rule
A. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs)
1. Background
a. RHC and FQHC Payment Methodologies
As discussed in 42 CFR part 405, subpart X, RHC and FQHC visits
generally are face-to-face encounters between a patient and one or more
RHC or FQHC practitioners during which one or more RHC or FQHC
qualifying services are furnished. RHC and FQHC practitioners are
physicians, NPs, PAs, CNMs, clinical psychologists (CPs), and clinical
social workers, and under certain conditions, a registered nurse or
licensed practical nurse furnishing care to a homebound RHC or FQHC
patient in an area with a shortage of home health agencies. A
Transitional Care Management (TCM) service can also be paid by Medicare
as an RHC or FQHC visit. In addition, a Diabetes Self-Management
Training (DSMT) service or a Medical Nutrition Therapy (MNT) service
furnished by a certified DSMT or MNT program may also be considered an
FQHC visit for Medicare payment purposes. Only medically necessary
medical, mental health, or qualified preventive health services that
require the skill level of an RHC or FQHC practitioner are RHC or FQHC
billable visits. Services furnished by auxiliary personnel (for
example, nurses, medical assistants, or other clinical personnel acting
under the supervision of the RHC or FQHC practitioner) are considered
incident to the visit and are included in the per-visit payment.
RHCs generally are paid an all-inclusive rate (AIR) for all
medically necessary medical and mental health services and qualified
preventive health services furnished on the same day (with some
exceptions). The AIR is subject to a payment limit, meaning that an RHC
will not receive any payment beyond the specified limit amount. As of
April 1, 2021, all RHCs are subject to a payment limit for the AIR, and
this limit will be determined for each RHC in accordance with section
130 of the Consolidated Appropriations Act, 2021 as described below.
FQHCs were paid under the same AIR methodology until October 1,
2014. Beginning that date, in accordance with section 1834(o) of the
Act (as added by section 10501(i)(3) of the Affordable Care Act), they
began to transition to an FQHC PPS system in which they are paid based
on the lesser of the FQHC PPS rate or their actual charges. The FQHC
PPS rate is adjusted for geographic differences in the cost of services
by the FQHC PPS geographic adjustment factor (GAF). The rate is
increased by 34 percent when an FQHC furnishes care to a patient that
is new to the FQHC, or to a beneficiary receiving an initial preventive
physical examination (IPPE) or has an annual wellness visit (AWV).
Both the RHC AIR and FQHC PPS payment rates were designed to
reflect the cost of all services and supplies that an RHC or FQHC
furnishes to a patient in a single day. The rates are not adjusted for
the complexity of the patient health care needs, the length of the
visit, or the number or type of practitioners involved in the patient's
care.
2. Payment Methodology for RHCs
a. Background
As we discussed previously, under Medicare Part B, payment to RHCs
for services (defined in Sec. 405.2411) furnished to beneficiaries is
made on the basis of an all-inclusive payment methodology subject to a
maximum payment per-visit (discussed in section III.A.3. of this final
rule) and annual reconciliation. Our regulations at Sec. 405.2470
provides that RHCs are required to submit cost reports to allow the
Medicare Administrative Contractor (MAC) to determine payment in
accordance with 42 CFR part 405, subpart X, and instructions issued by
CMS. The statutory payment requirements for RHC services are set forth
at section 1833(a)(3) of the Act, (as amended by the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 \60\),
which states that RHCs are paid reasonable costs * * * less the amount
a provider may charge as described in clause of section 1866(a)(2)(A)
of the Act, but in no case may the payment exceed 80 percent of such
costs. The beneficiary is responsible for the Medicare Part B
deductible and coinsurance amounts. Section 1866(a)(2)(A)(ii) of the
Act and implementing regulations at Sec. 405.2410(b) establish
beneficiary coinsurance at an amount not to exceed 20 percent of the
clinic's reasonable charges for covered services.
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We explain in Sec. 405.2464(a) the AIR is determined by the MAC at
the beginning of the cost reporting period. The MAC calculates the AIR
that will apply for the upcoming cost reporting period for each RHC by
dividing the estimated total allowable costs by estimated total visits
for RHC services. The MAC also periodically reviews the AIR throughout
the cost reporting period to assure that payments approximate actual
allowable costs and visits and may adjust the rate. Productivity,
payment limits, and other factors are also considered in the
calculation. Allowable costs must be reasonable and necessary and may
include practitioner compensation, overhead, equipment, space,
supplies, personnel, and other costs incident to the delivery of RHC
services (Sec. 405.2468).
Medicare payment for RHC services are ultimately determined at cost
report settlement. That is, during the annual reconciliation as
explained in Sec. 405.2466, MACs determine the total reimbursement
amount due the RHC for
[[Page 65199]]
covered services furnished to Medicare beneficiaries based on the
reporting period. The total reimbursement amount due is compared with
total payments made to the RHC for the reporting period, and the
difference constitutes the amount of the reconciliation. If the total
reimbursement due to the RHC exceeds the payments made for the
reporting period, the MAC makes a lump-sum payment to the RHC to bring
total payments into agreement with total reimbursement due the RHC. If
the total payments made to an RHC for the reporting period exceed the
total reimbursement due the RHC for the period, the MAC arranges with
the RHC for repayment.
In the event a new RHC is in its initial reporting period, and the
MAC does not have a cost report to set its AIR, the RHC provides the
MAC an estimate of what it expects its costs to be for its initial
reporting period. In the Provider Reimbursement Manual (Pub. 15-2),
chapter 46, section 4600,\61\ we explain that for an RHC's initial
reporting period, the clinic completes the cost report's worksheets
with estimates of costs and visits and other information required by
the reports. The MAC uses these estimates to determine an interim rate
of payment for the RHC. This interim rate may be adjusted throughout
the reporting period. Following the end of the RHC's reporting period,
the RHC is required to submit its worksheets, using data based on its
actual experience for the reporting period. The AIR for the following
year will then be based on the RHC's actual experience.
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As discussed in Pub. 100-02, Chapter 13, section 80.2,\62\ when
RHCs are part of the same organization with more than one RHC, they may
elect to file consolidated cost reports rather than individual cost
reports. Under this type of reporting, each RHC in the organization
need not file individual cost reports. Rather, the group of RHCs may
file a single report that accumulates the costs and visits for all RHCs
in the organization. In order to qualify for consolidation reporting,
all RHCs in the group must be owned, leased, or through any other
agreement, controlled by one organization.
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3. RHC Payment Limit Per-Visit
a. Background
Prior to the Balanced Budget Act of 1997 \63\ (BBA), the payment
methodology for an RHC depended on whether it was ``provider-based'' or
``independent.'' Specifically, payment to provider-based RHCs for
services furnished to Medicare beneficiaries was made on a reasonable
cost basis by the provider's MAC in accordance with the regulations at
42 CFR part 413; whereas payment to independent RHCs for services
furnished to Medicare beneficiaries was made on the basis of a uniform
all-inclusive rate payment methodology in accordance with 42 CFR part
405, subpart X. In addition, payment to independent RHCs also was
subject to a maximum payment per visit (also referred to as a ``payment
limit per-visit'', ``upper payment limit per-visit'', or ``cap'') as
set forth in section 1833(f) of the Act. This national statutory
payment limit was set at $46 and was adjusted annually based on the
Medicare Economic Index (MEI) described in section 1842(b)(3) of the
Act.
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Section 1833(f) of the Act was further amended by section 4205(a)
of the BBA) (Pub. L. 105-33) to permit an exception to the national
statutory payment limit for RHCs based in rural hospitals with less
than 50 beds. Our guidance directed Medicare intermediaries to use the
bed definition at Sec. 412.105(b) and the rural definition at Sec.
412.62(f)(1) to determine which RHCs are eligible for the exception.
The hospital bed definition was based on available bed days and the
rural definition was based on the Office of Management and Budget's
metropolitan statistical area (MSA) method.
Section 224 of the Medicare, Medicaid and SCHIP Benefits
Improvement and Protection Act of 2000 (Appendix F of Consolidated
Appropriations Act of 2001) (BIPA) \64\ (Pub. L. 106-554, December 21,
2000) further amended section 1833(f) of the Act by expanding the
eligibility criteria for receiving an exception to the national
statutory payment limit for RHCs. Specifically, this section of BIPA
extended the exemption to RHCs based in small, urban hospitals.
Effective July 1, 2001, all hospitals of less than 50 beds were
eligible to receive an exception from the per visit payment limit for
their RHCs.
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As discussed in Change Request 1958, Transmittal A-01-138 issued on
December 6, 2001, following the implementation of the BBA provision,
CMS announced an alternative bed size definition for very rural, sole
community hospitals with seasonal fluctuations in patient census. The
MAC reviews the number of beds twice a year to determine whether the
provider-based RHC meets the exception, during the Desk Review process
and during the interim rate process (that is, determining the RHC's
AIR). The provider-based RHC continues to receive the exception until
the hospital which they are affiliated with submits a cost report with
more than 50 beds. However, in the May 8, 2020 Federal Register, in
response to the PHE for COVID-19, we published the ``Medicare and
Medicaid Programs, Basic Health Program, and Exchanges; Additional
Policy and Regulatory Revisions in Response to the COVID-19 Public
Health Emergency and Delay of Certain Reporting Requirements for the
Skilled Nursing Facility Quality Reporting Program'' interim final rule
with comment period (85 FR 27550) (May 8, 2020 IFC). In the May 8, 2020
IFC, we implemented, on an interim basis, a change to the period of
time used to determine the number of beds in a hospital at Sec.
412.105(b) for purposes of determining which provider-based RHCs are
subject to the payment limit (85 FR 27569). That is, for the duration
of the PHE, we adopted an interim final policy to use the number of
beds from the cost reporting period prior to the start of the PHE as
the official hospital bed count for application of this policy. As
such, RHCs with provider-based status that were exempt from the
national statutory payment limit in the period prior to the effective
date of the PHE (January 27, 2020) would continue to be exempt from the
bed count requirement for the duration of the PHE for the COVID-19
pandemic, as defined at Sec. 400.200, even if the hospital raised its
bed count above 50. Once the PHE for COVID-19 ends, hospitals need to
lower their bed count to less than 50 beds to utilize an RHC policy
that has such a requirement.
b. Section 130 of the Consolidated Appropriations Act, 2021
In the CY 2022 PFS proposed rule (86 FR 39231 through 39232), we
discussed section 130 of the Consolidated Appropriations Act, 2021 (CAA
2021) (Pub. L. 116-260, December 27, 2020), which updated section
1833(f) of the Act by restructuring the payment limits for RHCs
beginning April 1, 2021. We noted that section 2 of H.R. 1868 (Pub. L.
117-7), enacted April 14, 2021, provided a technical correction to
[[Page 65200]]
section 1833(f) of the Act. The amendments made by this technical
correction take effect as if included in the enactment of the
Consolidated Appropriations Act of 2021 (Pub. L. 116-260).
We explained that section 1833(f)(2) of the Act, as added by
section 130 of the CAA 2021, states that beginning April 1, 2021, RHCs
will begin to receive an increase in their payment limit per visit over
an 8-year period, with a prescribed amount for each year from 2021
through 2028. Then, in a subsequent year, at the limit established for
the previous year increased by the percentage increase in the MEI
applicable to primary care services furnished as of the first of such
subsequent year. This provision also subjects all new RHCs (including
provider-based RHCs in a hospital with less than 50 beds and enrolled
in Medicare after December 31, 2020) to the national statutory payment
limit.
The national statutory payment limit for RHCs over an 8-year period
is as follows:
In 2021, after March 31, at $100 per visit;
In 2022, at $113 per visit;
In 2023, at $126 per visit;
In 2024, at $139 per visit;
In 2025, at $152 per visit;
In 2026, at $165 per visit;
In 2027, at $178 per visit; and
In 2028, at $190 per visit.
In addition, in the CY 2022 PFS proposed rule (86 FR 39231), we
stated that beginning April 1, 2021, provider-based RHCs that met the
qualifications in section 1833(f)(3)(B) of the Act, as added by section
130 of the CAA 2021 and amended by Public Law 117-7, were entitled to
special payment rules, as described in section 1833(f)(3)(B) of the
Act. That is, a provider-based RHC must meet the following criteria to
have its payment limit established based on its per visit payment
amount (or AIR):
As of December 31, 2020, was in a hospital with less than
50 beds and after December 31, 2020 in a hospital that continues to
have less than 50 beds (not taking into account any increase in the
number of beds pursuant to a waiver during the PHE for COVID-19); and
one of the following circumstances:
++ As of December 31, 2020, was enrolled in Medicare (including
temporary enrollment during the PHE for COVID-19); or
++ Submitted an application for enrollment in Medicare (or a
request for temporary enrollment during the PHE for COVID-19) that was
received not later than December 31, 2020.
Specifically, beginning April 1, 2021, for provider-based RHCs that
had a per visit payment amount (or AIR) established for services
furnished in 2020, the payment limit per visit shall be set at an
amount equal to the greater of: (1) The per visit payment amount
applicable to such RHC for services furnished in 2020, increased by the
percentage increase in the MEI applicable to primary care services
furnished as of the first day of 2021; or (2) the national statutory
payment limit for RHCs per visit. We stated that the details of the
most recent MEI rebasing and revising are discussed in the CY 2011 PFS
final rule with comment period (75 FR 73262). The MEI increase for an
update year is based on historical data through the second quarter of
the prior calendar year. For example, the 2021 update reflects data
through the second quarter 2020. IGI is a nationally recognized
economic and financial forecasting firm with which we contract to
forecast the components of the MEI and other CMS market baskets,
https://ihsmarkit.com/index.html.
We explained that in a subsequent year (that is, after 2021), the
provider-based RHC's payment limit per visit shall be set at an amount
equal to the greater of: (1) The payment limit per visit established
for the previous year, increased by the percentage increase in the MEI
applicable to primary care services furnished as of the first day of
such subsequent year; or (2) the national statutory payment limit for
RHCs. We stated that the proposed CY 2022 MEI update was 1.8 percent
based on the IGI 1st quarter 2021 forecast of the MEI and productivity
adjustment, which reflects historical MEI data through 4th quarter 2020
and historical MFP data through 2019. As is our general practice, we
proposed that if more recent data became available after the
publication of the proposed rule and before the publication of this
final rule (for example, a more recent estimate of the MEI percentage
increase or productivity adjustment), we would use such data, if
appropriate, to determine the final CY 2022 MEI update.
Based on the more recent data available for this CY 2022 PFS final
rule (that is, IGI's third quarter 2021 forecast of the 2006-based MEI
with historical data through the second quarter of 2021 and historical
MFP data through 2020), we estimate that the CY 2022 MEI update is 2.1
percent.
In the CY 2022 PFS proposed rule (86 FR 39231), we explained for
provider-based RHCs that meet certain requirements, but did not have a
per visit payment amount (or AIR) established for services furnished in
2020, the payment limit per visit shall be at an amount equal to the
greater of: (1) The per visit payment amount applicable to the
provider-based RHC for services furnished in 2021; or (2) the national
statutory payment limit for RHCs.
In a subsequent year (that is, after 2022), the provider-based RHCs
payment limit per visit will be the greater of: (1) The payment limit
per visit established for the previous year, increased by the
percentage increase in MEI applicable to primary care services
furnished as of the first day of such subsequent year; or (2) the
national statutory payment limit for RHCs.
We stated that a provider-based RHC that meets the qualifications
of section 1833(f)(3)(B) of the Act, as corrected by Public Law 117-7
will lose this designation if the hospital does not continue to have
less than 50 beds, beyond the exemptions provided for the PHE for
COVID-19. If this occurs, the provider-based RHC will be subject to the
statutory payment limit per visit applicable for such year and not able
to regain the specified provider-based payment limit.
Lastly, we stated that provider-based RHCs that are newly enrolled
beginning January 1, 2021, and after are subject to the national
statutory payment limit applicable for such year for RHCs.
c. Implementation of Section 130 of the Consolidated Appropriations
Act, 2021
In the CY 2022 PFS proposed rule (86 FR 39232 through 39233), we
stated that prior to this legislation, the CY 2020 national statutory
payment limit for RHCs was $86.31. We noted that due to this timing,
for calendar year 2021, there are two sets of payment rules for RHCs.
That is, for the period before March 31, 2021, independent RHCs and
provider-based RHCs that did not meet specified requirements were
subject to the payment limit of $87.52 that CMS announced in Change
Request 12035, Transmittal 10413 issued on October 29, 2020.\65\
Provider-based RHCs that met specified requirements were not subject to
a payment limit for the first quarter of calendar year 2021. However,
beginning April 1, 2021, in accordance with section 130 of the CAA
2021, all RHCs are now subject to a payment limit. For example,
beginning April 1, 2021 through December 31, 2021 the national
statutory payment limit for RHCs is $100.00. We explained in the
proposed rule that in order to prepare for this change in payment
limits during the calendar year, Change Request 12185, Transmittal
10679 was issued on March 16, 2021, to implement an
[[Page 65201]]
increase in the RHC statutory payment limit per visit and establish the
provider-based RHC payment limits per visit, which went in effect on
April 1, 2021. We noted Change Request 12185, Transmittal 10679, was
rescinded and replaced by Transmittal 10780 issued on May 4, 2021 to
reflect the technical corrections in section 2 of H.R. 1868 (Pub. L.
117-7). We also noted that this provision does not impact the way
beneficiary coinsurance is calculated as described in Sec.
405.2410(b)(1).
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\65\ https://www.cms.gov/files/document/r10413cp.pdf.
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i. Specified Provider-Based RHCs
In section III.A.3.b. of the CY 2022 PFS proposed rule (86 FR
39232) and section III.A.3.b. of this final rule, we discuss the
qualifications specified in section 1833(f)(3)(B) of the Act, as
amended by Public Law 117-7, that determine if a provider-based RHC is
entitled to the special payment rules described in section
1833(f)(3)(A) of the Act. To determine if an RHC was in a hospital with
less than 50 beds as of December 31, 2020, we stated that we would
review each provider-based RHC using the existing bed count review
process, as described previously, to determine if this criterion is
met. In addition, we explained that this process generally includes
ongoing review by the MACs two times a year. The beds to be counted for
purposes of this criterion are described in Sec. 412.105(b), in
accordance with existing policy.
In the CY 2022 PFS proposed rule (86 FR 39232), we discussed our
intent to continue with our existing policy and in accordance with
section 1833(f)(3)(B)(i) of the Act which states that ``as of December
31, 2020, was in a hospital with less than 50 beds and after such date
such hospital continues to have less than 50 beds'' an RHC will retain
its specified provider-based status until the hospital which they are
affiliated submits a cost report with more than 50 beds. An RHC will no
longer retain its specified provider-based status nor be eligible for
specified status in the future once the hospital which they are
affiliated submits a cost report with more than 50 beds. However, in
response to the PHE for COVID-19 and in accordance with section
1833(f)(3)(B)(I) of the Act, we stated that we would apply the policy
that allows for increased hospital bed counts, as described in the May
8, 2020 IFC, for purposes of determining this bed count criterion for
specified provider-based RHC status. That policy specified that for the
duration of the PHE, we would use the number of beds from the cost
reporting period prior to the start of the PHE as the official hospital
bed count. We noted that the criteria specified in section
1833(f)(3)(B)(i) of the Act specified in a hospital with less than 50
beds, therefore, beginning April 1, 2021, we would apply the bed
definition at Sec. 412.105(b) exclusively.
In the CY 2022 PFS proposed rule (86 FR 39232), we discussed
section 1833(f)(3)(B)(ii) of the Act, as added by section 2 of Public
Law 117-7, which requires that these specified provider-based RHCs as
of December 31, 2020 are ``enrolled under section 1866(j) of the Act
(including temporary enrollment during such emergency period for such
emergency period),'' or ``submitted an application for enrollment under
section 1866(j) of the Act (or a request for such a temporary
enrollment for such emergency period) that was received not later than
December 31, 2020.'' We proposed that the RHC's effective date of
enrollment (as established under existing regulations) would be used in
our determination as to whether an RHC is enrolled under section
1866(j) of the Act as of December 31, 2020. In addition, with regard to
an application for enrollment under section 1866(j) of the Act or a
request for temporary enrollment, we proposed to use the date an
application or request was received to determine if the RHC met the
qualification. We explained that RHCs that established temporary
locations for the purpose of responding to the PHE for COVID-19, in
accordance with their State pandemic response plan, are permitted to
enroll and receive temporary Medicare billing privileges. When the PHE
for COVID-19 ends, an RHC that had been temporarily enrolled under the
flexibilities described previously must submit a complete CMS-855
enrollment application in order to establish full Medicare billing
privileges. Failure to do so will result in the deactivation of the
RHC's temporary billing privileges. No payments can be made for
services provided while the temporary billing privileges are
deactivated. For RHCs enrolled through the temporary enrollment process
that will need to submit a complete CMS-855 enrollment application, we
proposed, regardless of when the temporarily enrolled RHC is fully
enrolled, that the RHC would be entitled to the special payment rules
as long as it was temporarily enrolled as of December 31, 2020 or a
temporary enrollment request was received by December 31, 2020, and it
meets the bed count requirement.
As we stated in the CY 2022 PFS proposed rule (86 FR 39233),
section 1833(f)(3)(A) of the Act instructs Medicare to set payment
limits per visit for these specified provider-based RHCs under certain
payment rules. Specifically, beginning April 1, 2021, a payment limit
per visit shall be set at an amount equal to the greater of: (1) The
per visit payment amount applicable to such RHC for services furnished
in 2020, increased by the percentage increase in the MEI applicable to
primary care services furnished as of the first day of 2021 or; (2) the
statutory payment limit per visit as described in section 1833(f)(2) of
the Act. For subsequent years, in accordance with section
1833(f)(3)(A)(ii) of the Act, that payment amount is increased by the
percentage increase in the MEI or the statutory payment limit described
in section 1833(f)(2) of the Act, whichever is greater.
As we explained in the CY 2022 PFS proposed rule (86 FR 39233), we
interpreted the ``per visit payment amount'' to align with the interim
rate process the MACs use in determining an RHC's AIR. That is, as
explained in Sec. 405.2464(a) the AIR is determined by the MAC using
the most recently available cost report. Therefore, with regard to
``services furnished in 2020'' we interpreted this to mean the period
at which the services were furnished in 2020 and that costs for those
services were reported. We understand that there may be more than one
cost report that reports costs for services furnished in calendar year
2020. However, since section 130 of the CAA 2021 states that the ``per
visit payment amount'' is to be increased by the CY 2021 MEI, if a
provider has a cost reporting period that differs from a calendar year
time-period then the MACs should use data based on the relevant cost
report period ending in 2020.
Finally, in the CY 2022 PFS proposed rule (86 FR 39233), we
acknowledged that certain RHCs file consolidated cost reports. We
stated that for specified provider-based RHCs, existing RHCs that are
independent, and existing RHCs that are in a hospital with greater than
50 beds, we will continue to use the parent RHCs' cost reports to
determine the payment limit per visit (for multi-facility RHC systems),
as consolidated cost reporting reduces the reporting burden and cost
report preparation time for RHCs. We noted that combining multiple
individual RHC cost reports into a consolidated cost report allows RHCs
to take advantage of administrative efficiencies and economies of scale
that do not exist otherwise.
However, we explained that in accordance with section 1833(f)(2) of
the Act, all new provider-based RHCs and independent RHCs enrolled, as
of January 1, 2021, shall have a payment limit established at the
national
[[Page 65202]]
statutory payment limit for RHCs. Therefore, beginning with RHCs
enrolled in Medicare as of January 1, 2021, we would no longer allow
new RHCs to file consolidated cost reports.
ii. All Other RHCs
In the CY 2022 PFS proposed rule (86 FR 39233), we explained that
while there are criteria that allow for specified provider-based RHCs
to be eligible for certain payment rules, all other RHCs are subject to
payment limits as described in section 1833(f)(2) of the Act. We stated
that while there may be new RHCs that are ``in a hospital with less
than 50 beds'' and ``enrolled under section 1866(j) [of the Act]'',
they will not have met these criteria by December 31, 2020. Thus, any
new RHCs will also be subject to the national statutory payment limits
as described in section 1833(f)(2) of the Act.
We noted that though the payment limit is described, these RHCs
will still have an AIR per visit determined based on their allowable
costs for each year going forward. The payment limit that is
established will be the maximum amount that an RHC will be paid by
Medicare per visit. At the time of reconciliation, if an RHC's costs
per visit are above the AIR, they will be paid an amount that reflects
these additional costs, not to exceed the payment limit. If an RHC's
costs per visit are below the AIR, then CMS would collect any
overpayment for that visit. In addition, we noted that to implement
this provision beginning April 1, 2021, CMS instructed the MACs to
increase the payment limits to $100 per visit.
In the CY 2022 PFS proposed rule (86 FR 39233), we stated that
while the payment limit per-visit as set forth in section 1833(f) of
the Act was implemented in administrative instructions issued to the
MACs in Change Request 12185, we proposed revisions to Sec. 405.2462
to reflect the provisions set forth in section 1833(f)(2) and (3) of
the Act. We solicited comment on these revisions and on our proposals
regarding the implementation of section 130 of the CAA 2021.
The following is a summary of the comments we received and our
responses.
Comment: While commenters supported the increased upper payment
limit for independent RHCs, some commenters expressed concern about how
the payment limit per visit is established for specified provider-based
RHCs. To be appropriately reflective of an individual clinic's true
costs, one commenter stated that grandfathered, clinic specific, upper
payment limits should be based on the final cost settled amount for
cost reporting periods that end in 2020, or 2021 (for grandfathered
RHCs that do not have cost reporting period that end in 2020), not an
interim rate. If an interim final rate is necessary for the time period
before final cost settled rates are adjudicated, the commenter
suggested that CMS set interim clinic-specific upper limits only until
such time that a final rate is established.
Response: We agree with the commenter and believe that what the
commenter describes is aligned with the statute and how we implemented
the payment limit per visit for specified provider-based RHCs through
Change Request 12185, Transmittal 10780, issued on May 4, 2021. That
is, in accordance with section 1833(f)(3)(A) of the Act, specified
provider-based RHCs that had a per visit payment amount (or AIR)
established for services furnished in 2020, had their payment limit per
visit based on their AIR determined from their final settled cost
report ending in 2020 increased by the percentage increase in the MEI
applicable to primary care services furnished as of the first day of
2021 (CY 2021 MEI of 1.4 percent). However, if the product of these two
numbers (AIR established for services furnished in 2020 * 1.014) were
less than the national statutory payment limit of $100, their payment
limit per visit was established at $100.
With regard to a specified provider-based RHC that does not have an
AIR established for services furnished in 2020 and is receiving an
interim rate until the MAC accepts and finalizes the RHC's initial cost
report, we again agree with the commenter. We believe that what the
commenter describes also aligns with the statute and how we implemented
the payment limit per visit for these specified provider-based RHCs
through Change Request 12185, Transmittal 10780, issued on May 4, 2021.
That is, in accordance with section 1833(f)(3)(A) of the Act, specified
provider-based RHCs that did not have an AIR established for services
furnished in 2020, will have their payment limit per visit established
based on their AIR determined by MACs using the RHC's final settled
cost report ending in 2021. The interim rate estimate will be
reconciled at cost report settlement for the cost reporting period
ending in 2021 which is used to establish the RHC's payment limit per
visit for services furnished in 2021.
Comment: One commenter noted that while the law and the CY 2022 PFS
proposed rule is a significant improvement for independent RHCs, they
are concerned that implementing the rule for provider-based RHCs will
have devastating consequences for the future of the provider-based RHC
program and rural health more broadly. The commenter suggested that CMS
monitor impacts of the provider-based RHC upper-payment limit changes
on access for rural beneficiaries and encouraged CMS to implement the
statute in a manner that limits the impact on current and future
provider-based RHCs. The commenter further expressed concern that there
are differing interpretations on the updated statute regarding the
provision that allows those entities who had submitted their CMS-855A
applications by December 31, 2020 to be eligible for grandfather status
by the regional MAC. Therefore, the commenter urged CMS to implement
the statute in a manner allowing all provider-based RHCs who had
submitted an CMS-855A application by December 31, 2020, to be eligible
for grandfathered rates.
Another commenter requested that CMS confirm that provider-based
RHCs whose enrollment application was received by CMS as of December
31, 2020, will not be required to complete their certification process
by the end of 2021 since completing this process can take as long as 6
months under normal circumstances and even longer during the PHE. One
commenter requested that CMS expand the definition of ``existing RHCs''
to include hospital-based clinics that can provide proof of material
efforts to establish a new RHC before December 31, 2020.
Response: We appreciate the commenter notifying us that they
believe that the regional MACs may have differing interpretations of
the statute and the accompanying Change Request 12185, Transmittal
10780, issued on May 4, 2021 that CMS issued to implement the
provisions required under section 130 of the CAA, 2021. In conjunction
with the issuance of this final rule, we expect to issue guidance that
clarifies what date is used to determine if a provider-based RHC is
entitled to the special payment rules described in section
1833(f)(3)(B)(ii) of the Act. The date CMS receives the application or
request is the date used to determine whether the RHC met the
qualifications.
Regarding the comment requesting that CMS confirm that provider-
based RHCs whose enrollment application was received by CMS as of
December 31, 2020 will not be required to complete their certification
process by the end of 2021, we confirm there is no requirement on the
timing of when the certification process needs to be
[[Page 65203]]
complete after the enrollment application is received by CMS.
With regard to the comment requesting that CMS expand the
definition of ``existing RHCs'' to include hospital-based clinics that
can provide proof of material efforts to establish a new RHC before
December 31, 2020, we believe that the statute was clear that to be
eligible for special payment consideration, the provider-based RHC
needed to be, as of December 31, 2020, enrolled in Medicare (including
temporary enrollment during the PHE for COVID-19) or have submitted an
application for enrollment in Medicare (or a request for temporary
enrollment during the PHE for COVID-19) that was received not later
than December 31, 2020. We do not believe that hospital-based clinics
that can provide proof of material efforts to establish a new RHC
before December 31, 2020 meets that criteria.
With regard to the comment suggesting that CMS monitor the impacts
of the provider-based RHC upper-payment limit changes on access for
rural beneficiaries, we agree with the commenter and CMS plans to
monitor the policy changes for potential health equity impacts,
including utilization and access to care for rural beneficiaries.
Comment: One commenter requested that CMS clarify whether a
hospital with an existing provider-based RHC may temporarily increase
capacity to 50 or more beds in response to any future localized or
national PHE without being penalized by losing its existing RHC status.
The commenter also requested that CMS reduce the administrative burden
on both MACs and hospitals by determining a hospital's bed count once a
year, based on that year's Medicare cost report.
Response: We appreciate the commenter's suggestion regarding future
PHE flexibilities as it relates to the exception for RHCs based in
rural hospitals with less than 50 beds. However, it is out of scope for
this proposal. For the duration of the COVID-19 PHE, we adopted an
interim final policy to use the number of beds from the cost reporting
period prior to the start of the COVID-19 PHE as the official hospital
bed count for application of this policy. As such, RHCs with provider-
based status that were exempt from the national statutory payment limit
in the period prior to the effective date of the COVID-19 PHE (January
27, 2020) would continue to be exempt from the bed count requirement
for the duration of the PHE for the COVID-19 pandemic, as defined at
Sec. 400.200, even if the hospital raised its bed count above 50. Once
the COVID-19 PHE ends, hospitals need to lower their bed count to less
than 50 beds to utilize the RHC exception. In addition, protocols are
already in place to determine how the MACs establish the bed count. The
MAC reviews the number of beds twice a year to determine whether the
provider-based RHC meets the exception, during the Desk Review process
and during the interim rate process (that is, determining the RHC's
AIR).
As described in Chapter 13 of the Medicare Benefit Policy Manual,
the MACs review is not an additional burden for the purpose of this
rule. We note that it is impossible to predict in advance the extent,
severity and impact of a future public health emergency, and not every
public health emergency, even a localized one, might require us to
provide the bed count flexibility the commenter seeks in order to
assure patients' access to services. We recognize that many interim
policies and waivers established during the COVID-19 PHE provided
needed flexibilities for Medicare providers and suppliers, and we
continue to study the effectiveness of these waivers in providing
patient access in the event of a future PHE.
Comment: One commenter requested that CMS not retroactively recoup
any potential overpayments that may accrue as a result of an audit
adjustment of a hospital's initial cost report, but instead incorporate
the audit adjustments into the RHCs AIR prospectively for future years.
Response: We do not believe that it would be necessary or
appropriate for CMS to incorporate the audit adjustments into the RHCs
AIR prospectively for future years. Applying audit adjustments
prospectively seems to imply that there should be forgiveness of any
errors in the cost report that determines the base rate. RHCs are
required to submit a cost report that is correct and in compliance with
provisions of the health care services laws and regulations, as are the
MACs. If an adjustment is proposed and the provider appeals the
adjustment, the appeal would be handled like any other appeal that
impacts subsequent years. While appeals have taken some years to
resolve, the Provider Reimbursement Review Board (PRRB) has implemented
new rules to make it easier to settle some appeals and, thereby, reduce
the time to resolve appeal and reduce the backlog of cases.
Comment: One commenter requested that CMS not punish any provider-
based RHC who may make updates to their facilities by removing their
grandfathered status. A provider-based RHC should be able to update
their facility or move facilities without losing their specified
provider-based status. Another commenter requested that CMS clarify
that if an existing RHC needs to change its address or alter its
enrollment application, it will not negate the RHC's existing status,
subjecting it to the national statutory payment limit. Another
commenter requested that the policies regarding grandfathering status
following an RHC change of address or change of ownership be explicitly
addressed in CMS guidance, as the statute is clear that these RHCs
should maintain their grandfathered status and clinic specific upper
payment limit in these scenarios.
Response: If an RHC undergoes a change of ownership (CHOW) and the
acquiring owner accepts assignment of the Medicare agreement, all
things associated with the agreement carries over to the new owner.
This would include the CMS certification number (CCN), any financial
obligations/repayments, the ``grandfather'' provision located at 42 CFR
491.5(b), which applies to location requirements, and the
qualifications specified in section 1833(f)(3)(B) of the Act, as
amended by Public Law 117-7, that determine if a provider-based RHC is
entitled to the special payment rules described in section
1833(f)(3)(A) of the Act.
Regarding a change of address, updates to a facility (for example,
cosmetic improvements), or altering of a specified provider-based
enrollment record, we do not believe that this would impact their
eligibility, as long as the RHC continues to meet the location
requirements of section 1861(aa)(2) of the Act and part 491 of this
chapter concerning RHC services and conditions for approval, and has
filed an agreement with CMS that meets the requirements in Sec.
405.2402 to provide RHC services under Medicare. We note that RHCs are
intended to provide services in rural areas.
Comment: A few commenters suggested that CMS revise the proposal to
no longer allow new RHCs to file consolidated reports. One commenter
suggested that CMS revise this proposal to only prohibit consolidated
cost reports when grandfathered and non-grandfathered RHCs are combined
and allow new RHCs to file consolidated cost reports with other RHCs
who are also subject to the national statutory payment limit. Another
commenter requested that CMS clarify whether a hospital who acquires a
new RHC that is subject to the lower national statutory payment limit
may still include the RHC on the consolidated cost report as long as
the RHC is reported using a separate
[[Page 65204]]
cost reporting line number. They stated that this solution will reduce
the administrative burden on both hospitals and MACs while achieving
CMS' goal of segregating the cost to provide care in existing RHCs from
new RHCs.
Response: We appreciate the commenters' feedback on the
flexibilities for RHCs to file consolidated cost reports. We were
persuaded by the commenters' suggestion to reconsider the benefits that
consolidated cost reporting provides for RHCs, such as administrative
efficiencies. At the time of the proposed rule, we had not contemplated
allowing only new RHCs that are subject to the national statutory
payment limit to file consolidated cost reports. However, we agree that
there are situations where new RHCs could file consolidated cost
reports with other RHCs to reduce their administrative burden. We
analyzed potential outcomes based on the different statuses of RHCs. We
compared provider-based RHCs that have or will have their payment limit
per-visit established based on their applicable AIR to RHCs that have
their payment limit per visit based on the national statutory payment
limit (that is, existing provider-based RHCs that are in a hospital
with greater than 50 beds, independent RHCs, and new RHCs).
We note that flexibility in requiring consolidated cost reports has
been a longstanding CMS policy. We have historically allowed multi-
facility RHC systems to file consolidated cost reports because often
sites under common ownership have integrated functions such as
bookkeeping and purchases (for example, medical supplies) in an effort
to operate more efficiently. We do not want to inadvertently cause a
disruption in the data reporting that is in place for RHCs or cause
undue burden for new RHCs that may be a part of a multi-facility RHC
system with other new RHCs.
Therefore, new RHCs (that is, enrolled under section 1866(j) of the
Act on or after January 1, 2021) are permitted to file consolidated
cost reports with:
New RHCs that are provider-based,
New RHCs that are independent,
Existing independent RHCs, and/or
Existing provider-based RHCs that are in a hospital that
has greater than 50 beds.
For reasons stated above, we believe that RHCs that have the same
national statutory payment limit should have the flexibility to file a
consolidated cost report and each of the types of RHCs listed above
will have a payment limit per-visit as described in section 1833(f) of
the Act.
We agree with commenters with regard to the types of RHCs that
should not be permitted to file consolidated cost reports.
Specifically, we will not permit specified provider-based RHCs to file
a consolidated cost report with a new RHC. We believe that it would not
be appropriate to allow a new RHC that the statute specifies should
have a payment limit per-visit set to the national statutory payment
limit provided at section 1833(f)(2) of the Act to file a consolidated
cost report with an RHC that otherwise has a payment limit per-visit
established on their applicable AIR.
Regarding the comment requesting CMS to clarify whether a hospital
that acquires a new RHC that is subject to the national statutory
payment limit may still include the new RHC on the consolidated cost
report, we agree that the hospital cost report provides this ability.
That is, hospitals have the ability to identify a group of RHCs as
consolidated and identify an individual RHC. More information on
identifying provider-based RHCs on the hospital cost report (FORM CMS-
2552-10) is available in PRM 15-2, Chapter 40, section 4010.
After consideration of the public comments, we are finalizing our
proposal to codify Sec. 405.2462 as proposed to reflect the provisions
set forth in section 1833(f)(2) and (3) of the Act.
3. Payment for Attending Physician Services Furnished by RHCs or FQHCs
to Hospice Patients
a. Background
In the Fiscal Year (FY) 2021 Hospice Payment Rate Update final rule
(85 FR 47070) we explain that hospice care is a comprehensive, holistic
approach to treatment that recognizes the impending death of a
terminally ill individual and warrants a change in the focus from
curative care to palliative care for relief of pain and for symptom
management. Palliative care is at the core of hospice philosophy and
care practices, and is a critical component of the Medicare hospice
benefit. The goal of hospice care is to help terminally ill individuals
continue life with minimal disruption to normal activities while
remaining primarily in the home environment.
A hospice uses an interdisciplinary approach to deliver medical,
nursing, social, psychological, emotional, and spiritual services
through a collaboration of professionals and other caregivers, with the
goal of making the beneficiary as physically and emotionally
comfortable as possible. As referenced in our regulations at Sec.
418.22(b)(1), to be eligible for Medicare hospice services, the
patient's attending physician (if any) and the hospice medical director
must certify that the individual is ``terminally ill,'' as defined in
section 1861(dd)(3)(A) of the Act and our regulations at Sec. 418.3;
that is, the individual's prognosis is for a life expectancy of 6
months or less if the terminal illness runs its normal course.
Section 1861(dd)(3)(B) of the Act defines the term ``attending
physician'' to mean, with respect to an individual, the physician, the
NP or PA who may be employed by a hospice program, whom the individual
identifies as having the most significant role in the determination and
delivery of medical care to the individual at the time the individual
makes an election to receive hospice care.
As explained in Pub. 100-02, chapter 9, section 20.1,\66\ the
attending physician is a doctor of medicine or osteopathy who is
legally authorized to practice medicine or surgery by the State in
which he or she performs that function, an NP, or PA, and is identified
by the individual, at the time he or she elects to receive hospice
care, as having the most significant role in the determination and
delivery of the individual's medical care. An NP is defined as a
registered nurse who performs such services as legally authorized to
perform (in the State in which the services are performed) in
accordance with State law (or State regulatory mechanism provided by
State law) and who meets training, education, and experience
requirements described in Sec. 410.75. A PA is defined as a
professional who has graduated from an accredited PA educational
program who performs such services as he or she is legally authorized
to perform (in the State in which the services are performed) in
accordance with State law (or State regulatory mechanism provided by
State law) and who meets the training, education, and experience
requirements as the Secretary may prescribe. The PA qualifications for
eligibility for furnishing services under the Medicare program can be
found in the regulations at Sec. 410.74(c).
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\66\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c09.pdf.
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RHCs and FQHCs are not authorized under the statute to serve in the
role of an attending physician. However, a physician, NP, or PA who
works for an RHC or FQHC may provide hospice attending physician
services during a time when they are not working for the RHC or FQHC
(unless prohibited by their RHC or FQHC contract or
[[Page 65205]]
employment agreement). These services would not be considered RHC or
FQHC services since they are not being provided by an RHC or FQHC
practitioner during RHC or FQHC hours. The physician, NP, or PA would
bill for services under Part B using their own provider number/NPI. In
addition, any service provided to a hospice beneficiary by an RHC or
FQHC practitioner must comply with Medicare prohibitions on
commingling. Further information regarding commingling is available in
Pub. 100-02, Chapter 13, section 100.\67\
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\67\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c13.pdf.
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b. Section 132 of the Consolidated Appropriations Act 2021
In the CY 2022 PFS proposed rule (86 FR 39234), we discussed that
section 132 of the CAA 2021 amended section 1834(o) of the Act and
added a new section 1834(y) to the Act, to provide the authority for
both FQHCs and RHCs, respectively, to receive payment for hospice
attending physician services. Specifically, when a designated attending
physician employed by or working under contract with an FQHC or RHC
furnishes hospice attending physician services (as described in section
1812(d)(2)(A)(ii) of the Act) on or after January 1, 2022, the FQHC or
RHC is eligible to receive payment under the FQHC PPS or RHC AIR,
respectively.
Therefore, beginning January 1, 2022, a physician, NP, or PA who is
employed by or working under contract with an RHC or FQHC may provide
hospice attending physician services during a time when they are
working for the RHC or FQHC. The RHC or FQHC would bill for these
services as they would for any other qualified service to be paid the
RHC AIR or the FQHC PPS rate, respectively. When the RHC/FQHC furnishes
a hospice attending physician service that has a TC, the provider
furnishing the TC would go to the hospice for payment as discussed in
the Medicare Claims Processing Manual at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c11.pdf.
We proposed to codify the new statutory provisions as described in
section 132 of the CAA 2021 in 42 CFR 405, subpart X, specifically:
At Sec. 405.2411, Scope of benefits, we are amending
Sec. 405.2411(b) to reflect that hospice attending physician services
are covered when furnished during a patient's hospice election only
when provided by an RHC/FQHC physician, NP, or PA designated by the
patient at the time of hospice election as his or her attending
physician and employed or under contract with the RHC or FQHC at the
time the services are furnished.
At Sec. 405.2446, Scope of services, we are amending
Sec. 405.2446(c) to include that FQHC services are covered when they
are hospice attending physician services furnished during a hospice
election.
We received public comments on the proposal to codify the new
statutory provisions as described in section 132 of the CAA 2021. The
following is a summary of the comments we received and our responses.
Comment: Many commenters were supportive of our proposal to codify
the new statutory provision as described in section 132 of the CAA 2021
in 42 CFR part 405, subpart X. One commenter noted that the new
statutory provision would remove an unnecessary barrier to the
efficient provision of hospice care for Medicare beneficiaries. Another
commenter stated that allowing RHC/FQHC providers to continue to care
for their patients who elect the hospice benefit should enhance the
quality of care and coordination of care.
A few commenters requested that CMS clarify that hospice patients
could change their attending physician to an RHC/FQHC provider after
their initial hospice election and expressed concern that the proposed
language in Sec. 405.2411(b)(3) limits this payment to RHC/FQHC
providers whom patients choose as their attending provider at the time
they elect to receive hospice care. Commenters stated that under
current Medicare rules, hospice patients are permitted to change their
attending provider after they have made their initial election to
receive hospice benefits, and that nothing in section 132 of the CAA
2021 would prohibit RHC/FQHC providers from serving as attending
providers for patients who select them after making their initial
hospice election. Commenters requested that the phrase ``at the time of
election'' be removed from the regulatory text. Several commenters
requested that CMS align FQHC policies with other Medicare providers
and permit patients to change their attending provider after they have
made their initial election to receive hospice benefits. Commenters
stated that CMS has the authority to provide more flexibility for
health center patients to ensure they have the provider of their choice
during every step of hospice care.
Response: Regarding the concerns that CMS align policies with other
Medicare providers and permit patients to change their attending
physician after they have made their initial election to receive
hospice benefits, we agree. The regulations at Sec. 418.24(g) provide
authority for changing the attending physician, and states ``to change
the designated attending physician, the individual (or representative)
must file a signed statement with the hospice that states that he or
she is changing his or her attending physician.'' Since hospice
beneficiaries can change their attending physician at any time during
their hospice election and we believe that this would also permit a
beneficiary to change from their attending physician designated at
their election to an RHC or FQHC practitioner, if they preferred.
Therefore, we will remove the phrase ``at the time of election'' stated
in our proposed regulation text at Sec. 405.2446(c).
After consideration of the comments received, we are finalizing our
proposal to codify the new statutory provision as described in section
132 of the CAA in 42 CFR 405, subpart X with a revision to the proposed
regulation text at Sec. 405.2446(c) to provide flexibility since
hospice patients are permitted to change their attending provider after
they have made their initial election.
Comment: One commenter stated that ``CMS did not specify in the
proposed rule which revenue code(s) RHCs can use when billing for these
encounters'' and requested that CMS provide clarity.
Response: We would point the commenter to subregulatory guidance
published in Transmittal 10907, Change Request 12357 on August 10,
2021. In exploring how to implement this policy, we found that there is
a HCPCS modifier, -GV, defined as ``attending physician not employed or
paid under arrangement by the patient's hospice provider'' currently in
existence and this modifier provides the necessary information for RHCs
and FQHCs to bill. Therefore, we believed that a new revenue code was
not needed.
Comment: We received one comment that was out of scope for this
rule. While supportive of our proposal to codify the new statutory
provision as described in section 132 of the CAA 2021 in 42 CFR 405,
subpart X, the commenter recommended that CMS authorize PAs employed by
a hospice to prescribe medications to Medicare hospice patients,
similar to hospice-employed physicians and NPs. The commenter noted
that CMS should allow a beneficiary to have the option to select a PA
employed by a hospice when the patient does not have a previously
established attending physician.
Response: We appreciate the feedback; however, this comment is
[[Page 65206]]
considered to be out of scope of the proposed rule, and therefore, we
are not addressing in this final rule.
4. Concurrent Billing for Chronic Care Management Services (CCM) and
Transitional Care Management (TCM) Services for RHCs and FQHCs
a. Background
In the CY 2013 PFS final rule (77 FR 68978 through 68994), we
authorized Medicare payment for TCM services furnished by an RHC or
FQHC practitioner, effective January 1, 2013, consistent with the
effective date of payment for TCM services under the PFS. We adopted
two CPT codes (99495 and 99496) to report physician or qualifying NPP
care management services for a patient following a discharge from an
inpatient hospital or SNF, an outpatient hospital stay for observation
or partial hospitalization services, or partial hospitalization in a
community mental health center. As a condition for receiving TCM
payment, a face-to-face visit was required.
In the CY 2016 PFS final rule with comment period (80 FR 71080
through 71088), we finalized policies for payment of CCM services in
RHCs and FQHCs. Payment for CCM services in RHCs and FQHCs was
effective beginning on January 1, 2016, for RHCs and FQHCs that furnish
a minimum of 20 minutes of qualifying CCM services during a calendar
month to patients with multiple (two or more) chronic conditions that
were expected to last at least 12 months or until the death of the
patient, and that would place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline. Payment was
made for CCM services when CPT code 99490 was billed alone or with
other payable services on an RHC or FQHC claim, and the rate was based
on the PFS national average non-facility payment rate. The requirement
that RHC or FQHC services be furnished face-to-face was waived for CCM
services furnished to an RHC or FQHC patient because CCM describes non-
face-to-face services.
In the CY 2018 PFS final rule, (82 FR 53172 through 53180), we
finalized a policy permitting payment for CCM, general Behavioral
Health Integration (BHI), and the psychiatric collaborative care model
(CoCM) services furnished by RHCs or FQHCs on or after January 1, 2018,
described by HCPCS codes G0511 and G0512. HCPCS code G0511 is a General
Care Management code for use by RHCs or FQHCs when at least 20 minutes
of qualified CCM or general BHI services are furnished to a patient in
a calendar month. HCPCS code G0512 is a psychiatric CoCM code for use
by RHCs or FQHCs when at least 70 minutes of initial psychiatric CoCM
services or 60 minutes of subsequent psychiatric CoCM services are
furnished to a patient in a calendar month. The payment amount for
HCPCS code G0511 is set at the average of the three national non-
facility PFS payment rates for the CCM and general BHI codes and
updated annually based on the PFS rates. The three codes are CPT code
99490 (20 minutes or more of CCM services), CPT code 99487 (60 minutes
or more of complex CCM services), and CPT code 99484 (20 minutes or
more of BHI services). The payment amount for HCPCS code G0512 is set
at the average of the two national non-facility PFS payment rates for
the CoCM codes and is updated annually based on the PFS rates. The two
codes are CPT code 99492 (70 minutes or more of initial psychiatric
CoCM services) and CPT code 99493 (60 minutes or more of subsequent
psychiatric CoCM services).
In the CY 2019 PFS final rule (83 FR 59687), we finalized a policy
that effective January 1, 2019, the payment rate for HCPCS code G0511
(General Care Management Services) is set at the average of the
national non-facility PFS payment rates for CPT codes 99490, 99487,
99484, and 99491.
In the CY 2020 PFS final rule with comment period (84 FR 62692), we
added HCPCS code G2064 (30 minutes of PCM services furnished by
physicians or NPPs) and G2065 (30 minutes or more of PCM services
furnished by clinical staff under the direct supervision of a physician
or NPP) as a general care management service and included it in the
calculation of HCPCS code G0511. Beginning January 1, 2021, the payment
for HCPCS code G0511 is set at the average of the national non-facility
PFS payment rates for CPT codes 99490, 99487, 99484, and 99491, and
HCPCS codes G2064 and G2065, and is updated annually based on the PFS
rates. Additional information on CCM requirements is available on the
CMS Care Management web page \68\ and on the CMS RHC \69\ and FQHC \70\
web pages.
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\68\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/Care-Management.html.
\69\ https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html.
\70\ https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
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Currently, RHCs and FQHCs may not bill for TCM services for a
beneficiary if another practitioner or facility has already billed for
CCM services for the same beneficiary during the same time-period.
b. Concurrent Billing for Chronic Care Management Services and TCM
Services for RHCs and FQHCs
As discussed in the CY 2022 PFS proposed rule (86 FR 39235), we
finalized a policy in the CY 2020 PFS final rule (84 FR 62687) allowing
suppliers paid under the PFS to concurrently bill care management codes
that were previously restricted from being billed with TCM for services
billed under the PFS. This included allowing concurrent billing of TCM
with 14 HCPCS codes, as well as CPT codes 99490 and 99491, which
describe CCM services furnished under the PFS. However, we did not
extend this policy to care management services furnished in RHCs or
FQHCs at that time.
Consistent with changes made in the CY 2020 PFS final rule for care
management services billed under the PFS, in the CY 2022 PFS proposed
rule (86 FR 39235) we proposed to allow RHCs and FQHCs to bill for TCM
and other care management services furnished for the same beneficiary
during the same service period, provided that all requirements for
billing each code are met. This would include the services described by
HCPCS codes G0511 (General Care Management for RHCs and FQHCs only) and
G0512 (Psychiatric CoCM code for RHCs and FQHCs only), which both
describe a service period of one calendar month. We stated that when
medically necessary, these services may complement each other rather
than substantially overlapping or duplicating services since TCM
services are furnished once within 30 days of a patient's discharge,
whereas CCM services require a more comprehensive care management plan,
care coordination and ongoing clinical care, and CoCM services describe
care management services specifically for behavioral health conditions.
We noted that under this proposal, time and effort could not be counted
more than once.
The following is a summary of the comments we received and our
responses.
Comment: Commenters supported the proposal to allow RHCs and FQHCs
to bill for TCM and other care management services furnished for the
same beneficiary during the same service period, provided that all
requirements for billing each code are met. Commenters agreed that
patients receiving TCM services after discharge would benefit from the
more comprehensive care management plan developed under CCM, as well as
the
[[Page 65207]]
behavioral health-specific care management included in the Psychiatric
Collaborative Care Management (CoCM) when furnished simultaneously.
Response: We appreciate the commenters' support and feedback on our
proposal to allow RHCs and FQHCs to concurrently bill TCM with other
care management services.
After consideration of the public comments, we are finalizing our
proposal to allow RHCs and FQHCs to bill for TCM and other care
management services furnished for the same beneficiary during the same
service period, provided all requirements for billing each code are
met.
5. Conforming Technical Changes to 42 CFR 405.2466
In the November 6, 2020 Federal Register, we published the
``Additional Policy and Regulatory Revisions in Response to the COVID-
19 Public Health Emergency'' interim final rule with request for
comment (85 FR 71145 through 71147) (hereinafter referred to as the
November 6, 2020 IFC). In the November 6, 2020 IFC, we implemented
section 3713 of the CARES Act (Pub. L 116-136, March 27, 2020), which
established Medicare Part B coverage and payment for a COVID-19 vaccine
and its administration.
As we discussed in that rule (85 FR 71147), section 3713 of the
CARES Act added the COVID-19 vaccine and administration to section
1861(s)(10)(A) of the Act in the same subparagraph as the influenza and
pneumococcal vaccines and their administration. Therefore, the Medicare
allowed amount and billing processes for COVID-19 vaccinations are
similar to those in place for influenza and pneumococcal vaccinations
across provider/supplier settings. The amendments made to section
1861(s)(10)(A) of the Act were effective on the date of enactment, that
is, March 27, 2020, and apply to a COVID-19 vaccine beginning on the
date that such vaccine is licensed under section 351 of the PHS Act (42
U.S.C. 262). A list of vaccines and their effective dates are updated
as they are available and located on the CMS website at https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies. Although there were regulations
updated to reflect the changes set forth by the CARES Act, we
inadvertently did not revise the specific regulation text that applies
to RHCs and FQHCs.
Therefore, in the CY 2022 PFS proposed rule (86 FR 39235)
consistent with the changes described previously, we proposed to make
conforming technical changes to the applicable RHC and FQHC regulations
in 42 CFR part 405, subpart X, specifically:
At Sec. 405.2466, Annual reconciliation, we proposed to
amend paragraph (b)(1)(iv) to include the COVID-19 vaccine in the list
of vaccines and their administration that would be paid at 100 percent
of Medicare reasonable cost.
We did not receive public comments on this provision, and
therefore, we are finalizing as proposed.
B. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs)--Telecommunications Technology
1. Revising the Definition of an RHC and FQHC Mental Health Visit
a. Payment Rules for RHC and FQHC Visits and for Medicare Telehealth
Services
Section 1861(aa)(1) of the Act defines RHC services as physicians'
services and such services and supplies that are furnished as an
incident to a physician's professional service, and items and services,
as well as certain vaccines and their administration. It also includes
services furnished by a PA, NP, clinical psychologist, or clinical
social worker and services and supplies furnished as incident to these
services as would otherwise be covered if furnished by a physician or
incident to a physician's service. In the case of an RHC in an area
with a home health agency shortage, part-time or intermittent nursing
care and related medical supplies may be furnished by a registered
professional nurse or licensed practical nurse to a homebound
individual under certain conditions. Section 1861(aa)(3) of the Act
defines FQHC services to include the specified RHC services and
preventive services, as well as required primary preventive health
services.
As previously stated, RHC and FQHC visits are defined as medically-
necessary, face-to-face encounters between a patient and an RHC or FQHC
practitioner, during which time one or more RHC or FQHC qualifying
services are furnished. Services furnished must be within the
practitioner's State scope of practice, and only services that require
the skill level of the RHC or FQHC practitioner are considered RHC or
FQHC visits. The RHC and FQHC payment is based on the costs of all
services, except in certain circumstances, such as vaccines and their
administration.
RHCs are paid an all-inclusive rate (AIR) for medically-necessary
primary health care services, and qualified preventive health services,
furnished by an RHC practitioner. Medicare pays 80 percent of the RHC
AIR, subject to a payment limit. Services furnished incident to an RHC
professional service are included in the AIR and are not billed as a
separate visit. The PC of a procedure is usually a covered service, but
is not a stand-alone billable visit. The costs of covered services
provided incident to a billable visit may be included on the RHC cost
report.
FQHCs are paid 80 percent of the lesser of the FQHC's charge or the
FQHC PPS payment rate. Except for grandfathered tribal FQHCs, the FQHC
PPS payment rate reflects a base rate that is the same for all FQHCs, a
geographic adjustment based on the location where services are
furnished, and other applicable adjustments. The FQHC PPS rate was
established based on the aggregate of FQHC total costs, and is updated
yearly by the productivity-adjusted FQHC market basket increase.
Under the PFS, Medicare makes payment to professionals and other
suppliers for physician's services, certain diagnostic tests, and some
preventive services. Section 1834(m) of the Act specifies for Medicare
telehealth services paid under the PFS, the payment amounts and
circumstances under which Medicare makes payment for a discrete set of
services, all of which must ordinarily be furnished in-person, when
they are instead furnished using interactive, real-time
telecommunication technology. When furnished under the telehealth
rules, many of these specified Medicare telehealth services are still
reported using codes that describe ``face-to-face'' services but are
furnished using audio/video, real-time communication technology instead
of in-person (82 FR 53006). Section 1834(m) of the Act also specifies
conditions related to which professionals can be paid by Medicare for
their professional services furnished via telehealth (referred to as
distant site practitioners) and the originating site (both setting of
care and geography) where a beneficiary is located while receiving
telehealth services furnished remotely by the physician or practitioner
through a telecommunications system. The regulation text at 42 CFR
410.78(f) describes a process for adding or deleting services to the
list of Medicare telehealth services through the annual PFS rulemaking
process and defines what technology may be used to furnish the service.
Under the statutory authority set out under section
1834(m)(4)(C)(ii) of the Act, RHCs and FQHCs, like hospitals, physician
offices, and other sites, are
[[Page 65208]]
authorized to serve as originating sites for eligible telehealth
services. As defined in section 1834(m)(4)(C)(i) of the Act, the
originating site is where the eligible telehealth individual is located
at the time the service is furnished via a telecommunications system.
As defined in section 1834(m)(4)(A) of the Act, the distant site is
where the physician or practitioner is located at the time the service
is provided via a telecommunications system. Originating sites are paid
an originating site facility fee that is billed using HCPCS code Q3014
and is assigned a rate of $27.02 for CY 2021.
Section 3704 of the Coronavirus Aid, Relief, and Economic Security
Act (the CARES Act) (Pub. L. 116-136, March 27, 2020) directs the
Secretary to establish Medicare payment for telehealth services
provided by RHCs and FQHCs serving as a distant site (that is, where
the practitioner is located) during the public health emergency (PHE)
for COVID-19. Separately, section 3703 of the CARES Act expanded CMS'
emergency waiver authority to allow for a waiver of any of the
statutory telehealth payment requirements under section 1834(m) of the
Act for telehealth services furnished during the PHE. Specifically,
section 1834(m)(8)(B) of the Act, as added by the CARES Act, requires
that the Secretary develop and implement payment methods for FQHCs and
RHCs that serve as a distant site during the PHE for the COVID-19
pandemic. The payment methodology outlined in the CARES Act requires
that rates shall be based on rates that are similar to the national
average payment rates for comparable telehealth services under the
Medicare PFS. CMS established rates based on the average amount for all
PFS telehealth services on the telehealth list, weighted by volume.
RHCs and FQHCs bill for these Medicare telehealth services using HCPCS
code G2025 and the rate for CY 2021 is $99.45. The temporary authority
under section 1834(m)(8) of the Act to pay RHCs and FQHCs for
furnishing distant site Medicare telehealth services expires when the
PHE for the COVID-19 pandemic is terminated. While they will continue
to be able to serve as an originating site for Medicare telehealth
services, the payment mechanism for the professional services of RHC
and FQHC practitioners will be FQHC and RHC payments under the
established methodology, that is the RHC AIR or the FQHC PPS.
b. Adoption of Telehealth Technologies for Mental Health Care
While not specific to RHC and FQHC telehealth services provided
during the PHE, according to MedPAC's report, Telehealth in Medicare
after the Coronavirus Public Health Emergency,\71\ there were 8.4
million telehealth services paid under the PFS in April 2020, compared
with 102,000 in February 2020. MedPAC also reported that during focus
groups held in the summer of 2020, clinicians and beneficiaries
supported continued access to telehealth visits with some combination
of in-person visits. They cited benefits of telehealth, including
improved access to care for those with physical impairments, increased
convenience from not traveling to an office, and increased access to
specialists outside of a local area. In their annual beneficiary
survey, over 90 percent of respondents who had a telehealth visit
reported being ``somewhat'' or ``very satisfied'' with their video or
audio visit, and nearly two-thirds reported being ``very satisfied.''
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Widespread use of telecommunications technology to furnish services
during the PHE has illustrated interest within the medical community
and among Medicare beneficiaries in furnishing and receiving care
through the use of technology beyond the PHE. During the PHE for COVID-
19 pandemic, RHCs and FQHCs, much like other provider types, have had
to change how they furnish care in order to meet the needs of their
patients, and use of the temporary authority to bill Medicare for PFS
telehealth services has been widely utilized by RHCs and FQHCs during
the PHE. This shift in how care is furnished has prompted us to
reevaluate the regulations regarding visit requirements for encounters
between an RHC or FQHC patient and an RHC or FQHC practitioner to
ensure that they reflect contemporary medical practice.
Recently enacted legislation modified the circumstances under which
Medicare makes payment for mental health services furnished via
telehealth technology under the PFS following the PHE. Division CC,
section 123 of the Consolidated Appropriations Act of 2021 (CAA) (Pub.
L. 116-260, December 27, 2020) removed the domestic geographic
originating site restrictions and added the home of the individual as a
permissible originating site for telehealth services billed under the
PFS when furnished for the purposes of diagnosis, evaluation, or
treatment of a mental health disorder. This change correlates with a
growing acceptance of the use of technology in the provision of mental
health care. Clinicians furnishing telepsychiatry services at
Massachusetts General Hospital Department of Psychiatry during the PHE
observed several advantages of the virtual format for furnishing
psychiatric services, noting that patients with psychiatric pathologies
that interfere with their ability to leave home (for example,
immobilizing depression, anxiety, agoraphobia, and/or time-consuming
obsessive-compulsive rituals) were able to access care more
consistently since eliminating the need to travel to a psychiatry
clinic can increase privacy, and therefore, decrease stigma-related
barriers to treatment, potentially bringing care to many more patients
in need, as well as enhanced ease of scheduling, decreased rate of no-
shows, increased understanding of family and home dynamics, and
protection for patients and practitioners with underlying health
conditions.\72\
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\72\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7347331/.
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These findings are consistent with our analysis of Medicare claims
data that indicate that use of interactive communication technology for
mental health care is likely to continue to be in broad use beyond the
circumstances of the pandemic. According to our analysis of Medicare
Part B claims data for services furnished via Medicare telehealth under
the PFS during the PHE, use of telehealth for many professional
services spiked in utilization around April 2020 and diminished over
time; however, utilization was still higher than it was prior to the
PHE. In contrast, Medicare claims data suggests that for mental health
services both permanently and temporarily added to the Medicare
Telehealth list, subsequent to April 2020, the trend is toward
maintaining a steady state of usage over time. Given this information,
broad acceptance in the public and medical community, and the
relatively stable Medicare utilization of services during the entire
COVID-19 pandemic, we believe use of interactive communication
technology in furnishing mental health care is becoming an established
part of medical practice, very likely to persist well after the COVID-
19 pandemic, and available across the country under Medicare statute
for the range of professionals furnishing mental health care and paid
under the PFS.
c. Revising the Definition of an RHC and FQHC Mental Health Visit
In the 2022 PFS proposed rule (86 FR 39237), we stated that
beneficiaries receiving mental health services from
[[Page 65209]]
RHC and FQHC practitioners should have the same access to mental health
care delivered via telecommunications technology as beneficiaries
receiving services from practitioners paid under the PFS. We believed
that disruptions in access to mental health care from trusted
practitioners can be particularly problematic for Medicare
beneficiaries, especially when it results in fragmented care. However,
absent changes in the definition of mental health visits, RHCs and
FQHCs would no longer be paid by Medicare for mental health care
services delivered via telecommunications technology and would likely
resume furnishing solely in-person, face-to-face mental health visits
after the PHE, thereby removing the ability for beneficiaries to be
able to receive these services from RHC/FQHC practitioners if furnished
via interactive communication technology.
Because the definitions of RHC and FQHC services, as specified in
sections 1861(aa)(1) and (3) of the Act, respectively, refer
specifically to physicians' services, and services that would be
physicians' services, but are instead furnished by certain other types
of practitioners, we felt it would be consistent to align policies to
provide access to services furnished by RHCs and FQHCs similar to PFS
services, where appropriate and within statutory requirements. To
ensure that beneficiaries could access services furnished by RHCs and
FQHCs in a manner similar to mental health services under the PFS after
the PHE, we stated that it would be appropriate to consider modifying
our regulatory definition of a mental health visit to provide for
remote access to RHC and FQHC services. Therefore, to avoid both the
inequities in access to modes of care, and to avoid potentially
problematic interruptions to care or the negative consequences of
fragmented care, for CY 2022, we proposed to revise the regulatory
requirement that an RHC or FQHC mental health visit must be a face-to-
face (that is, in person) encounter between an RHC or FQHC patient and
an RHC or FQHC practitioner to also include encounters furnished
through interactive, real-time telecommunications technology, but only
when furnishing services for the purposes of diagnosis, evaluation, or
treatment of a mental health disorder.
Additionally, similar to the discussion of mental health services
furnished under the PFS, as described in section II.D. of this final
rule, we believe that mental health telehealth services furnished via
audio-only communications technology would increase access to care,
especially in areas with poor broadband infrastructure and among
patient populations that either are not capable of, or do not consent
to, the use of devices that permit a two-way, audio/video interaction.
Therefore, in order to align with proposals related to use of audio-
only telecommunications technology to furnish similar mental health
services under the PFS, we proposed to allow RHCs and FQHCs to furnish
mental health visits using audio-only interactions in cases where
beneficiaries were not capable of, or did not consent to, the use of
devices that would permit a two-way, audio/video interaction. We noted
that the decision related to a service being furnished via
telecommunications technology should be a patient-centered choice and
that providers/practitioners should not force or impose services being
furnished via telecommunications technology on beneficiaries who prefer
to receive the services in-person. Additionally, some patients may have
preferred a hybrid whereby some mental health services are in person,
but other times they are done using telecommunications technology. We
stated that this decision should be based on the clinical judgment of
the practitioner, in consideration of patient needs and preferences.
This change would allow RHCs and FQHCs to report and be paid for
mental health visits furnished via real-time, telecommunication
technology in the same way they currently do when these services are
furnished in-person. This expansion of payable modes of mental health
services furnished by RHCs and FQHCs corresponds with the expanded
availability for professionals paid for Medicare telehealth services
under the PFS authorized by section 123 of the CAA and using the
technology available for use for corollary services when paid under the
PFS. This revision would not allow RHCs or FQHCs to report visits
furnished using asynchronous communications like email exchanges.
Rather, RHCs and FQHCs would continue to report and be paid for
furnishing medically necessary virtual communications services in
accordance with the requirements for HCPCS code G0071 (83 FR 59686).
Also, this change would not allow RHCs and FQHCs to report Medicare
telehealth services under section 1834(m) of the Act or be paid under
the PFS since RHCs and FQHCs are not authorized to serve as distant
site practitioners for Medicare telehealth services once the PHE for
the COVID-19 pandemic has been terminated. In order to track
utilization of mental health visits furnished using communication
technology, we proposed that RHCs and FQHCs would append the 95
modifier (Synchronous Telemedicine Service Rendered via Real-Time
Interactive Audio and Video Telecommunications System) in instances
where the service was furnished using audio-video communication
technology or a new service level modifier in cases where the service
was furnished audio-only.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: We received many public comments that were supportive of
the proposal to revise the current regulatory language for RHC or FQHC
mental health visits to include visits furnished using interactive,
real-time telecommunications technology. Some commenters pointed out
that rural residents often face significant barriers to accessing
mental health services, which result in significant disparities in care
and that patients in rural areas often must travel long distances to
receive specialized care such as mental health services. Commenters
stated that being able to access these services through local RHCs and
FQHCs via telecommunications technology would help to increase the
frequency in which rural residents can access mental health services.
Some commenters noted that patients without reliable transportation,
internet, or the necessary technology will still face difficulties
accessing services after the PHE ends.
One commenter stated that allowing RHCs to be reimbursed at the AIR
reduces administrative burden and ensures that providing equitable
mental health care remains a component of RHC provided care. A few
commenters requested that this flexibility be extended to medical
visits furnished at RHCs and FQHCs, not just mental health visits.
Additionally, MedPAC commented that FQHC and RHC-provided telehealth
services should be paid at rates comparable to those under the PFS.
Response: After consideration of the public comments, we are
finalizing our proposal to revise the current regulatory language for
RHC or FQHC mental health visits to include visits furnished using
interactive, real-time telecommunications technology and for RHCs and
FQHCs to report and be paid for mental health visits furnished via
real-time, telecommunication technology in the same way they currently
do when these services are furnished in-person. Since the flexibilities
authorized by the CARES Act will expire at the end of the PHE,
[[Page 65210]]
we do not believe we currently have the authority to pay RHCs and FQHCs
for services that would be paid under the AIR or PPS at the PFS rates
outside of the PHE. We note that payment for virtual communications and
care management services furnished at RHCs and FQHCs are paid based on
PFS rates; however, these services describe non-face-to-face encounters
between a patient and an RHC or FQHC practitioner and are paid outside
of the AIR or PPS. Therefore, we are finalizing for CY 2022 that RHCs
and FQHCs will be paid for mental health visits furnished via
telecommunications technology at the same rate they are paid for in-
person mental health visits (that is, the AIR or FQHC PPS).
In response to comments that this flexibility be extended to
medical visits furnished at RHCs and FQHCs, not just mental health
visits, we note that the use of telecommunications technology to
furnish medical visits at RHCs and FQHCs was not within the scope of
this proposal.
We received public comments on allowing RHCs and FQHCs to furnish
mental health visits using audio-only interactions in cases where
beneficiaries are not capable of, or do not consent to, the use of
devices that permit a two-way, audio/video interaction. The following
is a summary of the comments we received and our responses.
Comment: Many commenters supported the inclusion of audio-only
communications technology in this proposal and stated that this
flexibility especially benefits rural patients with poor broadband
structure. Several commenters stated that Medicare beneficiaries
receiving services through these facilities should have the same access
to mental and behavioral health services as those being treated by
providers practicing independently.
Response: After consideration of public comments, we are finalizing
our proposal to allow RHCs and FQHCs to furnish mental health visits
using audio-only interactions in cases where beneficiaries are not
capable of, or do not consent to, the use of devices that permit a two-
way, audio/video interaction. We are also finalizing our proposal for
RHCs and FQHCs to append the 95 modifier (Synchronous Telemedicine
Service Rendered via Real-Time Interactive Audio and Video
Telecommunications System) in instances where the service was furnished
using audio-video communication technology and to append a new service
level modifier in cases where the service was furnished audio-only.
This will allow us to track utilization of mental health visits
furnished using telecommunication technology at RHCs and FQHCs in order
inform future rulemaking.
Additionally, we noted in the proposed rule that section 123 of the
CAA also requires that there be an in-person service within 6 months
prior to the furnishing of the telehealth service and at intervals
thereafter as specified by the Secretary for mental health services
furnished via Medicare telehealth under the PFS. We solicited comment
on whether we should consider a similar requirement for mental health
services furnished by RHCs and FQHCs via telecommunications technology,
or whether this requirement may be especially burdensome for
beneficiaries receiving treatment at RHCs and FQHCs, particularly in
rural areas. In establishing a similar requirement for RHC and FQHC
mental health services, we would consider the changes described for
Medicare telehealth services described in section II.D. of this final
rule that there be an in-person service within 6 months prior to the
furnishing of the telecommunications service and that an in-person
service (without the use of telecommunications technology) be provided
at least every 6 months while the beneficiary is receiving services
furnished via telecommunications technology for diagnosis, evaluation,
or treatment of mental health disorders, which would be documented in
the patient's medical record, or whether we should defer to the
clinical judgment of the practitioner on how often an in-person visit
would be appropriate.
We received public comments on whether we should consider a similar
requirement for mental health services furnished by RHCs and FQHCs via
telecommunications technology, or whether this requirement may be
especially burdensome for beneficiaries receiving treatment at RHCs and
FQHCs, particularly in rural areas. The following is a summary of the
comments we received and our responses.
Comment: Several commenters were opposed to imposing an in-person
service requirement for telehealth mental health visits. A few
commenters described that existing evidence does not support the need
for such a requirement, which could negatively impact access to care
for beneficiaries and recommended CMS defer to the clinical judgment of
the practitioner on how often an in-person visit would be appropriate
and additionally noting that existing studies suggest low-income
patients and those living in rural communities face more transportation
barriers compared to other patients, and therefore, it is likely that
in-person requirements would more profoundly impede access to care for
the populations that RHCs and FQHCs serve. Other commenters encouraged
CMS to provide maximum flexibility for FQHCs implementing in-person
service requirements for patients receiving mental health services
furnished via telecommunications technology. One commenter recommended
that CMS provide a robust set of exceptions for patients unable or
unwilling to fulfill the once every six months in-person visit
requirement.
However, a few commenters supported requiring an in-person visit
every 6 months, asserting that these requirements ensure some level of
physical proximity between the patient and provider which is valuable
in the event of in-person mental health care needs. Some commenters
stated that this requirement would protect the integrity of the benefit
and aligns with FFS provider in-person requirements and that ensuring
that patients in rural areas receive mental health care via
telecommunications technology in a location reasonably situated to
where they receive in-person care would provide the most comprehensive
option in meeting patient needs. Several commenters stated that if CMS
had to establish an interval for subsequent in-person visits, it should
be at least 12 months, noting that even that would present a hardship
for rural patients and patients with disabilities.
Response: We appreciate all the comments received on this topic. We
are persuaded by the comments related to ensuring access in the event
of in-person needs and alignment with requirements under Medicare FFS.
Therefore, we are finalizing that there must be an in-person mental
health service furnished within 6 months prior to the furnishing of the
telecommunications service and that in general, there must be an in-
person mental health service (without the use of telecommunications
technology) must be provided at least every 12 months while the
beneficiary is receiving services furnished via telecommunications
technology for diagnosis, evaluation, or treatment of mental health
disorders. Consistent with policies finalized for mental health
services furnished via telehealth under the PFS, the in-person service
requirements apply only to telehealth services furnished to a patient
receiving the service at home. However, in response to commenters'
concerns regarding the requirement that an in-person, non-telehealth
visit be furnished every 12 months, we agree with
[[Page 65211]]
commenters that there may be specific circumstances when an in-person
visit within 12 months of each mental health visit furnished via
telecommunications technology may be inadvisable or impracticable for
an individual beneficiary. Therefore, we are finalizing a policy that
will allow for limited exceptions to the requirement that there be an
in-person, non-telehealth service every 12 months based on beneficiary
circumstances, in which case the basis for that decision should be
documented in the patient's medical record. Specifically, if the
patient and practitioner consider the risks and burdens of an in-person
service and agree that, on balance, these outweigh the benefits, and
the practitioner documents the basis for that decision in the patient's
medical record, then the in-person visit requirement is not applicable
for that 12-month period. Situations in which the risks and burdens
associated with an in-person service may outweigh the benefit could
include, but are not limited to, instances when an in-person service is
likely to cause disruption in service delivery or has the potential to
worsen the patient's condition(s). The risks and burdens associated
with an in-person service could also outweigh the benefit if a patient
receiving services is in partial or full remission and only requires a
maintenance level of care. Other justifications include the clinician's
professional judgment that the patient is clinically stable and/or that
an in-person visit has the risk of worsening the beneficiary's
condition, creating undue hardship on self or family, or if it is
determined that the patient is at risk for disengagement with care that
has been effective in managing the illness. We note that the 12-month
in-person visit requirement is not intended to dictate how often a
provider and patient should meet in person; rather, patients and
providers should determine the frequency of in-person meetings as
driven by clinical needs. This is consistent with the policies for
Medicare telehealth services furnished under PFS, as required by
section 123 of the CAA and as finalized in Section II.D of this final
rule. Given that this requirement may pose more of a challenge for
beneficiaries in rural areas, we will monitor the impact of this
requirement to determine whether it presents a disruption in access to
mental health care in the RHC/FQHC setting.
d. Regulatory Changes
We proposed to revise the regulation at Sec. 405.2463, to revise
paragraph (a)(1)(i) to state that a mental health visit is a face-to-
face (that is, in person) encounter (or, for mental health visits only,
an encounter that meets the requirements under paragraph (b)(3))
between an RHC patient and an RHC practitioner. We proposed to revise
paragraph (b)(3) to define a mental health visit as a face-to-face
encounter or an encounter where services are furnished using
interactive, real-time, audio and video telecommunications technology
or audio-only interactions in cases where beneficiaries are not capable
of, or do not consent to, the use of devices that permit a two-way,
audio/video interaction for the purposes of diagnosis, evaluation or
treatment of a mental health disorder. We also proposed to revise Sec.
405.2469, FQHC supplemental payments, to revise paragraph (d) by adding
that a supplemental payment required under this section is made to the
FQHC when a covered face-to-face (that is, in-person) encounter or an
encounter where services are furnished using interactive, real-time,
telecommunications technology or audio-only interactions in cases where
beneficiaries do not wish to use or do not have access to devices that
permit a two-way, audio/video interaction for the purposes of
diagnosis, evaluation or treatment of a mental health disorder occurs
between a MA enrollee and a practitioner as set forth in Sec.
405.2463.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: We received many public comments that were supportive of
the proposal to revise the current regulatory language for RHC or FQHC
mental health visits to include visits furnished using interactive,
real-time telecommunications technology.
Response: After consideration of public comments, we are finalizing
our proposal to revise the regulation at Sec. Sec. 405.2463 and
405.2469, as described above. Additionally, at Sec. 405.2463, we are
revising paragraph (b)(3) to state that there must be an in-person
mental health service furnished within 6 months prior to the furnishing
of the telecommunications service and that an in-person mental health
service (without the use of telecommunications technology) must be
provided at least every 12 months while the beneficiary is receiving
services furnished via telecommunications technology for diagnosis,
evaluation, or treatment of mental health disorders. We are also
revising Sec. Sec. 405.2463(b)(3) and 405.2469(d) to allow an
exception for a particular 12-month period when the physician or
practitioner and patient agree that the risks and burdens outweigh the
benefits associated with furnishing the in-person item or service, and
the practitioner documents the reasons for this decision in the
patient's medical record. At Sec. 405.2469, FQHC supplemental
payments, we are revising paragraph (d) to describe the same in-person
visit requirement referenced above.
C. Federally Qualified Health Centers (FQHCs) Payment for Tribal
FQHCs--Comment Solicitation
1. Health Services to American Indians and Alaska Natives (AI/AN)
There is a special government-to-government relationship between
the Federal Government and Federally-recognized tribes based on U.S.
treaties, laws, Supreme Court decisions, Executive Orders and the U.S.
Constitution. This government-to-government relationship forms the
basis for Federal health services to American Indians/Alaska Natives
(AI/AN) in the U.S. In 1976, the Indian Health Care Improvement Act
(IHCIA) (Pub. L. 94-437, September 30, 1976) amended the statute to
permit payment by Medicare and Medicaid for services provided to AI/ANs
in Indian Health Service (IHS) and tribal health care facilities that
meet the applicable requirements. Under this authority, Medicare
services to AI/ANs may be furnished by IHS operated facilities and
programs and tribally-operated facilities and programs under Title I or
Title V of the Indian Self Determination Education Assistance Act, as
amended (ISDEAA) (Pub. L 93-638, January 4, 1975). According to the IHS
Profile,\73\ the IHS healthcare delivery system currently consists of
46 hospitals, with 24 of those hospitals operated by the IHS and 22 of
them operated by tribes under the ISDEAA, as well as 492 health
centers, 75 operated by IHS and 417 operated by tribes under the
ISDEAA.
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\73\ https://www.ihs.gov/newsroom/factsheets/ihsprofile/.
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Payment rates for outpatient medical care (also referred to as
outpatient hospital services) furnished by the IHS and tribal
facilities is set annually by the IHS under the authority of sections
321(a) and 322(b) of the Public Health Service Act (the PHS Act) (42
U.S.C. 248 and 249(b)) (Pub. L. 83-568 (42 U.S.C. 2001(a)), and the
IHCIA, based on the previous year cost reports from Federal and tribal
hospitals. The IHCIA provided the authority for CMS (then HCFA) to pay
IHS and tribal facilities for its outpatient hospital services to
Medicare eligible patients, using an
[[Page 65212]]
outpatient per visit rate (also referred to as the Medicare all-
inclusive payment rate (AIR).
2. Federally Qualified Health Centers (FQHCs) Prospective Payment
System (PPS)
FQHCs were established in 1990 by section 4161 of the Omnibus
Budget Reconciliation Act of 1990 (OBRA 90) (Pub. L. 101-508, November
5, 1990), and were effective beginning on October 1, 1991. They are
facilities that furnish services that are typically furnished in an
outpatient clinic setting. The statutory requirements that FQHCs must
meet to furnish services to Medicare beneficiaries are in section
1861(aa)(4) of the Act. All FQHCs are subject to Medicare regulations
at 42 CFR part 405, subpart X, and 42 CFR part 491. Based on these
provisions, the following three types of organizations that are
eligible to enroll in Medicare as FQHCs:
Health Center Program grantees: Organizations receiving
grants under section 330 of the PHS Act (42 U.S.C. 254b).
Health Center Program ``lookalikes'': Organizations that
have been identified by the Health Resources and Services
Administration as meeting the requirements to receive a grant under
section 330 of the PHS Act, but which do not receive section 330 grant
funding.
Outpatient health programs or facilities operated by a
Tribe or tribal organization under the ISDEAA, or by an urban Indian
organization receiving funds under Title V of the IHCIA.
FQHCs are also entities that were treated by the Secretary, for
purposes of Medicare Part B, as a comprehensive Federally funded health
center as of January 1, 1990 (see section 1861(aa)(4)(C) of the Act).
Section 1834 of the Act was amended in 2010 by section 10501(i)(3)(A)
of the Affordable Care Act by adding a new subsection (o),
``Development and Implementation of Prospective Payment System'' for
FQHCs. Section 1834(o)(1)(A) of the Act requires that the system
include a process for appropriately describing the services furnished
by FQHCs, and establish payment rates based on such descriptions of
services, taking into account the type, intensity, and duration of
services furnished by FQHCs. It also stated that the new system may
include adjustments (such as geographic adjustments) as determined
appropriate by the Secretary. Section 1833(a)(1)(Z) of the Act, as
added by the Affordable Care Act, requires that Medicare payment for
FQHC services under section 1834(o) of the Act be 80 percent of the
lesser of the actual charge or the PPS amount determined under section
1834(o) of the Act.
In accordance with the requirements in the statute, as amended by
the Affordable Care Act, beginning on October 1, 2014, payment to FQHCs
is based on the lesser of the national encounter-based FQHC PPS rate,
or the FQHC's total charges, for primary health services and qualified
preventive health services furnished to Medicare beneficiaries. The
FQHC PPS rate is adjusted by the FQHC geographic adjustment factor
(GAF), which is based on the Geographic Practice Cost Index used under
the PFS. The FQHC PPS rate is also adjusted when the FQHC furnishes
services to a patient that is new to the FQHC, and when the FQHC
furnishes an IPPE or an AWV. Payment to the FQHC for a Medicare visit
is the lesser of the FQHC's charges (as established by the G-code), or
the PPS rate. The CY 2021 FQHC PPS rate is $176.45.
3. Grandfathered Tribal FQHCs
In the November 16, 2015 Federal Register, we published a final
rule, entitled ``Medicare Program; Revisions to Payment Policies Under
the Physician Fee Schedule and Other Revisions to Part B for CY 2016
(referred to as CY 2016 PFS final rule). In that rule, we discuss the
payment methodology and requirements finalized for grandfathered tribal
FQHCs (80 FR 71089 through 71096). We stated that tribal facilities
that met the conditions of Sec. 413.65(m) on or before April 7, 2000,
and had a change in their status on or after April 7, 2000, from IHS to
tribal operation, or vice versa, or the realignment of a facility from
one IHS or tribal hospital to another IHS or tribal hospital, such that
the organization no longer met the Medicare Conditions of Participation
(CoPs) for Medicare-participating hospitals at Sec. 482.12, the
``governing body'' of the facility could nevertheless seek to become
certified as a grandfathered tribal FQHC.
In CY 2016 PFS final rule, we explained that a different structure
was needed to maintain access to care for AI/AN populations served by
the hospitals and clinics impacted by the provider-based rules at Sec.
413.65, while also ensuring that the tribal clinics are in compliance
with our health and safety rules. We recognized that a tribal clinic
billing under an IHS hospital's CMS Certification Number (CCN), without
any additional administrative or clinical relationship with the IHS
hospital, could put that hospital at risk for noncompliance with their
CoPs because the clinic had a separate governing body although still
provider-based. We explained that the FQHC program provided an
alternative structure that met the needs of these tribal clinics and
the populations they served, while also ensuring the IHS hospitals were
not at risk of being cited for non-compliance with the requirements
with their CoPs (80 FR 71090).
As stated in Sec. 405.2462(d)(1) a ``grandfathered tribal FQHC''
is a FQHC that is operated by a tribe or tribal organization under the
ISDEAA; was billing as if it were provider-based to an IHS hospital on
or before April 7, 2000 and is not currently operating as a provider-
based department of an IHS hospital. We refer to these tribal FQHCs as
``grandfathered tribal FQHCs'' to distinguish them from freestanding
tribal FQHCs that are currently being paid the lesser of their charges
or the adjusted national FQHC PPS rate, and from provider-based tribal
clinics that may have begun operations subsequent to April 7, 2000.
Currently, there are 7 ``grandfathered tribal FQHCs''.
Under the authority in section 1834(o) of the Act to include
adjustments determined appropriate by the Secretary, we revised
Sec. Sec. 405.2462 and 405.2464 to pay these grandfathered tribal
FQHCs on the Medicare outpatient per visit rate as set annually by the
IHS, that is, the AIR and not the FQHC PPS payment rates (80 FR 71089).
Payment rates for outpatient medical care (also referred to as
outpatient hospital services) furnished by the IHS and tribal
facilities is set annually by the IHS under the authority of sections
321(a) and 322(b) of the Public Health Service Act (the PHS Act) (42
U.S.C. 248 and 249(b)) (Pub. L. 83-568 (42 U.S.C. 2001(a)), and the
IHCIA, based on the previous year cost reports from Federal and tribal
hospitals. The outpatient per visit rate is only applicable for those
IHS or tribal facilities that meet the definition of a provider-based
department as described at Sec. 413.65(m), or a ``grandfathered''
tribal FQHC as described at Sec. 405.2462(d)(1). There is an
outpatient per visit AIR for Medicare visits in Alaska and a separate
outpatient per visit AIR for Medicare visits in the lower 48 States.
For CY 2021, the outpatient per visit rate for Medicare visits in
Alaska is $662 and $414 in the lower 48 States (85 FR 86940). There are
no grandfathered tribal FQHCs in Alaska because the tribes operate the
hospitals, not IHS. We note that IHS does not operate any hospitals or
facilities in Hawaii or the territories, and thus, no rates are set in
those localities.
[[Page 65213]]
As we discussed in CY 2016 PFS final rule, the payment rate is not
adjusted by the FQHC GAF; for new patients, annual wellness visits, or
initial preventive physical examinations; or annually by the
productivity-adjusted FQHC PPS market basket increase, as further
adjustments would be unnecessary and/or duplicative of adjustments
already made by IHS in deriving the rate. Comparatively, the FQHC PPS
rate established by CMS is $176.45. The reimbursement is the lesser of
the charges or the IHS AIR rate. We stated as part of the CY 2016 PFS
final rule that we would monitor future costs and claims data of these
tribal clinics and reconsider options as appropriate.
4. Paying all IHS- and Tribally-Operated Outpatient Clinics the AIR
As we discussed in the CY 2022 PFS proposed rule (86 FR 39239), CMS
established a Tribal Technical Advisory Group (TTAG) in 2004 to provide
advice and input to CMS on policy and program issues impacting AI/AN
populations served by CMS programs. Although not a substitute for
formal consultation with Tribal leaders, the TTAG enhances the
government-to-government relationship and improves increased
understanding between CMS and Tribes. The TTAG has subject specific
subcommittees that meet on a regular basis in order to be more
effective and perform in-depth analysis of Medicare, Medicaid, CHIP,
and the Health Insurance Marketplace policies that have Tribal
implications. The TTAG is comprised of 17 representatives: An elected
Tribal leader, or an appointed representative from each of the 12
geographic areas of the IHS delivery system and a representative from
each of the national Indian organizations headquartered in Washington,
DC--the National Indian Health Board, the National Congress of American
Indians, and the Tribal Self-Governance Advisory Group. Section
5006(e)(1) of the American Recovery and Reinvestment Act of 2009, which
became effective July 1, 2009, mandates that TTAG shall be maintained
within CMS and added two new representative's positions: A
representative and alternate from a national urban Indian health
organization (National Council of Urban Indian Health); and a
representative and alternate from the IHS.
In the CY 2022 PFS proposed rule (86 FR 39239), we stated that the
TTAG has requested \74\ that CMS amend its Medicare regulations to make
all IHS and tribally-operated outpatient facilities eligible for
payment at the IHS Medicare outpatient per visit rate/AIR. The TTAG
explained that outpatient clinics, which are otherwise similar to
grandfathered tribal FQHCs, are paid at different rates depending upon
whether they meet the requirements as a ``provider based facility,'' a
``grandfathered tribal FQHC,'' a non-grandfathered tribal FQHC, or none
of the above. They believe that the rates vary based on the Medicare
regulatory definition, rather than the actual costs of the outpatient
clinic. There are varying payment differentials among Medicare enrolled
providers and suppliers under the authorities of the SSA. For example,
ASCs are paid differently than HOPDs; which are paid differently
whether they are under the under the outpatient prospective payments
system or a located in a critical access hospital.
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\74\ https://www.nihb.org/tribalhealthreform/wp-content/uploads/2020/06/TTAG-letter-to-CMS-requesting-IHS-rate-for-all-tribal-clinics-06.10.2020.pdf.
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The TTAG also questioned the need for grandfathered tribal FQHCs to
file cost reports. Specifically, the TTAG stated that the FQHC cost
reports have no relationship to the IHS Medicare outpatient per visit
rate/AIR paid to grandfathered tribal FQHCs, as they use hospital cost
reports in setting the rate. Therefore, they stated, the FQHCs should
only need to file a cost report to the extent necessary to support
payment for non-FQHC services that are reimbursed outside the Medicare
outpatient per visit rate/AIR. We noted that under section 1815(a) of
the Act, providers participating in the Medicare program are required
to submit financial and statistical information to achieve settlement
of costs relating to health care services rendered to Medicare
beneficiaries. Under the FQHC PPS, Medicare payment for FQHC services
is the lesser of the FQHC PPS rate or the charges on the claim. In the
establishment of the FQHC PPS, the statute does not exempt FQHCs from
submitting cost reports. In addition, Medicare payments for the
reasonable costs of the influenza and pneumococcal vaccines and their
administration, allowable graduate medical education costs, and bad
debts are determined and paid through the cost report. The FQHC market
basket also uses information from the FQHC cost report to determine the
cost share weights, which reflect the relative costs of input expenses
that FQHCs face in order to provide FQHC services. Having a full
picture of the costs of providing care by grandfathered FQHCs is
important so that CMS can be sure that payments are adequate.
5. Solicitation for Input and Comment
In the CY 2022 PFS proposed rule (86 FR 39240), we expressed
appreciation for the TTAG's concerns with ensuring that CMS make
appropriate payments among the clinics for similar services and the
impact this has on tribal Medicare beneficiaries and ensuring that
access to healthcare is available and equitable and we take these
concerns seriously, but noted that we had insufficient information
necessary to evaluate the costs and benefits of potential changes to
these policies. Therefore, we solicited comments on the TTAG's request
for CMS to amend its Medicare regulations to make all IHS- and
tribally-operated outpatient facilities/clinics eligible for payment at
the Medicare outpatient per visit rate/AIR, regardless of whether they
were owned, operated, or leased by IHS.
We solicited information on the kinds of and number of facilities
or clinics that could potentially enroll in Medicare as an FQHC, or are
already an FQHC paid under the FQHC PPS, and if these clinics are
freestanding or provider-based to expand on information provided by the
IHS Profile.
We solicited information regarding the relative operating costs of
IHS- and tribally-operated outpatient clinics compared to non-tribal
FQHCs, stakeholder feedback and supporting evidence to address whether
or why payment set at the IHS AIR would be more appropriate than
payment rate under the FQHC PPS.
Further, we solicited comment on how the IHS AIR, which is based
upon a limited number of hospital cost reports, relates to costs in
such clinics and the kinds of services that the clinics furnish.
Finally, we solicited comment on the concerns that the AI/AN
community may have on issues regarding access or inequity care in
situations where a payment differential exists.
We noted that although we have information on grandfathered tribal
FQHCs and the outpatient hospital cost reports, we did not have any
information specific to the composition of IHS and tribal facilities.
For example, if the facility is not enrolled in Medicare as an FQHC or
is not provider based to a hospital, is it a physician practice? It
would be helpful to know how the facilities are organized and related.
Are there other options for enrolling as different types of providers
or suppliers?
As increasing the rate would increase payments from the Medicare
Trust
[[Page 65214]]
Fund, we also requested comment on the magnitude of that payment change
and whether any program integrity concerns would be present with the
increased payment.
We also requested comments on FQHC services that are paid through
the cost report, like influenza, pneumococcal, and COVID-19
vaccinations and GME and how that impacts the request to not file cost
reports.
As stated previously, we believed that having a full picture of the
costs of providing care was important to ensure adequate payments.
We also solicited input on other potential uses of the adjustment
authority under section 1834(o)(1)(A) of the Act which provides that
the FQHC PPS may include adjustments determined appropriate by the
Secretary. For example, should we consider TTAG's request on the
expansion of the payment policy finalized in the CY 2016 PFS final rule
for grandfathered tribal FQHCs to all Tribally-operated outpatient
clinics. Alternatively, should we develop a payment adjustment
applicable to IHS- and tribally-operated outpatient clinics based on
the cost differential reported in their cost reports when compared to
non-IHS outpatient clinics, or non-provider-based clinics, if such
differentials exist and would be interested in specific comments about
appropriate adjustments to the FQHC PPS rate for clinics that are
enrolled as FQHCs.
Finally, we requested information on other potential ways to
determine whether the costs associated with furnishing services to AI/
AN are uniquely greater than other clinics within the confines of the
FQHC PPS outlined in section 1834(o)(1) of the Act.
We received several comments on these questions. Below, we provide
a summary of the comments we received and our response.
Comment: Commenters stated CMS should exercise its authority to
authorize all IHS clinics to bill at the same IHS AIR as a matter of
health equity. One commenter noted it is of particular importance in
fulfilling the Indian Self-Determination education Assistance Act
(ISDEAA) and preventing Tribes from being penalized for having assumed
control over their own clinics. Several commenters stated that there is
an equity issue when a facility's Medicare designation determines the
rate they will be reimbursed as IHS clinics are heavily reliant on
third-party reimbursements to fund operations. Commenters also noted
that the request for information regarding the make-up, structure, and
costs of IHS/Tribal clinics needed to evaluate the costs and benefits
of potential changes to Medicare policies was irrelevant to the issue.
Commenters did not agree that billing as an FQHC is the only or best
solution, especially since so few clinics elect to enroll as an FQHC
due to the burden of submitting cost reports, and suggested changes to
the tribal provider-based rules at Sec. 413.65(m) and an umbrella rule
providing that all outpatient Indian health programs qualify for
reimbursement at the AIR regardless of how they are enrolled in
Medicare. Commenters also proposed changes that would amend 42 CFR part
405. In addition, one commenter stated that allowing all Indian health
clinics to bill at the IHS AIR would have zero impact on program
integrity, especially since the IHS AIR is already available to some
Tribal clinics.
Response: Although we did not receive specific information on costs
or specific types of clinics, we will consider the commenters' requests
for CMS to amend its Medicare regulations to make all IHS- and
tribally-operated outpatient facilities/clinics eligible for payment at
the Medicare outpatient per visit rate/AIR, regardless of whether they
were owned, operated, or leased by IHS. We understand the commenters'
concerns and note that commenters do not agree that wholesale
enrollment as Medicare FQHCs is the preferred outcome. We would like to
continue these discussions to evaluate the impact of the commenters'
proposed changes to the current Medicare payment policies and will
consider these recommendations for future rulemaking.
D. Requiring Certain Manufacturers To Report Drug Pricing Information
for Part B and Determination of ASP for Certain Self-Administered Drug
Products
1. Requiring Certain Manufacturers To Report Drug Pricing Information
for Part B (Sec. Sec. 414.802 and 414.806)
a. Overview and Summary
Section 1927(b)(3)(A)(iii)(I) of the Act requires manufacturers
with a Medicaid drug rebate agreement to report Average Sales Price
(ASP) data as specified in section 1847A of the Act. Some manufacturers
without Medicaid drug rebate agreements voluntarily submit ASP data for
their single source drugs or biologicals that are payable under Part B;
however, other manufacturers without Medicaid drug rebate agreements do
not voluntarily submit such data. Without manufacturer reported ASP
data, CMS cannot calculate the ASP payment limit, and consequently,
payment is typically based on Wholesale Acquisition Cost (WAC).
Consistent with section 1847A(c)(3) of the Act and our regulations
at Sec. 414.804(a)(2), the ASP is net of price concessions. However,
consistent with the definition of WAC at section 1847A(c)(6)(B) of the
Act, the WAC is not net of price concessions, and thus is nearly
always, and sometimes significantly, higher than ASP. Drugs with
payment allowances based on WAC may have greater ``spreads'' between
acquisition costs and payment than drugs for which there is an ASP-
based payment allowance, which, in turn, may: (1) Incent the use of the
drug based on its spread rather than on purely clinical considerations;
(2) result in increased payments under Medicare Part B; and (3)
increase beneficiary cost sharing.
Section 401 of Division CC, Title IV of the CAA, 2021 (for the
purposes of this section of this proposed rule, hereinafter is referred
to as ``section 401'') amended section 1847A of the Act to add new
section 1847A(f)(2) of the Act, which requires manufacturers without a
Medicaid drug rebate agreement to report ASP information to CMS for
calendar quarters beginning on January 1, 2022, for drugs or
biologicals payable under Medicare Part B and described in sections
1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of the Act, including
items, services, supplies, and products that are payable under Part B
as a drug or biological. Section 401(b)(2) also amended section
1847A(c)(6)(A) of the Act to permit the Secretary to exclude
repackagers \75\ from the definition of ``manufacturer'' for purposes
of the ASP reporting requirement in section 1847A(f)(2) of
[[Page 65215]]
the Act, if the Secretary determines appropriate.
---------------------------------------------------------------------------
\75\ The FDA has defined ``repackag[ing],'' for purposes of drug
establishment registration, as ``the act of taking a finished drug
product or unfinished drug from the container in which it was placed
in commercial distribution and placing it into a different container
without manipulating, changing, or affecting the composition or
formulation of the drug.'' 21 CFR 207.1. The FDA has defined
``repack[ager]'' for purposes of drug establishment registration as
the person who owns or operates an establishment that repacks a drug
or drug package.'' Id. For more information about repackaging,
please see FDA guidance documents, including a January 2017 Guidance
for Industry titled, ``Repackaging of Certain Human Drug Products by
Pharmacies and Outsourcing Facilities,'' available at https://www.fda.gov/media/90978/download and the FDA's January 2018 Guidance
for Industry titled, ``Mixing, Diluting, or Repackaging Biological
Products Outside the Scope of an Approved Biologics License
Application,'' available at https://www.fda.gov/files/drugs/
published/Mixing_Diluting-or-Repackaging-Biological-Products-
Outside-the-Scope-of-an-Approved-Biologics-License-Application.pdf.
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Section 401(b)(1) also adds provisions to section 1847A of the Act
addressing confidentiality, audit and verification provisions; civil
money penalties for misrepresentation, late reporting, and reporting of
false information; and increasing oversight and enforcement provisions.
These provisions largely track the statutory provisions in section
1927(b) of the Act that apply to the reporting of ASP by manufacturers
with Medicaid drug rebate agreements. Additionally, section 401(d)
requires HHS Office of the Inspector General (OIG) to submit a report
on the accuracy of ASP submissions to Congress by January 1, 2023.
Finally, section 401 amended section 1927(b) of the Act to clarify
that for Part B ASP reporting, drugs would include items, services,
supplies, and products that are payable under Medicare Part B as a drug
or biological.
In the CY 2022 PFS proposed rule, we proposed regulatory changes to
implement the new reporting requirements at 42 CFR, part 414, subpart
J.
b. Reporting Requirements for Manufacturers Without a Medicaid Drug
Rebate Agreement
Starting with calendar quarters beginning on January 1, 2022,
manufacturers will be required to report ASP for drugs and biologicals
payable under Medicare Part B consistent with the statutory
requirements of section 1847A(f) of the Act, regardless of whether they
have Medicaid drug rebate agreements. Our existing regulations at 42
CFR part 414, subpart J implement the ASP reporting requirements
referenced in section 1847A(f)(1) of the Act, that is, the requirements
of section 1927(b)(3) of the Act. Thus, the existing regulations at
subpart J already set forth requirements for manufacturers with
Medicaid drug rebate agreements to report their ASP information (and if
required to make payment, WAC) each quarter.
Many manufacturers without Medicaid drug rebate agreements
voluntarily submit ASP data consistent with these requirements. Whether
obligated to report or voluntarily reporting, manufacturers are
accustomed to the existing regulatory requirements at subpart J, and
indeed, the methodology for reporting ASP reflected in these
regulations does not currently distinguish between manufacturers with
Medicaid drug rebate agreements and those without these agreements.
Because new section 1847A(f)(2) of the Act, as noted previously,
largely parallels section 1927(b)(3) of the Act, and thus both
manufacturers with Medicaid drug rebate agreements, as well as those
without such agreements, will be subject to requirements already
reflected in the existing regulations at subpart J, we did not believe
it was necessary to propose substantial changes to the regulation text.
For these reasons, our proposal to amend the regulations to reflect the
new requirements of section 1847A(f)(2) of the Act sought to preserve
the status quo to the extent possible.
c. Definitions
As noted previously, the new section 1847A(f)(2) of the Act, as
added by section 401(a), requires manufacturers without a Medicaid drug
rebate agreement to report ASP information to CMS for calendar quarters
beginning on January 1, 2022 for drugs or biologicals payable under
Medicare Part B and described in sections 1842(o)(1)(C), (E), or (G) or
1881(b)(14)(B) of the Act, including items, services, supplies, and
products that are payable under Part B as a drug or biological. Section
401 also made a conforming amendment to the ASP reporting requirements
applicable to manufacturers with Medicaid drug rebate agreements at
section 1927(b)(3)(A)(iii) of the Act to specify that those reporting
requirements also apply to items, services, supplies, and products that
are payable under Part B as a drug or biological.
To implement this change, we proposed to amend the definition of
the term ``drug'' at Sec. 414.802 to mean a drug or biological, and
includes an item, service, supply, or product that is payable under
Medicare Part B as a drug or biological.
We received public comments on amending the definition of the term
``drug'' at Sec. 414.802 to mean a drug or biological, and includes an
item, service, supply, or product that is payable under Medicare Part B
as a drug or biological. The following is a summary of the comments we
received and our responses.
Comment: Some commenters suggested that CMS provide more clarity or
be more specific in the definition of the term ``drug'' to further
describe which products, or groups of products, are subject to
requirement in section 401.
Response: We disagree that further clarification is needed for this
definition. The requirements in section 401 apply to drugs or
biologicals described in section 1842(o)(1)(C), (E), or (G) of the Act
or section 1881(b)(14)(B) of the Act, including items, services,
supplies, or products that are payable under [Medicare Part B] as a
drug or biological. That is, if a particular item, service, supply, or
product of any kind, is payable as a drug or biological under Part B,
then it is subject to the ASP reporting requirements.
Comment: One commenter requested that CMS confirm that
radiopharmaceuticals that do not currently report ASPs will be excluded
from this proposal. The commenter stated that ASPs are not currently
reported for all radiopharmaceuticals, and requiring ASP reporting for
all radiopharmaceuticals will require CMS to clarify how ASPs should be
calculated under circumstances that are unique to radiopharmaceuticals.
For these reasons, the commenter suggested that any proposal that
requires ASP reporting for all radiopharmaceuticals should be delayed
to allow CMS to provide sufficient information to radiopharmaceutical
manufacturers to allow for accurate ASP reporting, and to allow
radiopharmaceutical manufacturers to prepare.
Response: Consistent with section 303(h) of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
(Pub. L. 108-173, December 8, 2003), radiopharmaceuticals are not paid
under section 1847A of the Act. Section 401 requires manufacturers
without Medicaid drug rebate agreements to report ASP to the same
extent that manufacturers with Medicaid drug rebate agreements must do.
It does not change the scope of drugs and biologicals for which ASP
must be reported other than to clarify that the ASP reporting
requirements apply to items, services, supplies, and products that are
payable under Part B as a drug or biological and are described in
section 1842(o)(1)(C), (E) of the Act, or (G) or 1881(b)(14)(B) of the
Act.
Comment: One commenter generally expressed support of the proposal
to modify the definition of ``drug'' at Sec. 414.802 to include any
item, service, supply or product that is payable under Part B as a drug
or biological.
Response: We thank the commenter for their feedback.
After consideration of public comments, we are finalizing the
definition of the term ``drug'' at Sec. 414.802 as proposed.
Section 1847A(c)(6)(A) of the Act incorporates the definition of
manufacturer at section 1927(k)(5) of the Act, except that section
401(b)(2) permits the Secretary to exempt repackagers from the
definition of
[[Page 65216]]
manufacturer, as determined appropriate, for purposes of section
1847A(f)(2) of the Act. However, no such exemption is provided for
manufacturers with Medicaid drug rebate agreements (see the definition
of manufacturer at Sec. 447.502). Consequently, the current ASP data
reporting includes submissions by repackagers.
In the CY 2022 PFS proposed rule (86 FR 39241 through 39242), we
discussed Medicare Payment Advisory Commission's (MedPAC's) assertion
in their June 2017 report (available at http://medpac.gov/docs/default-source/reports/jun17_ch2.pdf) that many repackagers currently do not
report ASP data. We explained that we conducted an analysis to estimate
the proportion of repackaged products in our existing ASP data because
we believed it could inform our consideration of whether we should
propose to exclude repackagers from the definition of manufacturers for
purposes of section 1847A(f)(2) of the Act. If our existing ASP data do
not contain an appreciable proportion of repackaged products, it may be
appropriate to exclude repackagers from the definition of manufacturer
for this limited purpose. However, if repackaged products comprise an
appreciable proportion of our existing ASP data, we would reasonably
anticipate this trend to follow under the new requirements, and in such
a scenario, it would not be appropriate to exclude repackagers from the
definition of manufacturer for purposes of section 1847A(f)(2) of the
Act because excluding their sales could distort the ASP.
To effectuate this analysis, we obtained a list of National Drug
Codes (NDCs) of repackaged drugs from the United States Food and Drug
Administration (FDA).\76\ We also obtained a list of labeler codes for
which the manufacturers have Medicaid drug rebate agreements.\77\ We
then performed a crosswalk both of these to our composite file of ASP
data submissions to segregate our composite file of ASP data
submissions into four categories:
---------------------------------------------------------------------------
\76\ https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory. We note that this list only includes
prescription drugs approved under a New Drug Application (NDA) or
Abbreviated NDA (ANDA) and does not include biological products
approved under a Biologics License Application (BLA) or devices.
\77\ https://data.medicaid.gov/Uncategorized/Drug-Manufacturer-Contacts/uex2-n56q/data. This link has all labeler codes with
effective date and termination date, if applicable. If there is a
termination date, the code was not active as of that date.
---------------------------------------------------------------------------
(1) Repackaged products for which ASP data submissions were
required (that is, manufacturers with Medicaid drug rebate agreements);
(2) Repackaged products for which ASP data submissions were
voluntary (that is, for manufacturers without Medicaid drug rebate
agreements);
(3) Non-repackaged products for which ASP data submissions were
required; and
(4) Non-repackaged products for which ASP data submissions were
voluntary.
We estimated that, of all 6319 products for which we currently
receive ASP data submissions (the sum of categories (1) through (4)
above), repackaged products accounted for 271 (4.29 percent) of these
products. Additionally, repackaged products accounted for 137 (2.51
percent of) products for which ASP data submissions were required, and
134 (15.23 percent of) products for which ASP data were voluntarily
submitted.
Additionally, we conducted another analysis to estimate: (1) The
number of new ASP submissions we can expect as a result of the new
requirements under section 401; and (2) the proportion of those
submissions that involve repackaged products. To effectuate this
analysis, we obtained a crosswalk of NDCs and Healthcare Common
Procedure Coding System (HCPCS) codes that includes the NDCs and HCPCS
codes of items for which ASP reporting is not currently required.\78\
We supplemented this crosswalk by adding HCPCS codes with NDCs that are
payable under Part B, but not already reflected in the crosswalk.\79\
We then identified \80\ and removed from the crosswalk all of the
products contained in our composite file of ASP data submissions and
those HCPCS codes that are non-covered under Medicare Part B. Adding
the results of this analysis to the results of categories two and four
from the prior analysis (that is, repackaged and non-repackaged
products for which ASP submissions were voluntary), we estimated there
will be 6,994 total products for which manufacturers will now be
required to submit ASP data. We then compared this number to FDA's list
of repackaged products in the previous analysis, and found that of the
6,994 products for which manufacturers will be required to submit ASP
data, 223 (3.19 percent) are repackaged products. Further, we estimated
6,114 products for which their manufacturers did not previously
(voluntarily) submit ASP data and will now be required to do so under
the new reporting requirements of section 401. Of these, 89 (1.46
percent) are repackaged products.
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\78\ https://www.dmepdac.com/palmetto/PDACv2.nsf/DID/FFYLYC1WVL
Accessed April 12, 2021, using the April 2021 files.
\79\ We note that such products were spread across the second
and fourth categories in the prior analysis.
\80\ We used the April 2021 Alpha-Numeric HCPCS codes files
available at https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update. We selected HCPCS codes
with a coverage code of S (column AE), which indicates that the
product is non-covered by the Medicare statute.
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These data did not persuade us that it was necessary to exempt
repackagers from the new reporting requirements under section 401 at
this time. Our current operational process to verify the accuracy of
manufacturers' reported ASP data does not distinguish: (1) Products on
the basis of repackaging; and (2) manufacturers who are required to
report ASP data from those who do so voluntarily.
Each month, we review ASP data submissions at the NDC level (and
for products without NDCs, the manufacturer's product code).
Previously, we have not required manufacturers to identify which
products are repackaged as part of these submissions. Exempting
repackagers from the new requirements of section 1847A(f)(2) of the Act
would significantly increase our administrative burden because we would
have to undergo an additional quality check for each NDC from a
different database for which data are submitted as part of our
operational process to verify the accuracy of manufacturers' reported
ASP data. Moreover, for products without NDCs, our ability to determine
if these products are repackaged (without manufacturer attestation) to
that effect is significantly limited. Finally, any such attestation
would require a data source for us to verify the accuracy of the
attestation, and no such data source currently exists.
These additional checks could, in turn, significantly increase the
time it takes for us to calculate and display on our website the
volume-weighted ASP payment limits. Additionally, we were concerned
that exempting repackagers from the new reporting requirements could
lead to a gap in ASP reporting, meaning that ASPs could be distorted to
the extent that certain sales are carved out of the reporting
requirement through the use of repackagers. Consequently, in order to
maintain consistency and integrity of the ASP data for those
manufacturers with and without Medicaid drug rebate agreements, we did
not believe it was appropriate to exclude repackagers from the
requirements of section 401 at this time. However, we stated that we
may
[[Page 65217]]
propose to exempt repackagers in the future, if warranted.
We solicited comment on this approach.
The following is a summary of the comments we received and our
responses.
Comment: One commenter suggested that CMS exclude repackagers from
the proposed ASP reporting requirements. They stated that requiring all
repackagers to report would likely be duplicative and increase the
burden on all parties without providing tangible benefit. In addition,
they stated that, generally, most reporting requirements are simply not
applicable to repackagers, whose business is generally outside of the
scope of the proposed requirements. They recommend repackagers who
already report ASP data continue to do so, but that CMS not require
repackagers, as a group, to be subject to the reporting requirements at
this time.
Response: We are not persuaded that repackagers should be excluded
at this time. As previously stated in this section, in order to
maintain consistency and integrity of the ASP data for those
manufacturers with and without Medicaid drug rebate agreements, and for
operational reasons, we do not believe it is appropriate to exclude
repackagers from the ASP reporting requirements. If warranted, we could
revisit this in future rulemaking.
Comment: One commenter concluded that CMS' analysis and proposal
not to exclude repackagers without a rebate agreement from reporting
ASP data is reasonable. The commenter stated that given that
repackagers with a rebate agreement are required to report ASP data, it
is reasonable not to exclude repackagers without a rebate agreement
from the requirements of section 401. They added that having ASP data
from repackagers with and without rebate agreements could also permit
future analysis of the effect of repackagers' ASP submissions on
Medicare Part B payment rates.
Response: We agree it is reasonable not to exclude repackagers
without a Medicaid drug rebate agreement and thank the commenter for
their feedback.
After consideration of public comments, we are not excluding
repackagers from the definition of manufacturers for purposes of
section 1847A(f)(2) of the Act.
In summary, we proposed to modify the definition of drug at Sec.
414.802 to include any item, service, supply or product that is payable
under Part B as a drug or biological. We did not propose to exclude
repackagers from the definition of manufacturer for purposes of the
reporting requirements at section 1847A(f)(2) of the Act and are
finalizing the definition of drug at Sec. 414.802 as proposed.
d. Civil Money Penalties
As amended by section 401(b), section 1847A(d)(4)(A) of the Act
specifies the penalties associated with misrepresentations in the
reporting of the manufacturer's ASP for a drug or biological.
Consistent with our existing regulation at Sec. 414.806, if the
Secretary determines that a manufacturer has made a misrepresentation
in the reporting of ASP data, a civil money penalty in an amount of up
to $10,000 may be applied for each price misrepresentation and for each
day in which the price misrepresentation was applied.
New sections 1847A(d)(4)(B) and (C) of the Act, as added by section
401(b), apply civil money penalties for failure to report timely and
accurate ASP data for manufacturers without Medicaid drug rebate
agreements, consistent with the civil money penalties found at sections
1927(b)(3)(C)(i) and (ii) of the Act for manufacturers with Medicaid
drug rebate agreements. Our current regulations at Sec. 414.806 refer
to section 1927(b)(3)(C) of the Act, as amended by section 303(i)(4) of
the MMA, as specifying the penalties associated with a manufacturer's
failure to submit timely information or the submission of false
information.
We proposed to amend Sec. 414.806 to reflect the new provisions
specifying penalties for manufacturers without Medicaid drug rebate
agreements and to provide some technical changes to streamline the
regulations text. Specifically, we proposed to do the following:
Add paragraph (a), labeled as ``Misrepresentation'',
moving the existing regulatory language at Sec. 414.806 specific to
misrepresentation to this paragraph;
Remove the sentence which reads, ``If the Secretary
determines that a manufacturer has made a misrepresentation in the
reporting of ASP data, a civil money penalty in an amount of up to
$10,000 may be applied for each price misrepresentation and for each
day in which the price misrepresentation was applied,'' since the
previous sentence in the regulations text already references the
statutory provision for this language;
Add paragraph (b), labeled as ``Failure to provide timely
information or the submission of false information'';
Add paragraph (b)(1) to clarify that the existing language
at Sec. 414.806 regarding civil money penalties for failure to submit
timely information or for the submission of false information applies
to manufacturers with a Medicaid drug rebate agreement;
Remove the phrase ``as amended by section 303(i)(4) of the
MMA''; and
Add paragraph (b)(2) to reflect new sections
1847A(d)(4)(B) and (C) of the Act regarding civil money penalties for
failure to submit timely information or for the submission of false
information for manufacturers without a Medicaid drug rebate agreement.
We welcomed comments on these proposals.
We received one public comment on these proposals. The following is
a summary of the comment we received and our response.
Comment: One commenter stated that it fully supported CMS' proposed
revisions to the regulations at Sec. 414.806 to mirror the enforcement
provisions of the statute. In addition, the commenter expressed concern
that the current civil monetary penalties may not sufficiently ensure
that all manufacturers fully comply with the express requirements of
the new ASP reporting provisions and suggested that CMS address other
enforcement options it may use if manufacturers fail to comply with the
ASP reporting requirements. Specifically, the commenter suggested that
CMS could pursue action under the False Claims Act (31 U.S.C. 3729-
3733), elect to not reimburse certain products of a manufacturer that
does not report ASP, or adopt alternative reimbursement schemes for
certain products.
Response: We appreciate the commenter's support in finalizing these
proposals. We also appreciate the feedback regarding other methods of
enforcement; however, these are outside the purview of codifying and
implementing section 401.
After consideration of public comments, we are finalizing
amendments to Sec. 414.806 as proposed.
e. Summary of All Proposals
In summary, to implement the new reporting requirements for
manufacturers without Medicaid drug rebate agreements, we proposed to
modify:
The definition of drug at Sec. 414.802; and
The regulations describing civil money penalties at Sec.
414.806.
We welcomed comments on these proposals.
We received public comments on these proposals as described in
sections (c) and (d) above. We received several comments of general
support of section 401 implementation. The following is a
[[Page 65218]]
summary of these comments and our responses.
Comment: Several commenters expressed general support of section
401 and its implementation. They commended Congress and CMS for taking
the necessary steps to resolve the inconsistent treatment of similarly
situated products under the Medicare Part B program and support efforts
to require manufacturers to provide CMS with regular and accurate ASP
data for drugs and biological products payable under Medicare Part B as
a means to ensure accurate payment.
Response: We thank these commenters and appreciate their feedback.
We also received several comments that were not specifically related to
the proposals. The following is a summary of these comments and our
responses.
Comment: We received several comments requesting that CMS publish
an ASP payment limit in the ASP Drug Pricing File for all billing and
payment codes for which there are products reporting ASP data. These
commenters stated that this would create a level field for all
manufacturers, prevent overbilling to Medicare due to reimbursement
based on WAC prices, decrease beneficiary financial responsibility, and
ensure that clinicians select products based on clinical efficacy.
Commenters also stated that CMS has lacked transparency by not
publishing ASP payment limits for all billing and payment codes for
which there are products reporting ASP data. They suggested that
billing and payment codes with a published ASP payment limit have an
advantage over those that do not and that providers are hesitant to
prescribe products that do not appear on the ASP Drug Pricing File. In
addition, one commenter suggested that if an ASP payment limit is not
published in the ASP Drug Pricing File, then the Medicare payment
should be based on invoice pricing only, rather than basing payment on
the WAC. Two commenters suggested that CMS should expand the list of
published ASP payment limits to include all items separately payable
under Part B as done in Addendum B for the hospital outpatient setting.
Response: Section 401 does not address the ASP Drug Pricing File,
nor does it specify which products should be published on the file, and
the proposed rule did not include any proposals pertaining to the ASP
Drug Pricing File. CMS does not publish an ASP payment limit or
crosswalk for every product for which ASP data is reported.
Similarly, section 401 does not address MACs' discretion to use
WAC-based pricing or invoice pricing to determine payment amounts in
the absence of a published ASP payment limit, and the proposed rule did
not include any proposals pertaining to this discretion.
Comment: Some commenters recommended that CMS address the proper
treatment of lagged price concessions in the ASP for products that are
newly reporting ASP and that CMS confirm that manufacturers submitting
ASP data for the first time are estimating the price concessions based
on the most recent 12-month period for which data is available.
Response: Manufacturers that are newly reporting ASP data to CMS
must do so in the same manner as those who are already reporting ASP
data.
Specific information about calculating and reporting lagged price
concessions is available in the December 1, 2006 Federal Register (71
FR 69666), the September 16, 2004 Federal Register (69 FR 55763), and
the regulation text at Sec. 414.804(a)(3).
Comment: A few commenters requested that CMS consider deferring the
implementation of this requirement to provide more specific guidance
for manufacturers newly reporting ASP data.
Response: Section 401 requires manufacturers without a Medicaid
drug rebate agreement to report ASP information to CMS for calendar
quarters beginning on January 1, 2022, for drugs or biologicals payable
under Medicare Part B and described in sections 1842(o)(1)(C), (E), or
(G) or 1881(b)(14)(B) of the Act, including items, services, supplies,
and products that are payable under Part B as a drug or biological. CMS
does not have the authority to defer the statutory implementation date.
Comment: One commenter suggested that manufacturers should disclose
actual material and production costs to regulators, as well as research
and development costs contributing to a drug's pricing.
Response: We thank the commenter for their feedback; however,
manufacturers' reporting of actual material, production, research, and
development costs are outside the scope of this rule.
After consideration of public comments, we are finalizing these
proposals as proposed.
2. Determination of ASP for Certain Self-administered Drug Products
(Sec. 414.904)
a. Background
Drugs and biologicals payable under Medicare Part B fall into three
general categories: those furnished incident to a physician's services
(hereinafter referred to as ``incident to'') (section 1861(s)(2) of the
Act), those administered via a covered item of durable medical
equipment (DME) (section 1861(s)(6) of the Act), and others as
specified by statute (for example, certain vaccines described in
sections 1861(10)(A) and (B) of the Act). Payment limits for most drugs
and biologicals separately payable under Medicare Part B are determined
using the methodology in section 1847A of the Act, and in many cases,
payment is based on the ASP plus a statutorily mandated 6 percent add-
on. Most drugs payable under Part B are paid under the ``incident to''
benefit under section 1861(s)(2) of the Act, which includes drugs and
biologicals not usually self-administered by the patient.
Paragraphs (4)(A) and (6) of sections 1847A(b) of the Act require
that the Medicare Part B payment amount for a single-source drug or
biological be determined using all of the NDCs assigned to it. Section
1847A(b)(5) of the Act further states that the payment limit shall be
determined without regard to any special packaging, labeling, or
identifiers on the dosage form or product or package. In 2007, CMS
issued a program instruction (available at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_annoucement.pdf), as permitted under section
1847A(c)(5)(C) of the Act, stating that the payment limit for a single
source drug or biological will be based on the pricing information for
products produced or distributed under the applicable FDA approval
(such as a New Drug Application (NDA) or Biologics License Application
(BLA)). Therefore, all versions of a single source drug or biological
product (or NDCs) marketed under the same FDA approval number (for
example, NDA or BLA, including supplements) are considered the same
drug or biological for purposes of payments made under section 1847A of
the Act and are crosswalked to the same billing and payment code. This
means that a self-administered version marketed under the same FDA
approval is subject to the ASP reporting requirements and is not
excluded from the payment limit calculation, even though Medicare does
not make separate Part B payment for it. This is consistent with our
longstanding policy on the scope of the ASP reporting
[[Page 65219]]
requirements. (Please see our final rule titled, ``Medicare Program;
Revisions to Payment Policies, Five-Year Review of Work Relative Value
Units, Changes to the Practice Expense Methodology Under the Physician
Fee Schedule, and Other Changes to Payment Under Part B; Revisions to
the Payment Policies of Ambulance Services Under the Fee Schedule for
Ambulance Services; and Ambulance Inflation Factor Update for CY
2007,'' published in the December 1, 2006 Federal Register (71 FR
69675)). The price of a drug or biological product that may be
administered by the patient (that is, self-administered) may differ
from versions that are administered incident to a physician's service,
which may affect the ASP-based payment limit for drug or biological
product's billing and payment code.
The HHS OIG conducted studies 81 82 of payment-limit
calculations for certain drugs paid under section 1847A of the Act. The
OIG identified two highly utilized biological products for which there
are both Part-B-covered (versions administered incident to a
physician's service) and non-covered versions (those identified to be
self-administered) for which the NDCs were marketed under the same FDA
approval number. OIG's studies found that when the ASPs of the self-
administered versions are included in the payment limit calculation,
the resulting payment limit is substantially higher than if the ASPs of
only the incident-to versions had been included.
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\81\ https://www.oig.hhs.gov/oei/reports/oei-12-17-00260.pdf,
accessed March 15, 2021.
\82\ https://www.oig.hhs.gov/oei/reports/OEI-BL-20-00100.pdf,
accessed March 15, 2021.
---------------------------------------------------------------------------
The OIG studies concluded that as a result, Medicare payment
amounts were inflated, causing the program and its beneficiaries to pay
an additional $366 million from 2014 through 2016 and $497 million from
2017 through 2018. They recommended that legislative changes be made to
provide CMS the flexibility to determine when certain versions of a
drug identified to be self-administered should be included in ASP
payment limit calculations.
Section 405 of Division CC, Title IV of the CAA, 2021 (for the
purposes of this section, referred to as ``section 405''), amended
section 1847A of the Act by redesignating existing subsection (g) as
subsection (h) and adding new subsection (g), which describes the
Medicare Part B ASP payment-limit adjustment for certain drugs and
biological products for which NDCs have been identified by the OIG to
be self-administered and not covered under Medicare Part B. The new
section 1847A(g)(1) of the Act directs OIG to conduct periodic studies
to identify NDCs for drug or biological products that are identified to
be self-administered for which payment may not be made under Part B
pursuant to section 1861(s)(2) of the Act and that OIG determines
should be excluded from the determination of the payment amount under
section 1847A of the Act.
New section 1847A(g)(2) of the Act specifies that if the OIG
identifies an NDC under section 1847A(g)(1) of the Act, it must inform
the Secretary at such times as the Secretary may specify. Then the
Secretary shall, to the extent appropriate, apply as the payment limit
for the applicable billing and payment code the lesser of: (1) The
payment allowance that would be determined under section 1847A of the
Act if the NDC for the identified drug or biological product were
excluded from the calculation; or (2) the payment limit otherwise
determined under section 1847A of the Act without application of
section 1847A(g) of the Act. In other words, the Medicare payment limit
for a drug or biological product's billing and payment code in these
circumstances would be the lesser of the payment limit determined
including the NDCs identified to be self-administered and the payment
limit determined after excluding the NDCs identified to be self-
administered (hereinafter referred to as the ``lesser-of payment
methodology'').
Although section 1847A(g)(1) of the Act provides us with discretion
in whether to apply the lesser-of methodology to billing and payment
codes that include self-administered versions identified by the OIG
(because we are directed to apply the methodology to the extent deemed
appropriate), new section 1847A(g)(3) of the Act, requires the
application of the lesser-of methodology to the two billing and payment
codes identified in the OIG's July 2020 report titled, ``Loophole in
Drug Payment Rule Continues To Cost Medicare and Beneficiaries Hundreds
of Millions of Dollars,'' (available at https://oig.hhs.gov/oei/reports/OEI-BL-20-00100.asp) (hereinafter referred to as ``OIG's July
2020 report'')) beginning July 1, 2021. To meet the implementation date
required by this provision, we applied the lesser-of methodology to the
payment limit calculations for the billing and payment codes
representing Cimzia[supreg] (certolizumab pegol) and Orencia[supreg]
(abatacept), details on these calculations are described in this
section. In a memorandum providing supplemental information on the OIG
July 2020 report, the OIG provided specific NDCs that the report
identified: 00003-2188-11, 00003-2188-51, 00003-2814-11, 00003-2818-11,
50474-0710-79, 50474-0710-81. The lesser-of methodology was applied to
these billing and payment codes for the July 2021 ASP Drug Pricing
Files and crosswalks along with program instructions in a change
request (CR) at https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/2021-asp-drug-pricing-files.
In the CY 2022 PFS proposed rule (86 FR 39244), we proposed to
codify the new requirements of section 1847A(g) of the Act at Sec.
414.904. Our proposals sought to specify when the application of the
lesser-of methodology would be appropriate, describe how we would apply
the lesser-of payment methodology to billing and payment codes that OIG
has identified pursuant to studies described in section 1847A(g)(1) of
the Act, and how to codify the approach we used for the certolizumab
pegol and abatacept billing and payment codes.
b. Identification of Billing and Payment Codes to Which the Lesser-of
Policy Will Be Applied
As noted previously, section 1847A(g)(1) of the Act directs OIG to
conduct periodic studies to identify NDCs for drug or biological
products that are self-administered and for which payment is not made
under Part B. Section 1847A(g)(2) of the Act specifies that if OIG
makes an identification under section 1847A(g)(1) of the Act, OIG
informs CMS at such times as we may specify, and in such an event, we
apply the lesser-of methodology to the extent deemed appropriate. In
the CY 2022 PFS proposed rule (86 FR 39244), we proposed that when the
OIG conducts a periodic study, they would inform us at the time the
study becomes publicly available. CMS would then obtain the NDCs
identified by the OIG study described in section 1847A(g)(1) of the
Act. However, if the specific NDCs were not available in the OIG study
report, we would request OIG provide documentation of the identified
NDCs to CMS.
To allow operational time for assessment and application of the
lesser-of methodology, we stated it was reasonable that the application
of the lesser-of methodology be reflected beginning in the ASP pricing
file two quarters following the OIG study publication. For example, if
the OIG study became available to the public in the first quarter of
the calendar year, the lesser-of methodology would be applied to the
payment limit calculation of the applicable billing and payment code in
the third quarter ASP pricing file (in
[[Page 65220]]
other words, the July ASP pricing file) and each quarter thereafter.
We received public comments on the identification of billing and
payment codes to which the lesser-of methodology will be applied. The
following is a summary of the comments we received and our responses.
Comment: Several commenters expressed concern regarding the OIG
studies described in new section 1847A(g)(1) of the Act. Specifically,
there is concern that neither CMS nor the OIG has specified details
about future OIG studies, what criteria the OIG will use to initiate a
study, how often such studies will be conducted, or if external
stakeholders will be able to request a study. Commenters suggested that
CMS offer a timeframe under which the OIG would be expected to produce
such reports and work with the OIG to ensure transparency of factors
used to determine which NDCs are considered ``self-administered'' and
address study methodology. Another commenter urged the OIG to be
thoughtful and transparent in the factors that it will use when
determining which NDCs are ``self-administered.''
Response: The proposed rule did not include any proposals
pertaining to how, when, or under what conditions the OIG would produce
study reports as described in section 1847A(g)(1) of the Act. The
statute assigns to the OIG, and not to CMS, the determination of self-
administration for purposes of these studies, as well as study
methodology.
Comment: One commenter expressed concern that CMS does not
specifically define the term ``self-administered'' for purposes of the
lesser-of methodology. The commenter inquired whether CMS and/or the
OIG will refer to contractor self-administered drug (SAD) lists to
determine if a drug should be studied and the ``lesser-of'' methodology
be applied and, if so, if the drug will have to be on all contractor
SAD lists for the drug eligible for an OIG study.
Response: Section 1847A(g)(1) of the Act states the Inspector
General shall conduct periodic studies to identify which NDCs for drug
or biological products are self-administered and should be excluded
from the determination of the payment amount under this section. Such
studies shall be based on the same or similar methodologies to the
methodologies used in OIG's July 2020 report \83\ or in the November
2017 final report of the Inspector General entitled ``Excluding
Noncovered Versions When Setting Payment for Two Part B Drugs Would
Have Resulted in Lower Drug Costs for Medicare and its Beneficiaries.''
\84\ Methodologies for these studies are described in detail in each
report. As noted previously, the statute puts these determinations in
the OIG's purview.
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\83\ https://oig.hhs.gov/oei/reports/OEI-BL-20-00100.pdf;
accessed September 22, 2021.
\84\ https://www.oig.hhs.gov/oei/reports/oei-12-17-00260.pdf;
accessed September 22, 2021.
---------------------------------------------------------------------------
c. Calculation of Payment Allowance Using the Lesser-of Payment
Methodology
Sections 1847A(g)(2) and (g)(3) of the Act set forth the lesser-of
payment methodology for applicable billing and payment codes with NDCs
for certain drug or biological products identified by the OIG as self-
administered products for which payment may not be made under this part
because such products are not covered under section 1861(s)(2) of the
Act. In the CY 2022 PFS proposed rule (86 FR 39244), we proposed to
codify this methodology, which we currently use for the billing and
payment codes that describe certolizumab pegol and abatacept, and which
we also proposed to use for billing and payment codes for which OIG
identifies a drug or biological product with NDCs identified to be
self-administered as described in section 1847A(g)(1) of the Act.
The ASP payment limit calculation is described in section
1847A(b)(6) of the Act and codified at Sec. 414.904(b)(2)(ii) and
(c)(2)(ii), which specifies that for a billing and payment code, the
volume-weighted average of the ASPs reported by the manufacturer is
determined by:
Computing the sum of the products (for each NDC assigned
to such drug products) of:
++ The manufacturer's ASP determined by the Secretary without
dividing such price by the total number of billing units for the NDC
for the billing and payment code; and
++ The total number of units sold; and
Dividing the sum determined under (A) by the sum of by the
sum of the products (for each NDC assigned to such drug products) of
++ The total number of units specified sold; and
++ The total number of billing units for the NDC for the billing
and payment code.
When applying the lesser-of methodology described in 1847A(g)(2)
and (g)(3) of the Act, we proposed to make two calculations as
described in section 1847A(b)(6) of the Act: (1) The ASP payment limit
for the billing and payment code, excluding the NDCs that have been
identified by the OIG study (that is, excluding the ASPs for those
NDCs, as well as the units of such NDCs sold in the quarter); and (2)
the ASP payment limit for the billing and payment code, including such
NDCs' ASPs and units sold. The calculation resulting in the lower
payment limit would be used as the payment limit for the applicable
billing and payment code for that quarter's ASP pricing files. We
proposed to apply the lesser-of methodology to the billing and payment
codes containing OIG-identified products each quarter when determining
ASP payment limits.
New section 1847A(g) of the Act did not change ASP reporting
requirements, and consistent with section 1847A(f)(1) of the Act and,
beginning January 1, 2022, section 1847A(f)(2) of the Act,
manufacturers must continue to report ASP data for all NDCs of the drug
or biological product. Under new section 1847A(g) of the Act, ASP data
for all NDCs under the same FDA approval application (for example, NDA
or BLA, including any supplements) are required to carry out the
lesser-of calculations for the purposes of determining the payment
limit for the billing and payment code. Even if the resulting payment
limit does not reflect the ASPs or units sold of self-administered
versions of a product identified by the OIG, the manufacturer must
continue to report those versions' ASPs and units sold to the
Secretary.
The implementation of the lesser-of methodology is not expected to
be associated with substantial administrative costs and we incorporated
the methodology in the current operational process used to determine
ASP payment limits each quarter. The OIG found that Medicare and its
beneficiaries would have saved a combined $497 million on certolizumab
pegol and abatacept over 2 years (2017 through 2018) if such a
methodology had been in place.
We did not receive public comments on this provision, and
therefore, we are finalizing as proposed.
d. Exceptions
In the CY 2022 PFS proposed rule (86 FR 39245), we further proposed
that the application of the lesser-of methodology was deemed
appropriate in all cases in which OIG identifies a drug or biological
product in a periodic study described in section 1847A(g)(1) of the Act
and made publicly available, unless the drug or biological product is
in short supply.\85\ As stated in the OIG's July
[[Page 65221]]
2020 report, CMS expressed concern about the potential impact on
beneficiary access if certain versions identified to be self-
administered were excluded from the ASP payment limit calculation.
Because of the potential for drug shortages that may affect patient
care, beneficiary and provider access, and drug prices for providers,
we will consider it not appropriate to apply the lesser-of methodology
when a drug is in short supply. Similar to the average manufacturer
price (AMP) price substitution provision in section 1847A(d)(3)(C) of
the Act (codified in Sec. [thinsp]414.904(d)(3)), we proposed to add
Sec. 414.904(d)(4)(ii) to specify that we would not apply the lesser-
of methodology (that is, we would determine the payment allowance
including all NDCs of the drug or biological product) if the drug and
dosage form(s) represented by the billing and payment code are reported
by the Drug Shortage list established under section 506E of the Federal
Food, Drug, and Cosmetic Act (FFDCA) (Pub. L. 75-717) at the time that
ASP payment limits are being finalized for the next quarter. However,
we proposed that this exception to the application of the lesser-of
methodology would not apply in the case of the billing and payment
codes for certolizumab pegol and abatacept because section 1847A(g)(3)
of the Act does not provide us with the same discretion as section
1847A(g)(2) of the Act. Thus, for these applicable billing and payment
codes we will always apply the lesser-of methodology. We recognized
that NDCs identified by an OIG study described in section 1847A(g)(1)
or (g)(3) of the Act may change. In the event that the manufacturer of
an OIG-identified product simply redesignates the NDC for its product,
we stated the new NDC also would meet the same criteria defined in the
OIG study. In this circumstance, we expected that the product labeling
would not contain substantial changes regarding the redesignated NDC.
Therefore, we proposed to add Sec. 414.904(d)(4)(iv) to codify the
application of the lesser-of methodology such that the manufacturer-
reported pricing data associated with redesignated NDCs would be used
in the lesser-of methodology in the same way as the original OIG-
identified NDC.
---------------------------------------------------------------------------
\85\ Our regulation at Sec. 414.904(d)(3)(ii)(C) in reference
to AMP price substitution refers to drugs ``identified by FDA as
being in short supply.'' The current AMP price substitution policy
for shortages is consistent with the policy discussed here, as we
interpret the phrase ``identified by FDA as being in short supply''
at Sec. 414.904(d)(3)(ii)(C) to mean the list in effect under
section 506E of the Federal Food, Drug, and Cosmetic Act.
---------------------------------------------------------------------------
Once an OIG study identifies self-administered versions of a drug
or biological product, there may be subsequent FDA approvals of other
products with the same active ingredient, such as new syringe sizes,
new types of injector syringes, generic formulations, biosimilar
biological products, or interchangeable biological products. For
example, this would include the situation in which the current
manufacturer of certolizumab pegol or abatacept obtains a supplemental
FDA approval for a new version of the product. Similarly, this would
also include the situation in which another manufacturer gains FDA
approval of a product with the same active ingredient as an OIG-
identified self-administered version. We stated that we believe that
provisions at new section 1847A(g) of the Act would require a new OIG
study as described in section 1847A(g)(1) of the Act in order for us to
apply the lesser-of methodology to the drug or biological product.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: One commenter expressed support of the proposal to not
apply the lesser-of payment methodology to drugs or biological products
for which there is a shortage. The commenter stated that ensuring
patient access to needed medicines is critical both for individuals and
for our health care system more broadly, and not applying the lesser-of
payment methodology to products in short supply should help to improve
access.
Response: We appreciate the commenters feedback and agree that not
applying the lesser-of methodology to products in short supply will
help improve access.
After consideration of public comments, we are finalizing Sec.
414.904(d)(4)(ii) as proposed.
e. Summary
In summary, to implement new section 1847A(g) of the Act, we
proposed to:
Add Sec. 414.904(d)(4) to codify the lesser-of payment
methodology and define when the application of the lesser-of
methodology would first be reflected in the ASP pricing file following
the OIG study publication; and